Asenza Plus

Asenza Plus Adverse Reactions

pioglitazone + glimepiride

Manufacturer:

Ajanta Pharma Phil

Distributor:

Ajanta Pharma Phil
Full Prescribing Info
Adverse Reactions
Pioglitazone hydrochloride: Most clinical adverse events were similar between groups treated with Pioglitazone in combination with a sulfonylurea and those treated with Pioglitazone monotherapy. Other adverse events reported in at least 5 % of patients in controlled clinical studies between placebo and Pioglitazone monotherapy included myalgia (2.7% and 5.4%), tooth disorder (2.3% and 5.3%), diabetes mellitus aggravated (8.1% and 5.1%), and pharyngitis (0.8% and 5.1%), respectively.
In monotherapy studies, edema was reported for 4.8% (with doses from 7.5 mg to 45 mg) of patients treated with Pioglitazone versus 1.2% of placebo-treated patients. Most of these events were considered mild or moderate in intensity (see General: Pioglitazone hydrochloride, Edema under Precautions).
Postmarketing reports of new onset or worsening diabetic macular edema with decreased visual acuity have also been received (see General: Pioglitazone hydrochloride under Precautions).
The drug should not be used as first line of therapy for diabetes.
Glimepiride: Adverse events that occurred in controlled clinical trials with placebo and Glimepiride monotherapy, other than hypoglycemia, headache and nausea, also included dizziness (0.3% and 1.7%) and asthenia (1.0% and 1.6%), respectively.
Gastrointestinal Reactions: Vomiting, gastrointestinal pain, and diarrhea have been reported with Glimepiride, but the incidence in placebo-controlled trials was less than 1%. In rare cases, there may be an elevation of liver enzyme levels. In isolated instances, impairment of liver function (e.g. with cholestasis and jaundice), as well as hepatitis, which may also lead to liver failure have been reported with sulfonylureas, including Glimepiride.
Dermatologic Reactions: Allergic skin reactions, e.g., pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions, occur in less than 1% of Glimepiride-treated patients. These may be transient and may disappear despite continued use of Glimepiride. If those hypersensitivity reactions persist or worsen, the drug should be discontinued. Porphyria cutanea tarda, photosensitivity reactions, and allergic vasculitis have been reported with sulfonylureas.
Metabolic Reactions: hepatic porphyria reactions and disulfiram-like reactions have been reported with sulfonylureas; however, no cases have yet been reported with Glimepiride tablets. Cases of hyponatremia have been reported with Glimepiride and all other sulfonylureas, most often in patients who are on other medications or have medical conditions known to cause hyponatremia or increase release of antidiuretic hormone. The syndrome of inappropriate antidiuretic hormone (SIADH) secretion has been reported with certain other sulfonylureas, and it has been suggested that these sulfonylureas may augment the peripheral (antidiuretic) action of ADH and/or increase release of ADH.
Hematologic Reactions: Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, and pancytopenia have been reported with sulfonylureas.
Other Reactions: Changes in accommodation and/or blurred vision may occur with the use of Glimepiride. In placebo-controlled trials of Glimepiride, the incidence of blurred vision with placebo was 0.7% and with Glimepiride, 0.4%. This is thought to be due to changes in blood glucose, and may be more pronounced when treatment is initiated. This condition is also seen in untreated diabetic patients, and may actually be reduced by treatment.
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