pharmachologic effect
The effect of the drug Chondromed Plus is due to its constituent components. Chondroitin sulfate is a mucopolysaccharide and one of the components of cartilage. It has a high ability to bind water, thus ensuring the mechanical and elastic properties of cartilage. During degenerative processes in the joints, a decrease in the reserves of chondroitin sulfate in cartilage tissue, caused by specific lytic enzymes, is observed. As a result of the loss of the ability to bind water, cartilage degeneration and joint function worsen.
Chondroitin sulfate in vitro inhibits elastases, which destroy cartilage. The use of exogenous administration of chondroitin sulfate leads to the restoration of metabolic balance. Clinical effectiveness: clinical studies have shown that when using chondroitin sulfate, pain disappears or decreases and in most cases joint mobility improves.
Glucosamine - Administration of exogenous glucosamine provides nonspecific protection against chemical damage to cartilage. Another possible effect of glucosamine is the protection of damaged cartilage from metabolic destruction caused by nonsteroidal anti-inflammatory drugs (NSAIDs) and glucocorticosteroids (GCs), as well as its own moderate anti-inflammatory effect.
Chondromed 200mg/2ml No. 10 ampoules
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINE
CHONDROMED
Tradename
Chondromed
International Nonproprietary Name (INN)
Chondroitin sulfate
Dosage form
Solution for intramuscular administration
Description
Transparent, colorless or slightly yellowish solution.
Description
Transparent, colorless or slightly yellowish solution.
Compound
Active substance
: sodium chondroitin sulfate – 100 mg
Excipients
: benzyl alcohol 12.0 mg, 0.1 M sodium hydroxide solution or 0.1 M hydrochloric acid solution - up to pH 6.0-7.5. Water for injections up to 1.0 ml.
Pharmacotherapeutic group
tissue repair stimulator
ATX code : M01AX25
pharmachologic effect
It has chondrostimulating, regenerating, anti-inflammatory and analgesic effects. Chondroitin sulfate is involved in the construction of the main substance of cartilage and bone tissue. It has chondroprotective properties, enhances metabolic processes in hyaline and fibrous cartilage, subchondral bones; inhibits enzymes that cause degeneration (destruction) of articular cartilage; stimulates the production of proteoglycans by chondrocytes. Helps reduce the release of inflammatory mediators and pain factors into the synovial fluid, suppresses the secretion of leukotrienes and prostaglandins. Slows down bone tissue resorption and reduces calcium loss, accelerates bone tissue restoration processes. Chondroitin sulfate slows down the progression of osteoarthrosis and osteochondrosis. Helps restore the joint capsule and cartilaginous surfaces of the joints, prevents the collapse of connective tissue, and normalizes the production of joint fluid. When using the drug, pain decreases and mobility of the affected joints improves, while the therapeutic effect persists for a long time after the end of the course of therapy. When treating degenerative changes in joints accompanied by secondary synovitis, the effect is observed within 2-3 weeks from the start of the course. Possessing structural similarity to heparin, it can potentially prevent the formation of fibrin thrombi in the synovial and subchondral microvasculature.
Pharmacokinetics
After 30 minutes of intramuscular administration, it is found in the blood in significant concentrations; after 15 minutes - in the synovial fluid. The maximum concentration in plasma blood (Cmax) is achieved after 1 hour, then the concentration of the drug gradually decreases over 2 days. It accumulates mainly in cartilage tissue (the maximum concentration in articular cartilage is reached after 48 hours); the synovial membrane is not an obstacle to the penetration of the drug into the joint cavity. Excreted by the kidneys.
Indications for use
Degenerative-dystrophic diseases of the joints and spine: - osteoarthritis of peripheral joints; — intervertebral osteochondrosis and osteoarthrosis. To accelerate the formation of callus in fractures.
Contraindications
Increased individual sensitivity to chondroitin sulfate and any of the components of the drug; - bleeding, tendency to bleed; - thrombophlebitis; - children under 18 years of age (efficacy and safety have not been established).
Pregnancy and lactation
It is not recommended to use the drug during pregnancy. If it is necessary to use the drug during breastfeeding, breastfeeding should be discontinued due to lack of data.
Directions for use and doses
The drug is administered intramuscularly at a dose of 100 mg (1 ml) every other day. If well tolerated, the dose is increased to 200 mg (2 ml), starting with the fourth injection. The course of treatment is 25-35 injections. If necessary, after 6 months it is possible to repeat the course of treatment.
Side effect
Allergic reactions (skin itching, rash, erythema, urticaria, dermatitis, swelling); bleeding at the injection site.
Overdose
Currently, no cases of overdose of chondroitin sulfate have been reported.
