conivaptan (Rx)

Brand and Other Names:Vaprisol
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

premixed injectable solution

  • 5mg/mL (20mg/100mL D5W)
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Hyponatremia

Indicated to raise serum sodium in hospitalized patients with euvolemic and hypervolemic hyponatremia

Load: 20 mg IV infusion over 30 minutes; and THEN

20 mg IV as continuous infusion over 24-hour period for 2-4 days

After initial day of treatment, may increase to 40 mg/day if necessary

Monitor serum sodium and volume status frequently; a significant increase in serum sodium (>12 mEq/L/24 hours) may result in serious neurologic effects

Renal Impairment

CrCl > 60 mL/minute: No dosage adjustment required

CrCl 30-60 mL/minute: 10 mg infused over 30 minutes; follow by continuous infusion of 10 mg over 24 hr; may increase to maximum 20 mg over 24 hr if sodium levels do not increase as necessary; duration of therapy not to exceed 4 days

Severe (CrCl <30 mL/min): Not recommended

Hepatic Impairment

Moderate: Initiate with loading dose of 10 mg IV infused over 30 minutes, followed by 10 mg/day as a continuous infusion (ie, over 24 hr) for 2-4 days; may titrate up to 20 mg/day if serum sodium is not rising at desired rate

Safety and efficacy not established

Hyponatremia

Indicated to raise serum sodium in hospitalized patients with euvolemic and hypervolemic hyponatremia

Load: 20 mg IV infusion over 30 minutes; and THEN

20 mg IV as continuous infusion over 24-hour period for 2-4 days

After initial day of treatment, may increase to 40 mg/day if necessary

Monitor serum sodium and volume status frequently; a significant increase in serum sodium (>12 mEq/L/24 hours) may result in serious neurologic effects

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Interactions

Interaction Checker

and conivaptan

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Headache (12%)

            Infusion site phlebitis (15.8%)

            Infusion site reactions (20.2%)

            1-10%

            Anemia

            Atrial fibrillation

            Hypertension

            Hypotension

            Confusion

            Insomnia

            Dehydration

            Dry mouth

            Thirst

            Constipation

            Diarrhea

            Nausea

            Vomiting

            Erythema

            Hematuria

            Pollakiuria

            Polyuria

            UTI

            Hyperglycemia

            Hypoglycemia hypokalemia

            Hypomagnesemia

            Hyponatremia

            Oral candidiasis

            Pain

            Peripheral edema

            Phlebitis

            Pneumonia

            Pyrexia

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            Warnings

            Contraindications

            Hypersensitivity

            Hypovolemic hyponatremia

            Anuria; no benefit can be expected in patients unable to make urine

            Cautions

            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

            Safety data with hypervolemic hyponatremia associated with heart failure is limited; restrict use to raise serum sodium in such patients only after consideration of other treatment options

            Discontinue in patients who develop hypovolemia or hypotension, and monitor volume status and vital signs; once the patient is again euvolemic and is no longer hypotensive, resume therapy at a reduced dose if patient remains hyponatremic

            Infusion site reactions are common and can include serious reactions, even with proper infusion rates; administer via large veins, and rotate infusion site q24hr

            Discontinue if undesirably rapid rise in serum Na (>12 mEq/L/day)

            Osmotic demyelination syndrome: Associated with overly rapid correction of hyponatremia (ie, > 12 mEq/L/day) and results in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma, or death; susceptible patients include those with severe malnutrition, alcoholism, or advanced liver disease, use slower rates of correction

            Hepatic/renal impairment

            Conivaptan inhibits CYP3A4; rhabdomyolysis occurred in patients who were also receiving a CYP3A-metabolized HMG-CoA reductase inhibitor; avoid concomitant use with drugs eliminated primarily by CYP3A-mediated metabolism; subsequent treatment with CYP3A substrate drugs may be initiated no sooner than 1 week after conivaptan infusion completed

            Coadministration of digoxin with oral conivaptan resulted in a 1.8- and 1.4-fold increase in digoxin Cmax and AUC, respectively; monitor digoxin levels

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            Pregnancy & Lactation

            Pregnancy: There are no available data in pregnant women to inform a drug-associated risk for major birth defects and miscarriage

            Lactation: No information regarding conivaptan or metabolites in human milk, effects of conivaptan on breastfed infant, or effects of conivaptan on milk production; because of potential for serious adverse reactions, including electrolyte abnormalities (e.g., hypernatremia), hypotension, and volume depletion in breastfed infants, advise a woman not to breastfeed during treatment with conivaptan

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Arginine vasopressin receptor antagonist; antidiuretic action is mediated through antagonism of vasopressin at the V2 receptor, which regulates water and electrolyte balance at the collecting ducts in the kidney. Antagonism of the V2 receptor generates the excretion of free water (without electrolytes). This results in increased urine output and subsequent restoration of normal serum sodium concentrations

            Pharmacokinetics

            Protein Bound: 99%

            Metabolized through CYP3A4; produces four metabolites with limited activity

            Half-Life elimination: 5-8 hr

            Excretion: 83% feces; 12% urine

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            Administration

            IV Incompatibilities

            Solution: LR, NS

            Do not infuse with any other drug

            IV Compatibilities

            Solution: Dextrose 5% (D5W)

            Y-site: Physically and chemically compatible with 0.9% NaCl (NS) for up to 48 hr when coadministered at a flow rate of 4.2 mL/hr for conivaptan and either 2.1 mL/hr or 6.3 mL/hr for NS

            IV Administration

            Loading dose: Over 30 min

            Continuous infusion: Over 24 hr

            Storage

            Store premixed injectable solution at room temperature

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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