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

atcPomocomponents: diethylphthalate 2,286 mg, carboxypolymethylene 32.857 mg, magnesium stearate 15.857, povidone 27.857 mg, acrylic and methacrylic acid polymers 34.143 mg, talc 27,000 mg;

capsule shell: toOrpus - titanium dioxide (E171), gelatin qsp.; torosy - quinoline yellow (E104), indigotine (E132), titanium dioxide (E171), gelatin qsp.

Description:

Hard gelatin capsules are elongated. The case is white; The lid is a dark green color.

Contents of the capsule: granules of round shape from white to light yellow color.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID)

ATX: & nbsp

M.02.A.A.10 Ketoprofen

Pharmacodynamics:

Has anti-inflammatory, analgesic and antipyretic effect. Inhibiting cyclooxygenase I and II type, inhibits the synthesis of prostaglandins. It has anti-bradykinin activity, stabilizes lysosomal membranes, and delays the release of enzymes that promote tissue destruction in chronic inflammation. Reduces the secretion of cytokines, inhibits the activity of neutrophils.

Reduces the morning stiffness and swelling of the joints, increases the volume of movements. Ketoprofen lysine salt, in contrast to ketoprofen, is a rapidly dissolving molecule with a neutral pH and almost does not irritate the gastrointestinal tract.

Pharmacokinetics:

Suction

Assigned inside, ketoprofen sufficiently fully absorbed from the gastrointestinal tract, and its bioavailability exceeds 80%. The maximum plasma concentration when taking capsules of Arthrozilene is observed 4-10 hours after oral administration, its value directly depends on the dose taken. The half-life is 6.5 hours. The maximum concentration (C_mOh) of ketoprofen is 3-9 μg / ml. The maximum therapeutic effect is observed for 4 to 24 hours. Food contributes to a decrease in C_mOh and an increase in T_mOh without change AUC.

Distribution

Up to 99% of absorbed ketoprofen binds to plasma proteins, mainly with albumin. The volume of distribution is 0.1-0.2 l / kg. Easily penetrates through the histohematological barriers and is distributed in tissues and organs. Ketoprofen well penetrates into the synovial fluid and connective tissue.Although the concentration of ketoprofen in the synovial fluid is slightly lower than in the plasma, they are more stable (lasting up to 30 hours).

Metabolism

Ketoprofen is mainly metabolized in the liver, where it undergoes glucuronidation to form esters with glucuronic acid.

Excretion

Metabolites are excreted in the urine. With caloric masses less than 1% is excreted.

The drug does not cumulate.

Indications:

Pain relief of mild to moderate intensity, including: post-operative pain, post-traumatic pain and inflammatory pain.

Rheumatic diseases:

- rheumatoid arthritis;

- Spondyloarthritis;

- osteoarthrosis;

- gouty arthritis;

- Inflammation of the periarticular tissues.

Contraindications:

Hypersensitivity (including other NSAIDs), aspirin asthma, peptic ulcer and duodenal ulcer (exacerbation), ulcerative colitis (exacerbation), Crohn's disease, diverticulitis, peptic ulcer, hemophilia and other disorders of coagulation blood, CRF, children's age (under 18 years), pregnancy (III trimester), lactation.

Carefully:

Anemia, bronchial asthma, alcoholism, tobacco smoking, alcoholic cirrhosis of the liver,hyperbilirubinemia, hepatic failure, diabetes, dehydration, sepsis, chronic heart failure, edema, hypertension, blood diseases (including leukopenia), deficiency of glucose-6-phosphate dehydrogenase, stomatitis, advanced age, pregnancy (I, II trimester).

Pregnancy and lactation:

Like other NSAIDs, Arthrosilen should not be used in the third trimester of pregnancy. The use of the drug in I and II trimester should be carefully monitored by the attending physician.

Breastfeeding with the use of the drug should be discontinued.

Dosing and Administration:

1 capsule daily during or after a meal. Duration of treatment can be 3-4 months.

Side effects:

Gastrointestinal tract: abdominal pain, diarrhea, duodenitis, erosive and ulcerative lesions of the gastrointestinal tract, gastritis, gematomezis, esophagitis, stomatitis, melena.

Liver: increased bilirubin, increased "hepatic" enzymes, hepatitis, liver failure, increased liver size.

Nervous system: dizziness, hyperkinesia, tremor, vertigo, mood swings, anxiety, hallucinations, irritability, general malaise.

Sense organs: conjunctivitis, impaired vision.

Skin: urticaria, angioedema, erythematous exanthema, pruritus, maculopapular exanthema, increased sweating, multiform exudative erythema (including Stevens-Johnson syndrome).

Genitourinary system: painful urination, cystitis, swelling, hematuria, menstrual irregularity.

Organs of hematopoiesis: leukocytosis, leukocytosis, lymphangitis, decrease in prothrombin time, purpura, thrombocytopenia, thrombocytopenic purpura, enlarged spleen, vasculitis.

Respiratory system: bronchospasm, dyspnoea, sensation of spasm of the larynx, laryngospasm, laryngeal edema, rhinitis.

The cardiovascular system: hypertension, hypotension, tachycardia, chest pain, syncope, peripheral edema, pallor.

Allergic reactions: anaphylactoid reactions, edema of the oral mucosa, swelling of the pharynx, periorbital edema.

Overdose:

At present, cases of overdose with Arthrosylen have not been reported. In case of an overdose, monitoring of respiratory and cardiac activity is necessary. There is a specific antidote.If necessary, symptomatic therapy should be given. Hemodialysis is ineffective.

Interaction:

Inductors of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites.

Reduces the effectiveness of uricosuric drugs, enhances the effect of anticoagulants, antiaggregants, fibrinolytics, ethanol, side effects of mineral corticosteroids, glucocorticosteroids, estrogens. Reduces the effectiveness of antihypertensive and diuretics.

Joint reception with other NSAIDs, glucocorticosteroids, ethanol, corticotropin can lead to the formation of ulcers and the development of gastrointestinal bleeding, an increased risk of kidney dysfunction.

Simultaneous administration with oral anticoagulants, heparin, thrombolytic agents, antiaggregants, cefapazone, cefamandole and cefotetan increases the risk of bleeding.

Increases hypoglycemic action of insulin and oral hypoglycemic drugs (dose recalculation is necessary).

Co-administration with sodium valproate causes disruption of platelet aggregation. Increases the concentration in the plasma of verapamil and nifedipine, lithium preparations, methotrexate. Antacids and colestramine reduce absorption.

Special instructions:

During treatment, it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys.

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test.

Reception of ketoprofen can mask signs of an infectious disease.

If the kidney and liver function is impaired, a dose reduction and careful monitoring is necessary. The use of ketoprofen by patients suffering from bronchial asthma can lead to an attack of bronchial asthma.

Women planning a pregnancy, should refrain from taking the drug, tk. can reduce the likelihood of implantation of the egg.

Form release / dosage:Capsules, 320 mg.

Packaging:

10 capsules per blister of PVC / Al-Folga. For 1 blister in a cardboard box with instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C, in a dry place.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use the product after the date shown on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N010596 / 05

Date of registration:21.06.2010

Expiration Date:Unlimited

The owner of the registration certificate:Dompe Pharmacetici SpA Dompe Pharmacetici SpA Italy

Manufacturer: & nbsp

INSTITUTO de ANGELI, S.r.L. Italy

Representation: & nbspCBS CJSC LTDCBS CJSC LTDItaly

Information update date: & nbsp14.09.2017

Illustrated instructions

Instructions

Arthrosilen (Artrosilene)