conivaptan hydrochloride (VAPRISOL DEXTROSE IN PLASTIC CONTAINER)

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Trade Name: VAPRISOL DEXTROSE IN PLASTIC CONTAINER

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Cumberland Pharmaceuticals Inc.

Presentation: INJECTION, SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 20 mg/100mL

Storage and handling

CONIVAPTAN HYDROCHLORIDE Vasopressin Receptor Antagonists [MoA],Vasopressin Receptor Antagonist [EPC],Cytochrome P450 3A Inhibitors [MoA]

Disclaimer:

These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

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VAPRISOL is indicated to raise serum sodium in hospitalized patients with euvolemic and hypervolemic hyponatremia.n
Limitations of Use:
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.n
It has not been established that raising serum sodium with VAPRISOL provides a symptomatic benefit to patients.n
VAPRISOL is a vasopressin receptor antagonist indicated to raise serum sodium in hospitalized patients with euvolemic and hypervolemic hyponatremia ().n
Limitations of Use:n
It has not been established that raising serum sodium with VAPRISOL provides a symptomatic benefit to patients ().n

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Loading Dose: 20 mg IV administered over 30 minutes (), followed by:n
Continuous infusion: 20 mg/day over 24 hours, for 2 to 4 days ().n
Following initial day of treatment, dosage may be increased to 40 mg/day continuous infusion as needed to raise serum sodium ().n
Monitor volume status and serum sodium frequently and discontinue if patient develops hypovolemia, hypotension or undesirable rapid rate of increase in serum sodium (, ).n
Hepatic impairment: Decrease the dose in patients with moderate or severe hepatic impairment (, ).n

Intravenous injection solution: conivaptan hydrochloride 20 mg/100 mL premixed in 5% Dextrose in flexible plastic containers.n

Intravenous injection solution: conivaptan hydrochloride 20 mg/100 mL premixed in 5% Dextrose (, ).n

No data

Hypovolemic hyponatremia (). n
Coadministration with potent CYP3A inhibitors (, , ).n
Anuria: no benefit can be expected ().n

No data

Hypervolemic hyponatremia associated with heart failure
Overly rapid correction of serum sodium
Infusion site reactions

The following adverse reactions are discussed elsewhere in labeling:n
Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse event information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.n
The most common adverse reactions reported with VAPRISOL administration were infusion site reactions. In studies in patients and healthy volunteers, infusion site reactions occurred in 73% and 63% of subjects treated with VAPRISOL 20 mg/day and 40 mg/day, respectively, compared to 4% in the placebo group. Infusion site reactions were the most common type of adverse event leading to discontinuation of VAPRISOL. Discontinuations from treatment due to infusion site reactions were more common among VAPRISOL-treated patients (3%) than among placebo-treated patients (0%). Some serious infusion site reactions did occur .n
The adverse reactions presented in are derived from 72 healthy volunteers and 243 patients with euvolemic or hypervolemic hyponatremia who received VAPRISOL 20 mg IV as a loading dose followed by 40 mg/day IV for 2 to 4 days, from 37 patients with euvolemic or hypervolemic hyponatremia who received VAPRISOL 20 mg IV as a loading dose followed by 20 mg/day IV for 2 to 4 days in an open-label study, and from 40 healthy volunteers and 29 patients with euvolemic or hypervolemic hyponatremia who received placebo. The adverse reactions occurred in at least 5% of patients treated with VAPRISOL and at a higher incidence for VAPRISOL-treated patients than for placebo-treated patients.n
Although a dose of 80 mg/day of VAPRISOL was also studied, it was associated with a higher incidence of infusion site reactions and a higher rate of discontinuation for adverse events than was the 40 mg/day VAPRISOL dose. The maximum recommended daily dose of VAPRISOL (after the loading dose) is 40 mg/day.n
Most common adverse reactions (incidence u2265 10%) are infusion site reactions (including phlebitis), pyrexia, hypokalemia, headache and orthostatic hypotension ().n
To report SUSPECTED ADVERSE REACTIONS, contact Cumberland Pharmaceuticals Inc. at 1-887-484-2700 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Potent CYP3A inhibitors may increase the exposure of conivaptan and are contraindicated (, ).n
Generally avoid CYP3A substrates (, ).n
Exposure to coadministered digoxin may be increased and digoxin levels should be monitored ().n

No data

Lactation: Breastfeeding not recommended ().n
Pediatric Use: There are no studies ().n
Severe renal impairment: VAPRISOL is not recommended (, ).n

