METFORMIN HYDROCHLORIDE tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

REMEDYREPACK INC.

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Metformin Hydrochloride Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin Hydrochloride Tablets are contraindicated in patients with: - Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) [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 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].

Каталог на резюме:

Table 13: Metformin Hydrochloride Tablets Available Strengths, Units, and Appearance Metformin Hydrochloride Tablets 500 mg Bottles of 100 NDC 71093-132-04 Metformin Hydrochloride Tablets, USP 500 mg are blackberry flavored, white to off-white, round, biconvex, beveled edge film coated tablets, debossed with ‘SG’ on one side ‘105’ on other side. Bottles of 500 NDC 71093-132-05 Bottles of 1000 NDC 71093-132-06 850 mg Bottles of 100 NDC 71093-133-04 Metformin Hydrochloride Tablets, USP 850 mg are blackberry flavored, white to off-white, round, biconvex, beveled edge film coated tablets, debossed with ‘SG’ on one side ‘106’ on other side. Bottles of 500 NDC 71093-133-05 1000 mg Bottles of 100 NDC 71093-134-04 Metformin Hydrochloride Tablets, USP 1000 mg tablets are blackberry flavored, white to off-white, oval, biconvex, film coated tablets debossed on one side with S on the left side of bisect and G on the right side of bisect and other side 1 on the left side and 07 on the right side of the bisect. Bottles of 500 NDC 71093-134-05 Store at 20°to 25° C (68°to 77° F); excursions permitted to 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature.]

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METFORMIN HYDROCHLORIDE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METFORMIN
HYDROCHLORIDE TABLETS.
METFORMIN HYDROCHLORIDE 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
M C G /M L.(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
TABLETS AND INSTITUTE GENERAL
SUPPORTIVE MEASURES IN A HOSPITAL SETTING. PROMPT HEMODIALYSIS IS
RECOMMENDED. ( 5.1)
INDICATIONS AND USAGE
Metformin is a biguanide indicated as an adjunct to diet and exercise
to improve glycemic control in adults and pediatric
patients 10 years of age and older with type 2 diabetes mellitus. ( 1)
DOSAGE AND ADMINISTRATION
Adult Dosage for Metformin Hydrochloride Tablets:
Starting dose: 500 mg orally twice a day or 850 mg once a day, with
meals ( 2.1)
Increase the dose in increments of 500 mg weekly or 850 mg every 2
weeks, up to a maximum dose of 2550 mg per
day, given in divided doses ( 2.1)
Doses above 2000 mg may be better tolerated given 3 times a day with
meals