Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - spironolactone, quantity: 100 mg - tablet, uncoated - 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 - essential hypertension; oedematous disorders such as oedema and ascites of congestive cardiac failure, cirrhosis of the liver and nephrotic syndrome; diagnosis and treatment of primary aldosteronism; 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; hirsutism. 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. 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 contraindications and use in pregnancy.

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - spironolactone, quantity: 25 mg - 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 - essential hypertension; oedematous disorders such as oedema and ascites of congestive cardiac failure, cirrhosis of the liver and nephrotic syndrome; diagnosis and treatment of primary aldosteronism; 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; hirsutism. 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. 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 contraindications and use in pregnancy.

Australia - English - Department of Health (Therapeutic Goods Administration)

orion pharma (aus) pty limited - methotrexate sodium, quantity: 2.742 mg (equivalent: methotrexate, qty 2.5 mg) - tablet, uncoated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; magnesium stearate - antineoplastic chemotherapy treatment of breast cancer, gestational choriocarcinoma and in patients with chorioadenoma destruens and hydatidiform mole. palliation of acute and subacute lymphocytic leukaemia. greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemias. in combination with corticosteroids, methotrexate may be used for induction of remission. the drug is now most commonly used for the maintenance of induced remissions. chexate is also effective in the treatment of the advanced stages (iii and iv, peters staging system) of lymphosarcoma, particularly in children and in advanced cases of mycosis fungoides. psoriasis chemotherapy (see warnings box and section 4.4) because of the high risk attending to its use, chexate is only indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and / or after dermatologic consultations. rheumatoid arthritis chemotherapy (see warnings box and section 4.4) management of severe, recalcitrant, active rheumatoid arthritis in adults not responding to or intolerant of an adequate trial of nsaids and one or more disease modifying drugs. aspirin, nsaids and/or low dose steroids may be continued, although the possibility of increased toxicity with concomitant use of nsaids including salicylate has not been fully explored (see section 4.4, and 4.5). steroids may be reduced gradually in patients who respond to methotrexate. combined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine or cytotoxic agents has not been studied and may increase the incidence of adverse effects. rest and physiotherapy as indicated should be continued.

Australia - English - Department of Health (Therapeutic Goods Administration)

orion pharma (aus) pty limited - methotrexate sodium, quantity: 10.97 mg (equivalent: methotrexate, qty 10 mg) - tablet, uncoated - excipient ingredients: lactose monohydrate; magnesium stearate; microcrystalline cellulose - antineoplastic chemotherapy treatment of breast cancer, gestational choriocarcinoma and in patients with chorioadenoma destruens and hydatidiform mole. palliation of acute and subacute lymphocytic leukaemia. greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemias. in combination with corticosteroids, methotrexate may be used for induction of remission. the drug is now most commonly used for the maintenance of induced remissions. chexate is also effective in the treatment of the advanced stages (iii and iv, peters staging system) of lymphosarcoma, particularly in children and in advanced cases of mycosis fungoides. psoriasis chemotherapy (see warnings box and section 4.4) because of the high risk attending to its use, chexate is only indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and / or after dermatologic consultations. rheumatoid arthritis chemotherapy (see warnings box and section 4.4) management of severe, recalcitrant, active rheumatoid arthritis in adults not responding to or intolerant of an adequate trial of nsaids and one or more disease modifying drugs. aspirin, nsaids and/or low dose steroids may be continued, although the possibility of increased toxicity with concomitant use of nsaids including salicylate has not been fully explored (see section 4.4, and 4.5). steroids may be reduced gradually in patients who respond to methotrexate. combined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine or cytotoxic agents has not been studied and may increase the incidence of adverse effects. rest and physiotherapy as indicated should be continued.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - methotrexate, quantity: 2.5 mg - tablet, uncoated - excipient ingredients: magnesium stearate; maize starch; lactose monohydrate; polysorbate 80; microcrystalline cellulose; pregelatinised maize starch - antineoplastic chemotherapy: treatment of breast cancer, gestational choriocarcinoma, and in patients with chorioadenoma destruens and hydatidiform mole. palliation of acute and subacute lymphocytic leukaemia. greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemias. in combination with corticosteroids, methotrexate may be used for induction of remission. the drug is now most commonly used for the maintenance of induced remissions. methoblastin is also effective in the treatment of the advanced stages (iii and iv, peters staging system) of lymphosarcoma, particularly in children and in advanced cases of mycosis fungoides. psoriasis chemotherapy: (see warnings box and precautions). because of the high risk attending to its use, methoblastin is only indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatolo

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - spironolactone, quantity: 100 mg - tablet, uncoated - 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 - 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

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - spironolactone, quantity: 25 mg - 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 - 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

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - methotrexate, quantity: 10 mg - tablet, uncoated - excipient ingredients: pregelatinised maize starch; lactose monohydrate; maize starch; polysorbate 80; microcrystalline cellulose; magnesium stearate - treatment of breast cancer, gestational choriocarcinoma, and in patients with chorioadenoma destruens and hydatidiform mole. palliation of acute and subacute lymphocytic leukaemia. greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemias. in combination with corticosteroids, methotrexate may be used for induction of remission. the drug is now most commonly used for the maintenance of induced remissions. methoblastin is also effective in the treatment of the advanced stages (iii and iv, peters staging system) of lymphosarcoma, particularly in children and in advanced cases of mycosis fungoides. psoriasis chemotherapy: (see warnings box and precautions). because of the high risk attending to its use, methoblastin is only indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultations. rheumatoid

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - spironolactone, quantity: 100 mg - tablet, film coated - excipient ingredients: macrogol 400; maize starch; hypromellose; calcium sulfate dihydrate; povidone; magnesium stearate; titanium dioxide; purified water; iron oxide yellow; iron oxide red; industrial methylated spirit; flavour - essential hypertension; oedematous disorders such as oedema and ascites of congestive cardiac failure, cirrhosis of the liver, nephrotic syndrome; diagnosis and treatment of primary hyperaldosteronism; 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, hirsutism. essential hypertension: aldactone, when used alone, is effective in lowering both systolic and diastolic blood pressure. aldactone improves the hypotensive action of thiazide diuretics while at the same time reducing or preventing potassium loss due to the thiazide. aldactone enhances the effectiveness of other antihypertensive agents such as beta blockers, vasodilators etc. congestive cardiac failure: aldactone, when used alone, is effective in the management of oedema and sodium retention associated with congestive cardiac failure. alda

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - spironolactone, quantity: 25 mg - tablet, film coated - excipient ingredients: macrogol 400; hypromellose; maize starch; calcium sulfate dihydrate; magnesium stearate; povidone; flavour; titanium dioxide; purified water; iron oxide yellow; iron oxide red; industrial methylated spirit - essential hypertension; oedematous disorders such as oedema and ascites of congestive cardiac failure, cirrhosis of the liver, nephrotic syndrome; diagnosis and treatment of primary hyperaldosteronism; 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, hirsutism. essential hypertension: aldactone, when used alone, is effective in lowering both systolic and diastolic blood pressure. aldactone improves the hypotensive action of thiazide diuretics while at the same time reducing or preventing potassium loss due to the thiazide. aldactone enhances the effectiveness of other antihypertensive agents such as beta blockers, vasodilators etc. congestive cardiac failure: aldactone, when used alone, is effective in the management of oedema and sodium retention associated with congestive cardiac failure. alda