Producer: CJSC FP OBOLENSKOYE Russia
Code of automatic telephone exchange: M01AX21
Release form: Firm dosage forms. Capsules.
General characteristics. Structure:
Active ingredient: 50 mg of a diatserein in 1 capsule.
Excipients: starch corn, lactoses monohydrate, silicon dioxide colloid (aerosil), K-30 povidone, кросповидон (type A), sodium lauryl sulfate, magnesium stearate.
Gelatinous solid capsules: the case and a lid of the capsule - titanium dioxide of 1,3333%, dye of quinolinic yellow 0,9197%, dye a sunset of yellow 0,0044%, gelatin.
Pharmacodynamics. Diatserein - derivative an antrakhinolina, diacetylized derivative Rhine. It is metabolized to an active metabolite of Rhine, inhibits activity interleykina-1, the inflammation playing an important role in development and degradation of a cartilage at an osteoarthrosis.
Diatserein inhibits effect of other cytokines, including interleykin-6, a tumor necrosis factor - and. Action develops in 2-4 weeks.
Diatserein has analgeziruyushchy and antiinflammatory activity at intake.
Pharmacokinetics. Diatserein is quickly soaked up from digestive tract and completely deacetylated to Rhine. Bioavailability increases by 25% at a concomitant use with food.
Time of achievement of the maximum concentration of Rhine in a blood plasma (Teshakh) - 144 min. At a single dose of 50 mg of a diatserein the maximum concentration of Rhine in a blood plasma (Cmax) - 3,15 mg/l, at multiple dose, in connection with cumulation of drug, Cmax raises. Communication of Rhine with proteins (albumine) of nearly 100%. Rein gets through placental and hematoencephalic barriers.
The elimination half-life (T1/2) - Rein is removed 255 min. by kidneys in an invariable look (20%) and in the form of a glucuronide (60%) and sulfate (20%).
Indications to use:
Symptomatic treatment of an osteoarthrosis of hip and knee joints.
Route of administration and doses:
Inside, after food, swallowing entirely, washing down with water, 50 mg (1 capsule) 2 times a day (in the morning and in the evening).
Treatment is carried out is continuously long or courses lasting not less than 4 months.
As диацереин within the first two weeks can cause acceleration of transit in intestines, it is recommended to begin treatment with 1 capsule a day (in the evening, during food) within four weeks. Then after consultation with the doctor the dose can be increased to 100 mg (2 capsules) a day.
At patients with a renal failure of moderate severity (KK of 30-60 ml/min.), the dose of drug has to be lowered twice to 50 mg (1 capsule) a day.
Features of use:
Pregnancy and lactation. The researches confirming safety of use of a diatserein during pregnancy and feeding with a breast were not conducted. There are no data on influence of a diatserein on fetation. Use at pregnancy and during breastfeeding is contraindicated.
Duration of treatment can be long. Before therapeutic effect диацереин it is possible to accept along with analgeziruyushchy medicines (including non-steroidal anti-inflammatory drugs).
During treatment periodic control of indicators of blood, functional trials of a liver, urine is necessary.
At deterioration in function of kidneys the doctor has to make the decision on a dose decline of drug or its cancellation.
Coloring of urine can complicate interpretation of results of the analysis of urine (for example, on the content of glucose).
At emergence in the patient of diarrhea treatment by drug has to be stopped. Influence on ability to manage vehicles and mechanisms. Influence on concentration of attention, speed of psychomotor reactions at control of vehicles, mechanisms and occupation by other potentially dangerous types of activity it was not studied.
Frequency of development of undesirable reactions is presented as follows: very often (> 1/10 cases), it is frequent (> 1/100 and <1/10 cases), infrequently (> 1/1000 and <1/100 cases), is rare (> 1/10000 and <1/1000 cases) and is very rare (<1/10000 cases, including separate cases).
Allergic reactions: infrequently - allergic reactions of various degree, rash, an itch.
Other: infrequently - intensive coloring mochi1, is rare - a febricula.
1 - During treatment by drug perhaps intensive coloring of urine (depending on рН) from yellow till brown color that has no clinical value and does not demand drug withdrawal or a dose decline.
If any of the undesirable reactions specified in the instruction are aggravated, or you noticed other undesirable reactions which are not specified in the instruction, report about it to the doctor.
Interaction with other medicines:
Antacids reduce absorption of a diatserein.
At a concomitant use with the medicines influencing intestinal microflora (including with antibiotics), and also with the substances changing quality of contents of intestines and speed of its emptying (for example, cellulose), the frequency of undesirable reactions from the alimentary system can increase.
The medicines containing aluminum hydroxide and/or magnesium hydroxide reduce bioavailability of a diatserein.
Simultaneous use with laxatives is not recommended to means.
Hypersensitivity to a diatserein, other components of drug or derivatives of anthraquinone; inflammatory diseases of intestines (ulcer colitis, disease Krone); intestinal impassability; abdominal pain of not clear genesis; patients with liver diseases (including in the anamnesis); heavy renal failure (KK less than 30 ml/min.); deficit of lactase, lactose intolerance, glyukozo-galaktozny malabsorption; pregnancy and period of breastfeeding; children's age up to 18 years.
With care. Renal failure of moderate severity (KK of 30-60 ml/min.). Irritable colon. Patients of 65 years are also more senior.
Symptoms: diarrhea, weakness.
Treatment: symptomatic. At the expressed diarrhea completion of water and electrolytic balance is necessary.
In the dry place protected from light at a temperature not above 25 °C. To store in the place, unavailable to children. A period of validity - 2 years. Not to apply after the period of validity specified on packaging.
According to the recipe
Capsules, 50 mg. Packaging: on 10, 15 or 30 capsules in a blister strip packaging from a film of the polyvinyl chloride and printing aluminum foil varnished. On 1, 2, 3, 4, 5, 6 blister strip packagings together with the application instruction in a pack from a cardboard.