Glucovance Oral Warnings & Precautions - Glucovance Drug Warnings & Precautions

Glucovance Oral Warnings & Precautions

Warnings

Metformin can rarely cause a serious (sometimes fatal) condition called lactic acidosis. Stop taking this medication and seek immediate medical attention if you develop any of the following symptoms of lactic acidosis: unusual tiredness, severe drowsiness, chills, blue/cold skin, muscle pain, fast/difficult breathing, unusually slow/irregular heartbeat.

Lactic acidosis is more likely to occur in patients who have certain medical conditions, including kidney or liver disease, conditions that may cause a low oxygen blood level or poor circulation (e.g., severe congestive heart failure, recent heart attack, recent stroke), heavy alcohol use, a severe loss of body fluids (dehydration), X-ray or scanning procedures that require an injectable iodinated contrast drug, recent surgery, or a serious infection. Tell your doctor immediately if any of these conditions occur or if you notice a big change in your overall health. You may need to stop taking metformin temporarily. The elderly are also at higher risk, especially those older than 80 years who have not had kidney tests. (See also Side Effects and Precautions sections.)

Who should not take this medication?

Check with your physician if you have any of the following:

Conditions:

Alcohol Intoxication, Bacterial Infection of Blood or Tissues affecting the Whole Body, Heart Attack, Chronic Heart Failure Not Suddenly Currently Controlled by Medication, Significant Decrease in Lung Function, Liver Problems, Kidney Disease, Recent Operation, Fever, Body Temperature More Than 101 Degrees F, Shock, Blood Circulation Failure due to Serious Heart Condition, Severe Nausea and Vomiting that has Lasted a Long Time, Severe Vomiting, Severe Diarrhea, Decreased Oxygen In The Tissues Or Blood, Weakened Patient, Injury, Infection, Severe Infection, Diabetic Ketoacidosis, Coma in a Diabetic Patient, Low Blood Sugar, Pituitary Hormone Deficiency, Addison's Disease, Decreased Function of the Adrenal Gland, Inadequate Vitamin B12, Acidosis, Ketoacidosis, Accumulation of Ketones from Abnormal Metabolism, Increased Blood Acidity due to High Levels of Lactic Acid, Excess Body Acid, Extreme Loss of Body Water, Hepatic Porphyria, X-Ray Study with Intravenous Iodine Contrast Agent, Habit of Drinking Too Much Alcohol

Allergies:

SULFONYLUREAS BIGUANIDES

Glucovance Oral Precautions

Before taking this medication, tell your doctor or pharmacist if you are allergic to glyburide or metformin; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease, liver disease, conditions that may cause a low level of oxygen in the blood or poor circulation (e.g., severe congestive heart failure, recent heart attack, recent stroke), metabolic acidosis (e.g., diabetic ketoacidosis), serious infection, severe loss of body fluids (dehydration).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol use, severe breathing problems (e.g., obstructive lung disease, severe asthma), blood problems (e.g., anemia, vitamin B12 deficiency), electrolyte imbalance (hyponatremia), fertility problems (e.g., ovulation problems), certain hormonal conditions (adrenal/pituitary insufficiency, thyroid disease, syndrome of inappropriate antidiuretic hormone-SIADH).

Before having surgery or any X-ray/scanning procedure using injectable iodinated contrast material, tell your doctor that you are taking this medication. You will need to temporarily stop this medication before the time of your surgery/procedure. Consult your doctor for further instructions.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Use caution while driving, using machinery, or taking part in any other activity that requires clear vision and alertness.

Limit alcohol while taking this medication because it can increase the risk of developing low blood sugar and lactic acidosis. Rarely, alcohol can interact with glyburide and cause a serious reaction (disulfiram-like reaction) with symptoms such as facial flushing, nausea, vomiting, dizziness, or stomach pain. Consult your doctor or pharmacist about using alcohol safely.

It may be harder to control your blood sugar when your body is stressed (e.g., due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects such as lactic acidosis or low blood sugar while using this drug.

This medication can cause changes in the menstrual cycle (promote ovulation) and increase the risk of becoming pregnant. Consult your doctor or pharmacist about the use of reliable birth control while using this medication.

During pregnancy, this medication should be used only when clearly needed. Insulin treatment may be preferred during pregnancy. If you are using glyburide during your pregnancy, your doctor may switch you to insulin at least 2 weeks before the expected delivery date because of glyburide's risk of low blood sugar in your newborn. Discuss the risks and benefits with your doctor. Follow your doctor's instructions carefully.

It is not known whether this drug passes into breast milk. This drug could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

What should I know before taking this medication?

If you are:

Pregnant:

Possibly Safe

Nursing:

Precaution: UNLIKELY CLINICALLY SIGNIFICANT AMT EXCRETED, NO EFFECT ON ONE INFANT STUDIED

An adult over 60:

Precaution: (SOM) HIGHER RISK OF HYPOGLYCEMIA: USE CONSERVATIVE DOSES.

Giving this medication to a child under 12:

Warning: SAFETY AND EFFICACY IN PEDIATRICS NOT ESTABLISHED.

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