Chondroitin (Capsules, Solution, Lyophilisate) Instructions for Use

Instructions
Dosage forms

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 participates 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 causing the 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 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 may potentially prevent the formation of fibrin thrombi in the synovial and subchondral microcirculatory bed.

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 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.

With intra-articular administration, retention of chondroitin sulfate in the joint tissues and its gradual release into the bloodstream are observed. After a single intra-articular administration at a dose of 200 mg, C_max is reached in 1-2 hours and is 52.5-86.9 ng/ml, T_1/2 is 2.5 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

Open the list of 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.

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.

For intra-articular administration, a single dose is 200 mg. The frequency and duration of use are according to a special scheme.

Lyophilisate

Capsules

Orally, adults are prescribed 1.5-1 g twice daily.

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; pregnancy, breastfeeding period; children and adolescents under 18 years of age; presence of active inflammatory and infectious processes in the joint, presence of active skin disease and skin infection in the area of the intended injection.

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

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

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

Chondroitin sulfate [Biosintez, PJSC (Russia)]
Solution for intramuscular injection 100 mg/ml: amp. 1 ml or 2 ml 5 or 10 pcs.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Chondroitin sulfate

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 in the form of a transparent colorless or transparent liquid with a slight yellowish tint with a characteristic odor.

	1 ml
Chondroitin sulfate sodium (calculated on dry substance)	100 mg

Excipients : benzyl alcohol – 9 mg, sodium metabisulfite (sodium pyrosulfite) – 1 mg, 1M sodium hydroxide solution – to pH 6.0-7.5, water for injection – to 1 ml.

1 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
1 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
2 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
2 ml – ampoules (5) – contour cell packs (2) – cardboard packs.

Chondroitin sulfate [Global Pharma LLC (Russia)]
Solution for intramuscular injection 100 mg/1 ml: amp. 1 ml or 2 ml 5, 10 or 25 pcs.

Marketing Authorization Holder

Global Pharma LLC (Russia)

Manufactured By

Ellara, LLC (Russia)

Dosage Form

Chondroitin sulfate

Solution for intramuscular injection 100 mg/1 ml: amp. 1 ml or 2 ml 5, 10 or 25 pcs.

Dosage Form, Packaging, and Composition

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

	1 ml
Chondroitin sulfate sodium (calculated on dry substance)	100 mg

Excipients : sodium disulfite – 1 mg, benzyl alcohol – 9 mg, 1M sodium hydroxide solution – to pH 6.0-7.5, water for injection – to 1 ml.

1 ml – glass ampoules (5) – cardboard packs with insert.
1 ml – glass ampoules (10) – cardboard packs with insert.
1 ml – glass ampoules (25) – cardboard packs with insert.
2 ml – glass ampoules (5) – cardboard packs with insert.
2 ml – glass ampoules (10) – cardboard packs with insert.
2 ml – glass ampoules (25) – cardboard packs with insert.
1 ml – glass ampoules (5) – contour cell packs (1) – cardboard packs.
1 ml – glass ampoules (5) – contour cell packs (2) – cardboard packs.
1 ml – glass ampoules (5) – contour cell packs (5) – cardboard packs.
2 ml – glass ampoules (5) – contour cell packs (1) – cardboard packs.
2 ml – glass ampoules (5) – contour cell packs (2) – cardboard packs.
2 ml – glass ampoules (5) – contour cell packs (5) – cardboard packs.

Chondroitin sulfate [Kursk Biofactory - Firm "BIOK", FKP (Russia)]
Lyophilizate for solution for intramuscular administration 100 mg: 2 ml amp. 5 or 10 pcs

Marketing Authorization Holder

Kursk Biofactory – Firm "BIOK", FKP (Russia)

Dosage Form

Chondroitin sulfate

Lyophilizate for solution for intramuscular administration 100 mg: 2 ml amp. 5 or 10 pcs

Dosage Form, Packaging, and Composition

Lyophilizate for the preparation of solution for intramuscular injection in the form of a white or white with a yellowish tint, porous, compacted into a tablet or amorphous mass.

	1 amp.
Chondroitin sulfate sodium (calculated on 100% dry substance)	100 mg

5 pcs. – Ampoules with a capacity of 2 ml – contour cell packs (1) – cardboard packs.
5 pcs. – Ampoules with a capacity of 2 ml – contour cell packs (2) – cardboard packs.
5 pcs. – Ampoules with a capacity of 2 ml in a set with solvent amp. 5 pcs. – contour cell packs (1) – cardboard packs.
5 pcs. – Ampoules with a capacity of 2 ml – contour cell packs (50) – cardboard boxes (for hospitals).
5 pcs. – Ampoules with a capacity of 2 ml – contour cell packs (100) – cardboard boxes (for hospitals).
25 pcs. – Ampoules with a capacity of 2 ml in a set with solvent amp. 25 pcs. – contour cell packs (1) – cardboard boxes (for hospitals).
50 pcs. – Ampoules with a capacity of 2 ml in a set with solvent amp. 50 pcs. – contour cell packs (1) – cardboard boxes (for hospitals).

