Staurem

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT STHAURUM

Composition:

Active substance: sodium chondroitin sulfate;

1 ml contains sodium chondroitin sulfate 100 mg;

Excipients: benzyl alcohol, 0.1 M sodium hydroxide solution or 0.1 M hydrochloric acid solution, water for injections.

Pharmaceutical form. Solution for injection.

Main physicochemical properties: pale yellow clear solution, almost free from foreign particles.

Pharmacotherapeutic group. Medicinal products affecting the musculoskeletal system. 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 and is a key 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 joint cartilage that has been catabolized by pathological processes. It inhibits the activity of enzymes responsible for degradation of joint 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 influences phosphorus-calcium metabolism in cartilage tissue and 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-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.

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 helps reduce pain intensity.

Chondroitin sodium sulfate slows down bone tissue resorption, reduces calcium loss, and accelerates bone tissue regeneration.

Pharmacokinetics

Sodium chondroitin sulfate is rapidly absorbed. Significant concentrations in the blood are detectable as early as 30 minutes after intramuscular injection; Cmax is reached within 1 hour, then gradually decreases over 48 hours.

Sodium chondroitin sulfate accumulates predominantly in joint cartilage. The synovial membrane does not act as a barrier to its penetration into the joint cavity.

Sodium chondroitin sulfate appears in the synovial fluid within 15 minutes after intramuscular administration, and subsequently in the articular cartilage, where its concentration reaches a maximum within 48 hours.

Maximum concentration in synovial fluid is achieved 4–5 hours after injection. It is eliminated from the body within 24 hours. Excretion occurs primarily via the kidneys.

Clinical characteristics

Indications. Degenerative-dystrophic diseases of joints and spine: symptomatic treatment of osteoarthritis, arthropathy, intervertebral osteochondrosis, deforming osteoarthritis.

Contraindications. Hypersensitivity to sodium chondroitin sulfate or to any of the excipients, particularly benzyl alcohol, bleeding or tendency to bleeding, thrombophlebitis, hepatic insufficiency, renal insufficiency.

Interaction with other medicinal products and other forms of interaction

When used concomitantly with glucocorticosteroids 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 is enhanced by enriching the diet 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 for use

Chondroitin sulfate should not be administered to patients with prostate cancer or those at increased risk of developing prostate cancer due to a potential risk of increased prostate cancer progression or recurrence.

Chondroitin sulfate should not be administered to patients with bronchial asthma.
Patients with bronchial asthma may be at risk of asthma attacks when taking glucosamine-chondroitin sulfate.

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 treatment courses should be administered. Dose escalation under physician supervision is recommended for patients with excess body weight, peptic ulcer disease, those concurrently using diuretics, and at the beginning of treatment if an accelerated clinical response is needed.

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

1 ml of solution contains 12 mg of benzyl alcohol, which may cause poisoning and pseudoanaphylactic reactions in infants and children under 3 years of age.

Patients with hepatic impairment. There are no clinical data on the use of chondroitin sulfate in patients with impaired liver function.

Patients with renal impairment. There are no clinical data on the use of chondroitin sulfate in patients with impaired kidney function.

Sodium content. This medicinal product contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is practically sodium-free.

Use during pregnancy or breastfeeding. Do not use during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery. There are no restrictions regarding driving vehicles or operating other complex machinery during use of this medicinal product.

Administration and Dosage

Administer the medicinal product intramuscularly to adults at a dose of 1 mL every other day. In case of good tolerance, increase the dose to 2 mL starting from the fourth injection. Treatment course — 25–35 injections. Repeat courses — after 6 months.

Children. There is no experience with the use of the medicinal product in children. Do not use in children.

Overdose. Data regarding overdose are unavailable.

Side effects

The frequency of adverse reactions is defined according to the following categories: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10,000, < 1/1000); very rare (< 1/10,000); frequency not known (cannot be estimated from the available data).

When the medicinal product is used in individuals with hypersensitivity to its components, the following disorders may occur:

Immune system disorders:

Frequency not known: allergic reactions, anaphylactic shock, angioneurotic edema;

Skin and subcutaneous tissue disorders:

Rare: erythema, skin rashes, maculopapular rashes;

Very rare: itching sensation, urticaria, dermatitis;

Frequency not known: alopecia; at the injection site, redness and itching may occur;

Gastrointestinal disorders:

Rare: nausea, abdominal pain, diarrhea;

Frequency not known: vomiting, flatulence, dyspeptic symptoms, heartburn;

Other:

Frequency not known: visual disturbances, keratopathy, dizziness, peripheral edema.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after the medicinal product is authorized is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions

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

Keep out of reach and sight of children.

Incompatibility. 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 an ampoule; 5 or 10 ampoules per cardboard pack.

Prescription status. Prescription only.

Manufacturer. K.T. Rompharm Company S.R.L./S.C. Rompharm Company S.R.L.

Manufacturer's address and place of business. Str. Eroilor No. 1A, Otopeni, 075100, Ilfov County, Romania – Rompharm 1 and Rompharm 2 buildings / Eroilor str. No 1A, Otopeni city, 075100, county Ilfov, Romania – building Rompharm 1 and Rompharm 2.