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CIMETIDINE
Overview
What is CIMETIDINE?
Cimetidine is a histamine H-receptor antagonist. Chemically it is "-cyano--methyl-'-[2-[[(5-methyl-1-imidazol-4-yl)methyl]thio]-ethyl]-guanidine. Its structural formula is:
CHNS M.W. 252.34
Cimetidine contains an imidazole ring, and is chemically related to histamine.
Cimetidine has a bitter taste and characteristic odor.
Cimetidine is soluble in alcohol, slightly soluble in water, very slightly soluble in chloroform and insoluble in ether.
Each film-coated tablet, for oral administration, contains 300 mg, 400 mg or 800 mg of cimetidine. In addition, each tablet contains the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide.
What does CIMETIDINE look like?
What are the available doses of CIMETIDINE?
Sorry No records found.
What should I talk to my health care provider before I take CIMETIDINE?
Sorry No records found
How should I use CIMETIDINE?
Cimetidine tablets are indicated in:
1) Short-term treatment of active duodenal ulcer.
DOSAGE AND ADMINISTRATION
Duodenal Ulcer
2) Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer.
3) Short-term treatment of active benign gastric ulcer.
4) Erosive gastroesophageal reflux disease (GERD).
DOSAGE AND ADMINISTRATION
GERD
5) The treatment of pathological hypersecretory conditions
What interacts with CIMETIDINE?
Cimetidine is contraindicated for patients known to have hypersensitivity to the product.
What are the warnings of CIMETIDINE?
Sorry No Records found
What are the precautions of CIMETIDINE?
General
Rare instances of cardiac arrythmias and hypotension have been reported following the rapid administration of cimetidine hydrochloride injection by intravenous bolus.
Symptomatic response to treatment with cimetidine does not preclude the presence of a gastric malignancy. There have been rare reports of transient healing of gastric ulcers despite subsequently documented malignancy.
Reversible confusional states (see ) have been observed on occasion, predominantly, but not exclusively, in severely ill patients. Advancing age (50 or more years) and preexisting liver and/or renal disease appear to be contributing factors. In some patients these confusional states have been mild and have not required discontinuation of cimetidine. In cases where discontinuation was judged necessary, the condition usually cleared within 3 to 4 days of drug withdrawal.
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 300 mg four times daily or 800 mg at bedtime of cimetidine concomitantly with a 300 mg twice daily dosage of theophylline (Theo-Dur®) demonstrated less alteration in steady-state theophylline peak serum levels with the 800 mg at bedtime regimen, particularly in subjects aged 54 years and older. Data beyond ten days are not available. (Note: All patients receiving theophylline should be monitored appropriately, regardless of concomitant drug therapy.)
Dosage of the drugs mentioned above and other similarly metabolized drugs, particularly those of low therapeutic ratio or in patients with renal and/or hepatic impairment, may require adjustment when starting or stopping the concomitant administration of cimetidine to maintain optimum therapeutic blood levels.
Alteration of pH may affect the absorption of certain drugs (e.g., ketoconazole). If these products are needed, they should be given at least 2 hours before cimetidine administration.
Additional clinical experience may reveal other drugs affected by the concomitant administration of cimetidine.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 24-month toxicity study conducted in rats, at dose levels of 150, 378 and 950 mg/kg/day (approximately 8 to 48 times the recommended human dose), there was a small increase in the incidence of benign Leydig cell tumors in each dose group; when the combined drug-treated groups and control groups were compared, this increase reached statistical significance. In a subsequent 24-month study, there were no differences between the rats receiving 150 mg/kg/day and the untreated controls. However, a statistically significant increase in benign Leydig cell tumor incidence was seen in the rats that received 378 and 950 mg/kg/day. These tumors were common in control groups as well as treated groups and the difference became apparent only in aged rats.
Cimetidine has demonstrated a weak antiandrogenic effect. In animal studies this was manifested as reduced prostate and seminal vesicle weights. However, there was no impairment of mating performance or fertility, nor any harm to the fetus in these animals at doses 8 to 48 times the full therapeutic dose of cimetidine, as compared with controls. The cases of gynecomastia seen in patients treated for one month or longer may be related to this effect.
In human studies, cimetidine has been shown to have no effect on spermatogenesis, sperm count, motility, morphology or fertilizing capacity.
Pregnancy
Nursing Mothers
Cimetidine is secreted in human milk and, as a general rule, nursing should not be undertaken while a patient is on a drug.
Pediatric Use
Clinical experience in pediatric patients is limited. Therefore, therapy with cimetidine cannot be recommended for pediatric patients under 16, unless, in the judgement of the physician, anticipated benefits outweigh the potential risks. In very limited experience, doses of 20 to 40 mg/kg/day have been used.
Immunocompromised Patients
In immunocompromised patients, decreased gastric acidity, including that produced by acid-suppressing agents such as cimetidine, may increase the possibility of a hyperinfection of strongyloidiasis.
What are the side effects of CIMETIDINE?
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 treatment with cimetidine 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 patients being treated for pathological hypersecretory states, this occurred in about 4% of cases while in all others the incidence was 0.3% to 1% in various studies. No evidence of induced endocrine dysfunction was found, and the condition remained unchanged or returned toward normal with continuing treatment with cimetidine.
Reversible impotence has been reported in patients with pathological hypersecretory disorders, e.g., Zollinger-Ellison Syndrome, receiving cimetidine, particularly in high doses, for at least 12 months (range 12 to 79 months, mean 38 months). However, in large-scale surveillance studies at regular dosage, the incidence has not exceeded that commonly reported in the general population.
