Instructions Staurum solution for injection 200 mg / 2 ml 2 ml No. 10
Composition
active ingredient: chondroitin sodium sulfate;
1 ml contains chondroitin sodium sulfate 100 mg;
Excipients: benzyl alcohol, 0.1 M sodium hydroxide solution or 0.1 M hydrochloric acid solution, water for injection.
Dosage form
Solution for injection.
Main physicochemical properties: pale yellow transparent solution, almost free from foreign particles.
Pharmacotherapeutic group
Drugs affecting the musculoskeletal system. Nonsteroidal anti-inflammatory and antirheumatic drugs. Chondroitin sulfate. ATX code M01A X25.
Pharmacological properties
Pharmacodynamics
The main 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 mucopolysaccharide. It is the main component of proteoglycans, which together with collagen fibers form the cartilage matrix.
The drug inhibits the process of degeneration and stimulates the regeneration of cartilage tissue, has a chondroprotective, anti-inflammatory, analgesic effect. Replaces chondroitin sulfate of articular cartilage, catabolized by the pathological process. Inhibits the activity of enzymes that cause degradation of articular cartilage: inhibits metalloproteinases, namely leukocyte elastase. Reduces the activity of hyaluronidase. Partially blocks the release of free oxygen radicals; helps block chemotaxis, antigenic determinants. Stimulates the production of proteoglycans by chondrocytes. Affects phosphorus-calcium metabolism in cartilage tissue. Allows you to restore the 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 by inhibiting the secretion of leukotriene B and prostaglandin E.
The use of the drug promotes the restoration of the joint capsule and cartilaginous surfaces of the joints, prevents compression of the connective tissue, acts as a lubricant for the joint surfaces, normalizes the production of joint fluid, improves joint mobility, and helps reduce the intensity of pain.
Chondroitin sulfate slows down bone resorption and reduces calcium loss, accelerating bone tissue repair processes.
Pharmacokinetics
Chondroitin sulfate sodium is rapidly absorbed. Already 30 minutes after intramuscular injection, it is detected in significant concentrations in the blood: Cmax is reached in 1 hour, then gradually decreases over 2 days.
Chondroitin sulfate sodium accumulates mainly in cartilaginous joints. The synovial membrane is not a barrier to its penetration into the joint cavity.
Chondroitin sulfate sodium is detected in the synovial fluid 15 minutes after intramuscular injection, and then in the articular cartilage, where its content reaches a maximum after 48 hours.
The maximum concentration in the synovial fluid is reached 4–5 hours after injection. It is excreted from the body within 24 hours. It is eliminated mainly by the kidneys.
Indication
Degenerative-dystrophic diseases of the joints and spine: symptomatic treatment of osteoarthritis, arthropathy, intervertebral osteochondrosis, deforming osteoarthritis.
Contraindication
Increased individual sensitivity to chondroitin sulfate sodium or to any of the components of the drug, especially to benzyl alcohol, bleeding or tendency to bleeding, thrombophlebitis, liver failure, renal failure.
Interaction with other medicinal products and other types of interactions
When used simultaneously with glucocorticosteroids and nonsteroidal anti-inflammatory drugs, chondroitin sulfate can reduce the need for them, as well as for painkillers. It shows synergistic action when used simultaneously with glucosamine and other chondroprotectors. The effectiveness of treatment increases when the diet is enriched with vitamins A, C and salts of manganese, magnesium, copper, zinc and selenium.
When used simultaneously with acetylsalicylic acid or other anticoagulants or antiplatelet agents, it is recommended to monitor blood clotting. When used simultaneously with tetracyclines, chondroitin may affect the concentration of tetracycline in the blood serum.
Application features
Chondroitin sulfate should not be used in patients with prostate cancer or at increased risk of developing prostate cancer due to the possible risk of increasing the spread or recurrence of prostate cancer.
Chondroitin sulfate should not be used in patients with bronchial asthma.
To achieve a stable clinical effect, at least 25 injections of the drug are required. The effect persists for many months after the end of treatment. To prevent exacerbations, repeated courses of treatment should be used. It is recommended to increase doses under the supervision of a physician for patients with excess body weight, peptic ulcer of the stomach, while taking diuretics, as well as at the beginning of treatment if it is necessary to accelerate the clinical response.
In case of allergic reactions or hemorrhages, treatment should be discontinued.
1 ml of solution contains 12 mg of benzyl alcohol, which can cause poisoning and pseudoanaphylactic reactions in infants and children under 3 years of age.
Patients with liver failure.
There is no clinical experience with the use of chondroitin sulfate in patients with impaired liver function.
Patients with renal failure.
There is no clinical experience with the use of chondroitin sulfate in patients with renal impairment.
Use during pregnancy or breastfeeding
Do not use during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
There are no restrictions on driving vehicles and other complex mechanisms when using the drug.
Method of administration and doses
The drug is administered intramuscularly to adults in a dose of 1 ml every other day. In case of good tolerance, the dose is increased to 2 ml, starting from the fourth injection. The course of treatment is 25–35 injections. Repeated courses are carried out after 6 months.
Children
There is no experience with the use of the drug in children. Do not use in children.
Overdose
There are no data on overdose.
Adverse reactions
Adverse reactions are classified according to frequency as follows: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10000, < 1/1000); very rare (< 1/10000); frequency unknown (cannot be estimated from the available data).
When using the drug in people with increased hypersensitivity to the drug, the following disorders are possible:
from the immune system:
frequency unknown: allergic reactions, anaphylactic shock, angioedema;
from the skin and subcutaneous tissue:
Rare: erythema, skin rash, maculopapular rash;
very rare: itching, urticaria, dermatitis;
frequency unknown: alopecia; redness and itching at the injection site are possible;
from the gastrointestinal tract:
rarely: nausea, abdominal pain, diarrhea;
frequency unknown: vomiting, flatulence, dyspeptic phenomena, heartburn;
others:
frequency unknown: visual disturbances, keratopathy, dizziness, peripheral edema.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions after the marketing authorisation of a medicinal product is of great importance. This allows for continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions via the national reporting system.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Incompatibility.
No cases of incompatibility have been documented since the beginning of the use of chondroitin sulfate (1960), however, mixing solutions of high molecular weight polysaccharides (including chondroitin sulfate) with solutions of other drugs should be avoided.
Packaging
2 ml in an ampoule, 5 or 10 ampoules in a cardboard pack.
Vacation category
According to the recipe.
Producer
K.T. Rompharm Company SRL/SC Rompharm Company SRL
Location of the manufacturer and address of its place of business
Eroilor str. No 1 A, Otopeni city, 075100, county Ilfov, Romania.
