Buy Artrosilene solution intravenously and intramuscularly 80 mg/ml 2 ml No. 6 in pharmacies

For the treatment of joint and muscle pain, as well as sprains and osteoarthritis, the effective remedy “Artrosilene” is used. It contains ketoprofen in an easily digestible form. The medicine relieves pain well, prevents inflammation, and relieves swelling. Used to treat adults and children over 6 years of age.

Nosological classification (ICD-10)

• L40.5 Arthropathic psoriasis (M07.0-M07.3*, M09.0*)
• M06.9 Rheumatoid arthritis, unspecified
• M10 Gout
• M35 Other systemic connective tissue disorders
• M42 Osteochondrosis of the spine
• M45 Ankylosing spondylitis
• M65 Synovitis and tenosynovitis
• M71 Other bursopathies
• M77.9 Enthesopathy, unspecified
• M79.0 Rheumatism, unspecified
• M79.1 Myalgia
• M79.9 Soft tissue disease, unspecified
• R52.0 Acute pain
• R52.2 Other persistent pain
• T14.9 Injury, unspecified
• Z100* CLASS XXII Surgical practice

Composition and release form

10 pcs in blister; 1 blister in a cardboard pack.

in dark glass ampoules of 2 ml; 6 pcs in a pallet, 1 pallet in a cardboard pack.

5 pcs per strip; 2 strips in a cardboard pack.

in aluminum tubes of 30 and 50 g; in a cardboard pack 1 tube.

in 25 ml cylinders with a spray nozzle; 1 cylinder in a cardboard pack.

Artrosilene

Trade name: Artrosilen

ATX code: , M01AE03 (Ketoprofen) , Active substance: , ketoprofen (ketoprofen) Rec.INN registered by WHO

Dosage form

ARTHROZILEN

caps. 320 mg: 10 pcs.reg. No.: P N010596/05 dated 06/21/10 - Indefinitely

Release form, composition and packaging

The capsules are hard gelatin, oblong, the body is white, the cap is dark green, the contents of the capsules are round granules of light yellow color.

1 caps.

ketoprofen lysine salt 320 mg

Excipients: diethyl phthalate - 2.286 mg, carboxypolymethylene - 32.857 mg, magnesium stearate - 15.857 mg, povidone - 27.857 mg, polymers of acrylic and methacrylic acids - 34.143 mg, talc - 27 mg.

Composition of the capsule shell: body - titanium dioxide (E171), gelatin qsp, cap - quinoline yellow (E104), indigotine (E132), titanium dioxide (E171), gelatin qsp.

10 pieces. - blisters (1) - cardboard packs.

Clinical-pharmacological group: NSAIDs Pharmaco-therapeutic group: NSAIDs The scientific information provided is general and cannot be used to make a decision about the possibility of using a specific drug.

pharmachologic effect

NSAID, propionic acid derivative. It has analgesic, anti-inflammatory and antipyretic effects. The mechanism of action is associated with inhibition of the activity of COX, the main enzyme in the metabolism of arachidonic acid, which is a precursor of prostaglandins, which play a major role in the pathogenesis of inflammation, pain and fever.

The pronounced analgesic effect of ketoprofen is due to two mechanisms: peripheral (indirectly, through suppression of prostaglandin synthesis) and central (due to inhibition of prostaglandin synthesis in the central and peripheral nervous system, as well as the effect on the biological activity of other neurotropic substances that play a key role in the release of pain mediators in the spinal cord). brain). In addition, ketoprofen has antibradykinin activity, stabilizes lysosomal membranes, and causes significant inhibition of neutrophil activity in patients with rheumatoid arthritis. Suppresses platelet aggregation.

Pharmacokinetics

When taken orally and rectally, ketoprofen is well absorbed from the gastrointestinal tract. Cmax in plasma when administered orally is achieved after 1-5 hours (depending on the dosage form), with rectal administration - after 45-60 minutes, intramuscular administration - after 20-30 minutes, intravenous administration - after 5 minutes.

Plasma protein binding is 99%. Due to its pronounced lipophilicity, it quickly penetrates the BBB. Css in blood plasma and cerebrospinal fluid persists from 2 to 18 hours. Ketoprofen penetrates well into the synovial fluid, where its concentration 4 hours after administration exceeds that in plasma.

Metabolized by binding to glucuronic acid and, to a lesser extent, by hydroxylation.

It is excreted mainly by the kidneys and to a much lesser extent through the intestines. T1/2 of ketoprofen from plasma after oral administration is 1.5-2 hours, after rectal administration - about 2 hours, after intramuscular administration - 1.27 hours, after intravenous administration - 2 hours.