Chondroitin sulfate [Moscow Endocrine Plant FSUE (Russia)]
Solution for intramuscular and intra-articular injection 100 mg/1 ml: 1 ml or 2 ml amp. 5 or 10 pcs.

Marketing Authorization Holder

Moscow Endocrine Plant FSUE (Russia)

Dosage Form

Chondroitin sulfate

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

Dosage Form, Packaging, and Composition

Solution for intramuscular and intra-articular injection transparent, colorless or with a slight yellowish tint, with the odor of benzyl alcohol.

	1 ml
Chondroitin sulfate sodium	100 mg

Excipients : sodium metabisulfite E223, benzyl alcohol, 1M sodium hydroxide solution or 1M hydrochloric acid solution (for pH adjustment), water for injection.

Chondroitin sulfate [Salvus, LLC (Russia)]
Solution for intramuscular injection 100 mg/1 ml: amp. 2 ml 5 or 10 pcs.

Marketing Authorization Holder

Salvus, LLC (Russia)

Manufactured By

Lekpharm, SOOO (Republic of Belarus)

Syntex, S.A. (Argentina)

Dosage Form

Chondroitin sulfate

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.

	1 ml
Chondroitin sulfate sodium	100 mg

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

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

Chondroitin sulfate [Ellara, LLC (Russia)]
Lyophilizate for the preparation of solution for intramuscular administration 100 mg: amp. 5 or 10 pcs.

Marketing Authorization Holder

Ellara, LLC (Russia)

Dosage Form

Chondroitin sulfate

Lyophilizate for the preparation of solution for intramuscular administration 100 mg: amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

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

	1 amp.
Chondroitin sulfate	100 mg

Excipients : sodium disulfite – 0.5 mg.

Glass ampoules (5) – cardboard packs with insert.
Glass ampoules (10) – cardboard packs with insert.
Glass ampoules (5) – contour cell packs (1) – cardboard packs.
Glass ampoules (5) – contour cell packs (2) – cardboard packs.
Glass ampoules (5) – contour cell packs (1) in a set with solvent (amp. 1 ml 5 pcs.) – cardboard packs.
Glass ampoules (5) – contour cell packs (1) in a set with solvent (amp. 2 ml 5 pcs.) – cardboard packs.

Chondroitin Velpharm [Velpharm, LLC (Russia)]
Capsules 250 mg: 20, 30, 40, 50 or 60 pcs.

Marketing Authorization Holder

Velpharm, LLC (Russia)

Dosage Form

Chondroitin Velpharm

Capsules 250 mg: 20, 30, 40, 50 or 60 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, from light blue to dark blue, size No. 1; capsule contents – powder or compacted mass of white or white with a slight yellowish tint.

	1 caps.
Chondroitin sulfate sodium (calculated on dry substance)	250 mg

Excipients : talc – 5 mg.

Capsule shell composition indigo carmine (indigotine), titanium dioxide, gelatin.

10 pcs. – contour cell packs (PVC/aluminum foil) (2) – cardboard packs.
10 pcs. – contour cell packs (PVC/aluminum foil) (3) – cardboard packs.
10 pcs. – contour cell packs (PVC/aluminum foil) (4) – cardboard packs.
10 pcs. – contour cell packs (PVC/aluminum foil) (5) – cardboard packs.
10 pcs. – contour cell packs (PVC/aluminum foil) (6) – cardboard packs.
20 pcs. – jars made of polypropylene, low-pressure polyethylene (1) – cardboard packs.
30 pcs. – jars made of polypropylene, low-pressure polyethylene (1) – cardboard packs.
40 pcs. – jars made of polypropylene, low-pressure polyethylene (1) – cardboard packs.
50 pcs. – jars made of polypropylene, low-pressure polyethylene (1) – cardboard packs.
60 pcs. – jars made of polypropylene, low-pressure polyethylene (1) – cardboard packs.

Chondroitin Velpharm [Velpharm, LLC (Russia)]
Capsules 500 mg: 20, 30, 40, 50 or 60 pcs.

Marketing Authorization Holder

Velpharm, LLC (Russia)

Dosage Form

Chondroitin Velpharm

Capsules 500 mg: 20, 30, 40, 50 or 60 pcs.

Dosage Form, Packaging, and Composition

Capsules

Hard gelatin capsules, from light blue to dark blue in color, size No. 0; the capsule contents are a powder or compacted mass of white or white with a slightly yellowish tint color.

	1 caps.
Chondroitin sulfate sodium (calculated on a dry substance basis)	500 mg

Excipients: talc – 10 mg.

Capsule shell composition: indigotine (indigo carmine), titanium dioxide, gelatin.

