List Content Directory Christmas Island: April 2012

Saturday, 28 April 2012

Albac

Dosage Form: FOR ANIMAL USE ONLY
Albac®

50 Granular

Bacitracin Zinc

Type A Medicated Article

Antibacterial

For supplementing rations of chickens, turkeys, pheasants, quail, swine and cattle

Active drug ingredient

Each pound contains feed grade zinc bacitracin equivalent to 50 grams bacitracin (Master Standard).

Composition

The zinc salt of a dried fermentation product obtained by culturing Bacillus licheniformis Tracy on media adapted for microbiological production of bacitracin and calcium carbonate.

For use in the manufacture of medicated feeds only.

Mixing directions

Prepare an intermediate premix containing 5 grams per pound by mixing 1.0 lb. of Albac 50 in 9.0 lbs. of soybean meal or ground corn. Then add 0.8 to 10 lbs. of intermediate premix per ton of Type C medicated feed.

Usage levels for bacitracin from Albac 50

Species	Use for	Grams bacitracin per ton
Species	Use for	Min.	Max.
Growing chickens, turkeys and pheasants	Increased rate of weight gain and improved feed efficiency.	4	50
Growing quail (not over 5 weeks of age)	Increased rate of weight gain and improved feed efficiency.	5	20
Laying chickens	Increased egg production and improved feed efficiency.	10	25
Growing - finishing swine	Increased rate of weight gain and improved feed efficiency.	10	50
Feedlot cattle	Increased rate of weight gain and improved feed efficiency.	35 - 70 mg/head/day

Levels shown are minimum and maximum quantities.

The bacitracin zinc concentration may be varied between these levels.

Restricted Drug (California) - Use only as directed. Not for human use.

For use in dry feeds only. Not for use in liquid medicated feed.

Not for use in feeds for breeder chickens.

NADA 200-223, Approved by FDA

Marketed by

Alpharma Inc.

Bridgewater, New Jersey 08807

Net wt 50 LB (22.68 kg)

Trademarks registered

by Alpharma Inc.

004301 0909

PRINCIPAL DISPLAY PANEL - 50 Granular

Albac®

50 Granular

ALPHARMA®

Bacitracin Zinc

Type A Medicated Article

Antibacterial

Net wt 50 LB (22.68 kg)

ALPHARMA®

Albac
bacitracin zinc granule

Product Information
Product Type	OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG	NDC Product Code (Source)	46573-453
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Bacitracin Zinc (Bacitracin)	Bacitracin Zinc	50 g in 0.45 kg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	GRAY, YELLOW, BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	46573-453-00	22.68 kg In 1 BAG	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA200223	01/01/2009

Labeler - Alpharma Inc. Animal Health (070954094)

Revised: 05/2009Alpharma Inc. Animal Health

Tuesday, 24 April 2012

Geocillin

Generic Name: penicillin (Oral route, Injection route, Intravenous route, Intramuscular route)

Commonly used brand name(s)

In the U.S.

Amoxil

Bactocill

Bicillin L-A

Cloxapen

Crysticillin

Dynapen

Geocillin

Nafcil

Pfizerpen

Pipracil

Principen

Staphcillin

Ticar

Veetids

In Canada

Amoxil Pediatric

Ampicillin Sodium

Apo-Amoxi

Apo-Amoxi Sugar-Free

Apo-Cloxi

Apo-Pen-Vk

Gen-Amoxicillin

Med Amoxicillin

Nadopen V 200

Nadopen V 400

Novamoxin

Available Dosage Forms:

Powder for Suspension

Tablet

Tablet, Chewable

Tablet for Suspension

Tablet, Extended Release

Capsule

Powder for Solution

Suspension

Solution

Syrup

Uses For Geocillin

Penicillins are used to treat infections caused by bacteria. They work by killing the bacteria or preventing their growth.

There are several different kinds of penicillins. Each is used to treat different kinds of infections. One kind of penicillin usually may not be used in place of another. In addition, penicillins are used to treat bacterial infections in many different parts of the body. They are sometimes given with other antibacterial medicines (antibiotics). Some of the penicillins may also be used for other problems as determined by your doctor. However, none of the penicillins will work for colds, flu, or other virus infections.

Penicillins are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, penicillins are used in certain patients with the following medical conditions:

Chlamydia infections in pregnant women—Amoxicillin and ampicillin

Gas gangrene—Penicillin G

Helicobacter pylori-associated gastritis or peptic ulcer disease—Amoxicillin

Leptospirosis—Ampicillin and penicillin G

Lyme disease—Amoxicillin and penicillin V

Typhoid fever—Amoxicillin and ampicillin

Before Using Geocillin

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Many penicillins have been used in children and, in effective doses, are not expected to cause different side effects or problems in children than they do in adults.

Some strengths of the chewable tablets of amoxicillin contain aspartame, which is changed by the body to phenylalanine, a substance that is harmful to patients with phenylketonuria.

Geriatric

Penicillins have been used in the elderly and have not been shown to cause different side effects or problems in older people than they do in younger adults.

Pregnancy

Penicillins have not been studied in pregnant women. However, penicillins have been widely used in pregnant women and have not been shown to cause birth defects or other problems in animal studies.

Breast Feeding

Penicillins pass into the breast milk. Even though only small amounts may pass into breast milk, allergic reactions, diarrhea, fungus infections, and skin rash may occur in nursing babies.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Cyclosporine

Methotrexate

Vecuronium

Venlafaxine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of penicillin

This section provides information on the proper use of a number of products that contain penicillin. It may not be specific to Geocillin. Please read with care.

Penicillins (except bacampicillin tablets, amoxicillin, penicillin V, pivampicillin, and pivmecillinam) are best taken with a full glass (8 ounces) of water on an empty stomach (either 1 hour before or 2 hours after meals) unless otherwise directed by your doctor.

