Clinical Information
Gen. Code and Des.
5256 hyaluronidase INJECTION VIAL 150 UNIT/1
GCN and Des.
21151 hyaluronidase INJECTION VIAL 150 UNIT/1
Strength
150UN
Dose Form
VIAL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
44000000 ENZYMES
Active Ingredients
1887 hyaluronidase 9001541
Inactive Ingredients
18822 rubber, unspecified
3125 thimerosal 54648
3785 edetic acid 60004
9283 beef derived (bovine)
AMPHADASE hyaluronidase injection
Amphastar Pharmaceuticals, Inc.
INDICATIONS AND USAGE
Amphadase? is preparation of purified bovine testicular hyaluronidase, protein enzyme. The exact chemical structure of this enzyme is unknown. However, the amino acid sequence for the primary structure of the enzyme has been deduced from the sequence of purified peptides.
Amphadase? (hyaluronidase injection) is supplied as sterile, clear, colorless, ready for use solution. Each vial contains 150 USP units of hyaluronidase per mL with 8.5 mg sodium chloride, mg edetate disodium, 0.4 mg calcium chloride, monobasic sodium phosphate buffer, and not more than 0.1 mg thimerosal (mercury derivative).
Amphadase? has an approximate pH of 6.8 and an osmolality of 295 to 355 mOsm. Mechanism of Action
Hyaluronidase is dispersion agent, which modifies the permeability of connective tissue through the hydrolysis of hyaluronic acid, 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 and hemolytic streptococci. Hyaluronidase hydrolyzes hyaluronic acid by splitting the glucosaminidic bond between Cl of an N-acetylglucosamine moiety and C4 of glucuronic acid moiety. This temporarily decreases the viscosity of the cellular cement and promotes dispersion of injected fluids or of localized transudates or exudates, thus facilitating their absorption.
1.1 Subcutaneous Fluid Administration
Amphadase? is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration.
1.2 Dispersion and Absorption of Injected Drugs
Amphadase? is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs.
INDICATIONS AND USAGE
1.1 Subcutaneous Fluid Administration
Amphadase? is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration.
1.2 Dispersion and Absorption of Injected Drugs
Amphadase? is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs.
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 of Amphadase? (hyaluronidase injection) is injected subcutaneously over each scapula, followed by injection of the contrast medium at the same sites.
DOSAGE FORMS AND STRENGTHS
150 USP units/mL single dose vial
5.1 Spread of Localized Infection
Hyaluronidase should not be injected into or around an infected or acutely inflamed area because of the danger of spreading localized infection.
Hyaluronidase should not be used to reduce the swelling of bites or stings.
5.2 Ocular Damage
Hyaluronidase should not be applied directly to the cornea.
5.3 Enzyme Inactivation with Intravenous Administration
Hyaluronidase should not be used for intravenous injections because the enzyme is rapidly inactivated.
Pregnancy Category C.
HOW SUPPLIED/STORAGE AND HANDLING
Amphadase? (hyaluronidase injection) is supplied sterile as 150 USP units of hyaluronidase per mL in 2 mL single-use glass vial with gray rubber stopper and aluminum flip-off seal.
NDC 0548-9090-10, mL vial, 10 vials/carton.
PATIENT COUNSELING info.
17.1 Important Precautions Regarding Amphadase?
Instruct patient that Amphadase? is being used to increase the dispersion and absorption of fluids or other injected drugs, as appropriate to the intended use.
Instruct patient that there may be mild local injection site signs and symptoms, such as redness, swelling, itching, or pain localized to the site of injection.
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 Amphadase?. These medications have been found to be incompatible with hyaluronidase.
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 hyaluronidase for equivalent dispersing effect.
