Hitart

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT HİTART (HITART)

Composition:

Active substance: sodium chondroitin sulfate;

1 vial (2 ml of medicinal product) contains 200 mg of sodium chondroitin sulfate;

Excipients: benzyl alcohol, water for injections.

Pharmaceutical form. Solution for injection.

Main physicochemical properties: clear colorless or slightly yellowish solution.

Pharmacotherapeutic group. Medicinal products for the musculoskeletal system. Other non-steroidal anti-inflammatory and anti-rheumatic agents. 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). 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 medicinal product 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 inhibits the activity of enzymes causing degradation of articular cartilage: specifically, it inhibits metalloproteinases, including leukocyte elastase. It reduces hyaluronidase activity. It partially blocks the release of reactive oxygen species and promotes inhibition of chemotaxis and antigenic determinants. It stimulates chondrocytes to produce proteoglycans. It affects phosphorus-calcium metabolism in cartilage tissue. It helps restore the mechanical and elastic integrity of the cartilage matrix. The 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 medicinal product 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 a reduction in pain intensity.

Chondroitin sulfate slows down bone 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

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

Interaction with other medicinal products and other forms of interaction

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

When used concomitantly with acetylsalicylic acid or other anticoagulants or antiplatelet agents, monitoring of blood coagulation is recommended. Chondroitin may affect serum concentration of tetracycline when used concomitantly with tetracyclines.

Special precautions

To achieve a stable clinical effect, at least 25 injections of the medicinal product are required. The effect persists for many months after completion of treatment. To prevent exacerbations, repeated courses of treatment are recommended. Dose escalation under physician supervision is recommended for patients with excess body weight, gastric peptic ulcer, those receiving concomitant diuretic therapy, and at the beginning of treatment when a faster clinical response is needed.

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

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.

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

Use during pregnancy or breastfeeding

Contraindicated during pregnancy and breastfeeding.

Ability to affect reaction rate when driving or operating machinery

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

Dosage and Administration

Administer 1 mL intramuscularly every other day to adults. If well tolerated, increase the dose to 2 mL starting from the fourth injection. Treatment course: 25–35 injections. Repeat courses may be administered after 6 months.

Children

There is no experience with the use of this medicinal product in children.

Overdose

To date, there have been no reports of overdose symptoms associated with the use of chondroitin sulfate. However, exceeding the recommended daily dose may enhance the drug's adverse effects. Treatment is symptomatic.

Adverse Reactions

Frequency of adverse reactions according to MedDRA: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare (< 1/10000), frequency not known (based on available data, frequency cannot be determined).

The frequency of adverse reactions with this medicinal product is unknown.

In individuals with increased sensitivity to the medicinal product, the following disorders 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, pruritus, and swelling 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 authorization of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, or their legal representatives, are encouraged to report any suspected adverse reactions and lack of efficacy via the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua

Shelf life. 2 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children. Do not use any remaining medicinal product.

Incompatibilities. No incompatibility cases 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 a vial; 5 vials in a blister pack; 2 blister packs in a cardboard box.

Prescription status. Prescription only.

Manufacturer. Limited liability company "Novofarm-Biosyntez" (full-cycle manufacturing).

Manufacturer's location and address of business activity. 38 Zhитomirska Street, city of Zvyahel, Zvyahel district, Zhytomyr region, 11700, Ukraine.

Manufacturer. ASTRAFARM LLC (secondary packaging).

Manufacturer's location and address of business activity. 6 Kyivska Street, city of Vyshneve, Bucha district, Kyiv region, 08132, Ukraine.

Marketing Authorization Holder: ASTRAFARM LLC.

Address of Marketing Authorization Holder. 6 Kyivska Street, city of Vyshneve, Bucha district, Kyiv region, 08132, Ukraine.