Ketonal cream 50mg/g 30g №1

Product DescriptionKetonal. Release form Cream. INNKetoprofen. Pharmacological properties Pharmacodynamic properties Mechanism of action 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 propertiesAbsorption Transdermal absorption of non-steroidal anti-inflammatory drugs in the form of dosage forms for topical use is determined by the physicochemical properties of the excipients, which determine the rate of release of the active substance from the base and its subsequent absorption. Animal studies (experimental model in mice) have shown an increase in transdermal absorption of ketoprofen and an improvement in skin blood supply with the use of certain bases. The release rate of ketoprofen from the base of the cream also depends on the pH value: as the pH of the cream increases from 3 to 6, the release rate gradually increases. Compared to oral formulations, the bioavailability of ketoprofen in cream form is about 5%. Due to the low bioavailability of ketoprofen in the form of a cream, it acts locally and does not have systemic effects. Distribution Ketoprofen actively binds to plasma proteins (99%). The active substance is found in the synovial fluid at therapeutic concentrations; its concentration in the blood is negligible. With a triple topical application of 70-80 mg of ketoprofen in the form of a cream on the area of the knee joint, the maximum plasma concentration (0.0182 μg / ml ± 0.118) is observed after 6 hours. Twelve hours after the last application of ketoprofen cream to the area of the knee joints, the following concentrations of ketoprofen in the articular tissues were noted: in adipose tissue 4.7 μg / ml ± 3.87, in the articular membrane 2.35 μg / ml ± 2.41 and in synovial fluid 1.31 µg/ml ± 0.89. Metabolism and excretion Ketoprofen is metabolized in the liver to form conjugates, which are excreted mainly in the urine. The metabolism of ketoprofen does not change in the elderly, with severe renal insufficiency or cirrhosis of the liver. Ketoprofen is slowly excreted into the urine. DescriptionHomogeneous cream of white or almost white color. Composition 1 g of cream for external use contains 50 mg of ketoprofen. Excipients: glycerol sorbitan oleo stearate (Arlacel 481V), copolymer of dodecyl glycol and macrogol 45 (Elfacos ST 9), isopropyl myristate, magnesium sulfate heptahydrate, methyl parahydroxybenzoate E 218, propylene glycol, propyl parahydroxybenzoate E 216, white petrolatum, purified water. Pharmacotherapeutic groupNon-steroidal anti-inflammatory drugs for local use. ATX code: M02AA10. Indications for use Ketonal is a non-steroidal anti-inflammatory drug. It has a local analgesic and anti-inflammatory effect. In rheumatology, it is used for the treatment of arthrosis and extra-articular rheumatism as monotherapy or in combination with other systemic forms of ketoprofen. In traumatology, it is used to a lesser extent, mainly for sports injuries of the joints and soft tissues. According to a number of clinical studies, it has been established that ketoprofen for topical use in soft tissue injuries and sports injuries has a pronounced analgesic effect, exceeding the placebo effect and the effect of some other non-steroidal anti-inflammatory drugs. Ketonal is used: – for the local treatment of pain and inflammation of the joints in rheumatic diseases; – with post-traumatic pain. Method of application and doses For external use. Adult patients: Cream for external use Ketonal should be applied to the painful or inflamed area 2-4 times a day, gently rubbing into the skin. The duration of treatment is up to 7 days. The dosage should be adjusted according to the size of the affected area. Avoid contact with eyes or mucous membranes. It is not recommended to wear tight clothing (see section “Contraindications”). Wash your hands thoroughly after each application of the cream. Cream for external use Ketonal can be used in combination with other dosage forms of Ketonal (capsules, tablets, suppositories). The maximum daily dose, regardless of the dosage form, should not exceed 200 mg of ketoprofen. Elderly Patients There are no specific dosage recommendations for elderly patients. 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 Cream for external use Ketonal is contraindicated in patients with hypersensitivity to ketoprofen or other components of the drug. The use of Ketonal topical cream is also contraindicated: – in patients with past hypersensitivity reactions (eg bronchospasm, rhinitis, urticaria) to ketoprofen, other non-steroidal antirheumatic drugs, salicylates (eg acetylsalicylic acid), fenofibrate and thiaprofenic acid; – patients with acute gastric or duodenal ulcer; – on damaged and pathologically altered skin, for example, eczema, acne, various dermatoses, open wounds or infectious lesions; – with tight-fitting clothing; – under occlusive dressings; – simultaneously on the same site with other local means; – 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 odors; – Exposure of the area of application of the cream 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 can be reduced by prescribing the lowest effective dose for the shortest period of time necessary to control symptoms. Although systemic adverse reactions from topical ketoprofen should be low, the cream 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 cream for external use on the mucous membranes, the anus and genitals, around the eyes. Avoid contact with eyes. When the first signs of a skin reaction appear, the use of ketoprofen should be immediately discontinued. Topical application of ketoprofen may provoke asthma in susceptible individuals. A large amount of applied cream can cause systemic effects, including hypersensitivity and asthma. During treatment and for 2 weeks after its completion, skin areas treated with Ketonal cream must be protected with clothing to avoid exposure to UV radiation and the risk of photosensitivity. It is forbidden to apply the cream under occlusive dressings. Important information about some of the excipients Ketonal Cream contains methyl parahydroxybenzoate E218 and propyl parahydroxybenzoate E216, which are known to cause urticaria. Usually there is a delayed type of hypersensitivity reactions, such as, for example, contact dermatitis. Rarely, immediate hypersensitivity reactions such as urticaria and bronchospasm may occur. Interaction with other drugs Despite the unlikely interaction with other drugs due to the low concentration of ketoprofen in the blood after topical application, patients receiving methotrexate require special attention. 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 using ketoprofen during pregnancy has not been proven. During the first two trimesters of pregnancy, ketoprofen cannot be prescribed if the expected benefit to the mother does not outweigh the possible risk to the fetus. Ketoprofen is contraindicated during the last trimester of pregnancy (see section “Contraindications”). The use of ketoprofen in the last third trimester may interfere with the development of labor, 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 significant. 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); infrequent (≥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, itching, burning, eczema and mild transient dermatitis. Rare: Urticaria, rashes, photosensitivity reactions, blister rupture, purpura, erythema multiforme, lichen-like dermatitis, skin necrosis and Stevens-Johnson syndrome. More severe skin reactions have been described, such as bullous and phlyctenular eczema, which may worsen and 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 can cause very prolonged photosensitivity even after one application. Toxic epidermal necrolysis has been described. Renal and urinary disorders Very rare: worsening of renal failure has been described. Overdose Given the low levels of ketoprofen in the blood when administered locally, no cases of overdose have yet been described. Shelf life 5 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 out of the reach of children. Contents of the package 30 g or 50 g of cream in an aluminum tube. 1 tube with leaflet in a cardboard box. Conditions of release By prescription. Buy Ketonal cream 50mg/g 30g №1 Price for Ketonal cream 50mg/g 30g №1