Drugplain

CIMETIDINE 800 mg/1

CIMETIDINE · TABLET, FILM COATED · Aurobindo Pharma Limited

No Recall History
Plain English

CIMETIDINE is a tablet, film coated containing cimetidine at 800 mg/1, taken oral. Manufactured by Aurobindo Pharma Limited.

Key Facts

Brand Name
CIMETIDINE
Generic Name
CIMETIDINE
NDC Code (Product)
59651-826
Manufacturer
Aurobindo Pharma Limited
Strength
800 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA218997
Drug Class
Histamine-2 Receptor Antagonist [EPC]
Marketing Start
11/12/2024

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE 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 treatmen…

Dosage & Administration

DOSAGE AND ADMINISTRATION Duodenal Ulcer Active Duodenal Ulcer Clinical studies have indicated that suppression of nocturnal acid is the most important factor in duodenal ulcer healing (see CLINICAL PHARMACOLOGY: Antisecretory Activity: Acid Secretion ). This is supported by recent clinical trials (see CLINICAL TRIALS: Duodenal Ulcer: Active Duodenal Ulcer ). Therefore, there is no apparent rationale, except for familiarity with use, for treating with anything other than a once-daily at bedtime dosage regimen. In a U.S. dose-ranging study of 400 mg at bedtime, 800 mg at bedtime and 1600 mg at bedtime, a continuous dose-response relationship for ulcer healing was demonstrated. However, 800 mg at bedtime is the dose of choice for most patients, as it provides a high healing rate (the difference between 800 mg at bedtime and 1,600 mg at bedtime being small), maximal pain relief, a decreased potential for drug interactions (see PRECAUTIONS: Drug Interactions ) and maximal patient convenience. Patients unhealed at 4 weeks, or those with persistent symptoms, have been shown to benefit from 2 to 4 weeks of continued therapy. It has been shown that patients who both have an endoscopically …

Contraindications

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

Adverse Reactions

ADVERSE REACTIONS 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. Endocrine Gynecomastia has been reported in patients treated for 1 month or longer. In patients being treated for pathological hypersecretory states, this occurred in about 4% of cases…

Frequently Asked Questions

What is CIMETIDINE used for?

CIMETIDINE contains CIMETIDINE. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is CIMETIDINE a controlled substance?

CIMETIDINE is not classified as a controlled substance by the DEA.

What is the generic name for CIMETIDINE?

The generic name for CIMETIDINE is CIMETIDINE. There are 10 other brand versions of CIMETIDINE.

What is the NDC code for CIMETIDINE 800 mg/1?

The NDC (National Drug Code) for CIMETIDINE 800 mg/1 is 59651-826, listed by Aurobindo Pharma Limited.

Product NDC

59651-826

Package NDC

59651-826-01

Other Cimetidine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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