METFORMIN HYDROCHLORIDE tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Aphena Pharma Solutions - Tennessee, LLC

Designació comuna internacional (DCI):

METFORMIN HYDROCHLORIDE

Composición:

METFORMIN HYDROCHLORIDE 500 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Metformin hydrochloride tablet 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: Metformin hydrochloride tablets 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 PRECAUTIONS).

Resumen del producto:

Metformin Hydrochloride Tablets are available as follows: Metformin Hydrochloride Tablets, USP 500 mg are blackberry flavored, white to off-white, round, biconvex, beveled edge film coated tablets, debossed with ‘SG’ on one side ‘105’ on other side. 500 mg: Metformin Hydrochloride Tablets, USP 850 mg are blackberry flavored, white to off-white, round, biconvex, beveled edge film coated tablets, debossed with ‘SG’ on one side ‘106’ on other side. 850 mg: Metformin Hydrochloride Tablets, USP 1000 mg tablets are blackberry flavored, white to off-white, oval, biconvex, film coated tablets debossed on one side with S on the left side of bisect and G on the right side of bisect and other side 1 on the left side and 07 on the right side of the bisect. 1000 mg: Store at 20°to 25° C (68°to 77° F); excursions permitted to 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: Sciegen Pharmaceuticals, Inc Hauppauge, NY 11788 Marketed/Packaged by: GSMS, Inc.  Camarillo, CA 93012 Rev: 08/13 Rx Only METFORMIN HYDROCHLORIDE TABLETS, USP 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? Metformin hydrochloride 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, 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 help control your blood sugar in a number of ways. These  include helping your body respond better to the insulin it makes naturally, decreasing the amount of sugar your liver makes, and decreasing the amount of sugar your intestines absorb. Metformin hydrochloride tablets do not cause your body to make more insulin. Because of this, when taken alone, they rarely cause hypoglycemia (low blood sugar), and usually do not cause weight gain. However, when they are taken with a sulfonylurea or with insulin, hypoglycemia is more likely to occur, as is weight gain. WARNING: A small number of people who have taken metformin hydrochloride tablets have developed a serious condition called lactic acidosis. Lactic acidosis is caused by a buildup of lactic acid in the blood. This happens more often in people with kidney problems. Most people with kidney problems should not take metformin hydrochloride tablets. (See "What are the side effects of metformin hydrochloride tablets?") Who should not take metformin hydrochloride tablets? Some conditions increase your chance of getting lactic acidosis, or cause other problems if you take either of these medicines. Most of the conditions listed below can increase your chance of getting lactic acidosis. Do not take metformin hydrochloride tablets if you: • have kidney problems • have liver problems • have heart failure that is treated with medicines, such as Lanoxin® (digoxin) or Lasix® (furosemide) • drink a lot of alcohol. This means you binge drink for short periods or drink all the time • are seriously dehydrated (have lost a lot of water from your body) • are going to have an x-ray procedure with injection of dyes (contrast agents) • are going to have surgery • develop a serious condition, such as heart attack, severe infection, or a stroke • are 80 years or older and you have NOT had your kidney function tested Tell your doctor if you are pregnant or plan to become pregnant. Metformin hydrochloride tablets may not be right for you. Talk with your doctor about your choices. You should also discuss your choices with your doctor if you are nursing a child. Can metformin hydrochloride tablets be used in children? Metformin hydrochloride tablets has been shown to effectively lower glucose levels in children (ages 10 to 16 years) with type 2 diabetes. Metformin hydrochloride tablets has not been studied in children younger than 10 years old. Metformin hydrochloride tablets has not been studied in combination with other oral glucose-control medicines or insulin in children. If you have any questions about the use of metformin hydrochloride tablets in children, talk with your doctor or other healthcare provider. How should I take metformin hydrochloride tablets? Your doctor will tell you how much medicine to take and when to take it. You will probably start out with a low dose of the medicine. Your doctor may slowly increase your dose until your blood sugar is better controlled. You should take metformin hydrochloride tablets with meals. Your doctor may have you take other medicines along with metformin hydrochloride tablets to control your blood sugar. These medicines may include insulin shots. Taking metformin hydrochloride tablets with insulin may help you better control your blood sugar while reducing the insulin dose. Continue your exercise and diet program and test your blood sugar regularly while taking metformin hydrochloride tablets. Your doctor will monitor your diabetes and may perform blood tests on you from time to time to make sure your kidneys and your liver are functioning normally. There is no evidence that metformin hydrochloride tablets causes harm to the liver or kidneys. Tell your doctor if you: • have an illness that causes severe vomiting, diarrhea or fever, or if you drink a much lower amount of liquid than normal. These conditions can lead to severe dehydration (loss of water in your body). You may need to stop taking metformin hydrochloride tablets for a short time. • plan to have surgery or an x-ray procedure with injection of dye (contrast agent). You may need to stop taking metformin hydrochloride tablets for a short time. • start to take other medicines or change how you take a medicine. Metformin hydrochloride tablets can affect how well other drugs work, and some drugs can affect how well metformin hydrochloride tablets work. Some medicines may cause high blood sugar. What should I avoid while taking metformin hydrochloride tablets? Do not drink a lot of alcoholic drinks while taking metformin hydrochloride tablets. This means you should not binge drink for short periods, and you should not drink a lot of alcohol on a regular basis. Alcohol can increase the chance of getting lactic acidosis. What are the side effects of metformin hydrochloride tablets? Lactic Acidosis. In rare cases, metformin hydrochloride tablets can cause a serious side effect called lactic acidosis. This is caused by a buildup of lactic acid in your blood. This buildup can cause serious damage. Lactic acidosis caused by metformin hydrochloride tablets is rare and has occurred mostly in people whose kidneys were not working normally. Lactic acidosis has been reported in about one in 33,000 patients taking metformin hydrochloride tablets over the course of a year. Although rare, if lactic acidosis does occur, it can be fatal in up to half the people who develop it. It is also important for your liver to be working normally when you take metformin hydrochloride tablets. Your liver helps remove lactic acid from your blood. Make sure you tell your doctor

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, 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 HYDROCHLORIDE
TABLETS; 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 MCG/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
HYDROCHLORIDE TABLETS AND BY USE OF THE MINIMUM EFFECTIVE DOSE OF
METFORMIN HYDROCHLORIDE
TABLETS.