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Important Safety Information Full Prescribing Information

This information is intended for US healthcare professionals

Acute, Severe, Symptomatic Hyponatremia

32-year-old male was brought to the ED by friends with generalized tonic-clonic seizures. His serum sodium on admission was 106 mEq/L.

Neurological: tonic-clonic seizures, pupils reactive bilaterally

Emergency Department Laboratory Values
Serum [Na⁺] (normal: 135-145 mEq/L)	106 mEq/L
Serum [K⁺] (normal: 4.0-4.7 mEq/L)	4.2 mEq/L
Cl (normal: 96-106 mEq/L)	84 mEq/L
CO₂ (normal: 20-29 mmol/L)	25 mmol/L
BUN (normal: 10-20 mg/dL)	10 mg/dL
Creatinine (normal: 0.6-1.2 mg/dL)	0.6 mg/dL
Serum osmolality	214 mOsm/kg

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Learn more about the incidence and impact of hyponatremia.

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Learn more about how Vaprisol raises serum [Na⁺] in a prompt but controlled fashion.

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Vaprisol is indicated for the treatment of euvolemic and hypervolemic hyponatremia in hospitalized patients
Vaprisol is not indicated for the treatment of congestive heart failure. It should only be used for the treatment of hyponatremia in patients with underlying heart failure when the expected benefit of raising serum sodium outweighs the increased risk of adverse events

Vaprisol is contraindicated in patients with hypovolemic hyponatremia. In addition, coadministration of Vaprisol with potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, clarithromycin, ritonavir, and indinavir, is contraindicated
Serum sodium, volume, and neurological status must be monitored frequently because Vaprisol potentially can cause overly rapid correction of sodium leading to serious sequelae
The use of Vaprisol in patients with hepatic impairment (including ascites, cirrhosis, or portal hypertension) or renal impairment has not been systematically evaluated. Use caution when administering Vaprisol to these patients
The most common adverse reactions reported were infusion site reactions (incidence of 73% and 63% for 20 mg/day and 40 mg/day, respectively) which were also the most common type of adverse reaction 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%). Other common adverse reactions were headaches (8%, 10%), hypokalemia (22%, 10%), orthostatic hypotension (14%, 6%), and pyrexia (11%, 5%) for Vaprisol 20 mg/day and 40 mg/day, respectively