Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)
STAT Rx USA LLC
METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE 500 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
METFORMIN HYDROCHLORIDE - METFORMIN HYDROCHLORIDE TABLET, FILM COATED STAT Rx USA LLC ---------- 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 Preberite celoten dokument
METFORMIN HYDROCHLORIDE - METFORMIN HYDROCHLORIDE TABLET, FILM COATED STAT RX USA LLC ---------- 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 Preberite celoten dokument