Hondrofast^® (Solution) Instructions for Use

Marketing Authorization Holder

Vita Line, LLC (Russia)

Manufactured By

Lekpharm, SOOO (Republic of Belarus)

ATC Code

M01AX25 (Chondroitin sulfate)

Active Substance

Chondroitin sulfate sodium (Ph.Eur.)

Dosage Form

Hondrofast®

Solution for intramuscular injection 100 mg/ml: amp. 2 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular injection transparent, colorless or yellowish.

Excipients: benzyl alcohol – 12 mg, sodium hydroxide solution 0.1 M or hydrochloric acid solution 0.1 M – to pH 6.0-7.5, water for injections – to 1 ml.

2 ml – ampoules (5) – carton packs.
2 ml – ampoules (10) – carton packs.

Clinical-Pharmacological Group

Drug regulating metabolism in cartilage tissue

Pharmacotherapeutic Group

Tissue repair stimulant

Pharmacological Action

An agent affecting phosphorus-calcium metabolism in cartilage tissue, it is a high molecular weight mucopolysaccharide. It has chondrostimulating, regenerating, anti-inflammatory, and analgesic effects. Chondroitin sulfate is involved in the construction of the ground substance of cartilage and bone tissue.

It has chondroprotective properties, enhances metabolic processes in hyaline and fibrous cartilage, and subchondral bone; inhibits enzymes that cause degradation (destruction) of articular cartilage; stimulates the production of proteoglycans by chondrocytes.

It helps reduce the release of inflammatory mediators and pain factors into the synovial fluid, suppresses the secretion of leukotrienes and prostaglandins. It slows down bone tissue resorption and reduces calcium loss, accelerates bone tissue repair processes.

Chondroitin sulfate slows the progression of osteoarthritis and osteochondrosis. It promotes the restoration of the joint capsule and cartilaginous joint surfaces, prevents the collapse of connective tissue, and normalizes the production of synovial fluid.

Having structural similarity to heparin, it may potentially prevent the formation of fibrin thrombi in the synovial and subchondral microvasculature.

Pharmacokinetics

After intramuscular injection, Chondroitin sulfate sodium is readily absorbed. It is detected in the blood in significant concentrations as early as 30 minutes after injection.

The C_max of Chondroitin sulfate sodium in plasma is reached after 1 hour, then gradually decreases over 2 days. Chondroitin sulfate sodium accumulates mainly in the cartilage tissue forming the joints.

The synovial membrane is not a barrier to the penetration of the agent into the joint cavity. Fifteen minutes after intramuscular injection, Chondroitin sulfate sodium is detected in the synovial fluid, then penetrates into the articular cartilage, where its C_max is reached after 48 hours.

Indications

Degenerative-dystrophic diseases of the joints and spine (osteoarthritis of peripheral joints, intervertebral osteoarthrosis and osteochondrosis), to accelerate the formation of callus in fractures.

ICD codes

Dosage Regimen

Administer the solution by intramuscular injection only.

Initiate therapy at a dose of 100 mg every other day.

If the drug is well tolerated, increase the dose to 200 mg starting from the fourth injection.

The standard course of treatment consists of 25 to 30 injections.

If necessary, a repeated treatment course may be administered after an interval of 6 months.

Do not exceed the prescribed dosage or frequency of administration.

Adverse Reactions

Allergic reactions uncommon – skin itching, erythema, urticaria, dermatitis, angioedema.

Gastrointestinal system often – diarrhea, abdominal pain, nausea; frequency unknown – vomiting.

Local reactions pain and hemorrhage at the injection site.

Contraindications

Hypersensitivity to chondroitin sulfate, tendency to bleeding, thrombophlebitis; children and adolescents under 18 years of age; pregnancy, breastfeeding period.

With caution

Concomitant use with direct-acting anticoagulants.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

There are no specific instructions for use in elderly patients.

Special Precautions

In case of allergic reactions or hemorrhages, treatment should be discontinued.

Drug Interactions

It is possible to enhance the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics, which requires more frequent monitoring of blood coagulation parameters when used concomitantly.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.