Indications: Articular syndrome (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout), symptomatic treatment of inflammatory and degenerative diseases of the musculoskeletal system (periarthritis, arthrosynovitis, tendinitis, tenosynovitis, bursitis, lumbago), pain in the spine, neuralgia, myalgia. Uncomplicated injuries, in particular sports injuries, sprains, sprains or ruptures of ligaments and tendons, bruises, post-traumatic pain. As part of combination therapy for inflammatory diseases of the veins, lymphatic vessels, lymph nodes (phlebitis, periphlebitis, lymphangitis, superficial lymphadenitis). ICD-10 codes

Dosage regimen

They are set individually, taking into account the severity of the disease. For oral administration in adults, the initial daily dose is 300 mg in 2-3 divided doses. For maintenance treatment, the dose depends on the dosage form used. For the treatment of acute conditions or relief of exacerbation of a chronic process, 100 mg is administered as a single intramuscular injection. Next, ketoprofen is administered orally or rectally.

Externally - applied to the affected surface 2 times a day.

Maximum dose: when taken orally or rectally - 300 mg/day.

Side effect

From the digestive system: pain in the epigastric region, nausea, vomiting, constipation or diarrhea, anorexia, gastralgia, liver dysfunction, rarely - erosive and ulcerative lesions of the gastrointestinal tract, bleeding and perforation of the gastrointestinal tract.

From the central nervous system: headache, dizziness, tinnitus, drowsiness.

From the urinary system: renal dysfunction.

Allergic reactions: skin rash, rarely - bronchospasm.

Local reactions: when used in the form of suppositories, irritation of the rectal mucosa and painful bowel movements are possible; when used in the form of a gel, itching and skin rash at the site of application.

Contraindications for use

For oral administration: erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, “aspirin triad”, severe liver and/or kidney dysfunction, third trimester of pregnancy, age up to 15 years (for retard tablets), hypersensitivity to ketoprofen and salicylates.

For rectal use: history of proctitis and rectal bleeding.

For external use: weeping dermatoses, eczema, infected abrasions, wounds.

Use during pregnancy and breastfeeding

Contraindicated for use in the third trimester of pregnancy. In the first and second trimesters of pregnancy, the use of ketoprofen is possible in cases where the potential benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to use ketoprofen during lactation, it is recommended to stop breastfeeding.

Use for liver dysfunction

Contraindications for oral administration are severe liver dysfunction.

Use with extreme caution in patients with liver disease. During treatment, systematic monitoring of liver function is necessary.

Use for renal impairment

Contraindications for oral administration are severe renal dysfunction.

Use with extreme caution in patients with kidney disease. During treatment, systematic monitoring of renal function is necessary.

Use in children Contraindicated under the age of 15 years (for retard tablets).

Special instructions Use with extreme caution in patients with liver and kidney diseases, a history of gastrointestinal diseases, dyspeptic symptoms, and immediately after major surgical interventions. During treatment, systematic monitoring of liver and kidney function is necessary.

Drug interactions

With simultaneous use of ketoprofen with other NSAIDs, the risk of developing erosive and ulcerative lesions of the gastrointestinal tract and bleeding increases, with antihypertensive drugs (including beta-blockers, ACE inhibitors, diuretics) - their effect may be reduced, with thrombolytics - an increase in the risk of bleeding .

When used simultaneously with acetylsalicylic acid, it is possible to reduce the binding of ketoprofen to plasma proteins and increase its plasma clearance; with heparin, ticlopidine - an increased risk of bleeding; with lithium preparations - it is possible to increase the concentration of lithium in the blood plasma to toxic levels due to a decrease in its renal excretion.

When used simultaneously with diuretics, the risk of developing renal failure increases due to a decrease in renal blood flow caused by inhibition of prostaglandin synthesis and against the background of hypovolemia.

When used simultaneously with probenecid, it is possible to reduce the clearance of ketoprofen and its binding to plasma proteins, and with methotrexate, it is possible to increase the side effects of methotrexate.

With the simultaneous use of warfarin, severe, sometimes fatal bleeding may develop.

Description of the dosage form

Capsules: oblong hard gelatin capsules; the body is white, the lid is dark green. The contents of the capsule are round granules from white to light yellow.

Solution for intravenous and intramuscular administration: transparent, colorless or slightly yellowish solution.

Rectal suppositories: homogeneous, from white to light yellow, torpedo-shaped.

Gel: transparent, thick, with the smell of lavender.

Aerosol: white homogeneous foam; after the gas escapes, it is a clear, pale yellow liquid.

