METFORMIN HYDROCHLORIDE tablet METFORMIN HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Med-Health Pharma, LLC

INN (International Name):

METFORMIN HYDROCHLORIDE

Composition:

METFORMIN HYDROCHLORIDE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metformin hydrochloride tablets, USP 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 tablets, USP. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. Metformin 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

Product summary:

Store at controlled room temperature 15°-30° C (59°-86°F). Dispense in tight, light resistant container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET
MED-HEALTH PHARMA, LLC
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WARNINGS
LACTIC ACIDOSIS:
LACTIC ACIDOSIS IS A RARE, BUT SERIOUS, METABOLIC COMPLICATION THAT
CAN OCCUR DUE TO
METFORMIN ACCUMULATION DURING TREATMENT WITH METFORMIN; 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 ΜG/ML
ARE GENERALLY FOUND.
THE REPORTED INCIDENCE OF LACTIC ACIDOSIS IN PATIENTS RECEIVING
METFORMIN HYDROCHLORIDE
TABLETS, USP 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
AND BY USE OF THE MINIMUM EFFECTIVE DOSE OF METFORMIN. IN PARTICULAR,
TREATMENT OF THE
ELDERLY SHOULD BE ACCOMPANIED BY CAREFUL MONITORING OF RENAL FUNCT