Artra^® Chondroitin (Capsules) Instructions for Use

Marketing Authorization Holder

Unipharm, Inc. (USA)

ATC Code

M01AX25 (Chondroitin sulfate)

Active Substance

Chondroitin sulfate sodium (Ph.Eur. European Pharmacopoeia)

Dosage Forms

	Artra® Chondroitin	Capsules 250 mg: 60 pcs.
		Capsules 500 mg: 60 pcs.
		Capsules 750 mg: 60 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, opaque, from white to almost white; the capsule contents are a powder from white to almost white; a specific odor is allowed.

Excipients: rice flour, silicon dioxide, magnesium stearate.

Capsule shell composition gelatin, titanium dioxide.

15 pcs. – blisters (4) – cardboard packs.
60 pcs. – polyethylene bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Drug stimulating the process of regeneration of cartilage tissue

Pharmacotherapeutic Group

Tissue regeneration stimulant

Pharmacological Action

Stimulator of cartilage tissue regeneration. It affects metabolic processes in hyaline and fibrous cartilage, stimulates the biosynthesis of glycosaminoglycans.

It slows down bone tissue resorption and reduces calcium loss, accelerates bone tissue recovery processes. It reduces degenerative changes and stimulates the restoration of joint cartilage tissue, alleviates pain in the joints and spine, increases joint mobility, participates in the formation of bone tissue and ligaments, and maintains the elasticity and resilience of the vascular wall.

In the treatment of osteoarthritis, it alleviates the symptoms of the disease and reduces the need for NSAIDs. The therapeutic effect persists for a long time after the end of the treatment course.

Pharmacokinetics

Absorption and Distribution

After oral administration, more than 70% of chondroitin sulfate is absorbed from the gastrointestinal tract. The bioavailability of the drug is 13%. After a single oral dose at the average therapeutic dose, C_max in plasma is noted after 3-4 hours, and in synovial fluid after 4-5 hours. The drug absorbed from the gastrointestinal tract accumulates in the synovial fluid.

Elimination

It is excreted by the kidneys.

Indications

• Osteoarthritis of peripheral joints;
• Spinal osteochondrosis.

ICD codes

Dosage Regimen

The drug is prescribed orally for adults.

Capsules 250 mg – 2 caps. 2 times/day.

Capsules 500 mg – 1 cap. 2 times/day.

Capsules 750 mg – 1-2 caps./day.

The recommended duration of the initial treatment course is 6 months. The period of the drug’s action after its discontinuation is 3-5 months. The duration of repeated treatment courses is determined by the doctor individually.

Adverse Reactions

Rarely allergic reactions.

Contraindications

• Hypersensitivity to the drug components.

Use in Pregnancy and Lactation

It is not recommended to prescribe during pregnancy and lactation (breastfeeding) due to the lack of clinical experience in this category of patients.

Special Precautions

The drug should be prescribed with caution to patients with bleeding, as well as to patients prone to bleeding.

Overdose

Cases of overdose are unknown.

Treatment: gastric lavage, symptomatic therapy.

Drug Interactions

With simultaneous use, it is possible to enhance the effect of indirect anticoagulants, antiplatelet agents, and fibrinolytics.

The drug is compatible with NSAIDs and corticosteroids.

Storage Conditions

The drug should be stored out of the reach of children, in a dry place at a temperature from 10°C (50°F) to 30°C (86°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.