Generic Name and Formulations:
Conivaptan HCl 20mg/100mL in 5% dextrose; soln for IV infusion.
Cumberland Pharmaceuticals, Inc.
Indications for VAPRISOL:
Euvolemic and hypervolemic hyponatremia in hospitalized patients.
Limitations Of use:
Not effective for treating signs/symptoms of heart failure.
Administer via large veins; rotate infusion site every 24hrs. Loading dose: 20mg IV over 30mins, followed by 20mg continuous IV infusion over 24hrs. After initial day of treatment, give 20mg/day continuous IV infusion for an additional 1–3 days; may titrate up to max 40mg/day if serum sodium is not rising at desired rate. Max duration after loading dose: 4 days. Moderate and severe hepatic impairment: Loading dose: 10mg IV over 30mins, followed by 10mg/day as continuous IV infusion for 2–4 days; may titrate up to max 20mg/day if serum sodium is not rising at desired rate.
Hypovolemic hyponatremia. Concomitant potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir). Anuric patients.
Monitor serum sodium concentration, volume status, neurologic status. Discontinue if serum sodium rises too rapidly (>12mEq/L per 24hrs); may resume at reduced dose if hyponatremia persists or recurs and no evidence of neurologic sequelae. Discontinue if hypovolemia or hypotension develops; frequently monitor volume status and vital signs; may resume at reduced dose if euvolemic and not hypotensive. Severe renal impairment: not recommended. Pregnancy. Nursing mothers: not recommended.
Dual arginine vasopressin (V1A and V2) receptors antagonist.
See Contraindications. Potentiated by CYP3A4 inhibitors. Potentiates CYP3A4 substrates (eg, midazolam, simvastatin, amlodipine); avoid; allow at least 1 week after end of conivaptan administration before resuming these drugs. May potentiate digoxin; monitor.
Infusion site reactions (eg, phlebitis, erythema, pain), GI upset, headache, hypokalemia, hyponatremia, orthostatic hypotension, hyper- or hypotension, peripheral edema, thirst, pyrexia.
Single-use premixed soln—1