DRUGS & SUPPLEMENTS
1 INDICATIONS AND USAGE
1.1 Absorption and Dispersion of Injected Drugs
Hylase (hyaluronidase injection) is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs.
Hylase is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration.
1.3 Subcutaneous Urography
Hylase is indicated as an adjuvant in subcutaneous urography for improving resorption of radiopaque.
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
Do not administer Hylase intravenously because Hylase is enzyme is rapidly inactivated with intravenous administration.
Hylase may be administered for infiltration use, interstitial use, intramuscular use, intraocular use, retrobulbar use, soft tissue use and subcutaneous use.
Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever the solution and container permit.
Always use aseptic precautions.
2.2 Absorption and Dispersion of Subcutaneously Injected Drugs
Absorption and dispersion of other injected drugs may be enhanced by adding 50 to 300 Units, most typically 150 Units of Hylase, to the injection solution.
It is recommended that appropriate references be consulted regarding physical or chemical incompatibilities before adding Hylase to a solution containing another drug.
Insert needle with aseptic precautions. With tip lying free and movable between skin and muscle, begin clysis; fluid should start in readily without pain or lump. Then inject Hylase into rubber tubing close to needle.
An alternate method is to inject Hylase under skin prior to clysis. 150 Units will facilitate absorption of 1,000 mL or more of solution. As with all parenteral fluid therapy, observe effect closely, with same precautions for restoring fluid and electrolyte balance as in intravenous injections. The dose, the rate of injection, and the type of solution (saline, glucose, Ringer's, etc.) must be adjusted carefully to the individual patient. When solutions devoid of inorganic electrolytes are given by hypodermoclysis, hypovolemia may occur. This may be prevented by using solutions containing adequate amounts of inorganic electrolytes and/or controlling the volume and speed of administration.
Hylase may be added to small volumes of solution (up to 200 mL), such as small clysis for infants or solutions of drugs for subcutaneous injection. For infants and children less than 3 years old, the volume of a single clysis should be limited to 200 mL; and in premature infants or during the neonatal period, the daily dosage should not exceed 25 mL/kg of body weight; the rate of administration should not be greater than 2 mL per minute. For older patients, the rate and volume of administration should not exceed those employed for intravenous infusion.
2.4 Subcutaneous Urography
The subcutaneous route of administration of urographic contrast media is indicated when intravenous administration cannot be successfully accomplished, particularly in infants and small children. With the patient prone, 75 Units of Hylase (hyaluronidase injection) is injected subcutaneously over each scapula, followed by injection of the contrast medium at the same sites.
3 DOSAGE FORMS AND STRENGTHS
Injection: 150 USP Units/mL single dose vials.
Injection: 150 USP Units/mL in single-dose vials (3)
Hylase contraindicated in patients with known hypersensitivity to Hylase or any other ingredient in the formulation. A preliminary skin test for hypersensitivity to Hylase can be performed. The skin test is made by an intradermal injection of approximately 0.02 mL (3 Units) of a 150 Unit/mL solution [see Dosage and Administration (2)]. A positive reaction consists of a wheal with pseudopods appearing within five minutes and persisting for 20 to 30 minutes and accompanied by localized itching. Transient vasodilation at the site of the test, i.e., erythema, is not a positive reaction.
Discontinue Hylase if sensitization occurs.
5 WARNINGS AND PRECAUTIONS
5.1 Spread of Localized Injection
Hylase should not be injected into or around an infected or acutely inflamed area because of the danger of spreading a localized infection.
Hylase should not be used to reduce the swelling of bites or stings.
5.2 Ocular Damage
Hylase should not be applied directly to the cornea.
6 ADVERSE REACTIONS
The most frequently reported adverse experiences have been local injection site reactions.
Hylase has been reported to enhance the adverse events associated with co-administered drug products. Edema has been reported most frequently in association with hypodermoclysis.
