artrosilene ampoules 80mg/1ml 2ml №6

Mechanism of action

NSAIDs. It has anti-inflammatory, analgesic and antipyretic effects. Inhibiting COX-1 and COX-2, inhibits the synthesis of prostaglandins. Possesses anti-bradykinin activity, stabilizes lysosomal membranes and delays the release of enzymes from them, contributing to the destruction of tissues during chronic inflammation. Reduces cytokine secretion, inhibits neutrophil activity.
Reduces morning stiffness and swelling of joints, increases range of motion.
Ketoprofena lysine salt, unlike ketoprofena, is an instant compound with a neutral pH, due to which it almost does not irritate the gastrointestinal tract.
After oral administration, the maximum therapeutic effect is observed for from 4 to 24 hours.
When applied externally, artrosilene reduces the manifestations of inflammation and pain in the affected joints, tendons, ligaments, muscles. In case of articular syndrome, it causes a reduction in pain in the joints at rest and during movement, a decrease in morning stiffness and swelling of the joints.
Ketoprofena lysine salt has no catabolic effect on articular cartilage.

Indications and usage

For oral and rectal use
Relief of pain of low and moderate intensity, including:
- postoperative pain;
- posttraumatic pain;
- pain of an inflammatory nature.
Symptomatic treatment of rheumatic and inflammatory diseases, including:
- rheumatoid arthritis;
- spondyloarthritis;
- osteoarthritis;
- gouty arthritis;
- inflammatory lesion of periarticular tissues.
For parenteral use
Short-term treatment of acute pain:
- in diseases of the musculoskeletal system of various origins;
- in the postoperative period;
- after injuries and in inflammatory processes.
For external use
- acute and chronic inflammatory diseases of the musculoskeletal system (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis of the peripheral joints and spine, rheumatic lesions of soft tissues);
- muscle pain of rheumatic and non-rheumatic origin;
- traumatic injuries of soft tissues.

Inside artrosilene appoint 1 caps / day, during or after a meal. The duration of treatment may be 3-4 months.
Rectal designate 1 suppository 2-3 times / day. The maximum daily dose is 480 mg. Elderly patients should not be prescribed more than 2 suppositories per day.
In case of impaired renal and liver function, dose reduction is necessary
Parenteral (IM or IV) is prescribed in a dose of 160 mg (1 amp.) / Day.The maximum daily dose is 320 mg (1 amp. 2 times / day).
Elderly patients should be assigned not more than 1 amp. / Day.
Parenterally, the drug should be administered briefly (up to 3 days), then transferred to taking the drug inside or to the use of suppositories.
In / in the introduction of the drug is allowed only in the hospital. To increase the time of the drug is recommended to conduct a slow intravenous infusion. Duration of intravenous infusion is at least 30 minutes.
The solution for infusion is prepared on the basis of 50 ml or 500 ml of the following aqueous solutions: 0.9% sodium chloride solution, 10% aqueous solution of levulose, 5% aqueous solution of dextrose, Ringer's acetate solution, Ringer's Hartman lactate solution), a dextran colloidal solution in a 0.9% solution sodium chloride or 5% dextrose.
At dilution of artrosilene in solutions of a small volume (50 ml), the drug is introduced into / into the bolus.
When applied externally, a single dose of the gel is 3-5 g (volume of large cherries), aerosol - 1-2 g (walnut volume). The drug should be applied 2-3 times / day, gently rubbing until completely absorbed. The duration of treatment should not exceed 10 days (without consulting a doctor).

Adverse reactions

On the part of the digestive system: abdominal pain, diarrhea, stomatitis, esophagitis, gastritis, duodenitis, erosive and ulcerative lesions of the gastrointestinal tract, hematomesis, melena, increased bilirubin, increased liver enzymes, hepatitis, hepatic insufficiency, increased liver size.
On the part of the central nervous system: dizziness, hyperkinesia, tremor, vertigo, mood swings, anxiety, hallucinations, irritability, general malaise, blurred vision.
Allergic reactions: urticaria, angioedema, exudative erythema multiforme (including Stevens-Johnson syndrome), anaphylactoid reactions (edema of the oral cavity, pharyngeal edema, periorbital edema).
Dermatological reactions: erythematous rash, pruritus, maculopapular rash.
On the part of the urinary system: painful urination, cystitis, edema, hematuria.
On the part of the hematopoietic system: leukocytopenia, leukocytosis, lymphangitis, reduction of prothrombin time, thrombocytopenia, thrombocytopenic purpura, an increase in the size of the spleen, vasculitis.
On the part of the respiratory system: bronchospasm, dyspnea, sensation of spasm of the larynx, laryngospasm, laryngeal edema, rhinitis.
Since the cardiovascular system: hypertension, hypotension, tachycardia, chest pain, syncopal states, peripheral edema, pallor.
Others: conjunctivitis, menstrual disorders, increased sweating.
Local reactions with rectal administration: burning, itching, heaviness in the anorectal region, exacerbation of hemorrhoids.
Local reactions for external use: skin manifestations of allergic reactions, photosensitivity. With prolonged use on large surfaces of the skin may develop systemic side effects.
Ketoprofen lysine salt causes less side effects than Ketoprofen.