For patients taking amoxicillin, penicillin V, pivampicillin, and pivmecillinam:

Amoxicillin, penicillin V, pivampicillin, and pivmecillinam may be taken on a full or empty stomach.

The liquid form of amoxicillin may also be taken by itself or mixed with formulas, milk, fruit juice, water, ginger ale, or other cold drinks. If mixed with other liquids, take immediately after mixing. Be sure to drink all the liquid to get the full dose of medicine.

For patients taking bacampicillin:

The liquid form of this medicine is best taken with a full glass (8 ounces) of water on an empty stomach (either 1 hour before or 2 hours after meals) unless otherwise directed by your doctor.

The tablet form of this medicine may be taken on a full or empty stomach.

For patients taking penicillin G by mouth:

Do not drink acidic fruit juices (for example, orange or grapefruit juice) or other acidic beverages within 1 hour of taking penicillin G since this may keep the medicine from working properly.

For patients taking the oral liquid form of penicillins:

This medicine is to be taken by mouth even if it comes in a dropper bottle. If this medicine does not come in a dropper bottle, use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

Do not use after the expiration date on the label. The medicine may not work properly after that date. If you have any questions about this, check with your pharmacist.

For patients taking the chewable tablet form of amoxicillin:

Tablets should be chewed or crushed before they are swallowed.

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you have a ”strep” infection, you should keep taking this medicine for at least 10 days. This is especially important in ”strep” infections. Serious heart problems could develop later if your infection is not cleared up completely. Also, if you stop taking this medicine too soon, your symptoms may return.

This medicine works best when there is a constant amount in the blood or urine. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night . For example, if you are to take four doses a day, the doses should be spaced about 6 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.

Make certain your health care professional knows if you are on a low-sodium (low-salt) diet. Some of these medicines contain enough sodium to cause problems in some people.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

The number of tablets or teaspoonfuls of suspension that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking a penicillin.

For amoxicillin:
- For bacterial infections:
  - For oral dosage forms (capsules, oral suspension, tablets, and chewable tablets):
    - Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds)—250 to 500 milligrams (mg) every eight hours or 500 to 875 mg every twelve hours, depending on the type and severity of the infection.
    - Neonates and infants up to 3 months of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 15 mg per kg (6.8 mg per pound) of body weight or less every twelve hours.
    - Infants 3 months of age and older and children weighing up to 40 kg (88 lbs.)—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.7 to 13.3 mg per kg (3 to 6 mg per pound) of body weight every eight hours or 12.5 to 22.5 mg per kg (5.7 to 10.2 mg per pound) of body weight every twelve hours.
      - For duodenal ulcers (associated with Helicobacter pylori bacterial infection):
        For oral dosage forms (capsules, oral suspension, tablets, and chewable tablets):
        Adults: 1000 mg twice a day every twelve hours for fourteen days, along with the two other medicines, clarithromycin and lansoprazole, as directed by your doctor.
        
        Teenagers and children: Use and dose must be determined by your doctor.
        For dual medicine therapy—
        Adults: 1000 mg three times a day every eight hours for fourteen days, along with the other medicine, lansoprazole, as directed by your doctor.
        
        Teenagers and children: Use and dose must be determined by your doctor.

For ampicillin:
- For bacterial infections:
  - For oral dosage forms (capsules and oral suspension):
    - Adults, teenagers, and children weighing more than 20 kilograms (kg) (44 pounds)—250 to 500 milligrams (mg) every six hours.
    - Infants and children weighing up to 20 kg (44 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 12.5 to 25 mg per kg (5.7 to 11.4 mg per pound) of body weight every six hours; or 16.7 to 33.3 mg per kg (7.6 to 15 mg per pound) of body weight every eight hours.
      - For injection dosage form:
        Adults, teenagers, and children weighing more than 20 kg (44 pounds)—250 to 500 mg, injected into a vein or muscle every three to six hours.
        
        Infants and children weighing up to 20 kg (44 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 12.5 mg per kg (5.7 mg per pound) of body weight, injected into a vein or muscle every six hours.

For bacampicillin:
- For bacterial infections:
  - For oral dosage forms (oral suspension and tablets):
    - Adults, teenagers, and children weighing more than 25 kilograms (kg) (55 pounds)—400 to 800 milligrams (mg) every twelve hours.
    - Children weighing up to 25 kg (55 pounds)—Bacampicillin tablets are not recommended for use in children weighing up to 25 kg (55 pounds). The dose of the oral suspension is based on body weight and must be determined by your doctor. The usual dose is 12.5 to 25 mg per kg (5.7 to 11.4 mg per pound) of body weight every twelve hours.

For carbenicillin:
- For bacterial infections:
  - For oral dosage form (tablets):
    - Adults and teenagers—500 milligrams (mg) to 1 gram every six hours.
    - Children—Dose must be determined by your doctor.
      - For injection dosage form:
        Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The usual dose is 50 to 83.3 mg per kilogram (kg) (22.8 to 37.9 mg per pound) of body weight, injected into a vein or muscle every four hours.
        
        Older infants and children—Dose is based on body weight and must be determined by your doctor. The usual dose is 16.7 to 75 mg per kg (7.6 to 34 mg per pound) of body weight, injected into a vein or muscle every four to six hours.

For cloxacillin:
- For bacterial infections:
  - For oral dosage form (capsules and oral solution):
    - Adults, teenagers, and children weighing more than 20 kilograms (kg) (44 pounds)—250 to 500 milligrams (mg) every six hours.
    - Infants and children weighing up to 20 kg (44 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.25 to 12.5 mg per kg (2.8 to 5.7 mg per pound) of body weight every six hours.
      - For injection dosage form:
        Adults, teenagers, and children weighing more than 20 kg—250 to 500 mg, injected into a vein every six hours.
        
