Dosage and Administration
VAPRISOL is for intravenous use only.
Administration of VAPRISOL through large veins and change of the infusion site every 24 hours are recommended to minimize the risk of vascular irritation.
VAPRISOL therapy should begin with a loading dose of 20 mg IV administered over 30 minutes.
The loading dose should be followed by 20 mg of VAPRISOL administered in a continuous intravenous infusion over 24 hours. Following the initial day of treatment, VAPRISOL is to be administered for an additional 1 to 3 days in a continuous infusion of 20 mg/day. If serum sodium is not rising at the desired rate, VAPRISOL may be titrated upward to a dose of 40 mg daily, again administered in a continuous intravenous infusion.
The total duration of infusion of VAPRISOL (after the loading dose) should not exceed four days.
Patients receiving VAPRISOL must have frequent monitoring of serum sodium and volume status. An overly rapid rise in serum sodium (>12 mEq/L/24 hours) may result in serious sequelae. For patients who develop an undesirably rapid rate of rise of serum sodium, VAPRISOL should be discontinued, and serum sodium and neurologic status should be carefully monitored. If the serum sodium continues to rise, VAPRISOL should not be resumed. If hyponatremia persists or recurs, and the patient has had no evidence of neurologic sequelae of rapid rise in serum sodium, VAPRISOL may be resumed at a reduced dose. (see PRECAUTIONS: Overly Rapid Correction of Serum Sodium)
For patients who develop hypovolemia or hypotension while receiving VAPRISOL, VAPRISOL should be discontinued, and volume status and vital signs should be frequently monitored. Once the patient is again euvolemic and is no longer hypotensive, VAPRISOL may be resumed at a reduced dose if the patient remains hyponatremic.
Preparation
Compatibility and Stability
Caution: VAPRISOL should be diluted only with 5% Dextrose Injection.
VAPRISOL is compatible with 5% Dextrose Injection and is stable for up to 24 hours after mixing. VAPRISOL should not be mixed or administered with Lactated Ringer’s Injection or 0.9% Sodium Chloride Injection. Compatibility with other drugs has not been studied; therefore, VAPRISOL should not be combined with any other product in the same intravenous line or bag.
Loading Dose
Withdraw 4 mL (20 mg) of VAPRISOL (4 mL of conivaptan hydrochloride injection) and add to an infusion bag containing 100 mL of 5% Dextrose Injection, USP. Gently invert the bag several times to ensure complete mixing of the solution. The contents of the IV bag should be administered over 30 minutes.
Continuous Infusion
To prepare a continuous IV infusion containing 20 mg conivaptan hydrochloride, withdraw 4 mL (20 mg) from a single ampule of VAPRISOL and dilute into an IV bag containing 250 mL of 5% Dextrose Injection, USP. Gently invert the bag several times to ensure complete mixing of the solution. The contents of the IV bag should be administered over 24 hours.
To prepare a continuous IV infusion containing 40 mg conivaptan hydrochloride, withdraw 4 mL (20 mg) from each of two ampules of VAPRISOL (8 mL [40 mg] of conivaptan hydrochloride injection) and dilute into an IV bag containing 250 mL of 5% Dextrose Injection, USP. Gently invert the bag several times to ensure complete mixing of the solution. The contents of the IV bag should be administered over 24 hours.
The VAPRISOL ampule is for single use only. Discard unused contents of the ampule.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulate matter or cloudiness is observed, the drug solution should not be used.
The diluted solution of VAPRISOL should be used immediately and administration completed within 24 hours of mixing.
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