Motiper

Motiper may be available in the countries listed below.

Ingredient matches for Motiper

Domperidone

Domperidone is reported as an ingredient of Motiper in the following countries:

• Bangladesh

International Drug Name Search

Revatio

Revatio is a brand name of sildenafil, approved by the FDA in the following formulation(s):

REVATIO (sildenafil citrate - solution; intravenous)

• 
  Manufacturer: PFIZER
  
  Approval date: November 18, 2009
  
  Strength(s): EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) ^[RLD]

REVATIO (sildenafil citrate - tablet; oral)

• 
  Manufacturer: PFIZER
  
  Approval date: June 3, 2005
  
  Strength(s): EQ 20MG BASE ^[RLD]

Has a generic version of Revatio been approved?

No. There is currently no therapeutically equivalent version of Revatio available.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Revatio. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

• 
  Pyrazolopyrimidinone antianginal agents
  Patent 5,250,534
  Issued: October 5, 1993
  Inventor(s): Bell; Andrew S. & Brown; David & Terrett; Nicholas K.
  Assignee(s): Pfizer Inc.
  Compounds of the formula: ##STR1## wherein R.sup.1 is H, C.sub.1 -C.sub.3 alkyl, C.sub.3 -C.sub.5 cycloalkyl or C.sub.1 -C.sub.3 perfluoroalkyl; R.sup.2 is H, C.sub.1 -C.sub.6 alkyl optionally substituted by OH, C.sub.1 -C.sub.3 alkoxy or C.sub.3 -C.sub.6 cycloalkyl, or C.sub.1 -C.sub.3 perfluoroalkyl; R.sup.3 is C.sub.1 -C.sub.6 alkyl, C.sub.3 -C.sub.6 alkenyl, C.sub.3 -C.sub.6 alkynyl, C.sub.3 -C.sub.7 cycloalkyl, C.sub.1 -C.sub.6 perfluoroalkyl or (C.sub.3 -C.sub.6 cycloalkyl)C.sub.1 -C.sub.6 alkyl; R.sup.4 taken together with the nitrogen atom to which it is attached completes a pyrrolidinyl, piperidino, morpholino, or 4-N-(R.sup.6)-piperazinyl group; R.sup.5 is H, C.sub.1 -C.sub.4 alkyl, C.sub.1 -C.sub.3 alkoxy, NR.sup.7 R.sup.8, or CONR.sup.7 R.sup.8 ; R.sup.6 is H, C.sub.1 -C.sub.6 alkyl, (C.sub.1 -C.sub.3 alkoxy) C.sub.2 - C.sub.6 alkyl, hydroxy C.sub.2 -C.sub.6 alkyl, (R.sup.7 R.sup.8 N)C.sub.2 -C.sub.6 alkyl, (R.sup.7 R.sup.8 NCO)C.sub.1 -C.sub.6 alkyl, CONR.sup.7 R.sup.8, CSNR.sup.7 R.sup.8 or C(NH)NR.sup.7 R.sup.8 ; R.sup.7 and R.sup.8 are each independently H, C.sub.1 -C.sub.4 alkyl, (C.sub.1 -C.sub.3 alkoxy)C.sub.2 -C.sub.4 alkyl or hydroxy C.sub.2 -C.sub.4 alkyl; and pharmaceutically acceptable salts thereof, are selective cGMP PDE inhibitors useful in the treatment of cardiovascular disorders such as angina, hypertension, heart failure and atherosclerosis.
  
  Patent expiration dates:
  
  
  • March 27, 2012
    
    ✓ 
    Drug substance
    ✓ 
    Drug product
  
  
  
  • September 27, 2012
    
    ✓ 
    Pediatric exclusivity
  
  

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

• Exclusivity expiration dates:
  • May 7, 2012 - TREATMENT OF PULMONARY ARTERIAL HYPERTENSION INDICATION EXPANDED TO INCLUDE DELAY IN CLINICAL WORSENING
  
  
  • November 7, 2012 - PEDIATRIC EXCLUSIVITY
  
  
  • November 20, 2012 - NEW DOSAGE FORM
  
  
  • May 20, 2013 - PEDIATRIC EXCLUSIVITY
  
  

See also...

• Revatio Consumer Information (Drugs.com)
• Revatio Consumer Information (Wolters Kluwer)
• Revatio Injection Consumer Information (Wolters Kluwer)
• Revatio Consumer Information (Cerner Multum)
• Revatio Advanced Consumer Information (Micromedex)
• Revatio Intravenous Advanced Consumer Information (Micromedex)
• Sildenafil Consumer Information (Wolters Kluwer)
• Sildenafil Injection Consumer Information (Wolters Kluwer)
• Sildenafil Consumer Information (Cerner Multum)
• Sildenafil Advanced Consumer Information (Micromedex)
• Sildenafil Intravenous Advanced Consumer Information (Micromedex)
• Sildenafil Citrate AHFS DI Monographs (ASHP)

Clorhexidina Sanitas

Clorhexidina Sanitas may be available in the countries listed below.

Ingredient matches for Clorhexidina Sanitas

Chlorhexidine

Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Clorhexidina Sanitas in the following countries:

• Italy

International Drug Name Search

Enalek

Enalek may be available in the countries listed below.

Ingredient matches for Enalek

Enalapril

Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Enalek in the following countries:

• Czech Republic

International Drug Name Search

Ezeta

Ezeta may be available in the countries listed below.

Ingredient matches for Ezeta

Ezetimibe

Ezetimibe is reported as an ingredient of Ezeta in the following countries:

• Bangladesh

International Drug Name Search

Rilast Forte Turbuhaler Singad

Rilast Forte Turbuhaler Singad may be available in the countries listed below.

Ingredient matches for Rilast Forte Turbuhaler Singad

Budesonide

Budesonide is reported as an ingredient of Rilast Forte Turbuhaler Singad in the following countries:

• Denmark

Formoterol

Formoterol fumarate dihydrate (a derivative of Formoterol) is reported as an ingredient of Rilast Forte Turbuhaler Singad in the following countries:

• Denmark

International Drug Name Search

Normonal

Normonal may be available in the countries listed below.

Ingredient matches for Normonal

Tripamide

Tripamide is reported as an ingredient of Normonal in the following countries:

• Japan


• Thailand

International Drug Name Search

Interferon Alfa-n3

In the US, Interferon Alfa-n3 (interferon alfa-n3 systemic) is a member of the drug class interferons and is used to treat Condylomata Acuminata.

US matches:

• Interferon Alfa-n3 Solution


• Interferon alfa-n3

Ingredient matches for Interferon Alfa-n3

Interferon alfa

Interferon Alfa-n3 (USAN) is also known as Interferon alfa (Rec.INN)

International Drug Name Search

Glossary

Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Benfogamma

Benfogamma may be available in the countries listed below.

Ingredient matches for Benfogamma

Benfotiamine

Benfotiamine is reported as an ingredient of Benfogamma in the following countries:

• Bulgaria


• Czech Republic


• Estonia


• Georgia


• Hungary


• Latvia


• Lithuania


• Poland


• Romania


• Russian Federation


• Slovakia

International Drug Name Search

Bioglufer

Bioglufer may be available in the countries listed below.

Ingredient matches for Bioglufer

Ferrous Gluconate

Ferrous Gluconate is reported as an ingredient of Bioglufer in the following countries:

• Italy

International Drug Name Search

Coracten XL

Coracten XL may be available in the countries listed below.

UK matches:

• Coracten XL Joint SPC 30mg, 60mg (SPC)

Ingredient matches for Coracten XL

Nifedipine

Nifedipine is reported as an ingredient of Coracten XL in the following countries:

• United Kingdom

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Sekisan

Sekisan may be available in the countries listed below.

Ingredient matches for Sekisan

Cloperastine

Cloperastine fendizoate (a derivative of Cloperastine) is reported as an ingredient of Sekisan in the following countries:

• Spain

International Drug Name Search

Arlevert

Arlevert may be available in the countries listed below.

Ingredient matches for Arlevert

Cinnarizine

Cinnarizine is reported as an ingredient of Arlevert in the following countries:

• Germany


• Luxembourg


• Poland


• Slovakia


• Slovenia


• Switzerland


• United Kingdom

Dimenhydrinate

Dimenhydrinate is reported as an ingredient of Arlevert in the following countries:

• Germany


• Luxembourg


• Poland


• Slovakia


• Slovenia


• Switzerland


• United Kingdom

International Drug Name Search

Fenizolan

Fenizolan may be available in the countries listed below.

Ingredient matches for Fenizolan

Fenticonazole

Fenticonazole nitrate (a derivative of Fenticonazole) is reported as an ingredient of Fenizolan in the following countries:

• Germany

International Drug Name Search

Brimonal

Brimonal may be available in the countries listed below.

