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MAR-RANITIDINE is a brand name for Ranitidine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE....................................................................................3 CONTRAINDICATIONS..........................................................................................................3 WARNINGS AND…
Verbatim from this product's HC label. Tap a section to expand.
Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. The following adverse reactions have been reported as events in clinical trials or in the routine management of patients treated with ranitidine hydrochloride.
A cause and effect relationship to ranitidine hydrochloride is not always established. Central Nervous System Headache, sometimes severe; malaise; dizziness; somnolence; insomnia; vertigo; and reversible blurred vision suggestive of a change in accommodation.
Isolated cases of reversible mental confusion, agitation, depression, hallucinations have been reported, predominantly in severely ill elderly patients. In addition, reversible involuntary movement disorders have been reported rarely.
Cardiovascular Isolated reports of tachycardia, bradycardia, premature ventricular beats, AV block have been noted. Asystole has been reported in very few individuals with and without predisposing conditions following IV administration and has not been reported following oral administration of ranitidine hydrochloride (See WARNINGS AND PRECAUTIONS, DOSAGE AND ADMINISTRATION).
Gastrointestinal Constipation, diarrhea, nausea/vomiting and abdominal discomfort/pain. Hepatic In normal volunteers, transient and reversible SGPT and SGOT values were increased to at least twice the pretreatment levels in 6 of 12 subjects receiving ranitidine 100 mg qid intravenously for seven days, and in 4 of 24 subjects receiving 50 mg qid intravenously for five days.
Therefore, it may be prudent to monitor SGOT and SGPT in patients receiving intravenous treatment for five days or longer and in those with pre-existing liver diseases. With oral administration, there have been occasional reports of hepatitis, hepatocellular or hepatocanalicular or mixed, with or without jaundice.
In such circumstances, ranitidine should be discontinued immediately. These are usually reversible, but in exceedingly rare circumstances, death has occurred. Renal Very rare cases of acute interstitial nephritis have been reported. Page 7 of 27 Musculoskeletal Rare reports of arthralgia and myalgia.
General Concomitant NSAID Use Regular supervision of patients who are taking non-steroidal anti-inflammatory drugs concomitantly with MAR-RANITIDINE is recommended especially in the elderly and in those with a history of peptic ulcer.
Baseline endoscopy and histological evaluation is necessary to rule out gastric carcinoma. Cyanocobalamin (Vitamin B12) Deficiency The prolonged use of H2-receptor antagonists, may impair the absorption of proteinbound Vitamin B12 and may contribute to the development of cyanocobalamin (vitamin B12) deficiency.
Gastrointestinal Gastric Ulcer Treatment with a histamine H2-antagonist may mask symptoms associated with carcinoma of the stomach and, therefore, may delay diagnosis of that condition. Accordingly, where gastric ulcer is suspected the possibility of malignancy should be excluded before therapy with MAR-RANITIDINE (ranitidine hydrochloride) is instituted.
Hematologic Use in Patients with a History of Acute Porphyria Rare clinical reports suggest that ranitidine hydrochloride may precipitate acute porphyric attacks. Therefore, ranitidine should be avoided in patients with a history of acute porphyria.
Fertility There are no data on the effects of ranitidine hydrochloride on human fertility. There were no effects on male and female fertility in animal studies (see TOXICOLOGY). Renal Use in Impaired Renal Function Ranitidine is excreted via the kidneys and, in the presence of renal impairment, plasma levels of ranitidine are increased and elimination prolonged.
Accordingly, it is recommended in such patients, to decrease the dosage of MAR-RANITIDINE by one half. Accumulation of ranitidine with resulting elevated plasma concentrations will occur in patients with renal impairment (creatinine clearance less than 50 ml/min); a recommended daily dose of oral ranitidine in such patients should be 150 mg.
Page 5 of 27 Special Populations Pregnant Women:
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Haematologic Blood count changes (leukopenia, thrombocytopenia) have occurred in a few patients. These are usually reversible. Rare cases of agranulocytosis or pancytopenia, sometimes with marrow hypoplasia or aplasia have been reported.
Endocrine No clinically significant interference with endocrine or gonadal function has been reported. There have been a few reports of breast symptoms and breast conditions (such as gynaecomastia and galactorrhoea). Dermatologic Rash, including cases suggestive of mild erythema multiforme.
