GLYBURIDE-METFORMIN HYDROCHLORIDE tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Blenheim Pharmacal, Inc.

INN (Rahvusvaheline Nimetus):

GLYBURIDE

Koostis:

GLYBURIDE 2.5 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Glyburide and Metformin Hydrochloride Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glyburide and Metformin Hydrochloride Tablets is 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 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. Glyburide and Metformin Hydrochloride Tablets should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated

Toote kokkuvõte:

Glyburide and Metformin Hydrochloride Tablets USP Glyburide and Metformin Hydrochloride Tablets 1.25 mg/250mg is a pale yellow, oval shaped, biconvex, film coated tablets with “I 25” debossed on one side and plain on the other side. Glyburide and Metformin Hydrochloride Tablets 2.5 mg/500 mg is a pale orange, oval shaped, biconvex, film coated tablets with “I 23” debossed on one side and plain on the other side. Glyburide and Metformin Hydrochloride Tablets 5 mg/500 mg is a yellow, oval shaped, biconvex, film coated tablets with “I 24” debossed on one side and plain on the other side. Store at 25° C (77° F). [See USP Controlled Room Temperature.] Dispense in tight, light-resistant containers. GLUCOPHAGE ® is a registered trademark of Merck Santé 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. Rx Only Manufactured For Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 1.866.901.DRUG (3784) MADE IN INDIA Issued 10/13 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, by 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. Does 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 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 to 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? Lactic acidosis is caused by a buildup 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 1 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 Tablets. 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 Tablets 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 Tablets 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 physician. You should not take Glyburide and Metformin Hydrochloride Tablets 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 fluids is significantly reduced. These situations can lead to severe dehydration, and it may be necessary to stop taking Glyburide and Metformin Hydrochloride Tablets temporarily. You should let your doctor know if you are going to have any surgery or specialized x-ray procedures that require injection of contrast agents. Glyburide and Metformin Hydrochloride Tablets therapy will need to be stopped temporarily in such instances. Q14. Can I take Glyburide and Metformin Hydrochloride Tablets with other medications? Remind your doctor that you are taking Glyburide and Metformin Hydrochloride Tablets when any new drug 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 Met

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

GLYBURIDE-METFORMIN HYDROCHLORIDE- GLYBURIDE-METFORMIN HYDROCHLORIDE
TABLET
BLENHEIM PHARMACAL, INC.
----------
RX ONLY
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Glyburide and Metformin Hydrochloride Tablets combines glyburide and
metformin hydrochloride, 2
antihyperglycemic agents with complementary mechanisms of action, to
improve glycemic control in
patients with type 2 diabetes.
Glyburide appears to lower blood glucose acutely by stimulating the
release of insulin from the
pancreas, an effect dependent upon functioning beta cells in the
pancreatic islets. The mechanism by
which glyburide lowers blood glucose during long-term administration
has not been clearly
established. With chronic administration in patients with type 2
diabetes, the blood glucose lowering
effect persists despite a gradual decline in the insulin secretory
response to the drug. Extrapancreatic
effects may be involved in the mechanism of action of oral
sulfonylurea hypoglycemic drugs.
Metformin hydrochloride is an antihyperglycemic agent that improves
glucose tolerance in patients with
type 2 diabetes, lowering both basal and postprandial plasma glucose.
Metformin hydrochloride
decreases hepatic glucose production, decreases intestinal absorption
of glucose, and improves insulin
sensitivity by increasing peripheral glucose uptake and utilization.
PHARMACOKINETICS
ABSORPTION AND BIOAVAILABILITY
Glyburide and Metformin Hydrochloride Tablets
In bioavailability studies of Glyburide and Metformin Hydrochloride
Tablets 2.5 mg/500 mg and 5
mg/500 mg, the mean area under the plasma concentration versus time
curve (AUC) for the glyburide
component was 18% and 7%, respectively, greater than that of the
Micronase
brand of glyburide
coadministered with metformin. The glyburide component of Glyburide
and Metformin Hydrochloride
Tablets, therefore, is not bioequivalent to Micronase
. The metformin component of Glyburide and
Metformin Hydrochloride Tablets is bioequivalent to metformin
coadministered with glyburide.
Following administration of a single Gl