"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is warning of several treatment-related serious adverse events in association with implantable left ventricular assist devices (LVADs) in heart-failure patients.
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Conivaptan hydrochloride is chemically [1,1'-biphenyl]-2-carboxamide, N-[4-[(4,5-dihydro-2methylimidazo[4,5-d]benzazepin-6(1H)-yl)carbonyl]phenyl]-, monohydrochloride, having a molecular weight of 535.04 and molecular formula C32H26N4O2•HCl. The structural formula of conivaptan hydrochloride is:
Conivaptan hydrochloride is a white to off-white or pale orange-white powder that is very slightly soluble in water (0.15 mg/mL at 23° C). Conivaptan hydrochloride injection is supplied as a sterile premixed solution with dextrose in a flexible plastic container.
Each container contains a clear, colorless, sterile, non-pyrogenic solution of conivaptan hydrochloride in dextrose. Each 100 mL, single-use premixed INTRAVIA Container contains 20 mg of conivaptan hydrochloride and 5 g of Dextrose Hydrous, USP. Lactic Acid, USP is added for pH adjustment to pH 3.4 to 3.8. The flexible plastic container is fabricated from a specially designed multilayer plastic (PL 2408). Solutions in contact with the plastic container leach out certain of the chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. The flexible container has a foil overwrap. Water can permeate the plastic into the overwrap, but the amount is insufficient to significantly affect the premixed solution.
What are the possible side effects of conivaptan (Vaprisol)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Tell your caregivers at once if you have a serious side effect such as:
- feeling like you might pass out;
- low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);
- trouble speaking, trouble swallowing, weakness, mood changes, muscle spasm or weakness in your arms and legs, seizure;
- pain, redness, or swelling where...
Last reviewed on RxList: 2/28/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Vaprisol Information
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