The effectiveness of VAPRISOL for the treatment of congestive heart failure has not been established. In 10 Phase 2/pilot heart failure studies, VAPRISOL did not show statistically significant improvement for heart failure outcomes, including such measures as length of hospital stay, changes in categorized physical findings of heart failure, change in ejection fraction, change in exercise tolerance, change in functional status, or change in heart failure symptoms, compared to placebo. In these studies, the changes in the physical findings and heart failure symptoms were no worse in the VAPRISOL-treated group (N=818) compared to the placebo group (N=290) [see Indications and Usage (1)].
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 66220-160-10)
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.
Inform patients about the common adverse effects of VAPRISOL including infusion site effects (edema, erythema, pain, and phlebitis), pyrexia, hypokalemia, headache, orthostatic hypotension and potential for overly rapid increase in serum sodium which can cause serious neurologic sequelae. Instruct patients to inform their healthcare provider if they develop any unusual symptoms, or if any known symptom persists or worsens, with special attention to potential manifestations of osmotic demyelination syndrome.
Ask patients about what other medications they are currently taking with VAPRISOL, including over-the-counter medications.
Advise women not to breastfeed during treatment with VAPRISOL [see Use in Specific Populations (8.2)].
Cumberland Pharmaceuticals Inc.
Nashville TN 37203
VAPRISOL is a registered trademark of Cumberland Pharmaceuticals Inc.INTRAVIA is a registered trademark of Baxter International Inc.
US Patent Number 5,723,606
Principal Display Panel — Box Label
(conivaptan hydrochloride) injection
Premixed in 5% Dextrose
20 mg/100 mL (0.2 mg per mL)
SINGLE-DOSE INTRAVIA CONTAINER
Principal Display Panel — Pouch Label
Vaprisol® (CONIVAPTAN HYDROCHLORIDE)
PREMIXED IN 5% DEXTROSE
20 mg/100 mL (0.2 mg per mL)
INTRAVIA CONTAINER STERILE NONPYROGENIC
|VAPRISOL DEXTROSE IN PLASTIC CONTAINER conivaptan hydrochloride injection, solution|
|Labeler — Cumberland Pharmaceuticals Inc. (069532880)|
Revised: 10/2016 Cumberland Pharmaceuticals Inc.
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