Instruction for use: Ketonal

Active substance Ketoprofen

ATX code M02AA10Ketoprofen

Pharmacological group

Non-steroidal anti-inflammatory drug (NSAID) [NSAIDs - Propionic acid derivatives]

Nosological classification (ICD-10)

M02.3 Reiter's Disease

Reiter's syndrome, Arthritis is infectious-allergic, Arthritis Reactive, Urethro-oculo-synovial syndrome

M06.9 Other specified rheumatoid arthritis

Rheumatoid arthritis,Pain syndrome in rheumatic diseases, Pain in rheumatoid arthritis, Inflammation in rheumatoid arthritis, Degenerative forms of rheumatoid arthritis, Children's rheumatoid arthritis, Exacerbation of rheumatoid arthritis, Acute articular rheumatism, Rheumatic arthritis, Rheumatic polyarthritis, Rheumatoid arthritis, Rheumatic polyarthritis, Rheumatoid arthritis, Rheumatoid arthritis of active course, Rheumatoid arthritis, Rheumatoid polyarthritis, Acute rheumatoid arthritis, Acute rheumatism

M07.3 Other psoriatic arthropathies (L40.5 +)

Arthritis psoriatic, The generalized form of psoriatic arthritis, Psoriatic arthritis

M19.9 Arthrosis, unspecified

Change in brush with osteoarthritis, Osteoarthritis, Osteoarthrosis, Arthrosis of large joints, Pain syndrome in osteoarthritis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Deforming arthrosis, Deforming osteoarthritis, Deforming osteoarthritis of joints, Osteoarthritis in the acute stage, Osteoarthritis of large joints, Acute pain syndrome with osteoarthritis, Post-traumatic osteoarthritis, Rheumatic osteoarthritis, Spondylarthrosis, Chronic osteoarthritis

M45 Ankylosing spondylitis

Ankylosing spondylarthrosis, Marie-Strumpel disease, Ankylosing spondylitis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Bechterew's disease, Ankylosing spondylitis, Diseases of the spinal column, Rheumatic spondylitis, Bechterew-Marie-Strumpel disease

M54 Dorsalgia

Pain in the back area, Pain in the spine, Back pain, Pain in different parts of the spine, Backache, Painful pain syndrome in the spine, Pain in the musculoskeletal system

M54.1 Radiculopathy

Acute sciatica, Radiculopathy, Radiculitis, Radiculitis with radicular syndrome, Acute radiculopathy, Pain syndrome with radiculitis, Subacute radiculitis, Radiculitis, Chronic radiculitis, Diseases of the spinal column

M71 Other bursopathies

Bursitis, Bursopathy, Diseases of soft tissues, Osteoarthritis in musculo-articular diseases, Inflammatory disease of soft tissues, Subacute bursitis

M77.9 Other unspecified

Capsule, Periarthritis, Tendonitis, Tendopathy, Periarthropathy

M79.1 Myalgia

Myofascial pain syndromes ,Pain syndrome in musculo-articular diseases, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Pain in the muscles, Tenderness of muscles, Muscular soreness in severe physical exertion, Painful conditions of the musculoskeletal system, Pain in the musculoskeletal system, Pain in the muscles, Pain at rest, Muscle aches, Muscle pain, Musculoskeletal pain, Myalgia, Muscle pain, Muscle pain at rest, Muscle pain, Muscular pain of non-rheumatic origin, Muscle pain of rheumatic origin, Acute muscle pain, Rheumatic pain, Rheumatic pains, Myofascial syndrome, Fibromyalgia

M79.2 Neurology and neuritis, unspecified

Pain syndrome with neuralgia, Brachialgia, Occipital and intercostal neuralgia, Neuralgia, Neuralgic pain, Neuralgia, Neuralgia of intercostal nerves,Neuralgia of the posterior tibial nerve, Neuritis, Neuritis traumatic, Neuritis, Neurological Pain Syndromes, Neurological contractures with spasms, Acute neuritis, Peripheral neuritis,Post-traumatic neuralgia,Severe pain of a neurogenic nature, Chronic neuritis, Essential neuralgia

