DiaBeta

Common side effects include:

• nausea
• heartburn
• "feeling full"
• rash

This is not a complete list of Diabeta side effects. Ask your doctor or pharmacist for more information.

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

Serious side effects have been reported with Diabeta including the following:

• Diabeta may increase your chance of death from heart problems.
• Diabeta can cause low blood sugar levels (hypoglycemia) in patients. Tell your doctor if you have a history of kidney or liver disease or drink alcohol. Symptoms of low blood sugar include:
  • shakiness
  • tremors
  • cold sweat
  • fast heart rate
  • headache
  • moodiness
  • dizziness
  • blurred vision
  • confusion

• Diabeta can decrease the number of red blood cells in people with glucose-6-phosphate dehydrogenase (G6PD) deficiency.  Alert your doctor if you have a history of G6PD deficiency or anemia.

Ask your doctor about the safe use of alcoholic beverages while you are taking Diabeta. Alcohol can make the side effects from Diabeta worse. Consuming alcohol while taking Diabeta also rarely may cause symptoms such as flushing (reddening of the face), headache, nausea, vomiting, chest pain, weakness, blurred vision, mental confusion, sweating, choking, breathing difficulty, and anxiety.

Avoid unnecessary or prolonged exposure to sunlight, and wear protective clothing, sunglasses, and sunscreen. Diabeta may make your skin sensitive to sunlight.

Ask your doctor what to do if you get sick, develop an infection or fever, experience unusual stress, or are injured. These conditions can affect your blood sugar and the amount of Diabeta you may need.

After exposure to stress, such as fever, trauma, infection, or surgery, Diabeta may cause you to lose control over your blood glucose levels.

Do not take Diabeta if you:

• are allergic to Diabeta or to any of its ingredients
• have type 1 diabetes mellitus or diabetic ketoacidosis, with or without coma. These conditions should be treated with insulin.
• are being treated with bosentan

You should not use glyburide if you are allergic to it, or:

• if you are being treated with bosentan (Tracleer);

• if you have type 1 diabetes; or

• if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

To make sure glyburide is safe for you, tell your doctor if you have:

• hemolytic anemia (a lack of red blood cells);

• an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD);

• a nerve disorder affecting bodily functions;

• liver or kidney disease;

• if you have taken chlorpropamide in the past 2 weeks;

• if you are allergic to sulfa drugs; or

• if you have been using insulin or taking chlorpropamide (Diabinese).

Certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of taking glyburide.

It is not known whether glyburide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Your doctor may want you to use insulin during pregnancy.

It is not known whether glyburide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take glyburide with your first meal of the day, unless your doctor tells you otherwise.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, confusion, irritability, dizziness, or feeling shaky. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency.

If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Older adults may be more likely to have low blood sugar while taking glyburide.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor's advice.

Also check your blood sugar levels very closely during pregnancy.

If your doctor changes your brand, strength, or type of glyburide, your dosage needs may change. Ask your pharmacist if you have any questions about the new kind of glyburide you receive at the pharmacy.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using glyburide and call your doctor at once if you have:

• easy bruising or bleeding (nosebleeds, bleeding gums);

• sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, trouble swallowing;

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady.

Common side effects may include:

• nausea, upset stomach, heartburn, feeling full;

• muscle or joint pain;

• blurred vision; or

• mild rash or skin redness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Difficulty with swallowing
• dizziness
• fast heartbeat
• hives
• itching
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• shortness of breath
• skin rash
• tightness in the chest
• unusual tiredness or weakness
• wheezing

• Abdominal or stomach pain
• chills
• clay-colored stools
• dark urine
• diarrhea
• fever
• headache
• light-colored stools
• loss of appetite
• nausea and vomiting
• rash
• unpleasant breath odor
• upper right abdominal pain
• vomiting of blood
• yellow eyes and skin

• Agitation
• back, leg, or stomach pains
• bleeding gums
• blood in the urine or stools
• bloody, black, or tarry stools
• blurred vision
• change in near or distance vision
• chest pain
• coma
• confusion
• convulsions
• cough or hoarseness
• decreased urine output
• depression
• difficulty in focusing eyes
• difficulty with breathing
• fast or irregular heartbeat
• fluid-filled skin blisters
• general body swelling
• high fever
• hostility
• increased thirst
• irritability
• itching of the skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lethargy
• lower back or side pain
• muscle pain or cramps
• muscle twitching
• nosebleeds
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• rapid weight gain
• seizures
• sensitivity to the sun
• skin thinness
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stupor
• swelling of the face, ankles, or hands
• swollen or painful glands
• unusual bleeding or bruising

Get emergency help immediately if any of the following symptoms of overdose occur:

• Anxiety
• cold sweats
• cool, pale skin
• increased hunger
• nervousness
• nightmares
• shakiness
• slurred speech

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Indigestion
• passing of gas

• Difficulty with moving
• itching
• joint pain
• redness or other discoloration of the skin
• severe sunburn
• swollen joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY

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. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who were randomly assigned to one of four treatment groups (Diabetes 19 (supp. 2): 747–830, 1970).

UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 2-1/2 times that of patients treated with diet alone. A significant increase in total mortality was not observed, but the use of tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the opportunity for the study to show an increase in overall mortality. Despite controversy regarding the interpretation of these results, the findings of the UGDP study provide an adequate basis for this warning. The patient should be informed of the potential risks and advantages of Diaβeta and of alternative modes of therapy.

Although only one drug in the sulfonylurea class (tolbutamide) was included in this study, it is prudent from a safety standpoint to consider that this warning may also apply to other oral hypoglycemic drugs in this class, in view of their close similarities in mode of action and chemical structure.

Persons allergic to other sulfonamide derivatives may develop an allergic reaction to glyburide as well.

Hypoglycemia: See PRECAUTIONS and OVERDOSAGE Sections.

Gastrointestinal Reactions: Cholestatic jaundice and hepatitis may occur rarely which may progress to liver failure; Diaβeta should be discontinued if this occurs. Liver function abnormalities, including isolated transaminase elevations, have been reported. Gastrointestinal disturbances, e.g., nausea, epigastric fullness, and heartburn, are the most common reactions and occur in 1.8% of treated patients. They tend to be dose-related and may disappear when dosage is reduced.

Dermatologic Reactions: Allergic skin reactions, e.g., pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions, occur in 1.5% of treated patients. These may be transient and may disappear despite continued use of Diaβeta. Bullous reactions, erythema multiforme, and exfoliative dermatitis, have been reported. If skin reactions persist, the drug should be discontinued.

Porphyria cutanea tarda and photosensitivity reactions have been reported with sulfonylureas.

Hematologic Reactions: Leukopenia, agranulocytosis, thrombocytopenia, which occasionally may present as purpura, hemolytic anemia, aplastic anemia, and pancytopenia have been reported with sulfonylureas.

Metabolic Reactions: Hepatic porphyria reactions have been reported with sulfonylureas; however, these have not been reported with Diaβeta. Disulfiram-like reactions have been reported very rarely with Diaβeta. Cases of hyponatremia have been reported with glyburide and all other sulfonylureas, most often in patients who are on other medications or have medical conditions known to cause hyponatremia or increase release of antidiuretic hormone. The syndrome of inappropriate antidiuretic hormone (SIADH) secretion has been reported with certain other sulfonylureas, and it has been suggested that these sulfonylureas may augment the peripheral (antidiuretic) action of ADH and/or increase release of ADH. Diaβeta can cause weight gain.

Other Reactions: Changes in accommodation and/or blurred vision have been reported with glyburide and other sulfonylureas. These are thought to be related to fluctuation in glucose levels.

In addition to dermatologic reactions, allergic reactions such as angioedema, arthralgia, myalgia and vasculitis have been reported.

Overdosage of sulfonylureas, including Diaβeta, can produce hypoglycemia. Mild hypoglycemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalization. If hypoglycemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dL. Patients should be closely monitored for a minimum of 24 to 48 hours, since hypoglycemia may recur after apparent clinical recovery.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes Comments: If diet alone is inadequate for controlling blood glucose, insulin therapy should be considered.

There is limited data which suggests negligible levels of this drug are present in breast milk. A study in 8 women receiving a single-dose shortly after delivery estimates the maximum dose a fully breastfed infant would receive with 5 and 10 mg doses at less than 1.5% and less than 0.7% of the maternal weight-adjusted dose, respectively. Due to the limited data available and the potential for hypoglycemia in the nursing infant, the manufacturer suggests women who are not able to manage their blood sugar on diet alone consider insulin therapy while breastfeeding.

Summary of Use during Lactation

Limited data indicate that the levels of glyburide in milk are negligible. Monitoring of the breastfed infant's blood glucose is advisable during maternal therapy with hypoglycemic agents.[1][2]

Drug Levels

Maternal Levels. Eight women who had recently delivered were given a single dose of glyburide 5 mg (n = 6) or 10 mg (n = 2) orally. Glyburide was undetectable (<5 mcg/L) in milk at 2, 4, 6 and 8 hours after the dose. The authors estimated that the maximum dosages that a fully breastfed infant would receive with the 5 and 10 mg doses are <1.5% and <0.7% of the maternal weight-adjusted dosage, respectively.[3][4]

In a separate study reported in the same paper, 3 women who had delivered via cesarean section and were receiving glyburide 5 mg daily in the immediate postoperative period had milk glyburide levels measured. Trough glyburide milk levels were undetectable (<80 mcg/L).[3]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

The blood glucose level was normal in one breastfed infant whose mothers was taking oral glyburide 5 mg daily.[3]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Acarbose, Chlorpropamide, Insulin, Metformin, Tolbutamide

References

3. Everett JA. Use of oral antidiabetic agents during breastfeeding. J Hum Lact. 1997;13:319-21. PMID: 9429368

4. Berlin CM, Briggs GG. Drugs and chemicals in human milk. Semin Fetal Neonatal Med. 2005;10:149-59. PMID: 15701580

1. Feig DS, Briggs GG, Kraemer JM et al. Transfer of glyburide and glipizide into breast milk. Diabetes Care. 2005;28:1851-5. PMID: 16043722

2. Feig DS, Kraemer JM, Moskovitz DN et al. The transfer of glyburide into breast milk. Clin Pharmacol Ther. 2004;75(2):P24. Abstract.