Conivaptan
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
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Overview
Conivaptan is a Vasopressin antagonist that is FDA approved for the {{{indicationType}}} of raising serum sodium in hospitalized patients with euvolemic and hypervolemic hyponatremia.. Common adverse reactions include hypertension, orthostatic hypotension, peripheral edema, phlebitis, injection site reaction, hypokalemia, increased thirst, constipation, diarrhea, vomiting, headache, increased frequency of urination, polyuria, fever.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
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- Dosing Information
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Off-Label Use and Dosage (Adult)
Guideline-Supported Use
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Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Conivaptan FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
- Hypovolemic Hyponatremia
- VAPRISOL is contraindicated in patients with hypovolemic hyponatremia.
- Coadministration with Potent CYP3A Inhibitors
- The coadministration of VAPRISOL with potent CYP3A inhibitors, such as ketoconazole, itraconazole, clarithromycin, ritonavir, and indinavir, is contraindicated [see Drug Interactions (7.1)].
- Anuric Patients
- In patients unable to make urine, no benefit can be expected [see Clinical Pharmacology (12.3)].
- Known Allergy to Corn or Corn Products
- Solutions containing dextrose are contraindicated in patients with known allergy to corn or corn products.
Warnings
- Hypovolemic hyponatremia
- VAPRISOL is contraindicated in patients with hypovolemic hyponatremia.
- Coadministration with Potent CYP3A Inhibitors
- The coadministration of VAPRISOL with potent CYP3A inhibitors, such as ketoconazole, itraconazole, clarithromycin, ritonavir, and indinavir, is contraindicated [see Drug Interactions (7.1)].
- Anuric Patients
- In patients unable to make urine, no benefit can be expected [see Clinical Pharmacology (12.3)].
- Known Allergy to Corn or Corn Products
- Solutions containing dextrose are contraindicated in patients with known allergy to corn or corn products.
- hyponatremia Associated with Heart Failure
- The amount of safety data on the use of VAPRISOL in patients with hypervolemic hyponatremia associated with heart failure is limited. VAPRISOL should be used to raise serum sodium in such patients only after consideration of other treatment options [see Adverse Reactions (6.1)].
- Overly Rapid Correction of Serum Sodium
- Osmotic demyelination syndrome is a risk associated with overly rapid correction of hyponatremia (i.e., > 12 mEq/L/24 hours). Osmotic demyelination results in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma or death. In susceptible patients, including those with severe malnutrition, alcoholism or advanced liver disease, use slower rates of correction. In controlled clinical trials of VAPRISOL, about 9% of patients who received VAPRISOL in doses of 20-40 mg/day IV had rises of serum sodium >12 mEq/L/24 hours, but none of these patients had evidence of osmotic demyelination or permanent neurologic sequelae. Serum sodium concentration and neurologic status should be monitored appropriately during VAPRISOL administration, and VAPRISOL administration should be discontinued if the patient develops an undesirably rapid rate of rise of serum sodium. If the serum sodium concentration continues to rise, VAPRISOL should not be resumed. If hyponatremia persists or recurs (after initial discontinuation of VAPRISOL for an undesirably rapid rate of rise of serum sodium concentration), and the patient has had no evidence of neurologic sequelae of rapid rise in serum sodium, VAPRISOL may be resumed at a reduced dose [see Dosage and Administration (2.1)].
- Coadministration of VAPRISOL and Drugs Eliminated Primarily by CYP3A Mediated Metabolism
- In clinical trials of oral conivaptan, two cases of rhabdomyolysis occurred in patients who were also receiving a CYP3A-metabolized HMG-CoA reductase inhibitor. Avoid concomitant use of VAPRISOL with drugs eliminated primarily by CYP3A-mediated metabolism. Subsequent treatment with CYP3A substrate drugs may be initiated no sooner than 1 week after the infusion of VAPRISOL is completed [see Drug Interactions (7.1)].
- Coadministration of VAPRISOL and digoxin
- Infusion Site Reactions
- Infusion site reactions are common and can include serious reactions, even with proper infusion rates [see Adverse Reactions (6.1)]. Administer VAPRISOL via large veins, and rotate the infusion site every 24 hours [see Dosage and Administration (2.1)].
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Conivaptan Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Conivaptan Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Conivaptan Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Conivaptan in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Conivaptan in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Conivaptan during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Conivaptan in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Conivaptan in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Conivaptan in geriatric settings.
Gender
There is no FDA guidance on the use of Conivaptan with respect to specific gender populations.
Race
There is no FDA guidance on the use of Conivaptan with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Conivaptan in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Conivaptan in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Conivaptan in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Conivaptan in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Conivaptan Administration in the drug label.
Monitoring
There is limited information regarding Conivaptan Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Conivaptan and IV administrations.
Overdosage
There is limited information regarding Conivaptan overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Conivaptan Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Conivaptan Mechanism of Action in the drug label.
Structure
There is limited information regarding Conivaptan Structure in the drug label.
Pharmacodynamics
There is limited information regarding Conivaptan Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Conivaptan Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Conivaptan Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Conivaptan Clinical Studies in the drug label.
How Supplied
There is limited information regarding Conivaptan How Supplied in the drug label.
Storage
There is limited information regarding Conivaptan Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Conivaptan Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Conivaptan interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Conivaptan Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Conivaptan Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.