GLYBURIDE AND METFORMIN HYDROCHLORIDE tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

GLYBURIDE (UNII: SX6K58TVWC) (GLYBURIDE - UNII:SX6K58TVWC), METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)

Prieinama:

Aphena Pharma Solutions - Tennessee, Inc.

INN (Tarptautinis Pavadinimas):

GLYBURIDE

Sudėtis:

GLYBURIDE 5 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Glyburide and Metformin Hydrochloride Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glyburide and Metformin Hydrochloride Tablets are contraindicated in patients with: - Renal disease or renal dysfunction (eg., 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 or glyburide. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. Glyburide and Metformin Hydrochloride 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

Produkto santrauka:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Glyburide and Metformin Hydrochloride Tablets, USP are available as follows: 1.25 mg/250 mg —Each white to off-white, capsule-shaped, film coated tablet imprinted with and 751 on one side and plain on the other side contains 1.25 mg of glyburide USP and 250 mg of metformin hydrochloride USP. Tablets are supplied in bottles of 100 (NDC 0228-2751-11) with a child-resistant closure and bottles of 500 (NDC 0228-2751-50) without a child-resistant closure. 2.5 mg/500 mg —Each yellow, capsule-shaped, film coated tablet imprinted with and 752 on one side and plain on the other side contains 2.5 mg of glyburide USP and  500 mg of metformin hydrochloride USP. Tablets are supplied in bottles of 100 (NDC 0228-2752-11) with a child-resistant closure and bottles of 500 (NDC 0228-2752-50) without a child-resistant closure. 5 mg/500 mg —    Each blue, capsule-shaped, film coated tablet imprinted with and 753 on one side and plain on the other side contains 5 mg of glyburide USP and 500 mg of metformin hydrochloride USP. Tablets are supplied in bottles of 100 (NDC 0228-2753-11) with a child-resistant closure and bottles of 500 (NDC 0228-2753-50) without a child-resistant closure. Store at temperatures up to 25° C (77° F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA 40-9070 Revised — March 2010 Micronase® is a registered trademark of Pharmacia & Upjohn Company. --------------------------------------------------------------------------------------------------------------------- PATIENT INFORMATION ABOUT GLYBURIDE (micronized) AND METFORMIN HYDROCHLORIDE TABLETS, USP Revised – March 2010 WARNING: A small number of people who have taken metformin hydrochloride have developed a serious condition called lactic acidosis. Properly functioning kidneys are needed to help prevent lactic acidosis. Most people with kidney problems should not take Glyburide and Metformin Hydrochloride tablets. (See Question Nos. 9-13.) Q1. Why do I need to take Glyburide and Metformin Hydrochloride? Your doctor has prescribed Glyburide and Metformin Hydrochloride to treat your type 2 diabetes. This is also known as non-insulin-dependent diabetes mellitus. Q2 . What is type 2 diabetes? People with diabetes are not able to make enough insulin and/or respond normally to the insulin their body does 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. Q3 . Why is it important to control type 2 diabetes? The main goal of treating diabetes is to lower your blood sugar to a normal level. Studies have shown that good control of blood sugar may prevent or delay complications such as heart disease, kidney disease, or blindness. Q4. How is type 2 diabetes usually controlled? High blood sugar can be lowered by diet and exercise, by a number of oral medications, and insulin injections. Before taking Glyburide and Metformin Hydrochloride you should first try to control your diabetes by exercise and weight loss. Even if you are taking Glyburide and Metformin Hydrochloride, you should still exercise and follow the diet recommended for your diabetes. Q5. Does Glyburide and Metformin Hydrochloride work differently from other glucose-control medications? Yes it does. The Glyburide and Metformin Hydrochloride product combines two glucose-lowering drugs, glyburide and metformin. These two drugs work together to improve the different metabolic defects found in type 2 diabetes. Glyburide lowers blood sugar primarily by causing more of the body’s own insulin to be released, and metformin lowers blood sugar, in part, by helping your body use your own insulin more effectively. Together, they are efficient in helping you achieve better glucose control. Q6. What happens if my blood sugar is still too high? When blood sugar cannot be lowered enough by Glyburide and Metformin Hydrochloride your doctor may prescribe injectable insulin or take other measures to control your diabetes. Q7. Can Glyburide and Metformin Hydrochloride cause side effects? Glyburide and Metformin Hydrochloride, like all blood sugar-lowering medications, can cause side effects in some patients. Most of these side effects are minor. However, there are also serious, but rare, side effects related to Glyburide and Metformin Hydrochloride (see Q9 - Q13 ). Q8. What are the most common side effects of Glyburide and Metformin Hydrochloride? The most common side effects of Glyburide and Metformin Hydrochloride are normally minor ones such as diarrhea, nausea, and upset stomach. If these side effects occur, they usually occur during the first few weeks of therapy. Taking your Glyburide and Metformin Hydrochloride with meals can help reduce these side effects. Less frequently, symptoms of hypoglycemia (low blood sugar), such as lightheadedness, dizziness, shakiness, or hunger may occur. The risk of hypoglycemic symptoms increases when meals are skipped, too much alcohol is consumed, or heavy exercise occurs without enough food. Following the advice of your doctor can help you to avoid these symptoms. Q9. Are there any serious side effects that Glyburide and Metformin Hydrochloride can cause? People who have a condition known as glucose-6-phosphate dehydrogenase (G6PD) deficiency and who take Glyburide and Metformin Hydrochloride may develop hemolytic anemia (fast breakdown of red blood cells). G6PD deficiency usually runs in families. Tell your doctor if you or any members of your family have been diagnosed with G6PD deficiency before you start taking Glyburide and Metformin Hydrochloride. Glyburide and Metformin Hydrochloride rarely causes serious side effects. The most serious side effect that Glyburide and Metformin Hydrochloride can cause is called lactic acidosis. Q10. What is lactic acidosis and can it happen to me? Lactic acidosis is caused by a build-up of lactic acid in the blood. Lactic acidosis associated with 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 cases. It’s also important for your liver to be working normally when you take Glyburide and Metformin Hydrochloride. Your liver helps remove lactic acid from your bloodstream. 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 Glyburide and Metformin Hydrochloride causes harm to the kidneys or liver. Q11. Are there other risk factors for lactic acidosis? Your risk of developing lactic acidosis from taking Glyburide and Metformin Hydrochloride is very low as long as your kidneys and liver are healthy. However, some factors can increase your risk because they can affect kidney and liver function. You should discuss your risk with your doctor. You should not take Glyburide and Metformin Hydrochloride if: Q12. What are the symptoms of lactic acidosis? Some of the symptoms include: feeling very weak, tired or uncomfortable; unusual muscle pain, trouble breathing, unusual or unexpected stomach discomfort, feeling cold, feeling dizzy or lightheaded, or suddenly developing a slow or irregular heartbeat. If you notice these symptoms, or if your medical condition has suddenly changed, stop taking Glyburide and Metformin Hydrochloride tablets and call your doctor right away. Lactic acidosis is a medical emergency that must be treated in a hospital. Q13. What does my doctor need to know to decrease my risk of lactic acidosis? Tell your doctor if you have an illness that results in severe vomiting, diarrhea, and/or fever, or if your intake of fluid

