CIMETIDINE HYDROCHLORIDE 300 mg/5mL
CIMETIDINE HYDROCHLORIDE · SOLUTION · Chartwell RX, LLC
CIMETIDINE HYDROCHLORIDE is a solution containing cimetidine hydrochloride at 300 mg/5mL, taken oral. Manufactured by Chartwell RX, LLC.
Key Facts
- Brand Name
- CIMETIDINE HYDROCHLORIDE
- Generic Name
- CIMETIDINE HYDROCHLORIDE
- NDC Code (Product)
62135-809- Manufacturer
- Chartwell RX, LLC
- Strength
- 300 mg/5mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA074251
- Marketing Start
- 12/22/1994
Recall History
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Cimetidine Hydrochloride Oral Solution is indicated in: (1) Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine 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 oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of oral 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 400 mg h.s. 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 disease (GERD). Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for 12 weeks for healing of lesions and control of symptoms. The use of cimetidine beyond 12 weeks has not been established (see Dosage and Administration-GERD ). (5) The treatm…
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 Pharmacology-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 (h.s.). In a U.S. oral dose-ranging study of 400 mg h.s., 800 mg h.s. and 1600 mg h.s., a continuous dose response relationship for ulcer healing was demonstrated. However, 800 mg h.s. is the dose of choice for most patients, as it provides a high healing rate (the difference between 800 mg h.s. and 1600 mg h.s. 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 two to four weeks of continued therapy. It has been shown that patients who both have an endoscopically de…
Contraindications
CONTRAINDICATIONS Cimetidine is contraindicated for patients known to have hypersensitivity to the product.
Drug Interactions
Drug Interactions Cimetidine, apparently through an effect on certain microsomal enzyme systems, has been reported to reduce the hepatic metabolism of warfarin-type anticoagulants, phenytoin, propranolol, nifedipine, chlordiazepoxide, diazepam, certain tricyclic antidepressants, lidocaine, theophylline and metronidazole, thereby delaying elimination and increasing blood levels of these drugs. Clinically significant effects have been reported with the warfarin anticoagulants; therefore, close monitoring of prothrombin time is recommended, and adjustment of the anticoagulant dose may be necessary when cimetidine is administered concomitantly. Interaction with phenytoin, lidocaine and theophylline has also been reported to produce adverse clinical effects. However, a crossover study in healthy subjects receiving either cimetidine 300 mg q.i.d. or 800 mg h.s. concomitantly with a 300 mg b.i.d. dosage of theophylline extended-release tablets demonstrated less alteration in steady-state theophylline peak serum levels with the 800 mg h.s. regimen, particularly in subjects aged 54 years and older. Data beyond ten days are not available (Note: All patients receiving theophylline should be m…
Adverse Reactions
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact PAI Pharma at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Adverse effects reported in patients taking cimetidine are described below 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 1600 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 1600 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 cimetidine therapy and have cleared within 3 to 4 days of discontinuation of the drug. Endocrine Gynecomastia has been reported in patients treated for one month or longer. In …
Frequently Asked Questions
What is CIMETIDINE HYDROCHLORIDE used for?
CIMETIDINE HYDROCHLORIDE contains CIMETIDINE HYDROCHLORIDE. It is a solution taken oral. Consult your doctor for specific uses.
Is CIMETIDINE HYDROCHLORIDE a controlled substance?
CIMETIDINE HYDROCHLORIDE is not classified as a controlled substance by the DEA.
What is the generic name for CIMETIDINE HYDROCHLORIDE?
The generic name for CIMETIDINE HYDROCHLORIDE is CIMETIDINE HYDROCHLORIDE. There are 1 other brand versions of CIMETIDINE HYDROCHLORIDE.
What is the NDC code for CIMETIDINE HYDROCHLORIDE 300 mg/5mL?
The NDC (National Drug Code) for CIMETIDINE HYDROCHLORIDE 300 mg/5mL is 62135-809, listed by Chartwell RX, LLC.