rosiglitazone maleate

Drug Name

Generic Name : rosiglitazone maleate

Brand Name: Avandia

Classification: Antidiabetic, Thiazolidinedione

Pregnancy Category C 

Dosage & Route

Available forms : Tablets—2, 4, 8 mg

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.
Therapeutic actions
  • Rosiglitazone is a thiazolidinedione antidiabetic agent which improves insulin sensitivity by lowering blood glucose level without increasing pancreatic insulin secretion. It is dependent on the presence of insulin. Rosiglitazone is a potent agonist for the peroxisome proliferator-activated receptor-gamma, which in turn regulates the transcription of insulin-responsive genes involved in the control of glucose production, transport and utilization.
Indications
  • Monotherapy as an adjunct to diet and exercise to improve glucose control in patients with type 2 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
  • Unlabeled use: Increased ovulation frequency in women with polycystic ovary syndrome
Adverse effects
  • Upper respiratory tract infections, headache, back pain, hyperglycemia, fatigue, sinusitis, diarrhea, hypoglycemia, edema, anemia, weight gain.
  • Potentially Fatal: May cause or exacerbate congestive heart failure.
Contraindications
  • Hypersensitivity, symptomatic heart failure. Not to be used in patients with established NYHA (New York Heart Association) class III or IV heart failure. Pregnancy, lactation.
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.