Antidiabetic, oralUS FDA Database Verified

rosiglitazone (Rx)

Generic: Rosiglitazone

Brand: Avandia

(rose-i-glye'ta-zone)

Pregnancy Category: C

Pharmacological Action

Improves insulin resistance by hepatic glucose metabolism, insulin receptor kinase activity, insulin receptor phosphorylation

Therapeutic outcome: Decreased symptoms of diabetes mellitus

Uses

Stable type 2 diabetes mellitus alone or in combination with sulfonylureas, metformin, or insulin

Contraindications

Breastfeeding, children, hypersensitivity to thiazolidinediones, diabetic ketoacidosis, jaundice, type 1 diabetes

BLACK BOX WARNING: NYHA III or IV acute heart failure, heart failure

Precautions: Pregnancy C, geriatric, thyroid/renal/hepatic disease, heart failure, NYHA class I, II

BLACK BOX WARNING: MI

Dosage & Routes

Adult: PO 4 mg/day or in 2 divided doses, may increase to 8 mg/day or in 2 divided doses after 12 wk; may be added to metformin, sulfonylureas at the adult dose

Available forms: Tabs 2, 4, 8 mg

Implementation - Convert from other oral hypoglycemic agents if needed; change may be made without gradual dosage change; monitor blood glucose during conversion - Give tabs crushed and mixed with meal or fluids for patients with difficulty swallowing PO route - Give once or in 2 divided doses without regard to food - Store in airtight container in cool environment - Available only through the REMS Program 1-800-Avandia

Adverse Effects

CNS: Fatigue, headache

CV: CHF, MI, death (geriatric patients)

ENDO: Hyper/hypoglycemia

GI: Weight gain, hepatotoxicity, increased total cholesterol, LDL, HDL, decreased free fatty acids

MISC: Accidental injury, upper respiratory tract infection, sinusitis, anemia, back pain, diarrhea, edema, bone fractures (female), pulmonary/macular/peripheral edema

SYST: Anaphylaxis, Stevens-Johnson syndrome, lactic acidosis

Pharmacokinetics

Absorption: Unknown

Distribution: Protein binding 99.8%

Metabolism: Unknown

Excretion: Urine, feces, breast milk

Half-life: Elimination 3-4 hr

Pharmacodynamics

Onset: Unknown

Peak: 6-12 wk

Duration: Unknown

Interactions

Individual drugs FluvoxaMINE, gemfibrozil, ketoconazole: increased hypoglycemia; monitor glucose

Insulin: avoid concurrent use

Drug classifications CYP2 C5 inducers/inhibitors: may increase/decrease effect

Nitrates: avoid concurrent use

Drug/herb Horse chestnut: increased antidiabetic effect

Drug/lab test

Increased: ALT, HDL, LDL, total cholesterol, blood glucose

Decreased: Hgb/Hct

Nursing Considerations

Assessment

BLACK BOX WARNING: Use in NYHA III or IV acute heart failure is contraindicated; any deterioration in any cardiac status, discontinue product

BLACK BOX WARNING:

CHF/MI: assess for dyspnea, edema, weight gain ≥5 lb, jugular vein distention; may need to change or discontinue; do not use in acute coronary syndrome - Lactic acidosis: assess for dyspnea, abdominal pain, muscle pain; notify prescriber immediately - Assess for hypoglycemic reactions (sweating, weakness, dizziness, anxiety, tremors, hunger), hyperglycemic reactions soon after meals - Assess for systemic reactions: anaphylaxis, Stevens-Johnson syndrome -

Hepatotoxicity: check liver function tests periodically; AST, FBS, ALT (if ALT is >2.5 × ULN, do not use), HbA2 c, plasma lipids, lipoproteins, B/P, body weight during treatment

Patient/family education - Teach patient that in order to use product, provider/patient must be enrolled in the Avandia-Rosiglitazone Access Program - Teach patient to monitor capillary blood glucose test, that periodic liver function tests are mandatory; to report edema, weight gain - Teach patient symptoms of hypo/hyperglycemia, what to do about each - Advise patient that product must be continued on daily basis; explain consequence of discontinuing product abruptly - Advise patient to avoid OTC medications, nitrates, insulin, or herbal preparations unless approved by prescriber - Advise patient that diabetes is lifelong illness; that this product is not a cure, only controls symptoms - Advise patient that all food included in diet plan must be eaten to prevent hypoglycemia - Advise patient to carry/wear emergency ID and glucagon emergency kit for emergencies - Instruct patient to notify prescriber if oral contraceptives are used - Teach patient not to use if breastfeeding; may be secreted in breast milk -

Hepatotoxicity: advise patient to report nausea, vomiting, abdominal pain, fatigue, anorexia, dark urine, jaundice - Teach patient that 2 wk is needed to see a reduction in blood glucose, 2-3 mo to see full effect

Evaluation

Positive therapeutic outcome: Decrease in polyuria, polydipsia, polyphagia; clear sensorium; absence of dizziness; stable gait; blood glucose, A1 c improvement

Reference

Mosby's Drug Guide; Davis Drug Guide

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