Chondroxide® (Tablets, Solution, Gel) 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
Tissue regeneration 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 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 contributes to reducing 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 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 Cmax of Chondroitin sulfate sodium in plasma is reached after 1 hour, then gradually decreases over 2 days.
Chondroitin sulfate sodium accumulates primarily 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. |
Tablets
The drug should be taken orally at a dose of 500 mg (2 tablets) twice daily, with a small amount of water.
The recommended duration of the initial treatment course is 6 months.
The therapeutic effect of the drug persists for 3-5 months after its discontinuation, depending on the location and stage of the disease. If necessary, repeated courses of treatment can be conducted, the duration of which is determined individually.
Solution
Administer intramuscularly 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 can be conducted after 6 months.
Gel
The ointment or gel should be applied 2-3 times/day to the skin over the affected area. The ointment is rubbed in until completely absorbed for 2-3 minutes. The course of treatment with the ointment is 2-3 weeks. The gel is easily rubbed in with patting movements for 2-3 minutes until completely absorbed. The course of treatment with the gel ranges from 2-3 weeks to 2-3 months. If necessary, the treatment course is repeated.
Adverse Reactions
Allergic reactions infrequently – skin itching, erythema, urticaria, dermatitis, angioneurotic edema.
Gastrointestinal 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
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.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Tablets 250 mg: 30, 50, 60, 90 or 100 pcs.
Marketing Authorization Holder
Nizhpharm JSC (Russia)
Manufactured By
Chemopharm, LLC (Russia)
Dosage Form
 |
Chondroxide® | Tablets 250 mg: 30, 50, 60, 90 or 100 pcs. |
Dosage Form, Packaging, and Composition
Tablets from white with a yellowish tint to white with a creamy tint, inclusions are allowed, with a score and a bevel.
| 1 tab. | |
| Chondroitin sulfate sodium | 250 mg |
Excipients : calcium stearate monohydrate (calcium stearate 1-hydrate) – 4.8 mg, crospovidone (polyplasdone XL-10, kollidon CL-M) – 12.39 mg, povidone K30 (kollidon 30) – 9.312 mg, microcrystalline cellulose – 96 mg, magnesium hydroxycarbonate pentahydrate (basic magnesium carbonate hydrate) – 107.498 mg.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
Solution for intramuscular injection 100 mg/1 ml: amp. 1 ml or 2 ml 5 or 10 pcs.
Marketing Authorization Holder
Nizhpharm JSC (Russia)
Manufactured By
Belmedpreparaty RUP (Republic of Belarus)
Dosage Form
 |
Chondroxide® | 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 slight yellowish tint, with the smell of benzyl alcohol.
| 1 ml | |
| Chondroitin sulfate | 100 mg |
Excipients : benzyl alcohol – 9 mg, water for injections – up to 1 ml.
1 ml – glass ampoules (5) – contour cell packs (1) – cardboard packs.
1 ml – glass ampoules (5) – contour cell packs (2) – cardboard packs.
2 ml – glass ampoules (5) – contour cell packs (1) – cardboard packs.
2 ml – glass ampoules (5) – contour cell packs (2) – cardboard packs.
Gel for external use 5%: tubes 20 g, 25 g, 30 g, 35 g, or 40 g
Ointment for external use 5%: tubes 30 g or 50 g
Marketing Authorization Holder
Nizhpharm JSC (Russia)
Dosage Forms
|
Chondroxide® | Gel for external use 5%: tubes 20 g, 25 g, 30 g, 35 g, or 40 g |
| Ointment for external use 5%: tubes 30 g or 50 g |
Dosage Form, Packaging, and Composition
Gel for external use yellowish, semi-transparent, with a fruity odor.
| 1 g | |
| Chondroitin sulfate sodium | 50 mg |
Excipients : dimethyl sulfoxide (dimexide) – 100 mg, propylene glycol (1,2-propanediol) – 50 mg, isopropanol (isopropyl alcohol, 2-propanol) – 50 mg, ethanol (ethyl alcohol) – 200 mg, sodium disulfite (sodium metabisulfite) – 0.5 mg, methylparahydroxybenzoate (nipagin, methylparaben) – 1.2 mg, propylparahydroxybenzoate (nipasol, propylparaben) – 0.3 mg, carbomer (carbopol) – 35 mg, orange flavor (food flavor “Orange”) – 5 mg, purified water – up to 1 g.
20 g – aluminum tubes (1) – cardboard packs.
25 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
35 g – aluminum tubes (1) – cardboard packs.
40 g – aluminum tubes (1) – cardboard packs.
Ointment for external use light yellow in color with the smell of dimethyl sulfoxide.
| 1 g | |
| Chondroitin sulfate sodium | 50 mg |
Excipients : dimethyl sulfoxide (dimexide) – 100 mg, lanolin – 150 mg (anhydrous lanolin, wool wax), petrolatum – 485 mg, distilled monoglycerides – 15 mg, purified water – up to 1 g.
30 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
![Chondroxide® [Tablets, Solution, Gel] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Chondroxide® [Tablets, Solution, Gel] 2")