Interaction with other drugs
It is possible to enhance the effect of indirect anticoagulants, antiplatelet agents, and fibrinolytics.
Precautionary measures
When using the drug together with indirect anticoagulants, antiplatelet agents, fibrinolytics, more frequent monitoring of blood coagulation parameters is required. If allergic reactions or hemorrhages develop, treatment should be discontinued. To achieve a stable clinical effect, at least 25 injections of the drug are required, but the effect persists for several months after the end of the course of treatment. To prevent exacerbations, repeated courses of treatment are indicated.
Impact on the ability to drive vehicles and machinery
Does not affect the ability to drive vehicles and machinery.
Release form
Solution for intramuscular administration 100 mg/ml. 2 ml of the drug are placed in ampoules of colorless glass of the 1st hydrolytic class with a break ring. 5 ampoules are placed in a blister blister pack. 1 or 2 cell contour packages along with instructions for use in a cardboard pack.
Storage conditions
In a dark place at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Best before date
3 years. Do not use after the expiration date stated on the package.
Conditions for dispensing from pharmacies
On prescription
Manufacturer
K.O.RompharmCompany S.R.L.
Eroilor street 1A, Otopeni, Romania.
Pharmacokinetics
Chondroitin sulfate: after oral administration, the maximum concentration of the drug in plasma is achieved after 3-4 hours, in synovial fluid - after 4-5 hours. Bioavailability is about 13%. More than 70% of chondroitin sulfate is absorbed in the digestive tract. The drug absorbed in the gastrointestinal tract accumulates in the synovial fluid. Excreted from the body by the kidneys.
Glucosamine hydrochloride: rapidly absorbed in the small intestine. Bioavailability is 25-26% (due to the “first pass” effect through the liver). After tissue distribution, the highest concentrations are observed in the synovium, cartilage, liver and kidneys. Metabolized in the liver to form urea, water and carbon dioxide. It is excreted primarily in urine unchanged, and to a very small extent in feces. The half-life is about 70 hours.
Instructions for use CHONDROMED PLUS
Glucosamine hydrochloride
Suction
After oral administration of 14C-labeled glucosamine, it is rapidly and almost completely absorbed, and about 90% of the radioactive tracer is detected in the systemic circulation. The absolute bioavailability of glucosamine in humans after oral administration was 44%, taking into account the first pass effect. After daily oral administration of 1500 mg of glucosamine to healthy volunteers under fasting conditions, maximum plasma concentrations at steady state (Cmax,ss) averaged after 3 hours (Tmax) about 1602±426 ng/ml. At steady state, the AUC was 14,564±4138 ng×h/ml. It is unknown whether food intake has a significant effect on oral bioavailability. The pharmacokinetics of glucosamine are linear in the dose range of 750-1500 mg with deviation from linearity at a dose of 3000 mg due to lower bioavailability. There are no gender differences in the absorption and bioavailability of glucosamine. The pharmacokinetics of glucosamine were similar in healthy volunteers and patients with knee osteoarthritis.
Distribution
After oral absorption, glucosamine is distributed in various vascular compartments, incl. in synovial fluid, with an apparent volume of distribution 37 times higher than the total fluid volume in humans. Glucosamine does not bind to plasma proteins. Therefore, it is extremely unlikely that glucosamine is capable of drug interactions when taken together with other drugs that are highly bound to plasma proteins.
Metabolism
The metabolic profile of glucosamine has not been studied, since, being an endogenous substance, it is used as a “building material” for the biosynthesis of articular components of cartilage. Glucosamine is primarily metabolized by conversion to hexosamine, independent of the cytochrome system. It acts neither as an inhibitor nor as an inducer of human CYP450 isoenzymes, including CYP3A4, 1A2, 2E1, 2C9 and 2D6.00. There are no clinically significant interactions between glucosamine and other drugs that could occur through inhibition and/or induction of human CYP450 isoforms.
Removal
In humans, the half-life of glucosamine from plasma is 15 hours. After oral administration of 14C-labeled glucosamine, excretion in urine is 10±9%, in feces - 11.3±0.1% of the administered dose. The average excretion of unchanged glucosamine following oral administration in humans is approximately 1% of the administered dose, suggesting that the kidney and liver do not play a significant role in the elimination of glucosamine, its metabolites and/or its degradation products.
Pharmacokinetics in various categories of patients
Patients with impaired liver and kidney function.
Pharmacokinetic studies of glucosamine have not been conducted in patients with renal or hepatic impairment. These studies were considered inappropriate due to the insignificant contribution of the liver and kidneys in the processes of metabolism, degradation and excretion of glucosamine. Therefore, given the favorable safety profile and good tolerability of glucosamine, dosage adjustment of the drug is not required in patients with renal or hepatic impairment.