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

GLYBURIDE AND METFORMIN HYDROCHLORIDE - GLYBURIDE AND METFORMIN
HYDROCHLORIDE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, INC.
----------
GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS, USP
40-9070
Revised - March 2010
RX ONLY
DESCRIPTION
Glyburide and Metformin Hydrochloride tablets, USP contain two oral
antihyperglycemic drugs used in
the management of type 2 diabetes, glyburide and metformin
hydrochloride.
Glyburide is an oral antihyperglycemic drug of the sulfonylurea class.
The chemical name for
glyburide is
1-[[_p_-[2-(5-chloro-_o_-anisamido)ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea.
Glyburide is a
white to off-white crystalline compound with a molecular formula of C
H ClN O S and a molecular
weight of 494.00. The structural formula is represented below.
Metformin hydrochloride is an oral antihyperglycemic drug used in the
management of type 2 diabetes.
Metformin hydrochloride (_N_,_N_-dimethylimidodicarbonimidic diamide
monohydrochloride) is not
chemically or pharmacologically related to sulfonylureas,
thiazolidinediones, or α-glucosidase
inhibitors. It is a white to off-white crystalline compound with a
molecular formula of C H N ·HCl
and a molecular weight of 165.62. Metformin hydrochloride is freely
soluble in water and is practically
insoluble in acetone, ether, and chloroform. The pKa of metformin is
12.4. The pH of a 1% aqueous
solution of metformin hydrochloride is 6.68. The structural formula is
as shown:
23
28
3
5
4
11
5
Glyburide and Metformin Hydrochloride tablets are available for oral
administration in tablets
containing 1.25 mg glyburide with 250 mg metformin hydrochloride, 2.5
mg glyburide with 500 mg
metformin hydrochloride, and 5 mg glyburide with 500 mg metformin
hydrochloride. In addition, each
tablet contains the following inactive ingredients: ammonio
methacrylate copolymer (type B),
croscarmellose sodium, hypromellose, magnesium stearate,
microcrystalline cellulose, polydextrose,
polyethylene glycol, povidone, sodium hydroxide, sorbic acid, titanium
dioxide and triacetin. The 2.5
mg/5