Chondrotek^® Forte (Capsules) Instructions for Use

Marketing Authorization Holder

Nabros Pharma, Pvt. Ltd. (India)

ATC Code

M09AX (Other drugs for the treatment of musculoskeletal system diseases)

Active Substances

Tocopherol (Ph.Eur.)

Chondroitin sulfate sodium (Ph.Eur.)

Glucosamine (Rec.INN)

Dosage Form

Chondrotek® Forte

Capsules 500 mg+250 mg+8 mg: 20, 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 1, white body and cap, capsule contents – white powder or white with a yellowish tint.

Excipients: magnesium stearate – 2 mg, talc – 4 mg, butylated hydroxytoluene – 1 mg.

Composition of the gelatin capsule: titanium dioxide – 2.118%, methylparaben – 0.8%, propylparaben – 0.2%, purified water – from 14 to 15%, gelatin – q.s. to 100%.

10 pcs. – blisters (2) – cartons.
10 pcs. – blisters (5) – cartons.
10 pcs. – blisters (10) – cartons.

Clinical-Pharmacological Group

Drug stimulating the process of regeneration of cartilage tissue

Pharmacotherapeutic Group

Tissue repair stimulant

Pharmacological Action

Chondrotek^® Forte stimulates the regeneration (restoration) of cartilage tissue.

Glucosamine sulfate and chondroitin sulfate, which are part of the drug, participate in the synthesis of connective tissue, helping to prevent cartilage destruction processes and stimulating the regeneration of cartilage tissue.

The introduction of exogenous glucosamine sulfate enhances the production of cartilage matrix and provides non-specific protection of cartilage from chemical damage.

Glucosamine sulfate is involved in the biosynthesis of proteoglycans, hyaluronic acid, and chondroitin sulfuric acids, which are the building material for joint membranes, intra-articular fluid, and cartilage tissue.

Chondroitin sulfate is involved in the construction of cartilage tissue, serves as an additional substrate for the formation of a healthy cartilage matrix.

It stimulates the formation of hyaluronan, the synthesis of proteoglycans and type II collagen.

It protects hyaluronan from enzymatic cleavage (by suppressing the activity of hyaluronidase) and from the damaging effects of free radicals; maintains the viscosity of synovial fluid, stimulates the mechanisms of cartilage repair (restoration) and suppresses the activity of enzymes that break down cartilage (elastase, hyaluronidase).

Chondroitin sulfate promotes the restoration of elasticity of the joint capsule, cartilaginous surfaces of the joints, and acts as a natural lubricant for joint surfaces.

It reduces the activity of the inflammatory process in the tissues of cartilage and joints.

It reduces the need for non-steroidal anti-inflammatory drugs in patients with arthrosis.

Glucosamine sulfate and chondroitin sulfate, when acting together, have a greater effect due to synergism, compared to the individual effect of each of these components.

Vitamin E, as an antioxidant, inhibits the development of free radical reactions, prevents the formation of peroxides that damage cellular and subcellular membranes of cartilage, which is important for the body in osteoarthritis.

Pharmacokinetics

Glucosamine sulfate is distributed in tissues: the highest concentrations are found in the liver, kidneys, and articular cartilage.

About 30% of the administered dose persists for a long time in bone and muscle tissue.

It is excreted mainly in the urine unchanged; partially – in the feces. T_1/2 – 68 h.

Chondroitin sulfate is metabolized by desulfation.

It is excreted in the urine, T_1/2 – 310 min.

Vitamin E is absorbed from the duodenum by 50-80%.

It binds to blood beta-lipoproteins.

It is deposited in all organs and tissues, especially in adipose tissue, and is excreted in the bile (more than 90%).

Indications

• Osteoarthritis of stages I-III of peripheral joints and spine.

ICD codes

Dosage Regimen

Administer orally to adults and adolescents over 15 years of age.

Take before meals with a full glass of water.

The standard dosage is 2 capsules twice daily.

Continue treatment for a duration of 7 to 8 weeks.

Repeat the course if necessary based on clinical evaluation.

Do not exceed the recommended daily dose of 4 capsules.

For patients with a tendency to bleeding, use with caution due to potential enhancement of anticoagulant effects.

In diabetic patients, monitor blood glucose levels as a precaution.

In patients with bronchial asthma, monitor for potential hypersensitivity reactions.

If gastrointestinal discomfort occurs, administer with food.

Adverse Reactions

Rarely, gastrointestinal disorders (epigastric pain, flatulence, diarrhea or constipation), dizziness, allergic reactions are possible.

Contraindications

• Hypersensitivity to the components of the drug;
• Severe renal impairment;
• Children under 5 years of age;
• Pregnancy, lactation period.

With caution bleeding and tendency to bleed, diabetes mellitus, bronchial asthma.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Use in Renal Impairment

Contraindicated in severe renal impairment.

Pediatric Use

Contraindicated in children under 5 years of age.

Special Precautions

Effect on the ability to drive vehicles and mechanisms

There is no information on the possible effect of the drug on the ability to drive vehicles and mechanisms.

Overdose

Cases of overdose are not known.

Drug Interactions

Compatible with non-steroidal anti-inflammatory drugs, glucocorticosteroids.

During the drug intake, the need for non-steroidal anti-inflammatory drugs decreases, the absorption of tetracyclines is enhanced and that of penicillins is reduced.

It is possible to enhance the effect of anticoagulants, antiplatelet agents, fibrinolytics.

Storage Conditions

In a dry place at a temperature not exceeding 25°C (77°F).

Keep out of reach of children.

Shelf Life

Shelf life – 3 years.

Dispensing Status

Over-the-counter.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.