Ingredient matches for Brimonal

Brimonidine

Brimonidine tartrate (a derivative of Brimonidine) is reported as an ingredient of Brimonal in the following countries:

• Latvia


• Slovakia

International Drug Name Search

Lucef

Lucef may be available in the countries listed below.

Ingredient matches for Lucef

Cefalexin

Cefalexin is reported as an ingredient of Lucef in the following countries:

• Vietnam

International Drug Name Search

Lavement au phosphate

Lavement au phosphate may be available in the countries listed below.

Ingredient matches for Lavement au phosphate

Sodium Phosphate

Sodium Phosphate Dibasic dodecahydrate (a derivative of Sodium Phosphate) is reported as an ingredient of Lavement au phosphate in the following countries:

• Belgium

Sodium Phosphate Monobasic dihydrate (a derivative of Sodium Phosphate) is reported as an ingredient of Lavement au phosphate in the following countries:

• Belgium

International Drug Name Search

Renapur

Renapur may be available in the countries listed below.

Ingredient matches for Renapur

Potassium Sodium Hydrogen Citrate

Potassium Sodium Hydrogen Citrate is reported as an ingredient of Renapur in the following countries:

• Sweden

International Drug Name Search

Neosporin Irrigating Solution

Neosporin Irrigating Solution may be available in the countries listed below.

Ingredient matches for Neosporin Irrigating Solution

Neomycin

Neomycin sulfate (a derivative of Neomycin) is reported as an ingredient of Neosporin Irrigating Solution in the following countries:

• Canada

Polymyxin B

Polymyxin B sulfate (a derivative of Polymyxin B) is reported as an ingredient of Neosporin Irrigating Solution in the following countries:

• Canada

International Drug Name Search

Auxxil

Auxxil may be available in the countries listed below.

Ingredient matches for Auxxil

Levofloxacin

Levofloxacin is reported as an ingredient of Auxxil in the following countries:

• Chile

International Drug Name Search

Folic

Folic may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Folic

Folic Acid

Folic Acid is reported as an ingredient of Folic in the following countries:

• Australia


• Israel

International Drug Name Search

Finatux

Finatux may be available in the countries listed below.

Ingredient matches for Finatux

Carbocisteine

Carbocisteine is reported as an ingredient of Finatux in the following countries:

• Portugal

International Drug Name Search

ratio-Docusate Sodium

ratio-Docusate Sodium may be available in the countries listed below.

Ingredient matches for ratio-Docusate Sodium

Docusate

Docusate Sodium is reported as an ingredient of ratio-Docusate Sodium in the following countries:

• Canada

International Drug Name Search

Fluocaril bi-fluoré

Fluocaril bi-fluoré may be available in the countries listed below.

Ingredient matches for Fluocaril bi-fluoré

Sodium Fluoride

Sodium Fluoride is reported as an ingredient of Fluocaril bi-fluoré in the following countries:

• France


• Greece


• Italy

Sodium Monofluorophosphate

Sodium Monofluorophosphate is reported as an ingredient of Fluocaril bi-fluoré in the following countries:

• France


• Greece


• Italy

International Drug Name Search

Ropinirol AbZ

Ropinirol AbZ may be available in the countries listed below.

Ingredient matches for Ropinirol AbZ

Ropinirole

Ropinirole hydrochloride (a derivative of Ropinirole) is reported as an ingredient of Ropinirol AbZ in the following countries:

• Germany

International Drug Name Search

Minims Pilocarpinnitrat

Minims Pilocarpinnitrat may be available in the countries listed below.

Ingredient matches for Minims Pilocarpinnitrat

Pilocarpine

Pilocarpine nitrate (a derivative of Pilocarpine) is reported as an ingredient of Minims Pilocarpinnitrat in the following countries:

• Austria

International Drug Name Search

Clinda-saar

Clinda-saar may be available in the countries listed below.

Ingredient matches for Clinda-saar

Clindamycin

Clindamycin dihydrogen phosphate (a derivative of Clindamycin) is reported as an ingredient of Clinda-saar in the following countries:

• Germany

Clindamycin hydrochloride (a derivative of Clindamycin) is reported as an ingredient of Clinda-saar in the following countries:

• Germany

International Drug Name Search

DesOwen

DesOwen is a brand name of desonide topical, approved by the FDA in the following formulation(s):

DESOWEN (desonide - cream; topical)

• 
  Manufacturer: GALDERMA LABS LP
  
  Approval date: December 14, 1984
  
  Strength(s): 0.05% ^[AB]

Has a generic version of DesOwen been approved?

Yes. The following products are equivalent to DesOwen:

desonide cream; topical

• 
  Manufacturer: TARO
  
  Approval date: June 30, 1992
  
  Strength(s): 0.05% ^[AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of DesOwen. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

There are no current U.S. patents associated with DesOwen.

See also...

• DesOwen Cream Consumer Information (Wolters Kluwer)
• DesOwen Cream Kit Cream Consumer Information (Wolters Kluwer)
• DesOwen Lotion Consumer Information (Wolters Kluwer)
• DesOwen Lotion Kit Lotion Consumer Information (Wolters Kluwer)
• DesOwen Consumer Information (Cerner Multum)
• DesOwen 2 oz Consumer Information (Cerner Multum)
• DesOwen 4 oz Consumer Information (Cerner Multum)
• DesOwen Lotion 4 oz Kit Consumer Information (Cerner Multum)
• Desowen Advanced Consumer Information (Micromedex)
• Desonide Cream Consumer Information (Wolters Kluwer)
• Desonide Foam Consumer Information (Wolters Kluwer)
• Desonide Gel Consumer Information (Wolters Kluwer)
• Desonide Lotion Consumer Information (Wolters Kluwer)
• Desonide topical Consumer Information (Cerner Multum)
• Pms-Desonide Advanced Consumer Information (Micromedex)
• Desonide Topical application Advanced Consumer Information (Micromedex)
• Desonide AHFS DI Monographs (ASHP)

Heparina Sodica

Heparina Sodica may be available in the countries listed below.

Ingredient matches for Heparina Sodica

Heparin

Heparin sodium salt (a derivative of Heparin) is reported as an ingredient of Heparina Sodica in the following countries:

• Argentina


• Chile


• Colombia


• Venezuela

International Drug Name Search

Marromel

Marromel may be available in the countries listed below.

Ingredient matches for Marromel

Ofloxacin

Ofloxacin is reported as an ingredient of Marromel in the following countries:

• Japan

International Drug Name Search

Alphagan P

Alphagan P is a brand name of brimonidine ophthalmic, approved by the FDA in the following formulation(s):

ALPHAGAN P (brimonidine tartrate - solution/drops; ophthalmic)

• 
  Manufacturer: ALLERGAN
  
  Approval date: March 16, 2001
  
  Strength(s): 0.15% ^[RLD][AT]


• 
  Manufacturer: ALLERGAN
  
  Approval date: August 19, 2005
  
  Strength(s): 0.1% ^[RLD]

Has a generic version of Alphagan P been approved?

A generic version of Alphagan P has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Alphagan P and have been approved by the FDA:

brimonidine tartrate solution/drops; ophthalmic

• 
  Manufacturer: ALCON PHARMS LTD
  
  Approval date: May 22, 2006
  
  Strength(s): 0.15% ^[AT]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Alphagan P. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

• 
  Aqueous ophthalmic formulations and methods for preserving same
  Patent 5,424,078
  Issued: June 13, 1995
  Inventor(s): Dziabo; Anthony J. & Ripley; Paul S.
  Assignee(s): Allergan, Inc.
  Stabilized chlorine dioxide is a preservative for ophthalmic formulations. The stabilized chlorine dioxide, when employed as a preservative ophthalmic formulations is preferably present in an amount of from about 0.0002 or about 0.002 to about 0.02 weight/volume percent. The aqueous ophthalmic formulations, in addition to the stabilized chlorine dioxide and the water which functions as a vehicle for the formulations, contains an ophthalmically acceptable tonicity component effective to maintain the osmolality of the formulation at least about 200 mOsmol/kg, and a buffer to maintain the pH of the ophthalmic formulation within an acceptable physiological range. A method for preserving aqueous ophthalmic formulations utilizing stabilized chlorine dioxide is also set forth.
  
  Patent expiration dates:
  
  
  • June 13, 2012
    
    ✓ 
    Sponsor has requested patent be delisted
  
  
  
  • June 13, 2012
    
    ✓ 
    Drug product
    ✓ 
    Sponsor has requested patent be delisted
  
  
  
  • December 13, 2012
    
    ✓ 
    Pediatric exclusivity
  
  



• 
  Compositions containing therapeutically active components having enhanced solubility
  Patent 6,562,873
  Issued: May 13, 2003
  Inventor(s): Orest; Olejnik & Edward D. S.; Kerslake
  Assignee(s): Allergan, Inc.
  Compositions which include therapeutically active components, solubility enhancing components other than cyclodextrins, and oxy-chloro components, wherein the oxy-chloro components are substantially effective as preservatives. In one embodiment, the oxy-chloro components are useful for preserving the therapeutically active components. In one embodiment, the oxy-chloro components include chlorite components. In a useful embodiment, the solubility enhancing components include carboxymethylcellulose.
  
