Artrosilene, 1 piece, 25 ml, 15%, aerosol for external use

Nosological classification (ICD-10)

• L40.5 Arthropathic psoriasis (M07.0-M07.3*, M09.0*)
• M06.9 Rheumatoid arthritis, unspecified
• M07.3 Other psoriatic arthropathies (L40.5+)
• M10 Gout
• M19.9 Arthrosis, unspecified
• M35 Other systemic connective tissue disorders
• M35.3 Polymyalgia rheumatica
• 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
• R52.2 Other persistent pain
• T14.3 Dislocation, sprain and damage to the capsular-ligamentous apparatus of a joint of an unspecified area of ​​the body
• 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.

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.

Artrosilene 15% 25ml aerosol for external use

pharmachologic effect

Non-steroidal anti-inflammatory drug.

Composition and release form Artrosilene 15% 25ml aerosol for external use

Aerosol – 100 ml:

• active ingredient: ketoprofen lysine (ketoprofen lysine salt) 15.0 g (in terms of ketoprofen 9.375 g);
• excipients: polysorbate-80 4.0 g, propylene glycol 4.0 g, povidone 3.0 g, lavender-neroli flavor 0.2 g, gasoline alcohol 0.3 g, purified water up to 100 ml, propane-butane mixture 1 .25 g.

Aerosol for external use 15%.

25 g of the drug in a 25 ml aluminum aerosol can with a spray nozzle and a protective cap.

1 can along with instructions for use in a cardboard box.

Description of the dosage form

White or off-white homogeneous foam formed when released from an aluminum aerosol can with a spray nozzle.

After the gas is released, the contents of the cylinder are a transparent liquid from white to light yellow.

Directions for use and doses

Externally.

The drug is applied to the surface of the skin 2 times a day in accordance with the size of the treated area and the doctor’s instructions, gently rubbing until completely absorbed. With iontophoresis, the drug is applied to the negative pole.

The dosage in children aged 6 to 12 years corresponds to that in adults and depends on the area of ​​application and the doctor’s recommendations.

Duration of treatment: the drug is used for both acute and chronic diseases for a period varying from a few days to 3-4 weeks.

Before use, invert the container and shake vigorously. Spray by pressing the ribbed button.

Pharmacodynamics

It has a local anti-inflammatory, analgesic and anti-exudative effect. In the form of an aerosol, it provides a local therapeutic effect on affected joints, tendons, ligaments, and muscles. For articular syndrome, it reduces joint pain at rest and during movement, morning stiffness and swelling of the joints. Ketoprofen does not have a catabolic effect on articular cartilage.

Pharmacokinetics

After external application of the aerosol, the level of ketoprofen in the blood is less than 0.1 mcg/ml, and the amount of free or conjugated active substance excreted by the kidneys in the next 48 hours is equivalent to 0.62% of the drug dose. External application of the aerosol makes it possible to determine the level of ketoprofen in the synovial fluid, which is equivalent to 0.2-2 mcg/ml, depending on the dose applied.

Indications for use Artrosilene 15% 25ml aerosol for external use

Diseases of the musculoskeletal system: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis of peripheral joints and spine, rheumatic lesions of soft tissues.

Muscle pain of rheumatic and non-rheumatic origin.

Traumatic (including sports) injuries of soft tissues and joints.

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, and does not affect the progression of the disease.

Contraindications

Hypersensitivity to ketoprofen and other components of the drug, acetylsalicylic acid or other NSAIDs, fenofibrate, sunscreens (including a history); complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose or paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including a history); photosensitivity reactions (history); violation of the integrity of the skin (wetting dermatoses, eczema, infected abrasions, wounds) at the site of intended application; pregnancy (III trimester), breastfeeding period, childhood (up to 6 years). Exposure to sunlight, even on cloudy days, and solariums are contraindicated during treatment and for two weeks after the last use of the drug.

With caution: hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe dysfunction of the liver and kidneys, chronic heart failure, bronchial asthma, old age, children (from 6 to 12 years), pregnancy (I and II trimester).

Application of Artrosilene 15% 25ml aerosol for external use during pregnancy and breastfeeding

The use of the drug in the third trimester of pregnancy is contraindicated.

The use of the drug in the first and second trimesters of pregnancy is possible only after consultation with a doctor, if the expected benefit to the mother outweighs the potential risk to the fetus.

