SPIRACTIN 100 spironolactone 100mg tablets

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

spironolactone, Quantity: 100 mg

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: sunset yellow FCF aluminium lake; maize starch; povidone; magnesium stearate; Peppermint Oil; sodium starch glycollate; purified talc; erythrosine aluminium lake; polysorbate 80; quinoline yellow aluminium lake; lactose monohydrate; microcrystalline cellulose

Administration route:

Oral

Units in package:

100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Essential hypertension. Spironolactone, when used alone, is effective in lowering both systolic and diastolic blood pressure. Spironolactone improves the hypotensive action of thiazide diuretics, while at the same time reducing or preventing potassium loss due to the thiazide. Spironolactone enhances the effectiveness of other antihypertensive agents such as beta-blockers, vasodilators, etc. As adjunctive therapy in malignant hypertension. In diuretic induced hypokalaemia when other measures are considered inappropriate or inadequate. Prophylaxis of hypokalaemia in patients taking digitalis when other measures are considered inadequate or inappropriate. Congestive cardiac failure. When used alone, spironolactone is effective in the management of oedema and sodium retention associated with congestive cardiac failure. Spironolactone may be used in combination with a thiazide or other conventional diuretics for achieving diuresis in patients whose oedema is resistant to a thiazide or other conventional diuretics. Unlike conventional diuretics, spironolactone does not produce hypokalaemia. When administered with a thiazide or other conventional diuretics, spironolactone offsets hypokalaemia induced by these diuretics. The prevention of potassium loss is particularly important in the treatment of digitalised patients, since digitalis intoxication may be precipitated if hypokalaemia is induced by conventional diuretic therapy. Hepatic cirrhosis with ascites and oedema. When used alone, spironolactone is frequently adequate for the relief of ascites and oedema associated with hepatic cirrhosis. It provides a mild and even diuresis and prevents excessive potassium excretion caused by thiazide diuretics, thus avoiding possible precipitation of hepatic coma. Nephrotic syndrome. Although glucocorticoids, whose anti-inflammatory activity appears to benefit the primary pathological process in the renal glomerulus, should probably be employed first, spironolactone either alone or in combination with a conventional diuretic is useful for inducing diuresis. Primary hyperaldosteronism. Spironolactone may be used to establish the diagnosis of primary hyperaldosteronism by therapeutic trial. Spironolactone may also be used for the short-term preoperative treatment of patients with primary hyperaldosteronism, long-term maintenance therapy for patients with discrete aldosterone producing adrenal adenomas who are judged to be poor operative risks (or who decline surgery), and long-term maintenance therapy for patients with bilateral micro- or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Hirsutism in females. Spironolactone is effective in the treatment of females with hirsutism, an androgen related increase in facial and body hair. A reduction in hair growth, hair shaft diameter and hair pigmentation is seen. Use of Spiractin should be considered only after all other alternatives of non-drug therapy have been explored. For women of childbearing age, see Section 4.3 Contraindications and Section 4.6 Fertility, Pregnancy and Lactation - Use in Pregnancy.

Product summary:

Visual Identification: 11mm pale orange, normal convex, peppermint flavoured tablet marked "SP" breakline "2" on one side, "alpha" symbol on the reverse.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

1993-10-14

Patient Information leaflet

SPIRACTIN
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING SPIRACTIN?
SPIRACTIN contains the active ingredient spironolactone. SPIRACTIN is
used to treat essential hypertension, oedematous
disorders, primary aldosteronism, malignant hypertension, low
potassium and hirsutism.
For more information, see Section 1. Why am I using SPIRACTIN? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SPIRACTIN?
Do not use if you have ever had an allergic reaction to SPIRACTIN or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
SPIRACTIN? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with SPIRACTIN and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE SPIRACTIN?
Daily doses of SPIRACTIN in adults can range from 25 mg to 400 mg.
Depending on the dose and your condition, SPIRACTIN may
be taken once a day or divided into separate doses.
In the treatment of hirsutism (excess body hair) in females, your
doctor may tell you to take SPIRACTIN every day or in repeating
cycles with a break in between.
Doses of SPIRACTIN in children are measured according to body weight
and will be calculated by your doctor.
More instructions can be found in Section 4. How do I use SPIRACTIN?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SPIRACTIN?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using SPIRACTIN.
•
If you are about to have any blood tests, tell your doctor that you
are taking SPIRACTIN.
•
Tell your doctor if you are taking other types of medicines to treat
high blood pressure or to prevent blood
clo

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
SPIRACTIN
_Spironolactone uncoated tablet _
1
NAME OF THE MEDICINE
Spironolactone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 25 mg tablet contains 25 mg of spironolactone as the active
ingredient.
Each 100 mg tablet contains 100 mg of spironolactone as the active
ingredient.
Excipients with known effect: sugars as lactose and trace quantities
of galactose and sulfites.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
25 mg tablet: 7 mm pale orange, normal convex, peppermint flavoured,
marked "SP" breakline "1" on one
side, "α" symbol on the reverse.
100 mg tablet: 11 mm pale orange, normal convex, peppermint flavoured,
marked "SP" breakline "2" on one
side, "α" symbol on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ESSENTIAL HYPERTENSION._
Spironolactone, when used alone, is effective in lowering both
systolic and diastolic
blood pressure. Spironolactone improves the hypotensive action of
thiazide diuretics, while at the same time
reducing or preventing potassium loss due to the thiazide.
Spironolactone enhances the effectiveness of other
antihypertensive agents such as β-blockers, vasodilators, etc.
_AS ADJUNCTIVE THERAPY IN MALIGNANT HYPERTENSION. _
_IN DIURETIC-INDUCED HYPOKALAEMIA WHEN OTHER MEASURES ARE CONSIDERED
INAPPROPRIATE OR INADEQUATE. _
_PROPHYLAXIS OF HYPOKALAEMIA IN PATIENTS TAKING DIGITALIS WHEN OTHER
MEASURES ARE CONSIDERED INADEQUATE _
_OR INAPPROPRIATE. _
_CONGESTIVE CARDIAC FAILURE._
When used alone, spironolactone is effective in the management of
oedema and
sodium retention associated with congestive cardiac failure.
Spironolactone may be used in combination with
a thiazide or other conventional diuretics for achieving diuresis in
patients whose oedema is resistant to a
thiazide or other conventional diuretics. Unlike conventional
diuretics, spironolactone does not produce
hypokalaemia. When administered with a thiazide or other conventional
diuretics, spironolactone offsets
hypokalaemia ind