ARTIDA

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ARTRIDA® (ARTRIDA)

Composition:

Active ingredient: chondroitin sulphate sodium;

1 ampoule (2 ml) contains: chondroitin sodium sulfate, recalculated to 100% substance – 200 mg;

Excipients: benzyl alcohol, water for injections.

Pharmaceutical form. Solution for injection.

Main physicochemical properties: clear, colorless or slightly yellowish liquid with the smell of benzyl alcohol.

Pharmacotherapeutic group.

Drugs affecting the musculoskeletal system. Chondroitin sulfate.

ATC code M01AX25.

Pharmacological Properties.

Pharmacodynamics.

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

The drug inhibits degenerative processes and stimulates regeneration of cartilage tissue, exerting chondroprotective, anti-inflammatory, and analgesic effects; it replaces chondroitin sulfate in joint cartilage that has been catabolized by pathological processes. It suppresses the activity of enzymes causing degradation of joint cartilage: inhibits metalloproteinases, specifically leukocyte elastase. It reduces hyaluronidase activity. Partially blocks the release of free oxygen 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 factors into the synovial fluid by synoviocytes and macrophages of the synovial membrane, as well as due to inhibition of leukotriene B and prostaglandin E secretion.

The 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 production of synovial fluid, improves joint mobility, and contributes to reduction in pain intensity.

Chondroitin sulfate 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 diseases of joints and spine (primary osteoarthritis, intervertebral osteochondrosis, osteoarthrosis), osteoporosis, periodontal diseases, fractures (to accelerate formation of bone callus), as well as for treatment of consequences of joint surgeries.

Contraindications.

Increased individual sensitivity to any component of the drug, tendency to bleeding, thrombophlebitis, renal failure, hepatic insufficiency in decompensation stage. Pregnancy and lactation. Pediatric age (under 18 years).

Interaction with other medicinal products and other types of interactions.

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 action when used simultaneously with glucosamine and other chondroprotective agents. Treatment efficacy increases with diet enrichment with vitamins A, C and salts of manganese, magnesium, copper, zinc and selenium.

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

Special precautions for use.

To achieve a stable clinical effect, at least 25 injections of the drug are required. The therapeutic effect persists for many months after completion of treatment. To prevent exacerbations, repeated treatment courses should be administered. Dose escalation under physician supervision is recommended for patients with excess body weight, peptic ulcer of the stomach, those concurrently using diuretics, and at the beginning of treatment when a faster clinical response is needed.

Treatment should be discontinued in case of allergic reactions or hemorrhages.

Use with caution in patients with coagulation disorders; diabetes mellitus; individuals with increased body weight; patients on a low-salt diet; renal function impairment; and women planning pregnancy.

1 ml of the medicinal product contains 9 mg of benzyl alcohol; therefore, it should not be used in premature infants and newborns. Benzyl alcohol may cause toxic and allergic reactions in infants and children under 3 years of age.

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy and breastfeeding.

Ability to affect reaction rate while driving or operating machinery.

There are no restrictions regarding driving or operating complex machinery during treatment with this drug.

Method of administration and dosage.

The drug should be administered intramuscularly to adults at a dose of 1 ml every other day. If well tolerated, the dose should be increased to 2 ml starting from the fourth injection.

Treatment course – 25–35 injections.

Repeat courses – every 6 months.

Children. Experience with the use of chondroitin sulfate in children is lacking.

Overdose.

To date, there have been no reports of overdose symptoms associated with the use of chondroitin sulfate. Nevertheless, it can be assumed that exceeding the daily dose may enhance the drug's adverse effects. Treatment is symptomatic.

Side effects.

In patients with increased hypersensitivity to the drug, the following disturbances may occur:

Immune system disorders: allergic reactions, anaphylactic shock, angioedema;

Skin and subcutaneous tissue disorders: skin rashes, pruritus, erythema, urticaria, dermatitis, alopecia.

At the injection site, redness, swelling, and pruritus may occur.

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

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

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after medicinal product registration is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Incompatibilities.

No cases of incompatibility have been documented since the beginning of chondroitin sulfate use (1960), 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 in a tray. 2 trays in a cardboard box.

Prescription status.

Prescription only.

Manufacturer.

Haupt Pharma Livron.

Manufacturer's address and location of its operations.

1 Rue Comte de Sainard, 26250 Livron-sur-Drome, France.