GLYBURIDE-METFORMIN HYDROCHLORIDE tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

INN (Tên quốc tế):

GLYBURIDE

Thành phần:

GLYBURIDE 1.25 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Glyburide and metformin hydrochloride tablets, USP 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: - Severe renal impairment (eGFR below 30 mL/min/1.73m2) (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. - Concomitant administration of bosentan.

Tóm tắt sản phẩm:

Glyburide and Metformin Hydrochloride Tablets, USP Glyburide and metformin hydrochloride tablets, USP 1.25 mg/250 mg is a pale yellow, oval shaped, biconvex, film coated tablets with "I25" debossed on one side and plain on the other side. Glyburide and metformin hydrochloride tablets, USP 2.5 mg/500 mg is a pale orange, oval shaped, biconvex, film coated tablets with "I23" debossed on one side and plain on the other side. Glyburide and metformin hydrochloride tablets, USP 5 mg/500 mg is a yellow, oval shaped, biconvex, film coated tablets with "I24" debossed on one side and plain on the other side. STORAGE Store at 25° C (77° F). [See USP Controlled Room Temperature.] Dispense in light-resistant containers. GLUCOPHAGE® is a registered trademark of Merck Sant¡SR S.A.S., an associate of Merck KGaA of Darmstadt, Germany. Licensed to Bristol-Myers Squibb Company. Micronase®  is a registered trademark of Pharmacia & Upjohn Company LLC. Rx Only Distributed by: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) MADE IN INDIA Revised: 01/19 Patient Package Insert    Rx Only PATIENT INFORMATION ABOUT Glyburide and Metformin Hydrochloride Tablets, USP Q1.Why do I need to take glyburide and metformin hydrochloride tablets? Your doctor has prescribed glyburide and metformin hydrochloride tablets 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, a number of oral medications, and insulin injections. Before taking glyburide and metformin hydrochloride tablets you should first try to control your diabetes by exercise and weight loss. Even if you are taking glyburide and metformin hydrochloride tablets, you should still exercise and follow the diet recommended for your diabetes. Q5.Do Glyburide and metformin hydrochloride tablets work differently from other glucose-control medications? Yes, it does. Glyburide and metformin hydrochloride tablets combines 2 glucose-lowering drugs, glyburide and metformin. These 2 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 to 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 tablets your doctor may prescribe injectable insulin or take other measures to control your diabetes. Q7. Can glyburide and metformin hydrochloride tablets cause side effects? Glyburide and metformin hydrochloride tablets, 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 tablets (see Q9 - Q13 ). Q8. What are the most common side effects of glyburide and metformin hydrochloride tablets? The most common side effects of glyburide and metformin hydrochloride tablets 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 tablets 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 tablets can cause? People who have a condition known as glucose-6-phosphate dehydrogenase (G6PD) deficiency and who take Glyburide and Metformin Hydrochloride Tablets 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 tablets. Glyburide and metformin hydrochloride tablets rarely causes serious side effects. The most serious side effect that glyburide and metformin hydrochloride tablets can cause is called lactic acidosis. Q10.What is lactic acidosis and can it happen to me? Metformin, one of the medicine in glyburide and metformin hydrochloride tbalets can cause a rare but serious condition calles lactic acidosis (a build up of an acid in the blood) that can cause death. Lacticacidosis is a medical emergency and muct be treated in the hospital. Q11.Are there other risk factors for lactic acidosis? Most people wo have had lactic acidosis with metformin have other things that, combined with the metformin, led to the lactic acidosis. Tell your doctor if you have any of the following, because you have a higher chance of getting lactic acidosis with glyburide and metformin hydrochloride tablets if you: Q12.What are the symptoms of lactic acidosis? Call your doctor right away if you have any of the following symptoms, which could be signs of lactic acidosis: Q13.What does my doctor need to know to decrease my risk of lactic acidosis? Before you take glyburide and metformin hydrochloride tablets, tell your doctor if you: Q14. Can I take glyburide and metformin hydrochloride tablets withother medications? Remind your doctor that you are taking glyburide and metformin hydrochloride tablets when ant new drig is prescribed or a change is made in how you take a drug already prescribed. Glyburide and metformin hydrochloride tablets may interfere with the way some drugs work and some drugs may interfere with the action of glyburide and metformin hydrochloride tablets. Do not take glyburide and metformin hydrochloride tablets if you are taking bosentan used for pulmonary arterial hypertension (PAH), which is high blood pressure in the vessel of the lungs. Q15.What if I become pregnant while taking glyburide and metformin hydrochloride tablets? Tell your doctor if you plan to become pregnant or have become pregnant. As with other oral glucose-control medications, you should not take glyburide and metformin hydrochloride tablets during pregnancy. Usually your doctor will prescribe insulin while you are pregnant. As with all medications, you and your doctor should discuss the use of glyburide and metformin hydrochloride tablets if you are nursing a child. Q16.How do I take glyburide and metformin hydrochloride tablets? Your doctor will tell you how many glyburide and metformin hydrochloride tablets to take and how often. This should also be printed on the label of your prescription. You will probably be started on a low dose of glyburide and metformin hydrochloride tablets and your dosage will be increased gradually until your blood sugar is controlled. Q17. Where can I get more information about glyburide and metformin hydrochloride tablets? This leaflet is a summary of the most important information about glyburide and metformin hydrochloride tablets. If you have any questions or problems, you should talk to your doctor or other healthcare provider about type 2 diabetes as well as

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

GLYBURIDE-METFORMIN HYDROCHLORIDE- GLYBURIDE-METFORMIN HYDROCHLORIDE
TABLET
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
----------
GLYBURIDE AND METFORMIN HCL TABLETS USP
DESCRIPTION
Glyburide and metformin hydrochloride tablets USP contain 2 oral
antihyperglycemic drugs used in the
management of type 2 diabetes, glyburide, USP and metformin
hydrochloride, USP.
Glyburide, USP is an oral antihyperglycemic drug of the sulfonylurea
class. The chemical name for
Glyburide, USP is
1-[[p-[2-(5-chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea.
Glyburide, USP is a white to off-white crystalline compound with a
molecular formula of C
H
ClN O S and a molecular weight of 494.01. Micronized glyburide is used
in glyburide and metformin
hydrochloride tablets, USP. The structural formula is represented
below.
Metformin hydrochloride, USP 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 a-glucosidase
inhibitors. It is a white to off-white crystalline compound with a
molecular formula of C H ClN
(monohydrochloride) 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. The
structural formula is as shown:
Glyburide and metformin hydrochloride tablets, USP are available for
oral administration in tablets
containing 1.25 mg glyburide, USP with 250 mg metformin hydrochloride,
USP 2.5 mg glyburide, USP
with 500 mg metformin hydrochloride, USP and 5 mg glyburide, USP with
500 mg metformin
hydrochloride, USP. In addition, each tablet contains the following
inactive ingredients: Sodium Starch
Glycolate, Povidone, Colloidal Silicon Dioxide, Magnesium Stearate.
The tablets are film coated,
which provides color differentiation. A