metformin hydrochloride- metformin hydrochloride tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

metformin hydrochloride (UNII: 786Z46389E) (metformin - UNII:9100L32L2N)

Disponible desde:

Actavis Elizabeth LLC

Designación común internacional (DCI):

metformin hydrochloride

formulario farmacéutico:

TABLET

Composición:

500 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Metformin hydrochloride tablets, as monotherapy, are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Metformin is indicated in patients 10 years of age and older. Metformin may be used concomitantly with a sulfonylurea or insulin to improve glycemic control in adults (17 years of age nd older). Metformin hydrochloride tablets are contraindicated in patients with: 1. 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 WARNlNGSand PRECAUTIONS). 2. Congestive heart failure requiring pharmacologic treatment. 3. Known hypersensitivity to metformin hydrochloride. 4. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. Metformin should

Resumen del producto:

Metformin Hydrochloride Tablets are available as follows: 500 mg — Each white to off-white, oval, film coated tablet imprinted with 657 on one side and plain on the other contains 500 mg of metformin hydrochloride. Tablets are supplied in bottles of 100 (NDC 0228-2657-11) with a child-resistant closure and bottles of 100 (NDC 0228-2657-10), 500 (NDC 0228-2657-50) and 1000 (NDC 0228-2657-96) without a child-resistant closure. 850 mg — Each white to off-white, oval, film coated tablet imprinted with 715 on one side and plain on the other contains 850 mg of metformin hydrochloride. Tablets are supplied in bottles of 100 (NDC 0228-2715-11) with a child-resistant closure and bottles of 100 (NDC 0228-2715-10), 500 (NDC 0228-2715-50) and 1000 (NDC 0228-2715-96) without a child-resistant closure. 1000 mg — Each white to off-white, oval, film coated tablet imprinted twice with on one side and twice with 718 on the other and bisected on both sides contains 1000 mg of metformin hydrochloride. Tablets are supplied in bottles of 100 (NDC 0228-2718-11) with a child-resistant closure and bottles of 100 (NDC 0228-2718-10), 500 (NDC 0228-2718-50) and 1000 (NDC 0228-2718-96) without a child-resistant closure. Dispense in a tight, light-resistant container as defined in the USP. Store between 15°-30°C (59°-86°F). Manufactured by: PUREPAC PHARMACEUTICAL CO. Elizabeth, NJ 07207 USA 40-8871 Rev — September 2002 PHARMACIST – DETACH HERE AND GIVE PATIENT INFORMATION SHEET TO PATIENT --------------------------------------------------------------------------------------------------------------------- Rev – September 2002 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 is metformin? Metformin is 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, 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 helps 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 does 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 have developed a serious condition called lactic acidosis. Lactic acidosis is caused by a build-up of lactic acid in the blood. This happens more often in people with kidney problems. Most people with kidney problems should not take metformin. (See "What are the side effects of metformin?") Who should not take metformin? Some conditions increase your chance of getting lactic acidosis, or cause other problems if you take metformin.  Most of the conditions listed below can increase your chance of getting lactic acidosis. Do not take metformin 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 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 has been shown to effectively lower glucose levels in children (ages 10 to 16 years) with type 2 diabetes. Metformin has not been studied in children younger than 10 years old. Metformin hydrochloride tablets have 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 with meals. Your doctor may have you take other medicines along with metformin to control your blood sugar. These medicines may include insulin shots. Taking metformin 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. 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 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 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 can affect how   well other drugs work, and some drugs can affect how well metformin works. 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. 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? Lactic Acidosis . In rare cases, metformin can cause a serious side effect called lactic acidosis. This is caused by a build-up of lactic acid in your blood. This build-up can cause serious damage. Lactic acidosis caused by metformin 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 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. Your liver helps remove lactic acid from your blood. Make sure you tell your doctor before you use metformin if you have kidney or liver problems. You should also stop using metformin and

Ficha técnica

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET
ACTAVIS ELIZABETH LLC
----------
METFORMIN HYDROCHLORIDE TABLETS
40-8871
DESCRIPTION
Metformin hydrochloride is an oral antihyperglycemic drug used in the
management of type 2 diabetes.
Metformin hydrochloride ( _N_,_N_-dimethylimidodicarbonimidic diamide
hydrochloride) is not chemically
or pharmacologically related to any other classes of oral
antihyperglycemic agents. The structural
formula is as shown:
Metformin hydrochloride is a white to off-white crystalline compound
with a molecular formula of
C H N •HCl and a molecular weight of 165.63. Metformin hydrochloride
is freely soluble in water
and is practically insoluble in acetone, ether and chloroform. The pK
of metformin is 12.4. The pH of a
1% aqueous solution of metformin hydrochloride is 6.68.
Metformin hydrochloride tablets contain 500 mg, 850 mg and 1000 mg of
metformin hydrochloride. In
addition, each tablet contains the following inactive ingredients:
crospovidone, hydroxypropyl
methylcellulose, maltodextrin, polyethylene glycol, povidone, stearic
acid.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION:
Metformin is an antihyperglycemic agent which improves glucose
tolerance in patients with type 2
diabetes, lowering both basal and postprandial plasma glucose. Its
pharmacologic mechanisms of action
are different from other classes of oral antihyperglycemic agents.
Metformin decreases hepatic
glucose production, decreases intestinal absorption of glucose, and
improves insulin sensitivity by
increasing peripheral glucose uptake and utilization. Unlike
sulfonylureas, metformin does not produce
hypoglycemia in either patients with type 2 diabetes or normal
subjects (except in special
circumstances, see PRECAUTIONS) and does not cause hyperinsulinemia.
With metformin therapy,
insulin secretion remains unchanged while fasting insulin levels and
day-long plasma insulin response
may actually decrease.
PHARMACOKINETICS :
ABSORPTION AND BIOAVAILABILITY: The absolute bioavailability of a
metformin hydrochloride 5