METFORMIN HYDROCHLORIDE tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Rebel Distributors Corp.

INN (nemzetközi neve):

METFORMIN HYDROCHLORIDE

Összetétel:

METFORMIN HYDROCHLORIDE 500 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 of renal function. (See also PRECAU

Termék összefoglaló:

Metformin hydrochloride tablets, USP 500 mg Bottles of 30                           NDC 21695-471-30 500 mg Bottles of 60                           NDC 21695-471-60 500 mg Bottles of 90                           NDC 21695-471-90 500 mg Bottles of 100                         NDC 21695-471-00 500 mg Bottles of 180                         NDC 21695-471-78 850 mg Bottles of 30                           NDC 21695-472-30 850 mg Bottles of 60                         NDC 21695-472-60 1000 mg Bottles of 30                         NDC 21695-473-30 1000 mg Bottles of 60                       NDC 21695-473-60 1000 mg Bottles of 90                       NDC 21695-473-90 1000 mg Bottles of 180                     NDC 21695-473-78 Metformin hydrochloride 500 mg tablets, USP are round, white to off-white, film coated tablets debossed with “397” on one side and plain on the other side. Metformin hydrochloride 850 mg tablets, USP are round, white to off-white, film coated tablets debossed with “435” on one side and plain on the other side. Metformin hydrochloride 1000 mg tablets, USP are white to off-white colored, oval shaped, film coated tablets debossed with “C” & “474” on one side and scored on both sides. Store at controlled room temperature 15°-30° C (59°-86°F). Dispense in tight, light resistant container as defined in the USP.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET
REBEL DISTRIBUTORS CORP.
----------
METFORMIN HYDROCHLORIDE
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