Ketonal gel 25mg/g 50g №1

Name:
Ketonal gel. Release formGel. INNKetoprofen.
Description:
Homogeneous, transparent gel. Composition 1 g of gel for external use contains 25 mg of ketoprofen. Excipients: carbomer, trolamine (triethanolamine), ethanol (96%), lavender essential oil, purified water. Pharmacotherapeutic groupNon-steroidal anti-inflammatory drugs ATX code: M01AE03. Pharmacological properties Pharmacodynamic properties Ketoprofen is one of the most powerful inhibitors of the cyclooxygenase enzyme. It also inhibits lipoxygenase activity and bradykinin synthesis. By stabilizing lysosomal membranes, ketoprofen prevents the release of enzymes that are involved in the inflammatory process. Ketoprofen has similar pharmacodynamic properties and effects with non-steroidal anti-inflammatory drugs. It has analgesic, anti-inflammatory and antipyretic effects. The effects of ketoprofen have been established in animal experiments and in many clinical studies in humans. Pharmacokinetic properties Plasma and tissue levels of ketoprofen were studied in 24 patients after knee surgery. After repeated application of the gel to the skin, its plasma level was 60 times lower (9-39 ng/g) than that after a single oral dose of ketoprofen (490-3300 ng/g). The tissue level of ketoprofen at the site of application was in the same range of concentrations for the gel and oral forms, although the variability between patients was significantly higher when using the gel. When applied externally, the bioavailability of ketoprofen was estimated to be about 5% of the level observed after oral administration, according to urinary excretion. Plasma protein binding is 99%. Ketoprofen is excreted by the kidneys, mainly in the form of glucuronides. Indications for use Ketonal is a non-steroidal anti-inflammatory drug. It has analgesic and anti-inflammatory effects. Ketonal is used: – to relieve acute painful conditions caused by injuries, such as sports injuries, ligament and tendon injuries, bruises; – for pain in non-severe arthritis. Dosage and administration Adult patients: Apply the gel to the painful or inflamed area 2-4 times a day, gently rubbing into the skin. The dose depends on the area of the diseased area. The duration of treatment is up to 7 days. 5 cm of gel correspond to 100 mg of ketoprofen, 10 cm of gel correspond to 200 mg of ketoprofen. Avoid contact with eyes or mucous membranes. Wash your hands thoroughly after each application of the gel. It is not recommended to wear tight clothing during treatment. Gel Ketonal can be used in combination with other dosage forms of Ketonal (capsules, tablets, suppositories). The total maximum daily dose, regardless of dosage form, should not exceed 200 mg of ketoprofen. Elderly Patients: There are no specific dosage recommendations for the elderly. In those most prone to adverse reactions, the lowest dose should be combined with adequate clinical safety monitoring. Children: Not recommended as safety in children has not been established. Contraindications The use of Ketonal gel is contraindicated in: – patients with hypersensitivity to ketoprofen or any other component of the drug; – patients with known hypersensitivity reactions (eg bronchospasm, rhinitis, urticaria) to ketoprofen, other nonsteroidal antirheumatic drugs, salicylates (eg acetylsalicylic acid), fenofibrate and thiaprofenic acid; – on damaged and pathologically altered skin, for example, eczema, acne, various dermatoses, open wounds or infectious lesions; – during the last trimester of pregnancy; – Patients with past photosensitivity reactions; – patients with a history of allergic reactions to ketoprofen, fenofibrate, thiaprofenic acid, UV blockers or fragrances; – Exposure of the gel application area to sunlight (including in cloudy weather), as well as UV radiation (solarium) throughout the entire period of treatment and for 2 weeks after stopping the use of the drug. Children: Not recommended as safety in children has not been established. Precautions Undesirable effects may be reduced by administering the lowest effective dose for the shortest period of time necessary to control symptoms. Although systemic adverse reactions from topical administration of ketoprofen should be rare, the gel should be used with caution in patients with renal, cardiac or hepatic insufficiency, with