Apo-Amiloride 5 mg Tablet

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Amiloride hydrochloride dihydrate 5.7 mg (equivalent to amiloride hydrochloride 5 mg)

Available from:

Apotex NZ Ltd

INN (International Name):

Amiloride hydrochloride dihydrate 5.7 mg (equivalent to amiloride hydrochloride 5 mg)

Dosage:

5 mg

Pharmaceutical form:

Tablet

Units in package:

Bottle, plastic, HDPE with PP cap and induction seal, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Bal Pharma Ltd

Therapeutic indications:

Indicated as concomitant therapy with diuretics to conserve potassium during periods of vigorous diuresis and during long-term maintenance therapy with thiazides or other more potent diuretics. Apo-Amiloride when used alone has mild diuretic and antihypertensive activity.

Authorization date:

2011-06-30

Summary of Product characteristics

NEW ZEALAND DATA SHEET
APO-AMILORIDE
Amiloride Hydrochloride 5mg
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page
1
PRESENTATION
Apo-Amiloride tablets are yellow,
diamond shaped,
biconvex tablets,
engraved “5” on one side
and plain on the other side.
INDICATIONS
Apo-Amiloride’s main indication is as concomitant
therapy with diuretics to conserve potassium
during periods of
vigorous diuresis and during long-term maintenance therapy with
thiazides or
other
more
potent
diuretics.
Apo-Amiloride
when
used
alone,
has
mild
diuretic
and
antihypertensive activity.
_Oedema of_
_cardiac origin._
Although Apo-Amiloride alone may provide adequate diuresis for
some patients with oedema of
cardiac origin,
it
is primarily indicated for
concomitant
use in
patients receiving thiazides or
more potent
saluretic-diuretic agents.
In these patients it
may
provide increased sodium, chloride and water excretion and decreased
potassium excretion. The
positive effect of Apo-Amiloride on potassium balance may be
especially important for digitalised
cardiac patients,
in whom potassium depletion sensitises or
exaggerates the response of
the
heart to the toxic effects of digitalis (e.g.
increased ventricular irritability),
which may precipitate
digitalis intoxication with potentially serious cardiac arrhythmias.
_Hypertension._
Apo-Amiloride is used as an adjunctive agent
for
the prevention of
potassium
depletion in patients receiving thiazides or other oral
saluretic antihypertensive therapy over a
prolonged period. When combined with hydrochlorothiazide,
Apo-Amiloride produces an additive
antihypertensive effect.
_Hepatic cirrhosis with ascites and oedema._
Apo-Amiloride when used alone,
usually provides
adequate diuresis with diminished potassium loss and with a reduced
risk of metabolic alkalosis.
Apo-Amiloride may also be used with other more potent saluretic
diuretic agents where greater
diuresis is needed while maintaining a more balanced serum electrolyte
pattern.
As with all therapy for th