Although no data on overdosage in humans are available, VAPRISOL has been administered as a 20 mg loading dose on Day 1 followed by continuous infusion of 80u00a0mg/day for 4 days in hyponatremia patients and up to 120 mg/day for 2 days in CHF patients. No new toxicities were identified at these higher doses, but adverse events related to the pharmacologic activity of VAPRISOL, e.g. hypotension and thirst, occurred more frequently at these higher doses.n
In case of overdose, based on expected exaggerated pharmacological activity, symptomatic treatment with frequent monitoring of vital signs and close observation of the patient is recommended.n

Conivaptan hydrochloride is chemically [1,1'-biphenyl]-2-carboxamide, -[4-[(4,5-dihydro-2-methylimidazo[4,5-][1]benzazepin-6(1)-yl)carbonyl]phenyl]-, monohydrochloride, having a molecular weight of 535.04 and molecular formula CHNOu2219HCl. The structural formula of conivaptan hydrochloride is:n
Conivaptan hydrochloride is a white to off-white or pale orange-white powder that is very slightly soluble in water (0.15u00a0mg/mL at 23u00b0u00a0C). Conivaptan hydrochloride injection is supplied as a sterile premixed solution with dextrose in a flexible plastic container.n
Each container contains a clear, colorless, sterile, non-pyrogenic solution of conivaptan hydrochloride in dextrose injection for intravenous use. 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 affect the premixed solution significantly.n

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Standard lifetime (104 week) carcinogenicity bioassays were conducted in mice and rats. Male and female mice were given oral doses of conivaptan hydrochloride up to 30 mg/kg/day and 10 mg/kg/day, respectively, by gavage. Male and female rats were given oral doses of up to 10 mg/kg/day and 30 mg/kg/day, respectively, by gavage. There was no increased incidence of tumors associated with exposure to conivaptan in either species. The 30 mg/kg/day dosage regimen in male mice and female rats was shown to result in a systemic exposure (AUC) about twice the human systemic exposure from an IV bolus of 20 mg on day 1 followed by IV infusion of 40 mg/day for 3 days. The 10 mg/kg/day dosage regimen in female mice and male rats was shown to result in about one-fourth and one-half the human therapeutic exposure, respectively.n
Conivaptan was not genotoxic in the bacterial reverse mutation assay, the human peripheral blood lymphocyte chromosomal aberration assay, or rat micronucleus assay.n
Fertility of male rats treated with conivaptan hydrochloride by IV bolus doses of up to 2.5 mg/kg/day for the 4 weeks preceding mating and throughout the mating period was unaffected. However, when female rats were given IV bolus conivaptan from 15 days before mating through gestation day 7, there was prolonged diestrus, decreased fertility (decreased numbers of corpora lutea and implantations) and increased post-implantation loss at 2.5 mg/kg/day (systemic exposure less than human exposure at the therapeutic dose).n

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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.n
VAPRISOL in INTRAVIA Plastic Containers should be stored at 25u00b0C (77u00b0F); however, brief exposure up to 40u00b0C (104u00b0F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light until ready to use.n

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.n
Ask patients about what other medications they are currently taking with VAPRISOL, including over-the-counter medications.n
Lactation
Advise women not to breastfeed during treatment with VAPRISOL n
Marketed by:n Nashville TN 37203n
VAPRISOL is a registered trademark of Cumberland Pharmaceuticals Inc.INTRAVIA is a registered trademark of Baxter International Inc.n
US Patent Number 5,723,606n
07-19-73-925n

Principal Display Panel - Box Label
NDC 66220-160-10n
Vaprisoln
(conivaptan hydrochloride) injectionn
Premixed in 5% Dextrosen
20 mg/100 mL
100 mL
STERILE NONPYROGENIC
SINGLE-DOSE INTRAVIA CONTAINER

Principal Display Panel - Pouch Label
100 mL
2J1451
12B017-VAPttttttn
NDC 66220-160-10ttttttn
Vaprisoln
INJECTIONn
PREMIXED IN 5% DEXTROSEn
20 mg/100 mL (0.2 mg per mL)n
SINGLE-DOSE
INTRAVIA CONTAINERtSTERILE NONPYROGENIC

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of conivaptan hydrochloride (VAPRISOL DEXTROSE IN PLASTIC CONTAINER) which is also known as VAPRISOL DEXTROSE IN PLASTIC CONTAINER and Manufactured by Cumberland Pharmaceuticals Inc.. It is available in strength of 20 mg/100mL.

conivaptan hydrochloride (VAPRISOL DEXTROSE IN PLASTIC CONTAINER) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.