Amizide tablet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hydrochlorothiazide, Quantity: 50 mg; amiloride hydrochloride dihydrate, Quantity: 5 mg

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: sodium starch glycollate; lactose monohydrate; magnesium stearate; povidone; wheat starch

Administration route:

Oral

Units in package:

30, 50

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Amizide is indicated in the treatment of patients with: oedema of cardiac origin; hepatic cirrhosis with ascites; hypertension in whom potassium depletion might be anticipated. Amizide, with its combination of amiloride hydrochloride and hydrochlorothiazide, minimizes the possibility of the development of excessive potassium loss in patients during vigorous diuresis for prolonged periods. Amizide, with it's built in potassium sparing agent, is especially indicated in those conditions where the positive effect on potassium balance is particularly important. Hypertension. Amizide may be used alone or as an adjunct to other anti-hypertensive drugs. Since it enhances the action of these agents, the dosage of these antihypertensive drugs may need to be reduced to avoid the risk of an excessive drop in blood pressure.

Product summary:

Visual Identification: 8mm off-white flat bevelled edged tablet marked H breakline A on one side, with the Alphapharm logo on reverse.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-09-20

Patient Information leaflet

AMIZIDE
_contains the active ingredients hydrochlorothiazide and amiloride
hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Amizide.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Amizide against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT AMIZIDE IS USED
FOR
Amizide is used for:
•
oedema, swelling of the ankles,
feet and legs
•
ascites due to liver disease
resulting in fluid accumulation in
the stomach area
•
lower high blood pressure
(hypertension).
Amizide contains a combination of
two diuretics, amiloride
hydrochloride and
hydrochlorothiazide as the active
ingredients. It helps reduce the
amount of excess fluid in the body by
increasing the amount of urine
produced, while at the same time,
minimizing potassium loss.
Amizide works by making your
kidneys pass more water and salt
whilst retaining potassium. This
helps reduce high blood pressure and
some forms of swelling, while at the
same time helping to maintain
normal levels of potassium in your
blood.
Amizide may be taken alone or in
combination with other medicines to
treat your condition.
Your doctor may have prescribed
Amizide for another reason. Ask
your doctor if you have any questions
about why Amizide has been
prescribed for you.
Amizide is available only with a
doctor's prescription. There is no
evidence that Amizide is addictive.
BEFORE YOU TAKE
AMIZIDE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE AMIZIDE IF YOU ARE
ALLERGIC TO MEDICINES CONTAINING
EITHER AMILORIDE OR
HYDROCHLOROTHIAZIDE OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
DO NOT TAKE AMIZIDE IF YOU ARE
ALLERGIC TO MEDICINES WHICH CONTAIN
SULFUR (SULFONAMIDES).
Hydrochlorothiazide, one

Summary of Product characteristics

AMIZIDE
_Hydrochlorothiazide and Amiloride hydrochloride _
PRODUCT INFORMATION
NAME OF THE MEDICINE
Active ingredients: Hydrochlorothiazide
Amiloride hydrochloride
Chemical names:
6-chloro-3,4-dihydro-2_H_-1,2,4-benzo-
thiadiazine-7-sulphonamide 1,1-dioxide
3,5-diamino-_N_-carbamimidoyl-6-chloro-
pyrazine-2-carboxamide
Structural formulas:
Molecular formulas:
C
7
H
8
ClN
3
O
4
S
2
C
6
H
9
Cl
2
N
7
O,2H
2
O
Molecular weights:
297.7
302.1
CAS Registry Nos:
58-93-5
17440-83-4
DESCRIPTION
Hydrochlorothiazide is a white or almost white, odourless, crystalline
powder with a slightly bitter taste. It is very
slightly soluble in water, sparingly soluble in ethanol (96%) and
soluble in acetone. It dissolves in dilute solutions of
alkali hydroxides.
Amiloride hydrochloride is a pyrazinecarbonylguanidine that is
unrelated chemically to other known diuretic or
antikaliuretic agents. It is not acidic like the thiazides, but is the
salt of a moderately strong base, amiloride, pKa 8.7.
Amiloride hydrochloride is a pale yellow to greenish-yellow, almost
odourless powder. It is slightly soluble in water
and ethanol (96%), and practically insoluble in chloroform and in
ether.
Amizide tablets contain 50 mg hydrochlorothiazide and 5 mg amiloride
hydrochloride. The tablets also contain the
following inactive ingredients: lactose, starch – wheat, povidone,
sodium starch glycollate, magnesium stearate.
PHARMACOLOGY
Amizide combines the potassium-conserving action of amiloride
hydrochloride with the natriuretic action of
hydrochlorothiazide.
Amizide provides diuretic and antihypertensive activity (principally
due to the hydrochlorothiazide component),
while acting through the amiloride component to prevent the excessive
potassium loss that may occur in patients
receiving a thiazide diuretic. Due to its amiloride component, the
urinary excretion of magnesium is less with
Amizide than with a thiazide or loop diuretic used alone (see
PRECAUTIONS). The onset of the diuretic action of
Amizide is within 1 to 2 hours and this action appears