Diaflex Rompharm capsules 50mg, 30pcs

Composition

1 capsule contains diacerein 50 mg

Pharmacological action

Pharmacogroup:

NSAIDs.

Pharmaceutical action:  

Diaflex Rompharm is a drug used for inflammatory and inflammatory-dystrophic diseases of the musculoskeletal system. Diacerein is an anthraquinoline derivative, a diacetylated derivative of rhein. Metabolized to the active metabolite rein, it inhibits the activity of interleukin-1, which plays an important role in the development of inflammation and cartilage degradation in osteoarthritis.

Inhibits the action of other cytokines (including interleukin-6, tumor necrosis factor-alpha). The action develops in 2-4 weeks. Diacerein has analgesic and anti-inflammatory activity when taken orally.

Pharmacokinetics: Rapidly absorbed from the gastrointestinal tract, bioavailability increases by 25% when taken simultaneously with food. The time to reach Cmax is 144 minutes. With a single dose of 50 mg, Cmax is 3.15 mg / l, with repeated use due to the accumulation of the drug, Cmax increases. It is completely deacetylated to rhein. The binding of rhein to proteins (albumin) is almost 100%. Rein penetrates the placental and blood-brain barriers.

T1 / 2 – 255 min. Excreted by the kidneys in unchanged form-20%, in the form of glucuronide-60%, in the form of sulfate-20%.

Indications

Primary and secondary osteoarthritis.

Contraindications

-age up to 18 years; – lactose intolerance, lactase deficiency, glucose-galactose malabsorption— – hypersensitivity to diacerein and other components of Diaflex Rompharm (including anthraquinone laxatives). With caution: severe liver or kidney failure, intestinal obstruction, inflammatory bowel diseases.

Side effects

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

Allergic reactions:  urticaria, fever, bronchospasm, angioedema, anaphylactic shock.

Other services:  malaise, intense staining of urine (depending on pH) from yellow to brown (has no clinical significance).

Interaction

Antacids reduce the absorption of the drug. When taken simultaneously with drugs that affect the intestinal microflora (including antibiotics), with substances that change the quality of intestinal contents and the speed of its emptying (fiber), the frequency of intestinal side effects increases.

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

Concomitant use with laxatives is not recommended.

How to take, course of use and dosage

of Diaflex is taken orally, after meals, it is necessary to swallow whole, without chewing, with water,50 mg 2 times a day (morning and evening).

Continuously for a long time or in courses (at least 4 months).

Diacerein during the first 2 weeks can cause an acceleration of intestinal transit, so it is recommended to start treatment with one capsule a day in the evening with food for 4 weeks.

Then the dose is increased to 100 mg / day.

Overdose

Symptoms: diarrhea, weakness.

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

Special instructions

The duration of treatment may be long. Before the onset of therapeutic effect, diacerein can be taken simultaneously with analgesic drugs (including NSAIDs). Periodic monitoring of blood parameters, liver function tests, and urine is required. If renal function worsens, the dose of the drug should be reduced.

In patients with CRF, with creatinine clearance less than 30 ml/min, the dose of diacerein should be reduced to 50 mg / day and then titrated according to tolerability and clinical efficacy.

Urine staining can make it difficult to interpret the results of a urine test (for example, for glucose).

Form of production

Capsules.

Storage conditions

The drug should be stored in a place protected from light, out of reach of children, at a temperature not exceeding 25°C.

Shelf life

3 years

Active ingredient

Diacerein

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Description

For adults as directed by your doctor

Indications

Osteoarthritis