VAPRISOL ® (conivaptan hydrochloride) Injection
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Standard Dilution [Amount of drug] [Infusion volume] [Infusion rate]
Intravenous injection solution: conivaptan hydrochloride 20 mg/100 mL premixed in 5% Dextrose.Dosage and administration.
Stability / Miscellaneous
INDICATIONS AND USAGE
It has not been established that raising serum sodium with VAPRISOL provides a symptomatic benefit to patients.
General Dosing Information
Administer VAPRISOL through large veins and change of the infusion site every 24 hours to minimize the risk of vascular irritation [see package insert for Warnings and Precautions].
Initiate with a loading dose of 20 mg IV administered over 30 minutes.
Follow the loading dose with 20 mg of VAPRISOL administered in a continuous intravenous infusion over 24 hours. After the initial day of treatment, administer VAPRISOL 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, 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 Warnings and Precautions (5.2)]. 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
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 is physically and chemically compatible with 0.9% Sodium Chloride Injection for up to 22 hours when the two solutions are co-administered via a Y-site connection at a flow rate for VAPRISOL of 4.2 mL/hour and at flow rates for 0.9% Sodium Chloride Injection of either 2.1 mL/hour or 6.3 mL/hour. 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.
Loading Dose -------------------
For patients requiring 40 mg VAPRISOL injection per day, administer the content of 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.
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.
DOSAGE FORMS AND STRENGTHS
WARNINGS AND PRECAUTIONS:
To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. at 1-800-727-7003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS:
HOW SUPPLIED/STORAGE AND HANDLING
VAPRISOL (conivaptan hydrochloride) Injection is supplied as a single-use, premixed solution, containing 20 mg of conivaptan hydrochloride in 5% Dextrose in 100 mL INTRAVIA Plastic Containers.
1 container/carton (NDC 0469-1602-10)
VAPRISOL in INTRAVIA Plastic Containers should be stored at 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light until ready to use.
VAPRISOL is a registered trademark of Astellas Pharma US, Inc.