        Infants and children weighing up to 20 kg (44 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.25 to 12.5 mg per kg (2.8 to 5.7 mg per pound) of body weight, injected into a vein every six hours.

For dicloxacillin:
- For bacterial infections:
  - For oral dosage form (capsules and oral suspension):
    - Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds)—125 to 250 milligrams (mg) every six hours.
    - Infants and children weighing up to 40 kg (88 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 3.1 to 6.2 mg per kg (1.4 to 2.8 mg per pound) of body weight every six hours.

For flucloxacillin:
- For bacterial infections:
  - For oral dosage form (capsules and oral suspension):
    - Adults, teenagers, and children more than 12 years of age and weighing more than 40 kilograms (kg) (88 pounds)—250 to 500 milligrams (mg) every six hours.
    - Children less than 12 years of age and weighing up to 40 kg (88 pounds)—125 to 250 mg every six hours; or 6.25 to 12.5 mg per kg (2.8 to 5.7 mg per pound) of body weight every six hours.
    - Infants up to 6 months of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.25 mg per kg (2.8 mg per pound) of body weight every six hours.

For methicillin:
- For bacterial infections:
  - For injection dosage form:
    - Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds)—1 gram injected into a muscle every four to six hours; or 1 gram injected into a vein every six hours.
    - Children weighing up to 40 kg (88 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 25 milligrams (mg) per kg (11.4 mg per pound) of body weight, injected into a vein or muscle every six hours.

For mezlocillin:
- For bacterial infections:
  - For injection dosage form:
    - Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The usual dose is 33.3 to 87.5 milligrams (mg) per kilogram (kg) (15.1 to 39.8 mg per pound) of body weight, injected into a vein or muscle every four to six hours; or 3 to 4 grams every four to six hours.
    - Infants over 1 month of age and children up to 12 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 50 mg per kg (22.7 mg per pound) of body weight, injected into a vein or muscle every four hours.

For nafcillin:
- For bacterial infections:
  - For oral dosage form (capsules and tablets):
    - Adults and teenagers—250 milligrams (mg) to 1 gram every four to six hours.
    - Older infants and children—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.25 to 12.5 mg per kilogram (kg) (2.8 to 5.7 mg per pound) of body weight every six hours.
    - Newborns—Dose is based on body weight and must be determined by your doctor. The usual dose is 10 mg per kg (4.5 mg per pound) of body weight every six to eight hours.
      - For injection dosage form:
        Adults and teenagers—500 mg to 2 grams injected into a vein or muscle every four to six hours.
        
        Infants and children—Dose is based on body weight and must be determined by your doctor. The usual dose is 10 to 25 mg per kg (4.5 to 11.4 mg per pound) of body weight, injected into a muscle every twelve hours; or 10 to 40 mg per kg (4.5 to 18.2 mg per pound) of body weight, injected into a vein every four to eight hours.

For oxacillin:
- For bacterial infections:
  - For oral dosage form (capsules and oral solution):
    - Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds)—500 milligrams (mg) to 1 gram every four to six hours.
    - Children weighing up to 40 kg (88 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 12.5 to 25 mg per kg (5.7 to 11.4 mg per pound) of body weight every six hours.
      - For injection dosage form:
        Adults, teenagers, and children weighing more than 40 kg (88 pounds)—250 mg to 1 gram injected into a vein or muscle every four to six hours.
        
        Children weighing up to 40 kg (88 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 12.5 to 25 mg per kg (5.7 to 11.4 mg per pound) of body weight, injected into a vein or muscle every four to six hours.
        
        Premature infants and newborns—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.25 mg per kg (2.8 mg per pound) of body weight, injected into a vein or muscle every six hours.

For penicillin G:
- For bacterial infections:
  - For oral dosage form (oral solution, oral suspension, and tablets):
    - Adults and teenagers—200,000 to 500,000 Units (125 to 312 milligrams [mg]) every four to six hours.
    - Infants and children less than 12 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 4167 to 30,000 Units per kilogram (kg) (189 to 13,636 Units per pound) of body weight every four to eight hours.
      - For benzathine injection dosage form:
        Adults and teenagers—1,200,000 to 2,400,000 Units injected into a muscle as a single dose.
        
        Infants and children—300,000 to 1,200,000 Units injected into a muscle as a single dose; or 50,000 Units per kg (22,727 Units per pound) of body weight injected into a muscle as a single dose.
        For injection dosage forms (potassium and sodium salts):
        Adults and teenagers—1,000,000 to 5,000,000 Units, injected into a vein or muscle every four to six hours.
        
        Older infants and children—Dose is based on body weight and must be determined by your doctor. The usual dose is 8333 to 25,000 Units per kg (3788 to 11,363 Units per pound) of body weight, injected into a vein or muscle every four to six hours.
        
        Premature infants and newborns—Dose is based on body weight and must be determined by your doctor. The usual dose is 30,000 Units per kg (13,636 Units per pound) of body weight, injected into a vein or muscle every twelve hours.
        For procaine injection dosage form:
        Adults and teenagers—600,000 to 1,200,000 Units injected into a muscle once a day.
        
        Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 50,000 Units per kg (22,727 Units per pound) of body weight, injected into a muscle once a day.

For penicillin V:
- For bacterial infections:
  - For the benzathine salt oral dosage form (oral solution):
    - Adults and teenagers—200,000 to 500,000 Units every six to eight hours.
    - Children—100,000 to 250,000 Units every six to eight hours.
      - For the potassium salt oral dosage forms (oral solution, oral suspension, and tablets):
        Adults and teenagers—125 to 500 milligrams (mg) every six to eight hours.
        
        Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2.5 to 16.7 mg per kilogram (kg) (1.1 to 7.6 mg per pound) of body weight every four to eight hours.

For piperacillin:
- For bacterial infections:
  - For injection dosage form:
    - Adults and teenagers—3 to 4 grams, injected into a vein or muscle every four to six hours.
    - Infants and children—Dose must be determined by your doctor.

For pivampicillin:
- For bacterial infections:
  - For oral dosage form (oral suspension):
    - Adults, teenagers, and children 10 years of age and older—525 to 1050 milligrams (mg) two times a day.
    - Children 7 to 10 years of age—350 mg two times a day.
    - Children 4 to 6 years of age—262.5 mg two times a day.
    - Children 1 to 3 years of age—175 mg two times a day.
    - Infants 3 to 12 months of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 20 to 30 mg per kilogram (kg) (9.1 to 13.6 mg per pound) of body weight two times a day.
      - For oral dosage form (tablets):
        Adults, teenagers, and children 10 years of age and older—500 mg to 1 gram two times a day.
        
        Children up to 10 years of age—Dose must be determined by your doctor.

For pivmecillinam:
- For bacterial infections:
  - For oral dosage form (tablets):
    - Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds)—200 milligrams (mg) two to four times a day for three days.
    - Children up to 40 kg (88 pounds)—Dose must be determined by your doctor.

For ticarcillin:
- For bacterial infections:
  - For injection dosage form:
    - Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds)—3 grams injected into a vein every four hours; or 4 grams injected into a vein every six hours.
    - Children up to 40 kg (88 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 33.3 to 75 milligrams (mg) per kg (15 to 34 mg per pound) of body weight, injected into a vein every four to six hours.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Geocillin

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Penicillins may cause diarrhea in some patients.

Check with your doctor if severe diarrhea occurs. Severe diarrhea may be a sign of a serious side effect. Do not take any diarrhea medicine without first checking with your doctor. Diarrhea medicines may make your diarrhea worse or make it last longer.

For mild diarrhea, diarrhea medicine containing kaolin or attapulgite (e.g., Kaopectate tablets, Diasorb) may be taken. However, other kinds of diarrhea medicine should not be taken. They may make your diarrhea worse or make it last longer.

If you have any questions about this or if mild diarrhea continues or gets worse, check with your health care professional.

Oral contraceptives (birth control pills) containing estrogen may not work properly if you take them while you are taking ampicillin, amoxicillin, or penicillin V. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are taking any of these penicillins. If you have any questions about this, check with your health care professional.

For diabetic patients:

Penicillins may cause false test results with some urine sugar tests. Check with your doctor before changing your diet or the dosage of your diabetes medicine.

Before you have any medical tests, tell the doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Geocillin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Less common

Fast or irregular breathing

fever

joint pain

lightheadedness or fainting (sudden)

puffiness or swelling around the face

red, scaly skin

shortness of breath

skin rash, hives, itching

Check with your doctor immediately if any of the following side effects occur:

Rare

Abdominal or stomach cramps and pain (severe)

abdominal tenderness

convulsions (seizures)

decreased amount of urine

diarrhea (watery and severe), which may also be bloody

mental depression

nausea and vomiting

pain at place of injection

sore throat and fever

unusual bleeding or bruising

yellow eyes or skin

Rare - For penicillin G procaine only

Agitation or combativeness

anxiety

confusion

fear of impending death

feeling, hearing, or seeing things that are not real

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Diarrhea (mild)

headache

sore mouth or tongue

vaginal itching and discharge

white patches in the mouth and/or on the tongue

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Geocillin side effects (in more detail)

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More Geocillin resources

Geocillin Side Effects (in more detail)
Geocillin Use in Pregnancy & Breastfeeding
Drug Images
Geocillin Drug Interactions
Geocillin Support Group
11 Reviews for Geocillin - Add your own review/rating

Geocillin Prescribing Information (FDA)

Geocillin Concise Consumer Information (Cerner Multum)

Geocillin Monograph (AHFS DI)

Geocillin MedFacts Consumer Leaflet (Wolters Kluwer)

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Prevention of Perinatal Group B Streptococcal Disease
Rat-bite Fever
Rheumatic Fever Prophylaxis
Skin Infection
Strep Throat
Syphilis, Early
Syphilis, Latent
Tertiary Syphilis
Tonsillitis/Pharyngitis
Upper Respiratory Tract Infection

Monday, 23 April 2012

Ibuleve

Ibuleve may be available in the countries listed below.

Ingredient matches for Ibuleve

Ibuprofen

Ibuprofen is reported as an ingredient of Ibuleve in the following countries:

Israel

International Drug Name Search

hydrocortisone and urea topical

Generic Name: hydrocortisone and urea topical (HYE droe KOR ti sone and yoo REE a TOP ik al)

Brand names: Carmol HC (obs), Keratol HC (obsolete), Uremol HC

What is hydrocortisone and urea topical?

Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Urea is a skin softener. It is used to moisturize the skin.

Hydrocortisone and urea topical is used to treat inflammation of the skin caused by a number of conditions such as allergic reactions, eczema, or psoriasis.

Hydrocortisone and urea topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about hydrocortisone and urea topical?

Use this medication exactly as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended.

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone and urea topical.

Hydrocortisone and urea topical will not treat a bacterial, fungal, or viral skin infection.

Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

What should I discuss with my healthcare provider before using hydrocortisone and urea topical?

Do not use this medication if you are allergic to hydrocortisone.

Hydrocortisone and urea topical will not treat a bacterial, fungal, or viral skin infection.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether hydrocortisone and urea topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone and urea topical.

How should I use hydrocortisone and urea topical?

Use this medication exactly as it has been prescribed by your doctor. Do not use the medication in larger or smaller amounts, or use it for longer than recommended.