Allergic reactions (urticaria, angioedema) have been reported in less than 0.1% of patients receiving Hylase. Anaphylactic-like reactions following retrobulbar block or intravenous injections have occurred, rarely.
The most frequently reported adverse reactions have been local injections site reactions. Allergic reactions (urticarial, angioedema) anaphylactic-like reactions have been reported, rarely. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Akorn, Inc. at 1-800-932-5676, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
7 DRUG INTERACTIONS
It is recommended that appropriate references be consulted regarding physical or chemical incompatibilities before adding Hylase to a solution containing another drug.
Furosemide, the benzodiazepines and phenytoin have been found to be incompatible with Hylase.
7.2 Drug-Specific Precautions
Hylase 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 Hylase, it is recommended that appropriate references first be consulted to determine the usual precautions for the use of the other drug.
7.3 Local Anesthetics
When Hylase 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 incidence of systemic reaction.
7.4 Salicylates, Cortisone, ACTH, Estrogens or Antihistamines
Patients receiving large doses of salicylates, cortisone, ACTH, estrogens or antihistamines may require larger amounts of Hylase for equivalent dispersing effect, since these drugs apparently render tissues partly resistant to the action of Hylase.
8 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
No adequate and well controlled animal studies have been conducted with Hylase to determine reproductive effects. Hylase should be used during pregnancy only if clearly needed.
8.2 Labor and Delivery
Administration of Hylase during labor was reported to cause no complications: no increase in blood loss or differences in cervical trauma were observed. It is not known whether Hylase has an effect on the later growth, development, and functional maturation of the infant.
8.3 Nursing Mothers
It is not known whether Hylase is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Hylase is administered to a nursing woman.
8.4 Pediatric Use
Hylase may be added to small volumes of solution, such as small clysis for infants or solutions of drugs for subcutaneous injection. The potential for chemical or physical incompatibilities should be kept in mind [see Dosage and Administration (2)].
For infants and children less than 3 years old, the volume of a single clysis should be limited to 200 mL; and in premature infants or during the neonatal period, the daily dosage should not exceed 25 mL/kg of body weight; the rate of administration should not be greater than 2 mL per minute. For older patients, the rate and volume of administration should not exceed those employed for intravenous infusion.
During hypodermoclysis, special care must be taken in pediatric patients to avoid overhydration by controlling the rate and total volume of the clysis [see Dosage and Administration (2.1)].
8.5 Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.
Symptoms of toxicity consist of local edema or urticaria, erythema, chills, nausea, vomiting, dizziness, tachycardia, and hypotension. The enzyme should be discontinued and supportive measures initiated immediately.
Hylase (hyaluronidase injection) is a preparation of purified bovine testicular Hylase, a protein enzyme. The exact chemical structure of this enzyme is unknown.
Hylase (hyaluronidase injection) is supplied as sterile, colorless, odorless, ready for use solution. Each vial contains 150 USP units of Hylase per mL calcium chloride (0.4 mg), edetate disodium (1 mg), sodium chloride (8.5 mg), monobasic sodium phosphate buffer, sodium hydroxide to adjust the pH, and sterile water.
Hylase has an approximate pH of 6.9 and an osmolality of 275 to 305 mOsm.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Hylase is a spreading or diffusing substance which modifies the permeability of connective tissue through the hydrolysis of hyaluronic acid, a polysaccharide found in the intercellular ground substance of connective tissue, and of certain specialized tissues, such as the umbilical cord and vitreous humor. Hyaluronic acid is also present in the capsules of type A and C hemolytic streptococci. Hylase hydrolyzes hyaluronic acid by splitting the glucosaminidic bond between C1 of the glucosamine moiety and C4 of glucuronic acid. This temporarily decreases the viscosity of the cellular cement and promotes diffusion of injected fluids or of localized transudates or exudates, thus facilitating their absorption.
