METFORMIN HYDROCHLORIDE- metformin hydrochloride tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

STAT Rx USA LLC

INN (International Name):

METFORMIN HYDROCHLORIDE

Sammensetning:

METFORMIN HYDROCHLORIDE 500 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Metformin hydrochloride tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride tablets and metformin hydrochloride extended-release 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 and metformin hydrochloride

Produkt oppsummering:

Metformin Hydrochloride Tablets, USP Metformin Hydrochloride Tablets USP, 500 mg are white to off-white, round shaped, film coated tablets debossed with the logo of "70" on one side and "Z" on the other side and are supplied as follows. Bottles of 30  -  NDC # 16590-313-30 Bottles of 60  -  NDC # 16590-313-60 Bottles of 90  -  NDC # 16590-313-90 Bottles of 120 - NDC # 16590-313-72 Bottles of 180 - NDC # 16590-313-82 Metformin Hydrochloride Tablets USP, 1000 mg are white to off white, oval shaped, biconvex, film coated tablets with a bisect line on both the sides, one surface is debossed with "Z" and "71" on each side of bisect and are supplied as follows. Bottles of 30  -  NDC # 16590-397-30 Bottles of 60  -  NDC # 16590-397-60 Bottles of 90  -  NDC # 16590-397-90 Relabeling and Repackaging by: STAT Rx USA LLC Gainesville, GA  30501 Store at 20° - 25°C (68°- 77°F) [See USP Controlled Room Temperature]. Dispense in light-resistant containers. All trademarks are the property of Zydus Group.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

METFORMIN HYDROCHLORIDE - METFORMIN HYDROCHLORIDE TABLET, FILM COATED
STAT Rx USA LLC
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PATIENT INFORMATION
Read this information carefully before you start taking this medicine
and each time you refill your
prescription. There may be new information. This information does not
take the place of your doctor’s
advice. Ask your doctor or pharmacist if you do not understand some of
this information or if you want to
know more about this medicine.
WHAT ARE METFORMIN HYDROCHLORIDE TABLETS AND METFORMIN
HYDROCHLORIDE EXTENDED-RELEASE TABLETS?
Metformin hydrochloride tablets and metformin hydrochloride
extended-release tablets are used to treat
type 2 diabetes. This is also known as non-insulin-dependent diabetes
mellitus. People with type 2
diabetes are not able to make enough insulin or respond normally to
the insulin their bodies make. When
this happens, sugar (glucose) builds up in the blood. This can lead to
serious medical problems including
kidney damage, amputations, and blindness. Diabetes is also closely
linked to heart disease. The main
goal of treating diabetes is to lower your blood sugar to a normal
level.
High blood sugar can be lowered by diet and exercise, by a number of
medicines taken by mouth, and by
insulin shots. Before you take metformin hydrochloride tablets or
metformin hydrochloride extended-
release tablets, try to control your diabetes by exercise and weight
loss. While you take your diabetes
medicine, continue to exercise and follow the diet advised for your
diabetes. No matter what your
recommended diabetes management plan is, studies have shown that
maintaining good blood sugar
control can prevent or delay complications of diabetes, such as
blindness.
Metformin hydrochloride tablets and metformin hydrochloride
extended-release tablets have the same
active ingredient. However, metformin hydrochloride extended-release
tablets work longer in your body.
Both of these medicines help control your blood sugar in a number of
ways. These include helping your
body respond better to the ins

Preparatomtale

METFORMIN HYDROCHLORIDE - METFORMIN HYDROCHLORIDE TABLET, FILM COATED
STAT RX USA LLC
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METFORMIN HYDROCHLORIDE TABLETS, USP
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 CAREFUL