Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
MISOPROSTOL
Pharmacia Ireland
200 Microgram
Tablets
1999-04-11
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cytotec 200 microgram Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 micrograms misoprostol. Excipients - Contains hydrogenated Castor Oil 1.0mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to off-white, flat, hexagonal-shaped tablets, scored on both sides with ‘SEARLE’ over ‘1461’ on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management and prophylaxis of peptic ulcers associated with use of non-steroidal anti-inflammatory drugs. In the short-term management of gastric and duodenal ulcer. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS HEALING OF DUODENAL ULCER, GASTRIC ULCER AND NSAID-INDUCED PEPTIC ULCER: 800 micrograms daily in two or four divided doses taken with breakfast and / or each main meal and at bedtime. Treatment should be given initially for at least 4 weeks even if symptomatic relief has been achieved sooner. In most patients ulcers will be healed in 4 weeks but treatment may be continued for up to 8 weeks if required. If the ulcer relapses further treatment courses may be given. PROPHYLAXIS OF NSAID-INDUCED PEPTIC ULCER: 200 micrograms twice daily, three times daily or four times daily. Treatment can be continued as required. Dosage should be individualised according to the clinical condition of each patient. ELDERLY The usual dosage may be used. RENAL IMPAIRMENT: Available evidence indicates that no adjustment of dosage is necessary in patients with renal impairment. HEPATIC IMPAIRMENT: Cytotec is metabolised by fatty acid oxidising systems present in organs throughout the body. Its metabolism and plasma levels are therefore unlikely to be affected markedly in patients with hepatic impairment. Pročitajte cijeli dokument