Endoglycosidase

Amphadase

Approved 26 Oct 2004InjectionInjectable

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Indications

Amphadase ® is an endoglycosidase indicated as an adjuvant:

in subcutaneous fluid administration for achieving hydration ( 1.1 )
to increase absorption and dispersion of other injected drugs ( 1.2 )
in subcutaneous urography for improving resorption of radiopaque agents ( 1.3 )

1.1Subcutaneous Fluid Administration

Amphadase ® is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration.

1.2Dispersion and Absorption of Injected Drugs

Amphadase ® is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs.

1.3Subcutaneous Urography

Amphadase ® is indicated as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.

Contraindications

Hypersensitivity ( 4.1 )

4.1Hypersensitivity Hypersensitivity

to hyaluronidase or any other ingredient in the formulation is a contraindication to the use of this product.

Warnings and precautions

Spread of Localized Infection ( 5.1 )
Ocular Damage ( 5.2 )
Enzyme Inactivation with Intravenous Administration ( 5.3 )

5.1Spread 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.

5.2Ocular Damage

Hyaluronidase should not be applied directly to the cornea.

At a glance

Brand name: Amphadase
Active substance: hyaluronidase
Pharmacologic class: Endoglycosidase
Route: Injection
Dosage form: Injectable
Applicant: Amphastar Pharm
Status: Prescription
FDA approval: 26 Oct 2004
Application: BLA021665-001

Indications

Amphadase ® is an endoglycosidase indicated as an adjuvant:

in subcutaneous fluid administration for achieving hydration ( 1.1 )
to increase absorption and dispersion of other injected drugs ( 1.2 )
in subcutaneous urography for improving resorption of radiopaque agents ( 1.3 )

1.1Subcutaneous Fluid Administration

Amphadase ® is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration.

1.2Dispersion and Absorption of Injected Drugs

Amphadase ® is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs.

1.3Subcutaneous Urography

Amphadase ® is indicated as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.

Warnings and precautions

Spread of Localized Infection ( 5.1 )
Ocular Damage ( 5.2 )
Enzyme Inactivation with Intravenous Administration ( 5.3 )

5.1Spread of Localized Infection

5.2Ocular Damage

Hyaluronidase should not be applied directly to the cornea.

Interactions

It is recommended that appropriate references be consulted regarding physical or chemical incompatibilities before adding Amphadase ® to a solution containing another drug.

Furosemide, the benzodiazepines and phenytoin are incompatible with hyaluronidase ( 7.1 )
Hyaluronidase should not be used to enhance the absorption and dispersion of dopamine and/or alpha agonist drugs ( 7.2 )
Local anesthetics: Hyaluronidase hastens onset and shortens duration of effect, increases incidence of systemic reactions ( 7.3 )
Large doses of salicylates, cortisone, adrenocorticotropic hormone (ACTH), estrogens or antihistamines may require larger amounts of hyaluronidase for equivalent dispersing effect ( 7.4 )

7.1Incompatibilities Furosemide,

the benzodiazepines and phenytoin have been found to be incompatible with hyaluronidase. Admixture stability studies have shown that 2% lidocaine with 1:100,000 or 1:200,000 epinephrine is incompatible with hyaluronidase due to the presence of sodium metabisulfite, a common additive in anesthetic products containing epinephrine.

7.2Drug-Specific Precautions

Hyaluronidase should not be used to enhance the dispersion and absorption 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; e.g., when epinephrine is injected along with hyaluronidase, the precautions for the use of epinephrine in cardiovascular disease, thyroid disease, diabetes, digital nerve block, ischemia of the fingers and toes etc., should be observed.

7.3Local Anesthetics

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 incidence of systemic reaction.

7.4Salicylates, Cortisone, ACTH, Estrogens and Antihistamines

Patients receiving large doses of salicylates, cortisone, , adrenocorticotropic hormone (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.

Amphadase

Indications

1.1Subcutaneous Fluid Administration

1.2Dispersion and Absorption of Injected Drugs

1.3Subcutaneous Urography

Contraindications

4.1Hypersensitivity Hypersensitivity

Warnings and precautions

5.1Spread of Localized Infection

5.2Ocular Damage

At a glance

Two medicines in one question?

Amphadase

Indications

1.1Subcutaneous Fluid Administration

1.2Dispersion and Absorption of Injected Drugs

1.3Subcutaneous Urography

Contraindications

4.1Hypersensitivity Hypersensitivity

Warnings and precautions

5.1Spread of Localized Infection

5.2Ocular Damage

At a glance

Two medicines in one question?

Interactions

7.1Incompatibilities Furosemide,

7.2Drug-Specific Precautions

7.3Local Anesthetics

7.4Salicylates, Cortisone, ACTH, Estrogens and Antihistamines

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

Composition

Official product information