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36.(b) Duetact (Pioglitazone hydrochloride and
Glimepiride) tablets contain two oral anti-
hyperglycemic agents used in the management of
type 2 diabetes: Pioglitazone hydrochloride and
Glimepiride.
Pioglitazone hydrochloride is an oral
antihyperglycemic agent that acts primarily by
decreasing insulin resistance whereas Glimepiride is
an oral blood glucose-lowering drug of the
sulfonylurea class.
Duetact is available as a tablet for oral
administration containing 30 mg Pioglitazone
hydrochloride (as the base) with 2 mg Glimepiride
(30 mg/2 mg) or 30 mg Pioglitazone hydrochloride
(as the base) with 4 mg Glimepiride.
Duetact is indicated as an adjunct to diet and
exercise to improve glycemic control in adults with
type 2 diabetes mellitus who are already treated
with a thiazolidinedione and a sulfonylurea or who
have inadequate glycemic control on a
thiazolidinedione alone or a sulfonylurea alone.
Based on the usual starting dose of Pioglitazone (15
mg or 30 mg daily), Duetact may be initiated at 30
mg/2 mg or 30 mg/4 mg tablet strengths once daily,
and adjusted after assessing adequacy of
therapeutic response.
Therapy with Duetact should not be initiated if the
patient exhibits clinical evidence of active liver
disease or increased serum transaminase levels
(ALT greater than 2.5 times the upper limit of
normal) at start of therapy. Edema, weight gain,
liver toxicity, upper respiratory tract infections and
hypoglycemia are reported side effects of the drug.
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