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Vaprisol

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Vaprisol

Vaprisol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Vaprisol (conivaptan hydrochloride) is used to treat hyponatremia (low sodium levels). It improves urine flow without causing the body to lose too much sodium as you urinate. It reduces the level of a hormone that regulates the balance of water and salt (sodium) in the body. Common side effects include mild fever, headache, insomnia, painful white patches in the mouth or throat, or mild thirst and increased urination.

Vaprisol is for use in hospitalized patients only. Treatment starts with a loading dose of 20 mg IV administered over 30 minutes, followed by 20 mg administered in a continuous intravenous infusion over 24 hours. After the initial day of treatment, it is administered for an additional 1 to 3 days in a continuous infusion of 20 mg/day. Other drugs may interact with Vaprisol. Tell your doctor all medications and supplements you use. During pregnancy, Vaprisol should be used only if prescribed. It is unknown if it will be harmful to a fetus. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Vaprisol (conivaptan hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Vaprisol in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

  • feeling like you might pass out;
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);
  • trouble speaking, trouble swallowing, weakness, mood changes, muscle spasm or weakness in your arms and legs, seizure;
  • pain, redness, or swelling where the IV needle is placed;
  • swelling, rapid weight gain; or
  • pain or burning when you urinate.

Less serious side effects may include:

  • mild fever;
  • headache;
  • diarrhea; or
  • vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Vaprisol (Conivaptan Hcl Injection) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Vaprisol FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed elsewhere in labeling:

  • Osmotic demyelination syndrome [see WARNINGS AND PRECAUTIONS]
  • Infusion site reactions [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

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.

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 [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].

The adverse reactions presented in Table 1 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.

Table 1: VAPRISOL Injection: Adverse Reactions Occurring in ≥ 5% of Patients or Healthy Volunteers and VAPRISOL Incidence > Placebo Incidence Hyponatremia and Healthy Volunteer Studies

Term Placebo
(N=69)
N (%)
20 mg
(N=37)
N (%)
40 mg
(N=315)
N (%)
Blood and lymphatic system disorders
  Anemia NOS 2 ( 3%) 2 ( 5%) 18 ( 6%)
Cardiac disorders
  Atrial fibrillation 0 ( 0%) 2 ( 5%) 7 ( 2%)
Gastrointestinal disorders
  Constipation 2 ( 3%) 3 ( 8%) 20 ( 6%)
  Diarrhea NOS 0 ( 0%) 0 ( 0%) 23 ( 7%)
  Nausea 3 ( 4%) 1 ( 3%) 17 ( 5%)
  Vomiting NOS 0 ( 0%) 2 ( 5%) 23 ( 7%)
General disorders and administration site conditions
  Edema peripheral 1 ( 1%) 1 ( 3%) 24 ( 8%)
  Infusion site erythema 0 ( 0%) 0 ( 0%) 18 ( 6%)
  Infusion site pain 1 ( 1%) 0 ( 0%) 16 ( 5%)
  Infusion site phlebitis 1 ( 1%) 19 (51%) 102 (32%)
  Infusion site reaction 0 ( 0%) 8 (22%) 61 (19%)
  Pyrexia 0 ( 0%) 4 (11%) 15 ( 5%)
  Thirst 1 ( 1%) 1 ( 3%) 19 ( 6%)
Infections and infestations
  Pneumonia NOS 0 ( 0%) 2 ( 5%) 7 ( 2%)
  Urinary tract infection NOS 2 ( 3%) 2 ( 5%) 14 ( 4%)
Injury, poisoning and procedural complications
  Post procedural diarrhea 0 ( 0%) 2 ( 5%) 0 ( 0%)
Investigations
  Electrocardiogram ST segment depression 0 ( 0%) 2 ( 5%) 0 ( 0%)
Metabolism and nutrition disorders
  Hypokalemia 2 ( 3%) 8 (22%) 30 ( 10%)
  Hypomagnesemia 0 ( 0%) 2 ( 5%) 6 ( 2%)
  Hyponatremia 1 ( 1%) 3 ( 8%) 20 ( 6%)
Nervous system disorders
  Headache 2 ( 3%) 3 ( 8%) 32 (10%)
Psychiatric disorders
  Confusional state 2 ( 3%) 0 ( 0%) 16 ( 5%)
  Insomnia 0 ( 0%) 2 ( 5%) 12 ( 4%)
Respiratory, thoracic and mediastinal disorders
  Pharyngolaryngeal pain 3 ( 4%) 2 ( 5%) 3 ( 1%)
Skin and subcutaneous tissue disorders
  Pruritus 0 ( 0%) 2 ( 5%) 2 ( 1%)
Vascular disorders
  Hypertension NOS 0 ( 0%) 3 ( 8%) 20 ( 6%)
  Hypotension NOS 2 ( 3%) 3 ( 8%) 16 ( 5%)
  Orthostatic hypotension 0 ( 0%) 5 (14%) 18 ( 6%)
Adapted from MedDRA version 6.0

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.

Heart failure with hypervolemic hyponatremia

In clinical trials where VAPRISOL was administered to 79 hypervolemic hyponatremic patients with underlying heart failure and intravenous placebo administered to 10 patients, adverse cardiac failure events, atrial dysrhythmias, and sepsis occurred more frequently among patients treated with VAPRISOL (32%, 5% and 8% respectively) than among patients treated with placebo (20%, 0% and 0% respectively) [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Vaprisol (Conivaptan Hcl Injection) »

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