  Patent expiration dates:
  
  
  • July 10, 2021
    
  
  
  
  • July 10, 2021
    
    ✓ 
    Drug product
  
  
  
  • January 10, 2022
    
    ✓ 
    Pediatric exclusivity
  
  



• 
  Compositions containing &agr;-2-adrenergic agonist components
  Patent 6,627,210
  Issued: September 30, 2003
  Inventor(s): Orest; Olejnik & Edward D. S.; Kerslake
  Assignee(s): Allergan, Inc.
  Compositions useful for improving effectiveness of alpha-2-adrenergic agonist components include carrier components, alpha-2-adrenergic agonist components, solubility enhancing components which aid in solubilizing the alpha-2-adrenergic agonist components. In one embodiment, the alpha-2-adrenergic agonist components include alpha-2-adrenergic agonists. In another embodiment, the solubility enhancing components include carboxymethylcellulose.
  
  Patent expiration dates:
  
  
  • July 18, 2021
    
    ✓ 
    Drug product
  
  
  
  • January 18, 2022
    
    ✓ 
    Pediatric exclusivity
  
  



• 
  Compositions containing alpha-2-adrenergic agonist components
  Patent 6,641,834
  Issued: November 4, 2003
  Inventor(s): Orest; Olejnik & Edward D. S.; Kerslake
  Assignee(s): Allergan Sales, Inc.
  Compositions useful for improving effectiveness of alpha-2-adrenergic agonist components include carrier components, alpha-2-adrenergic agonist components, solubility enhancing components which aid in solubilizing the alpha-2-adrenergic agonist components. In one embodiment, the alpha-2-adrenergic agonist components include alpha-2-adrenergic agonists. In another embodiment, the solubility enhancing components include carboxymethylcellulose.
  
  Patent expiration dates:
  
  
  • July 28, 2021
    
    ✓ 
    Drug product
  
  
  
  • January 28, 2022
    
    ✓ 
    Pediatric exclusivity
  
  



• 
  Compositions containing alpha-2-adrenergic agonist components
  Patent 6,673,337
  Issued: January 6, 2004
  Inventor(s): Orest; Olejnik & Edward D. S.; Kerslake
  Assignee(s): Allergan, Inc.
  Compositions useful for improving effectiveness of alpha-2-adrenergic agonist components include carrier components, alpha-2-adrenergic agonist components, solubility enhancing components which aid in solubilizing the alpha-2-adrenergic agonist components. In one embodiment, the alpha-2-adrenergic agonist components include alpha-2-adrenergic agonists. In another embodiment, the solubility enhancing components include carboxymethylcellulose.
  
  Patent expiration dates:
  
  
  • July 26, 2021
    
    ✓ 
    Drug product
  
  
  
  • January 26, 2022
    
    ✓ 
    Pediatric exclusivity
  
  

See also...

• Alphagan P Consumer Information (Wolters Kluwer)
• Alphagan P Consumer Information (Cerner Multum)
• Alphagan P Advanced Consumer Information (Micromedex)
• Alphagan P AHFS DI Monographs (ASHP)
• Brimonidine Consumer Information (Wolters Kluwer)
• Brimonidine ophthalmic Consumer Information (Cerner Multum)
• Brimonidine Ophthalmic Advanced Consumer Information (Micromedex)
• Brimonidine Tartrate AHFS DI Monographs (ASHP)

Drimen

Drimen may be available in the countries listed below.

Ingredient matches for Drimen

Dimenhydrinate

Dimenhydrinate is reported as an ingredient of Drimen in the following countries:

• Greece

International Drug Name Search

Resporito

Resporito may be available in the countries listed below.

Ingredient matches for Resporito

Labetalol

Labetalol hydrochloride (a derivative of Labetalol) is reported as an ingredient of Resporito in the following countries:

• Japan

International Drug Name Search

Apo-Flunarizine

Apo-Flunarizine may be available in the countries listed below.

Ingredient matches for Apo-Flunarizine

Flunarizine

Flunarizine dihydrochloride (a derivative of Flunarizine) is reported as an ingredient of Apo-Flunarizine in the following countries:

• Canada

International Drug Name Search

Differin

Differin is a brand name of adapalene topical, approved by the FDA in the following formulation(s):

DIFFERIN (adapalene - cream; topical)

• 
  Manufacturer: GALDERMA LABS LP
  
  Approval date: May 26, 2000
  
  Strength(s): 0.1% ^[RLD][AB]

DIFFERIN (adapalene - gel; topical)

• 
  Manufacturer: GALDERMA LABS LP
  
  Approval date: May 31, 1996
  
  Strength(s): 0.1% ^[RLD][AB]


• 
  Manufacturer: GALDERMA LABS LP
  
  Approval date: June 19, 2007
  
  Strength(s): 0.3% ^[RLD]

DIFFERIN (adapalene - lotion; topical)

• 
  Manufacturer: GALDERMA R AND D
  
  Approval date: March 17, 2010
  
  Strength(s): 0.1% ^[RLD]

Has a generic version of Differin been approved?

A generic version of Differin has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Differin and have been approved by the FDA:

adapalene cream; topical

• 
  Manufacturer: FOUGERA PHARMS
  
  Approval date: June 30, 2010
  
  Strength(s): 0.1% ^[AB]

adapalene gel; topical

• 
  Manufacturer: GLENMARK GENERICS
  
  Approval date: July 1, 2010
  
  Strength(s): 0.1% ^[AB]


• 
  Manufacturer: PLIVA HRVATSKA DOO
  
  Approval date: June 2, 2010
  
  Strength(s): 0.1% ^[AB]

Note: No generic formulation of the following product is available.

• adapalene - lotion; topical

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Differin. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

• 
  Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
  Patent 7,579,377
  Issued: August 25, 2009
  Inventor(s): Graeber; Michael & Czernielewski; Janusz
  Assignee(s): Galderma Research & Development
  Dermatological disorders having an inflammatory or proliferative component are treated with pharmaceutical compositions containing on the order of 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthanoic acid (adapalene) or salt thereof, formulated into pharmaceutically acceptable media therefore, advantageously topically applicable gels, creams or lotions.
  
  Patent expiration dates:
  
  
  • February 23, 2025
    
    ✓ 
    Patent use: TOPICAL TREATMENT OF ACNE VULGARIS
  
  



• 
  Pharmaceutical compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
  Patent 7,737,181
  Issued: June 15, 2010
  Inventor(s): Graeber; Michael & Czernielewski; Janusz
  Assignee(s): Galderma Research & Development
  Dermatological disorders having an inflammatory or proliferative component, notably common acne, are treated with topically applicable pharmaceutical compositions containing about 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthanoic acid (adapalene) or salt thereof, formulated into pharmaceutically acceptable media therefor, advantageously formulated into topically applicable gels, preferably aqueous gels, creams, lotions or solutions.
  
  Patent expiration dates:
  
  
  • August 29, 2024
    
    ✓ 
    Drug product
  
  



• 
  Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphtoic acid for the treatment of dermatological disorders
  Patent 7,834,060
  Issued: November 16, 2010
  Inventor(s): Graeber; Michael & Czernielewski; Janusz
  Assignee(s): Galderma Research & Development
  Dermatological disorders having an inflammatory or proliferative component are treated with pharmaceutical compositions containing on the order of 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthanoic acid (adapalene) or salt thereof, formulated into pharmaceutically acceptable media therefor, advantageously topically applicable gels, creams or lotions.
  
  Patent expiration dates:
  
  
  • March 12, 2023
    
    ✓ 
    Patent use: TREATMENT OF ACNE
  
  



• 
  Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
  Patent 7,838,558
  Issued: November 23, 2010
  Inventor(s): Graeber; Michael & Czernielewski; Janusz
  Assignee(s): Galderma Research & Development S.N.C.
  Dermatological disorders having an inflammatory or proliferative component are treated with pharmaceutical compositions containing on the order of 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthanoic acid (adapalene) or salt thereof, formulated into pharmaceutically acceptable media therefor, advantageously topically applicable gels, creams or lotions.
  
  Patent expiration dates:
  
  
  • March 12, 2023
    
    ✓ 
    Drug product
  
  



• 
  Method for the treatment of acne using compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid
  Patent 7,868,044
  Issued: January 11, 2011
  Inventor(s): Graeber; Michael & Czernielewski; Janusz
  Assignee(s): Galderma Research & Development
  Dermatological disorders having an inflammatory or proliferative component, notably common acne, are treated with topically applicable pharmaceutical compositions containing about 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthanoic acid (adapalene) or salt thereof, formulated into pharmaceutically acceptable media therefor, advantageously formulated into topically applicable gels, preferably aqueous gels, creams, lotions or solutions.
  
