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Amphadase

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Amphadase

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Spread of Localized Infection

Hyaluronidase should not be injected into or around an infected or acutely inflamed area because of the danger of spreading a localized infection.

Hyaluronidase should not be used to reduce the swelling of bites or stings.

Ocular Damage

Hyaluronidase should not be applied directly to the cornea.

Enzyme Inactivation with Intravenous Administration

Hyaluronidase should not be used for intravenous injections because the enzyme is rapidly inactivated.

Nonclinical Toxicology

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 with the production of organ-specific antibodies against this enzyme following repeated injections. Human studies on the effect of intravaginal hyaluronidase in sterility due to oligospermia indicated that hyaluronidase may have aided conception. Thus, it appears that hyaluronidase may not adversely affect fertility in females.

Use In Specific Populations

Pregnancy

Pregnancy Category C

No adequate and well controlled studies have been conducted with Amphadase® in pregnant women. No adequate and well controlled animal studies have been conducted with Amphadase® to determine reproductive effects. Amphadase® should be used during pregnancy only if clearly needed.

Labor and Delivery

Administration of hyaluronidase during labor was reported to cause no complications: no increase in blood loss or differences in cervical trauma were observed.

Nursing Mothers

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.

Pediatric Use

The safety and effectiveness of Amphadase have been established in pediatric patients. Use of Amphadase 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 Amphadase.

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 incompatibilities 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].

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.

Last reviewed on RxList: 7/5/2012
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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