Chymotrypsin (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Samson-Med LLC (Russia)

ATC Code

D03BA (Proteolytic enzymes)

Active Substance

Chymotrypsin (Rec.INN registered by WHO)

Dosage Form

Chymotrypsin

Lyophilizate for solution for injection, topical and external use 10 mg: vial 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for the preparation of a solution for injection, topical and external use in the form of a tablet, lumps, powder, plates, or shiny flakes of white color.

* obtained from the pancreas of cattle.

Glass vials with a capacity of 5 ml (5) – cardboard packs.
Glass vials with a capacity of 5 ml (10) – cardboard packs.

Clinical-Pharmacological Group

Drug with proteolytic activity

Pharmacotherapeutic Group

Other hematological agents; enzymes

Pharmacological Action

It hydrolyzes proteins and peptones, forming relatively low molecular weight peptides, and cleaves bonds formed by residues of aromatic amino acids (tyrosine, tryptophan, phenylalanine, methionine).

In medical practice, the use of Chymotrypsin is based on its specific ability to break down necrotized tissues and fibrinous formations, liquefy viscous secretions, exudates, and blood clots, and, when administered intramuscularly, to exert an anti-inflammatory effect. The enzyme is inactive and safe in relation to healthy tissues.

Indications

• Purulent diseases of the respiratory organs (bronchiectasis, pneumonia, lung abscess, atelectasis, exudative pleurisy, pleural empyema, bronchitis);
• Burns;
• Bedsores;
• Purulent wounds;
• Thrombophlebitis;
• Periodontal disease (inflammatory-dystrophic forms);
• In ophthalmology – fresh extensive thromboses of the central retinal vein, acute obstruction of the central retinal artery, opacification of the vitreous body of traumatic and inflammatory origin, cataract extraction;
• In otorhinolaryngology – purulent sinusitis, subacute laryngotracheitis, after tracheostomy to facilitate the removal of thick viscous exudate, in acute, subacute, purulent, chronic otitis media and eustachitis with viscous exudate.

ICD codes

Dosage Regimen

For intramuscular injection, 5 mg of the drug is dissolved immediately before use in 1-2 ml of 0.9% sodium chloride solution for injection or 0.5-2% procaine solution. The course of treatment is 6-15 injections.

For diseases of the respiratory organs, the drug is administered intramuscularly in doses of 5-10 mg/day for 10-12 days, possibly in combination with the use of Chymotrypsin as an aerosol in a 5% aqueous solution in an amount of 3-4 ml. After 7-10 days, the course of treatment can be repeated.

For the treatment of burns and bedsores, Chymotrypsin at a dose of 20 mg is dissolved in 20 ml of 0.25% procaine solution and injected under the eschar with a thin needle in several injections.

Sterile napkins moistened with a solution of 25-50 mg of Chymotrypsin in 10-50 ml of 0.25% procaine solution are applied to purulent wound surfaces for 8 hours. For the treatment of purulent wounds, intramuscular injections of the drug are combined with local treatment of the wound with tampons moistened with a 5% aqueous solution of Chymotrypsin.

For thrombophlebitis, the drug is prescribed intramuscularly at 5-10 mg daily for 7-10 days.

For cataract extraction, Chymotrypsin diluted 1:5000 is injected into the posterior chamber of the eye, followed by irrigation of the anterior chamber of the eye with 0.9% sodium chloride solution 4 minutes after administration of the drug.

For the treatment of thromboses of the central retinal vein, acute obstruction of the central retinal artery, Chymotrypsin is administered subconjunctivally at 0.2 ml of a 5% solution prepared in a 1% procaine solution, 1-2 times a week.

For sinusitis, the drug is injected into the corresponding cavity in an amount of 5-10 mg in 3-5 ml of 0.9% sodium chloride solution after puncture and irrigation of the cavity.

For otitis, 0.5-1 ml of a 0.1% solution of Chymotrypsin in 0.9% sodium chloride solution is instilled into the ear.

For microsurgery on the ear to soften fibrinous formations in the middle ear during surgery, a 0.1% solution of Chymotrypsin is injected into the cavity. Simultaneously, Chymotrypsin should be administered intramuscularly at 2.5-5 mg 1-2 times/day. The drug is diluted in 1-2 ml of 0.25-0.5% procaine solution or 0.9% sodium chloride solution for injection.

Adverse Reactions

Possible allergic reactions, increase in body temperature to subfebrile, tachycardia.

After inhalation administration irritation of the mucous membranes of the upper respiratory tract, hoarseness.

With subconjunctival administration, irritation and swelling of the conjunctiva are possible; in such cases, it is recommended to reduce the concentration of the solution used.

Local reactions after intramuscular injection may include pain and redness at the injection sites.

Contraindications

• Hypersensitivity;
• Malignant neoplasms;
• Pulmonary tuberculosis (open form);
• Chronic heart failure of II-III degree;
• Dystrophy and cirrhosis of the liver;
• Viral hepatitis;
• Pancreatitis;
• Hemorrhagic diathesis;
• Pulmonary emphysema with respiratory failure.

It should not be injected into bleeding cavities or applied to ulcerated surfaces of malignant tumors to avoid the spread of the malignant process.

With caution: pleural empyema of tuberculous etiology (resorption of exudate may in some cases contribute to the development of bronchopleural fistula).

Use in Pregnancy and Lactation

There are no data on the use of the drug during pregnancy and lactation.

Use in Hepatic Impairment

The use of the drug is contraindicated in dystrophy and cirrhosis of the liver, viral hepatitis.

Special Precautions

Influence on the ability to drive vehicles and mechanisms

No negative effects on the ability to drive vehicles and mechanisms have been noted.

Overdose

No information on overdose is available.

Drug Interactions

Not described.

Storage Conditions

The drug should be stored out of the reach of children, protected from light, at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years. Do not use after the expiration date.

Dispensing Status

The drug is dispensed 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.