  Patent expiration dates:
  
  
  • March 12, 2023
    
    ✓ 
    Patent use: TREATMENT OF ACNE
  
  



• 
  Cosmetic/dermatological compositions comprising naphthoic acid compounds and polyurethane polymers
  Patent 7,998,467
  Issued: August 16, 2011
  Inventor(s): Mallard; Claire & Ferrara; Eve
  Assignee(s): Galderma Research & Development
  Cosmetic/dermatological compositions for topical application and useful for the treatment, e.g., of acne, contain, formulated into a physiologically acceptable medium, at least one naphthoic acid compound and at least one polyurethane polymer or derivative thereof, the at least one naphthoic acid compound being dispersed therein.
  
  Patent expiration dates:
  
  
  • May 31, 2028
    
    ✓ 
    Patent use: TREATMENT OF ACNE
    ✓ 
    Drug product
  
  

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

• Exclusivity expiration dates:
  • March 17, 2013 - NEW DOSAGE FORM
  
  

See also...

• Differin Consumer Information (Drugs.com)
• Differin Cream Consumer Information (Wolters Kluwer)
• Differin Lotion Consumer Information (Wolters Kluwer)
• Differin Pads Consumer Information (Wolters Kluwer)
• Differin Solution Consumer Information (Wolters Kluwer)
• Differin Consumer Information (Cerner Multum)
• Differin Topical Advanced Consumer Information (Micromedex)
• Differin AHFS DI Monographs (ASHP)
• Adapalene Cream Consumer Information (Wolters Kluwer)
• Adapalene Lotion Consumer Information (Wolters Kluwer)
• Adapalene Pads Consumer Information (Wolters Kluwer)
• Adapalene Solution Consumer Information (Wolters Kluwer)
• Adapalene topical Consumer Information (Cerner Multum)
• Adapalene Topical Advanced Consumer Information (Micromedex)
• Adapalene AHFS DI Monographs (ASHP)

Bigeloil

Dosage Form: FOR ANIMAL USE ONLY
Bigeloil®

The Professional Liniment

Can be used before, during and after competition

Can also be used on dogs

Indications

For temporary relief of minor pain and swelling from sprains, strains, bruises, arthritis, overworked muscles and minor wounds.

Directions for Use

Rub onto sore area 2 to 3 times a day. For faster relief, rub with hair and wrap or blanket, especially overnight. Body Wash: mix 2 to 4 oz. with 1 gal. water, apply with sponge, avoid eyes. Brace: mix 2 to 3 oz. with 1 quart water, apply with sponge to warm horse up before workout, avoid eyes and saddle area. Arthritis: rub onto knees, hocks and fetlocks before workout, apply again at night and lightly wrap. Antiseptic: for minor wounds and skin irritations, apply full strength without rubbing.

Caution: Avoid contact with eyes and mucous membranes. Stop using if skin irritation develops or symptoms persist for more than 10 days. For severe injuries consult a veterinarian. For external use only. Keep out of reach of children.

Warning

Flammable. Keep away from fire, sparks and heated surfaces. Store at room temperature. For animal use only.

Active Ingredients

Menthol 1.25% W/W.

Other Ingredients

Alcohol, D&C Green #5, FD&C Yellow #5, Fragrance, Juniperberry Oil, Methyl Salicylate, Salicylic Acid, Thymol and Purified Water.

Distributed by:

W. F. Young, Inc.

302 Benton Drive

E. Longmeadow, MA 01028 USA

© WFY

www.absorbine.com

RM 342328-3

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Bigeloil®

THE PROFESSIONAL'S LINIMENT

• Reduces Pain & Swelling of Sore

Muscles, Joints, Legs & Arthritis

• Excellent Under Wraps

TOPICAL PAIN

RELIEF LIQUID

16 fl oz. (473 mL)

Bigeloil  menthol  liquid

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 11444-130 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (Menthol) Menthol 1.25 g  in 115 mL

Inactive Ingredients Ingredient Name Strength Alcohol   D&C Green NO. 5   FD&C Yellow NO. 5   Methyl Salicylate   Salicylic Acid   Thymol   Water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 11444-130-01 473 mL In 1 BOTTLE, PLASTIC None 2 11444-130-02 946 mL In 1 BOTTLE, PLASTIC None 3 11444-130-03 3785 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		01/01/1997

Labeler - W. F. Young, Inc. (001114669)

Revised: 05/2010W. F. Young, Inc.

Miambutol

Miambutol may be available in the countries listed below.

Ingredient matches for Miambutol

Ethambutol

Ethambutol dihydrochloride (a derivative of Ethambutol) is reported as an ingredient of Miambutol in the following countries:

• Bosnia & Herzegowina


• Italy


• Turkey

International Drug Name Search

Citofen

Citofen may be available in the countries listed below.

Ingredient matches for Citofen

Tamoxifen

Tamoxifen citrate (a derivative of Tamoxifen) is reported as an ingredient of Citofen in the following countries:

• Bosnia & Herzegowina

International Drug Name Search

Terbinafin Actavis

Terbinafin Actavis may be available in the countries listed below.

Ingredient matches for Terbinafin Actavis

Terbinafine

Terbinafine hydrochloride (a derivative of Terbinafine) is reported as an ingredient of Terbinafin Actavis in the following countries:

• Austria


• Czech Republic


• Denmark


• Estonia


• Latvia


• Lithuania


• Slovakia


• Sweden


• Switzerland

International Drug Name Search

Larcadip

Larcadip may be available in the countries listed below.

Ingredient matches for Larcadip

Lercanidipine

Lercanidipine hydrochloride (a derivative of Lercanidipine) is reported as an ingredient of Larcadip in the following countries:

• Bangladesh

International Drug Name Search

Lugesteron

Lugesteron may be available in the countries listed below.

Ingredient matches for Lugesteron

Progesterone

Progesterone is reported as an ingredient of Lugesteron in the following countries:

• Finland

International Drug Name Search

Aceo

Aceo may be available in the countries listed below.

Ingredient matches for Aceo

Acemetacin

Acemetacin is reported as an ingredient of Aceo in the following countries:

• Taiwan

International Drug Name Search

Ampi-Ject

Ampi-Ject may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Ampi-Ject

Ampicillin

Ampicillin trihydrate (a derivative of Ampicillin) is reported as an ingredient of Ampi-Ject in the following countries:

• Netherlands

International Drug Name Search

Trapax

Trapax may be available in the countries listed below.

Ingredient matches for Trapax

Lorazepam

Lorazepam is reported as an ingredient of Trapax in the following countries:

• Argentina

International Drug Name Search

Grifonitren

Grifonitren may be available in the countries listed below.

Ingredient matches for Grifonitren

Nitrendipine

Nitrendipine is reported as an ingredient of Grifonitren in the following countries:

• Chile

International Drug Name Search

ratio-Fluoxetine

ratio-Fluoxetine may be available in the countries listed below.

Ingredient matches for ratio-Fluoxetine

Fluoxetine

Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of ratio-Fluoxetine in the following countries:

• Canada

International Drug Name Search

Verpir

Verpir may be available in the countries listed below.

Ingredient matches for Verpir

Acyclovir

Aciclovir is reported as an ingredient of Verpir in the following countries:

• Greece

International Drug Name Search

Rybix ODT Orally Disintegrating Tablets

Pronunciation: TRAM-a-dol
Generic Name: Tramadol
Brand Name: Rybix ODT

Rybix ODT Orally Disintegrating Tablets are used for:

Treating moderate to moderately severe pain.

Rybix ODT Orally Disintegrating Tablets are an analgesic. It works in certain areas of the brain and nervous system to decrease pain.

Do NOT use Rybix ODT Orally Disintegrating Tablets if:

• you are allergic to any ingredient in Rybix ODT Orally Disintegrating Tablets


• you have had a severe allergic reaction (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue) to codeine or another opioid (eg, morphine)


• you have phenylketonuria or severe or persistent diarrhea caused by antibiotic use


• you have suicidal thoughts or actions, or a history of alcohol or other substance abuse or addiction


• you are intoxicated with alcohol, opioids or narcotics (eg, codeine, morphine), or sedatives or sleeping medicines (eg, temazepam, zolpidem)


• you are taking carbamazepine, nefazodone, sodium oxybate (GHB), a thioxanthene (eg, thiothixene), or another product that contains tramadol

Contact your doctor or health care provider right away if any of these apply to you.

