Chondrolon^® (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

Manufactured By

Microgen NPO, JSC (Russia)

ATC Code

M01AX25 (Chondroitin sulfate)

Active Substance

Chondroitin sulfate sodium (Ph.Eur. European Pharmacopoeia)

Dosage Form

Chondrolon®

Lyophilizate for solution for intramuscular administration 100 mg: amp. 5, 10, or 20 pcs. in set with solvent

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for intramuscular administration in the form of a white porous mass, compacted into a tablet, odorless.

100 mg – ampoules (5) in a set with solvent (water for injections 1 ml – amp. 5 pcs.) – carton packs.
100 mg – ampoules (10) in a set with solvent (water for injections 1 ml – amp. 10 pcs.) – carton packs.
100 mg – ampoules (10) – carton packs.
100 mg – ampoules (10) – contour plastic packs (1) – carton packs.
100 mg – ampoules (10) – contour plastic packs (2) – carton packs.
100 mg – ampoules (10) – contour plastic packs (4) – carton packs.
100 mg – ampoules (5) – contour plastic packs (1) – carton packs.
100 mg – ampoules (5) – contour plastic packs (2) – carton packs.
100 mg – ampoules (5) – contour plastic packs (4) – carton packs.

Clinical-Pharmacological Group

Drug regulating metabolism in cartilage tissue

Pharmacotherapeutic Group

Anti-inflammatory and antirheumatic drugs; non-steroidal anti-inflammatory and antirheumatic drugs; other non-steroidal anti-inflammatory and antirheumatic drugs

Pharmacological Action

Chondroitin sulfate is the main component of proteoglycans, which together with collagen fibers constitute the cartilage matrix. It has chondroprotective properties; suppresses the activity of enzymes that cause degradation of articular cartilage; stimulates the production of proteoglycans by chondrocytes; enhances metabolic processes in cartilage and subchondral bone; participates in the construction of the main substance of bone and cartilage tissue.

It has anti-inflammatory and analgesic effects, helps reduce the release of inflammatory mediators and pain factors into the synovial fluid through synoviocytes and macrophages of the synovial membrane, suppresses the secretion of leukotriene B₄ and prostaglandin E₂.

The drug promotes the restoration of joint cartilage surfaces, prevents the collapse of connective tissue; normalizes the production of synovial fluid, which leads to improved joint mobility and reduced pain intensity.

Pharmacokinetics

Chondrolon^® is easily absorbed upon intramuscular administration. The maximum concentration is reached 1 hour after administration.

The drug accumulates in the synovial fluid. It is eliminated from the body mainly by the kidneys within 24 hours.

Indications

• Osteoarthritis of peripheral joints and spine.

ICD codes

Dosage Regimen

Administer intramuscularly at 100 mg (1 ampoule) every other day. Before use, the contents of the ampoule are dissolved in 1 ml of water for injections. If well tolerated, the dose is increased to 200 mg (2 ampoules), starting from the fourth injection. The course of treatment is 25-35 injections. Repeated courses – after 6 months.

The duration of repeated treatment courses is determined by the doctor.

To achieve a stable clinical effect, at least 25 injections of Chondrolon are necessary, and the effect persists for a long time after the end of the repeated treatment course.

There is no experience with the use of the drug in children.

Adverse Reactions

Allergic reactions, hemorrhages at the injection site.

Contraindications

• Hypersensitivity to chondroitin sulfate;
• Tendency to bleeding;
• Thrombophlebitis;
• Pregnancy;
• Breastfeeding period (breastfeeding should be discontinued during treatment).

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Pediatric Use

There is no experience with the use of the drug in children.

Drug Interactions

Chondrolon^® may enhance the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics, which requires more frequent monitoring of blood coagulation parameters when using the drugs concomitantly.

Storage Conditions

In a dry place, protected from light, out of the reach of children, at a temperature not exceeding 20°C (68°F).

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.