Hylase cleaves glycosidic bonds of hyaluronic acid and, to a variable degree, some other acid mucopolysaccharides of the connective tissue. The activity is measured in vitro by monitoring the decrease in the amount of an insoluble serum albumin-hyaluronic acid complex as the enzyme cleaves the hyaluronic acid component.
When no spreading factor is present, material injected subcutaneously spreads very slowly, but Hylase causes rapid spreading, provided local interstitial pressure is adequate to furnish the necessary mechanical impulse. Such an impulse is normally initiated by injected solutions.
The rate of diffusion is proportionate to the amount of enzyme, and the extent is proportionate to the volume of solution.
Knowledge of the mechanisms involved in the disappearance of injected Hylase is limited. It is known, however, that the blood of a number of mammalian species brings about the inactivation of Hylase. Studies have demonstrated that Hylase is antigenic; repeated injections of relatively large amounts of this enzyme may result in the formation of neutralizing anti-bodies. The reconstitution of the dermal barrier removed by intradermal injection of Hylase (20, 2, 0.2, 0.02, and 0.002 Units/mL) to adult humans indicated that at 24 hours the restoration of the barrier is incomplete and inversely related to the dosage of enzyme; at 48 hours the barrier is completely restored in all treated areas.
Results from an experimental study, in humans that evaluated the influence of Hylase in bone repair support the conclusion that this enzyme alone does not deter bone healing when given at the usual clinical dosage.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies have not been performed to assess the carcinogenic or mutagenic potential of Hylase. Hylase is found in most tissues of the body.
Long-term animal studies have not been performed to assess whether Hylase 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 Hylase in sterility due to oligospermia indicated that Hylase may have aided conception.
16 HOW SUPPLIED/STORAGE AND HANDLING
Hylase (hyaluronidase injection) Bovine is supplied sterile as 150 units/mL bovine of Hylase in a single-dose glass vial containing 1 mL.
NDC 17478-560-01 Package of 1 vial.
NDC 17478-560-06 Package of 6 vials.
NDC 17478-560-10 Package of 10 vials.
Not recommended for IV Use.
Storage: Store in a refrigerator at 2° to 8°C (36° to 46°F).
DO NOT FREEZE.
17 PATIENT COUNSELING INFORMATION
17.1 Important Precautions Regarding Hylase
Instruct patient that Hylase is being used to increase the dispersion and absorption of fluids or other injected drugs, as appropriate to the intended use.
17.2 What Patients Should Know About Adverse Reactions
The most frequently reported adverse reactions have been mild local injection site reactions such as redness, swelling, itching, or pain.
Anaphylactic-like reactions, and allergic reactions, such as hives, have been reported rarely in patients receiving hyaluronidases.
17.3 Patients Should Inform Their Doctors If Taking Other Medications
You may not receive furosemide, the benzodiazepines, phenytoin, dopamine and/or alpha agonists with Hylase . These medications have been found to be incompatible with Hylase.
If you are taking salicylates (e.g., aspirin), steroids (e.g., cortisone or estrogens) or antihistamines your doctor may need to prescribe larger amounts of Hylase for equivalent dispersing effect.
Manufactured by: Akorn, Inc.
Lake Forest, IL 60045
HD00N Rev. 10/15
Principal Display Panel Text for Container Label:
150 USP Units/mL
for IV use.
Principal Display Panel Text for Carton Label:
150 USP Units/mL
Hylase pharmaceutical active ingredients containing related brand and generic drugs:
Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.
Hylase available forms, composition, doses:
Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.
Hylase destination | category:
Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.
Hylase Anatomical Therapeutic Chemical codes:
A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.
Hylase pharmaceutical companies:
Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Hylase?
Depending on the reaction of the Hylase after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Hylase not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Hylase addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
Reviewsdrugs.com conducted a study on Hylase, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Hylase consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.
Two visitors reported age
The information was verified by Dr. Arunabha Ray, MD Pharmacology