Diacerein - instructions for use, dose, side effects, contraindications

Excipients: lactose monohydrate 222.5 mg, croscarmellose sodium 18 mg, hypromellose 3 cps 3 mg, silicon colloidal dioxide 3 mg, magnesium stearate 1.5 mg;

capsule composition: methyl parahydroxybenzoate 0.80%, propyl parahydroxybenzoate 0.20%, sodium lauryl sulfate 0.08%, water 14.5%, titanium dioxide (E 171) 1.4625%, dye azorubin (E 122) 0.003%, blue dye patented E 131) 0.09%, gelatin to 100%;

composition of black ink used to mark the cap of the capsule: ethanol 29-33%, isopropanol 9-12%, butanol 4-7%, shellac 24-28%, iron dye oxide black (E 172) 24-28%, ammonia solution concentrated 1-3%, macrogol 0.5 -2.0%;

the composition of the white ink used to mark the capsule body, ethanol 19-23%, isopropanol 19-23%, shellac 21-25%, titanium dioxide (E 171) 32-36%, a solution of ammonia concentrated 1-3%, polysorbate-80 0.5-2.0%.

Description:

Hard gelatin capsules No. 1 blue with black marking on the "Dr. REDDY'S" lid and white "Movagain" on the body. The contents of the capsules are a granular powder of yellow color.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug.

ATX: & nbsp

M.01.A.X.21 Diacerein

Pharmacodynamics:

Anthraquinoline derivative, diacetylated rhein derivative. Metabolizing to the active metabolite of rhein, inhibits the activity of interleukin-1, which plays an important role in the development of inflammation and cartilage degradation in osteoarthritis.

Inhibits the effect of other cytokines (including interleukin-6, TNF alpha). The action develops in 2-4 weeks.

Pharmacokinetics:

Quickly absorbed from the gastrointestinal tract (GIT), bioavailability increases by 25% with simultaneous intake with food.

Time to reach the maximum concentration (Tc_max) - 144 min. With a single admission of 50 mg, the maximum concentration (C_max) - 3.15 mg / l, with repeated admission, due to the cumulation of the drug, C_max increases. Completely deacetylated to rhein. The connection of rhein with proteins (albumin) is almost 100%. The Rhine penetrates the placental and blood-brain barrier.

The half-life (T_1/2) - 255 min. It is excreted by the kidneys unchanged (20%), in the form of glucuronide (60%) and in the form of sulfate (20%).

Indications:Primary and secondary osteoarthritis.

Contraindications:Hypersensitivity to the components of the drug (including anthraquinone drugs - laxatives), lactose intolerance, impaired absorption of glucose-galactose, lactase deficiency, pregnancy, lactation, age under 18 years.

Carefully:Chronic renal failure, irritation of the lower intestine.

Pregnancy and lactation:Studies confirming the safety of the drug during pregnancy and lactation were not conducted. There are no data on the effect on fetal development. The drug is contraindicated for use in pregnancy and lactation (breastfeeding).

Dosing and Administration:

Inside, after eating, you must swallow whole, with water, 50 mg twice a day (morning and evening).

Continuously long or courses (at least 4 months).

Diacerein for the first 2 weeks can cause acceleration of transit in the intestine, so it is recommended to start treatment with one capsule per day in the evening with food for 4 weeks. Then the dose is increased to 100 mg / day.

Side effects:

The frequency of side effects is classified according to the incidence of the case: often - 1-10%, infrequently - 0.1-1%, rarely - 0.01-0.1%, very rarely - less than 0.01%, including individual cases .

With increased sensitivity to the components of the drug, allergic reactions of various degrees, rash, itching may be rare. In the initial period of taking the drug, there can rarely be phenomena from the digestive system: diarrhea, nausea, vomiting, abdominal pain, general malaise. Infrequent urine staining (depending on pH) is rarely observed from yellow to brown (it has no clinical significance, does not require drug withdrawal or dose reduction).

Overdose:

Symptoms, diarrhea, weakness.

Treatment: symptomatic. With severe diarrhea, control of the electrolyte composition of the plasma is necessary.

Interaction:

Antacids reduce the absorption of the drug.With simultaneous admission with drugs that affect the intestinal microflora (including antibiotics), as well as with substances that change the quality of the contents of the intestine and the rate of its emptying (fiber), the incidence of side effects from the intestine increases.

Drugs containing aluminum hydroxide and / or magnesium hydroxide, reduce the bioavailability of diacerein.

Simultaneous use of the drug with laxatives is not recommended.

Special instructions:

The duration of treatment can be long. Before the therapeutic effect, diacerein can be taken simultaneously with analgesic drugs (including non-steroidal anti-inflammatory drugs). Periodic monitoring of blood counts, functional liver and urine samples is necessary. If the kidney function worsens, it is necessary to reduce the dose of the drug. In patients with chronic renal failure, with creatinine clearance less than 30 ml / min, the dose of diacerein should be reduced to 50 mg / day and then adjusted according to tolerability and clinical efficacy.

Staining of urine may make it difficult to interpret the results of the urinalysis (for example, on the glucose content).

Effect on the ability to drive transp. cf. and fur:The effect of the drug on the concentration of attention, the speed of psychomotor reactions when driving motor vehicles and engaging in other potentially dangerous activities is unlikely.

Form release / dosage:Capsules 50 mg.

Packaging:For 10 capsules in an aluminum strip, laminated with polyethylene. For 3 or 6 strips with instructions for use in a pack of cardboard.

Storage conditions:In a dry, protected from light place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:2 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-002073

Date of registration:23.05.2013 / 18.09.2014

Expiration Date:23.05.2018

Date of cancellation:2017-12-14

The owner of the registration certificate:Dr. Reddy's Laboratories Ltd.Dr. Reddy's Laboratories Ltd. India

Manufacturer: & nbsp

DR. REDDY`S LABORATORIES, LTD. India

Representation: & nbspDR REDDY'S LABORATORIS LTD. DR REDDY'S LABORATORIS LTD. India

Information update date: & nbsp14.12.2017

Illustrated instructions

Instructions

Diacerein (Diacerein)