Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
spironolactone, Quantity: 25 mg
Alphapharm Pty Ltd
Tablet, uncoated
Excipient Ingredients: quinoline yellow aluminium lake; Peppermint Oil; purified talc; sodium starch glycollate; lactose monohydrate; povidone; microcrystalline cellulose; magnesium stearate; polysorbate 80; sunset yellow FCF aluminium lake; erythrosine aluminium lake; maize starch
Oral
100 tablets
(S4) Prescription Only Medicine
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.
Visual Identification: 7mm pale orange, normal convex, peppermint flavoured tablet marked "SP" breakline "1" 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
Licence status A
1993-10-14
SPIRACTIN S P I R A C T I N 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 Read the complete document
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 Read the complete document