Wash your hands before and after each application, unless you are using this medication to treat a hand condition.

Apply a small amount to the affected area and rub it gently into the skin.

Avoid using this medication on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone and urea topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days. It is important to use hydrocortisone and urea topical regularly to get the most benefit. Store the medicine at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it. An overdose of hydrocortisone and urea topical applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while using hydrocortisone and urea topical?

Do not use plastic bandages, dressings, or diapers that do not allow air to circulate to the area (occlusive dressings), unless your doctor directs you to do so. The use of occlusive dressings can greatly increase the amount of drug the body absorbs. Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use hydrocortisone and urea topical on sunburned, windburned, irritated, or broken skin. Also avoid using this medication in open wounds.

Avoid using skin products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Hydrocortisone and urea topical side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

blurred vision, or seeing halos around lights;

uneven heartbeats;

sleep problems (insomnia);

weight gain, puffiness in your face; or

feeling tired.

Less serious side effects may include:

skin redness, burning, itching, or peeling;

thinning of your skin;

blistering skin; or

stretch marks.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Hydrocortisone and urea topical Dosing Information

Usual Adult Dose for Dermatological Disorders:

Apply thin film topically to affected area 2 to 4 times daily depending on the severity of the condition.

Usual Pediatric Dose for Dermatological Disorders:

Apply thin film topically to affected area 2 times daily.

What other drugs will affect hydrocortisone and urea topical?

There may be other drugs that can interact with hydrocortisone and urea. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Compare hydrocortisone and urea topical with other medications

Dermatological Disorders

Where can I get more information?

Your pharmacist can provide more information about hydrocortisone and urea topical.

See also: hydrocortisone and urea side effects (in more detail)

Wednesday, 18 April 2012

Antigout agents

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Antigout agents are also called antihyperuricemic agents. These agents work to either correct overproduction or underexcretion of uric acid.

For the long term control of gout, hyperuricemia caused by formation of uric acid from purines, can be effectively controlled with these agents. The choice of xanthine oxidase inhibitors or uricosuric medicines is based on the level of urinary uric acid excretion, renal function, age of the patient, history of renal calculi and presence of tophi.

1. Name Of The Medicinal Product

Sore Mouth Gel

2. Qualitative And Quantitative Composition

Active ingredients	Quantity % w/w
Lidocaine base	0.6
Cetylpyridinium chloride	0.02

3. Pharmaceutical Form

Oromucosal Gel

4. Clinical Particulars

4.1 Therapeutic Indications

For the rapid relief of pain caused by minor recurrent aphthous mouth ulcers.

4.2 Posology And Method Of Administration

For topical application to the mouth and gums.

Adults and children

A small quantity of gel to be applied to the sore area with a clean finger every three hours as necessary.

Babies

Not suitable.

4.3 Contraindications

Patients hypersensitive to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Keep all medicines out of the reach of children.

If symptoms persist for more than seven days consult your doctor or dentist.

Sore Mouth Gel is not suitable for the treatment of teething troubles in babies.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant drug interactions known.

4.6 Pregnancy And Lactation

The safety of Sore Mouth Gel during pregnancy and lactation has not been established but is not considered to constitute a hazard.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

Hypersensitivity reactions due to lidocaine have been reported rarely and to cetylpyridinium chloride occasionally.

4.9 Overdose

Overdosage with Sore Mouth Gel is unlikely to constitute a hazard and therefore symptomatic treatment only is necessary.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Lidocaine is a local anaesthetic of the amide type. Cetylpyridinium chloride is a cationic antiseptic.

5.2 Pharmacokinetic Properties

Lidocaine is rapidly absorbed from mucous membranes. The plasma elimination half life is about two hours.

Lidocaine undergoes significant first pass metabolism in the liver and is rapidly de-ethylated to the active metabolite monoethylglycinexylidide and then hydrolysed to various metabolites including glycinexylidide. Less than 10% is excreted unchanged by the kidneys. The metabolites are also excreted in the urine.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Refined sugar

Cetomacrogol 1000

Hypromellose

Alcohol 96%

Eucalyptol

Levomenthol synthetic or natural

Star anise oil

Purified water

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

A collapsible aluminium tube, internally lacquered with a polyamide/polyimide lacquer system with a membrane seal fitted with a wadless polythene cap or polypropylene cap.

Pack size: 15 gm.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8. Marketing Authorisation Number(S)

PL 0014/0150

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of First Authorisation: 25 June 1974

Date of Last Renewal: 16 April 2004

10. Date Of Revision Of The Text

July 2005

Tuesday, 17 April 2012

Uramaxin Pads

Generic Name: urea

Dosage Form: topical cloth
Uramaxin (45% Urea) Pads

For external use only. Not for ophthalmic use.

DESCRIPTION: Uramaxin® (45% Urea) Pads contain a 45% solution of urea on a textured cloth. Each gram of medicated solution contains 45% urea, camphor, edetate disodium, eucalyptus oil, hydroxyethyl cellulose, menthol, propylene glycol and purified water.

Urea is a diamide of carbonic acid with the following chemical structure:

CLINICAL PHARMACOLOGY: Urea gently dissolves the intercellular matrix, which results in loosening of the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas.

PHARMACOKINETICS: The mechanism of action of topically applied Urea is not yet known.

INDICATIONS AND USES: For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses.

CONTRAINDICATIONS: Known hypersensitivity to any of the listed ingredients.

WARNINGS: For external use only. Avoid contact with eyes, lips or mucous membranes.

PRECAUTIONS: This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use.

PREGNANCY: Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, Uramaxin® (45% Urea) Pads should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS: It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Uramaxin® (45% Urea) Pads is administered to a nursing woman.

KEEP THIS AND ALL MEDICATIONS OUT OF THE

REACH OF CHILDREN.

ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.

DOSAGE AND ADMINISTRATION: Gently apply Uramaxin® (45% Urea) Pad to affected area(s) twice daily, or as directed by a physician. After application, discard pad. Do not flush.

HOW SUPPLIED:Uramaxin® (45% Urea) Pads NDC 43538-260-45, are supplied in a carton containing 45 foil pouches, each with a single-use medicated cloth (15 g each).

Store at controlled room temperature 15°-30° C (59°-86° F).

Protect from freezing.

Manufactured for:

MEDIMETRIKS PHARMACEUTICALS, INC.

363 Route 46 West

Fairfield, NJ 07004-2402 USA

www.medimetriks.com

Manufactured by:

Groupe PARIMA, Inc.

Montreal, QC H4S 1X6 CANADA

URAMAXIN PADS
urea cloth

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	43538-260
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UREA (UREA)	UREA	450 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (SYNTHETIC)
EDETATE DISODIUM
EUCALYPTUS OIL
HYDROXYETHYL CELLULOSE (4000 CPS AT 1%)
LEVOMENTHOL
PROPYLENE GLYCOL
WATER

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	43538-260-45	45 POUCH In 1 CARTON	contains a POUCH
1		15 g In 1 POUCH	This package is contained within the CARTON (43538-260-45)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/07/2010

Labeler - Medimetriks Pharmaceuticals, Inc. (019903816)

Registrant - Groupe PARIMA, Inc. (252437850)

Establishment
Name	Address	ID/FEI	Operations
Groupe PARIMA, Inc.		252437850	manufacture

Revised: 10/2010Medimetriks Pharmaceuticals, Inc.

More Uramaxin Pads resources

Uramaxin Pads Side Effects (in more detail)
Uramaxin Pads Use in Pregnancy & Breastfeeding
Uramaxin Pads Support Group
0 Reviews for Uramaxins - Add your own review/rating

Compare Uramaxin Pads with other medications

Dermatological Disorders
Dry Skin
Pityriasis rubra pilaris

Friday, 13 April 2012

lansoprazole and naproxen

lan-SOE-pra-zole, na-PROX-en

Oral routeKit

CARDIOVASCULAR RISK
- NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk

Naproxen is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery .

GASTROINTESTINAL RISK
- NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events .

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Naproxen is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s):

In the U.S.

Prevacid NapraPAC

Available Dosage Forms:

Tablet

Capsule, Delayed Release

Uses For lansoprazole and naproxen

Lansoprazole and naproxen combination is used to relieve the symptoms of ankylosing spondylitis, osteoarthritis, and rheumatoid arthritis. It is used for patients who have had stomach ulcers and who need to take a nonsteroidal anti-inflammatory drug (NSAID) for arthritis.

Lansoprazole is a proton pump inhibitor (PPI) that is used to treat certain conditions (e.g., duodenal and gastric ulcers) where there is too much acid in the stomach. Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that is used to treat pain and the symptoms of arthritis, such as inflammation, swelling, stiffness, and joint pain.

lansoprazole and naproxen is available only with your doctor's prescription.

Before Using lansoprazole and naproxen

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For lansoprazole and naproxen, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to lansoprazole and naproxen or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of lansoprazole and naproxen combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lansoprazole and naproxen combination in the elderly. However, elderly patients may be more sensitive to the effects of lansoprazole and naproxen combination than younger adults, and are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving lansoprazole and naproxen.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Lansoprazole

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Naproxen

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Using lansoprazole and naproxen with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Ketorolac

Using lansoprazole and naproxen with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Ardeparin

Atazanavir

Beta Glucan

Certoparin

Clopidogrel

Dalteparin

Danaparoid

Dasatinib

Delavirdine

Enoxaparin

Erlotinib

Ginkgo

Methotrexate

Mycophenolate Mofetil

Nadroparin

Nelfinavir

Parnaparin

Pemetrexed

Reviparin

Tacrolimus

Tinzaparin

Warfarin

Using lansoprazole and naproxen with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acenocoumarol

Acetohexamide

Alacepril

Aluminum Carbonate, Basic

Aluminum Hydroxide

Aluminum Phosphate

Amiloride

Azosemide

Bemetizide

Benazepril

Bendroflumethiazide

Benzthiazide

Bumetanide

Buthiazide

Calcium Carbonate

Candesartan Cilexetil

Canrenoate

Captopril

Chlorothiazide

Chlorpropamide

Chlorthalidone

Cilazapril

Citalopram

Clopamide

Clopidogrel

Clovoxamine

Cranberry

Cyclopenthiazide

Cyclosporine

Cyclothiazide

Delapril

Desvenlafaxine

Dicumarol

Dihydroxyaluminum Aminoacetate

Dihydroxyaluminum Sodium Carbonate

Duloxetine

Enalaprilat

Enalapril Maleate

Eprosartan

Escitalopram

Ethacrynic Acid

Femoxetine

Flesinoxan

Fluoxetine

Fluvoxamine

Fosinopril

Furosemide

Gliclazide

Glimepiride

Glipizide

Gliquidone

Glyburide

Hydrochlorothiazide

Hydroflumethiazide

Imidapril

Indapamide

Irbesartan

Lisinopril

Losartan

Magaldrate

Magnesium Carbonate

Magnesium Hydroxide

Magnesium Oxide

Magnesium Trisilicate

Methyclothiazide

Metolazone

Milnacipran

Moexipril

Nefazodone

Olmesartan Medoxomil

Paroxetine

Pentopril

Perindopril

Phenprocoumon

Piretanide

Polythiazide

Quinapril

Quinethazone

Ramipril

Sertraline

Spirapril

Spironolactone

Tasosartan

Telmisartan

Temocapril

Tolazamide

Tolbutamide

Torsemide

Trandolapril

Triamterene

Trichlormethiazide

Valsartan

Venlafaxine

Warfarin

Xipamide

Zimeldine

Zofenopril

Interactions with Food/Tobacco/Alcohol

Proper Use of lansoprazole and naproxen

Use lansoprazole and naproxen exactly as ordered by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of lansoprazole and naproxen may increase the chance of unwanted effects, especially in elderly patients.

lansoprazole and naproxen should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

lansoprazole and naproxen is packaged as a kit. The kit contains two different medicines that are used together for 7 days or 28 days. Each daily dose consists of one Prevacid® capsule and two Naprosyn® tablets.

