THIS INFORMATION IS INTENDED FOR US HEALTHCARE PROFESSIONALS
ABOUT CUMBERLAND  |  IMPORTANT SAFETY INFORMATION  |  FULL PRESCRIBING INFORMATION  |  NEWS
logo
register

Safety Profile

Accurate premixed IV formulation

  • In clinical studies of Vaprisol, the adverse event profile in elderly patients was similar to that seen in the general population1
    • In clinical studies of IV Vaprisol, 89% (20 mg/day regimen) and 60% (40 mg/day regimen) of participants were at least 65 years of age and 60% (20 mg/day regimen) and 40% (40 mg/day regimen) were at least 75 years of age
Most Common Adverse Events With Vaprisol*% Placebo
[n=69]
% Vaprisol 20 mg
[n=37]
% Vaprisol 40 mg
[n=315]
Anemia NOS 3 5 6
Atrial fibrillation 0 5 2
Confusional state 3 0 5
Constipation 3 8 6
Diarrhea NOS 0 0 7
Edema peripheral 1 3 8
ECG ST segment depression 0 5 0
Headache 3 8 10
Hypertension NOS 0 8 6
Hypokalemia 3 22 10
Hypomagnesemia 0 5 2
Hyponatremia 1 8 6
Hypotension NOS 3 8 5
Infusion site erythema 0 0 6
Infusion site pain 1 0 5
Infusion site phlebitis 1 51 32
Infusion site reaction 0 22 19
Insomnia 0 5 4
Nausea 4 3 5
Orthostatic hypotension 0 14 6
Pharyngolaryngeal pain 4 5 1
Pneumonia NOS 0 5 2
Postprocedural diarrhea 0 5 0
Pruritus 0 5 1
Pyrexia 0 11 5
Thirst 1 3 6
Urinary tract infection NOS 3 5 4
Vomiting NOS 0 5 7
ECG = electrocardiogram.
*Incidence ≥5% and higher than placebo.
†Not otherwise specified.


REFERENCE: 1. Vaprisol Prescribing Information. Cumberland Pharmaceuticals Inc.