R52.9 Unspecified Pain

Pain after cholecystectomy, Pain shooting, Non-malignant pain, Obstetric and gynecological pain, Pain syndrome, Pain in the postoperative period, Pain in the postoperative period after orthopedic surgery, Pain of inflammatory genesis, Pain than cancer genesis, Pain syndrome after diagnostic procedures, Pain after surgery Diagnostic, Pain after surgery, Pain after orthopedic surgery, Pain after injuries, Pain after the removal of hemorrhoids, Pain at the non-rheumatic inflammation of nature, Pain in inflammatory lesions of the peripheral nervous system, Pain in diabetic neuropathy, Pain in acute inflammatory diseases of the musculoskeletal system, Pain when the tendon pathology, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs, Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), Pain in trauma syndrome, Pain with injuries and after surgical interventions, Pain in chronic inflammatory diseases of the musculoskeletal system, Pain with duodenal ulcer, Pain syndrome in gastric ulcer, Pain syndrome in gastric ulcer and duodenal ulcer, pain, Pain during menstruation, pain syndromes, painful condition, Painful foot fatigue, Sore gums when wearing dentures, Soreness of the cranial nerves exit points, Painful menstrual irregularities, Painful dressings, Painful muscle spasm, Painful teeth growth, Melosalgia, Pain in the area of the surgical wound, Pain in the postoperative period, Pain in the body, Pain after diagnostic procedures, Pain after orthopedic surgery, Pain after surgery, The pains of the flu, Pain in diabetic polyneuropathy, Pain for burns, Pain during sexual intercourse, Pain during diagnostic procedures, Pain during therapeutic procedures, for colds Pain, Pain in sinusitis, Pain in trauma, Pain traumatic, The pain in the postoperative period, Pain after diagnostic procedures, The pain after sclerotherapy, Pain after surgery, postoperative Pain, Pain postoperative and posttraumatic, posttraumatic pain, Pain when swallowing, Pain in infectious and inflammatory diseases of the upper respiratory tract, The pain of burns, The pain in traumatic muscle injury, Pain in trauma, The pain of tooth extraction, The pain of traumatic origin, Pain caused by spasm of smooth muscles, Expressed pain syndrome, Expressed pain syndrome, traumatic origin, Postoperative pain, Post-traumatic pain, Post-traumatic pain syndrome, Torpid pain, Traumatic pain, Traumatic pain, Mild pain, Moderately severe pain, Moderate pain, Polyarthralgia with polymyositis

R68.8.0 * Inflammatory syndrome

Painful syndrome of inflammatory genesis, Pain syndrome with inflammation of non-rheumatic nature, Pain syndrome with inflammatory lesions of the peripheral nervous system, Painful inflammation of the shoulder joint, Painful inflammation after trauma or surgery, Painful inflammation after surgery, Painful hemorrhoids, Inflammation of the tympanic membrane, Inflammation of the larynx, Inflammation of the gums, Inflammation of cellulose, Inflammation of lymph nodes, Tonsillitis, Inflammation of muscles, Inflammation of soft tissues, Inflammation of the mouth, Inflammation after surgery and trauma, Inflammation after orthopedic surgery, Inflammation after trauma, Inflammation in rheumatoid arthritis, Inflammation of the middle ear, Inflammatory gum disease, Inflammatory diseases of the eyelids, Inflammatory eye diseases, Inflammatory swelling of soft tissues, Inflammatory processes, Inflammatory processes after surgical interventions, Inflammatory process, Inflammatory Syndrome, Inflammatory syndrome of non-rheumatic origin, Inflammatory syndrome after surgery, Purulent infections, Infringements of function of a liver of an inflammatory etiology, Acute inflammation of the musculoskeletal tissue, Pre-inflammatory soft tissue inflammation

T14 Injury of unspecified site

Pain syndrome with injuries and after surgical interventions, Injuries, Extensive trauma to the skin and soft tissues, Muscle and ligament injuries, Injuries, Fibroma traumatic, Acute sport injuries

T14.3 Dislocation, sprain and damage to the capsular-ligamentous apparatus of the joint of the unspecified area of the body

