Sustamol ZD chondro (Ointment) Instructions for Use

Marketing Authorization Holder

Zelenaya Dubrava, CJSC (Russia)

ATC Code

M01AX25 (Chondroitin sulfate)

Active Substance

Chondroitin sulfate sodium (Ph.Eur. European Pharmacopoeia)

Dosage Form

Sustamol ZD chondro

Ointment for external use 5%: tubes 30 g or 50 g

Dosage Form, Packaging, and Composition

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

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 boxes.
50 g – aluminum tubes (1) – cardboard boxes.

Clinical-Pharmacological Group

Drug regulating metabolism in cartilage tissue

Pharmacotherapeutic Group

Tissue repair stimulant

Pharmacological Action

A substance 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.

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, rapidly and selectively penetrates into joint tissues, reaching C_max within 30 minutes, followed by 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).

ICD codes

Dosage Regimen

Apply the ointment externally to the affected skin area. Use a thin layer of the preparation.

Rub the ointment in with gentle, circular motions until fully absorbed.

Apply the ointment 2-3 times per day for the standard treatment course.

The standard treatment duration is 2 to 3 weeks.

If required, repeat the treatment course after a medical consultation.

Avoid application on damaged skin, open wounds, or mucous membranes.

Wash hands thoroughly with soap and water after each application.

Do not apply occlusive dressings over the treated area unless directed by a physician.

Discontinue use and consult a doctor if allergic reactions or skin irritation occur.

Do not exceed the recommended dosage or duration of use without medical supervision.

Adverse Reactions

Allergic reactions infrequently – skin itching, erythema, urticaria.

Contraindications

Hypersensitivity to chondroitin sulfate.

With caution

Pregnancy, breastfeeding period, childhood and adolescence under 18 years.

Use in Pregnancy and Lactation

Use with caution during pregnancy and 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 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.