It is best to take lansoprazole and naproxen on an empty stomach, but take your medicine with a glass of water.

Swallow the Prevacid® capsule whole. Do not break, crush, or chew it. If you are also taking sucralfate, take the Prevacid® capsule 30 minutes before sucralfate.

Dosing

The dose of lansoprazole and naproxen will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of lansoprazole and naproxen. If your dose is different, do not change it unless your doctor tells you to do so.

For oral dosage forms (capsules and tablets):
- For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
  - Adults—One Prevacid® capsule and one Naprosyn® tablet in the morning before eating. Take the second Naprosyn® tablet in the evening.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of lansoprazole and naproxen, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using lansoprazole and naproxen

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Naproxen may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use lansoprazole and naproxen for a long time might also have a higher risk.

Naproxen may cause bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (such as steroids or a blood thinner).

lansoprazole and naproxen may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using lansoprazole and naproxen.

Serious skin reactions can occur during treatment with lansoprazole and naproxen. Check with your doctor right away if you have any of the following symptoms while taking lansoprazole and naproxen: blistering, peeling, loosening of the skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores ulcers, white spots in the mouth or on the lips, or unusual tiredness or weakness.

Using lansoprazole and naproxen during late pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Check with your doctor right away if you have any symptoms of liver problems including dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellowing of your skin or the whites of your eyes.

lansoprazole and naproxen may cause some people to become dizzy, drowsy, depressed, or less alert than they are normally. Make sure you know how you react to lansoprazole and naproxen before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Before having any kind of surgery or medical tests, tell your doctor that you are taking lansoprazole and naproxen. It may be necessary for you to stop the medicine for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

lansoprazole and naproxen Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Abdominal or stomach pain, cramping, or burning

