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CIMETIDINE is a brand name for Cimetidine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: CIMETIDINE (Cimetidine) is primary therapy - for conditions where the inhibition of gastric acid secretion is likely to be beneficial such as: • Duodenal ulcer therapy. • Non-malignant gastric ulcer therapy. • Prophylaxis of recurrent duodenal or gastric ulcer. • Gastroesophageal reflux disease. • Pathological…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing considerations Dosage adjustment for patients with impaired renal function: Patients with severely impaired renal function have been treated with cimetidine; however, such usage has been very limited. On the basis of this experience, the recommended dosage is 300 mg every 12 hours orally.
Should the patient’s condition require, the frequency of dosing may be increased to every 8 hours or even further with caution. In se vere renal failure accumulation may occur and the lowest frequency of dosing compatible with an adequate CIMETIDINE (Cimetidine) Page 5 of 28 patient response should be used.
When liver impairment is also present, further reductions in dosage may be necessary. Hemodialysis: Hemodialysis reduces the level of circulating cimetidine. Greater than 80% of a 300 mg intravenous dose is cleared in a single 4 hour period of hemodialysis.
It is completely cleared in an 8 hour period. Ideally, the dosage schedule should be adjusted so that the timing of a scheduled dose is administered after dialysis treatment. Peritoneal Dialysis: Peritoneal dialysis does not appear to remove cimetidine to any appreciable extent.
2 Recommended Dose and Dosage Adjustment In clinical studies, cimetidine has been used in divided doses of up to 2400 mg/day in adults.
Duodenal Ulcer and Non-Malignant Gastric Ulcer: For active ulcer:
The recommended adult oral dose is 800 to 1200 mg per day. This may be given as follows: 800 mg once daily at bedtime; or 600 mg twice daily, at breakfast and bedtime; or 300 mg four times daily with meals and at bedtime. In some patients, 400 mg twice daily has been shown to be effective.
While healing with cimetidine may occur during the first week or two, treatment should be continued for at least four weeks for duodenal ulcer and at least six weeks for non-malignant gastric ulcer unless healing has been demonstrated by endoscopic examination.
While some patients may require concomitant antacids initially, cimetidine alone has been shown to promote rapid relief of symptoms. Prophylaxis of Recurrent Duodenal or Gastric Ulcer: For most adult patients the following regimens have been shown to be effective: 400 mg once daily at bedtime; or 300 mg twice daily, at breakfast and bedtime.
1 Adverse Reaction Overview The following overview of adverse reactions contains information obtained from both clinical trials and post-market data. CIMETIDINE (Cimetidine) Page 9 of 28 Cardiovascular Rare occurrences of sinus bradycardia, tachycardia, heart block and anaphylaxis have been reported in patients treated with H2 antagonists.
CNS Tiredness, and dizziness have been reported in a small number of patients during treatment with cimetidine. A few cases of reversible confusional states have been reported, usually in elderly and/or severely ill patients, such as those with renal insufficiency or organic brain syndrome.
These confusional states generally cleared within a few days of drug withdrawal. Hallucination has been reported very rarely. Depression has been reported infrequently. Endocrine There have been reports that a few patients have developed reversible nonprogressive gynecomastia during prolonged treatment.
No evidence of induced endocrine dysfunction was found, and the condition remained unchanged or returned toward normal with continuing cimetidine treatment. No effect of cimetidine (in recommended doses) on spermatogenesis, sperm count, motility or morphology has been found in double blind controlled studies.
Fertilizing capacity has not been affected in vitro. Blood levels of androgen and gonadotropin were unchanged. Reversible impotence has been reported in rare instances. Gastrointestinal Mild and transient diarrhea have been reported in a small number of patients during treatment with cimetidine.
Hematologic H2 antagonist administration has been associated with the occurrence of leukopenia (including agranulocytosis), thrombocytopenia, pancytopenia, and aplastic anemia, as well as extremely rare reports of immune hemolytic anemia.