Before using Rybix ODT Orally Disintegrating Tablets:

Some medical conditions may interact with Rybix ODT Orally Disintegrating Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription (especially depression medicines) or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have liver, kidney, or thyroid problems; a blockage in the bladder; diabetes; heart problems (eg, cor pulmonale); high blood pressure; pancreas problems; prostate problems; or metabolism problems


• if you have or have recently had any head injury, brain injury or tumor, increased pressure in the brain, or an infection of the brain or nervous system


• if you have a history of recent stomach or bowel surgery or any other stomach or bowel problems (eg, pain, inflammation, ulcers)


• if you have a history of lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease [COPD]) or seizures (eg, epilepsy)


• if you drink alcohol; are going through withdrawal from alcohol or other substances; or if you have a history of alcohol or other substance abuse, mood or mental problems (eg, depression), or suicidal thoughts or actions

Some MEDICINES MAY INTERACT with Rybix ODT Orally Disintegrating Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Alpha-2 receptor blockers (eg, yohimbine), azole antifungals (eg, ketoconazole), linezolid, lithium, macrolide antibiotics (eg, erythromycin), monoamine oxidase inhibitors (MAOIs) (eg, phenelzine, selegiline), nefazodone, quinidine, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine), serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine), St. John's wort, tricyclic antidepressants (eg, amitriptyline), or "triptans" (eg, sumatriptan) because the risk of seizures or serotonin syndrome may be increased


• Anorexiants (eg, phentermine), butyrophenones (eg, haloperidol), cyclobenzaprine, furazolidone, loxapine, certain medicines for mental or mood disorders (eg, olanzapine), molindone, opioid pain medicines (eg, codeine, hydrocodone), phenothiazines (eg, promethazine), sleeping medicines (eg, zolpidem), sodium oxybate (GHB), thioxanthenes (eg, thiothixene), or tiagabine because the risk of side effects, including excessive drowsiness, trouble breathing, liver problems, or seizures, may be increased


• Carbamazepine because it may decrease Rybix ODT Orally Disintegrating Tablets's effectiveness and the risk of seizures may be increased


• Other products containing tramadol because they may increase the risk of Rybix ODT Orally Disintegrating Tablets's side effects


• Rifampin because it may decrease Rybix ODT Orally Disintegrating Tablets's effectiveness


• Anticoagulants (eg, warfarin) or digoxin because the risk of their side effects may be increased by Rybix ODT Orally Disintegrating Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Rybix ODT Orally Disintegrating Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Rybix ODT Orally Disintegrating Tablets:

Use Rybix ODT Orally Disintegrating Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Rybix ODT Orally Disintegrating Tablets by mouth with or without food.


• To open the blister pack, peel back the foil on the blister. Do NOT push the tablet through the foil.


• Do NOT chew, break, or split the tablet.


• To take Rybix ODT Orally Disintegrating Tablets, place the tablet in your mouth. Let it dissolve, and then swallow it with saliva. Rybix ODT Orally Disintegrating Tablets may be taken with or without water.


• If you miss a dose of Rybix ODT Orally Disintegrating Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Rybix ODT Orally Disintegrating Tablets.

Important safety information:

• Rybix ODT Orally Disintegrating Tablets may cause drowsiness, dizziness, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Rybix ODT Orally Disintegrating Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol while you are taking Rybix ODT Orally Disintegrating Tablets.


• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers, narcotic pain medicines) while you are taking Rybix ODT Orally Disintegrating Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Rybix ODT Orally Disintegrating Tablets may cause dizziness; alcohol, hot weather, exercise, or fever may increase this effect. To prevent it, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of this effect.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Doing so may increase the risk of seizures or breathing problems.


• Tell your doctor or dentist that you take Rybix ODT Orally Disintegrating Tablets before you receive any medical or dental care, emergency care, or surgery.


• Rybix ODT Orally Disintegrating Tablets may increase your risk of seizures. Your risk may be greater if you also have certain medical conditions, use certain medicines, or if you use a lot of alcohol. Talk to your doctor to see if you may have a greater risk of seizures while taking Rybix ODT Orally Disintegrating Tablets.


• Serotonin syndrome is a possibly fatal syndrome that can be caused by Rybix ODT Orally Disintegrating Tablets. Your risk may be greater if you take Rybix ODT Orally Disintegrating Tablets with certain other medicines (eg, "triptans," MAOIs, antidepressants). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.


• This product contains phenylalanine. If you must have a diet that is low in phenylalanine, check with your doctor before you take Rybix ODT Orally Disintegrating Tablets.


• Use Rybix ODT Orally Disintegrating Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, weakness or tiredness, severe light-headedness, and indigestion.


• Rybix ODT Orally Disintegrating Tablets should not be used in CHILDREN younger than 16 years; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Rybix ODT Orally Disintegrating Tablets has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Rybix ODT Orally Disintegrating Tablets while you are pregnant. Rybix ODT Orally Disintegrating Tablets are found in breast milk. Do not breast-feed while taking Rybix ODT Orally Disintegrating Tablets.

When used for long periods of time or at high doses, Rybix ODT Orally Disintegrating Tablets may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Rybix ODT Orally Disintegrating Tablets stops working well. Do not take more than prescribed.

Some people who use Rybix ODT Orally Disintegrating Tablets for a long time without a break may develop a physical need to continue taking it. This is known as physical DEPENDENCE.

If you suddenly stop taking Rybix ODT Orally Disintegrating Tablets, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Rybix ODT Orally Disintegrating Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; increased sweating; indigestion; mild itching; nausea; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); agitation; chest pain; confusion; difficult or painful urination; disorientation; excessive sweating; fainting; fast or irregular heartbeat; fever; hallucinations; loss of coordination; mood or mental changes (eg, depression); red, blistered, swollen, or peeling skin; seizures; severe dizziness or light-headedness; severe nausea, vomiting, or diarrhea; severe or persistent headache; slow or shallow breathing; suicidal thoughts or behaviors; tremor; vision problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Rybix ODT side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bluish skin; cold, clammy skin; difficult, shallow, or slow breathing; drowsiness leading to unresponsiveness or coma; excessive sweating; limp muscles; pinpoint pupils; seizures; slow or irregular heartbeat.

Proper storage of Rybix ODT Orally Disintegrating Tablets:

Store Rybix ODT Orally Disintegrating Tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Rybix ODT Orally Disintegrating Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Rybix ODT Orally Disintegrating Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Rybix ODT Orally Disintegrating Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Rybix ODT Orally Disintegrating Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Rybix ODT resources

• Rybix ODT Side Effects (in more detail)
• Rybix ODT Use in Pregnancy & Breastfeeding
• Rybix ODT Drug Interactions
• 0 Reviews for Rybix ODT - Add your own review/rating

Compare Rybix ODT with other medications

• Back Pain
• Pain

ratio-Mometasone

ratio-Mometasone may be available in the countries listed below.

Ingredient matches for ratio-Mometasone

Mometasone

Mometasone 17-(2-furoate) (a derivative of Mometasone) is reported as an ingredient of ratio-Mometasone in the following countries:

• Canada

International Drug Name Search

Cebion

Cebion may be available in the countries listed below.

Ingredient matches for Cebion

Ascorbic Acid

Ascorbic Acid is reported as an ingredient of Cebion in the following countries:

• Austria


• Brazil


• Chile


• Colombia


• Ethiopia


• Germany


• Hungary


• Italy


• Peru


• Poland


• Portugal


• Romania


• Venezuela

International Drug Name Search

Glucostabil

Glucostabil may be available in the countries listed below.

Ingredient matches for Glucostabil

Gliclazide

Gliclazide is reported as an ingredient of Glucostabil in the following countries:

• Russian Federation

International Drug Name Search

Testosterone Cypionate

In the US, Testosterone Cypionate (testosterone systemic) is a member of the drug class androgens and anabolic steroids and is used to treat Breast Cancer - Palliative, Delayed Puberty - Male, Hypogonadism - Male and Postpartum Breast Pain.

US matches:

• Testosterone Cypionate

Ingredient matches for Testosterone Cypionate

Testosterone

Testosterone 17ß-cipionate (a derivative of Testosterone) is reported as an ingredient of Testosterone Cypionate in the following countries:

• Taiwan


• United States

International Drug Name Search

Renvela

In the US, Renvela (sevelamer systemic) is a member of the drug class chelating agents and is used to treat Hyperphosphatemia of Renal Failure.

US matches:

• Renvela


• Renvela Powder Packets

Ingredient matches for Renvela

Sevelamer

Sevelamer carbonate (a derivative of Sevelamer) is reported as an ingredient of Renvela in the following countries:

• Germany


• United States

International Drug Name Search

Selsun

Selsun is a brand name of selenium sulfide topical, approved by the FDA in the following formulation(s):

SELSUN (selenium sulfide - lotion/shampoo; topical)

• 
  Manufacturer: CHATTEM
  
  Approved Prior to Jan 1, 1982
  
  Strength(s): 2.5% ^[RLD][AT]

Has a generic version of Selsun been approved?