Hematologic
Decreased white blood cell counts in patients treated with cimetidine (approximately 1 per 100,000 patients), including agranulocytosis (approximately 3 per million patients), have been reported, including a few reports of recurrence on rechallenge. Most of these reports were in patients who had serious concomitant illnesses and received drugs and/or treatment known to produce neutropenia. Thrombocytopenia (approximately 3 per million patients) and, very rarely, cases of pancytopenia or aplastic anemia have also been reported. As with some other H-receptor antagonists, there have been extremely rare reports of immune hemolytic anemia.
Hepatobiliary
Dose-related increases in serum transaminase have been reported. In most cases they did not progress with continued therapy and returned to normal at the end of therapy. There have been rare reports of cholestatic or mixed cholestatic-hepatocellular effects. These were usually reversible. Because of the predominance of cholestatic features, severe parenchymal injury is considered highly unlikely. However, as in the occasional liver injury with other H-receptor antagonists, in exceedingly rare circumstances fatal outcomes have been reported.
There has been reported a single case of biopsy-proven periportal hepatic fibrosis in a patient receiving cimetidine.
Rare cases of pancreatitis, which cleared on withdrawal of the drug, have been reported.
Hypersensitivity
Rare cases of fever and allergic reactions including anaphylaxis and hypersensitivity vasculitis, which cleared on withdrawal of the drug, have been reported.
Renal
Small, possibly dose-related increases in plasma creatinine, presumably due to competition for renal tubular secretion, are not uncommon and do not signify deteriorating renal function. Rare cases of interstitial nephritis and urinary retention, which cleared on withdrawal of the drug, have been reported.
Cardiovascular
Rare cases of bradycardia, tachycardia and AV heart block have been reported with H-receptor antagonists.
Musculoskeletal
There have been rare reports of reversible arthralgia and myalgia; exacerbation of joint symptoms in patients with preexisting arthritis has also been reported. Such symptoms have usually been alleviated by a reduction in the dosage of cimetidine. Rare cases of polymyositis have been reported, but no causal relationship has been established.
Integumental
Mild rash and, very rarely, cases of severe generalized skin reactions including Stevens-Johnson syndrome, epidermal necrolysis, erythema multiforme, exfoliative dermatitis and generalized exfoliative erythroderma have been reported with H-receptor antagonists. Reversible alopecia has been reported very rarely.
Immune function
There have been extremely rare reports of strongyloidiasis hyperinfection in immunocompromised patients.
What should I look out for while using CIMETIDINE?
Cimetidine is contraindicated for patients known to have hypersensitivity to the product.
What might happen if I take too much CIMETIDINE?
Studies in animals indicate that toxic doses are associated with respiratory failure and tachycardia that may be controlled by assisted respiration and the administration of a beta-blocker.
Reported acute ingestions orally of up to 20 grams have been associated with transient adverse effects similar to those encountered in normal clinical experience. The usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring, and supportive therapy should be employed.
There have been reports of severe CNS symptoms, including unresponsiveness, following ingestion of between 20 and 40 grams of cimetidine, and extremely rare reports following concomitant use of multiple CNS-active medications and ingestion of cimetidine at doses less than 20 grams. An elderly, terminally ill dehydrated patient with organic brain syndrome receiving concomitant antipsychotic agents and 4800 mg of cimetidine intravenously over a 24-hour period experienced mental deterioration with reversal on discontinuation.
There have been two deaths in adults who were reported to have ingested over 40 grams orally on a single occasion of cimetidine.
How should I store and handle CIMETIDINE?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Cimetidine competitively inhibits the action of histamine at the histamine H-receptors of the parietal cells and thus is a histamine H-receptor antagonist.
Cimetidine is not an anticholinergic agent. Studies have shown that cimetidine inhibits both daytime and nocturnal basal gastric acid secretion. Cimetidine also inhibits gastric acid secretion stimulated by food, histamine, pentagastrin, caffeine and insulin.
Non-Clinical Toxicology
Cimetidine is contraindicated for patients known to have hypersensitivity to the product.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 300 mg four times daily or 800 mg at bedtime of cimetidine concomitantly with a 300 mg twice daily dosage of theophylline (Theo-Dur®) demonstrated less alteration in steady-state theophylline peak serum levels with the 800 mg at bedtime regimen, particularly in subjects aged 54 years and older. Data beyond ten days are not available. (Note: All patients receiving theophylline should be monitored appropriately, regardless of concomitant drug therapy.)
Dosage of the drugs mentioned above and other similarly metabolized drugs, particularly those of low therapeutic ratio or in patients with renal and/or hepatic impairment, may require adjustment when starting or stopping the concomitant administration of cimetidine to maintain optimum therapeutic blood levels.
Alteration of pH may affect the absorption of certain drugs (e.g., ketoconazole). If these products are needed, they should be given at least 2 hours before cimetidine administration.
Additional clinical experience may reveal other drugs affected by the concomitant administration of cimetidine.
Rare instances of cardiac arrythmias and hypotension have been reported following the rapid administration of cimetidine hydrochloride injection by intravenous bolus.
Symptomatic response to treatment with cimetidine does not preclude the presence of a gastric malignancy. There have been rare reports of transient healing of gastric ulcers despite subsequently documented malignancy.
Reversible confusional states (see ) have been observed on occasion, predominantly, but not exclusively, in severely ill patients. Advancing age (50 or more years) and preexisting liver and/or renal disease appear to be contributing factors. In some patients these confusional states have been mild and have not required discontinuation of cimetidine. In cases where discontinuation was judged necessary, the condition usually cleared within 3 to 4 days of drug withdrawal.
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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