DUETACT Oral Warnings - Duetact Warnings & Precautions

DUETACT Oral Warnings
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This medication may infrequently cause or worsen a certain heart problem (congestive heart failure). Tell your doctor immediately if you notice any symptoms of heart failure, including: swelling of the hands/feet, unusual/sudden weight gain, trouble breathing, or unusual tiredness.

Who should not take this medication?

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

Conditions:

Macular Edema, Chronic Heart Failure, Severe Heart Failure, Chronic Heart Failure Not Suddenly Currently Controlled by Medication, Liver Problems, Kidney Disease, Recent Operation, Body Temperature More Than 101 Degrees F, Visible Water Retention, Weakened Patient, Broken Bone, Injury, A Mother who is Producing Milk and Breastfeeding, Infection, Severe Infection, Type 1 Diabetes Mellitus, Low Blood Sugar, Pituitary Hormone Deficiency, Addison's Disease, Water Retention, Hepatic Porphyria, Habit of Drinking Too Much Alcohol

Allergies:

SULFONYLUREAS PIOGLITAZONE DERIVATIVES

DUETACT Oral Precautions

Before taking this medication, tell your doctor or pharmacist if you are allergic to pioglitazone or glimepiride; or to other "glitazones" (e.g., rosiglitazone); or to other sulfonylureas (e.g., glipizide, tolbutamide); 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: type 1 diabetes (insulin-dependent diabetes), very high blood sugar levels (diabetic ketoacidosis), newly diagnosed or worsening heart failure (acute congestive heart failure), history of liver disease, active liver disease.

Before taking this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., chronic congestive heart failure), fluid in your lungs, swelling (edema, fluid retention), liver problems, kidney disease, thyroid problems, certain hormonal conditions (adrenal/pituitary insufficiency, syndrome of inappropriate secretion of antidiuretic hormone-SIADH), mineral imbalance (hyponatremia), anemia, eye (retina) problems.

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

Limit alcohol while taking this medication because it can increase your risk of developing low blood sugar (hypoglycemia).

It may be harder to control your blood sugar when your body is stressed (e.g., due to fever, infection, injury, or surgery). In these cases, consult your doctor because you 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.

This medication may increase the risk of bone fracture (e.g., upper arm, hand, foot, ankle) in female patients. To lower the chance of getting injured, use caution when doing activities such as contact sports.

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

This medication can cause changes in the menstrual cycle (promote ovulation) in women with certain fertility problems. Women of child-bearing age should use a reliable form of birth control while taking this medication. Consult your doctor for more details.

This medication is not recommended for use during pregnancy. Your doctor may direct you to switch to insulin treatment during your pregnancy. Use of pioglitazone/glimepiride close to the expected delivery date may increase the risk of low blood sugar in your newborn. Consult your doctor for more details, and follow all instructions carefully.

It is not known whether this medication passes into breast milk. Because drugs similar to glimepiride pass into breast milk and can cause low blood sugar in nursing babies, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.

What should I know before taking this medication?

If you are:

Pregnant:

Only When Necessary: RISK OF HYPOGLYCEMIA IN NEONATE IF USED NEAR DELIVERY

Nursing:

Absolute Contraindication: NOT RECOMMEND;EXCRETED IN RATS;POSSIBILITY OF HYPOGLYCEMIA IN NURSING INFANTS

An adult over 60:

Precaution: AGE & DECREASED RENAL FXN INCREASES RISK OF HYPOGLYCEMIA.

Giving this medication to a child under 12:

Relative Contraindication: NOT RECOMMENDED IN PEDIATRICS DUE TO INSUFFICIENT CLINICAL DATA.

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