METFORMIN HYDROCHLORIDE tablet, extended release

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Eon Labs, Inc.

INN（国際名）:

METFORMIN HYDROCHLORIDE

構図:

METFORMIN HYDROCHLORIDE 500 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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: 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 metformin was administered to pregnant Sprague Dawley rats and rabbits during the period of organogenesis at doses up to 2- and 5- times, respectively, a 2550 mg clinical dose, based on body surface area [see Data]. The estima

製品概要:

Table 13. Metformin Hydrochloride Extended Release Tablets Available Strengths, Units, and Appearance Metformin hydrochloride extended-release tablets, USP 500 mg Bottles of 100 NDC 0185-4416-01 white, oblong, biconvex tablets, debossed “E4416” on one side and plain on the other side Bottles of 500 NDC 0185-4416-05 Bottles of 750 NDC 0185-4416-75 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in light-resistant container as defined in the USP with a child-resistant closure, as required. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
EON LABS, INC.
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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._
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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 forMetformin Hydrochloride Extended Release Tablets
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Renal Impairment:
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Discontinuation for Iodinated Contrast Imaging Procedures:
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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)
Swallow metformin hydrochloride extended