Chymopsin (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Samson-Med LLC (Russia)

ATC Code

D03BA (Proteolytic enzymes)

Active Substances

Trypsin (BAN)

Chymotrypsin (Rec.INN)

Dosage Form

Chymopsin

Lyophilizate for solution for topical and external use 50 mg: vial 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for the preparation of a solution for topical and external use in the form of a lyophilized powder or porous mass (tablet or lumps) white or white with a slight yellowish tint.

* 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

Drugs for the treatment of wounds and ulcers; enzyme preparations; proteolytic enzymes

Pharmacological Action

An enzymatic preparation with proteolytic action, it breaks down necrotic tissue without affecting living tissue due to the presence of specific antienzymes in it. Thins viscous secretions and exudates.

Indications

Purulent bronchopulmonary diseases:

• Bronchiectasis;
• Lung abscess;
• Atelectasis;
• Exudative pleurisy (to thin thick viscous sputum and sanitize the respiratory tract).

Diseases of the ENT organs:

• Purulent sinusitis;
• Purulent otitis (acute, subacute, chronic);
• Eustachitis with viscous exudate;
• After tracheostomy to facilitate the removal of thick viscous exudate;
• Chronic rhinitis.

In ophthalmology:

• Corneal diseases (ulcer, herpetic keratitis);
• Burn of the eye mucosa;
• Obstruction of the lacrimal ducts;
• Sluggish healing of eyelid skin wounds.

Burns, bedsores, trophic ulcers, purulent wounds (cleansing from purulent-necrotic masses, accelerating healing).

ICD codes

Dosage Regimen

In respiratory diseases, the drug at a dose of 25-30 mg is dissolved in 5 ml of distilled water and administered into the respiratory tract through an inhalation apparatus, bronchoscope, endotracheal tube, or tracheostomy tube. The number of inhalations is from 1 to 3 times/day for several days depending on the indications. Antibiotics and bronchodilators that enhance the action of Chymopsin can be added to the drug solutions.

For chronic rhinitis, the nasal cavity is instilled or irrigated with a solution of Chymopsin 2-3 times/day (5 mg in 5 ml of 0.9% sodium chloride solution).

For chronic purulent otitis, complicated by cholesteatoma, after washing with 0.9% sodium chloride solution, 0.5% Chymopsin solution (in 0.9% sodium chloride solution) is instilled into the ear 2-3 times/day.

For third-degree thermal burns, a thin layer of Chymopsin is applied to the scab at the rate of 1 g per 100 cm² of the wound surface and covered with a bandage soaked in 0.9% sodium chloride solution or 0.25% procaine solution. An impermeable dressing is applied on top to slow the drying of the dressings. Dressings are changed after 24 hours.

For the treatment of purulent wounds and bedsores, the drug is used in doses of 25-50 mg (in 10-50 ml of 0.25% procaine solution). Sterile gauze tampons are moistened with the solution and applied to the wound surface for a period of 2 hours to a day, depending on the thickness of the purulent-necrotic masses. Dressings with Chymopsin are changed every 3-5 days.

For the treatment of ulcers, corneal burns, and keratitis, Chymopsin is used in the form of eye baths in a 1:500 solution daily for 2-3 days or in the form of drops of a 0.25% solution (prepared ex tempore) 4 times/day for 1-2 days, 2 drops each.

For the treatment of obstruction of the lacrimal ducts and eyelid skin wounds, the drug is used in the form of a 1% solution (prepared ex tempore), by irrigating the wound and washing the lacrimal ducts.

Adverse Reactions

Possible occurrence of allergic reactions.

After inhalation administration, occasional hoarseness, irritation of the respiratory tract mucosa, and transient low-grade fever.

In ophthalmology, irritation and swelling of the conjunctiva may be noted; in such cases, it is recommended to reduce the concentration of the drug used.

Contraindications

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

Should not be administered into bleeding cavities or applied to ulcerated surfaces of malignant tumors.

With caution in empyema of the pleura of tuberculous etiology (resorption of exudate may 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 breastfeeding.

Use in Hepatic Impairment

Contraindicated in dystrophy and cirrhosis of the liver, viral hepatitis.

Special Precautions

Before using the drug in persons prone to allergic reactions, a single therapeutic dose of antihistamines should be administered (subcutaneously or intramuscularly).

In the hours following inhalations, the patient should cough up sputum thoroughly or it should be removed by suction.

Drug Interactions

Not described.

Storage Conditions

The drug should be stored out of the reach of children, in a dry place, protected from light, at a temperature not exceeding 20°C (68°F).

Shelf Life

Shelf life – 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.