Ranisan® 150 mg
coated tablets
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- Manufacturer:
- PRO.MED.CS Praha a.s.
- Marketing authorisation holder:
- PRO.MED.CS Praha a.s.
- Composition:
- Ranitidini hydrochloridum 168 mg equivalent to ranitidine 150 mg in one coated tablet.
- Indication group:
- antiulceric agent, H2-receptor antagonist
The following information is for health professionals only.
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Characteristics:
Ranitidine, a histamine H2-receptors antagonist, inhibits diurnal and nocturnal gastric secretion, both basal and stimulated, thus causing a decrease in the acidity and volume of gastric juice. On oral administration, ranitidine is absorbed very rapidly, the maximal plasma level is achieved within 1-3 hours. Contemporary content of the stomach does not affect biological availability of ranitidine. Biological half-life ranges between 2-3 hours, in renal insufficiency it is prolonged.
Indications:
Prophylaxis and therapy of peptic ulcers in all locations, reflux esophagitis, conditions connected with hyperacidity, gastropathy caused by non-steroidal antirheumatic drugs (NSAID), some types of functional gastropathy, conditions connected with a risk of aspirating acid gastric contents.
Contraindications:
Hypersensitivity to ranitidine and other components of the preparation, malign nature of ulcer disease prior to bioptic examination. Urgency of administration should be taken into consideration in pregnancy and in children (because of lack of experience). In the period of lactation, ranitidine administration is not recommended because of lack of experience. Caution is necessary in patients with severe affections of the kidney and liver.
Undesirable effects:
Ranitidine is very well tolerated. Headache, dizziness, confusion in the elderly, dry mouth, nausea, flatulation, constipation, diarrhoea, loss of appetite, allergic skin reactions, and sporadically an increase in liver enzymes, leukopenia, and thrombocytopenia may sometimes occur. Cardiac arrhythmia was very rarely observed.
Interactions:
By decreasing the acidity of gastric contents, ranitidine decreases absorption of ketokonazol and itrakonazol. Ranitidine increases the plasma level of concomitantly administered theophylline, thus increasing its undesirable effects. Antacids decrease ranitidine absorption. For this reason, they should be administered 1-2 hours after ranitidine administration. Concomitant administration of ranitidine and sucralfate or complex bismuth salts is not suitable (acid gastric medium is necessary for their optimal effect). Ranitidine is eliminated from the organism by glomerular filtration and tubular secretion, and this very mechanism is responsible for some clinically significant drug interactions of ranitidine (with procainamide, acetylprocainamide, and triamterene).
Caution:
Prior to the commencement of treatment of a peptic ulcer, it is necessary to exclude its malignant character!
Dosage:
Peptic ulcer treatment: 150 mg two times a day (morning and evening), or 300 mg once a day at bedtime (usually for 4-6 weeks).
Treatment of reflux esophagitis, ulcers produced by the action of NSAID: 300 mg twice a day for 2-3 months.
Prophylaxis of a relapsing peptic ulcer: 150 mg daily in the long term.
Prophylaxis of an ulcer produced by the action of NSAID: 150 mg twice a day.
Prophylaxis of aspiration of acid gastric contents: 150 mg in the evening before operation.
On renal insufficiency, it is necessary to adjust dosing according to creatinine clearance (at creatinine clearance of 50 ml/min, usually 150 mg of ranitidine is administered daily). Tablets are taken unchewed, before or after meals, and they are sufficiently washed down.
Package:
30 or 60 coated tablets.
Complete information about the preparation is included in the drug information sheet.
Date of the latest revision of the text: April 1, 2009.
The preparation is available on medical prescription only.