METFORMIN HYDROCHLORIDE tablet, extended release

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)

可用日期:

Amneal Pharmaceuticals of New York LLC

INN（国际名称）:

METFORMIN HYDROCHLORIDE

组成:

METFORMIN HYDROCHLORIDE 500 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride extended-release 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. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Risk Summary Limited data with metformin hydrochloride extended-release tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see Data]. There are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see Clinical Considerations]. No adverse developmental effects were observed when me

產品總結:

Metformin Hydrochloride Extended-release Tablets USP, 500 mg are white, capsule shaped, biconvex tablets debossed "IP 178" on one side and plain on the other side. They are available as follows: Bottles of 30:              NDC 53746-178-30 Bottles of 90:              NDC 53746-178-90 Bottles of 100:            NDC 53746-178-01 Bottles of 500:            NDC 53746-178-05 Bottles of 1,000:         NDC 53746-178-10 Metformin Hydrochloride Extended-release Tablets USP, 750 mg are white, capsule shaped, biconvex tablets debossed "IP 179" on one side and plain on the other side. They are available as follows: Bottles of 30:              NDC 53746-179-30 Bottles of 90:              NDC 53746-179-90 Bottles of 100:            NDC 53746-179-01 Bottles of 500:            NDC 53746-179-05 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in light-resistant containers as defined in the USP.

授权状态:

Abbreviated New Drug Application

产品特点

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METFORMIN
HYDROCHLORIDE EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS.
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
WARNING: LACTIC ACIDOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
POSTMARKETING CASES OF METFORMIN-ASSOCIATED LACTIC ACIDOSIS HAVE
RESULTED IN DEATH,
HYPOTHERMIA, HYPOTENSION, AND RESISTANT BRADYARRHYTHMIAS. SYMPTOMS
INCLUDED
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 STUDIES 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 METFORMIN HYDROCHLORIDE
EXTENDED-
RELEASE TABLETS AND INSTITUTE GENERAL SUPPORTIVE MEASURES IN A
HOSPITAL SETTING.
PROMPT HEMODIALYSIS IS RECOMMENDED. (5.1)
INDICATIONS AND USAGE
Metformin hydrochloride extended-release tablets are 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 for Metformin Hydrochloride Extended-Release Tablets:
Swallow metformin hydrochloride extended-release tablets whole and
never crush, cut or chew. (2.1)
Starting dose: 500 mg orally once daily with the evening meal. (2.1)
Increase the dose in i