Drug Detail:Vaprisol (Conivaptan [ koe-nye-vap-tan ])
Generic Name: CONIVAPTAN HYDROCHLORIDE 20mg in 100mL
Dosage Form: injection, solution
Drug Class: Vasopressin antagonists
VAPRISOL is for intravenous use only.
VAPRISOL is for use in hospitalized patients 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. The maximum daily dose of VAPRISOL (after the loading dose) is 40 mg/day.
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 neurologic 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
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulate matter, discoloration or cloudiness is observed, the drug solution should not be used.
VAPRISOL (conivaptan hydrochloride injection) Ampule
Caution: VAPRISOL ampule should be diluted only with 5% Dextrose Injection.
The VAPRISOL ampule is compatible with 5% Dextrose Injection and is stable for up to 24 hours after mixing. The VAPRISOL ampule 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 container.
The diluted solution of VAPRISOL should be used immediately and administration completed within 24 hours of mixing.
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.
VAPRISOL (conivaptan hydrochloride injection) Premixed in 5% Dextrose
VAPRISOL is supplied in a single-use 100 mL flexible INTRAVIA container containing a sterile premixed dilute, ready-to-use, nonpyrogenic solution of conivaptan hydrochloride, 0.2 mg per mL (20 mg/100 mL) in 5% dextrose. NO FURTHER DILUTION OF THIS PREPARATION IS NECESSARY.
VAPRISOL is compatible with 5% Dextrose Injection. VAPRISOL should not be administered with Lactated Ringer's Injection. VAPRISOL should not be combined with any other product in the same intravenous line or container.
Continuous Infusion
For patients requiring 20 mg conivaptan hydrochloride injection per day, administer one 20 mg/100 mL VAPRISOL flexible plastic container over 24 hours.
For patients requiring 40 mg conivaptan hydrochloride injection per day, administer two consecutive 20 mg/100 mL VAPRISOL flexible plastic containers over 24 hours.
Since the flexible container is for single-use only, any unused portion should be discarded.
CAUTION: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.
Directions for VAPRISOL (conivaptan hydrochloride injection) Premixed in 5% Dextrose:
Do not remove container from overwrap until ready for use. The overwrap is a moisture and light barrier. The inner container maintains the sterility of the product.
Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. After removing overwrap, check for minute leaks by squeezing inner container firmly. If leaks are found, discard solution as sterility may be impaired. Do not use if the solution is cloudy or a precipitate is present.
DO NOT ADD SUPPLEMENTARY MEDICATION.
Preparation for Administration:
- 1.
- Suspend container from eyelet support.
- 2.
- Remove protector from outlet port at bottom of container.
- 3.
- Attach administration set. Refer to complete directions accompanying set.