a history of gastric or duodenal ulcer or inflammatory bowel disease, cerebrovascular bleeding or hemorrhagic diathesis. Do not apply Ketonal gel to the mucous membranes, the anus, genitals and around the eyes. Avoid getting the gel in your eyes. Do not wear tight clothing during treatment. It is forbidden to apply the gel under occlusive dressings. When the first signs of a skin reaction appear, the application of ketoprofen should be immediately discontinued. Topical application of ketoprofen may trigger asthma in susceptible individuals. Large amounts of topical gel may cause systemic effects including hypersensitivity and asthma. Areas of the skin to which Ketonal gel was applied should be protected with clothing during treatment and for 2 weeks after its completion to avoid exposure to ultraviolet radiation and the risk of photosensitivity. Interaction with other drugs Although interactions with other drugs are unlikely, since the concentration of ketoprofen in the blood after topical application is low, attention should be paid to patients taking methotrexate. Serious interactions have been described after the use of a high dose of methotrexate and NSAIDs, including ketoprofen, when administered orally or parenterally. It is advisable to monitor patients receiving coumarin treatment. Pregnancy and lactation Pregnancy The safety of ketoprofen during pregnancy has not been proven. During the first two trimesters of pregnancy, ketoprofen should be discontinued unless the expected benefit to the mother outweighs the possible risk to the fetus. Ketoprofen is contraindicated during the last trimester of pregnancy. The use of ketoprofen in the last third trimester can cause delayed delivery, increased bleeding in the mother and newborn, cause premature closure of the ductus arteriosus with the development of pulmonary hypertension in the newborn. Lactation Ketonal should not be used during lactation, as the safety of using Ketoprofen during lactation has not been proven. Influence on the ability to drive vehicles and work with mechanisms Not applicable. Side effects The most common adverse effects associated with topical application of ketoprofen are localized skin reactions that may spread beyond the site of application. Classification of adverse effects according to “MedDRA” by organs and systems and frequency of occurrence: Very common (≥1/10); Frequent (≥1/100, <1/10); Uncommon (≥1/1000, <1/100); Rare (≥1/10,000, <1/1,000); Very rare (<1/10,000), including isolated reports. Immune System Disorders: Hypersensitivity reactions may include non-specific reactions and anaphylaxis. Very rare: angioedema and anaphylaxis have been reported with systemic and local administration of ketoprofen. Skin and subcutaneous tissue disorders Uncommon: pruritic rash, erythema, pruritus, burning, eczema and mild transient dermatitis. Rare: Urticaria, photosensitivity reactions, purpura, erythema multiforme, lichen-like dermatitis, skin necrosis, and Stevens-Johnson syndrome have been described. More severe skin reactions have been described, such as bullous and phlyctenular eczema, which may spread. Very rare: Severe contact dermatitis has been described in a patient due to poor hygiene and sun exposure. A severe diffuse contact prolonged photoallergic reaction may occur. Ketoprofen may be responsible for very prolonged photosensitivity after only one application. Toxic epidermal necrolysis has been described. Renal and urinary disorders Very rare: one case of worsening of chronic renal failure has been described following the use of ketoprofen gel. Topical NSAIDs can cause interstitial nephritis. Cases of worsening of already existing renal insufficiency of a small degree of severity are described. Overdose Given the low levels of ketoprofen in the blood when administered locally, no cases of overdose have yet been described. Shelf life 3 years. The medicinal product must not be used after the expiration date indicated on the package. Storage conditionsStore at a temperature not exceeding 25°C. Keep tube tightly closed. Keep out of the reach of children. Contents of the package 50 g of gel in an aluminum tube. 1 tube with leaflet in a cardboard box. Conditions of releaseBy prescription.ManufacturerSalutas Pharma GmbH, Ostervedingen, Germany Buy Ketonal gel 25mg/g 50g No. 1