Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
MINOXIDIL
Pharmacia Ireland
5 Milligram
Tablets
2001-04-06
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Loniten 5mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg minoxidil. Excipients - Contains Lactose Monohydrate 94.0mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Round, white biconvex tablets, 5 imprinted on one side, scored on the reverse with a ‘U’ on either side of the score. The score line has no practical function. These tablets should not be broken in half. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Loniten is indicated for the treatment of severe hypertension that is symptomatic or associated with target organ damage. It is indicated for the treatment of hypertension not controlled adequately by a combination of a diuretic and a sympathetic suppressant agent such as a beta blocker. Additionally, it is indicated in hypertension that is not manageable with maximum therapeutic doses of a diuretic plus two other antihypertensive drugs. It should not be used as the sole agent to initiate therapy. It is a peripheral vasodilator and should be given in conjunction with a diuretic, to control salt and water retention, and a beta -adrenergic blocking agent, or appropriate substitute, to control reflex tachycardia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral Administration Adults and Patients over 12 years of age An initial daily dose of 5 mg, which may be given as a single or divided dosage, is recommended. The dose can be increased to 20mg and later 40mg/day in single or divided dosages, if required for optimum blood pressure control. Dosage adjustment should be made at intervals of not less than three days, until optimum control of blood pressure is achieved. It is seldom necessary to exceed 50 mg per day although, Přečtěte si celý dokument