Arthrosilen gel for external use 5%, 50g

Composition

1 g of gel contains ketoprofen lysine salt 50 mg

Pharmacological action

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

Reduces morning stiffness and swelling of the joints, increases the amount of movement.

Ketoprofen lysine salt, unlike ketoprofen, is a fast-soluble molecule with a neutral pH and almost does not irritate the gastrointestinal tract.

When applied topically, it has a local anti-inflammatory, anti-exudative and analgesic effect. In the form of a spray or gel, it provides a local therapeutic effect on affected joints, tendons, ligaments, and muscles.

With joint syndrome, it causes a reduction in joint pain at rest and during movement, a decrease in morning stiffness and swelling of the joints. The lysine salt of ketoprofen has no catabolic effect on articular cartilage.

Indications

• Diseases of the musculoskeletal system (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis of the peripheral joints and spine, rheumatic soft tissue lesions).
• Muscle pain of rheumatic and non-rheumatic origin.
• Traumatic soft tissue injuries.
• Wet dermatoses.
• Eczema.
• Violation of the integrity of the skin.

Use during pregnancy and lactation

Do not use in the third trimester of pregnancy.

There is no experience of using Arthrosilene during lactation.

Use in the first and second trimesters is only possible after consulting a doctor.

Contraindicated for children under 6 years of age.

Contraindications

• Hypersensitivity, including to other NSAIDs.
• Aspirin asthma.
• Lactation period.
• Peptic ulcer of the stomach and duodenum in the acute phase, peptic ulcer.
• Ulcerative colitis in the acute phase.
• Crohn’s disease.
• Diverticulitis.
• Hemophilia and other blood clotting disorders.
• Chronic renal failure.
• Wet dermatoses.
• Eczema.
• Violation of the integrity of the skin.

Side effects

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

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

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

From the side of the senses:  conjunctivitis, visual impairment.

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

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

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

Respiratory system disorders:  bronchospasm, dyspnea, sensation of laryngeal spasm, laryngospasm, laryngeal edema, rhinitis.

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

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

Interaction

Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants) when used concomitantly with Artrozylene enhance ketoprofen metabolism (increase the production of hydroxylated active metabolites).

When used concomitantly with Artrozylene, the effectiveness of uricosuric drugs decreases, the effect of anticoagulants, antiplatelet agents, fibrinolytics, ethanol, side effects of mineralocorticoids, glucocorticoids, estrogens increases; the effectiveness of antihypertensive drugs and diuretics decreases.

Concomitant use of Artrozylene with other NSAIDs, corticosteroids, ethanol, and corticotropin may lead to ulceration and gastrointestinal bleeding, and increase the risk of developing impaired renal function.

Concomitant use of Artrozylene with oral anticoagulants, heparin, thrombolytics, antiplatelet agents, cefoperazone, cefamandol and cefotetan increases the risk of bleeding.

The drug Artrozylene, when used simultaneously, increases the hypoglycemic effect of insulin and oral hypoglycemic drugs (dose recalculation is necessary).

Co-use of Arthrosilene with sodium valproate causes a violation of platelet aggregation.

Ketoprofen increases plasma concentrations of verapamil and nifedipine, lithium, and methotrexate when used simultaneously.

Antacids and colestyramine, when co-administered orally with Artrozylene, reduce the absorption of ketoprofen.

How to take, course of use and dosage

A single dose of gel is 3-5 g (the volume of a large cherry), aerosol-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 according to the doctor’s instructions, gently rubbing until completely absorbed.

In iontophoresis, the drug is applied to the negative pole.

The duration of treatment without consulting a doctor should not exceed 10 days.

Overdose

Currently, no cases of overdose with Artrozylene have been reported.

Special instructions

The drug should only be applied to undamaged skin. Avoid contact with eyes and mucous membranes.

To avoid signs of hypersensitivity and photosensitivity, it is recommended to avoid exposing the skin to sunlight during the course of treatment.

Form of production

Gel

Storage conditions

In a dark place, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Ketoprofen

Dosage form

gel for external use

Description

Children over 6 years of age, Pregnant women in the first and second trimester as prescribed by a doctor, For adults

Indications

Bursitis, Lumbago, Trigeminal Neuralgia, Swelling after injuries and operations, Gout, Osteoarthritis, Osteoarthritis, Bruises, Osteochondrosis, Myositis, Arthritis, Sciatica, Rheumatoid Arthritis