10 pcs. – contour cell packs (PVC/aluminum foil) (2) – cardboard packs.
10 pcs. – contour cell packs (PVC/aluminum foil) (3) – cardboard packs.
10 pcs. – contour cell packs (PVC/aluminum foil) (4) – cardboard packs.
10 pcs. – contour cell packs (PVC/aluminum foil) (5) – cardboard packs.
10 pcs. – contour cell packs (PVC/aluminum foil) (6) – cardboard packs.
20 pcs. – polypropylene, low-density polyethylene jars (1) – cardboard packs.
30 pcs. – polypropylene, low-density polyethylene jars (1) – cardboard packs.
40 pcs. – polypropylene, low-density polyethylene jars (1) – cardboard packs.
50 pcs. – polypropylene, low-density polyethylene jars (1) – cardboard packs.
60 pcs. – polypropylene, low-density polyethylene jars (1) – cardboard packs.

Chondroitin-Apex [Pharmapex, LLC (Russia)]
Solution for intramuscular injection 100 mg/1 ml: amp. 1 ml or 2 ml 5 or 10 pcs.

Marketing Authorization Holder

Pharmapex, LLC (Russia)

Manufactured By

Kursk Biopharmaceutical Plant – Firm “Biok”, FKP (Russia)

Dosage Form

Chondroitin-Apex

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

Dosage Form, Packaging, and Composition

Solution for intramuscular injection

Transparent, colorless or with a yellowish tint.

	1 ml
Chondroitin sulfate sodium	100 mg

Excipients: water for injections – up to 1 ml.

Chondroitin-Binergy [Binergia JSC (Russia)]
Solution for intramuscular and intra-articular injection 100 mg/ml: 1 ml or 2 ml amp. 5 or 10 pcs.

Marketing Authorization Holder

Binergia JSC (Russia)

Manufactured By

Bryntsalov-A, JSC (Russia)

Dosage Form

Chondroitin-Binergy

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

Dosage Form, Packaging, and Composition

Solution for intramuscular and intra-articular injection

Transparent, colorless or with a slightly yellowish tint, with a smell of benzyl alcohol.

	1 amp.
Chondroitin sulfate sodium	100 mg

Excipients: benzyl alcohol, sodium disulfite, sodium hydroxide solution 1M, water for injections.

1 ml – ampoules (5) – cardboard packs.
1 ml – ampoules (10) – cardboard packs.
2 ml – ampoules (5) – cardboard packs.
2 ml – ampoules (10) – cardboard packs.

Chondroitin-Ferein [Bryntsalov-A, JSC (Russia)]
Solution for intramuscular injection 100 mg/ml: 1 ml or 2 ml amp. 5 or 10 pcs.

Marketing Authorization Holder

Bryntsalov-A, JSC (Russia)

Dosage Form

Chondroitin-Ferein

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

Dosage Form, Packaging, and Composition

Solution for intramuscular injection

Transparent, colorless or with a yellowish tint, with a smell of benzyl alcohol.

	1 ml
Chondroitin sulfate	100 mg

Excipients: benzyl alcohol, sodium metabisulfite, sodium hydroxide solution 1 M, water for injections.

1 ml – ampoules (5) – contour cell packs (aluminum/PVC) (1) – cardboard packs.
1 ml – ampoules (5) – contour cell packs (aluminum/PVC) (2) – cardboard packs.
1 ml – ampoules (5) – contour cell packs made of polyvinyl chloride film (1) – cardboard packs.
1 ml – ampoules (5) – contour cell packs made of polyvinyl chloride film (2) – cardboard packs.
1 ml – ampoules (5) – cardboard packs with an insert.
1 ml – ampoules (10) – cardboard packs with an insert.
1 ml – ampoules (5) – plastic contour packs.
1 ml – ampoules (10) – plastic contour packs.
2 ml – ampoules (5) – contour cell packs (aluminum/PVC) (1) – cardboard packs.
2 ml – ampoules (5) – contour cell packs (aluminum/PVC) (2) – cardboard packs.
2 ml – ampoules (5) – contour cell packs made of polyvinyl chloride film (1) – cardboard packs.
2 ml – ampoules (5) – contour cell packs made of polyvinyl chloride film (2) – cardboard packs.
2 ml – ampoules (5) – cardboard packs with an insert.
2 ml – ampoules (10) – cardboard packs with an insert.
2 ml – ampoules (5) – plastic contour packs.
2 ml – ampoules (10) – plastic contour packs.

Chondroitin-Verte [Vertex, JSC (Russia)]
Capsules 250 mg: 30, 50, or 60 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Chondroitin-Verte

Capsules 250 mg: 30, 50, or 60 pcs.

Dosage Form, Packaging, and Composition

Capsules	1 caps.
Chondroitin sulfate	250 mg

60 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.

Chondroitin-Vertex [Vertex, JSC (Russia)]
Capsules 250 mg: 30, 50, 60 or 100 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Chondroitin-Vertex

Capsules 250 mg: 30, 50, 60 or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules

Hard gelatin capsules No. 0, white in color; the capsule contents are a powder or compacted mass from white with a yellowish tint to light yellow in color, disintegrating when pressed with a glass rod.

	1 caps.
Chondroitin sulfate sodium	250 mg

Excipients: lactose monohydrate – 97 mg, calcium stearate – 3 mg.

Composition of the hard gelatin capsule: titanium dioxide – 2%, gelatin – up to 100%.

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
20 pcs. – contour cell packs (5) – cardboard packs.

Medixlife (Author)

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