Cimetidine

Cimetidine tablets are indicated in: 1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine tablets at full dosage for longer than 6 to 8 weeks (see DOSAGE AND ADMINISTRATION: Duodenal Ulcer ). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of cimetidine tablets and antacids is not recommended, since antacids have been reported to interfere with the absorption of cimetidine. 2.

Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimetidine tablets 400 mg at bedtime for periods of up to 5 years. 3. Short-term treatment of active benign gastric ulcer. There is no information concerning usefulness of treatment periods of longer than 8 weeks. 4. Erosive gastroesophageal reflux (GERD). Erosive esophagitis diagnosed by endoscopy.

Treatment is indicated for 12 weeks for healing of lesions and control of symptoms. The use of cimetidine tablets beyond 12 weeks has not been established (see DOSAGE AND ADMINISTRATION: GERD ). 5. The treatment of pathological hypersecretory conditions (i.e., Zollinger-Ellison Syndrome, systemic mastocytosis, multiple endocrine adenomas).

Cimetidine tablets are contraindicated for patients known to have hypersensitivity to the product.

Adverse effects reported in patients taking cimetidine tablets are described as follows by body system. Incidence figures of 1 in 100 and greater are generally derived from controlled clinical studies. Gastrointestinal Diarrhea (usually mild) has been reported in approximately 1 in 100 patients. CNS Headaches, ranging from mild to severe, have been reported in 3.5% of 924 patients taking 1,600 mg/day, 2.1% of 2,225 patients taking 800 mg/day and 2.3% of 1,897 patients taking placebo.

Dizziness and somnolence (usually mild) have been reported in approximately 1 in 100 patients on either 1,600 mg/day or 800 mg/day. Reversible confusional states, e.g., mental confusion, agitation, psychosis, depression, anxiety, hallucinations, disorientation, have been reported predominantly, but not exclusively, in severely ill patients. They have usually developed within 2 to 3 days of initiation of treatment with cimetidine tablets and have cleared within 3 to 4 days of discontinuation of the drug.