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:

Apotheca Inc.

INN (International Name):

METFORMIN HYDROCHLORIDE

Composition:

METFORMIN HYDROCHLORIDE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metformin hydrochloride tablets USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. Metformin hydrochloride is 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 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 of renal f

Product summary:

Metformin hydrochloride tablets USP: Metformin hydrochloride tablets 500 mg are white to off-white, round shape, biconvex coated tablets debossed with "227" on one side and plain on the other side. Tablets are supplied as following: NDC 12634-756-00 Bottles of 10 NDC 12634-756-01 Bottles of 100 NDC 12634-756-09 Bottles of 35 NDC 12634-756-12 Bottles of 120 NDC 12634-756-18 Bottles of 180 NDC 12634-756-40 Bottles of 40 NDC 12634-756-42 Bottles of 42 NDC 12634-756-45 Bottles of 45 NDC 12634-756-50 Bottles of 50 NDC 12634-756-52 Blister Pack of 12 NDC 12634-756-54 Blister Pack of 14 NDC 12634-756-57 Blister Pack of 20 NDC 12634-756-59 Blister Pack of 30 NDC 12634-756-60 Bottles of 60 NDC 12634-756-61 Blister Pack of 10 NDC 12634-756-63 Blister Pack of 3 NDC 12634-756-66 Blister Pack of 6 NDC 12634-756-67 Blister Pack of 7 NDC 12634-756-69 Blister Pack of 9 NDC 12634-756-71 Bottles of 30 NDC 12634-756-74 Bottles of 24 NDC 12634-756-78 Bottles of 28 NDC 12634-756-79 Bottles of 25 NDC 12634-756-80 Bottles of 20 NDC 12634-756-81 Bottles of 21 NDC 12634-756-82 Bottles of 12 NDC 12634-756-84 Bottles of 14 NDC 12634-756-85 Bottles of 15 NDC 12634-756-90 Bottles of 90 NDC 12634-756-91 Blister Pack of 1 NDC 12634-756-92 Bottles of 2 NDC 12634-756-93 Bottles of 3 NDC 12634-756-94 Bottles of 4 NDC 12634-756-95 Bottles of 5 NDC 12634-756-96 Bottles of 6 NDC 12634-756-97 Bottles of 7 NDC 12634-756-98 Bottles of 8 NDC 12634-756-99 Bottles of 9 Metformin hydrochloride tablets 850 mg are white to off-white, round shape, biconvex coated tablets debossed with "228" on one side and plain on the other side. Tablets are supplied as following: NDC 12634-757-00 Bottles of 10 NDC 12634-757-01 Bottles of 100 NDC 12634-757-09 Bottles of 35 NDC 12634-757-12 Bottles of 120 NDC 12634-757-18 Bottles of 180 NDC 12634-757-40 Bottles of 40 NDC 12634-757-42 Bottles of 42 NDC 12634-757-45 Bottles of 45 NDC 12634-757-50 Bottles of 50 NDC 12634-757-52 Blister Pack of 12 NDC 12634-757-54 Blister Pack of 14 NDC 12634-757-57 Blister Pack of 20 NDC 12634-757-59 Blister Pack of 30 NDC 12634-757-60 Bottles of 60 NDC 12634-757-61 Blister Pack of 10 NDC 12634-757-63 Blister Pack of 3 NDC 12634-757-66 Blister Pack of 6 NDC 12634-757-67 Blister Pack of 7 NDC 12634-757-69 Blister Pack of 9 NDC 12634-757-71 Bottles of 30 NDC 12634-757-74 Bottles of 24 NDC 12634-757-78 Bottles of 28 NDC 12634-757-79 Bottles of 25 NDC 12634-757-80 Bottles of 20 NDC 12634-757-81 Bottles of 21 NDC 12634-757-82 Bottles of 12 NDC 12634-757-84 Bottles of 14 NDC 12634-757-85 Bottles of 15 NDC 12634-757-90 Bottles of 90 NDC 12634-757-91 Blister Pack of 1 NDC 12634-757-92 Bottles of 2 NDC 12634-757-93 Bottles of 3 NDC 12634-757-94 Bottles of 4 NDC 12634-757-95 Bottles of 5 NDC 12634-757-96 Bottles of 6 NDC 12634-757-97 Bottles of 7 NDC 12634-757-98 Bottles of 8 NDC 12634-757-99 Bottles of 9 Metformin hydrochloride tablets 1000 mg are white to off white, oval, capsule shaped, biconvex, coated tablets debossed with “229/229” on one side and a bisect line on both sides. Tablets are supplied as following: NDC 12634-789-00 Bottles of 10 NDC 12634-789-01 Bottles of 100 NDC 12634-789-09 Bottles of 35 NDC 12634-789-12 Bottles of 120 NDC 12634-789-18 Bottles of 180 NDC 12634-789-40 Bottles of 40 NDC 12634-789-42 Bottles of 42 NDC 12634-789-45 Bottles of 45 NDC 12634-789-50 Bottles of 50 NDC 12634-789-52 Blister Pack of 12 NDC 12634-789-54 Blister Pack of 14 NDC 12634-789-57 Blister Pack of 20 NDC 12634-789-59 Blister Pack of 30 NDC 12634-789-60 Bottles of 60 NDC 12634-789-61 Blister Pack of 10 NDC 12634-789-63 Blister Pack of 3 NDC 12634-789-66 Blister Pack of 6 NDC 12634-789-67 Blister Pack of 7 NDC 12634-789-69 Blister Pack of 9 NDC 12634-789-71 Bottles of 30 NDC 12634-789-74 Bottles of 24 NDC 12634-789-78 Bottles of 28 NDC 12634-789-79 Bottles of 25 NDC 12634-789-80 Bottles of 20 NDC 12634-789-81 Bottles of 21 NDC 12634-789-82 Bottles of 12 NDC 12634-789-84 Bottles of 14 NDC 12634-789-85 Bottles of 15 NDC 12634-789-90 Bottles of 90 NDC 12634-789-91 Blister Pack of 1 NDC 12634-789-92 Bottles of 2 NDC 12634-789-93 Bottles of 3 NDC 12634-789-94 Bottles of 4 NDC 12634-789-95 Bottles of 5 NDC 12634-789-96 Bottles of 6 NDC 12634-789-97 Bottles of 7 NDC 12634-789-98 Bottles of 8 NDC 12634-789-99 Bottles of 9 Store at 20°–25° C (68°–77° F); excursions permitted to 15°–30° C (59°–86° F). [See USP Controlled Room Temperature.]  Dispense in light-resistant containers. Manufactured by: Alkem Laboratories Limited ALKEM HOUSE, Lower Parel, Mumbai – 400 013, INDIA September, 2013 Distributed by: Ascend Laboratories, LLC. Montvale, NJ 07645 PT1260-05

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
APOTHECA INC.
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METFORMIN HYDROCHLORIDE TABLETS USP
BOXED WARNING
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 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