Yes. The following products are equivalent to Selsun:

selenium sulfide lotion/shampoo; topical

• 
  Manufacturer: PERRIGO NEW YORK
  
  Approval date: January 10, 1991
  
  Strength(s): 2.5% ^[AT]


• 
  Manufacturer: WOCKHARDT
  
  Approval date: September 1, 1983
  
  Strength(s): 2.5% ^[AT]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Selsun. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

There are no current U.S. patents associated with Selsun.

See also...

• Selsun Consumer Information (Cerner Multum)
• Selenium Foam Consumer Information (Wolters Kluwer)
• Selenium Lotion Consumer Information (Wolters Kluwer)
• Selenium/Urea/Zinc Pyrithione Consumer Information (Wolters Kluwer)
• Selonos Consumer Information (Wolters Kluwer)
• Selenium sulfide topical Consumer Information (Cerner Multum)
• Versel Topical Advanced Consumer Information (Micromedex)
• Selenium sulfide Topical Advanced Consumer Information (Micromedex)
• Selenium Sulfide AHFS DI Monographs (ASHP)

Midazolam Sintetica

Midazolam Sintetica may be available in the countries listed below.

Ingredient matches for Midazolam Sintetica

Midazolam

Midazolam is reported as an ingredient of Midazolam Sintetica in the following countries:

• Switzerland

Midazolam hydrochloride (a derivative of Midazolam) is reported as an ingredient of Midazolam Sintetica in the following countries:

• Switzerland

International Drug Name Search

Pubertal Gynecomastia Medications

Definition of Pubertal Gynecomastia: Pubertal gynecomastia is breast enlargement in boys during puberty.

Drugs associated with Pubertal Gynecomastia

The following drugs and medications are in some way related to, or used in the treatment of Pubertal Gynecomastia. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Drug List:

Arimidex

Oxyquinol potassium

Oxyquinol potassium may be available in the countries listed below.

Ingredient matches for Oxyquinol potassium

Oxyquinoline

Oxyquinol potassium (DCF) is known as Oxyquinoline in the US.

International Drug Name Search

Glossary

DCF	Dénomination Commune Française

Click for further information on drug naming conventions and International Nonproprietary Names.

Rennie

Rennie may be available in the countries listed below.

Ingredient matches for Rennie

Calcium Carbonate

Calcium Carbonate is reported as an ingredient of Rennie in the following countries:

• Austria


• Belgium


• Croatia (Hrvatska)


• Germany


• Hungary


• Malta


• Netherlands


• Oman


• Singapore


• South Africa


• Spain


• Sweden


• Switzerland

Magnesium Carbonate

Magnesium Carbonate is reported as an ingredient of Rennie in the following countries:

• Austria


• Belgium


• Croatia (Hrvatska)


• Netherlands


• Oman


• South Africa


• Spain


• Sweden

Magnesium Carbonate heavy (a derivative of Magnesium Carbonate) is reported as an ingredient of Rennie in the following countries:

• Germany


• Hungary


• Malta


• Singapore


• Switzerland

International Drug Name Search

Reparcillin

Reparcillin may be available in the countries listed below.

Ingredient matches for Reparcillin

Piperacillin

Piperacillin sodium salt (a derivative of Piperacillin) is reported as an ingredient of Reparcillin in the following countries:

• Italy

International Drug Name Search

Griseofulvina L.CH.

Griseofulvina L.CH. may be available in the countries listed below.

Ingredient matches for Griseofulvina L.CH.

Griseofulvin

Griseofulvin is reported as an ingredient of Griseofulvina L.CH. in the following countries:

• Chile

International Drug Name Search

Ritalin

Generic Name: methylphenidate hydrochloride

Dosage Form: tablet and tablet, extended release
Ritalin

Ritalin® hydrochloride methylphenidate hydrochloride tablets USP
Ritalin-SR® methylphenidate hydrochloride USP sustained-release tablets

Rx only

Prescribing Information

DESCRIPTION

Ritalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous system (CNS) stimulant, available as tablets of 5, 10, and 20 mg for oral administration; Ritalin-SR is available as sustained-release tablets of 20 mg for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is 

Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77.

Inactive Ingredients. Ritalin tablets: D&C Yellow No. 10 (5-mg and 20-mg tablets), FD&C Green No. 3 (10-mg tablets), lactose, magnesium stearate, polyethylene glycol, starch (5-mg and 10-mg tablets), sucrose, talc, and tragacanth (20-mg tablets).

Ritalin-SR tablets: Cellulose compounds, cetostearyl alcohol, lactose, magnesium stearate, mineral oil, povidone, titanium dioxide, and zein.

CLINICAL PHARMACOLOGY

Pharmacodynamics

Ritalin is a mild central nervous system stimulant.

The mode of action in man is not completely understood, but Ritalin presumably activates the brain stem arousal system and cortex to produce its stimulant effect.

There is neither specific evidence which clearly establishes the mechanism whereby Ritalin produces its mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.

Effects on QT Interval

The effect of Focalin® XR (dexmethylphenidate, the pharmacologically active d-enantiomer of Ritalin) on the QT interval was evaluated in a double-blind, placebo- and open label active (moxifloxacin)-controlled study following single doses of Focalin® XR 40mg in 75 healthy volunteers. ECGs were collected up to 12 h post-dose. Frederica’s method for heart rate correction was employed to derive the corrected QT interval (QTcF). The maximum mean prolongation of QTcF intervals was <5 ms, and the upper limit of the 90% confidence interval was below 10 ms for all time matched comparisons versus placebo. This was below the threshold of clinical concern and there was no evident-exposure response relationship.

Pharmacokinetics

Ritalin in the SR tablets is more slowly but as extensively absorbed as in the regular tablets. Relative bioavailability of the SR tablet compared to the Ritalin tablet, measured by the urinary excretion of Ritalin major metabolite (α-phenyl-2-piperidine acetic acid) was 105% (49%-168%) in children and 101% (85%-152%) in adults. The time to peak rate in children was 4.7 hours (1.3-8.2 hours) for the SR tablets and 1.9 hours (0.3-4.4 hours) for the tablets. An average of 67% of SR tablet dose was excreted in children as compared to 86% in adults.

In a clinical study involving adult subjects who received SR tablets, plasma concentrations of Ritalin’s major metabolite appeared to be greater in females than in males. No gender differences were observed for Ritalin plasma concentration in the same subjects.

INDICATIONS

Attention Deficit Disorders, Narcolepsy

Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction.

Ritalin is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.

Special Diagnostic Considerations

Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources.

Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics.

Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the child’s symptoms.

CONTRAINDICATIONS

Marked anxiety, tension, and agitation are contraindications to Ritalin, since the drug may aggravate these symptoms. Ritalin is contraindicated also in patients known to be hypersensitive to the drug, in patients with glaucoma, and in patients with motor tics or with a family history or diagnosis of Tourette’s syndrome.

Ritalin is contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result).

WARNINGS

Serious Cardiovascular Events

Sudden Death and Pre-Existing Structural Cardiac Abnormalities or Other Serious Heart Problems

Children and Adolescents

Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Although some serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.

Adults

Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs.

Hypertension and Other Cardiovascular Conditions

Stimulant medications cause a modest increase in average blood pressure (about 2-4 mmHg) and average heart rate (about 3-6 bpm), and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia.

Assessing Cardiovascular Status in Patients being Treated with Stimulant Medications

Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease (e.g., electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.

Psychiatric Adverse Events

Pre-Existing Psychosis

Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.

Bipolar Illness

Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/ manic episode in such patients. Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

Emergence of New Psychotic or Manic Symptoms

Treatment emergent psychotic or manic symptoms, e. g., hallucinations, delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.1% (4 patients with events out of 3,482 exposed to methylphenidate or amphetamine for several weeks at usual doses) of stimulant-treated patients compared to 0 in placebo-treated patients.

Aggression

Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or hostility, patients beginning treatment for ADHD should be monitored for the appearance of or worsening of aggressive behavior or hostility.

Long-Term Suppression of Growth

Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development. Published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

Seizures

There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.

Visual Disturbance

Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

Use in Children Under Six Years of Age

Ritalin should not be used in children under 6 years, since safety and efficacy in this age group have not been established.

Drug Dependence

Ritalin should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use, since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

PRECAUTIONS

Patients with an element of agitation may react adversely; discontinue therapy if necessary.

Periodic CBC, differential, and platelet counts are advised during prolonged therapy.

Drug treatment is not indicated in all cases of this behavioral syndrome and should be considered only in light of the complete history and evaluation of the child. The decision to prescribe Ritalin should depend on the physician’s assessment of the chronicity and severity of the child’s symptoms and their appropriateness for his/her age. Prescription should not depend solely on the presence of one or more of the behavioral characteristics.

When these symptoms are associated with acute stress reactions, treatment with Ritalin is usually not indicated.

