Loading…
MINT-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.
Verbatim from this product's HC label. Tap a section to expand.
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 desired.
Maintenance therapy Duodenal ulcers, benign gastric ulcers:
Patients who have responded to short-term therapy, particularly those with a history of recurrent ulcer, may benefit from chronic maintenance therapy at a reduced oral dosage of 150 mg once daily at bedtime. 2 times higher in one trial), and such patients should be advised to stop smoking.
In those patients who fail to comply with such advice, 300 mg nightly provides additional therapeutic benefit over the 150 mg once daily dosage regimen. Reflux esophagitis Acute treatment 300 mg once daily at bedtime, or alternatively 150 mg twice daily, taken in the morning and before retiring for up to eight weeks.
In patients with moderate to severe esophagitis, the dosage of ranitidine may be increased to 150 mg four times daily for up to 12 weeks. Long-term Management For the long-term management of reflux esophagitis, the recommended adult oral dose is 150 mg twice daily.
Post-operative peptic ulcer 150 mg twice daily, taken in the morning and before retiring. Pathological hypersecretory conditions (Zollinger-Ellison Syndrome) 150 mg three times daily may be administered initially. In some patients, it may be necessary to administer MINT-RANITIDINE 150 mg doses more frequently.
Doses should be adjusted to individual patient needs. Doses up to six grams per day have been well tolerated. Treatment of NSAID-induced lesions (both ulcers and erosions) and their gastrointestinal symptoms and prevention of their recurrence In ulcers following non-steroidal anti-inflammatory drug therapy or associated with continued non-steroidal anti-inflammatory drugs, 150 mg twice daily for 8-12 weeks may be necessary.
For the prevention of non-steroidal anti-inflammatory drug associated ulcer recurrence, 150 mg twice daily may be given concomitantly with non-steroidal anti-inflammatory drug therapy. Prophylaxis of acid aspiration syndrome (AAS) Page 9 of 28 150 mg the evening prior to anaesthesia induction is recommended, however, 150 mg two hours before anaesthesia induction is also effective.
For the prevention of AAS in pre-partum patients who elect for anaesthesia, 150 mg every six hours may be employed, but if general anaesthesia is warranted, a non-particulate oral antacid (for example, sodium citrate) could supplement MINT- RANITIDINE therapy.
MINT-RANITIDINE (ranitidine hydrochloride) is contraindicated for patients known to have hypersensitivity to ranitidine or to any ingredient in the formulation. For a complete listing, see COMPOSITION. WARNINGS 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 MINT– RANITIDINE (ranitidine hydrochloride) is instituted. Cyanocobalamin (Vitamin B12) Deficiency The prolonged use of H2-receptor antagonists may impair the absorption of protein bound Vitamin B12 and may contribute to the development of cyanocobalamin (vitamin B12) deficiency.
Concomitant NSAID Use Regular supervision of patients who are taking non-steroidal anti-inflammatory drugs concomitantly with MINT-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.
Use in Patients with a History of Acute Porphyria Rare clinical reports suggest that ranitidine 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). Use in Pregnancy and Nursing Mothers 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 MINT-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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ranitidine in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
In an emergency situation, the use of alkalis, antacids, and meticulous anaesthetic technique is still necessary as MINT-RANITIDINE does not affect the pH and volume of the existing gastric content. Prophylaxis of haemorrhage from stress ulceration in seriously ill patients or prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration who are currently managed by intravenous ranitidine An oral dose of 150 mg twice daily may be substituted for the injection once oral feeding commences.
Dosage for the Elderly For all conditions listed above, the drug dosage for the elderly who are seriously ill should start at the lowest recommended dose and be adjusted as necessary with close supervision. Patients over 50 years of age (see ACTIONS AND CLINICAL PHARMACOLOGY, Patients over 50 years of age).
Page 10 of 28 PHARMACEUTICAL INFORMATION Drug Substance Proper Name:
Ranitidine hydrochloride Chemical Names: 1) Dimethyl {5-[2-(1-methylamino-2-nitro vinyl amino) ethyl thio- methyl]-furfuryl}-amine hydrochloride. 86 g/mol (as hydrochloride salt) Structural Formula: Page 11 of 28 Physical Description: Ranitidine hydrochloride is a white to pale yellow, crystalline, practically odorless powder.
It is sensitive to light and moisture, and melts at about 140ºC, with decomposition.
Solubility:
It is very soluble in water, sparingly soluble in alcohol. 18, including purified water Polymorphism: Ranitidine HCl exists in 2 different polymorphic (crystal) forms: Form I and Form II. 08 (strongly basic) Melting Point: Melts at about 140ºC, with decomposition.
Composition In addition to ranitidine hydrochloride, each film–coated tablet contains the non–medicinal ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, Opadry 200 White and purified water. Opadry 200 White consists of polyvinyl alcohol-part.
hydrolyzed, titanium dioxide, talc, glyceryl monostearate and sodium lauryl sulphate. STORAGE AND STABILITY Store between 15°C - 30°C. Protect from light.
AVAILABILITY OF DOSAGE FORMS MINT–RANITIDINE (Ranitidine tablets USP) 150 mg:
White to off-white, round shaped tablets debossed with ‘V’ on one side and ‘02’ on the other side. Each tablet contains 150 mg of ranitidine (as ranitidine hydrochloride). Available in bottles of 60 tablets.
MINT–RANITIDINE (Ranitidine tablets USP) 300 mg:
White to off-white, oval shaped tablets debossed with ‘V’ on one side and ‘03’ on the other side Each tablet contains 300 mg of ranitidine (as ranitidine hydrochloride). Available in bottles of 30 tablets. Page 12 of 28 PHARMACOLOGY Animal Pharmacology Ranitidine is a potent competitive […]
Ranitidine is secreted in breast milk in lactating mothers but the clinical significance of this has not been fully evaluated. Like other drugs, MINT-RANITIDINE should only be used during nursing if considered essential. Page 5 of 28 Children Experience with ranitidine 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. PRECAUTIONS 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 ranitidine hydrochloride by one half. Accumulation of MINT-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.
Interaction 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 treatment of Zollinger-Ellison syndrome) may reduce the excretion of procainamide and N- acetylprocainamide 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 hydrochloride have not shown interaction.
Page 6 of 28 If high doses (two grams) of sucralfate are coadministered with ranitidine hydrochloride, the absorption of ranitidine hydrochloride may be reduced. This effect is not seen if sucralfate is taken at least two hours after ranitidine hydrochloride administration.
Special Populations 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). Use in the Elderly Since malignancy is more common in the elderly, particular consideration must be given to this before therapy with MINT-RANITIDINE is instituted.
Elderly patients receiving non-steroidal anti-inflammatory drugs concomitantly with MINT-RANITIDINE should be closely supervised. As with all medication in the elderly, when prescribing MINT-RANITIDINE, consideration should be given to the patient’s concurrent drug therapy.
[…]