International non-proprietary name:Chondroitin sulfate.

 

Composition

Affected substance:   1 ampoule contains  200 mg of chondroitin sulfate (in the form of chondroitin sodium sulfate).

Auxiliary substances:benzyl alcohol, 0.1M sodium hydroxide solution or 0.1M hydrochloric acid solution

• Water for injection, pH up to 6.0-7.5.

 

Description

It is a clear, colorless or slightly yellowish liquid.

 

Pharmacotherapeutic group

Other non-steroidal anti-inflammatory and anti-rheumatic drugs.

ATC code:M01AX25.

 

pharmacological properties

Pharmacodynamics

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

The drug has an anti-inflammatory, analgesic effect. It reduces the activity of enzymes that cause the degradation of joint cartilage: it inhibits metalloproteinases, especially leukocyte elastase. Free oxygen partially blocks the release of radicals; causes chemotaxis, blockade of antigenic determinants. Anti-inflammatory and analgesic effects are obtained as a result of reducing the secretion of inflammatory mediators and pain factors into the synovial fluid by synoviocytes and macrophages of the synovial membrane, as well as turning off the secretion of leukotriene B4 and prostaglandin E2.

The use of the drug prevents the accumulation of connective tissue, plays a role in the lubrication of joint surfaces, normalizes the production of joint fluid, improves the mobility of the joints, causes a decrease in the intensity of pain, and improves the quality of life.

Pharmacokinetics

After intramuscular injection, the maximum concentration is recorded within 1 hour, then the concentration of the drug slowly decreases within 2 days. It accumulates mainly in the cartilage tissue (the maximum concentration in the articular cartilage is noted after 48 hours); the synovial membrane does not prevent it from passing into the joint cavity.

It is mainly excreted by the kidneys within 24 hours.

 

Instructions for use

 Degenerative-dystrophic diseases of joints and spine:

• primary arthrosis;

• osteoarthrosis, mainly with damage to large joints;

• intervertebral osteochondrosis.

Contraindications

Individual hypersensitivity to any of the components of the preparation, tendency to bleeding, thrombophlebitis, pregnancy, lactation period (breastfeeding should be stopped during treatment). Children up to 15 years of age (effectiveness and safety have not been established).

With caution: in disorders of blood coagulation, diabetes, people with excessive body mass, patients on a diet with a low level of salts, children under 18 years, kidney function disorders, women planning pregnancy.

 

Special instructions and precautions

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

At least 25 injections of the Xondromed drug are needed to achieve a stable clinical effect. After the end of the treatment course, the effect is kept long-term for several months. Repeated courses of treatment are indicated to prevent exacerbation.

 

Interaction with other drugs

When used together with non-steroidal anti-inflammatory drugs, Khondromed causes a decrease in their dose.

It is possible to increase the effect of indirect anticoagulants, antiaggregants, fibrinolytics, which requires more frequent monitoring of blood coagulation indicators during joint use.

 

Use during pregnancy and lactation

Due to the lack of data confirming the safety of use of the drug during pregnancy and lactation in women, it is not recommended to use this drug during these periods.

 

Use in pediatrics

Due to the lack of data on the safety and efficacy of the drug in children, it is not recommended to prescribe this drug to children. 

 

Effects on the ability to drive vehicles and other potentially dangerous mechanisms

It does not affect the ability to drive vehicles and other potentially dangerous mechanisms.

 

Method of use and dosage

The drug is administered intramuscularly in a dose of 1 ml daily. If the injection goes well, the dose is increased to 2 ml starting from the 4th injection. Treatment course – 25-35 injections. After the doctor's advice, it is advisable to repeat the course of treatment after 6 months.

 

Additional effect

Allergic reactions: skin itching, erythema, urticaria, dermatitis.

Digestive system: rare - nausea, vomiting, diarrhea.

Other: bleeding at the injection site.    

 

Overdose

Symptoms: allergic reactions, hemorrhages at the injection site.

Treatment: if necessary, symptomatic treatment is prescribed.

 

Release form  

2 ml of solution in a colorless glass ampoule with a break ring.  5 bulbs in slotted packaging. 1 or 2 slot packaging is packed in a cardboard box with an insert.

 

Store condition

It should be stored at a temperature not higher than 25 ºC, protected from light and out of the reach of children.

 

Shelf life

3 years.

Do not use after the expiration date.

 

Condition of release from pharmacy

It is released on the basis of a prescription.

 

Producer

Lekfarm; BMMC, Republic of Belarus, Minskaya str., 2a, 223141, Logoysk city,

Tel.:/Fax:+375 1774 53-801.

Email: office@lekpharm.by