Cimetidine Hydrochloride Oral Solution

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Overview

What is Cimetidine Hydrochloride Oral Solution?

Cimetidine is a histamine H2-receptor antagonist. Chemically it is "-cyano--methyl--[2-[[(5-methyl-1 -imidazol-4-yl) methyl]thio]-ethyl], guanidine.

The molecular formula for cimetidine hydrochloride is CHNS●HCI and the molecular weight is 288.80. The structural formula of cimetidine hydrochloride is:

Cimetidine contains an imidazole ring, and is chemically related to histamine.

Cimetidine has a bitter taste and characteristic odor.

What does Cimetidine Hydrochloride Oral Solution look like?

What are the available doses of Cimetidine Hydrochloride Oral Solution?

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What should I talk to my health care provider before I take Cimetidine Hydrochloride Oral Solution?

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How should I use Cimetidine Hydrochloride Oral Solution?

Cimetidine Hydrochloride Oral Solution is indicated in:

What interacts with Cimetidine Hydrochloride Oral Solution?

Cimetidine is contraindicated for patients known to have hypersensitivity to the product.

What are the warnings of Cimetidine Hydrochloride Oral Solution?

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What are the precautions of Cimetidine Hydrochloride Oral Solution?

General

Symptomatic response to cimetidine therapy 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 Adverse Reactions) 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 therapy. 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 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 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 concomitantly administered cimetidine to maintain optimum therapeutic blood levels.

Alteration of pH may affect 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 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 be 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 in vitro fertilizing capacity.

Pregnancy

Pregnancy Category B: Reproduction studies have been performed in rats, rabbits and mice at doses up to 40 times the normal human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cimetidine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

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, cimetidine therapy 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 per 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 Hydrochloride Oral Solution?

To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 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 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 cimetidine treatment.

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 cimetidine-treated patients (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 know 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 H2-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 the 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 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 A-V 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 cimetidine dosage. 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 H2-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 Hydrochloride Oral Solution?

Cimetidine is contraindicated for patients known to have hypersensitivity to the product.

What might happen if I take too much Cimetidine Hydrochloride Oral Solution?

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 cimetidine 4800 mg intravenously over a 24-hour period experienced mental deterioration with reversal on Cimetidine discontinuation.

There have been two deaths in adults who have been reported to ingest over 40 grams orally on a single occasion.

How should I store and handle Cimetidine Hydrochloride Oral Solution?

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .Cimetidine Hydrochloride Oral Solution is a clear yellow, orange flavored solution containing 300 mg of cimetidine per 5 mL (teaspoonful) supplied in 8 fl oz (237 mL) amber PET containers NDC 50383-050-08 and 16 fl oz (473 mL) amber PET containers NDC 50383-050-16.Store at controlled room temperature, 15°-30°C (59°-86°F).Dispense in a tight, light-resistant container.Rx OnlyHI-TECH PHARMACAL CO., INC.Amityville, NY 11701Rev. 050:02 3/09Cimetidine Hydrochloride Oral Solution is a clear yellow, orange flavored solution containing 300 mg of cimetidine per 5 mL (teaspoonful) supplied in 8 fl oz (237 mL) amber PET containers NDC 50383-050-08 and 16 fl oz (473 mL) amber PET containers NDC 50383-050-16.Store at controlled room temperature, 15°-30°C (59°-86°F).Dispense in a tight, light-resistant container.Rx OnlyHI-TECH PHARMACAL CO., INC.Amityville, NY 11701Rev. 050:02 3/09Cimetidine Hydrochloride Oral Solution is a clear yellow, orange flavored solution containing 300 mg of cimetidine per 5 mL (teaspoonful) supplied in 8 fl oz (237 mL) amber PET containers NDC 50383-050-08 and 16 fl oz (473 mL) amber PET containers NDC 50383-050-16.Store at controlled room temperature, 15°-30°C (59°-86°F).Dispense in a tight, light-resistant container.Rx OnlyHI-TECH PHARMACAL CO., INC.Amityville, NY 11701Rev. 050:02 3/09Cimetidine Hydrochloride Oral Solution is a clear yellow, orange flavored solution containing 300 mg of cimetidine per 5 mL (teaspoonful) supplied in 8 fl oz (237 mL) amber PET containers NDC 50383-050-08 and 16 fl oz (473 mL) amber PET containers NDC 50383-050-16.Store at controlled room temperature, 15°-30°C (59°-86°F).Dispense in a tight, light-resistant container.Rx OnlyHI-TECH PHARMACAL CO., INC.Amityville, NY 11701Rev. 050:02 3/09Cimetidine Hydrochloride Oral Solution is a clear yellow, orange flavored solution containing 300 mg of cimetidine per 5 mL (teaspoonful) supplied in 8 fl oz (237 mL) amber PET containers NDC 50383-050-08 and 16 fl oz (473 mL) amber PET containers NDC 50383-050-16.Store at controlled room temperature, 15°-30°C (59°-86°F).Dispense in a tight, light-resistant container.Rx OnlyHI-TECH PHARMACAL CO., INC.Amityville, NY 11701Rev. 050:02 3/09Cimetidine Hydrochloride Oral Solution is a clear yellow, orange flavored solution containing 300 mg of cimetidine per 5 mL (teaspoonful) supplied in 8 fl oz (237 mL) amber PET containers NDC 50383-050-08 and 16 fl oz (473 mL) amber PET containers NDC 50383-050-16.Store at controlled room temperature, 15°-30°C (59°-86°F).Dispense in a tight, light-resistant container.Rx OnlyHI-TECH PHARMACAL CO., INC.Amityville, NY 11701Rev. 050:02 3/09Cimetidine Hydrochloride Oral Solution is a clear yellow, orange flavored solution containing 300 mg of cimetidine per 5 mL (teaspoonful) supplied in 8 fl oz (237 mL) amber PET containers NDC 50383-050-08 and 16 fl oz (473 mL) amber PET containers NDC 50383-050-16.Store at controlled room temperature, 15°-30°C (59°-86°F).Dispense in a tight, light-resistant container.Rx OnlyHI-TECH PHARMACAL CO., INC.Amityville, NY 11701Rev. 050:02 3/09

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Clinical Information

Chemical Structure

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Clinical Pharmacology

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 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 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 concomitantly administered cimetidine to maintain optimum therapeutic blood levels.

Alteration of pH may affect 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.

Symptomatic response to cimetidine therapy 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 Adverse Reactions) 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 therapy. In cases where discontinuation was judged necessary, the condition usually cleared within 3 to 4 days of drug withdrawal.

To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 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.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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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. 315.72

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Interactions

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