GLYBURIDE AND METFORMIN HYDROCHLORIDE tablet, film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

GLYBURIDE (UNII: SX6K58TVWC) (GLYBURIDE - UNII:SX6K58TVWC), METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)

Sẵn có từ:

Rising Health, LLC

INN (Tên quốc tế):

GLYBURIDE

Thành phần:

GLYBURIDE 1.25 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 be disco

Tóm tắt sản phẩm:

Glyburide and Metformin Hydrochloride Tablets USP, 1.25 mg/250 mg: Yellow, capsule shaped, biconvex, film-coated tablet with ‘A’ debossed on one side and ‘46’ on the other side.             Bottles of 100                                    NDC 57237-023-01             Bottles of 500                                    NDC 57237-023-05 Glyburide and Metformin Hydrochloride Tablets USP, 2.5 mg/500 mg: Light pink, capsule shaped, biconvex, film-coated tablet with ‘A’ debossed on one side and ‘47’ on the other side.             Bottles of 100                                    NDC 57237-024-01             Bottles of 500                                    NDC 57237-024-05 Glyburide and Metformin Hydrochloride Tablets USP, 5 mg/500 mg: Yellow, capsule shaped, biconvex, film-coated tablet with ‘A’ debossed on one side and ‘48’ on the other side.             Bottles of 100                                    NDC 57237-025-01             Bottles of 500                                    NDC 57237-025-05  Store at 20° to 25°C (68º to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].   Dispense in light-resistant containers.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

GLYBURIDE AND METFORMIN HYDROCHLORIDE - GLYBURIDE AND METFORMIN
HYDROCHLORIDE TABLET, FILM COATED
RISING HEALTH, LLC
----------
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
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)
DOSAGE AND ADMINISTRATION
Adult Dosage:
Give glyburide and metformin hydrochloride tablets in divided doses,
twice daily, with meals. (2.1)
For patients not treated with either glyburide (or another
sulfonylurea) or metformi