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

arrotex pharmaceuticals pty ltd - diazepam, quantity: 5 mg - tablet, uncoated - excipient ingredients: magnesium stearate; maize starch; quinoline yellow aluminium lake; lactose monohydrate - management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. in acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. diazepam is a useful adjunct for the relief of reflex muscle spasm due to local trauma (injury, inflammation) to muscles, bones and joints. it can also be used to combat spasticity due to upper motor neuron lesions such as cerebral palsy and paraplegia, as well as in athetosis and stiff-man syndrome.

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

medsurge pharma pty ltd - hydroxycarbamide (hydroxyurea), quantity: 500 mg - capsule, hard - excipient ingredients: erythrosine; titanium dioxide; lactose monohydrate; gelatin; citric acid; quinoline yellow; magnesium stearate; indigo carmine; dibasic sodium phosphate; sodium lauryl sulfate - significant tumour response to hydroxycarbamide (hydroxyurea) has been demonstrated in chronic myelocytic leukaemia (pretreatment phase and palliative care) and recurrent, metastatic, or inoperable carcinoma of the ovary.

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)

sandoz pty ltd - tamsulosin hydrochloride, quantity: 400 microgram - tablet, modified release - excipient ingredients: quinoline yellow; purified talc; polyethylene oxide; cochineal; microcrystalline cellulose; magnesium stearate; hyprolose; butylated hydroxytoluene; macrogol 400; titanium dioxide; iron oxide black; hypromellose; colloidal anhydrous silica - for the relief of lower urinary tract symptoms (luts) associated with benign prostatic hyperplasia (bph).

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

alphapharm pty ltd - oxazepam, quantity: 30 mg - tablet, uncoated - excipient ingredients: magnesium stearate; lactose monohydrate; quinoline yellow aluminium lake; maize starch; erythrosine aluminium lake - indications as at 25 january 2005 : alepam is indicated for: management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety associated with depression is also responsive to oxazepam therapy. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the physician should periodically reassess the usefulness of the drug for the individual patient. alcoholics with acute tremulousness, confusional state or anxiety associated with alcohol withdrawal are responsive to therapy.

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

alphapharm pty ltd - oxazepam, quantity: 15 mg - tablet, uncoated - excipient ingredients: magnesium stearate; erythrosine aluminium lake; maize starch; quinoline yellow aluminium lake; lactose monohydrate - indications as at 25 january 2005 : alepam is indicated for: management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety associated with depression is also responsive to oxazepam therapy. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the physician should periodically reassess the usefulness of the drug for the individual patient. alcoholics with acute tremulousness, confusional state or anxiety associated with alcohol withdrawal are responsive to therapy.

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

sandoz pty ltd - tamsulosin hydrochloride, quantity: 400 microgram - tablet, modified release - excipient ingredients: quinoline yellow; purified talc; polyethylene oxide; cochineal; microcrystalline cellulose; magnesium stearate; hyprolose; butylated hydroxytoluene; macrogol 400; titanium dioxide; iron oxide black; hypromellose; colloidal anhydrous silica - for the relief of lower urinary tract symptoms (luts) associated with benign prostatic hyperplasia (bph).

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

waymade australia pty limited - levothyroxine sodium, quantity: 0.1 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; sunset yellow fcf aluminium lake; magnesium stearate; colloidal anhydrous silica; quinoline yellow aluminium lake; purified talc; pregelatinised starch - thyrox is indicated for the management of demonstrated thyroid hormone deficiency.,thyrox is also used to suppress thyrotropin (tsh) for the management of tsh-responsive tumours of the thyroid.

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

pharmaco australia ltd - mefloquine hydrochloride, quantity: 274.09 mg (equivalent: mefloquine, qty 250 mg) - tablet, uncoated - excipient ingredients: ammonium alginate; crospovidone; lactose monohydrate; magnesium stearate; microcrystalline cellulose; purified talc; maize starch; poloxamer - malaria treatment: lariam is indicated for the treatment of acute attacks of malaria due to p.falciparum infection resistant to conventional antimalarial drugs. following therapy of mixed p.falciparum/p.vivax malaria with lariam relapse prophylaxis with an 8-aminoquinoline derivative (e.g. primaquine) should be considered in order to eliminate liver forms of p.vivax. malaria prophylaxis: for travellers to countries with documented chloroquine and antifolate combination ( [sulfadoxine/pyrimethamine] / [dapsone/pyrimethamine] ) resistant p.falciparum malaria, who are considered to be at high risk for malaria in view of their residence or travel (of up to 3 months duration) through rural areas (between the dusk to dawn period). for travellers hypersensitive to sulphonamides and sulphones, who are considered to be at high risk for malaria in view of their residence or travel (of up to 3 months duration) through rural areas, (between the dusk to dawn period) in countries with high level chloroquine-resistant p.fal