VAPRISOL DEXTROSE IN PLASTIC CONTAINER (Page 5 of 5)

14.2 Heart Failure

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)].

16 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 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.

17 PATIENT COUNSELING INFORMATION

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.

Lactation

Advise women not to breastfeed during treatment with VAPRISOL [see Use in Specific Populations (8.2)].

Marketed by:
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

07-19-73-925

Principal Display Panel — Box Label

NDC 66220-160-10

Vaprisol®

(conivaptan hydrochloride) injection

Premixed in 5% Dextrose

20 mg/100 mL (0.2 mg per mL)

100 mL

STERILE NONPYROGENIC

SINGLE-DOSE INTRAVIA CONTAINER

Principal Display Panel -- Box Label
(click image for full-size original)

Principal Display Panel — Pouch Label

100 mL

2J1451

12B017-VAP

NDC 66220-160-10

Vaprisol® (CONIVAPTAN HYDROCHLORIDE)

INJECTION

PREMIXED IN 5% DEXTROSE

20 mg/100 mL (0.2 mg per mL)

SINGLE-DOSE

INTRAVIA CONTAINER STERILE NONPYROGENIC

Principal Display Panel -- Pouch Label
(click image for full-size original)
VAPRISOL DEXTROSE IN PLASTIC CONTAINER conivaptan hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66220-160
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
conivaptan hydrochloride (conivaptan) conivaptan hydrochloride 20 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
dextrose
lactic acid
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66220-160-10 1 BAG in 1 BOX contains a BAG
1 1 POUCH in 1 BAG This package is contained within the BOX (66220-160-10) and contains a POUCH
1 100 mL in 1 POUCH This package is contained within a BAG and a BOX (66220-160-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021697 10/08/2008
Labeler — Cumberland Pharmaceuticals Inc. (069532880)

Revised: 10/2016 Cumberland Pharmaceuticals Inc.

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