Artravir®-complex (Capsules) Instructions for Use
ATC Code
M01BX (Anti-inflammatory and antirheumatic agents in combination with other drugs)
Active Substances
Chondroitin sulfate sodium (Ph.Eur.)
Glucosamine (Rec.INN)
Clinical-Pharmacological Group
Tissue repair stimulant
Pharmacotherapeutic Group
Anti-inflammatory and antirheumatic agents; anti-inflammatory/antirheumatic agents in combination; other anti-inflammatory/antirheumatic agents in combination with other agents
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 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, regardless of whether it is absorbed in an 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 the mechanisms of cartilage repair and suppresses the activity of those 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).
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. T1/2 is 68 hours.
Chondroitin sulfate
After a single oral dose of 800 mg (or 400 mg twice a day), 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 Vd is about 0.44 ml/g.
It is metabolized by desulfation.
It is excreted in the urine. T1/2 is 310 minutes.
Indications
Osteoarthritis stages I-III.
ICD codes
| ICD-10 code | Indication |
| M15 | Polyosteoarthritis |
| M19.9 | Unspecified arthrosis |
| M47 | Spondylosis |
| ICD-11 code | Indication |
| FA05 | Polyosteoarthritis |
| FA0Z | Osteoarthritis, unspecified |
| FA8Z | Degenerative disease of spine, unspecified |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Administer orally as capsules.
Take 2-3 times daily with meals to minimize potential gastrointestinal discomfort.
Establish the individual dose based on the patient’s clinical presentation and response to therapy.
Initiate therapy with a loading dose for the first 4-6 weeks to rapidly achieve therapeutic concentrations in the joint tissues.
Follow the loading period with a maintenance dose for long-term management and symptomatic control.
The minimum treatment course is typically 3-6 months to assess full therapeutic potential.
Re-evaluate the diagnosis if no clinical improvement is observed after 4 weeks of treatment at the recommended dosage.
Reduce the dose by half if adverse gastrointestinal effects occur; discontinue the drug if symptoms persist.
Adhere strictly to the prescribed regimen for optimal outcomes in managing osteoarthritis stages I-III.
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
Bleeding tendency, 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 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 is limited data on the 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.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Capsules 250 mg+200 mg: 5, 6, 10, 12, 15, 18, 20, 24, 25, 30, 36, 40, 50, 60, 72, 100, or 120 pcs.
Marketing Authorization Holder
Trivium-XXI, LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
 |
Artravir®-complex-Incampharm® | 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, white body, blue cap, opaque; capsule contents – 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.
| 1 caps. | |
| Sodium chloride glucosamine sulfate | 314 mg, |
| Equivalent to glucosamine sulfate content | 250 mg |
| Chondroitin sulfate sodium | 200 mg |
Excipients: croscarmellose sodium – 20 mg, povidone K25 – 5 mg, microcrystalline cellulose – 36 mg, magnesium stearate – 5 mg.
Capsule shell composition titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition dye azorubine – 0.0821%, dye ponceau 4R – 0.0192%, dye patent blue – 0.1314%, dye brilliant black – 0.1533%, titanium dioxide – 2%, gelatin – up to 100%.
5 pcs. – blister packs (1) – cardboard packs.
5 pcs. – blister packs (2) – cardboard packs.
5 pcs. – blister packs (3) – cardboard packs.
5 pcs. – blister packs (4) – cardboard packs.
5 pcs. – blister packs (5) – cardboard packs.
5 pcs. – blister packs (6) – cardboard packs.
5 pcs. – blister packs (10) – cardboard packs.
5 pcs. – blister packs (12) – cardboard packs.
6 pcs. – blister packs (1) – cardboard packs.
6 pcs. – blister packs (2) – cardboard packs.
6 pcs. – blister packs (3) – cardboard packs.
6 pcs. – blister packs (4) – cardboard packs.
6 pcs. – blister packs (5) – cardboard packs.
6 pcs. – blister packs (6) – cardboard packs.
6 pcs. – blister packs (10) – cardboard packs.
6 pcs. – blister 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.
Capsules 500 mg+400 mg: 5, 6, 10, 12, 15, 18, 20, 24, 25, 30, 36, 40, 50, 60, 72, 100, or 120 pcs.
Marketing Authorization Holder
Trivium-XXI, LLC (Russia)
Manufactured By
Bryntsalov-A, JSC (Russia)
Dosage Form
|
Artravir®-complex-Trivium® | Capsules 500 mg+400 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 hard gelatin, No. 000, white with white caps, opaque; capsule contents – 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.
| 1 caps. | |
| Sodium chloride glucosamine sulfate | 628 mg, |
| Equivalent to glucosamine sulfate content | 500 mg |
| Chondroitin sulfate sodium | 400 mg |
Excipients: croscarmellose sodium – 40 mg, povidone K25 – 10 mg, microcrystalline cellulose (MCC-101) – 72 mg, magnesium stearate – 10 mg.
Capsule shell composition titanium dioxide – 2 %, gelatin – up to 100 %.
Capsule cap composition titanium dioxide – 2%, gelatin – up to 100 %.
5 pcs. – blister pack (1) – cardboard packs.
5 pcs. – blister pack (2) – cardboard packs.
5 pcs. – blister pack (3) – cardboard packs.
5 pcs. – blister pack (4) – cardboard packs.
5 pcs. – blister pack (5) – cardboard packs.
5 pcs. – blister pack (6) – cardboard packs.
5 pcs. – blister pack (10) – cardboard packs.
5 pcs. – blister pack (12) – cardboard packs.
6 pcs. – blister pack (1) – cardboard packs.
6 pcs. – blister pack (2) – cardboard packs.
6 pcs. – blister pack (3) – cardboard packs.
6 pcs. – blister pack (4) – cardboard packs.
6 pcs. – blister pack (5) – cardboard packs.
6 pcs. – blister pack (6) – cardboard packs.
6 pcs. – blister pack (10) – cardboard packs.
6 pcs. – blister pack (12) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
120 pcs. – jars (1) – cardboard packs.
![Artravir®-complex [Capsules] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Artravir®-complex [Capsules] 2")