Posology : מינונים

3. DOSAGE AND ADMINISTRATION

3.1 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 (5.1) and Use in Specific Populations (8.5, 8.6)].

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 to 2 weeks. A conservative titration scheme is recommended for patients at increased risk for hypoglycemia [see Warnings and Precautions (5.1) and Use in Specific Populations (8.5, 8.6)].

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 to 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.



4. DOSAGE FORMS AND STRENGTHS

AMARYL is formulated as tablets of:
• 1 mg (pink, oblong tablets, biplanar with score-line on both sides, imprinted on both sides).
• 2 mg (green, tablets, biplanar with score-line on both sides, imprinted on both sides).
• 3mg (yellow, tablets, biplanar with score-line on both sides, imprinted on both sides).
• 4 mg (blue, tablets, biplanar with score-line on both sides, imprinted on both sides).
Tablets for oral administration.
The tablets can be divided into two equal doses along the score line.