Rare cases of vasculitis and alopecia have been reported. Other Rare cases of hypersensitivity reactions (including chest pain, bronchospasm, fever, rash, eosinophilia, anaphylaxis, urticaria, angioneurotic edema, hypotension) and small increases in serum creatinine have occasionally occurred after a single dose.
Acute pancreatitis and reversible impotence has been reported rarely. DRUG INTERACTIONS Interactions with Other Drugs Ranitidine has the potential to affect the absorption, metabolism or renal excretion of other drugs. The altered pharmacokinetics may necessitate dosage adjustment of the affected drug or discontinuation of treatment.
Interactions occur by several mechanisms including: 1.
Inhibition of cytochrome P450-linked mixed function oxygenase system:
Ranitidine at usual therapeutic doses does not potentiate the actions of drugs which are inactivated by this enzyme system such as diazepam, lidocaine, phenytoin, propranolol and theophylline. g. warfarin). Due to the narrow therapeutic index, close monitoring of increased or decreased prothrombin time is recommended during concurrent treatment with ranitidine.
2.
Competition for renal tubular secretion:
Since ranitidine is partially eliminated by the cationic system, it may affect the clearance of other drugs eliminated by this route. g such as those used in the Page 8 of 27 treatment of Zollinger-Ellison syndrome) may reduce the excretion of procainamide and Nacetylprocainamide resulting in increased plasma levels of these drugs.
3.
Alteration of gastric pH:
The bioavailability of certain drugs may be affected. g. g. ketoconazole, atazanavir, delaviridine, gefitnib). Sporadic cases of drug interactions have been reported in elderly patients involving both hypoglycaemic drugs and theophylline.
The significance of these reports cannot be determined at present, as controlled clinical trials with theophylline and ranitidine have not shown interaction. If high doses (two grams) of sucralfate are coadministered with MAR-RANITIDINE, the absorption of MAR-RANITIDINE may be reduced.
This effect is not seen if sucralfate is taken at least two hours after ranitidine hydrochloride administration. DOSAGE AND ADMINISTRATION Recommended Dose and Dosage Adjustment Duodenal ulcer or benign gastric ulcer 300 mg once daily at bedtime or 150 mg twice daily taken in the morning and before retiring.
It is not necessary to time the dose in relation to meals. In most cases of duodenal ulcer and benign gastric ulcer, healing will occur in four weeks. In the small number of patients whose ulcers may not have fully healed, these are likely to respond to a further four week course of therapy.
In the treatment of duodenal ulcers, 300 mg twice daily for 4 weeks may be of benefit when more rapid healing is […]
The safety of ranitidine hydrochloride in the treatment of conditions where a controlled reduction of gastric secretion is required during pregnancy has not been established. Reproduction studies performed in rats and rabbits have revealed no evidence of ranitidine hydrochloride induced impaired fertility or harm to the fetus.
Ranitidine crosses the placenta. Nevertheless, if the administration of MAR-RANITIDINE is considered to be necessary, its use requires that the potential benefits be weighed against possible hazards to the patient and to the fetus.
Nursing Women:
Ranitidine is secreted in breast milk in lactating mothers but the clinical significance of this has not been fully evaluated. Like other drugs, MAR-RANITIDINE should only be used during nursing if considered essential.
Pediatrics:
Experience with ranitidine hydrochloride products in children is limited. It has, however, been used successfully in children aged 8 to 18 years in oral doses up to 150 mg twice daily.
Geriatrics:
In patients such as the elderly, persons with chronic lung disease, diabetes or the immunocompromised, there may be an increased risk of developing community acquired pneumonia. 48). Since malignancy is more common in the elderly, particular consideration must be given to this before therapy with MAR-RANITIDINE is instituted.
Elderly patients receiving non-steroidal anti- inflammatory drugs concomitantly with MAR-RANITIDINE should be closely supervised. As with all medication in the elderly, when prescribing MAR-RANITIDINE, consideration should be given to the patient's concurrent drug therapy.
Sporadic cases of drug interaction have been reported in elderly patients involving both hypoglycaemic drugs and theophylline. The significance of these reports cannot be determined at present, as controlled clinical trials with theophylline and ranitidine hydrochloride have not shown interaction.
Elderly patients may be at increased risk for confusional states and depression. Page 6 of