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Actoplus Met (Pioglitazone Metformin)
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Endocrine/metabolic
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Antidiabetic agent
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Type 2 diabetes in patients already on pioglitazone and metformin, or when response to pioglitazone or metformin alone is inadequate.
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1. Adults: Initially 15mg/500mg or 15mg/850mg once or twice daily; may adjust after 8-12 weeks; max 45mg pioglitazone/2550mg metformin per day. 2. Children: Not recommended
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Category C
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Upper respiratory infection, GI upset, edema, headache, urinary tract infection, dizziness, weight gain, lactic acidosis, risk of fracture in women
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Pregnancy Risk Categories defined:
A: Studies in pregnant women failed to show a risk to the fetus in the first
trimester - with no evidence of risk in the later trimesters.
B: Animals studies indicate no adverse effect to the fetus, but there are no adequate,
clinical studies in pregnant women.
C: Animal studies have shown an adverse effect on the fetus, but there are no adequate,
clinical studies in humans. Despite potential risks, the drug may be useful in pregnant
women.
D: There is evidence of risk to the human fetus, but the potential benefits of use in
pregnant women may be acceptable, despite potential risks.
X: Studies in animals or humans show fetal abnormalities, or adverse reaction reports
indicate evidence of fetal risk. Warning: the risks involved clearly outweigh any
potential benefit from using the drug in pregnant women, regardless of trimester.
NR: Not rated (i.e., no information available at this time as to the potential
risks or benefits).
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