Loniten

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Minoxidil 5mg;  

Available from:

Pharmacia Limited Company trading as Pharmacia

INN (International Name):

Minoxidil 5 mg

Dosage:

5 mg

Pharmaceutical form:

Tablet

Composition:

Active: Minoxidil 5mg   Excipient: Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Microcrystalline cellulose Starch

Units in package:

Bottle, plastic, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Pharmacia & Upjohn Company LLC

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, - 100 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1982-03-11

Summary of Product characteristics

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