Information for Patients

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with methylphenidate and should counsel them in its appropriate use. A patient Medication Guide is available for Ritalin and Ritalin-SR. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Drug Interactions

Ritalin should not be used in patients being treated (currently or within the proceeding two weeks) with MAO Inhibitors (see CONTRAINDICATIONS, Monoamine Oxidase Inhibitors). Because of possible effects on blood pressure, Ritalin should be used cautiously with pressor agents.

Methylphenidate may decrease the effectiveness of drugs used to treat hypertension. Methylphenidate is metabolized primarily to Ritalinic acid by de-esterification and not through oxidative pathways.

Human pharmacologic studies have shown that racemic methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone), and tricyclic drugs (e.g., imipramine, clomipramine, desipramine). Downward dose adjustments of these drugs may be required when given concomitantly with methylphenidate. It may be necessary to adjust the dosage and monitor plasma drug concentration (or, in case of coumarin, coagulation times), when initiating or discontinuing methylphenidate.

Carcinogenesis/Mutagenesis/Impairment of Fertility

In a lifetime carcinogenicity study carried out in B6C3F1 mice, methylphenidate caused an increase in hepatocellular adenomas and, in males only, an increase in hepatoblastomas, at a daily dose of approximately 60 mg/kg/day. This dose is approximately 30 times and 4 times the maximum recommended human dose on a mg/kg and mg/m2 basis, respectively. Hepatoblastoma is a relatively rare rodent malignant tumor type. There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors, and the significance of these results to humans is unknown.

Methylphenidate did not cause any increases in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which is approximately 22 times and 5 times the maximum recommended human dose on a mg/kg and mg/m2 basis, respectively.

In a 24-week carcinogenicity study in the transgenic mouse strain p53+/-, which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity. Male and female mice were fed diets containing the same concentration of methylphenidate as in the lifetime carcinogenicity study; the high-dose groups were exposed to 60-74 mg/kg/day of methylphenidate.

Methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay or in the in vitro mouse lymphoma cell forward mutation assay. Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay in cultured Chinese Hamster Ovary (CHO) cells. Methylphenidate was negative in vivo in males and females in the mouse bone marrow micronucleus assay.

Methlyphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week Continuous Breeding study. The study was conducted at doses up to 160 mg/kg/day, approximately 80-fold and 8-fold the highest recommended dose on a mg/kg and mg/m2 basis, respectively.

PREGNANCY

Pregnancy Category C

In studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. Teratogenic effects (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 40 times the maximum recommended human dose (MRHD) on a mg/m2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (11 times the MRHD on a mg/m2 basis). There was no evidence of specific teratogenic activity in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (7 times the MRHD on a mg/m2 basis), which was also maternally toxic. The no effect level for embryo-fetal development in rats was 25 mg/kg/day (2 times the MRHD on a mg/m2 basis). When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (4 times the MRHD on a mg/m2 basis), but no other effects on postnatal development were observed. The no effect level for pre- and postnatal development in rats was 15 mg/kg/day (equal to the MRHD on a mg/m2 basis).

Adequate and well-controlled studies in pregnant women have not been conducted. Ritalin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether methylphenidate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if Ritalin is administered to a nursing woman.

Pediatric Use

Ritalin should not be used in children under six years of age (see WARNINGS).

In a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (Postnatal Day 7) and continuing through sexual maturity (Postnatal Week 10). When these animals were tested as adults (Postnatal Weeks 13-14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 6 times the maximum recommended human dose [MRHD] on a mg/m2 basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (12 times the MRHD on a mg/m2 basis). The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (half the MRHD on a mg/m2 basis). The clinical significance of the long-term behavioral effects observed in rats is unknown.

ADVERSE REACTIONS

Nervousness and insomnia are the most common adverse reactions but are usually controlled by reducing dosage and omitting the drug in the afternoon or evening. Other reactions include hypersensitivity (including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura); anorexia; nausea; dizziness; palpitations; headache; dyskinesia; drowsiness; blood pressure and pulse changes, both up and down; tachycardia; angina; cardiac arrhythmia; abdominal pain; weight loss during prolonged therapy. There have been rare reports of Tourette’s syndrome. Toxic psychosis has been reported. Although a definite causal relationship has not been established, the following have been reported in patients taking this drug: instances of abnormal liver function, ranging from transaminase elevation to hepatic coma; isolated cases of cerebral arteritis and/or occlusion; leukopenia and/or anemia; transient depressed mood; aggressive behavior; a few instances of scalp hair loss. Very rare reports of neuroleptic malignant syndrome (NMS) have been received, and, in most of these, patients were concurrently receiving therapies associated with NMS. In a single report, a ten-year-old boy who had been taking methylphenidate for approximately 18 months experienced an NMS-like event within 45 minutes of ingesting his first dose of venlafaxine. It is uncertain whether this case represented a drug-drug interaction, a response to either drug alone, or some other cause.

In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed above may also occur.

DOSAGE AND ADMINISTRATION

Dosage should be individualized according to the needs and responses of the patient.

Adults

Tablets: Administer in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Average dosage is 20 to 30 mg daily. Some patients may require 40 to 60 mg daily. In others, 10 to 15 mg daily will be adequate. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.

SR Tablets: Ritalin-SR tablets have a duration of action of approximately 8 hours. Therefore, Ritalin-SR tablets may be used in place of Ritalin tablets when the 8-hour dosage of Ritalin-SR corresponds to the titrated 8-hour dosage of Ritalin. Ritalin-SR tablets must be swallowed whole and never crushed or chewed.

Children (6 years and over)

Ritalin should be initiated in small doses, with gradual weekly increments. Daily dosage above 60 mg is not recommended.

If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

Tablets: Start with 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly.

SR Tablets: Ritalin-SR tablets have a duration of action of approximately 8 hours. Therefore, Ritalin-SR tablets may be used in place of Ritalin tablets when the 8-hour dosage of Ritalin-SR corresponds to the titrated 8-hour dosage of Ritalin. Ritalin-SR tablets must be swallowed whole and never crushed or chewed.

If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug.

Ritalin should be periodically discontinued to assess the child’s condition. Improvement may be sustained when the drug is either temporarily or permanently discontinued.

Drug treatment should not and need not be indefinite and usually may be discontinued after puberty.

OVERDOSAGE

Signs and symptoms of acute overdosage, resulting principally from overstimulation of the central nervous system and from excessive sympathomimetic effects, may include the following: vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, mydriasis, and dryness of mucous membranes.

Consult with a Certified Poison Control Center regarding treatment for up-to-date guidance and advice.

Treatment consists of appropriate supportive measures. The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. Gastric contents may be evacuated by gastric lavage. In the presence of severe intoxication, use a carefully titrated dosage of a short-acting barbiturate before performing gastric lavage. Other measures to detoxify the gut include administration of activated charcoal and a cathartic.

Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia.

Efficacy of peritoneal dialysis or extracorporeal hemodialysis for Ritalin overdosage has not been established.

HOW SUPPLIED

Tablets 5 mg - round, yellow (imprinted CIBA 7)

Bottles of 100       ……………………………......NDC 0078-0439-05

Tablets 10 mg - round, pale green, scored (imprinted CIBA 3)

Bottles of 100       NDC 0078-0440-05

Tablets 20 mg - round, pale yellow, scored (imprinted CIBA 34)

Bottles of 100       ………………………………………………………......NDC 0078-0441-05

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from light.

Dispense in tight, light-resistant container (USP).

SR Tablets 20 mg - round, white, coated (imprinted CIBA 16)

Bottles of 100……………………………………………………………...NDC 0078-0442-05

Note: SR Tablets are color-additive free.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Dispense in tight, light-resistant container (USP).

MEDICATION GUIDE

Ritalin® 

(methylphenidate hydrochloride tablets, USP) CII

Read the Medication Guide that comes with Ritalin® before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your child’s treatment with Ritalin®.

What is the most important information I should know about Ritalin®? The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines. 1. Heart-related problems: sudden death in patients who have heart problems or heart defects stroke and heart attack in adults increased blood pressure and heart rate Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting Ritalin®. Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with Ritalin®. Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Ritalin®. 2. Mental (Psychiatric) problems: All Patients new or worse behavior and thought problems new or worse bipolar illness new or worse aggressive behavior or hostility Children and Teenagers new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Ritalin®, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

What Is Ritalin®?

Ritalin® is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Ritalin® may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Ritalin® should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Ritalin® is also used in the treatment of a sleep disorder called narcolepsy.

Ritalin® is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Ritalin® in a safe place to prevent misuse and abuse.  Selling or giving away Ritalin® may harm others, and is against the law. Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take Ritalin®?

Ritalin® should not be taken if you or your child:

• are very anxious, tense, or agitated
  


• have an eye problem called glaucoma
  


• have tics or Tourette’s syndrome, or a family history of Tourette’s syndrome. Tics are hard to control repeated movements or sounds.
  


• are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
  


• are allergic to anything in Ritalin®. See the end of this Medication Guide for a complete list of ingredients.