Pharmacodynamics

It has anti-inflammatory, analgesic and antipyretic effects. By inhibiting COX-1 and -2, it inhibits the synthesis of PG. It has anti-bradykinin activity, stabilizes lysosomal membranes and delays the release of enzymes from them that contribute to tissue destruction during chronic inflammation. Reduces the release of cytokines, inhibits the activity of neutrophils.

Reduces morning stiffness and swelling of joints, increases range of motion.

Ketoprofen lysine salt, unlike ketoprofen, is a rapidly soluble molecule with a neutral pH and is almost non-irritating to the gastrointestinal tract.

When applied topically, it has local anti-inflammatory, antiexudative and analgesic effects. In the form of a spray or gel, it provides a local therapeutic effect on affected joints, tendons, ligaments, and muscles. In case of articular syndrome, it causes a decrease in joint pain at rest and during movement, a decrease in morning stiffness and swelling of the joints. The lysine salt of ketoprofen does not have a catabolic effect on articular cartilage.

Buy Artrosilene solution intravenously and intramuscularly 80 mg/ml 2 ml No. 6 in pharmacies

Artrosilene Buy Artrosilene in pharmacies DOSAGE FORMS solution for intravenous and intramuscular administration 80mg/ml solution for injection 160mg/2ml

MANUFACTURERS Abiogen Pharma S.p.A. (Italy) Dompe S.p.A. (Italy) Dompe Pharmaceutici (Italy)

GROUP Anti-inflammatory drugs - propionic acid derivatives

COMPOSITION Active substance - ketoprofen.

INTERNATIONAL NON-PROPENTED NAME Ketoprofen

SYNONYMS Actron, Arketal Rompharm, Artrum, Bystrumgel, Bystrumcaps, Ketonal, Ketonal Duo, Ketoprofen, Ketoprofen MV, Ketoprofen Organica, Ketoprofen-Verte, Ketoprofen-Vramed, Oki, Profenid, Fastum, Febrofid, Flamax, Flamax forte, Flexen

PHARMACOLOGICAL ACTION Anti-inflammatory, analgesic, antipyretic, antiaggregant. It has anti-bradykinin activity, stabilizes lysosomal membranes and delays the release of enzymes from them that contribute to tissue destruction during chronic inflammation. When administered orally, it is absorbed quite completely. Absorption is accompanied by a “first pass” effect through the liver. The concentration in the blood is dose-dependent. Easily passes through histohematic barriers and is distributed in tissues and organs. Biotransforms in the liver (almost completely). Metabolites are excreted in the urine. Reduces morning stiffness and swelling of joints, increases range of motion.

INDICATIONS FOR USE Rheumatoid arthritis, nonspecific spondylitis (ankylosing and psoriatic spondylitis), pain syndrome (postoperative, post-traumatic pain, pain with bone metastases), gouty arthritis, pseudogout, osteoarthritis, extra-articular rheumatism (tenosynovitis, bursitis, capsulitis), renal colic, algodismenorrhea. Gel - uncomplicated injuries (sprains and ruptures of tendons and ligaments, muscle bruises, swelling).

CONTRAINDICATIONS Hypersensitivity, renal and liver failure, peptic ulcer of the stomach and duodenum in the acute phase, aspirin-induced asthma, pregnancy and childhood. Candles - proctitis and proctorragia; Gel - dermatoses, eczema, infected abrasions and wounds (wetting).

SIDE EFFECTS : Headache, dizziness, tinnitus, drowsiness, weakness, visual disturbances, dyspeptic symptoms (nausea, vomiting, abdominal pain, diarrhea, flatulence, constipation, anorexia), stomatitis, impaired renal and liver function, hyperemia, allergic reactions.

INTERACTION Increases the toxicity of methotrexate. The concentration of ketoprofen in plasma increases against the background of probenecid (inhibits renal excretion). Enhances the effect of anticoagulants, heparin, ticlopidine, corticosteroids, oral antidiabetic agents and alcohol, weakens the effect of spironolactone, peripheral vasodilators.

METHOD OF APPLICATION AND DOSAGE Intramuscularly, intravenously, 2 ml 1-2 times a day.

OVERDOSE No data available.

SPECIAL INSTRUCTIONS Taking ketoprofen can mask the signs of an infectious disease. If renal or liver function is impaired, dose reduction and careful monitoring are necessary. Do not allow the gel to come into contact with mucous membranes or eyes. Use with caution while working for vehicle drivers and people whose profession involves increased concentration. During treatment you should stop drinking alcoholic beverages. In patients with bronchial asthma or allergic diathesis, the use of Ketoprofen may cause bronchospasm.

STORAGE CONDITIONS Store at room temperature in a dry place, protected from light and out of reach of children.

