Indications
ActoMeg is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes who are already treated with a combination of pioglitazone and metformin or whose diabetes is not adequately controlled with metformin alone, or for those patients who have initially responded to pioglitazone alone and require additional glycemic control. Management of type 2 diabetes should also include nutritional counseling, weight reduction as needed and exercise. These efforts are important not only in the primary treatment of type 2 diabetes, but also to maintain the efficacy of drug
Dosage and administration
Selecting the starting dose of ActoMeg should be based on the patient’s current regimen of pioglitazone and/or metformin. ActoMeg should be given in divided daily doses with meals to reduce the gastrointestinal side effects associated with Metformin.
Starting dose for patients inadequately controlled on metformin monotherapy: Based on the usual starting dose of pioglitazone (15-30 mg daily), ActoMeg may be initiated at either the ActoMeg -500 or ActoMeg -850 tablet once or twice daily, and gradually titrated after assessing adequacy of therapeutic response.
Starting dose for patients who initially responded to pioglitazone monotherapy and require additional glycemic control: Based on the usual starting doses of metformin (500 mg twice daily or 850 mg daily), ActoMeg may be initiated at either the ActoMeg -500 twice daily or ActoMeg -850 tablet strength once daily, and gradually titrated after assessing adequacy of therapeutic response.
Starting dose for patients switching from combination therapy of pioglitazone plus metformin as separate tablets: ActoMeg may be initiated with either the ActoMeg-500 or ActoMeg-850 tablet strengths based on the dose of pioglitazone and metformin already being taken.
Use in pregnancy and lactation:Â Metformin Hydrochloride and Pioglitazone are not recommended for use in pregnancy. No studies have been conducted with the combined components of Metformin Hydrochloride and Pioglitazone tablets. In studies performed with the individual components, both Metformin and Pioglitazone are secreted in the milk of lactating rats. It is not known whether Metformin and/or Pioglitazone is secreted in human milk. Because many drugs are secreted in human milk, Metformin Hydrochloride and Pioglitazone tablets should not be administered to a breastfeeding woman.
Side effects:Â The most common adverse events reported were upper respiratory tract infection, diarrhea, combined edema/peripheral edema and headache. Other adverse events reported in Pioglitazone monotherapy included myalgia, tooth disorder, diabetes mellitus aggravated and pharyngitis. Most of these events wereconsidered mild or moderate in intensity.
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