Mastodon

Artravir®-Trivium (Capsules, Solution, Ointment) Instructions for Use

ATC Code

M01AX25 (Chondroitin sulfate)

Active Substance

Chondroitin sulfate sodium (Ph.Eur. European Pharmacopoeia)

Clinical-Pharmacological Group

Drug stimulating the process of regeneration of 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 fundamental 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 intramuscular administration, Chondroitin sulfate sodium is readily absorbed. Significant concentrations are detected in the blood as early as 30 minutes after injection.

The Cmax 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 Cmax is reached after 48 hours.

Indications

Degenerative-dystrophic diseases of the joints and spine (osteoarthritis of peripheral joints, intervertebral osteoarthritis 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.

Ointment

Externally – 2 times/day for 2-3 weeks.

Solution

Intramuscularly, it is prescribed at a dose of 100 mg every other day. With good tolerance, the dose is increased to 200 mg, starting from the fourth injection. The course of treatment is 25-30 injections. If necessary, repeated courses of treatment can be conducted after 6 months.

Capsules

Orally, adults are prescribed 1.5-1 g 2 times/day.

Adverse Reactions

Allergic reactions infrequently – skin itching, erythema, urticaria, dermatitis, angioneurotic edema.

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 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 8°C (46°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.

Medical Disclaimer

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

Marketing Authorization Holder

Trivium-XXI, LLC (Russia)

Manufactured By

Tver Pharmaceutical Factory, PJSC (Russia)

Dosage Form

Bottle OTC Icon Artravir®-Trivium® 5% ointment for external use: 10 g, 15 g, 20 g, 25 g, 30 g, or 50 g tubes; 20 g, 25 g, 30 g, or 50 g jars

Dosage Form, Packaging, and Composition

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

100 g
Chondroitin sulfate sodium 5 g

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

10 g – aluminum tubes (1) – cardboard packs.
15 g – aluminum tubes (1) – cardboard packs.
20 g – aluminum tubes (1) – cardboard packs.
25 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
20 g – glass jars (1) – cardboard packs.
25 g – glass jars (1) – cardboard packs.
30 g – glass jars (1) – cardboard packs.
50 g – glass jars (1) – cardboard packs.

Marketing Authorization Holder

Trivium-XXI, LLC (Russia)

Manufactured By

Armavir Biopharmaceutical Plant, FSE (Russia)

Dosage Form

Bottle Rx Icon Artravir®-Trivium® Solution for intramuscular injection 100 mg/ml: amp. 1 ml or 2 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular injection colorless or slightly yellowish, transparent.

1 ml
Chondroitin sulfate sodium 100 mg

Excipients : water for injections – up to 1 ml.

1 ml – glass ampoules (5) – contour cell packaging (1) – cardboard packs.
2 ml – glass ampoules (5) – contour cell packaging (1) – cardboard packs.
1 ml – glass ampoules (5) – plastic trays (1) – cardboard packs.
2 ml – glass ampoules (5) – plastic trays (1) – cardboard packs.
1 ml – glass ampoules (10) – cardboard packs.
2 ml – glass ampoules (10) – cardboard packs.

Marketing Authorization Holder

Trivium-XXI, LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Forms

Bottle OTC Icon Artravir®-Trivium® Capsules 250 mg: 5, 6, 10, 12, 15, 18, 20, 24, 25, 30, 36, 40, 50, 60, 72, or 120 pcs.
Capsules 500 mg: 5, 6, 10, 12, 15, 18, 20, 24, 25, 30, 36, 40, 50, 60, 72, or 120 pcs.

Dosage Form, Packaging, and Composition

Capsules No. 0 with a white body and a dark green cap, opaque; 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, disintegrating when pressed with a glass rod.

1 caps.
Chondroitin sulfate sodium 250 mg

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

Capsule composition: capsule body titanium dioxide – 2%, gelatin – up to 100%; 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%.

5 pcs. – contour cell packaging (1) – cardboard packs.
5 pcs. – contour cell packaging (2) – cardboard packs.
5 pcs. – contour cell packaging (3) – cardboard packs.
5 pcs. – contour cell packaging (4) – cardboard packs.
5 pcs. – contour cell packaging (5) – cardboard packs.
5 pcs. – contour cell packaging (6) – cardboard packs.
5 pcs. – contour cell packaging (12) – cardboard packs.
6 pcs. – contour cell packaging (1) – cardboard packs.
6 pcs. – contour cell packaging (2) – cardboard packs.
6 pcs. – contour cell packaging (3) – cardboard packs.
6 pcs. – contour cell packaging (4) – cardboard packs.
6 pcs. – contour cell packaging (5) – cardboard packs.
6 pcs. – contour cell packaging (6) – cardboard packs.
6 pcs. – contour cell packaging (12) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (12) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
120 pcs. – polymer jars (1) – cardboard packs.

Capsules No. 00 with a body and cap of bright red color, opaque; 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, disintegrating when pressed with a glass rod.

1 caps.
Chondroitin sulfate sodium 500 mg

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

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

5 pcs. – contour cell packaging (1) – cardboard packs.
5 pcs. – contour cell packaging (2) – cardboard packs.
5 pcs. – contour cell packaging (3) – cardboard packs.
5 pcs. – contour cell packaging (4) – cardboard packs.
5 pcs. – contour cell packaging (5) – cardboard packs.
5 pcs. – contour cell packaging (6) – cardboard packs.
5 pcs. – contour cell packaging (12) – cardboard packs.
6 pcs. – contour cell packaging (1) – cardboard packs.
6 pcs. – contour cell packaging (2) – cardboard packs.
6 pcs. – contour cell packaging (3) – cardboard packs.
6 pcs. – contour cell packaging (4) – cardboard packs.
6 pcs. – contour cell packaging (5) – cardboard packs.
6 pcs. – contour cell packaging (6) – cardboard packs.
6 pcs. – contour cell packaging (12) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (12) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
120 pcs. – polymer jars (1) – cardboard packs.

Table of Contents

→ TABLE OF CONTENTS