Artra^® (Tablets) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

Ameripharma Labs, LLC (USA)

Packaging and Quality Control Release

UNIPHARM, Inc. (USA)

Contact Information

NIZHPHARM group of companies (Russia)

ATC Code

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

Active Substances

Chondroitin sulfate sodium (Ph.Eur. European Pharmacopoeia)

Glucosamine (Rec.INN WHO registered)

Dosage Form

Artra®

Film-coated tablets, 500 mg+500 mg: 30, 60, or 120 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from white to white with a yellowish tint, biconvex, oval in shape, with an engraving “ARTRA” on one side, with a characteristic odor.

* the manufacturing process uses a substance-mixture consisting of glucosamine hydrochloride and chondroitin sulfate sodium, incorporated with an excess of 525.5 mg (calculated on a dry substance basis) and 613.1 mg (calculated on a dry substance basis), respectively.

Excipients: microcrystalline cellulose – 223 mg, calcium hydrogen phosphate dihydrate – 125 mg, croscarmellose sodium – 100 mg, stearic acid – 50 mg, magnesium stearate – 17 mg.

Shell composition transparent film coating – 5 mg (hypromellose – 3.75 mg, triacetin – 1.25 mg), yellow film coating – 35 mg (hypromellose – 10.85 mg, titanium dioxide – 9.41 mg, polydextrose – 9.1 mg, talc – 2.45 mg, maltodextrin – 1.75 mg, medium-chain triglycerides – 1.4 mg, iron oxide yellow dye – 0.04 mg).

30 pcs. – high-density polyethylene bottles^x (1) – cardboard packs.
60 pcs. – high-density polyethylene bottles^x (1) – cardboard packs.
120 pcs. – high-density polyethylene bottles^x (1) – cardboard packs.

^x with first opening control

Clinical-Pharmacological Group

Drug stimulating the process of regeneration of cartilage tissue

Pharmacotherapeutic Group

Tissue regeneration stimulant

Pharmacological Action

It stimulates the regeneration of cartilage tissue. Glucosamine and Chondroitin sulfate sodium are involved in the biosynthesis of connective tissue, helping to prevent cartilage destruction processes and stimulating tissue regeneration.

The introduction of exogenous glucosamine enhances the production of cartilage matrix and provides nonspecific protection, including from NSAIDs and corticosteroids. The drug has a moderate anti-inflammatory effect.

Chondroitin sulfate sodium, whether absorbed in its intact form or as individual components, serves as an additional substrate for the formation of a healthy cartilage matrix.

It stimulates the formation of proteoglycans and type II collagen, and also protects the cartilage matrix from enzymatic cleavage (by suppressing hyaluronidase activity) and from the damaging effects of free radicals; maintains the viscosity of synovial fluid, stimulates cartilage repair mechanisms and suppresses the activity of enzymes (elastase, hyaluronidase) that break down cartilage. In the treatment of osteoarthritis, it alleviates the symptoms of the disease and reduces the need for NSAIDs.

Pharmacokinetics

Absorption

The bioavailability of glucosamine when taken orally is 25% (due to the “first-pass” effect through the liver). The bioavailability of chondroitin sulfate is 13%.

Distribution

It is distributed in tissues: the highest concentrations of glucosamine 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.

Elimination

Glucosamine is excreted mainly in the urine unchanged; partially – in the feces. T_1/2 of glucosamine is 68 hours.

Indications

• Osteoarthritis of the peripheral joints and spine.

ICD codes

Dosage Regimen

Take the drug orally with food.

For adults and children over 15 years of age, administer 1 tablet twice daily for the first three weeks of therapy.

After the initial three-week period, reduce the dosage to 1 tablet once daily for all subsequent weeks and months of treatment.

Take tablets whole; do not crush or chew.

Adhere strictly to the twice-daily and subsequent once-daily schedule to maintain consistent plasma levels.

For optimal therapeutic outcomes, continue treatment for a minimum of 6 months.

The sustained clinical effect is dose- and duration-dependent.

If a dose is missed, take it as soon as remembered unless it is nearly time for the next scheduled dose.

Do not double the dose to make up for a missed one.

Regular, long-term administration is critical for achieving the full regenerative effect on cartilage tissue.

Adverse Reactions

Glucosamine

From the digestive system mild gastrointestinal disturbances are possible – epigastric pain, flatulence, diarrhea, constipation.

From the nervous system dizziness.

Glucosamine and chondroitin

Other allergic reactions.

Contraindications

• Severe renal impairment;
• Hypersensitivity to the drug components.

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

Use in Pregnancy and Lactation

The drug is not recommended for use during pregnancy and lactation.

Use in Renal Impairment

The drug is contraindicated in severe renal impairment.

Pediatric Use

Prescribed for children over 15 years of age.

Special Precautions

Effect on ability to drive vehicles and machinery

No data.

Overdose

Cases of overdose are unknown.

Treatment gastric lavage, symptomatic therapy.

Drug Interactions

Concomitant use may enhance the effect of anticoagulants and antiplatelet agents.

Artra^® increases the absorption of tetracyclines and decreases the effect of semisynthetic penicillins.

The drug is compatible with corticosteroids.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 2 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is dispensed without a prescription.

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.