Investigations Small increases of plasma creatinine have been reported. These did not progress with continued therapy and disappeared at the end of therapy. Some increases in serum transaminase and rare cases of hepatitis, fever, hypersensitivity vasculitis, interstitial nephritis, urinary retention and pancreatitis, which cleared on withdrawal of the drug, have been reported.
1 Adverse Reactions Overview, CNS. 2 CONTRAINDICATIONS CIMETIDINE is contraindicated in: Patients who are hypersensitive to the drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 1 Dosing considerations Dosage adjustment for patients with impaired renal function: Patients with severely impaired renal function have been treated with cimetidine; however, such usage has been very limited.
On the basis of this experience, the recommended dosage is 300 mg every 12 hours orally. Should the patient’s condition require, the frequency of dosing may be increased to every 8 hours or even further with caution. In se vere renal failure accumulation may occur and the lowest frequency of dosing compatible with an adequate CIMETIDINE (Cimetidine) Page 5 of 28 patient response should be used.
When liver impairment is also present, further reductions in dosage may be necessary. Hemodialysis: Hemodialysis reduces the level of circulating cimetidine. Greater than 80% of a 300 mg intravenous dose is cleared in a single 4 hour period of hemodialysis.
It is completely cleared in an 8 hour period. Ideally, the dosage schedule should be adjusted so that the timing of a scheduled dose is administered after dialysis treatment. Peritoneal Dialysis: Peritoneal dialysis does not appear to remove cimetidine to any appreciable extent.
2 Recommended Dose and Dosage Adjustment In clinical studies, cimetidine has been used in divided doses of up to 2400 mg/day in adults.
Duodenal Ulcer and Non-Malignant Gastric Ulcer: For active ulcer:
The recommended adult oral dose is 800 to 1200 mg per day. This may be given as follows: 800 mg once daily at bedtime; or 600 mg twice daily, at breakfast and bedtime; or 300 mg four times daily with meals and at bedtime. In some patients, 400 mg twice daily has been shown to be effective.
CIMETIDINE is contraindicated in: Patients who are hypersensitive to the drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Daily maintenance therapy may be used for those patients who would benefit from a reduction of gastric acid secretion, as well as those patients who are known to suffer frequent recurrence of duodenal or gastric ulcers, and should be continued for at least 6 to 12 months.
Re-evaluation of the gastric ulcer patient should be undertaken at regular time intervals. 2 g per day which may be given as follows: 800 mg once daily at bedtime; or 600 mg twice daily, at breakfast and at bedtime; or 300 mg four times daily with meals and at bedtime, for 8 to 12 weeks.
While some patients may require concomitant antacids initially, cimetidine alone has been shown to promote rapid relief of symptoms. , Zollinger-Ellison Syndrome, systemic mastocytosis and multiple endocrine adenomas): The recommended adult dosage is 300 mg four times a day, with meals and at bedtime.
In some patients, it may be necessary to administer higher and/or more frequent doses to control symptoms. Dosage should be adjusted to individual patient’s needs, but usually should not exceed 2400 mg per day. Adjunctive therapy in the management of cystic fibrosis in children: Clinical experience in pediatric patients is limited; however, doses of 20 to 40 mg/kg per day have been used.
NSAID-Induced Lesions (ulcers, erosions) and Gastrointestinal Symptoms: The recommended adult dose of cimetidine is 800 mg/day, either as 800 mg at bedtime or 400 mg twice daily, for 8 weeks. In patients with NSAID-induced lesions who have responded to an initial course of treatment and who require ongoing NSAID therapy, recurrence of lesions may be prevented by continual concomitant maintenance treatment with cimetidine.
The recommended dosage for maintenance treatment is 400 mg of cimetidine at bedtime. 5 Missed Dose If the patient misses a dose, instruct the patient to take the dose as soon as they remember. If it is almost time for the next dose, inform the patient to skip the missed dose and continue the regular dosing schedule.
