METFORMIN HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Carlsbad Technology, Inc.

INN (International Name):

METFORMIN HYDROCHLORIDE

Composition:

METFORMIN HYDROCHLORIDE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. Metformin hydrochloride tablets are contraindicated in patients with: - Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see WARNINGS and PRECAUTIONS ). - Known hypersensitivity to metformin hydrochloride. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. Metformin hydrochloride tablets should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration o

Product summary:

Metformin Hydrochloride Tablets are available as follows: 500 mg: Bottles of 100 NDC 61442-361-01 Bottles of 500 NDC 61442-361-05 Bottles of 1000 NDC 61442-361-10 850 mg: Bottles of 100 NDC 61442-362-01 Bottles of 500 NDC 61442-362-05 1000 mg: Bottles of 100 NDC 61442-363-01 Bottles of 500 NDC 61442-363-05 Metformin Hydrochloride Tablets, USP 500 mg are white to off-white, round, biconvex, beveled edge film coated tablets, debossed with ‘SG' on one side ‘105' on other side. Metformin Hydrochloride Tablets, USP 850 mg are white to off-white, round, biconvex, beveled edge film coated tablets, debossed with ‘SG' on one side ‘106' on other side. Metformin Hydrochloride Tablets, USP 1000 mg tablets are 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. 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.] Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: Sciegen Pharmaceuticals Inc 20 Davids Drive Hauppauge NY 11788 Distributed by: Carlsbad Technology, Inc. 5923 Balfour Court Carlsbad, CA 92008 Rev: 01/14 Rx Only

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
CARLSBAD TECHNOLOGY, INC.
----------
METFORMIN HYDROCHLORIDE TABLETS USP
RX ONLY
LACTIC ACIDOSIS:
LACTIC ACIDOSIS IS A RARE, BUT SERIOUS, METABOLIC COMPLICATION THAT
CAN OCCUR DUE TO
METFORMIN ACCUMULATION DURING TREATMENT WITH METFORMIN HYDROCHLORIDE
TABLETS; WHEN IT
OCCURS, IT IS FATAL IN APPROXIMATELY 50% OF CASES. LACTIC ACIDOSIS MAY
ALSO OCCUR IN
ASSOCIATION WITH A NUMBER OF PATHOPHYSIOLOGIC CONDITIONS, INCLUDING
DIABETES MELLITUS, AND
WHENEVER THERE IS SIGNIFICANT TISSUE HYPOPERFUSION AND HYPOXEMIA.
LACTIC ACIDOSIS IS
CHARACTERIZED BY ELEVATED BLOOD LACTATE LEVELS (>5 MMOL/L), DECREASED
BLOOD PH, ELECTROLYTE
DISTURBANCES WITH AN INCREASED ANION GAP, AND AN INCREASED
LACTATE/PYRUVATE RATIO. WHEN
METFORMIN IS IMPLICATED AS THE CAUSE OF LACTIC ACIDOSIS, METFORMIN
PLASMA LEVELS >5 MCG/ML
ARE GENERALLY FOUND.
THE REPORTED INCIDENCE OF LACTIC ACIDOSIS IN PATIENTS RECEIVING
METFORMIN HYDROCHLORIDE IS
VERY LOW (APPROXIMATELY 0.03 CASES/1000 PATIENT-YEARS, WITH
APPROXIMATELY 0.015 FATAL
CASES/1000 PATIENT-YEARS). IN MORE THAN 20,000 PATIENT-YEARS EXPOSURE
TO METFORMIN IN
CLINICAL TRIALS, THERE WERE NO REPORTS OF LACTIC ACIDOSIS. REPORTED
CASES HAVE OCCURRED
PRIMARILY IN DIABETIC PATIENTS WITH SIGNIFICANT RENAL INSUFFICIENCY,
INCLUDING BOTH INTRINSIC
RENAL DISEASE AND RENAL HYPOPERFUSION, OFTEN IN THE SETTING OF
MULTIPLE CONCOMITANT
MEDICAL/SURGICAL PROBLEMS AND MULTIPLE CONCOMITANT MEDICATIONS.
PATIENTS WITH CONGESTIVE
HEART FAILURE REQUIRING PHARMACOLOGIC MANAGEMENT, IN PARTICULAR THOSE
WITH UNSTABLE OR
ACUTE CONGESTIVE HEART FAILURE WHO ARE AT RISK OF HYPOPERFUSION AND
HYPOXEMIA, ARE AT
INCREASED RISK OF LACTIC ACIDOSIS. THE RISK OF LACTIC ACIDOSIS
INCREASES WITH THE DEGREE OF
RENAL DYSFUNCTION AND THE PATIENT'S AGE. THE RISK OF LACTIC ACIDOSIS
MAY, THEREFORE, BE
SIGNIFICANTLY DECREASED BY REGULAR MONITORING OF RENAL FUNCTION IN
PATIENTS TAKING METFORMIN
HYDROCHLORIDE TABLETS AND BY USE OF THE MINIMUM EFFECTIVE DOSE OF
METFORMIN HYDROCHLORIDE
TAB