METFORMIN HYDROCHLORIDE tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

RedPharm Drug, Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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. Use in Specific Populations 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 Consideration

Resumen del producto:

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.]

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET
REDPHARM DRUG, INC.
----------
METFORMIN 1000MG
WARNING: LACTIC ACIDOSIS
POSTMARKETING CASES OF METFORMIN-ASSOCIATED LACTIC ACIDOSIS HAVE
RESULTED IN DEATH,
HYPOTHERMIA, HYPOTENSION, AND RESISTANT BRADYARRHYTHMIAS. THE ONSET OF
METFORMIN-
ASSOCIATED LACTIC ACIDOSIS IS OFTEN SUBTLE, ACCOMPANIED ONLY BY
NONSPECIFIC SYMPTOMS SUCH
AS MALAISE, MYALGIAS, RESPIRATORY DISTRESS, SOMNOLENCE, AND ABDOMINAL
PAIN. METFORMIN-
ASSOCIATED LACTIC ACIDOSIS WAS CHARACTERIZED BY ELEVATED BLOOD LACTATE
LEVELS (>5
MMOL/LITER), ANION GAP ACIDOSIS (WITHOUT EVIDENCE OF KETONURIA OR
KETONEMIA), AN INCREASED
LACTATE/PYRUVATE RATIO; AND METFORMIN PLASMA LEVELS GENERALLY >5
MCG/ML [SEE _WARNINGS AND_
_PRECAUTIONS (5.1)_].
RISK FACTORS FOR METFORMIN-ASSOCIATED LACTIC ACIDOSIS INCLUDE RENAL
IMPAIRMENT,
CONCOMITANT USE OF CERTAIN DRUGS (E.G. CARBONIC ANHYDRASE INHIBITORS
SUCH AS TOPIRAMATE),
AGE 65 YEARS OLD OR GREATER, HAVING A RADIOLOGICAL STUDY WITH
CONTRAST, SURGERY AND OTHER
PROCEDURES, HYPOXIC STATES (E.G., ACUTE CONGESTIVE HEART FAILURE),
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 (SEE _DOSAGE AND ADMINISTRATION (2.3),
CONTRAINDICATIONS (4), WARNINGS_
_AND PRECAUTIONS (5.1)_].
IF METFORMIN-ASSOCIATED LACTIC ACIDOSIS IS SUSPECTED, IMMEDIATELY
DISCONTINUE METFORMIN
AND INSTITUTE GENERAL SUPPORTIVE MEASURES IN A HOSPITAL SETTING.
PROMPT HEMODIALYSIS IS
RECOMMENDED [SEE _WARNINGS AND PRECAUTIONS (5.1)]_.
1 INDICATIONS AND USAGE
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.
3 DOSAGE FORMS AND STRENGTHS
Metformin Hydrochloride Tablets, USP are available as:
Metformin Hydrochloride Tablets, USP 500 mg are blackberry flavored,
white to off-white, round,
biconvex, beveled edge film coated tablets, debossed with ‘SG’ on