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

Excipients: lactose monohydrate - 214.3 mg, croscarmellose sodium - 11.5 mg, povidone K30 -11.5 mg, silicon colloidal dioxide - 11.5 mg, magnesium stearate - 1.2 mg.

Shell composition: gelatin - 74,73918 mg, indigocarmine - 0,4106 mg, iron oxide yellow - 0,00272 mg, titanium dioxide -2,8475 mg.

Description:Hard gelatin capsules (size 1), consisting of a white opaque body and a green opaque lid. Capsules contain a mixture of granules and yellow powder, odorless.

Pharmacotherapeutic group:Anti-inflammatory agent with a symptom-modifying effect of delayed action

ATX: & nbsp

M.01.A.X.21 Diacerein

Pharmacodynamics:Diacerein inhibits the synthesis and activity of interleukin - 1 (IL - 1), which plays an important role in the development of inflammation, degradation and subsequent destruction of cartilage in osteoarthritis. Besides, Diacerein inhibits the effect of other cytokines that cause inflammation, including IL-6, TNF-α. Diacerein also slows the formation of metalloproteinases (collagenase, elastase), which are involved in the process of damage to the cartilaginous tissue. With prolonged use Diacerein stimulates the synthesis of proteoglycans and does not affect the synthesis of prostaglandins.

Pharmacokinetics:After oral administration Diacerein It is rapidly absorbed from the gastrointestinal tract and completely deacetylated to rhein. Simultaneous intake of the drug with food increases bioavailability by 25%. The maximum concentration (C max) of rhein in plasma is reached after 144 minutes. The half-life of the plasma is 255 minutes. The connection of rhein with albumin is almost 100%. With a single admission, 50 mg of C max is 3.15 mg / l. With repeated administration of the drug, Cmax increases in connection with the cumulation of the drug. The Rhine is excreted by the kidneys unchanged (20%) and in the form of glucuronide (60%) and sulfate (20%). The Rhine penetrates the placental and blood-brain barrier.

Indications:

Primary and secondary osteoarthritis.

Contraindications:Individual intolerance to the components of the drug or a high sensitivity to anthrachion preparations (eg, laxatives). Children's age (up to 18 years).Pregnancy, lactation.

Carefully:Patients with irritation of the lower intestinal tract drug is prescribed only in special cases. It is extremely cautious to use the drug and in the presence of chronic kidney failure.

Dosing and Administration:Standard intake of 1 capsule 2 times a day (morning and evening, after meals). Capsules should be swallowed whole, not liquid, and washed down with water. The effect of treatment should be expected in 2-4 weeks. Arthrodarin is taken continuously for a long time or by courses lasting not less than 4 months.

Side effects:

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

In 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 capsule per day.

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

Overdose:

Overdose may cause diarrhea, weakness.In case of overdose or accidental medication, children should consult a doctor. Treatment is symptomatic.

Interaction:

Arthrodarin should not be taken together with substances that affect the quality of the contents of the intestine and the rate of its emptying (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.

Special instructions:

The duration of treatment, depending on the result achieved, can be long. In the period preceding the development of the therapeutic effect, Arthroarin can be taken concomitantly with analgesics and non-steroidal anti-inflammatory drugs. Periodic monitoring of blood counts, hepatic enzymes, and urine is necessary. If the kidney function worsens, the doctor should lower the dose of the drug.

Form release / dosage:Capsules 50 mg.

Packaging:

10 capsules in an aluminum foil / thermoformed PVC blister.

3 blisters together with instructions for use are placed in a cardboard box.

Storage conditions:In a place protected from light and inaccessible to children at a temperature not exceeding + 25 ° С.

Shelf life:3 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-005403/08

Date of registration:14.07.2008 / 18.05.2010

Expiration Date:Unlimited

The owner of the registration certificate:TRB Kemedika International SA TRB Kemedika International SA Argentina

Manufacturer: & nbsp

TRB Pharma, S.A. Argentina

Representation: & nbspTRB Kemedika International SA TRB Kemedika International SA Argentina

Information update date: & nbsp13.09.2017

Illustrated instructions

Instructions

Arthroarin® (Artrodarin®)