Terridecase (Lyophilisate) Instructions for Use

Marketing Authorization Holder

St. Petersburg Research Institute of Vaccines and Sera of the FMBA, FSUE (Russia)

ATC Code

D03BA (Proteolytic enzymes)

Dosage Forms

	Terridecase	Lyophilisate for preparation of solution for intracavitary and external use 100 PU: fl. 10 pcs.
		Lyophilisate for preparation of solution for intracavitary and external use 100 PU: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for intracavitary and external use as a porous mass or powder, white or white with a yellowish tint.

100 PU – ampoules (10) – carton packs.

Lyophilisate for preparation of solution for intracavitary and external use as a porous mass or powder, white or white with a yellowish tint.

100 PU – vials (10) – carton packs.

Clinical-Pharmacological Group

Drug with proteolytic activity for external use

Pharmacotherapeutic Group

Proteolytic agent

Pharmacological Action

Terridecase is a proteolytic enzyme obtained by covalent attachment of terrilithin to oxidized polyglucin.

Terrilithin is a microbial proteolytic enzyme obtained from native solutions of the Aspergillus terricola culture, strain H-20, possessing a broad spectrum of specific hydrolytic action against various protein substrates, used as a necrolytic and wound healing agent for external use.

Attachment of polyglucin to terrilithin significantly reduced the allergenic and locally irritating effects of the drug.

The main mechanism of action is due to the proteolytic activity of terrilithin and its ability to hydrolyze various protein substrates, including mucin, as well as to exert a fibrinolytic effect.

Pharmacokinetics

Pharmacokinetics for this drug have not been studied.

Indications

• Purulent wounds;
• Bedsores;
• Trophic ulcers;
• Abscesses of subcutaneous tissue of various locations (after opening, removal of non-viable tissues, thorough drainage of the abscess cavity);
• Pleural empyema;
• Clotted hemothorax;
• Purulent tracheobronchitis;
• Bronchiectasis;
• Sputum retention after lung resection.

ICD codes

Dosage Regimen

Terridecase is used as a solution; for this, the contents of a vial (ampoule) of 100 PU (Proteolytic Units) are dissolved in 2-5 ml of distilled water or 0.9% sodium chloride solution, or 0.25% procaine solution.

It is used externally, intrapleurally, intratracheally, intrabronchially.

For purulent wounds, bedsores, trophic ulcers, apply napkins soaked in Terridecase solution, covered with a waterproof bandage; the dressing with the drug is changed once a day or every other day.

For open sanitation of pleural empyema, turundas with the drug are introduced into the pleural cavity.

For closed puncture sanitation, Terridecase solution in a dose of 100 PU is administered intrapleurally both in the pre- and postoperative periods once a day. The course of treatment is 2-7 procedures.

For closed puncture treatment of postoperative hemothorax, Terridecase solution is administered intrapleurally in a dose of 100-200 PU per day in courses of 3-7 administrations with aspiration of liquefied exudate (2-3 hours after enzyme administration).

For purulent tracheobronchitis, 3-5 ml of Terridecase solution (100 PU) is administered through an endotracheal tube (or intratracheally) 5-6 times a day for 3-4 days.

For sputum retention in the postoperative period after lung resection, 2-3 ml of Terridecase solution (10-15 PU) is administered intrabronchially. For this, 100 PU of the drug is dissolved in 20 ml of 0.9% sodium chloride solution.

The course of treatment is 1-3 procedures.

Adverse Reactions

Increased body temperature – associated with the absorption of proteolysis products of viable tissues with insufficient wound drainage, allergic reactions.

Contraindications

• Bleeding wounds;
• Bleeding ulcers;
• Ulcerated surfaces of malignant tumors;
• Concomitant use of thrombolytic drugs to avoid hemorrhagic complications;
• Do not inject into inflammation sites (before opening);
• Pregnancy, lactation;
• Children under 18 years of age;
• Individual intolerance.

Use in Pregnancy and Lactation

The safety of the drug during pregnancy and lactation with external and intracavitary use has not been studied.

Pediatric Use

Due to the lack of data on the use of the drug in children under 18 years of age (the efficacy and safety of the drug have not been established), the drug should not be prescribed without consulting a doctor.

Special Precautions

Do not administer intravenously.

In case of complications, conditions for good outflow of pus from the wound should be created, or the drug should be discontinued.

Effect on ability to drive vehicles and machinery

No adverse effects on the ability to drive a car or operate machinery have been reported.

Overdose

No cases of overdose have been identified.

Drug Interactions

Terridecase promotes better penetration of other drugs into the inflammation site (hydroxymethylquinoxalinedioxide, ampicillin+oxacillin, lincomycin).

The drug is compatible with antimicrobial and chemotherapeutic agents.

Storage Conditions

At a temperature from 0 to 10°C (50°F) in a dry, light-protected place. Keep out of reach of children.

Shelf Life

Shelf life – 3 years.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.