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The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. Therefore, AMARYL should be administered at least 4 hours prior to colesevelam.Īll sulfonylureas, including AMARYL, can cause severe hypoglycemia. When colesevelam is coadministered with glimepiride, maximum plasma concentration and total exposure to glimepiride is reduced.

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. The maximum recommended dose is 8 mg once daily. A conservative titration scheme is recommended for patients at increased risk for hypoglycemia. Uptitration should not occur more frequently than every 1 to 2 weeks. Īfter 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. Patients at increased risk for hypoglycemia (e.g., the elderly or patients with renal impairment) should be started on 1 mg once daily. The recommended starting dose of AMARYL is 1 mg or 2 mg once daily. FULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosing 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Hypoglycemia 5.2 Hypersensitivity Reactions 5.3 Hemolytic Anemia 5.4 Increased Risk of Cardiovascular Mortality with Sulfonylureas 5.5 Macrovascular Outcomes 6 ADVERSE REACTIONS 6.1Ĝlinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1ĝrugs Affecting Glucose Metabolism 7.2 Miconazole 7.3Ĝytochrome P450 2C9 Interactions 7.4Ĝoncomitant Administration of Colesevelam 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Renal Impairment 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility 14 CLINICAL STUDIES 14.1 Monotherapy 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed.ĪMARYL should be administered with breakfast or the first main meal of the day.

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