ted in less than 0.1% of patients receiving hyaluronidase. Anaphylactic-like reactions following retrobulbar block or intravenous injections have occurred, rarely.
•7 DRUG INTERACTIONS
It is recommended that appropriate references be consulted regarding physical or chemical incompatibilities before adding VITRASE to a solution containing another drug.
7.1 Incompatibilities
Furosemide, the benzodiazepines and phenytoin have been found to be incompatible with hyaluronidase.
7.2 Drug Specific Precautions
Hyaluronidase should not be used to enhance the absorption and dispersion of dopamine and/or alpha agonist drugs.
When considering the administration of any other drug with hyaluronidase, it is recommended that appropriate references first be consulted to determine the usual precautions for the use of the other drug.
7.3 Local Anesthetic Agent
When hyaluronidase is added to a local anesthetic agent, it hastens the onset of analgesia and tends to reduce the swelling caused by local infiltration, but the wider spread of the local anesthetic solution increases its absorption; this shortens its duration of action and tends to increase the incidences of systemic reaction.
7.4 Salicylates, Cortisone, ACTH, Estrogens, Antihistamines
Patients receiving large doses of salicylates, cortisone, ACTH, estrogens, or antihistamines may require larger amounts of hyaluronidase for equivalent dispersing effect, since these drugs apparently render tissues partly resistant to the action of hyaluronidase.
•8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
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 should be given to a pregnant woman only if clearly needed.
8.2 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.
8.3 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.
8.4 Pediatric Use
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 incompatibilities should be kept in mind [see Drug Interactions (7)].
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 th |
