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

Excipients: corn starch 30,0 mg, lactose monohydrate 188,95 mg, silicon dioxide colloid (aerosil) 1,5 mg, povidone K-30 2.2 mg, crospovidone (type A) 24,0 mg, sodium lauryl sulfate 0,35 mg, magnesium stearate 3,0 mg;

hard gelatine capsules: Body and cap capsule - Titanium dioxide 1,3333 %, quinoline yellow dye 0,9197 %, coloring sunset sunset yellow 0,0044 %, gelatin up to 100%.

Description:

Hard gelatin capsules No. 1 with a body and a lid of yellow color. The contents of the capsules are a yellow powder.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug.

ATX: & nbsp

M.01.A.X.21 Diacerein

Pharmacodynamics:Diacerein an anthraquinoline derivative, a diacetylated derivative of rhein. Metabolized 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.

Diacerein inhibits the effects of other cytokines, including interleukin-6, tumor necrosis factor-a. The action develops in 2-4 weeks.

Diacerein has analgesic and anti-inflammatory activity when taken orally.

Pharmacokinetics:

Diacerein is rapidly absorbed from the gastrointestinal tract and completely deacetylated to rhein. Bioavailability increases by 25% with simultaneous intake with food.

Time to reach the maximum concentration of rhein in the blood plasma (Teshah) - 144 min. With a single admission of 50 mg of diacerein, the maximum concentration of rhein in the blood plasma (C_m_Oh) - 3.15 mg / l, with repeated admission, in connection with the cumulation of the drug, C_m_Ohincreases. 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. The Rhine is excreted by the kidneys unchanged (20%) and in the form of glucuronide (60%) and sulfate (20%).

Indications:Symptomatic treatment of osteoarthrosis of the hip and knee joints.

Contraindications:Hypersensitivity to diacerein, other components of the drug or anthraquinone derivative; inflammatory bowel disease (ulcerative colitis,Crohn's disease); intestinal obstruction; abdominal pain of unknown origin; patients with liver diseases (including in history); severe renal failure (CC less than 30 ml / min); deficiency of lactase, lactose intolerance, glucose-galactose malabsorption; pregnancy and the period of breastfeeding; children's age till 18 years.

Carefully:Renal failure of moderate severity (CK 30-60 ml / min).

Irritable bowel syndrome.

Patients 65 years of age or older.

Pregnancy and lactation:Studies confirming the safety of diacerein during pregnancy and lactation were not conducted. Data on the influence of diacerein on the development of the fetus there. Application during pregnancy and during breastfeeding is contraindicated.

Dosing and Administration:

Inside, after eating, swallowing whole, with water, 50 mg (1 capsule) 2 times a day (morning and evening).

Treatment is conducted continuously for a long time or courses lasting at least 4 months.

Because the diacerein during the first two weeks can cause acceleration of transit in the intestine, it is recommended to start treatment with 1 capsule per day (in the evening, during meals) for four weeks. Then, after consulting a doctor, the dose can be increased to 100 mg (2 capsules) per day.

In patients with moderate renal insufficiency (KK 30-60 ml / min), the dose of the drug should be reduced by half to 50 mg (1 capsule) per day.

Side effects:

The frequency of unwanted reactions is as follows: very often (>1/10 cases), often (>1/100 and <1/10 cases), infrequently (>1/1000 and <1/100 cases), rarely (>1/10000 and <1/1000 cases) and very rarely (<1/10000 cases, including individual cases).

Allergic reactions: infrequently - allergic reactions of various degrees, rash, itching.

From the digestive system: rarely - diarrhea, nausea, vomiting, abdominal pain.

Other: infrequent - intensive staining of urine¹, rarely - a general malaise.

¹ - During the treatment, the drug can intensively stain urine (depending on pH) from yellow to brown, which is not clinically important and does not require drug withdrawal or dose reduction.

If any of the unwanted reactions listed in the manual is aggravated, or if you notice other undesirable reactions not listed in the manual, inform the doctor about it.

Overdose:

Symptoms: diarrhea, weakness.

Treatment: symptomatic. With severe diarrhea, it is necessary to replenish the water-electrolyte balance.

Interaction:

Antacids reduce the absorption of diacerein.

At the same time taking 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 (for example, fiber), the frequency of undesirable reactions from the digestive system can increase. Drugs containing aluminum hydroxide and / or magnesium hydroxide, reduce the bioavailability of diacerein.

Simultaneous use 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).

During treatment, periodic monitoring of blood counts, functional tests of the liver, urine is necessary.

If the kidney function worsens, the doctor must decide whether to reduce the dose or to cancel it.

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

When a patient has diarrhea, the drug should be discontinued.

Effect on the ability to drive transp. cf. and fur:Influence on the concentration of attention, the speed of psychomotor reactions in the management of vehicles, mechanisms and employment of other potentially hazardous activities has not been studied.

Form release / dosage:

Capsules, 50 mg.

Packaging:

For 10, 15 or 30 capsules in a contour cell box made of a polyvinylchloride film and aluminum foil printed lacquered.

For 1, 2, 3, 4, 5, 6 contour squares with instructions for use in a pack of cardboard.

Storage conditions:In dry, dark 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 expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-002723

Date of registration:21.11.2014

Date of cancellation:2019-11-21

The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Manufacturer: & nbsp

OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Information update date: & nbsp17.01.2016

Illustrated instructions

Instructions

Diartrin (Diartrine)