The use of the drug during breastfeeding is not recommended.

special instructions

The drug should be applied only to intact skin.

Avoid contact of the aerosol with the eyes and mucous membranes.

To avoid manifestations of hypersensitivity and photosensitivity, it is recommended not to expose the treated areas of skin to sunlight during the course of treatment and two weeks after its completion.

After using the drug, you must wash your hands thoroughly.

Do not use an occlusive dressing.

You should immediately stop using the drug if any skin reaction occurs while using sunscreens or other cosmetics containing octocrylene.

Impact on the ability to drive vehicles and operate machinery

There is no data on the negative effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities that require concentration and speed of psychomotor reactions.

Overdose

The extremely low systemic absorption of the active components of the drug when used externally makes overdose almost impossible. If large quantities of the drug (more than 20 g) are accidentally ingested, systemic adverse reactions characteristic of NSAIDs may occur. It is necessary to lavage the stomach and take activated charcoal.

Side effects Artrosilene 15% 25ml aerosol for external use

Local skin reactions such as erythema, rash, burning sensation, itching. Sometimes these reactions can spread beyond the area of ​​application of the drug and very rarely can be severe and generalized.

Allergic reactions, dermatitis, contact eczema, urticaria, bullous dermatitis, photosensitivity reactions.

Systemic adverse reactions such as renal dysfunction occur very rarely.

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

Drug interactions

The drug may enhance the effect of drugs that cause photosensitivity.

Although interaction with other drugs used topically or systemically is unlikely, in the case of long-term treatment or treatment with high doses, the possibility of competition between absorbed ketoprofen and other drugs that are easily bound to plasma proteins must be taken into account.

Patients taking coumarin anticoagulants are recommended to regularly monitor the international normalized ratio (INR).

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%.

Artrosilene aerosol for external use 15% 25 ml in Naberezhnye Chelny

Pharmacological action: Inhibits the activity of COX-1 and COX-2, inhibits the synthesis of PG and LT. 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.

The anti-inflammatory effect occurs by the end of 1 week of use. The lysine salt of ketoprofen has equally pronounced anti-inflammatory, analgesic, and antipyretic effects.

In case of articular syndrome, it relieves pain in the joints at rest and during movement, reduces morning stiffness and swelling of the joints, and helps to increase the range of movements.

When taken orally, it is absorbed quickly and quite completely, bioavailability is about 90%. Cmax in the blood is achieved 0.5–2 hours after oral administration, 1.4–4 hours after rectal administration, 15–30 minutes after parenteral administration, and 5–8 hours after application to the skin. When taking retardated forms, the minimum effective concentration is determined after 2–3 hours, Cmax is usually achieved within 6–7 hours. When taken simultaneously with food, the total bioavailability (AUC) does not change, the rate of absorption slows down (for both regular and retardated forms) . Absorption is accompanied by a “first pass” effect through the liver. Binding to blood plasma proteins, mainly albumin - 99%. Equilibrium plasma concentrations are achieved 24 hours after the start of regular use. Easily passes through histohematic barriers and is distributed in tissues and organs. It does not penetrate the BBB in significant quantities. The level of ketoprofen in the synovial fluid is lower than in the blood, but remains within therapeutic limits for a longer time (6–8 hours). Metabolized in the liver by glucuronidation. It is excreted primarily by the kidneys - 80% within 24 hours, mainly in the form of a glucuronic derivative. T1/2 - (2.05±0.58) hours after i.v. administration; 2–4 hours after oral administration in the usual dosage form at a dose of 200 mg; (5.4±2.2) hours after taking the retarded form at a dose of 200 mg. In renal failure, excretion slows down.

Lysine salt of ketoprofen: Tmax after oral administration in the form of granules - 15 minutes, with parenteral administration - 20-30 minutes, with rectal administration - 45-60 minutes. When taken in the form of delayed-release capsules, the effective concentration is achieved within 20–30 minutes and persists for 24 hours.

Therapeutic concentration in synovial fluid persists for 18–20 hours. Metabolized by microsomal liver enzymes. Excreted by the kidneys, 60–80% in the form of glucuronide in 24 hours.

In elderly patients, plasma and renal clearance are reduced, the values ​​of Cmax, AUC and unbound fraction increase with increasing age (more in women than in men).

