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Artrafik® (Capsules, Ointment) Instructions for Use

ATC Code

M01AX25 (Chondroitin sulfate)

Active Substance

Chondroitin sulfate sodium (Ph.Eur. European Pharmacopoeia)

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

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 possesses 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.

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

Pharmacokinetics

After a single oral administration of the average therapeutic dose, Cmax in plasma is reached in 3-4 hours, and in synovial fluid – in 4-5 hours. Bioavailability is 13%. It is excreted by the kidneys within 24 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

ICD-10 code Indication
M15 Polyosteoarthritis
M19.9 Unspecified arthrosis
M42 Spinal osteochondrosis
M47 Spondylosis
T14.2 Fracture in unspecified part of body
ICD-11 code Indication
FA05 Polyosteoarthritis
FA0Z Osteoarthritis, unspecified
FA85.Z Defects of vertebral end-plates, unspecified
FA8Z Degenerative disease of spine, unspecified
ND56.2 Fracture in unspecified part of body

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

For the ointment, apply externally to the affected area two to three times daily. Rub in until fully absorbed. The typical treatment course is two to three weeks. Continue use as directed by a physician.

For the capsules, administer orally. The standard adult dosage is 1 gram taken twice daily. Alternatively, a dose of 1.5 grams twice daily may be prescribed based on clinical evaluation. Take capsules with a full glass of water, preferably with meals to improve gastrointestinal tolerance.

The initial therapeutic course typically lasts from three to six months. The duration of treatment is determined by the treating physician based on the severity of symptoms and clinical response. A repeat course of therapy may be considered following a medical consultation.

To accelerate callus formation in fractures, initiate therapy as soon as possible after the fracture. The dosage remains 1 gram twice daily. The treatment duration for this indication is determined individually, based on radiographic evidence of bone healing.

Do not exceed the recommended daily dose. If a dose is missed, take it as soon as remembered unless it is almost time for the next dose. Do not double the dose to catch up. Discontinue use and consult a physician if adverse reactions occur.

Adverse Reactions

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

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

Contraindications

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

With caution

Concomitant use with direct-acting anticoagulants.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and breastfeeding.

Pediatric Use

Use is contraindicated 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 effects 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

Over-the-Counter

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle OTC Icon Artrafik® Ointment for external use 5%: tubes 30 g or 50 g

Dosage Form, Packaging, and Composition

Ointment for external use light yellow in color, with a characteristic odor.

100 g
Chondroitin sulfate sodium* 5 g

* calculated on the dry substance.

Excipients : petrolatum – 50 g, lanolin – 15 g, dimethyl sulfoxide – 10 g, purified water – up to 100 g.

30 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Forms

Bottle OTC Icon Artrafik® Capsules 250 mg: from 5 to 180 pcs.
Capsules 500 mg: from 5 to 180 pcs.

Dosage Form, Packaging, and Composition

Capsules opaque, capsule body white, cap – dark green; capsule contents – a mixture of powder and granules with crystalline inclusions, white or white with a yellowish tint; granules of irregular shape, varying in size, compaction of the capsule contents according to the shape of the capsule is allowed, easily disintegrating when pressed.

1 caps.
Chondroitin sulfate sodium 250 mg

Excipients : croscarmellose sodium – 20 mg, povidone K25 – 5 mg, microcrystalline cellulose – 140 mg, magnesium stearate – 5 mg.

Composition of the capsule body : titanium dioxide – 2%, gelatin – up to 100%;
Composition of the capsule cap : dye azorubine – 0.0016%, dye quinoline yellow – 1.1496%, dye patent blue – 0.1642%, dye brilliant black – 0.0958%, titanium dioxide – 1.3333%, gelatin – up to 100%.

From 5 to 15 pcs. – contour cell packs (from 1 to 12 pcs.) – cardboard packs.
From 10 to 120 pcs. – jars (1) – cardboard packs.

Capsules opaque, capsule body bright red, cap – bright red; capsule contents – a mixture of powder and granules with crystalline inclusions, white or white with a yellowish tint; granules of irregular shape, varying in size, compaction of the capsule contents according to the shape of the capsule is allowed, easily disintegrating when pressed.

1 caps.
Chondroitin sulfate sodium 500 mg

Excipients : croscarmellose sodium – 20 mg, povidone K25 – 5 mg, microcrystalline cellulose – 60 mg, magnesium stearate – 5 mg.

Composition of the capsule body : dye azorubine – 0.568%, dye brilliant black – 0.0019%, dye sunset yellow – 0.1861%, titanium dioxide – 1.3333%, gelatin – up to 100%;
Composition of the capsule cap : dye azorubine – 0.568%, dye brilliant black – 0.0019%, dye sunset yellow – 0.1861%, titanium dioxide – 1.3333%, gelatin – up to 100%.

From 5 to 15 pcs. – contour cell packs (from 1 to 12 pcs.) – cardboard packs.
From 10 to 120 pcs. – jars (1) – cardboard packs.

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