Contraindications

- "Aspirin Triad";
- III trimester of pregnancy;
- lactation period;
- hypersensitivity to ketoprofen or other components of the drug, Acetylsalicylic acid or other NSAIDs.
For system use
- peptic ulcer of the stomach and duodenum in the acute phase;
- ulcerative colitis in the acute phase;
- Crohn's disease;
- diverticulitis;
- peptic ulcer;
- coagulation disorders (including hemophilia);
- chronic renal failure;
- children's and teenage age up to 18 years.
For external use
- weeping dermatosis;
- eczema;
- violation of the integrity of the skin;
- children's age up to 6 years.
Precautions should be prescribed the drug in the I and II trimesters of pregnancy, as well as in elderly patients. With systemic use, caution should be exercised with anemia, bronchial asthma, alcoholism, tobacco smoking, alcoholic cirrhosis of the liver, hyperbilirubinemia, liver failure, diabetes, dehydration, sepsis, chronic heart failure, edema, hypertension, blood diseases (including leukopie ), deficiency of glucose-6-phosphate dehydrogenase, stomatitis; with external use - with exacerbation of hepatic porphyria, erosive and ulcerative lesions of the gastrointestinal tract, severe impaired liver and kidney function, chronic heart failure, bronchial asthma, as well as in children under 12 years of age.

Pregnancy and breastfeeding

The use of the drug artrosilene in the third trimester of pregnancy is contraindicated. In the I and II trimesters of pregnancy, the drug artrosilene should be used with caution and under the supervision of a physician. If necessary, the use of the drug during lactation breastfeeding should be discontinued.
Women planning a pregnancy should refrain from taking the drug artrosilene, because against the background of its reception, the probability of implantation of an egg cell may decrease.

Special notes

During treatment with the drug artrosilene, it is necessary to periodically monitor the pattern of peripheral blood and the functional state of the liver and kidneys.
If necessary, determine the 17-ketosteroids drug should be canceled 48 hours before the study.
Taking Artrozilena may mask signs of an infectious disease.
The use of artrosilene in bronchial asthma can provoke an attack of suffocation.
When applied externally, the drug should be applied only to intact skin. Avoid contact with eyes and mucous membranes. In order to avoid manifestations of hypersensitivity and photosensitivity, it is recommended to avoid exposure of the skin to sunlight during the course of treatment.
Aqueous solutions of ketoprofen lysine salt, as well as gel for external use can be used in physiotherapy treatment (iontophoresis, mesotherapy): with iontophoresis, the drug is applied to the negative pole.
Influence on ability to drive motor transport and control mechanisms
During the period of use of the drug should refrain from potentially hazardous activities that require high concentration of attention and speed of psychomotor reactions.

Currently, no cases of overdose with artrosilene have been reported.
In case of overdose, symptomatic therapy, monitoring of respiratory and cardiovascular activity should be carried out. There is no specific antidote. Hemodialysis is ineffective.

Inductors of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants), while being used with artrosilene, increase the metabolism of ketoprofen (increase the production of hydroxylated active metabolites).
Against the background of simultaneous use with the drug artrosilene, the effectiveness of uricosuric drugs decreases, the effect of anticoagulants, antiplatelet agents, fibrinolytics, ethanol, side effects of mineralocorticoids, glucocorticoids, estrogens increases; reduces the effectiveness of antihypertensive drugs and diuretics.
The simultaneous use of the drug artrosilene with other NSAIDs, GCS, ethanol, corticotropin can lead to the formation of ulcers and the development of Gastrointestinal bleeding, to an increased risk of developing impaired renal function.
The simultaneous appointment of Artrozilena with oral anticoagulants, Heparin, thrombolytic agents, antiplatelet agents, cefoperazone, cefamandol and cefotetanom increases the risk of bleeding.
The drug artrosilene with simultaneous use enhances the hypoglycemic effect of insulin and oral hypoglycemic drugs (dose recalculation is necessary).
Joint appointment Artrozilena with sodium valproate causes a violation of platelet aggregation.
Ketoprofen with simultaneous use increases the plasma concentration of Verapamil and Nifedipine, lithium, Methotrexate.
Antacids and colestiramine while ingesting with the drug artrosilene reduce the absorption of ketoprofen.

The drug should be stored in a dark place, out of the reach of children at a temperature up to 25 ° C. Aerosol can not overheat! Shelf life of rectal capsules and suppositories is 5 years, solution for IV and IM administration, gel and aerosol for external use is 3 years.

Pharmacy sales terms

Dosage forms for systemic use are available on prescription.
Dosage forms for external use are allowed for use as a means of non-prescription.