METFORMIN HYDROCHLORIDE tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Laurus Labs Limited

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Metformin hydrochloride tablets, USP 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 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 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 met

Povzetek izdelek:

Metformin Hydrochloride Tablets, USP are supplied in the following strengths and package configurations: Metformin Hydrochloride Tablets USP, 500 mg are supplied as white to off white, round, biconvex, flavored, film coated tablets with ‘LL’ debossed on one side and plain on the other side. Bottles of 90                                                                           NDC 42385-947-90 Bottles of 100                                                                         NDC 42385-947-01 Bottles of 180                                                                         NDC 42385-947-18 Bottles of 500                                                                         NDC 42385-947-05 Bottles of 1,000                                                                      NDC 42385-947-11 Carton with 100 (10×10) Unit-Dose Tablets                           NDC 42385-947-19 Metformin Hydrochloride Tablets USP, 850 mg are supplied as white to off white, capsule shaped, biconvex, flavored, film coated tablets with ‘L06’ debossed on one side and plain on the other side. Bottles of 90                                                                        NDC 42385-948-90 Bottles of 100                                                                      NDC 42385-948-01 Bottles of 180                                                                      NDC 42385-948-18 Bottles of 500                                                                      NDC 42385-948-05 Bottles of 1,000                                                                   NDC 42385-948-11 Carton with 100 (10×10) Unit-Dose Tablets                       NDC 42385-948-19 Metformin Hydrochloride Tablets USP, 1,000 mg are supplied as white to off white, oval, biconvex, flavored, film coated tablets, with score line on both sides, with ‘L’ and ‘11’ debossed on either side of score line on one side. Bottles of 60                                                                       NDC 42385-949-60 Bottles of 90                                                                       NDC 42385-949-90 Bottles of 100                                                                     NDC 42385-949-01 Bottles of 180                                                                     NDC 42385-949-18 Bottles of 500                                                                     NDC 42385-949-05 Bottles of 1,000                                                                  NDC 42385-949-11 Carton with 100 (10×10) Unit-Dose Tablets                       NDC 42385-949-19 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.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

METFORMIN HYDROCHLORIDE - METFORMIN HYDROCHLORIDE TABLET, FILM COATED
LAURUS LABS LIMITED
----------
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
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 AND INSTITUTE
GENERAL SUPPORTIVE MEASURES IN A HOSPITAL SETTING. PROMPT HEMODIALYSIS
IS
RECOMMENDED. (5.1)
INDICATIONS AND USAGE
Metformin hydrochloride tablets, USP are 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
2,550 mg per day, given in divided doses (2.1)
Doses above 2,000 mg may be better