Prescription Drug Information: Glyburide and Metformin Hydrochloride (Page 5 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Glyburide and Metformin Hydrochloride Tablets USP, 1.25 mg/250 mg: Yellow, capsule shaped, biconvex, film-coated tablet with ‘A’ debossed on one side and ‘46’ on the other side.

Bottles of 30 NDC 65862-080-30
Bottles of 100 NDC 65862-080-01
Bottles of 500 NDC 65862-080-05

Glyburide and Metformin Hydrochloride Tablets USP, 2.5 mg/500 mg: Light pink, capsule shaped, biconvex, film-coated tablet with ‘A’ debossed on one side and ‘47’ on the other side.

Bottles of 30 NDC 65862-081-30
Bottles of 100 NDC 65862-081-01
Bottles of 500 NDC 65862-081-05

Glyburide and Metformin Hydrochloride Tablets USP, 5 mg/500 mg: Yellow, capsule shaped, biconvex, film-coated tablet with ‘A’ debossed on one side and ‘48’ on the other side.

Bottles of 30 NDC 65862-082-30
Bottles of 100 NDC 65862-082-01
Bottles of 500 NDC 65862-082-05

Store at 20° to 25°C (68º to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Dispense in light-resistant containers.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Lactic Acidosis:

Explain the risks of lactic acidosis, its symptoms, and conditions that predispose to its development. Advise patients to discontinue glyburide and metformin hydrochloride immediately and to promptly notify their healthcare provider practitioner if unexplained hyperventilation, myalgia, malaise, unusual somnolence, or other nonspecific symptoms occur. Counsel patients against excessive alcohol intake and inform patients about importance of regular testing of renal function while receiving glyburide and metformin hydrochloride. Instruct patients to inform their doctor that they are taking glyburide and metformin hydrochloride prior to any surgical or radiological procedure, as temporary discontinuation may be required [see Warnings and Precautions (5.1)].

Hypoglycemia:

Inform patients that hypoglycemia may occur when taking glyburide and metformin hydrochloride. Explain to patients the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development [see Warnings and Precautions (5.2)].

Cardiovascular Mortality:

Inform patients that the administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. Inform patients of the potential risks and benefits of glyburide and of alternative modes of therapy [see Warnings and Precautions (5.3)].

Vitamin B12 Deficiency:

Inform patients about importance of regular hematological testing while receiving glyburide and metformin hydrochloride [see Warnings and Precautions (5.5)].

Females of Reproductive Age:

Inform females that treatment with glyburide and metformin hydrochloride may result in ovulation in some premenopausal anovulatory women which may lead to unintended pregnancy [see Use in Specific Populations (8.3)].

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India

Trademarks are the property of their respective owners.

Revised: 02/2019

PATIENT INFORMATION

Glyburide and Metformin Hydrochloride Tablets USP, for oral use

(glye’ bure ide and met for’ min hye” droe klor’ ide)

What is the most important information I should know about glyburide and metformin hydrochloride tablets?

Glyburide and metformin hydrochloride tablets can cause serious side effects, including:

Lactic Acidosis. Metformin hydrochloride, a medicine in glyburide and metformin hydrochloride tablets, can cause a rare, but serious, side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.

Stop taking glyburide and metformin hydrochloride tablets and call your healthcare provider right away if you get any of the following symptoms of lactic acidosis:

  • feel very weak and tired
  • have unusual sleepiness or sleep longer than usual
  • have unusual (not normal) muscle pain
  • feel cold, especially in your arms and legs
  • have trouble breathing
  • feel dizzy or lightheaded
  • have unexplained stomach or intestinal problems with nausea and vomiting, or diarrhea
  • have a slow or irregular heartbeat

You have a higher chance of getting lactic acidosis if you:

  • have severe kidney problems. “See “Do not take glyburide and metformin hydrochloride tablets if you:”
  • have liver problems.
  • drink a lot of alcohol (very often or short-term “binge” drinking).
  • get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids.
  • have certain x-ray tests with injectable dyes or contrast agents.
  • have surgery or other procedures for which you need to restrict the amount of food and liquid you eat and drink.
  • have congestive heart failure.
  • have a heart attack, severe infection, or stroke.
  • are 65 years of age or older.

Tell your healthcare provider if you have any of the problems in the list above.

Tell your healthcare provider that you are taking glyburide and metformin hydrochloride tablets before you have surgery or x-ray tests.

Your healthcare provider may need to stop glyburide and metformin hydrochloride tablets for a while if you have surgery or certain x-ray tests.

Glyburide and metformin hydrochloride tablets can have other serious side effects. See “What are the possible side effects of glyburide and metformin hydrochloride tablets?”

What is glyburide and metformin hydrochloride tablets?

  • Glyburide and metformin hydrochloride tablets are a prescription medicine that contains glyburide (sulfonylurea) and metformin hydrochloride. Glyburide and metformin hydrochloride tablets is used with diet and exercise to help control high blood sugar (hyperglycemia) in adults with type 2 diabetes.
  • It is not known if glyburide and metformin hydrochloride tablets are safe and effective in children under 18 years of age.

Do not take glyburide and metformin hydrochloride tablets if you:

  • have severe kidney problems.
  • are allergic to metformin hydrochloride, glyburide or any of the ingredients in glyburide and metformin hydrochloride tablets. See the end of this Patient Information leaflet for a complete list of ingredients in glyburide and metformin hydrochloride tablets.
  • have a condition called metabolic acidosis, including diabetic ketoacidosis (high levels of certain acids called “ketones” in your blood or urine).
  • take bosentan.

