AMARYL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies].

Important Limitations of Use

AMARYL should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

Recommended Dosing

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 [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

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 [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

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.

Dosage Forms And Strengths

AMARYL is formulated as tablets of:

• 1 mg (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
• 2 mg (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
• 4 mg (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)

Storage And Handling

AMARYL tablets are available in the following strengths and package sizes:

1 mg tablets (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0221-10)

2 mg tablets (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0222-10)

4 mg tablets (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0223-10)

Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F) (see USP Controlled Room Temperature).

Dispense in well-closed containers with safety closures.

sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Revised: 01/2012

Last reviewed on RxList: 2/15/2012
This monograph has been modified to include the generic and brand name in many instances.