Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
GLYBURIDE (UNII: SX6K58TVWC) (GLYBURIDE - UNII:SX6K58TVWC), METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)
Zydus Pharmaceuticals (USA) Inc.
GLYBURIDE
GLYBURIDE 1.25 mg
ORAL
PRESCRIPTION DRUG
Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glyburide and metformin hydrochloride tablets are contraindicated in patients with: - Severe renal impairment (eGFR below 30 mL/min/1.73 m2 ) [see Warnings and Precautions (5.1) ]. - Hypersensitivity to metformin or glyburide. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. - Concomitant administration of bosentan [see Drug Interactions (7) ]. Risk Summary Available data from a small number of published studies and postmarketing experience with glyburide use in pregnancy over decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal outcomes. However, sulfonylureas (including glyburide) cross the placenta and have been associated with neonatal adverse reactions such as hypoglycemia. Therefore, glyburide and metformin hydrochloride should
Glyburide and metformin hydrochloride tablets, USP are available as follows: Glyburide and metformin hydrochloride tablets, 1.25 mg/250 mg are white to off-white colored, capsule shaped, biconvex coated tablets, debossed with "653" on one side and plain on the other side and are supplied as follows: NDC 68382-653-06 in bottles of 30 tablets NDC 68382-653-16 in bottles of 90 tablets NDC 68382-653-01 in bottles of 100 tablets NDC 68382-653-05 in bottles of 500 tablets NDC 68382-653-10 in bottles of 1000 tablets NDC 68382-653-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Glyburide and metformin hydrochloride tablets, 2.5 mg/500 mg are tan to scarlet yellow colored, capsule shaped, biconvex coated tablets debossed with "654" on one side and plain on the other side and are supplied as follows: NDC 68382-654-06 in bottles of 30 tablets NDC 68382-654-16 in bottles of 90 tablets NDC 68382-654-01 in bottles of 100 tablets NDC 68382-654-05 in bottles of 500 tablets NDC 68382-654-10 in bottles of 1000 tablets NDC 68382-654-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Glyburide and metformin hydrochloride tablets, 5 mg/500 mg are pale yellow colored, capsule shaped, biconvex coated tablets, debossed with "655" on one side and plain on the other side and are supplied as follows: NDC 68382-655-06 in bottles of 30 tablets NDC 68382-655-16 in bottles of 90 tablets NDC 68382-655-01 in bottles of 100 tablets NDC 68382-655-05 in bottles of 500 tablets NDC 68382-655-10 in bottles of 1000 tablets NDC 68382-655-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Store at temperatures up to 25°C (77°F). [See USP Controlled Room Temperature.] Dispense in light-resistant containers.
Abbreviated New Drug Application
GLYBURIDE AND METFORMIN HYDROCHLORIDE - GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET ZYDUS PHARMACEUTICALS (USA) INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS. GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2000 WARNING: LACTIC ACIDOSIS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ POST-MARKETING CASES OF METFORMIN -ASSOCIATED LACTIC ACIDOSIS HAVE RESULTED IN DEATH, HYPOTHERMIA, HYPOTENSION, AND RESISTANT BRADYARRHYTHMIAS. SYMPTOMS INCLUDE MALAISE, MYALGIAS, RESPIRATORY DISTRESS, SOMNOLENCE, AND ABDOMINAL PAIN. LABORATORY ABNORMALITIES INCLUDED ELEVATED BLOOD LACTATE LEVELS, ANION GAP ACIDOSIS, INCREASED LACTATE/PYRUVATE RATIO; AND METFORMIN PLASMA LEVELS GENERALLY >5 MCG/ML. (5.1) RISK FACTORS INCLUDE RENAL IMPAIRMENT, CONCOMITANT USE OF CERTAIN DRUGS, AGE > 65 YEARS OLD, RADIOLOGICAL STUDY WITH CONTRAST, SURGERY AND OTHER PROCEDURES, HYPOXIC STATES, EXCESSIVE ALCOHOL INTAKE, AND HEPATIC IMPAIRMENT. STEPS TO REDUCE THE RISK OF AND MANAGE METFORMIN-ASSOCIATED LACTIC ACIDOSIS IN THESE HIGH RISK GROUPS ARE PROVIDED IN THE FULL PRESCRIBING INFORMATION. (5.1) IF LACTIC ACIDOSIS IS SUSPECTED, DISCONTINUE GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS AND INSTITUTE GENERAL SUPPORTIVE MEASURES IN A HOSPITAL SETTING. PROMPT HEMODIALYSIS IS RECOMMENDED. (5.1) INDICATIONS AND USAGE Glyburide and metformin hydrochloride tablets are a combination of glyburide, a sulfonylurea, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1) (1) DOSAGE AND ADMINISTRATION Adult Dosage: (2) Give glyburide and metformin hydrochloride tablets in divided doses, twice daily, with meals. (2.1) For patients not treated with either glyburide (or another sulfonylu Đọc toàn bộ tài liệu