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Molecule

Hyaluronidase

Endoglycosidase
Available on requestBiologicCold chain
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Hyaluronidase is an endoglycosidase indicated as an adjuvant, among other approved uses. It is available as injection for subcutaneous use. MedsAcross supplies Hyaluronidase for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Endoglycosidase
US FDA first approval
5 May 2004
EU status
Application withdrawn
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Subcutaneous
Dosage forms
Injection
Biologic
Yes
Identifiers
UNII 8KOG53Z5EMRxCUI 5464CAS 9001-54-1Q72482735

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Amphadase ® is an endoglycosidase indicated as an adjuvant: • in subcutaneous fluid administration for achieving hydration. • to increase absorption and dispersion of other injected drugs. • in subcutaneous urography for improving resorption of radiopaque agents

Source: US FDA prescribing information

How it works

Hyaluronidase is a dispersion agent, 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. Hyaluronidase hydrolyzes hyaluronic acid by splitting the glucosaminidic bond between C 1 of an N-acetylglucosamine moiety and C 4 of a 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. Hyaluronidase cleaves glycosidic bonds of hyaluronic acid and, to a variable degree, some other acid mucopolysaccharides of the connective tissue.

Source: US FDA prescribing information

Dosing overview

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. • Subcutaneous Fluid Administration: 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 Amphadase ® (hyaluronidase injection) into rubber tubing close to needle. • Absorption and Dispersion of Injected Drugs: Absorption and dispersion of other injected drugs may be enhanced by adding 50 units to 300 units, most typically 150 units hyaluronidase, to the injection solution. • 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.

Source: US FDA prescribing information

Contraindications

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

Source: US FDA prescribing information

Warnings and precautions

• Spread of Localized Infection. • Ocular Damage. • Enzyme Inactivation with Intravenous Administration 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.

Source: US FDA prescribing information

Side effects

The following adverse reactions have been identified during post-approval use of hyaluronidase products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most frequently reported adverse reactions have been local injection site reactions. Hyaluronidase has been reported to enhance the adverse reactions 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 hyaluronidase. Anaphylactic-like reactions following retrobulbar block or intravenous injections have occurred, rarely. Allergic and anaphylactic-like reactions have been reported, rarely

Source: US FDA prescribing information

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

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Hyaluronidase, sorted by availability.

MedicineManufacturerRegisterAvailability
Amphadase 150 units/mL injectionSubcutaneous Cold chainAmphastar PharmaceuticalsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 5 May 2004Drugs@FDA
EU (EMA)Application withdrawnEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Hyaluronidase available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Hyaluronidase and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Hyaluronidase have?

The catalogue lists 1 brand names for Hyaluronidase, including Amphadase.

Is Hyaluronidase approved by the US FDA?

Yes. The US FDA first approved Hyaluronidase on 5 May 2004, according to Drugs@FDA.

Does Hyaluronidase need cold chain shipping?

At least one listed presentation of Hyaluronidase must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

References

  1. AMPHADASE prescribing information (Amphastar Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 1 February 2024

Request Hyaluronidase for export supply

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