"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Spread Of Localized Infection
Hyaluronidase should not be injected into or around infected or acutely inflamed area because of the danger of spreading to a localized infection. Hyaluronidase should not be used to reduce the swelling of bites or stings.
VITRASE® (hyaluronidase injection) should not be applied directly to the cornea.
Enzyme Inactivation With Intravenous Administration
VITRASE should not be used for intravenous injections because the enzyme is rapidly inactivated.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long-term animal studies have not been performed to assess the carcinogenic or mutagenic potential of hyaluronidase. Hyaluronidase is found in most tissues of the body.
Long-term animal studies have not been performed to assess whether hyaluronidase impaired fertility; however, it has been reported that testicular degeneration may occur from the production of organspecific antibodies against this enzyme following repeated injections.
Use In Specific Populations
Pregnancy Category C
Animal reproduction studies have not been conducted with VITRASE. Human studies on the effect of intravaginal hyaluronidase in sterility due to oligospermia indicated the hyaluronidase may have aided conception. Thus, it appears that hyaluronidase may not adversely affect fertility in females. VITRASE (hyaluronidase injection) should be given to a pregnant woman only if clearly needed.
Labor And Delivery
It is not known whether hyaluronidase is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when hyaluronidase is administered to a nursing woman.
The safety and effectiveness of VITRASE have been established in pediatric patients. Use of VITRASE in these patients is supported by evidence from adequate and well controlled studies. Clinical hydration requirements for children can be achieved through administration of subcutaneous fluids facilitated with VITRASE.
The dosage of subcutaneous fluids administered is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations. The potential for chemical or physical incompatabilities should be kept in mind [see DRUG INTERACTIONS].
The rate and volume of subcutaneous fluid administration should not exceed those employed for intravenous infusion. 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.
During subcutaneous fluid administration, special care must be taken in pediatric patients to avoid over hydration by controlling the rate and total volume of the infusion [see DOSAGE AND ADMINISTRATION].
No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/14/2015
Additional Vitrase Information
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