Arthroject^® (Solution) Instructions for Use

Marketing Authorization Holder

Lekpharm, SOOO (Republic of Belarus)

ATC Code

M01AX25 (Chondroitin sulfate)

Active Substance

Chondroitin sulfate sodium (Ph.Eur. European Pharmacopoeia)

Dosage Form

Arthroject®

Solution for intramuscular injection 100 mg/1 ml: amp. 2 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular injection transparent, colorless or with a slight yellowish tint.

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

2 ml – ampoules made of colorless glass (5) – contour cell packaging (1) – cardboard packs.
2 ml – ampoules made of colorless glass (5) – contour cell packaging (2) – cardboard packs.

Clinical-Pharmacological Group

Drug stimulating the process of regeneration of cartilage tissue

Pharmacotherapeutic Group

Tissue repair stimulant

Pharmacological Action

A drug 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 fundamental substance of cartilage and bone tissue. It has chondroprotective properties, enhances metabolic processes in hyaline and fibrous cartilage, and subchondral bone; it inhibits enzymes that cause degradation (destruction) of articular cartilage; it 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 recovery 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.

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

Pharmacokinetics

After intramuscular injection, Chondroitin sulfate sodium is readily absorbed. Significant concentrations are detected in the blood 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 drug into the joint cavity. Fifteen minutes after intramuscular injection, Chondroitin sulfate sodium is detected in the synovial fluid, then it 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 deep intramuscular injection only.

The initial dose is 100 mg (1 ml) every other day.

If the drug is well tolerated, increase the dose to 200 mg (2 ml) starting from the fourth injection.

Inject slowly to minimize local reactions.

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

If necessary, a repeat course of treatment can be administered after an interval of 6 months.

Do not exceed the recommended dosage or frequency of administration.

Use the solution immediately after opening the ampoule; discard any unused portion.

Visually inspect the solution for particulate matter and discoloration prior to administration.

Adverse Reactions

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

From the digestive system often – diarrhea, abdominal pain, nausea; frequency unknown – vomiting.

Local reactions pain and hemorrhages 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

Potentiation of the effect of indirect anticoagulants, antiplatelet agents, and fibrinolytics is possible, 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.