Pharmacokinetics

Capsules

Suction. When administered orally, ketoprofen is quite completely absorbed from the gastrointestinal tract, and its bioavailability exceeds 80%. Cmax in plasma when taking Artrosilene capsules is observed 4–10 hours after oral administration, its value directly depends on the dose taken and is 3–9 μg/ml. T1/2 is 6.5 hours. The maximum therapeutic effect is observed over a period of 4 to 24 hours. Food helps to reduce Cmax values ​​​​and increase Tmax without changing AUC.

Distribution. Up to 99% of absorbed ketoprofen is bound to plasma proteins, mainly albumin. Vd - 0.1–0.2 l/kg. Easily penetrates histohematic barriers and is distributed in tissues and organs. Ketoprofen penetrates well into synovial fluid and connective tissue. Although the concentration of ketoprofen in synovial fluid is slightly lower than in plasma, it is more stable (lasts up to 30 hours).

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

Excretion. Metabolites are excreted in the urine. Less than 1% is excreted in feces. The drug does not accumulate.

Solution for intravenous and intramuscular administration

Tmax for parenteral administration is 20–30 minutes. The effective concentration lasts 24 hours. Therapeutic concentration in synovial fluid lasts 18–20 hours.

Distribution. Up to 99% of absorbed ketoprofen is bound to plasma proteins, mainly albumin. Vd - 0.1–0.2 l/kg. Easily penetrates histohematic barriers and is distributed in tissues and organs. Ketoprofen penetrates well into synovial fluid and connective tissue. Although the concentration of ketoprofen in synovial fluid is slightly lower than in plasma, it is more stable (lasts up to 30 hours).

Metabolized by microsomal liver enzymes. Excreted by the kidneys, 60–80% in the form of glucuronide in 24 hours.

Suppositories

Suction. Ketoprofen lysine salt is rapidly absorbed: Tmax after rectal administration is 45–60 minutes. The plasma concentration depends linearly on the dose taken.

Distribution. Up to 99% of absorbed ketoprofen is bound to plasma proteins, mainly albumin. Vd - 0.1–0.2 l/kg. Easily penetrates histohematic barriers and is distributed in tissues and organs. Ketoprofen penetrates well into synovial fluid and connective tissue. Although the concentration of ketoprofen in synovial fluid is slightly lower than in plasma, it is more stable (lasts up to 30 hours).

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

Excretion. Metabolites are excreted mainly in the urine (up to 76% after 24 hours). The drug does not accumulate.

Gel, aerosol

When applied cutaneously, it is absorbed slowly; a dose of 50–150 mg over 5–8 hours produces a plasma concentration level of 0.08–0.15 mcg/ml. Practically does not accumulate in the body. Bioavailability is about 5%.

Use during pregnancy and breastfeeding

Capsules, solution for intravenous and intramuscular administration, suppositories

Like other NSAIDs, Artrosilene should not be used in the third trimester of pregnancy. The use of the drug in the first and second trimesters should be carefully monitored by the attending physician. Breastfeeding should be discontinued while using the drug.

Gel, aerosol

Cannot be used in the third trimester of pregnancy.

There is no experience with the use of Artrosilene during lactation. Use in the first and second trimesters is possible only after consultation with a doctor.

Side effects

Capsules, solution for intravenous and intramuscular administration, suppositories

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

From the liver: increased bilirubin levels, increased activity of liver enzymes, hepatitis, liver failure, increased liver size

From the nervous system: dizziness, hyperkinesia, tremor, vertigo, mood swings, anxiety, hallucinations, irritability, general malaise.

From the senses: conjunctivitis, visual impairment.

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

From the genitourinary system: painful urination, cystitis, edema, hematuria, menstrual irregularities.

From the hematopoietic organs: leukocytopenia, leukocytosis, lymphangitis, decreased PV, thrombocytopenia, thrombocytopenic purpura, enlarged spleen, vasculitis.

From the respiratory system: bronchospasm, dyspnea, sensation of laryngeal spasm, laryngospasm, laryngeal edema, rhinitis.

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

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

Suppositories additionally

Local reactions: burning, itching, heaviness in the anorectal area, exacerbation of hemorrhoids.

Gel, aerosol

Allergic reactions, photosensitivity.

If any adverse event occurs, you should consult a doctor.

Indications for use

The drug is indicated for use mainly for the treatment of pathologies of the musculoskeletal system, for example:

• arthritis of various natures;
• osteoarthritis;
• rheumatism of soft tissue;
• spondylitis of ankylosing type;
• muscle pain, including those not associated with rheumatism.

The drug is also indicated for use in the following cases:

• eczema;
• wounds and other injuries to the skin;
• weeping type dermatosis;
• injuries, soft tissue damage.

