Mastodon

Chondroitin (Ointment, Gel) Instructions for Use

ATC Code

M01AX25 (Chondroitin sulfate)

Active Substance

Chondroitin sulfate sodium (Ph.Eur. European Pharmacopoeia)

Clinical-Pharmacological Group

A drug that stimulates the process of cartilage tissue regeneration, with anti-inflammatory action

Pharmacotherapeutic Group

Other agents for the treatment of musculoskeletal system diseases

Pharmacological Action

A drug that affects phosphorus-calcium metabolism in cartilage tissue, 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, 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 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.

When applied externally, it slows the progression of osteoarthritis. It normalizes metabolism in hyaline tissue. It stimulates the regeneration of articular cartilage.

Pharmacokinetics

Chondroitin sulfate after application to the skin quickly and selectively penetrates into the joint tissues, reaching Cmax after 30 minutes, followed by a biphasic elimination from the cartilage tissue. The completion of the rapid elimination phase occurs 1 hour after application. The retention time in the joint is 5 hours.

Indications

  • Degenerative-dystrophic diseases of the joints and spine.
  • Osteoarthritis of peripheral joints.
  • Intervertebral osteoarthritis and osteochondrosis.

Apply the preparation to manage symptoms associated with cartilage degradation and to stimulate tissue regeneration processes.

ICD codes

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

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.

Apply the ointment or gel externally to the affected area two to three times daily. Rub it in gently until fully absorbed.

The standard treatment course is two to three weeks. The duration of therapy can be adjusted based on the severity of symptoms and clinical response. Do not apply to open wounds or damaged skin.

Adverse Reactions

Adverse reactions are generally infrequent and mild in nature. Discontinue use if any severe reactions occur.

Local skin reactions at the application site may include itching, erythema, and urticaria. Allergic contact dermatitis is possible in individuals with known hypersensitivity to the active substance or any excipient.

Contraindications

  • Hypersensitivity to chondroitin sulfate or any other component of the formulation.

Exercise caution in specific patient populations due to limited safety data. Avoid application on mucous membranes, damaged skin, or open wounds.

Drug Interactions

No specific drug interactions have been reported with the topical application of this preparation.

The systemic absorption of chondroitin sulfate after topical use is minimal, making clinically significant pharmacokinetic interactions unlikely. Monitor for potential effects when using concurrently with other topical medications applied to the same area.

Overdose

Overdose from topical application is unlikely due to limited systemic absorption. Excessive application may lead to localized skin irritation.

In case of accidental ingestion, seek medical attention. Treatment is symptomatic and supportive. There is no specific antidote.

Use in Pregnancy and Lactation

Use with caution during pregnancy and the period of breastfeeding.

Pediatric Use

Use with caution 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.

Storage Conditions

Store at 2°C (36°F) to 15°C (59°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

West, LLC (Russia)

Manufactured By

Samaramedprom, OJSC (Russia)

Dosage Form

Bottle OTC Icon Chondroitin Ointment for external use 5%: jars or tubes 25 g, 30 g, 40 g, 50 g, or 100 g

Dosage Form, Packaging, and Composition

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

100 g
Chondroitin sulfate sodium* 5 g

* calculated on the dry substance.

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

25 g – jars (1) – cardboard packs.
30 g – jars (1) – cardboard packs.
40 g – jars (1) – cardboard packs.
50 g – jars (1) – cardboard packs.
100 g – jars (1) – cardboard packs.
25 g – tubes (1) – cardboard packs.
30 g – tubes (1) – cardboard packs.
40 g – tubes (1) – cardboard packs.
50 g – tubes (1) – cardboard packs.
100 g – tubes (1) – cardboard packs.

Marketing Authorization Holder

Zelenaya Dubrava, CJSC (Russia)

Dosage Form

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

Dosage Form, Packaging, and Composition

Ointment for external use homogeneous, light yellow in color with a specific odor of dimethyl sulfoxide.

1 g
Chondroitin sulfate sodium (calculated on 100% dry substance) 0.05 g

Excipients : petrolatum – 0.485 g, lanolin – 0.15 g, dimethyl sulfoxide – 0.1 g, distilled monoglycerides – 0.015 g, purified water – up to 1 g.

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

Marketing Authorization Holder

Ivanovo Pharmaceutical Factory PJSC (Russia)

Dosage Form

Bottle OTC Icon Chondroitin Ointment for external use 5%: jars or tubes 30 g, 50 g, or 100 g

Dosage Form, Packaging, and Composition

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

100 g
Chondroitin sulfate sodium (calculated on the dry substance) 5 g

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

30 g – jars (1) – cardboard packs.
50 g – jars (1) – cardboard packs.
100 g – jars (1) – cardboard packs.
30 g – tubes (1) – cardboard packs.
50 g – tubes (1) – cardboard packs.
100 g – tubes (1) – cardboard packs.

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Chondroitin Ointment for external use 5%: tubes 10 g, 20 g, 30 g, 40 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 (calculated on the dry substance) 5 g

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

10 g – tubes (1) – cardboard packs.
20 g – tubes (1) – cardboard packs.
30 g – tubes (1) – cardboard packs.
40 g – tubes (1) – cardboard packs.
50 g – tubes (1) – cardboard packs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Bottle OTC Icon Chondroitin-Vertex Gel for external use 5%: tubes 30 g or 50 g

Dosage Form, Packaging, and Composition

Gel for external use colorless or with a light yellow tint, transparent, with a specific odor; opalescence and the presence of air bubbles are allowed.

1 g
Chondroitin sulfate sodium 50 mg

Excipients : dimethyl sulfoxide – 75 mg, propylene glycol – 75 mg, carbomer – 30 mg, trolamine (triethanolamine) – 30 mg-40 mg (to pH 6.0), macrogol glyceryl hydroxystearate – 4 mg, disodium edetate – 1 mg, methylparahydroxybenzoate (methylparaben) – 1 mg, lavender oil – 1 mg, orange flower oil (neroli oil) – 0.5 mg, purified water – up to 1 g.

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

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