With cutaneous application, slow transdermal absorption of ketoprofen occurs, which ensures that its concentration in inflamed tissues is maintained within a therapeutic level for a long time. Penetrates well into synovial fluid and connective tissue. Absorption into the systemic circulation is insignificant, bioavailability for gel and spray is about 5%.

When using a solution for topical use (rinse solution) at a dose of 160 mg, Tmax is 1 hour, Cmax value is 350 mg/ml (4% of the concentration obtained by oral administration of 80 mg).

Carcinogenicity, mutagenicity, effect on fertility

Chronic toxicity studies in mice when administered orally (up to 32 mg/kg/day, 96 mg/m2/day, approximately 0.5 MRDC) did not reveal the carcinogenic effect of ketoprofen. In a two-year carcinogenicity study in rats at doses up to 6 mg/kg/day (36 mg/m2/day), no adverse oncogenic effects were detected. Moreover, animals in all groups received drugs for 104 weeks, with the exception of females who received 6 mg/kg/day (36 mg/m2/day) for 81 weeks due to low survival. Survival rate in groups receiving drugs for 104 weeks was 6% compared to the control group.

The mutagenicity of ketoprofen was not detected in the Ames test. When ketoprofen was administered to male rats (up to 9 mg/kg/day, 54 mg/m2/day), no significant effect on reproductive function and fertility was found. In female rats at doses of 6 or 9 mg/kg/day (36 or 54 mg/m2/day), a decrease in the number of implantations was noted.

At high doses, spermatogenesis is disrupted and inhibited in rats and dogs, and testicular weight decreases in dogs and baboon monkeys.

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.

Overdose and special instructions

The drug is safe for health if the dosage is observed. Cases of overdose have not been described to date. The composition should be applied only to undamaged parts of the skin. It is necessary to avoid contact with the surface of the eyes, as well as mucous membranes, for example, the oral cavity.

During the course of therapy, you should not be in the sun or sunbathe, including in a solarium. Infrared radiation destroys the active ingredient, which is why the therapeutic effect is reduced to zero.

The drug should be used during pregnancy, but only during the 1st and 2nd trimester. It is also prescribed to children aged 6 years and older.

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.

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.

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.

Instructions for use "Artrosilene"

The gel is taken only externally, applied generously to the surface of the body. The area must first be washed with soap and water and wiped dry. A single amount of cream is from 3 to 4 g (like a large cherry). The spray is applied in an amount of 2 g (like a walnut).

The composition is applied to the surface and gently rubbed into the skin. This procedure is repeated 2 to 3 times a day, in agreement with the doctor. The duration of treatment is 7-10 days. It can also be increased for medical reasons.

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.

Artrosilene gel for external use 5% tubes 50g

Compound

Active substance: ketoprofen lysine (ketoprofen lysine salt) - 5 g. Excipients: carbomer - 1 g, trolamine - 1.9 g, polysorbate 80 - 0.8 g, ethanol 96% - 5 g, methyl parahydroxybenzoate - 0.1 g, lavender-nerolium flavor - 0.2 g, purified water - 86 ml.

Pharmacokinetics

Ketoprofen is absorbed very slowly and practically does not accumulate in the body. Bioavailability is 5%. Ketoprofen penetrates into the subcutaneous tissue, ligaments and muscles, synovial fluid and reaches therapeutic concentrations there. The concentration of the drug in the blood plasma is extremely low. Ketoprofen is metabolized in the liver to form conjugates, which are mainly excreted in the urine. Ketoprofen is characterized by slow excretion in urine.

Indications for use

Symptomatic treatment of painful and inflammatory processes of various origins, including:

• rheumatoid arthritis and periarthritis;
• ankylosing spondylitis (ankylosing spondylitis);
• psoriatic arthritis;
• reactive arthritis (Reiter's syndrome);
• osteoarthritis of various localizations;
• tendonitis, bursitis;
• myalgia;
• neuralgia;
• radiculitis;
• injuries of the musculoskeletal system (including sports), bruises of muscles and ligaments, sprains, ruptures of ligaments and muscle tendons.