Interaction

Inducers 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, antiplatelet agents, fibrinolytics, ethanol, side effects of mineralocorticoids, corticosteroids, estrogens; antihypertensive and diuretic drugs.

Combined use with other NSAIDs, corticosteroids, ethanol, corticotropin can lead to the formation of ulcers and the development of gastrointestinal bleeding, increasing the risk of developing renal dysfunction.

Co-administration with oral anticoagulants, heparin, thrombolytics, antiplatelet agents, cefoperazone, cefamandole and cefotetan increases the risk of bleeding.

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

Co-administration with sodium valproate causes disruption of platelet aggregation.

Increases plasma concentrations of verapamil and nifedipine, lithium, methotrexate.

Antacids and cholestyramine reduce absorption.

Side effects

Side effects are observed infrequently, and reactions can occur from different organ systems:

• diarrhea;
• gastritis;
• ulcers on the mucous membranes of the digestive organs;
• hepatitis of various nature;
• esophagitis;
• visual impairment;
• allergic reactions;
• stomatitis;
• irritability;
• unstable mood;
• hives;
• increased sweating;
• swelling;
• cystitis;
• problems with the menstrual cycle;
• leukocytosis;
• bronchospasms;
• spasms of the larynx;
• rhinitis;
• high blood pressure;
• hives;
• discomfort when urinating;
• pale skin;
• heart rhythm disturbance;
• swelling of the oral mucosa and pharynx.

Directions for use and doses

Inside, parenterally, rectally, externally.

The drug is prescribed 1 caps orally. per day during or after meals. The duration of treatment can be 3–4 months.

IM or IV 1 amp. per day. The maximum daily dose is 1 amp. 2 times a day. IV administration of the drug is allowed only in a hospital. The drug is used for short-term treatment - up to 3 days. If further use of the drug is necessary, it is recommended to switch to oral dosage forms or suppositories. In elderly patients, use no more than 1 amp. per day.

Ampoules should be opened along a special break line. After opening the ampoule, use the solution immediately.

Aqueous solutions of ketoprofen lysine salt can be used in physiotherapeutic treatment (iontophoresis, mesotherapy); In iontophoresis, the solution is applied to the negative pole.

When administered intravenously, a slow intravenous infusion is recommended to increase the duration of action of the drug. The solution for infusion is prepared on the basis of 50 or 500 ml of the following aqueous solutions: 0.9% sodium chloride solution, 10% aqueous levulose solution, 5% aqueous dextrose solution, Ringer acetate solution, Ringer lactate solution (Hartmann), colloidal dextran solution in 0 .9% sodium chloride solution or 5% dextrose solution. When diluting Artrosilene in small volume solutions (50 ml), the drug is administered intravenously as a bolus. In large volume solutions (500 ml), the infusion duration is at least 30 minutes.

Rectally 1 sup. 2–3 times a day. The maximum daily dose is 480 mg. In elderly patients, no more than 2 supp. should be used. per day.

Externally. A single dose of gel is 3–5 g (the volume of a large cherry), an aerosol is 1–2 g (the volume of a walnut). Depending on the size of the damaged area, the drug should be applied 2-3 times a day or as prescribed by the doctor, gently rubbing until completely absorbed. With iontophoresis, the drug is applied to the negative pole. The duration of treatment without consulting a doctor should not exceed 10 days.

special instructions

Capsules, solution for intravenous and intramuscular administration, suppositories

During treatment, it is necessary to monitor the peripheral blood picture 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 study.

Taking ketoprofen can mask the signs of an infectious disease.

If renal or liver function is impaired, dose reduction and careful monitoring are necessary.

The use of ketoprofen by patients suffering from bronchial asthma can lead to an attack of bronchial asthma.

Women planning pregnancy should refrain from using the drug, because the likelihood of egg implantation may decrease.

Impact on the ability to drive vehicles and control machinery - during the period of use of the drug, you should refrain from potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

Gel, aerosol

The drug should be applied only to intact skin. Avoid contact with eyes and mucous membranes. To avoid hypersensitivity and photosensitivity, it is recommended to avoid exposure of the skin to sunlight during the course of treatment.

Contraindications

In some cases, the drug cannot be used - the list of contraindications is quite large:

• Aspirin asthma;
• pregnancy (only during the last trimester);
• lactation;
• hypersensitivity to ketoprofen;
• ulcerative lesions of the digestive system;
• peptic ulcer;
• ulcerative colitis (with exacerbation);
• blood clotting problems, including hemophilia;
• Crohn's pathology;
• insufficiency of kidney function;
• diverticulitis.