Painful stretching of muscles, Pain and inflammation in tension, Dislocation of dislocation, Degenerative changes in the ligamentous apparatus, Edema due to sprains and bruises, Edema after interventions for sprains, Damage and rupture of ligaments, The musculoskeletal system is damaged, Damage to ligaments, Damage to the joints, Ligament ruptures, Tendon tendons,Ruptures of the tendons of muscles,Stretching, Crick, Stretching of the muscle, Sprain, Tension of the tendons, Extensions,Stretch muscles, Sprains, Tension of the tendons, Injury of the musculoskeletal system, Injuries to the joints, Injuries of capsule-articular tissues, Injuries of the osteoarticular system, Injuries to ligamentsInjuries to the joints, Joint wounds, Stretching of the ligamentous apparatus, Habitual stretching and tearing

T14.9 Injury unspecified

Pain syndrome after trauma, Pain syndrome with injuries, Pain syndrome with trauma and after surgery, Pain in case of injury, Pain of a traumatic nature, Joint pain with injuries, Postoperative and post-traumatic pain, Pain in case of injury, Pain of a traumatic origin, Severe pain syndrome of traumatic origin, Deep tissue damage, Deep scratches on the trunk, Closed injury, Minor Household Injuries, Minor skin damage, Violations of the integrity of soft tissues, Uncomplicated trauma, Extensive traumatic injury, Acute pain syndrome of traumatic origin, Edema with trauma, Postponed sports injuries, Post-traumatic pain, Soft tissue injuries, Joint wounds, Sports injuries, Injury, Traumatic pain, Traumatic pains, Traumatic infiltrate,Injuries to sports

Composition

Gel for external use 1 g

active substance:

ketoprofen 25 mg

auxiliary substances: carbomer - 20 mg; trolamine (triethanolamine) - 37 mg; ethanol 96% - 285 mg; lavender oil (lavender essential oil) - 0.28 mg; water 632.72 mg

Description of dosage form

Gel: homogeneous colorless transparent.

pharmachologic effect

Pharmacological action - anti-inflammatory local, analgesic local.

Pharmacodynamics

Ketoprofen - one of the most effective inhibitors of COX, also inhibits the activity of lipoxygenase and bradykinin. Stabilizes the lysosomal membranes and prevents the release of enzymes involved in the inflammatory process.

The main properties of ketoprofen are analgesic, anti-inflammatory and anti-edematous action. Ketoprofen does not adversely affect the condition of the articular cartilage.

Pharmacokinetics

Ketoprofen with topical application in the form of a gel does not accumulate in the body. Bioavailability of the gel is about 5%. Cmax ketoprofen in blood plasma is achieved 6 hours after application of the drug. Penetrates into the tissues of the joints, incl. synovial fluid, and reaches there therapeutic concentrations. The concentration of the drug in the blood plasma is extremely low.

Ketoprofen is metabolized in the liver with the formation of conjugates, which are excreted mainly by the kidneys. Metabolism of ketoprofen does not depend on age, the presence of severe renal failure or cirrhosis of the liver. The excretion of ketoprofen by the kidneys is slow.

Indications

Symptomatic therapy - reduction of pain and inflammation at the time of use - under the following conditions (for the progression of the disease does not affect):

reactive arthritis (Reiter's syndrome);

osteoarthrosis of different localization;

periarthritis, tendonitis, bursitis, myalgia, neuralgia, sciatica;

injuries of the musculoskeletal system (including sports), contusion of muscles and ligaments, sprains of ligaments, ruptures of ligaments and tendons of muscles.

Contraindications

hypersensitivity to ketoprofen or other components of the drug, as well as to salicylates, tiaprofenic acid or other NSAIDs, fenofibrate; skin allergy in a history of sunscreen and perfumes;

complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including in the anamnesis);

III trimester of pregnancy;

children's age (up to 15 years);

violation of the integrity of the skin in the area of application of the gel (eczema, acne, dandruff, open or infected wound);

reaction of photosensitivity in the anamnesis;

exposure to sunlight, incl. indirect sunlight and UV irradiation in the solarium throughout the treatment period and another 2 weeks after discontinuation of treatment with the drug.

With caution: impaired liver function and / or kidney function; erosive-ulcerative lesion of the gastrointestinal tract; blood diseases; bronchial asthma; chronic heart failure; hepatic porphyria (exacerbation).

Before using the gel, consult a doctor.

pregnancy and lactation

Application in I and II trimesters of pregnancy. Since the safety of ketoprofen in pregnant women has not been evaluated, the use of ketoprofen in I and II trimesters of pregnancy should be avoided.

