KONDROnova^® (Capsules) Instructions for Use

Marketing Authorization Holder

Panacea Biotec, Ltd. (India)

ATC Code

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

Active Substances

Chondroitin sulfate sodium (Ph.Eur.)

Glucosamine (Rec.INN)

Dosage Form

KONDROnova®

Capsules 250 mg+200 mg: 30 or 120 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size “0”, light blue in color; the capsule contents are a white or almost white powder.

* content calculated on a dry substance basis.

Excipients: mannitol – 60 mg, croscarmellose sodium – 20 mg, magnesium stearate – 5 mg, purified talc – 5 mg.

Capsule shell composition: purified water – 13.536 mg, gelatin – 81.024 mg, sodium lauryl sulfate – 0.096 mg, povidone – 0.096 mg, bronopol – 0.096 mg, colorant titanium dioxide – 1.056 mg, colorant brilliant blue – 0.08832 mg, colorant quinoline yellow – 0.00768 mg.

10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (12) – cardboard packs.

Clinical-Pharmacological Group

Drug regulating metabolism in cartilage tissue

Pharmacotherapeutic Group

Tissue repair stimulant

Pharmacological Action

A combined agent that stimulates the regeneration of cartilage tissue.

Glucosamine sulfate is one of the components in the synthesis of hyaluronic acid, which is necessary for the formation of proteoglycans in the structural matrix of joints.

It has also been established that Glucosamine sulfate protects articular cartilage from the damaging effects of some NSAIDs. The sulfate ion is necessary for the synthesis of glycosaminoglycans, which are esters of sulfuric acid. Oral intake of exogenous glucosamine stimulates the production of cartilage matrix and provides its non-specific protection. It has a certain anti-inflammatory effect.

Chondroitin sulfate, whether absorbed in its intact form or as individual fragments, 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, and also protects the cartilage tissue matrix from enzymatic cleavage (by suppressing hyaluronidase activity) and from the damaging effects of free radicals. It maintains the viscosity of the synovial fluid, stimulates cartilage repair mechanisms, and suppresses the activity of enzymes (elastases, hyaluronidases) that break down cartilage. In the treatment of osteoarthritis, it alleviates the symptoms of the disease and reduces the need for NSAIDs.

Pharmacokinetics

Glucosamine

Bioavailability after oral administration is 25% (first-pass effect through the liver).

It 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 is 68 h.

Chondroitin sulfate

After a single oral dose of 800 mg (or 400 mg twice daily), the plasma concentration increases sharply over 24 hours. Absolute bioavailability is 12%. About 10% and 20% of the administered dose is absorbed as high-molecular-weight and low-molecular-weight derivatives, respectively.

Apparent V_d is about 0.44 ml/g.

It is metabolized via desulfation.

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

Indications

Osteoarthritis stages I-III.

ICD codes

Dosage Regimen

Administer orally with meals to minimize potential gastrointestinal discomfort.

Take two capsules three times daily as the standard initial dosage.

After a treatment period of 2-4 months, consider a reduction to a maintenance dose of one capsule three times daily, based on clinical response.

Set the individual dose according to the patient’s body weight and severity of symptoms.

Continue treatment for several months as required; treatment courses may be repeated, with intervals determined by the physician.

If adverse gastrointestinal effects occur, reduce the dose by half; discontinue the drug if no improvement is observed.

Re-evaluate the diagnosis if there is no clinical improvement after four weeks of therapy at the recommended dosage.

Adverse Reactions

From the cardiovascular system: tachycardia.

From the nervous system: dizziness, headache, drowsiness, insomnia.

From the digestive system: abdominal pain, flatulence, constipation or diarrhea.

Allergic reactions: skin allergic reactions, allergic reactions, exacerbation of bronchial asthma.

Other: leg pain and peripheral edema.

Contraindications

Hypersensitivity to the components of the combination; phenylketonuria; severe renal impairment; pregnancy, lactation (breastfeeding); age under 15 years (efficacy and safety have not been established).

With caution

Tendency to bleeding, diabetes mellitus, bronchial asthma, cardiac and/or renal failure.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation (breastfeeding).

Use in Renal Impairment

Use with caution in renal failure.

Contraindicated in severe renal impairment.

Pediatric Use

Contraindicated in children under 15 years of age (efficacy and safety have not been established).

Special Precautions

If undesirable effects from the gastrointestinal tract appear, the dose should be reduced by half, and if there is no improvement, the drug should be discontinued.

If there is no clinical effect after a treatment course at the recommended dose for 4 weeks, the diagnosis should be reconsidered.

Drug Interactions

Increases the absorption of tetracyclines, reduces the effect of semisynthetic penicillins.

This combination is compatible with NSAIDs and corticosteroids.

There are limited data on a possible interaction of glucosamine with warfarin, which may lead to an increase in INR and the risk of bleeding. When used concomitantly, blood coagulation parameters should be monitored.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

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.