United States - English - NLM (National Library of Medicine)

glaxosmithkline llc - rosiglitazone maleate (unii: kx2339dp44) (rosiglitazone - unii:05v02f2kdg) - rosiglitazone 2 mg - avandia is a thiazolidinedione antidiabetic agent indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. important limitations of use: risk summary limited data with avandia in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . in animal reproduction studies, no adverse developmental effects were observed when rosiglitazone was administered to pregnant rats and rabbits during organogenesis at exposures up to 4 times the maximum recommended human dose (mrhd) of 8 mg daily (see data). the estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20% to 25% in women with a hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. in the

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

glaxosmithkline australia pty ltd - rosiglitazone maleate -

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - rosiglitazone maleate (unii: kx2339dp44) (rosiglitazone - unii:05v02f2kdg) - rosiglitazone maleate 2 mg - avandia is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. - due to its mechanism of action, avandia is active only in the presence of endogenous insulin. therefore, avandia should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. - the coadministration of avandia and insulin is not recommended. - the use of avandia with nitrates is not recommended. initiation of avandia in patients with established new york heart association (nyha) class iii or iv heart failure is contraindicated [see boxed warning] . pregnancy category c. all pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. this background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. it is essential for patients with diabetes or history of gestational diabetes to maintain good metabolic control before con

European Union - English - EMA (European Medicines Agency)

smithkline beecham plc - rosiglitazone - diabetes mellitus, type 2 - drugs used in diabetes - rosiglitazone is indicated in the treatment of type 2 diabetes mellitus:as monotherapy-in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intoleranceas dual oral therapy in combination with-metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin-a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite monotherapy with a sulphonylureaas triple oral therapy in combination with-metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy (see section 4.4).

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

glaxosmithkline australia pty ltd - rosiglitazone maleate -

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

glaxosmithkline australia pty ltd - rosiglitazone maleate -

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - rosiglitazone maleate 1.33mg equivalent to 1 mg rosiglitazone - film coated tablet - 1 mg - active: rosiglitazone maleate 1.33mg equivalent to 1 mg rosiglitazone excipient: hypromellose lactose monohydrate magnesium stearate opadry yellow oy-l-22809 powdered cellulose sodium starch glycolate

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - rosiglitazone maleate 2.65mg equivalent to 2 mg rosiglitazone - film coated tablet - 2 mg - active: rosiglitazone maleate 2.65mg equivalent to 2 mg rosiglitazone excipient: hypromellose lactose monohydrate magnesium stearate opadry pink oy-l-24802 powdered cellulose sodium starch glycolate

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - rosiglitazone maleate 5.3mg equivalent to 4 mg rosiglitazone - film coated tablet - 4 mg - active: rosiglitazone maleate 5.3mg equivalent to 4 mg rosiglitazone excipient: hypromellose lactose monohydrate magnesium stearate opadry orange oy-l-23028 powdered cellulose sodium starch glycolate

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - rosiglitazone maleate 10.6mg equivalent to 8 mg rosiglitazone - film coated tablet - 8 mg - active: rosiglitazone maleate 10.6mg equivalent to 8 mg rosiglitazone excipient: hypromellose lactose monohydrate magnesium stearate opadry pink oy-l-24803 powdered cellulose sodium starch glycolate