black, tarry stools

bruising

constipation

diarrhea

difficult or labored breathing

heartburn

indigestion

large, flat, blue, or purplish patches in the skin

nausea

pale skin

shortness of breath

skin blisters

swelling

tightness in the chest

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

wheezing

Less common

Irregular heartbeat

pinpoint red or purple spots on the skin

sweating

thirst

Rare

Abdominal or stomach fullness

abdominal or stomach pain with gas

ankle, knee, or great toe joint pain

anxiety

arm, back, or jaw pain

back, leg, or stomach pains

bladder pain

bleeding from rectum or bloody stools

bleeding gums

blistering, burning, crusting, dryness, or flaking of the skin

blistering, peeling, or loosening of the skin

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine or stools

bloody nose

bloody or cloudy urine

blue lips and fingernails

blurred vision

body aches or pain

burning while urinating

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

canker sores

change in consciousness

changes in menstrual periods

chest pain, discomfort, or burning

chest tightness or heaviness

clay-colored stools

cold, clammy skin

cold sweats

confusion

congestion

cool, pale skin

cough increased

cough or hoarseness

cough producing mucus

coughing or spitting up blood

coughing that sometimes produces a pink frothy sputum

cracks in the skin

dark-colored urine

decrease in the amount of urine

decreased frequency or amount of urine

decreased sexual ability in males

decreased urination

decreased urine output

depression

difficult or troubled breathing

difficult, burning, or painful urination

difficult, fast, or noisy breathing, sometimes with wheezing

difficulty with swallowing

dilated neck veins

dizziness

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

dry cough

dry mouth

dry skin and hair

dry, puffy skin

dryness or soreness of the throat

extreme fatigue

fainting

fast, irregular, pounding, or racing heartbeat or pulse

fast, weak pulse feeling

feeling of warmth or heat

fever with or without chills

fluid-filled skin blisters

flushed, dry skin

flushing or redness of the skin, especially on the face and neck

frequent strong or increased urge to urinate

frequent urge to defecate or urinate

fruit-like breath odor

general body swelling

general feeling of discomfort or illness

general feeling of tiredness or weakness

greatly decreased frequency of urination or amount of urine

hair loss

headache

high blood pressure

high fever

hives

inability to speak

increase in heart rate

increased blood pressure

increased clear or white vaginal discharge

increased hunger

increased need to urinate

increased sweating

increased thirst

increased urination

irregular, fast or slow, or shallow breathing

itching, scaling, severe redness, soreness, or swelling of the skin

joint or muscle pain

joint stiffness or swelling

kidney pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

light-colored stools

lightheadedness, dizziness, or fainting

loss of appetite

loss of consciousness

loss of heat from the body

lower back or side pain

muscle cramps and stiffness

neck pain

nervousness

nightmares

noisy breathing

nosebleeds

numbness or tingling in the hands, feet, or lips

pain

pain in the ankles or knees

pain in the groin or genitals

pain or burning in the throat

pain or discomfort in the arms, jaw, back, or neck

pain or tenderness around the eyes and cheekbones

pain with swallowing

painful, red lumps under the skin, mostly on the legs

pains in the stomach, side, or abdomen, possibly radiating to the back

pale or blue lips, fingernails, or skin

passing of gas

passing urine more often

pounding in the ears

rapid weight gain

rapid, shallow breathing

rash

rectal bleeding

recurrent fever

red skin lesions, often with a purple center

red, irritated eyes

red, swollen skin

redness, soreness, or itching skin

runny nose

scaly skin

seizures

sensitivity to the sun

severe and continuing nausea

severe or continuing stomach pain

severe or sudden headache

severe stomach pain, cramping, or burning

shakiness in the legs, arms, hands, or feet

sharp back pain just below ribs

shivering

skin thinness

slurred speech

sneezing

sore throat

sores, ulcers, or white spots on the lips or tongue or inside the mouth

sores, welting, or blisters

stiff neck or back

stomach pain, continuing

stomach pain, fullness, or discomfort

straining while passing stool

sudden decrease in amount of urine

sunken eyes

swelling of the face, fingers, feet, or lower legs

swelling of the front part of the neck

swollen, painful, or tender lymph glands in the neck, armpit, or groin

temporary blindness

tenderness

thirst

tiredness

trouble with sleeping

trouble with swallowing

troubled breathing with exertion

unexplained bleeding or bruising

unexplained weight loss

unpleasant breath odor

unusual weight gain or loss

upper right abdominal pain

voice changes

vomiting

watery or bloody diarrhea

weakness in the arm or leg on one side of the body, sudden and severe

weakness or heaviness of the legs

weight gain or loss

wrinkled skin

yellow eyes and skin

Incidence not known

Change in mental status

clay colored stools

decrease in frequency of urination

decreased appetite

difficulty in passing urine (dribbling)

difficulty with speaking

difficulty with swallowing

greatly decreased frequency of urination or amount of urine

nosebleeds

pains in the stomach, side, or abdomen, possibly radiating to the back

More common

Absent missed or irregular menstrual periods

belching

continuing ringing or buzzing or other unexplained noise in the ears

excess air or gas in the stomach or intestines

hearing loss

pain in the chest below the breastbone

passing gas

sleepiness

stopping of menstrual bleeding

Less common

Acid or sour stomach

change in hearing

disturbed color perception

double vision

feeling of constant movement of self or surroundings

loss of hearing

night blindness

overbright appearance of lights

seeing halos around lights

sensation of spinning

swelling or inflammation of the mouth

tunnel vision

Rare

Abnormal dreams

abnormal menses

abnormal stools

bad breath

blemishes on the skin

bone deformity

breast enlargement, pain, or tenderness

breath odor

burning feeling in the chest or stomach

burning, dry, or itching eyes

change in ability to see colors, especially blue or yellow

change in color vision

change in hearing

changes in vision

cold sweats

coma

continuing ringing or buzzing or other unexplained noise in the ears

cool, pale skin

cramps

crying

deafness

decrease in height

decrease or change in vision

decreased interest in sexual intercourse

decreased vision

depersonalization

difficulty seeing at night

discharge, excessive tearing

discoloration of the fingernails or toenails

discouragement

double vision

drooping upper eyelids

dysphoria

earache

enlarged abdomen

euphoria

excessive muscle tone

eye pain

fear

fecal discoloration

feeling of constant movement of self or surroundings

feeling of unreality

feeling sad or empty

fruit-like breath odor

hair loss or thinning of the hair

headache, severe and throbbing

heavy bleeding

hiccup

hostility

hyperventilation

impaired vision

inability to concentrate

inability to have or keep an erection

inability to move the legs or arms

increase in body movements

increased in sexual ability, desire, drive, or performance

increased interest in sexual intercourse

increased salivation

increased sensitivity of the skin to sunlight

irritability

itching of the vagina or genital area

lack of appetite

lack of feeling or emotion

lack or loss of strength

leg cramps

longer or heavier menstrual periods

loss of interest or pleasure

loss of memory

loss of strength or energy

mood or mental changes

mouth ulceration

muscle aching or cramping

muscle or bone pain

muscle tension or tightness

muscle weakness

neck pain or rigidity

nightmares

pain during sexual intercourse

pain in the back, ribs, arms, or legs

paralysis of one side of the body

paranoia

passing gas

pelvic pain

persistent non-healing sore

pimples

poor insight and judgment

problems with memory or speech

quick to react or overreact emotionally

rapidly changing moods

rash with flat lesions or small raised lesions on the skin

red-green color blindness

reddish patch or irritated area

redness or other discoloration of the skin

redness or swelling in the arms or legs

redness or swelling in the ear

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

redness, swelling, or soreness of the tongue

restlessness

seeing double

seeing, hearing, or feeling things that are not there

seizures

sensation of spinning

sense of detachment from self or body

severe sunburn

shiny bump

skin disorder

sleep disorder

swelling of the breasts or breast soreness in both females and males

swelling or inflammation of the mouth

taste loss

tearing

thick, white vaginal discharge with no odor or with a mild odor

tiredness

transient, mild, pleasant aromatic odor

trouble performing routine tasks, recognizing objects, thinking and planning, or walking

uncaring

unexplained weight loss

urethral pain

white patches with diaper rash

white, yellow, or waxy scar-like area

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.

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1. Name Of The Medicinal Product

2. Qualitative And Quantitative Composition

3. Pharmaceutical Form

4. Clinical Particulars

4.1 Therapeutic Indications

4.2 Posology And Method Of Administration

4.3 Contraindications

4.4 Special Warnings And Precautions For Use

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

4.6 Pregnancy And Lactation

4.7 Effects On Ability To Drive And Use Machines

4.8 Undesirable Effects

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5.1 Pharmacodynamic Properties

5.2 Pharmacokinetic Properties

5.3 Preclinical Safety Data

6. Pharmaceutical Particulars

6.1 List Of Excipients

6.2 Incompatibilities

6.3 Shelf Life

6.4 Special Precautions For Storage

6.5 Nature And Contents Of Container

6.6 Special Precautions For Disposal And Other Handling

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