•HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use VITRASE® (hyaluronidase injection) Ovine, 200 USP/mL safely and effectively. See full prescribing information for VITRASE® (hyaluronidase injection) Ovine, 200 USP Units/mL.
VITRASE (hyaluronidase injection) Ovine, 200 USP Units/mL
Initial U.S. Approval: 2004
RECENT MAJOR CHANGES
Dosage and Administration (2) - 03/2012
Contraindications (4) – 03/2012
INDICATIONS AND USAGE
•VITRASE is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration (1.1)
•to increase the dispersion and absorption of other injected drugs (1.2)
•in subcutaneous urography for improving resorption of radiopaque agents (1.3)
DOSAGE AND ADMINISTRATION
Draw the desired amount of VITRASE into the syringe to obtain target hyaluronidase activity (USP Units) according to table. (2)
•Subcutaneous Fluid Administration: Inject 200 Units of VITRASE prior to clysis. It will facilitate absorption of 1,000 mL or more of solution. The dosage of subcutaneous fluids administered is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations. The rate and volume of subcutaneous fluid administration should not exceed those employed for intravenous infusion. (2.1)
•Increasing absorption and dispersion of injected drugs: Add 50 – 300 Units (most typically 150 units) of VITRASE to the injection solution. (2.2)
•Subcutaneous Urography: With the patient prone, inject 75 Units of VITRASE subcutaneously over each scapula, followed by injection of the contrast medium at the same sites. (2.3)
DOSAGE FORMS AND STRENGTHS
Ovine hyaluronidase: 200 USP units/mL single use vials (3)
CONTRAINDICATIONS
Hypersensitivity (4)
WARNINGS AND PRECAUTIONS
•Spread of Localized Infection (5.1)
•Ocular Damage (5.2)
•Enzyme Inactivation with Intravenous Administration (5.3)
ADVERSE REACTIONS
Allergic and anaphylactic-like reactions have been reported, rarely (6). To report SUSPECTED ADVERSE REACTIONS, contact ISTA Pharmaceuticals, Inc. at 1-877-788-2020, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
•Furosemide, the benzodiazepines and phenytoin are incompatible with hyaluronidase. (7.1)
•Hyaluronidase should not be used to enhance the absorption and dispersion of dopamine and/or alpha agonist drugs. (7.2)
•Local anesthetics: Hyaulronidase hastens onset and shortens duration of effect, increases incidence of systemic reactions. (7.3)
•Large doses of salicylates, cortisone, ACTH, estrogens or antihistamines may require larger amounts of hyaluronidase for equivalent dispersing effect. (7.4)
USE IN SPECIFIC POPULATIONS
Pediatric Use: The dosage of subcutaneous fluids administered is dependent upon the age, weight and clinical condition of the patient. For premature infants or during the neonatal period, the daily dosage should not exceed 25 mL/kg of body weight, and the rate of administration should not be greater than 2 mL per minute. Special care must be taken in pediatric patients to avoid over hydration by controlling the rate and total volume of the infusion (2.1, 8.4).
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 5/2012
•FULL PRESCRIBING INFORMATION: CONTENTS*
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