Instruction for use: Artrodarin

Active substance Diacerein

ATX M01AX21 Diacerein

Pharmacological group

Other non-narcotic analgesics, including non-steroidal and other anti-inflammatory drugs

Nosological classification (ICD-10)

M19.9 Arthrosis, unspecified

Change in brush with osteoarthritis, Osteoarthritis, Osteoarthrosis, Arthrosis of large joints, Pain syndrome in osteoarthritis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Deforming arthrosis, Deforming osteoarthritis, Deforming osteoarthritis of joints, Osteoarthritis in the acute stage, Osteoarthritis of large joints, Acute pain syndrome with osteoarthritis, Post-traumatic osteoarthritis, Rheumatic osteoarthritis, Spondylarthrosis, Chronic osteoarthritis

Composition and form of release

Capsules 1 caps.

diacerein 50 mg

auxiliary substances: lactose monohydrate; croscarmellose sodium; povidone K30; silicon dioxide colloidal; magnesium stearate; indigotine (E132); iron oxide yellow (E172); titanium oxide (E171); gelatin

packing: 10 capsules in aluminum foil / thermoformed PVC blister; in a box of cardboard 3 blisters.

Description of dosage form

Capsules hard gelatin, size 1, consisting of a white opaque body and a green opaque cap; the contents of the capsules are yellow, odorless granules.

Characteristic

It is the original anti-inflammatory drug (not related to NSAIDs) for the treatment of osteoarthritis.

pharmachologic effect

Pharmacological action - anti-inflammatory, antirheumatic.

Pharmacodynamics

The drug has a symptom-modifying effect of delayed action. Diacerein inhibits the synthesis and activity of IL-1, which plays an important role in the development of inflammation, degradation and subsequent destruction of cartilage in osteoarthritis. In addition, diacerein inhibits the effects of other cytokines that cause inflammation, including IL-6, tumor necrosis factor-α. Diacerein also slows the formation of metalloproteinases (collagenase, elastase), which are involved in the process of damage to cartilaginous tissue. With long-term use, diacerein stimulates the synthesis of proteoglycans and does not affect the synthesis of PG.

Pharmacokinetics

Absorption and Metabolism

After oral administration, diacerein is rapidly absorbed from the digestive tract and completely deacetylated to rhein. Taking the drug simultaneously with food increases bioavailability by 25%. Cmax rhein in plasma is achieved after 144 min. With a single admission of the drug, 50 mg Cmax reaches 3.15 mg / l. With multiple admission, Cmax increases in connection with the cumulation of the drug.

Distribution and deduction

Binding of rhein to albumin is almost 100%. Rein penetrates through the BBB and placental barriers. T1 / 2 - 255 min. Rein is excreted by the kidneys unchanged (20%) and in the form of glucuronide (60%) and sulfate (20%).

Indications

Primary and secondary osteoarthritis.

Contraindications

individual intolerance of drug components or high sensitivity to anthraquinone drugs (eg, laxatives);

children and adolescents under 18;

pregnancy;

lactation period (breastfeeding).

With care - patients with irritation of the lower intestine and with chronic renal failure.

pregnancy and lactation

Contraindicated in pregnancy. For the duration of treatment, breastfeeding should be discontinued.

Side effects

With increased sensitivity to the components of the drug, allergic reactions of various degrees may be noted.

At the initial period of taking the drug, there can be temporary phenomena from the digestive system: diarrhea, nausea, vomiting, abdominal pain. In this case, the dosage can be reduced to 1 caps. in a day.

In the process of treatment, intensive staining of urine can occur - from yellow to brown (depending on pH), which does not require a reduction in the dose (withdrawal) of the drug.

Interaction

Artrodarin® should not be taken with substances that affect the quality of the contents of the intestine and the rate at which it is emptied (eg, high amounts of fiber). Antacids reduce the absorption of the drug. With simultaneous administration with antibiotics or chemotherapeutic drugs that affect the intestinal microflora, the frequency of adverse events from the intestine can increase.

Dosing and Administration

Inside, swallowing whole, without chewing, washing with water. Standard reception - 1 caps. 2 times a day (morning and evening, after meals). The effect of treatment should be expected in 2-4 weeks.

Artrodarin® is taken continuously for a long time or by courses lasting at least 4 months.

Overdose

Symptoms: Possible - diarrhea, weakness.

Treatment: symptomatic.

In case of overdose or accidental medication, children should consult a doctor.

special instructions

The duration of treatment, depending on the result achieved, can be prolonged. In the period preceding the development of the therapeutic effect, Arthroarin® can be taken concomitantly with analgesics and NSAIDs. Periodic monitoring of blood counts, hepatic enzymes, and urine is necessary. Caution is prescribed for chronic kidney failure. If the kidney function worsens, the doctor should lower the dose of the drug.

Conditions of leave from pharmacies

On prescription.

storage Conditions

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life

3 years.

Do not use after the expiry date printed on the package.