Fleccerin (diacerein) capsules 50 mg. №30

Description

Fleccerin Composition
active substance: diacerein;

1 capsule contains diacerein 50 mg;

excipients: lactose, monohydrate, croscarmellose sodium, povidone, colloidal anhydrous silicon dioxide, magnesium stearate;

hard gelatin capsule: gelatin, indigo carmine (indigotin) (E 132), quinoline yellow (E 104), titanium dioxide (E 171).

Fleccerin Dosage form.

The capsules are hard.

Basic physical and chemical properties: hard gelatin capsules with a green lid and body. The contents of the capsules are yellow granular powder.

Pharmacotherapeutic group.

Non-steroidal anti-inflammatory and antirheumatic drugs. ATX code M01A X21.

Pharmacological properties

Pharmacodynamics.

Flekcerin is a drug for the treatment of osteoarthritis and osteoarthritis, which has analgesic, antipyretic and anti-inflammatory properties. Diacerein is classified as a slow-acting agent, the effect of which appears within 2-4 weeks of treatment and reaches clinical significance after 4-6 weeks. It has an original mechanism of action that differs from the mechanism of action of non-steroidal anti-inflammatory drugs (NSAIDs).

Diacerein, like its active metabolite rhein, inhibits the synthesis and activity of interleukin-1 (IL-1), which plays a leading role in the pathogenesis of osteoarthritis, and at the same time increases the production of transforming growth factor-b (TGF-b), which initiates the proliferation of chondrocytes and stimulating the production of collagen II, proteoglycans and hyaluron.

Unlike non-steroidal anti-inflammatory drugs, diacerein does not inhibit prostaglandin synthesis and therefore does not have gastroduodenal side effects.

Fleccerin Pharmacokinetics.

The absorption of diacerein is slowed down when used simultaneously with food. Diacerein is completely converted to rhein-metabolite by deacylation before entering the central circulation. The bioavailability of the rhein metabolite is 35-56%. The volume of distribution is approximately 13.2 liters. The rhein metabolite binds to plasma proteins by almost 99%, but this connection is not stable. Rhein-metabolite is either excreted by the kidneys unchanged (20%), or conjugated in the liver to rhein-glucuronide (60%) or rhein-sulfate (20%), which are also excreted in the urine. The half-life is approximately 7-8 hours.

When diacerein was used in elderly patients, no changes in its pharmacokinetic properties were observed.

Clinical characteristics.

Indications
Rheumatic diseases of the joints (osteoarthritis, osteoarthritis).

Contraindications
A history of hypersensitivity to drug components or to anthraquinone.
Explicit or history of liver disease.
Inflammatory intestinal diseases (ulcerative colitis, Crohn’s disease).
Intestinal obstruction or pseudo-obstruction.
Abdominal pain of unknown origin.
The period of pregnancy or lactation.