Artrafic^® Pro (Capsules) Instructions for Use

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Or

Ozon Pharm, LLC (Russia)

ATC Code

M01AX (Other non-steroidal anti-inflammatory drugs)

Active Substances

Chondroitin sulfate sodium (Ph.Eur. European Pharmacopoeia)

Glucosamine (Rec.INN WHO registered)

Dosage Form

Artrafic® Pro

Capsules 250 mg+200 mg: 5, 6, 10, 12, 15, 18, 20, 24, 25, 30, 36, 40, 50, 60, 72, 100, or 120 pcs.

Dosage Form, Packaging, and Composition

Capsules No. 0 with a white body and a blue cap, opaque; the capsule contents are a mixture of powder and granules with crystalline inclusions, white or white with a yellowish tint; granules of irregular shape, different sizes, compaction of the capsule contents according to the shape of the capsule is allowed.

Excipients : croscarmellose sodium – 20 mg, povidone K25 – 5 mg, microcrystalline cellulose (MCC-101 Premium) – 36 mg, magnesium stearate – 5 mg.

Capsule composition capsule body: titanium dioxide – 2%, gelatin – up to 100%. Capsule cap: azorubine dye – 0.0821%, ponceau 4R dye – 0.0192%, patent blue V dye – 0.1314%, brilliant black BN dye – 0.1533%, titanium dioxide – 2%, gelatin – up to 100%.

5 pcs. – contour cell packs (1) – cardboard packs.
5 pcs. – contour cell packs (2) – cardboard packs.
5 pcs. – contour cell packs (3) – cardboard packs.
5 pcs. – contour cell packs (4) – cardboard packs.
5 pcs. – contour cell packs (5) – cardboard packs.
5 pcs. – contour cell packs (6) – cardboard packs.
5 pcs. – contour cell packs (10) – cardboard packs.
5 pcs. – contour cell packs (12) – cardboard packs.
6 pcs. – contour cell packs (1) – cardboard packs.
6 pcs. – contour cell packs (2) – cardboard packs.
6 pcs. – contour cell packs (3) – cardboard packs.
6 pcs. – contour cell packs (4) – cardboard packs.
6 pcs. – contour cell packs (5) – cardboard packs.
6 pcs. – contour cell packs (6) – cardboard packs.
6 pcs. – contour cell packs (10) – cardboard packs.
6 pcs. – contour cell packs (12) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – contour cell packs (12) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.
120 pcs. – polymer jars (1) – cardboard packs.

Clinical-Pharmacological Group

Drug stimulating the process of regeneration of 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 of hyaluronic acid synthesis, which is necessary for the formation of proteoglycans of 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 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 this disease and reduces the need for NSAIDs.

Pharmacokinetics

Glucosamine

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

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.

Excreted mainly in the urine unchanged; partially in the feces. T_1/2 – 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 – about 0.44 ml/g.

Metabolized by desulfation.

Excreted in the urine. T_1/2 – 310 min.

Indications

Osteoarthritis stages I-III.

ICD codes

Dosage Regimen

Administer orally with a full glass of water.

Take with meals to minimize potential gastrointestinal discomfort.

The standard adult dosage is one capsule two to three times daily.

Initiate therapy at the higher frequency for the first three to four weeks.

Subsequently, based on therapeutic response, reduce the frequency to a maintenance dose of one capsule once or twice daily.

The total daily dose should not exceed three capsules.

Individualize the dose based on the severity of symptoms and patient response.

The full therapeutic effect typically develops after two to six weeks of continuous use.

Continue treatment for several months, or as long as clinically indicated.

Re-evaluate the patient if no clinical improvement is observed after a four-week course at the recommended dose.

Reduce the dose by half if adverse gastrointestinal effects occur.

Discontinue the drug if gastrointestinal symptoms persist despite dose reduction.

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, heart 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 adverse effects from the gastrointestinal tract occur, 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 is 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 25°C (77°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.