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Vaprisol

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Vaprisol

Vaprisol

INDICATIONS

VAPRISOL® is indicated to raise serum sodium in hospitalized patients with euvolemic and hypervolemic hyponatremia.

Important Limitations

VAPRISOL has not been shown to be effective for the treatment of the signs and symptoms of heart failure and is not approved for this indication.

It has not been established that raising serum sodium with VAPRISOL provides a symptomatic benefit to patients.

DOSAGE AND ADMINISTRATION

General Dosing Information

VAPRISOL is for intravenous use only.

VAPRISOL is for use in hospitalized patients only.

Administer VAPRISOL through large veins and change of the infusion site every 24 hours to minimize the risk of vascular irritation [see 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]. 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 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 48 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 has been shown to be incompatible with both Lactated Ringer's Injection and furosemide injection when these products are mixed in the same container; therefore, do not combine VAPRISOL with these products in the same intravenous line or container.

VAPRISOL should also not be combined with any other product in the same intravenous line or container.

Loading Dose

Administer the content of a 20 mg/100 mL VAPRISOL flexible plastic container over 30 minutes.

Continuous Infusion

For patients requiring 20 mg VAPRISOL injection per day, administer the content of one 20 mg/100 mL VAPRISOL flexible plastic container over 24 hours.

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.

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.

Hepatic Impairment

In patients with moderate hepatic impairment, initiate VAPRISOL with a loading dose of 10 mg over 30 minutes followed by 10 mg per day as a continuous infusion for 2 to 4 days. If serum sodium is not rising at the desired rate, VAPRISOL may be titrated upward to 20 mg per day [see Use in Specific Populations and CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

Intravenous injection solution: conivaptan hydrochloride 20 mg/100 mL premixed in 5% Dextrose [see DOSAGE AND ADMINISTRATION].

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.

Marketed by: Astellas Pharma US, Inc. Deerfield, IL 60015-2548. Manufactured by: Baxter Healthcare Corporation Deerfield, IL 60015. Revised: February 2012

Last reviewed on RxList: 2/28/2012
This monograph has been modified to include the generic and brand name in many instances.

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