Pays: Nouvelle-Zélande
Langue: anglais
Source: Medsafe (Medicines Safety Authority)
Minoxidil 10mg;
Pharmacia Limited Company trading as Pharmacia
Minoxidil 10 mg
10 mg
Tablet
Active: Minoxidil 10mg
Bottle, plastic, 100 tablets
Prescription
Prescription
Pharmacia & Upjohn Company LLC
Package - Contents - Shelf Life: Bottle, plastic, - 100 tablets - 36 months from date of manufacture stored at or below 30°C
1982-03-11
Version: pfdlonit10519 Supersedes: pfdlonit11116 Page 1 of 9 NEW ZEALAND DATA SHEET 1. PRODUCT NAME _ _ LONITEN ® 10 mg tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each LONITEN tablet contains 10 mg minoxidil. EXCIPIENT(S) WITH KNOWN EFFECT • Lactose monohydrate, For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet LONITEN 10 mg tablets are white to light tan circular, half oval, scored tablets marked ‘10’ on one side and ‘U’ and ‘137’ on the reverse side. The pure compound is soluble in water to the extent of approximately 2 mg/mL and is readily soluble in propylene glycol or ethanol. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LONITEN (minoxidil) is an orally active peripheral vasodilator. Indicated as adjunctive therapy in adults with severe refractory hypertension which has failed to respond to extensive multiple therapy. When used in combination with an accompanying diuretic and beta-blocker, minoxidil (LONITEN) has been shown to reverse encephalopathy and retinopathy in severe hypertensives. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE The usual adult dosage range of LONITEN is 5-40 mg/day. The maximum recommended dosage is 100 mg/day. Version: pfdlonit10519 Supersedes: pfdlonit11116 Page 2 of 9 LONITEN therapy can be initiated with a single or divided daily dosage. If the desired reduction in diastolic pressure is greater than 30 mm Hg, divided dosage will minimise diurnal fluctuations. Dosage adjustments should be made at intervals of 3 days or longer. A more rapid reduction of pressure can be achieved using continuous blood pressure monitoring and incremental doses of 5 mg every 6 hours. Dosage requirements may be lower in patients with renal failure or undergoing chronic dialysis. For patients with hepatic impairment dosage adjustment should be considered, starting therapy at a reduced dose once daily and titrating up to the lowest effective dose to obtain desired therapeutic effect (see section 5.2). Prior to introducing LONITEN, it is recommende Lire le document complet