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

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:

Time to reach C_mOh with parenteral administration - 20-30 minutes.Effective concentration persists for 24 hours. The therapeutic concentration in the synovial fluid is maintained for 18-20 hours.

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 passes 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).

Metabolized by microsomal enzymes of the liver.

It is excreted by the kidneys, 60-80% - in the form of glucuronide for 24 hours.

Indications:

For short-term treatment of acute pain syndrome: diseases of the musculoskeletal system of various genesis; postoperative pain; post-traumatic pains and pain associated with inflammation.

Contraindications:

Hypersensitivity (including to other NSAIDs), "Aspirin" asthma, gastric ulcer and duodenum 12 (exacerbation), ulcerative colitis (exacerbation), Crohn's disease, diverticulitis, peptic ulcer, hemophilia and others. Coagulation disorders , CRF, children's age (under 18), pregnancy, lactation.

Carefully:

Anemia, bronchial asthma, alcoholism, tobacco smoking, alcoholic liver cirrhosis, hyperbilirubinemia, hepatic insufficiency, diabetes mellitus, dehydration, sepsis, CHF, edema, arterial hypertension, blood diseases (including leukopenia), glucose-6-phosphate dehydrogenase deficiency, stomatitis, advanced age.

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 ampoule per day intramuscularly or intravenously.

The maximum dose of 1 ampoule 2 times a day. Intravenous administration of the drug is allowed only in a hospital. The drug is used for short treatment - up to 3 days. If it is necessary to continue using the drug, it is recommended to switch to taking oral dosage forms or suppositories. In elderly patients, use no more than 1 ampoule a day.

Ampoules should be opened on a special line of the fracture. After opening the ampoule, use the solution immediately.

Aqueous solutions of ketoprofen lysine salt can be used in physiotherapy (ionophoresis, mesotherapy): with iontophoresis the solution is applied to the negative pole.

When using intravenously, slow infusion is recommended to increase the duration of the drug.

Solution for infusion of Arthrosilen is prepared on the basis of 50 or 500 ml of the following aqueous solutions: 0.9% solution of sodium chloride, 10% aqueous solution of levulose, 5% aqueous solution of dextrose, Ringer's acetate solution, Ringer's lactate solution (Hartman), colloidal dextran solution in 0.9% solution of sodium chloride or 5% glucose solution.

When Arthrosilen is diluted in small volume solutions (50 ml), the drug is administered iv bolus.

In solutions of large volume (500 ml), the infusion duration is at least 30 minutes.

Side effects:

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

Liver: increased bilirubin, increased "hepatic" enzymes, hepatitis, hepatic insufficiency, increase in liver size.

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

Sense organs: conjunctivitis, impaired vision.

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

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

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

Respiratory system: bronhospazm, dyspnea, sensation of spasm of the larynx, laryngospasm, laryngeal edema, rhinitis.

The cardiovascular system: ghypertension, 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 no 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 development of renal dysfunction.

Simultaneous administration with oral anticoagulants, heparin, thrombolytic agents, antiaggregants, cefoperazone, cefamandol 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.

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 using the drug, because can reduce the likelihood of implantation of the egg.

Effect on the ability to drive transp. cf. and fur:

During the period of application of the drug, one should refrain from potentially dangerous activities related to the need for concentration of attention and rapid psychomotor reactions.

Form release / dosage:

Solution for intravenous and intramuscular injection, 160 mg / 2 ml.

Packaging:

2 ml per ampoule of dark glass (hydrolytic glass type 1. Heb., Pharm.).

6 ampoules per pallet of plastic. One pallet in a cardboard box with instructions for use.

Storage conditions:

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

Keep out of the reach of children!

Shelf life:

2 years.

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

Terms of leave from pharmacies:On prescription

Registration number:П N010596 / 03

Date of registration:10.06.2010 / 13.08.2010

Expiration Date:Unlimited

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

Manufacturer: & nbsp

ABIOGEN PHARMA, S.p.A. Italy

Representation: & nbspCBS CJSC LTDCBS CJSC LTDItaly

Information update date: & nbsp14.09.2017

Illustrated instructions

Instructions

Arthrosilen (Artrosilene)