rosiglitazone maleate

rosiglitazone maleate

(roh zee glit' ah zohn)

Avandia

Pregnancy Category C

Drug classes

Antidiabetic

Thiazolidinedione

Therapeutic actions

Resensitizes tissues to insulin; decreases hepatic gluconeogenesis and increases insulin-dependent muscle glucose uptake.

Indications

·        Monotherapy as an adjunct to diet and exercise to improve glucose control in patients with type 2 (non–insulin-dependent) diabetes

·        As part of combination with insulin, metformin or a sulfonylurea when diet, exercise, and either agent alone does not result in adequate glycemic control in type 2 diabetes

Contraindications and cautions

·        Contraindicated with allergy to any thiazolidinedione; type 1 (insulin-dependent) diabetes, ketoacidosis, lactation.

·        Use cautiously with advanced heart disease, liver failure, pregnancy, heart failure.

Available forms

Tablets—2, 4, 8 mg

Dosages

ADULTS

4 mg as a single oral dose or divided into two doses; if adequate response is not seen in 8–12 wk, may be increased to 8 mg daily PO.

·        Combination therapy with metformin: 4 mg daily PO added to the established dose of metformin; may be increased after 12 wk to 8 mg daily PO.

·        Combination with insulin: Continue insulin dose and start with 4 mg/day; monitor patient and decrease insulin dose by 10–25% based on patient response.

PEDIATRIC PATIENTS

Safety and efficacy not established.

PATIENTS WITH HEPATIC IMPAIRMENT

Use caution and monitor patient closely. Do not administer if AST > 2.5 times the upper level of normal.

Pharmacokinetics

Route	Onset	Peak
Oral	Rapid	1.3–3.5 hr

Metabolism: Hepatic; T_1/2: 3–4 hr

Distribution: Crosses placenta; enters breast milk

Excretion: Feces, urine

Adverse effects

·        CNS: Headache, pain

·        Endocrine: Hypoglycemia, hyperglycemia

·        GI: Diarrhea, liver injury

·        Respiratory: Sinusitis, URI, rhinitis

·        Other: Infections, fatigue, accidental injury, edema

Interactions

Drug-drug

·        Risk of increased serum levels if combined with gemfibrozil; monitor patient and adjust dosage as needed.

Nursing considerations

Assessment

·        History: Allergy to any thiazolidinedione; type 1 diabetes, ketoacidosis, serious hepatic impairment, advanced heart disease, pregnancy, lactation

·        Physical: T; orientation, reflexes, peripheral sensation; R, adventitious sounds; liver evaluation; LFTs, blood glucose, CBC

Interventions

·        Monitor serum glucose levels frequently to determine effectiveness of drug and dosage being used.

·        Monitor baseline LFTs before beginning therapy and periodically during therapy.

·        Administer without regard to meals.

·        Arrange for consult with dietitian to establish weight loss program and dietary control as appropriate.

·        Arrange for thorough diabetic teaching program to include disease, dietary control, exercise, signs and symptoms of hypo- and hyperglycemia, avoidance of infection, hygiene.

Teaching points

·        Do not discontinue this medication without consulting your health care provider; continue with diet and exercise program for diabetes control.

·        Take this drug with meals if desired. If dose is missed, it may be taken at the next meal. If dose is missed for an entire day, do not double dose the next day.

·        Monitor urine or blood for glucose and ketones as prescribed; watch very closely while adjusting to drug.

·        Report fever, sore throat, unusual bleeding or bruising, rash, dark urine, light-colored stools, hypo- or hyperglycemic reactions.

Adverse effects in Italic are most common; those in Bold are life-threatening.