Application in the III trimester of pregnancy. Ketonal® gel is contraindicated in the third trimester of pregnancy. During the III trimester of pregnancy, all prostaglandin synthetase inhibitors, including ketoprofen, can have toxic effects on the heart, lungs and kidneys of the fetus. At the end of pregnancy, an increase in the time of bleeding in the mother and child is possible. NSAIDs may delay the onset of labor.

To date, there is no data on the isolation of ketoprofen in breast milk, so the use of Ketonal® gel during breastfeeding is not recommended.

Side effects

According to WHO, the undesirable effects are classified according to their frequency of development as follows: very often (≥1 / 10); often (from ≥1 / 100 to <1/10); infrequently (from ≥1 / 1000 to <1/100); rarely (from ≥1 / 10000 to <1/1000); very rarely (<1/10000); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

On the part of the immune system: the frequency is unknown - anaphylactic shock, angioedema (Quincke's edema), hypersensitivity reactions.

From the digestive tract: very rarely - peptic ulcer, bleeding, diarrhea.

From the skin and subcutaneous tissues: infrequently - local skin reactions such as erythema, eczema, itching and burning; rarely photosensitivity reactions, hives. There have been rare reports of more severe reactions, such as bullous or fluke-venous eczema, which can spread beyond the area of application or become generalized.

From the side of the kidneys and urinary tract: very rarely - impairment of renal function in patients with CRF.

If any side effects occur, discontinue use and consult a doctor.

Interaction

With external application of ketoprofen in the gel dosage form, it is possible to enhance the effect of drugs that cause photosensitivity. Patients taking anticoagulants coumarinic series, it is recommended to conduct regular monitoring of MHO.

Ketoprofen, like other NSAIDs, can reduce the excretion of methotrexate and increase its toxicity.

Interaction with other drugs and the effect on their excretion are not significant.

Dosing and Administration

Outwardly.

A small amount of gel (3-5 cm) is applied a thin layer on the skin of an inflamed or painful area of the body 1-2 times a day and gently rubbed.

The dosage should be selected according to the area of the affected area: 5 cm of Ketonal® gel correspond to 100 mg of ketoprofen, 10 cm to 200 mg of ketoprofen.

If necessary Ketonal® gel can be combined with other dosage forms of Ketonal® preparation (capsules, tablets, suppositories rectal, solution for intravenous administration).

The maximum dose of ketoprofen is 200 mg / day. An occlusive dressing is not recommended. Do not use without consulting a doctor for more than 14 days.

If the patient forgot to apply the gel, it should be applied at a time when the next dose should be applied, but not to double it.

Overdose

Overdose is unlikely with external application of the drug.

Treatment: Rinse skin thoroughly with running water, stop using Ketonal® cream and consult your doctor.

In case of ingestion, systemic undesirable reactions may develop. Symptomatic treatment and maintenance therapy are indicated.

special instructions

You should avoid getting the gel in the eyes, on the skin around the eyes, mucous membranes.

When skin reactions appear, incl. developed when combined with octocrylene-containing sunscreens, should immediately stop treatment.

Patients suffering from bronchial asthma in combination with chronic rhinitis, chronic sinusitis and / or polyposis of the nose or paranasal sinuses, have a higher risk of developing allergic reactions with aspirin NSAIDs, including. than the rest of the population.

To reduce the risk of photosensitivity, it is recommended to protect gel-treated skin areas with clothing from exposure to UV irradiation throughout the treatment period and for another 2 weeks after discontinuation of use. Do not exceed the recommended duration of treatment because of the increased risk of contact dermatitis and photosensitivity reactions over time.

Wash hands thoroughly after each application.

Influence on the ability to drive vehicles, mechanisms. Data on the negative effect of Ketonal® gel on the ability to drive vehicles and engage in other potentially dangerous activities that require concentration of attention and speed of psychomotor reactions are not.

Form of issue

Gel for external use, 2.5%. For 50 or 100 grams of gel in an aluminum tube, sealed with a membrane on the neck of the tube, sealed with a screwed plastic cap. One tube in a cardboard box.

Conditions of leave from pharmacies

Without recipe.

storage conditions

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf Life

3 years.

Do not use after the expiry date printed on the package.