Chondroitin sulfate - instructions for use, dose, side effects, contraindications

Active substance:
Chondroitin sodium sulfate (in terms of dry matter)	- 100.0 mg
Excipients:
Sodium disulfite	2.0 mg
Methylparahydroxybenzoate	- 0.5 mg
1 M sodium hydroxide solution	- to pH 6.0-7.5
Water for injections	- up to 1.0 ml

Description:Transparent, colorless or slightly yellowish shade solution.

Pharmacotherapeutic group:Reparation of tissue stimulant

ATX: & nbsp

M.01.A.X.25 Chondroitin sulfate

Pharmacodynamics:

Chondroitin sulfate is the main component of proteoglycans that make up the cartilaginous matrix together with collagen fibers.

Pharmacodynamics

Has chondro-stimulating, regenerating, anti-inflammatory and analgesic effect. Chondroitin sulfate participates in the construction of the main substance of cartilage and bone tissue. Has chondroprotective properties; strengthens metabolic processes in hyaline and fibrous cartilage and subchondral bone; suppresses the activity of enzymes,causing degradation (destruction) of articular cartilage; stimulates the production of proteoglycans by chondrocytes; affects the phosphoric-calcium metabolism in the cartilaginous tissue, stimulates its regeneration, participates in the construction of the basic substance of bone and cartilaginous tissue. It has anti-inflammatory and analgesic properties, it helps to reduce the release of mediators of inflammation and pain factors into the synovial fluid through synoviocytes and macrophages of the synovial membrane, inhibits the secretion of leukotrienes and prostaglandins. The drug prevents the degeneration of connective tissue and reduces calcium loss, accelerates the recovery of bone tissue.

Chondroitin sulfate slows the progression of osteoarthritis and osteochondrosis. Promotes the restoration of the articular bag and the cartilaginous surfaces of the joints, prevents the collapse of connective tissue, normalizes the production of joint fluid.

The clinical effect is manifested by improved mobility of the joints, a decrease in pain intensity, while the therapeutic effect persists for a long time after the end of the course of therapy.In the treatment of degenerative joint changes accompanied by a secondary synovitis, the effect is observed after 2-3 weeks from the start of the course.

Having a structural similarity with heparin, it can potentially prevent the formation of fibrin clots in the synovial and subchondral microcirculatory bed.

Pharmacokinetics:

Chondroitin sodium sulfate is readily absorbed when administered intramuscularly. 30 minutes after intramuscular injection is found in the blood in significant concentrations; after 15 minutes - in the synovial fluid. Maximum concentration in blood plasma (C_max) is achieved 1 hour after the administration, then the concentration of the drug gradually decreases within 2 days.

It accumulates mainly in the cartilaginous tissue (the maximum concentration in the articular cartilage is reached after 48 hours); the synovial membrane is not an obstacle to the penetration of the drug into the joint cavity. It is excreted from the body mainly by the kidneys within 24 hours.

Indications:

Degenerative and dystrophic diseases of the joints and spine:

- osteoarthritis of peripheral joints;

- intervertebral osteochondrosis and osteoarthritis.

To accelerate the formation of bone callus in fractures.

Contraindications:

- Hypersensitivity to chondroitin sulfate;

bleeding, tendency to bleeding;

- thrombophlebitis;

- pregnancy, the period of breastfeeding (at the time of treatment, breastfeeding should be discontinued);

- Children's age (data on efficiency and safety are absent).

Pregnancy and lactation:

Application of the drug Chondroitin sulfate during pregnancy is contraindicated.

If the drug is used during breastfeeding, breast-feeding should be discontinued.

Dosing and Administration:

Intramuscularly, 1 ml every other day. With good tolerability, the dose is increased to 2 ml, starting with the fourth injection. The course of treatment - 25-35 injections. If necessary, after 6 months, a repeat course of treatment is possible. The duration of repeated courses of treatment is set by the doctor.

For the formation of bone callus, the course of treatment is 3-4 weeks (10-14 injections every other day).

Side effects:

When using the drug in people with hypersensitivity to the drug may be violations:

- from the side of the immune system: allergic reactions, angioedema;

- from the skin and subcutaneous tissue: skin rash, itching, erythema, urticaria, dermatitis;

- from the gastrointestinal tract: dyspeptic phenomena.

At the injection site, redness, itching, and hemorrhage are possible.

Overdose:

Currently, cases of drug overdose Chondroitin sulfate not reported. At the same time, it can be assumed that if the daily dose is exceeded, an increase in the detection of the side effect of the drug is possible.

Treatment: symptomatic.

Interaction:

It is possible to increase the effect of indirect anticoagulants, antiplatelet agents and fibrinolytic agents, which requires more frequent monitoring of the coagulation rates when combined.

It exhibits synergism of action with simultaneous application with glucosamine and other chondroprotectors.

Special instructions:

It is recommended to increase the doses under the supervision of a doctor for patients with excessive body weight, peptic ulcer of the stomach or duodenum, while taking diuretics, as well as at the beginning of treatment, if necessary to accelerate the clinical response.

In case of allergic reactions or the appearance of hemorrhages, treatment should be discontinued.

Use in Pediatrics

Data on the efficacy and safety of chondroitin sulfate in children are currently not available.

Effect on the ability to drive transp. cf. and fur:

In the recommended range of doses, the influence on the concentration of attention and the speed of psychomotor reactions is not established. When taking high doses, it is advisable to use caution when driving vehicles, working with mechanisms and engaging in other potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Solution for intramuscular injection, 100 mg / ml.

Packaging:

1 or 2 ml into neutral glass ampoules.

5 ampoules are placed in a contour mesh package from a PVC film or from a PET film.

1 or 2 contour mesh packages together with the instruction for use and the ampoule scarifier are placed in a pack of cardboard.

5 or 10 ampoules together with the instruction for use and the ampoule scarifier are placed in a pack of cardboard with a corrugated liner.

When packing ampoules with a dot or a ring of fracture, the ampoule scaper is not inserted.

Packing for hospitals. 4, 5 or 10 contiguous cell packs, together with instructions for use in an amount equal to the number of contiguous cell packs, are placed in a pack of cardboard.

50 or 100 contour mesh packages together with instructions for use in an amount equal to the number of contiguous mesh packages are placed in a cardboard box.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-004116

Date of registration:02.02.2017

Expiration Date:02.02.2022

The owner of the registration certificate:ELLARA, LTD. ELLARA, LTD. Russia

Manufacturer: & nbsp

ELLARA, LTD. Russia

Information update date: & nbsp24.02.2017

Illustrated instructions

Instructions

Chondroitin sulfate (Chondroitin sulfate)