Musculoskeletal There have been rare reports of reversible arthralgia and myalgia; exacerbation of joint symptoms in patients with pre-existing 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. CIMETIDINE (Cimetidine) Page 10 of 28 Skin Skin rashes, sometimes severe, including Stevens- Johnson syndrome, epidermal necrolysis, erythema multiforme, exfoliative dermatitis and generalized exfoliative erythroderma have been reported with H2 receptor antagonists.
Reversible alopecia has also been reported. Other Concomitant NSAID administration does not alter the incidence of adverse reactions resulting from therapy with cimetidine for those NSAIDs that have been tested. Reported adverse reactions in children include neurotoxicity, and inhibition of hepatic microsomal metabolism.
No change in adenohypophyseal secretion has been noted in studies in children receiving cimetidine. Cimetidine may produce transi ent cholestasis. 2 Clinical Trial Adverse Reactions Information is not available. 5 Post-Market Adverse Reactions Information is not available.
While healing with cimetidine may occur during the first week or two, treatment should be continued for at least four weeks for duodenal ulcer and at least six weeks for non-malignant gastric ulcer unless healing has been demonstrated by endoscopic examination.
While some patients may require concomitant antacids initially, cimetidine alone has been shown to promote rapid relief of symptoms. Prophylaxis of Recurrent Duodenal or Gastric Ulcer: For most adult patients the following regimens have been shown to be effective: 400 mg once daily at bedtime; or 300 mg twice daily, at breakfast and bedtime.
Daily maintenance therapy may be used for those patients who would benefit from a reduction of gastric acid secretion, as well as those patients who are known to suffer frequent recurrence of duodenal or gastric ulcers, and should be continued for at least 6 to 12 months.
Re-evaluation of the gastric ulcer patient should be undertaken at regular time intervals. 2 g per day which may be given as follows: 800 mg once daily at bedtime; or 600 mg twice daily, at breakfast and at bedtime; or 300 mg four times daily with meals and at bedtime, for 8 to 12 weeks.
While some patients may require concomitant antacids initially, cimetidine alone has been shown to promote rapid relief of symptoms. , Zollinger-Ellison Syndrome, systemic mastocytosis and multiple endocrine adenomas): The recommended adult dosage is 300 mg four times a day, with meals and at bedtime.
In some patients, it may be necessary to administer higher and/or more frequent doses to control symptoms. Dosage should be adjusted to individual patient’s needs, but usually should not exceed 2400 mg per day. Adjunctive therapy in the management of cystic fibrosis in children: Clinical experience in pediatric patients is limited; however, doses of 20 to 40 mg/kg per day have been used.
NSAID-Induced Lesions (ulcers, erosions) and Gastrointestinal Symptoms: The recommended adult dose of cimetidine is 800 mg/day, either as 800 mg at bedtime or 400 mg twice daily, for 8 weeks. In patients with NSAID-induced lesions who have responded to an initial course of treatment and who require ongoing NSAID therapy, recurrence of lesions may be prevented by continual concomitant maintenance treatment with cimetidine.
The recommended dosage for maintenance treatment is 400 mg of cimetidine at bedtime. 5 Missed Dose If the patient misses a dose, instruct the patient to take the dose as soon as they remember. If it is almost time for the next dose, inform the patient to skip the missed dose and continue the regular dosing schedule.
5 OVERDOSAGE In cases reported to date, involving oral ingestion of up to 20 grams of cimetidine, transient adverse effects similar to those encountered in normal clini cal experience were noted and recovery has been uneventful. There have been reports of severe CNS symptoms, including unresponsiveness, following ingestion of between 20 and 40 mg of Cimetidine, and extremely rare reports following concomitant use of multiple CNS-active medictions and ingestion of Cimetidine at doses less than 20 mg.
Two deaths were reported in adults who ingested over 40 mg orally on a single occasion. Treatment of overdose: The usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring and supportive therapy should be employed.
Studies in animals indicate that assisted respiration and the administration of a beta-blocker may be of value. For management of a suspected drug overdose, contact your regi onal poison control centre. CIMETIDINE (Cimetidine) Page 7 of 28 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging CIMETIDINE 200 mg […]