Chondrosat

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT CHONDROSAT CHONDROSUT

Composition:

Active substance: 1 ampoule (2 ml) contains 200 mg of chondroitin sodium sulfate, calculated as the dry substance;

Excipients: benzyl alcohol, water for injections.

Pharmaceutical form. Solution for injection.

Main physicochemical properties: clear, colorless or slightly yellowish liquid.

Pharmacotherapeutic group. Drugs affecting the musculoskeletal system. Chondroitin sulfate. ATC Code M01AX25.

Pharmacological Properties

Pharmacodynamics

The active ingredients of the medicinal product are sodium salts of chondroitin sulfate A and C (average molecular weight 11,000 daltons). Sodium chondroitin sulfate is a high-molecular-weight mucopolysaccharide. It is a major component of proteoglycans, which, together with collagen fibers, form the cartilage matrix.

The drug inhibits the degenerative process and stimulates regeneration of cartilage tissue, exerting chondroprotective, anti-inflammatory, and analgesic effects. It replaces chondroitin sulfate in articular cartilage that has been catabolized by the pathological process. It suppresses the activity of enzymes responsible for degradation of articular cartilage: inhibits metalloproteinases, particularly leukocyte elastase. It reduces hyaluronidase activity. Partially blocks the release of oxygen free radicals; promotes inhibition of chemotaxis and antigenic determinants. Stimulates chondrocytes to produce proteoglycans. Influences phosphorus-calcium metabolism in cartilage tissue. Helps restore mechanical and elastic integrity of the cartilage matrix. Anti-inflammatory and analgesic effects are achieved by reducing the release of inflammatory mediators and pain-inducing factors into the synovial fluid by synoviocytes and macrophages of the synovial membrane, as well as by inhibiting the secretion of leukotriene B and prostaglandin E.

Use of the drug promotes restoration of the joint capsule and articular cartilage surfaces, prevents compression of connective tissue, acts as a lubricant for joint surfaces, normalizes synovial fluid production, improves joint mobility, reduces pain intensity, and enhances quality of life.

The drug slows down bone tissue resorption and reduces calcium loss, while accelerating bone tissue regeneration processes.

Pharmacokinetics

After intramuscular administration, chondroitin sulfate penetrates into the synovial fluid. Maximum concentration in synovial fluid is reached within 4–5 hours after injection. It is eliminated from the body within 24 hours. Excretion occurs predominantly via the kidneys.

Clinical characteristics.

Indications.

Degenerative-dystrophic joint and spinal diseases (primary osteoarthritis, intervertebral osteochondrosis, osteoarthrosis), osteoporosis, periodontal diseases, fractures (to accelerate formation of bony callus). Treatment of post-surgical joint complications.

Contraindications.

Hypersensitivity to any component of the drug, predisposition to bleeding, thrombophlebitis, renal failure, hepatic insufficiency in the stage of decompensation.

Interaction with other medicinal products and other forms of interaction.

When used concomitantly with glucocorticoids and nonsteroidal anti-inflammatory agents, chondroitin sulfate may reduce the need for these drugs as well as for analgesics. It exhibits synergistic effects when used simultaneously with glucosamine and other chondroprotective agents. Treatment efficacy is enhanced by enriching the diet with vitamins A and C, and salts of manganese, magnesium, copper, zinc, and selenium.

When administered concurrently with acetylsalicylic acid or other anticoagulants or antiplatelet agents, monitoring of blood coagulation is recommended. When used concomitantly with tetracycline, chondroitin may affect tetracycline concentration in blood serum.

Usage characteristics.

Use with caution: in disorders of blood coagulation, diabetes mellitus, increased body weight, adherence to a low-salt diet, renal function impairment, and in women planning pregnancy.

For achieving a stable clinical effect, at least 25 injections of the drug are required. The effect persists for many months after completion of treatment. To prevent exacerbations, repeated treatment courses are recommended. Dose escalation under physician supervision is recommended for patients with excess body weight, gastric or duodenal peptic ulcer, those concurrently using diuretics, and at the beginning of treatment when an accelerated clinical response is needed.

If allergic reactions or hemorrhages occur, treatment should be discontinued. 2 ml of solution contains 18 mg of benzyl alcohol, which may cause pseudoanaphylactic reactions and other manifestations of allergy in infants and children under 3 years of age.

Use during pregnancy or breastfeeding.

Do not use during pregnancy and breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

There are no restrictions regarding driving or operating complex machinery during use of this medication.

Administration and Dosage

The drug is administered intramuscularly to adults at a dose of 1 ml every other day. If tolerated well, the dose may be increased to 2 ml starting from the fourth injection. The treatment course consists of 25–35 injections. Repeat courses should be administered after 6 months.

Children

There is no experience with the use of the drug in children.

Overdose

To date, there have been no reports of overdose symptoms associated with the use of this medicinal product. Nevertheless, it can be assumed that exceeding the daily dose may enhance the manifestation of adverse drug reactions. Treatment is symptomatic.

Side effects.

When using the drug in individuals with increased sensitivity to it, the following disorders are possible:

From the immune system: allergic reactions, anaphylactic shock, angioneurotic edema;

From the skin and subcutaneous tissue: skin rashes, itching, erythema, urticaria, dermatitis, alopecia.

At the injection site, redness and itching may occur.

Gastrointestinal disorders may occur: nausea, vomiting, abdominal pain, flatulence, dyspeptic symptoms.

Other: disturbances of visual organs, keratopathy, dizziness, peripheral edema.

Shelf life.

3 years. It is forbidden to use the medicinal product after the expiry date.

Storage conditions.

Store in the original packaging, protected from light, at a temperature between 2 and 8 °C.

Keep out of reach of children.

Incompatibility.

Since the beginning of the use of chondroitin sulfate (1960), no cases of incompatibility have been documented. However, mixing solutions of high-molecular-weight polysaccharides (including chondroitin sulfate) with solutions of other medicinal products should be avoided.

Packaging.

2 ml in ampoules. 5 ampoules per blister; 2 blisters per cardboard box.

Prescription status. Prescription only.

Manufacturer: LLC "FZ "STADA", Ukraine.

Manufacturer's address and place of business.

37, Kyivska St., Bila Tserkva, Kyiv region, 09100, Ukraine.