Contraindications

• hypersensitivity to ketoprofen;
• hypersensitivity to salicylates, tiaprofenic acid or other NSAIDs, fenofibrate, UV blockers, fragrances;
• violation of the integrity of the skin (eczema, weeping dermatitis, open or infected wound);
• indications in the anamnesis of attacks of bronchial asthma caused by taking NSAIDs and salicylates;
• history of photosensitivity reactions;
• exposure to sunlight, incl. indirect sunlight and UV irradiation in a solarium throughout the entire treatment period and for another 2 weeks after stopping treatment;
• III trimester of pregnancy; children under 15 years of age.

Carefully

Impaired liver and/or kidney function, erosive and ulcerative lesions of the gastrointestinal tract, blood diseases, bronchial asthma, chronic heart failure.

Directions for use and doses

Externally.

Use 1-1.5 g of the drug (the volume of cherries) once. The drug is applied to the surface of the skin 2 times a day in accordance with the size of the treated area and the doctor’s instructions, gently rubbing until completely absorbed. With iontophoresis, the drug is applied to the negative pole.

The dosage in children aged 6 to 12 years corresponds to that in adults and depends on the area of ​​application and the doctor’s recommendations.

Duration of treatment - the drug is used for both acute and chronic diseases for a period varying from a few days to 3-4 weeks.

Storage conditions

Store out of the reach of children at a temperature not exceeding 25°C.

Best before date

3 years. Do not use the drug after the date indicated on the package.

special instructions

It is necessary to avoid contact of this product with the eyes, the skin around the eyes, and mucous membranes.

Ketoprofen can be used externally in combination with oral administration. The total daily dose, regardless of the dosage form, should not exceed 200 mg.

To reduce the risk of developing photosensitivity, it is recommended to protect skin areas treated with ketoprofen with clothing from exposure to ultraviolet radiation throughout the entire treatment period and for another 2 weeks after stopping use of the gel.

Do not use as occlusive dressings.

Description

NSAIDs for external use.

Dosage form

The gel for external use is transparent, light yellow in color, with a characteristic odor.

Use in children

Contraindication: children under 15 years of age.

Pharmacodynamics

NSAIDs. It has analgesic, anti-inflammatory and anti-edema effects. Inhibits the activity of COX, which leads to inhibition of prostaglandin synthesis. In addition, ketoprofen inhibits lipoxygenase, bradykinin synthesis, stabilizes lysosomal membranes and prevents the release of enzymes involved in the inflammatory process.

Ketoprofen does not have a negative effect on the condition of articular cartilage.

Side effects

Allergic reactions: very rarely - angioedema, anaphylaxis.

From the skin and subcutaneous fat: infrequently - erythema, itching, burning, eczema, mild transient dermatitis; rarely - urticaria, rash, photosensitivity, bullous dermatitis, purpura, erythema multiforme, lichenoid dermatitis, skin necrosis, Stevens-Johnson syndrome; very rarely - a single case of severe contact dermatitis (due to poor hygiene and insolation), a single case of severe generalized photodermatitis, toxic epidermal necrolysis.

From the respiratory system: very rarely - asthmatic attacks (as a variant of an allergic reaction).

From the urinary system: very rarely - deterioration of renal function in patients with chronic renal failure.

Use during pregnancy and breastfeeding

Use is contraindicated in the third trimester of pregnancy. Use in the first and second trimesters is possible in cases where the expected benefit of therapy for the mother outweighs the potential risk for the fetus.

Use during lactation (breastfeeding) is not recommended.

Interaction

• Since the concentration of ketoprofen in the blood plasma is extremely low, symptoms of interaction with other drugs (similar symptoms with systemic use) are possible only with frequent and prolonged use.
• The simultaneous use of other topical products containing ketoprofen or other NSAIDs is not recommended.
• Simultaneous administration of acetylsalicylic acid reduces the degree of binding of ketoprofen to plasma proteins.
• Ketoprofen reduces the excretion of methotrexate and increases its toxicity.
• Patients taking coumarin-containing anticoagulant drugs are advised to undergo treatment under medical supervision.

Overdose

The extremely low systemic absorption of the active components of the drug when used externally makes overdose almost impossible. If large quantities of gel (more than 20 g) are accidentally ingested, systemic adverse reactions characteristic of NSAIDs may occur. It is necessary to lavage the stomach and take activated charcoal.

Impact on the ability to drive vehicles and operate machinery

There is no data on the negative effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities that require concentration and speed of psychomotor reactions.