Ritalin® should not be used in children less than 6 years old because it has not been studied in this age group.

Ritalin® may not be right for you or your child. Before starting Ritalin® tell your or your child’s doctor about all health conditions (or a family history of) including:

• heart problems, heart defects, high blood pressure
  


• mental problems including psychosis, mania, bipolar illness, or depression
  


• tics or Tourette’s syndrome
  


• seizures or have had an abnormal brain wave test (EEG)

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breast-feeding.

Can Ritalin® be taken with other medicines?

Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. Ritalin® and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Ritalin®.

Your doctor will decide whether Ritalin® can be taken with other medicines.

Especially tell your doctor if you or your child takes:

• anti-depression medicines including MAOIs
  


• seizure medicines
  


• blood thinner medicines
  


• blood pressure medicines
  


• cold or allergy medicines that contain decongestants

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking Ritalin® without talking to your doctor first.

How should Ritalin® be taken?

• Take Ritalin® exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
  


• Ritalin is usually taken 2 to 3 times a day.
  


• Take Ritalin® 30 to 45 minutes before a meal.
  


• From time to time, your doctor may stop Ritalin® treatment for a while to check ADHD symptoms.
  


• Your doctor may do regular checks of the blood, heart, and blood pressure while taking Ritalin®. Children should have their height and weight checked often while taking Ritalin®. Ritalin® treatment may be stopped if a problem is found during these check-ups.
  


• If you or your child takes too much Ritalin® or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of Ritalin®?

See “What is the most important information I should know about Ritalin®?” for information on reported heart and mental problems.

Other serious side effects include:

• slowing of growth (height and weight) in children
  


• seizures, mainly in patients with a history of seizures
  


• eyesight changes or blurred vision

Common side effects include:

• headache             • decreased appetite
  


• stomach ache       • nervousness
  


• trouble sleeping
  


• nausea      

Talk to your doctor if you or your child has side effects that are bothersome or do not go away.

This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.

How should I store Ritalin®?

• Store Ritalin in a safe place at room temperature, 59 to 86° F (15 to 30° C). Protect from light.
  


• Keep Ritalin® and all medicines out of the reach of children.

General information about Ritalin®

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Ritalin® for a condition for which it was not prescribed. Do not give Ritalin® to other people, even if they have the same condition. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about Ritalin®. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Ritalin® that was written for healthcare professionals. For more information about Ritalin® call 1-888-669-6682.

What are the ingredients in Ritalin®?

Active Ingredient: methylphenidate HCL

Inactive Ingredients: D&C Yellow No.10 (5-mg and 20-mg tablets), FD&C Green No.3 (10-mg tablets), lactose, magnesium stearate, polyethylene glycol, starch (5-mg and 10-mg tablets), sucrose, talc, and tragacanth (20-mg tablets).

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

MEDICATION GUIDE

Ritalin-SR® 

(methylphenidate hydrochloride, USP) sustained-release tablets CII

Read the Medication Guide that comes with Ritalin-SR® before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your child’s treatment with Ritalin-SR®.

What is the most important information I should know about Ritalin-SR®? The following have been reported with use of methylphenidate hydrochloride  and other stimulant medicines. 1. Heart-related problems: sudden death in patients who have heart problems or heart defects stroke and heart attack in adults increased blood pressure and heart rate Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting Ritalin-SR®. Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with Ritalin-SR®. Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Ritalin-SR®. 2. Mental (Psychiatric) problems: All Patients new or worse behavior and thought problems new or worse bipolar illness new or worse aggressive behavior or hostility Children and Teenagers new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Ritalin-SR®, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

What Is Ritalin-SR®?

Ritalin-SR® is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Ritalin-SR® may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Ritalin-SR® should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Ritalin-SR® is also used in the treatment of a sleep disorder called narcolepsy.

Ritalin-SR® is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Ritalin-SR® in a safe place to prevent misuse and abuse.  Selling or giving away Ritalin-SR® may harm others, and is against the law. Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take Ritalin-SR®?

Ritalin-SR® should not be taken if you or your child:

• are very anxious, tense, or agitated
  


• have an eye problem called glaucoma
  


• have tics or Tourette’s syndrome, or a family history of Tourette’s syndrome. Tics are hard to control repeated movements or sounds.
  


• are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
  


• are allergic to anything in Ritalin-SR®. See the end of this Medication Guide for a complete list of ingredients.

Ritalin-SR® should not be used in children less than 6 years old because it has not been studied in this age group.

Ritalin-SR® may not be right for you or your child. Before starting Ritalin-SR® tell your or your child’s doctor about all health conditions (or a family history of) including:

• heart problems, heart defects, high blood pressure
  


• mental problems including psychosis, mania, bipolar illness, or depression
  


• tics or Tourette’s syndrome
  


• seizures or have had an abnormal brain wave test (EEG)

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breast-feeding.

Can Ritalin-SR® be taken with other medicines?

Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. Ritalin-SR® and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Ritalin-SR®.

Your doctor will decide whether Ritalin-SR® can be taken with other medicines.

Especially tell your doctor if you or your child takes:

• anti-depression medicines including MAOIs
  


• seizure medicines
  


• blood thinner medicines
  


• blood pressure medicines
  


• cold or allergy medicines that contain decongestants

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking Ritalin-SR® without talking to your doctor first.

How should Ritalin-SR® be taken?

• Take Ritalin-SR® exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
  


• Take Ritalin-SR® 30 to 45 minutes before a meal. The effect of a dose of Ritalin-SR usually lasts about 8 hours.
  


• Do not chew or crush Ritalin-SR® tablets. Swallow Ritalin-SR® tablets whole with water or other liquids. Tell your doctor if you or your child cannot swallow Ritalin-SR® whole. A different medicine may need to be prescribed.
  


• From time to time, your doctor may stop Ritalin-SR® treatment for a while to check ADHD symptoms.
  


• Your doctor may do regular checks of the blood, heart, and blood pressure while taking Ritalin-SR®. Children should have their height and weight checked often while taking Ritalin-SR®. Ritalin-SR® treatment may be stopped if a problem is found during these check-ups.
  


• If you or your child takes too much Ritalin-SR® or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of Ritalin-SR®?

See “What is the most important information I should know about Ritalin-SR®?” for information on reported heart and mental problems.

Other serious side effects include:

• slowing of growth (height and weight) in children
  


• seizures, mainly in patients with a history of seizures
  


• eyesight changes or blurred vision

Common side effects include:

• headache             • decreased appetite
  


• stomach ache       • nervousness
  


• trouble sleeping
  


• nausea           

Talk to your doctor if you or your child has side effects that are bothersome or do not go away.

This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.

How should I store Ritalin-SR®?

• Store Ritalin-SR® in a safe place at room temperature, 59 to 86° F (15 to 30° C). Protect from moisture.
  


• Keep Ritalin-SR® and all medicines out of the reach of children.

General information about Ritalin-SR®

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Ritalin-SR® for a condition for which it was not prescribed. Do not give Ritalin-SR® to other people, even if they have the same condition. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about Ritalin-SR®. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Ritalin-SR® that was written for healthcare professionals. For more information about Ritalin-SR call 1-888-669-6682.

What are the ingredients in Ritalin-SR®?

Active Ingredient: methylphenidate HCL, USP

Inactive Ingredients: cellulose compounds, cetostearyl alcohol, lactose, magnesium stearate, mineral oil, povidone, titanium dioxide, and zein

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

REV: DECEMBER 2010                                                 T2010-119/T2009-57/T2009-58

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936

© Novartis

PRINCIPAL DISPLAY PANEL

Package Label – 5 mg

Rx Only             NDC 0078-0439-05

Ritalin® HCL 

Methylphenidate HCL USP

5 mg

100 Tablets

Dispense with Medication Guide attached or provided separately.

PRINCIPAL DISPLAY PANEL

Package Label – 10 mg

Rx Only             NDC 0078-0440-05

Ritalin® HCL 

Methylphenidate HCL USP

10 mg

100 Tablets

Dispense with Medication Guide attached or provided separately.

PRINCIPAL DISPLAY PANEL

Package Label – 20 mg

Rx Only             NDC 0078-0441-05

Ritalin® HCL 

Methylphenidate HCL USP

20 mg

100 Tablets

Dispense with Medication Guide attached or provided separately.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL – 20 MG SUSTAINED-RELEASE

Rx Only             NDC 0078-0442-05

Ritalin-SR® 

Methylphenidate HCL USP

sustained-release tablets

20 mg

100 Tablets

Dispense with Medication Guide attached or provided separately.

Ritalin  methylphenidate hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0078-0439 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE) METHYLPHENIDATE HYDROCHLORIDE 5 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   POLYETHYLENE GLYCOL   SUCROSE   TALC

Product Characteristics Color YELLOW Score no score Shape ROUN