Axid AR

Axid XR is used to treat and prevent heartburn.

This medication may be prescribed for other uses. Please contact your doctor or pharmacist for more information.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

For all patients taking Axid AR:

• Dizziness.
• Headache.
• Loose stools (diarrhea).

Children:

• Nose or throat irritation.
• Throwing up.
• Feeling irritable.
• Stuffy nose.
• Cough.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• store at 20-25°C (68-77°F)
• protect from light
• replace cap tightly after opening bottle
• keep the carton and package insert. They contain important information

colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pharmaceutical ink, polyethylene glycol, pregelatinized starch, propylene glycol, synthetic iron oxides, titanium dioxide

Other drugs may interact with nizatidine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Applies to nizatidine: oral capsules, oral tablets for

Side effects include:

Headache, dizziness.

Initial: 300 mg orally once a day at bedtime, or alternatively may use 150 mg orally twice a day.
Maintenance: 150 mg orally once a day at bedtime.

150 mg twice daily.

75 mg orally once or twice a day, taken right before or up to 60 minutes before eating.

Investigational:

Greater than 1 year (n=26): In mild to moderate reflux esophagitis: 10 mg/kg/day divided in two doses for 8 weeks.

Greater than or equal to 4 to 11 years (n=104): 6 mg/kg/day divided in two doses, one dose given at 9 PM the night before surgery, and the other given at 6:30 AM the day of surgery.

CrCl less than 20 mL/min: Initial dose: 150 mg orally every other day.
Maintenance dose: 150 mg orally every 3 days.

CrCl 20 to 50 mL/min: Initial dose: 150 mg orally once a day.
Maintenance dose: 150 mg orally every other day.

Hemodialysis: The ability of hemodialysis to remove nizatidine from the body has not been conclusively shown; however, due to its large volume of distribution, nizatidine is not expected to be efficiently removed from the body.

The duration of nizatidine therapy should generally not exceed 12 weeks.