Clinical Indications

In the United States, rosiglitazone and pioglitazone are approved by the FDA for use as monotherapy and in combination with the sulfonylureas, metformin and with insulin. In Europe however, the thiazolidinediones are not approved for use in combination with insulin. The usual starting dose of rosiglitazone is 4mg orally as a single dose once daily or in divided doses twice daily (9). For pioglitazone, initial therapy may be initiated at 15 or 30 mg p.o. once daily and the dose increased to 45 mg p.o. once daily (10). In combination therapy, the maximum approved dose of pioglitazone is 30 mg daily and for rosiglitazone, the maximum approved dose is 8mg daily, except in combination with insulin, where the dose is 4 mg daily. The thiazolidinediones should not be used in adolescents and children, since their safety in these age groups has not yet been established. Thiazolidinedione use is contraindicated in pregnancy and lactating women.

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