Before taking glyburide and metformin hydrochloride tablets tell your healthcare provider about all medical conditions, including if you:

  • have a history or risk for diabetic ketoacidosis. See “Do not take glyburide and metformin hydrochloride tablets if you:”
  • have kidney problems.
  • have liver problems.
  • have heart problems, including congestive heart failure.
  • are 65 year of age or older.
  • drink alcohol very often, or drink a lot of alcohol in short-term “binge” drinking.
  • have or any members of your family have glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • are taking insulin or another sulfonylurea medicine.
  • are pregnant or plan to become pregnant. It is not known if glyburide and metformin hydrochloride tablets will harm your unborn baby. You should not take glyburide and metformin hydrochloride tablets during the last 2 weeks of your pregnancy. If you are pregnant, talk with your healthcare provider about the best way to control your blood sugar while you are pregnant.
  • are a woman who has not gone through menopause (premenopausal) who does not have periods regularly or at all. Glyburide and metformin hydrochloride tablets can cause the release of an egg from an ovary in a woman (ovulation). This can increase your chance of getting pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if glyburide one of the medicines in glyburide and metformin hydrochloride tablets passes into your breast milk. Metformin the other medicine in glyburide and metformin hydrochloride tablets can pass into your breastmilk. Talk with your healthcare provider about the best way to feed your baby while you take glyburide and metformin hydrochloride tablets.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Glyburide and metformin hydrochloride tablets may affect the way other medicines work, and other medicines may affect how glyburide and metformin hydrochloride tablet works.

How should I take glyburide and metformin hydrochloride tablets?

  • Take glyburide and metformin hydrochloride tablets exactly as your healthcare provider tells you.
  • glyburide and metformin hydrochloride tablets should be taken 2 times each day with meals to help decrease an upset stomach side effect and avoid hypoglycemia.
  • If you are taking colesevelam and glyburide and metformin hydrochloride tablets, take your glyburide and metformin hydrochloride tablets at least 4 hours before taking your colesevelam.
  • Your healthcare provider should do blood tests to check how well your kidneys are working before and during your treatment with glyburide and metformin hydrochloride tablets.
  • Your healthcare provider will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1c.
  • Low blood sugar (hypoglycemia) can happen more often when glyburide and metformin hydrochloride tablets is taken with certain other diabetes medicines. Talk to your healthcare provider about how to prevent, recognize, and manage low blood sugar. See “What are the possible side effects of glyburide and metformin hydrochloride tablets?”
  • Check your blood sugar as your healthcare provider tells you to.
  • If you take too much glyburide and metformin hydrochloride, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking glyburide and metformin hydrochloride tablets?

  • Do not drink a lot of alcoholic drinks while taking glyburide and 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.
  • Do not drive, operate machinery, or do other dangerous activities until you know how glyburide and metformin hydrochloride tablets affects you.

What are the possible side effects of glyburide and metformin hydrochloride tablets?

Glyburide and metformin hydrochloride tablets can cause serious side effects, including:

  • See “What is the most important information I should know about glyburide and metformin hydrochloride tablets?”
  • low blood sugar (hypoglycemia). Low blood sugar is a serious, but common side effect of glyburide and metformin hydrochloride tablets. If you take glyburide and metformin hydrochloride tablets with another medicine that can cause low blood sugar, such as insulin, you have a higher risk of getting low blood sugar. The dose of insulin or other diabetic medicines may need to be lowered while you take glyburide and metformin hydrochloride tablets. Signs and symptoms of low blood sugar may include:
    • headache
    • hunger
    • dizziness
    • drowsiness
    • fast heartbeat
    • sweating
    • weakness
    • confusion
    • blurred vision
    • irritability
    • shaking or feeling jittery
    • anxiety
    • slurred speech
    • mood changes
  • increased risk of cardiovascular deaths. Taking oral hypoglycemic medicines like glyburide and metformin hydrochloride tablets to treat diabetes have increased the risk of death from heart disease or stroke compared to treating diabetes with diet alone or diet and insulin.
  • hemolytic anemia. People with G6PD deficiency who take glyburide and metformin hydrochloride tablets may develop hemolytic anemia (fast breakdown of red blood cells).
  • low vitamin B12 (vitamin B12 deficiency). Using glyburide and metformin hydrochloride tablets may cause a decrease in the amount of vitamin B12 in your blood, especially if you have had low vitamin B12 levels before. Your healthcare provider may do blood tests to check your vitamin B12 levels.

The most common side effects of glyburide and metformin hydrochloride tablets include :

  • diarrhea
  • vomiting
  • headache
  • stomach pain
  • nausea
  • dizziness

These are not all the possible side effects of glyburide and metformin hydrochloride tablets.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store glyburide and metformin hydrochloride tablets?

  • Store glyburide and metformin hydrochloride tablets at room temperature between 68°F to 77°F (20°C to 25°C).

Keep glyburide and metformin hydrochloride tablets and all medicines out of the reach of children.

General information about the safe and effective use glyburide and metformin hydrochloride tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use glyburide and metformin hydrochloride tablets for a condition for which it was not prescribed. Do not give glyburide and metformin hydrochloride tablets to other people, even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about glyburide and metformin hydrochloride tablets that is written for health professionals.

What are the ingredients in glyburide and metformin hydrochloride tablets?

Active ingredients: glyburide and metformin hydrochloride.

Inactive ingredients: microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate, hypromellose, propylene glycol, polysorbate 80, talc, titanium dioxide and FD&C Yellow#6 aluminum lake. The 1.25 mg/250 mg and 5 mg/500 mg strengths also contain D&C Yellow#10 aluminum lake; The 2.5 mg/500 mg strength also contains FD&C Red#40 aluminum lake.

Trademarks are the property of their respective owners.

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India
This Patient Package Insert has been approved by the U.S. Food and Drug Administration
Revised: 02/2019

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