Amaryl

/ Sanofi

AMARYL should be administered with breakfast or the first main meal of the day.
The recommended starting dose of AMARYL is 1 mg or 2 mg once daily. Patients at increased risk for hypoglycemia (e.g., the elderly or patients with renal impairment) should be started on 1 mg once daily.
After reaching a daily dose of 2 mg, further dose increases can be made in increments of 1 mg or 2 mg based upon the patient’s glycemic response. Uptitration should not occur more frequently than every 1-2 weeks. A conservative titration scheme is recommended for patients at increased
risk for hypoglycemia.
The maximum recommended dose is 8 mg once daily.
Patients being transferred to AMARYL from longer half-life sulfonylureas (e.g.,
chlorpropamide) may have overlapping drug effect for 1-2 weeks and should be appropriately monitored for hypoglycemia.
When colesevelam is coadministered with glimepiride, maximum plasma concentration and total exposure to glimepiride is reduced. Therefore, Amaryl should be administered at least 4 hours prior to colesevelam.

As an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin-dependent (type II) diabetes mellitus (NIDDM), whose hyperglycemia cannot be controlled by diet and exercise alone, in combination with insulin to lower blood glucose in patients whose hyperglycemia cannot be controlled by diet and exercise in conjunction with an oral hypoglycemic agent. Combined use of glimepiride and insulin may increase the potential for hypoglycemia.
See prescribing information for full details.

Known hypersensitivity to the drug, diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.

Hypoglycemia. All sulfonylurea drugs are capable of producing severe hypoglycemia. Impaired renal function. Exposure to stress such as fever, trauma, infection, or surgery, a loss of control may occur. Amaryl should be discontinued in nursing mothers. Safety and effectiveness in pediatric patients have not been established.

Vomiting, gastrointestinal pain, and diarrhea have been reported, but the incidence in placebo-controlled trials was less than 1%. Allergic skin reactions, e.g., pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions, occur in less than 1% of treated patients. Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia and pancytopenia have been reported with sulfonylureas. Patients transferred to human insulin will find that early warning symptoms of hypoglycaemia are less pronounced than with insulins of animal source. Dosage adjustments may be necessary during infections, pregnancy, emotional distress, renal or hepatic impairment.

See prescribing information for full details.