Children and teenagers.
The pharmacokinetics of glucosamine have not been studied in children and adolescents.
Elderly patients.
Pharmacokinetic studies have not been conducted in elderly patients, however, clinical trials of the efficacy and safety of glucosamine included mainly elderly patients. It has been shown that there is no need for dose adjustment in this category of patients.
Chondroitin sulfate
Pharmacokinetics have not been studied.
Interaction with other drugs
With the simultaneous use of Chondromed plus with other drugs, it is possible to enhance the effect of indirect anticoagulants, antiplatelet agents, and fibrinolytics.
When used in combination, Chondromed Plus increases the absorption of tetracyclines and reduces the absorption of semisynthetic penicillins and chloramphenicol.
Compatible with non-steroidal anti-inflammatory drugs and glucocorticoids.
When used together, it enhances the anti-inflammatory and analgesic effect of NSAIDs.
Chondromed capsules 250 mg No. 10x3 No. 10x6
Name
Chondromed caps 250 mg in container pack No. 10x3
Description
Hard gelatin capsules number 0, yellow. The contents of the capsules are powder from white with a yellowish tint to light yellow with a grayish tint, odorless.
Main active ingredient
Chondroitin sulfate
Release form
Capsules.
Dosage
250mg
Pharmacodynamics
Chondroitin sulfate is the main component of proteoglycans, which together with collagen fibers make up the cartilage matrix. Has chondroprotective properties; inhibits the activity of enzymes that cause degradation of articular cartilage; stimulates the production of proteoglycans by chondrocytes; enhances metabolic processes in cartilage and subchondral bone; influences phosphorus-calcium metabolism in cartilage tissue, stimulates its regeneration, and participates in the construction of the basic substance of bone and cartilage tissue. Chondroitin sulfate has anti-inflammatory and analgesic properties, helps reduce the release of inflammatory mediators and pain factors into the synovial fluid through synoviocytes and macrophages of the synovial membrane, and suppresses the secretion of leukotriene B4 and prostaglandin E2. The drug helps restore the articular capsule of the cartilaginous surfaces of the joints, prevents compression of the connective tissue, and acts as a lubricant for the articular surfaces; normalizes the production of joint fluid, improves joint mobility.
Pharmacokinetics
After oral administration, the maximum concentration of the drug in plasma is achieved after 3-4 hours, in synovial fluid - after 4-5 hours. Bioavailability is about 13%. More than 70% of chondroitin sulfate is absorbed in the digestive tract. The drug absorbed in the gastrointestinal tract accumulates in the synovial fluid. The drug is excreted from the body by the kidneys.
Indications for use
For the adjunctive treatment of pain associated with osteoarthritis of the knee and hip.
Directions for use and doses
The drug is taken orally with a glass of water. Adults and children over 15 years of age are prescribed 500 mg (2 capsules) 2 times a day (1 g per day). There are no data on the use of chondroitin sulfate in children under 18 years of age, so prescribing the drug to children is not recommended. The duration of the initial course of treatment is 6 months, the period of action of the drug after its discontinuation is 3-5 months, depending on the location and stage of the disease, the duration of repeated courses of treatment is determined by the doctor.
Use during pregnancy and lactation
It is not recommended to use this drug during pregnancy and lactation due to the lack of data confirming the safety of its use in women during this period.
Precautionary measures
Caution should be used in patients with bleeding, as well as in patients with a tendency to bleeding. This drug is not recommended for use during pregnancy and breastfeeding. If adverse reactions occur, treatment should be discontinued.
Interaction with other drugs
With the simultaneous use of Chondromed with other drugs, it is possible to enhance the effect of indirect anticoagulants, antiplatelet agents, and fibrinolytics.
Contraindications
Hypersensitivity to chondroitin sulfate and other components of the drug, pregnancy, lactation, children under 15 years of age.
Compound
Active substance: chondroitin sulfate sodium salt - 250 mg. Excipients: calcium stearate, potato starch. Capsule shell composition: quinoline yellow (E 104), crimson 4R (E 124), azorubine (E 122), titanium dioxide (E 171), purified water, gelatin.
Overdose
In rare cases, symptoms of overdose from the gastrointestinal tract may occur: nausea, vomiting, diarrhea; with prolonged use of excessively high doses (over 3 g per day), hemorrhagic rashes are possible. Treatment is symptomatic.
Side effect
Allergic reactions are rare. From the digestive system: rarely – nausea, vomiting, diarrhea.
Storage conditions
In a place protected from moisture and light at a temperature not exceeding 25 oC. Keep out of the reach of children.
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Instructions for use for Chondromed caps 250 mg in container pack No. 10x6