H. pylori agent; anti-ulcer drug.

How The Drug Works

This drug, when combined with other drugs, acts as an anti-infective to help eliminate the bacteria that is responsible for many cases of peptic ulcer disease.

Uses

Used in combination with clarithromycin to treat active duodenal ulcers caused by H. pylori infection. Do not use ranitidine bismuth citrate alone.

Clarithromycin Therapy: If H. pylori infection is not eradicated after ranitidine bismuth citrate and clarithromycin treatment, the infection may be resistant to clarithromycin. Any patients who do not respond to this therapy should not be retreated with a regimen containing clarithromycin.

Darkening of The Tongue: The bismuth may cause a temporary and harmless darkening of the tongue or stool. Stool darkening should not be confused with blood in the stool.

Pregnancy: Adequate studies have not been done in pregnant women, or animal studies may have shown a risk to the fetus. Use only if clearly needed and potential benefits outweigh possible risks to the fetus.

Breastfeeding: It is not known if ranitidine bismuth citrate appears in breast milk. Consult your doctor before you begin breastfeeding.

Children: Safety and effectiveness in children have not been established.

Drug Interactions

Tell your doctor or pharmacist if you are taking or planning to take any over­the-counter or prescription medications or dietary supplements while taking this medicine. Doses of one or both drugs may need to be modified or a different drug may need to be prescribed. The following drugs and drug classes interact with this medicine:

Antacids

Aspirin

Side Effects

Every drug is capable of producing side effects. Many patients experience no, or minor, side effects. The frequency and severity of side effects depend on many factors including dose, duration of therapy and individual susceptibility. Possible side effects include:

Digestive Tract: Diarrhea; nausea; vomiting; constipation.

Nervous System: Headache; dizziness.

Other: Itching; gynecological problems; taste changes; sleep problems; chest pain.

Guidelines for Use

The usual dose of ranitidine bismuth citrate is 400 mg twice a day for 4 weeks in conjunction with c1arithromycin 500 mg three times a day for the first 2 weeks.

Both ranitidine bismuth citrate and clarithromycin may be taken without regard to food.

If a dose is missed, take it as soon as possible. If several hours have passed or if it is nearing time for the nextdose, do not double the dose in order to "catch up" (unless advised to do so by your doctor). If more than one dose is missed or it is necessary to establish a new dosage schedule, contact your doctor or pharmacist. Use exactly as prescribed.

The bismuth may cause a temporary and harmless darkening of the tongue or stool. Stool darkening should not be confused with blood in the stool.

May cause dizziness. Use caution while driving or performing other tasks which require alertness, coordination or physical dexterity.

Avoid alcohol, aspirin and NSAIDS (eg, ibuprofen) while taking this medicine,

Store at room temperature or in the refrigerator (36° to 86°F). Protect from moisture and light.