Guidelines for Using Thiazolidinediones

Type of Drug:

Oral antidiabetic (blood sugar lowering) agent used in the management of type 2 diabetes (adult-onset; non-insulin-dependent diabetes mellitus [NIDDM]) not adequately controlled with diet and exercise.

How the Drug Works:

The thiazolidinedione hypoglycemic agents appear to lower blood sugar (glucose) by improving target cell response or sensitivity to insulin. They also decrease glucose output from the liver and increase insulin-dependent glucose disposal in skeletal muscle. They do not stimulate insulin production but lower tissue resistance (eg, increase sensitivity) to insulin.

Uses:

Used alone or as an adjunct to diet and exercise to treat type 2 diabetes or in combination with a sulfonamide or insulin, or mentoring to improve glycolic control when diet, exercise, and a single diabetic drug do not accomplish adequate control of blood glucose levels.

Precautions:

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and potential benefits to the mother outweigh the possible hazard to the fetus. Most experts recommend that insulin be used to control diabetes during pregnancy.

Braastfeeding: It is not known if thiazolidinediones appear in breast milk. Do not administer to a nursing woman.

Children: Safety and effectiveness in patients under 18 years of age have not been established.

Lab Tests: Lab Tests will bo roqlliroci to monitor theropy Tests may include blood glucose,glycosylated,hemogolobin,and liver funtion.

Drug Interactions:

Tell your doctor or pharmacist if you are taking or planning to take any over­the-counter or prescription medications or dietary supplements while taking thiazolidinediones. Doses of one or both drugs may need to be modified or a different drug may need to be prescribed. Insulin interacts with thiazolidinediones. The following drugs and drug classes interact with pioglitazone only:

Side Effects:

Every drug is capable of producing side effects. Many thiazolidinedione users experience no, or minor, side effects. The frequency and severity of side effects depend on many factors including dose, duration of therapy, and individual susceptibility. Possible side effects include:

Digestive Tract: Nausea; diarrhea; weight gain.

Other: Headache; runny nose; sore throat; muscle or back pain; fluid retention; upper respiratory tract infection; elevated liver enzymes; dark urine; anemia; blood sugar changes; abnormal blood tests.

Guidelines for Use:

• Dosage will be individualized. Take exactly as prescribed.

• Do not change the dose or stop taking unless advised by your doctor. This could have serious consequences.

• Take pioglitazone once daily without regard to meals.

• Take rosiglitazone as a single dose or divided into 2 doses. May be taken without regard to meals.

• Dietary restriction, weight loss (if obese), and exercise are essential to optimal management of diabetes and help improve insulin sensitivity. Follow your prescribed diet and exercise program closely.

• During periods of stress such as fever, trauma, infection, or surgery, medication requirements may change. Consult your doctor.

• Insulin, a sulfonylurea, or a metformin dose may need to be reduced if hypoglycemia occurs when starting a thiazolidinedione.

• Notify your doctor immediately if you experience nausea, vomiting, stomach pain, fatigue, appetite loss, dark urine, yellowing of skin or eyes.

• Talk to your doctor about low blood sugar risks, predisposing conditions, symptoms (eg, numbness, fatigue, hunger, sweating, rapid pulse, confusion) and treatment (administration of sugar-containing beverage or food) associated with combination therapy with insulin or other oral antidiabetic agents.

• Thiazolidinediones may cause ovulation in nonovulating premenopausal women. Talk to your doctor about adequate contraception.

• Pioglitazone may reduce the effectiveness of oral contraceptives (eg, Ortho-Novum). Talk to your doctor about an oral contraceptive with higher levels of estrogen and progestin or an alternative method of contraception.

• Lab tests will be required to monitor therapy. Be sure to keep appointments.

• Store at room temperature (59° to 86°F) in a tightly closed container. Protect from light and moisture.