Vaprisol

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Geriatric Patient With Euvolemic Hyponatremia

Diagnosis

Euvolemic hyponatremia secondary to pneumonia in an elderly patient*

Why VAPRISOL was chosen for treatment

In this patient with euvolemic hyponatremia and a history of hypertension, VAPRISOL was selected as treatment to raise serum sodium and to try to avoid excess sodium and fluid overload. Fluid restriction alone might suffice to treat the hyponatremia but it can take up to a week to manage the patient’s water/sodium balance.

Initial Presentation

The patient is an 82-year-old white male admitted to the hospital from a nursing home with 2 to 3 days of increasing confusion and a cough.

Medical History

  • Hypertension
  • Gout

Medications

  • Hydrochlorothiazide
  • Allopurinol
  • Propanolol

Exam Findings

Vital Signs BP: 126/62 mm Hg, HR: 90 bpm without orthostatic changes, temperature: 100.2° F, RR: 14
Mental Status Patient was oriented to person, place, and time but appeared confused about the timelines of recent events
Lungs Rhonchi and slight wheezing noted on auscultation of left lower lobe
EKG Normal sinus rhythm with evidence of left ventricular hypertrophy
Chest X-ray Infiltrate noted in left lower lobe. No evidence of pleural effusion or increased pulmonary vasculature
Other No pedal edema

Patient’s progression from admission through follow-up at day 10

  VITAL SIGNS LAB VALUES  
  BP
(mm Hg)
HR
(bpm)
Weight
(lb)
Urine Output
(cc)
Urine Osmolality
(mOsm/kg-H20)
Urine
Na+
(mEq/L)
Serum
Na+
(mEq/L)
NOTES
Upon
Admission
126/62 90 180 655 57 124 Broad spectrum antibiotics started. A loading dose of VAPRISOL 20-mg IV administered over 30 minutes was followed by a 20-mg continuous infusion administered over 24 hours
Day 1 130/60 76 179 2400 128 20-mg VAPRISOL IV infusion administered over 24 hours
Day 2 132/64 70 178 1700 164 9 132 20-mg VAPRISOL IV infusion administered over 24 hours. Patient switched to oral antibiotics based on sputum culture results
Day 3 136/68 66 178 1200 103 10 136 Fluid restriction 1 L/day; discharged to nursing home
Follow-up
Day 10
136/70 64 178 138 Patient no longer restricting fluids

*In clinical studies of VAPRISOL, the adverse event profile in elderly patients was similar to that seen in the general population.1

REFERENCE: 1. Vaprisol® [Package Insert] Cumberland Pharmaceuticals Inc. Nashville, TN 2016

Indication: VAPRISOL is indicated to raise serum sodium in hospitalized patients with euvolemic and hypervolemic hyponatremia.
Important Limitations: 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. It has not been established that raising serum sodium with VAPRISOL provides a symptomatic benefit to patients.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
VAPRISOL is contraindicated in patients with hypovolemic hyponatremia. The coadministration of VAPRISOL with potent CYP3A inhibitors, such as ketoconazole, itraconazole, clarithromycin, ritonavir, and indinavir, is contraindicated. In addition, no benefit can be expected in patients unable to make urine.

WARNINGS & PRECAUTIONS
Hyponatremia associated with heart failure: Safety data on the use of VAPRISOL in these patients are limited. Consider other treatment options.
Overly rapid correction of serum sodium: Monitor serum sodium, volume and neurologic status and if the patient develops an undesirably rapid rate of rise of serum, VAPRISOL should be discontinued. If serum sodium concentration continues to rise, VAPRISOL should not be resumed. Serious neurologic sequelae, including osmotic demyelination syndrome, can result from over rapid correction of serum sodium. In susceptible patients, including those with severe malnutrition, alcoholism or advanced liver disease, slower rates of correction should be used.
Hypovolemia or Hypotension: For patients who develop hypovolemia or hypotension while receiving VAPRISOL, VAPRISOL should be discontinued, and volume status and vital signs should be monitored.
Infusion site reactions: Serious reactions have occurred. Administer through large veins and change infusion site every 24 hours.

ADVERSE REACTIONS
The most common adverse reactions (incidence ≥10%) reported in clinical trials were infusion site reactions (including phlebitis), pyrexia, hypokalemia, headache and orthostatic hypotension.

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

USE IN SPECIAL POPULATIONS
Use in Patients with Hepatic Impairment
In patients with moderate to severe hepatic impairment, initiate VAPRISOL with a loading dose of 10 mg over 30 minutes followed by 10 mg/day as a continuous infusion for 2 to 4 days. If no rise in serum sodium, VAPRISOL may be titrated upward to 20 mg/day.