Fort-gel 2.5% 50g №1

Name Fort-gel gel 2.5% in tubes 30 (50) g No. 1 Basic physical and chemical properties The gel is colorless, almost transparent, of uniform consistency, with a fragrant smell. Active ingredient: 1 g of gel contains 0.025 g of ketoprofen; excipients: ethanol 96%, carbomer, triethanolamine, lavender oil, purified water. Pharmacotherapeutic groupNon-steroidal anti-inflammatory drugs for local use. Ketoprofen. ATX code: M02AA10. Pharmacological properties Pharmacodynamics Ketoprofen belongs to non-steroidal anti-inflammatory drugs, derivatives of propionic acid. It exhibits analgesic and anti-inflammatory effects due to inhibition of the action of cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2), inhibition of bradykinin activity, stabilization of lysosomal membranes and inhibition of macrophage migration. Ketoprofen exhibits analgesic and anti-inflammatory effects at an early stage (vascular phase) and at a late stage (cellular phase) of the inflammatory response. Ketoprofen also inhibits platelet aggregation. Pharmacokinetics When applied topically, ketoprofen gel is absorbed from the skin and penetrates locally into inflamed tissues. Absorption to the systemic circulation is very low (only 5% of the dose that is applied). The drug applied to the skin quickly penetrates into the problem area and maintains a therapeutic concentration in it. Absorption into the general circulation, on the contrary, proceeds slowly. When applied to the skin of a gel containing from 50 mg to 150 mg of ketoprofen, after 5-8 hours in the blood plasma, the concentration of the active substance is not more than 0.08-0.15 μg / ml, which practically does not have a clinically significant effect on the body. Indications Post-traumatic pain in muscles and joints, tendovaginitis. Contraindications Hypersensitivity to ketoprofen or other excipients of the drug, salicylates and other non-steroidal anti-inflammatory drugs. Hypersensitivity reactions are known, for example, symptoms of bronchial asthma, allergic rhinitis or urticaria after the use of ketoprofen, other NSAIDs, acetylsalicylic acid, fenofibrate, thiaprofenic acid. Exacerbation of peptic ulcer of the stomach or duodenum. History of gastrointestinal bleeding. Chronic dyspepsia (discomfort and pain in the upper abdomen). Severe renal failure. Skin injuries and diseases, skin injuries, irritation, itching, acne, burns (rash, eczema, skin infections). The gel should not be applied to affected skin (dermatoses, open and infected wounds). Do not use airtight bandages. Any history of photosensitivity reactions. A history of skin manifestations of allergies that have arisen with the use of ketoprofen, other excipients of the drug, fenofibrate, thiaprofenic acid, ultraviolet (UV) blockers, or perfumes. Exposure to sunlight (even on a foggy day), including indirect sunlight and UV radiation in a solarium, throughout the treatment period and for 2 weeks after stopping the drug. Pregnancy (III trimester), lactation period. Childhood. Interactions with other drugs and other types of interactions Monitoring of patients who take coumarin is recommended. The simultaneous use of other topical dosage forms that contain ketoprofen or other non-steroidal anti-inflammatory drugs is not recommended, as this may enhance their effect as well as the adverse reactions caused by them. With the simultaneous use of acetylsalicylic acid and ketoprofen, the binding of ketoprofen to plasma proteins decreases. The simultaneous use of probenecid and ketoprofen leads to a decrease in the plasma clearance of ketoprofen and the degree of its protein binding. Ketoprofen, like other non-steroidal anti-inflammatory drugs, reduces the excretion of methotrexate, which leads to an increase in its toxicity. Despite the low degree of absorption of ketoprofen through the skin, its simultaneous use with high doses of methotrexate is not recommended due to a decrease in the excretion of methotrexate, resulting in a significant increase in its toxicity. Due to the increased risk of bleeding with the simultaneous use of ketoprofen and oral anticoagulants or corticosteroids, the patient should be under constant medical supervision. With anticoagulants, antithrombotic agents, with acetylsalicylic acid or other NSAIDs, glucocorticosteroids – enhancing the effect of the above-mentioned drugs. With the simultaneous use of ketoprofen and cardiac glycosides, lithium preparations and cyclosporine, their toxicity increases due to a decrease in excretion. Ketoprofen can reduce the effect of diuretics and antihypertensive drugs, increase the effectiveness of oral hypoglycemic drugs – sulfonylurea derivatives, as well as some anticonvulsants (phenytoin). The simultaneous use of ketoprofen and diuretics or angiotensin convertase inhibitors increases the risk of impaired renal function. Ketoprofen can reduce the effect of mifepristone, therefore, at least 8 days should elapse between the course of treatment with mifepristone and the start of therapy with ketoprofen. Application features The drug should be used externally only. If the time of applying the gel is missed, do not double the dose with the next use of the drug. Despite the fact that there are practically no systemic side effects of ketoprofen when applied topically, the gel should be used with caution in patients with impaired renal, cardiac or hepatic function, with a history of peptic ulcer or intestinal inflammation, cerebrovascular bleeding or hemorrhagic diathesis. Isolated cases of systemic adverse reactions associated with kidney damage have been reported. Do not apply the gel on the anus and genitals. Do not use the gel together with other topical agents on the same areas of the skin. Topical application of a large amount of gel can provoke the appearance of systemic effects, including attacks of bronchial asthma and manifestations of hypersensitivity, such as contact dermatitis, urticaria and bronchospasm. The recommended amount of gel and duration of treatment should not be exceeded, as the risk of developing contact dermatitis and photosensitivity reactions increases over time. The gel should not be applied to the affected skin surface (eczema, open or infected wound, dermatitis in the exudative phase). It is necessary to avoid getting the gel on the mucous membranes, in the eyes and on the skin around the eyes. Do not use under occlusive dressings, on large areas of the skin, in quantities and with frequency exceeding the required dose, near an open flame (because the preparation contains ethanol). Octocrylene is included in some cosmetic and hygiene products, such as shampoos, aftershave gels, shower gels, creams, lipsticks, anti-aging creams, makeup removers, hair sprays, to delay their photodegradation. If changes appear on the skin, treatment should be temporarily stopped. With severe irritation, it is not recommended to continue treatment. Wash hands thoroughly after each application of the gel. If it is necessary to rub Fort-gel into the skin for a long time, surgical gloves should be used. It is necessary to protect from the sun (including UV rays in a solarium) areas of the skin on which the drug is applied during treatment, as well as for 2 weeks after treatment, to reduce any risk of photosensitivity; immediately stop treatment if any skin reactions occur, including skin reactions after simultaneous use with products that contain octocrylene (some cosmetic and hygiene products). Direct sunlight and UV radiation (solarium) should be avoided during the entire period of treatment and for 2 weeks after discontinuation of the drug. The drug should be administered with caution to patients who use anticoagulants, diuretics and lithium salts. It is recommended to regularly monitor the condition of patients who are being treated with coumarin-containing products. Topical application of a large amount of gel can provoke the appearance of systemic effects, including attacks of bronchial asthma and manifestations of hypersensitivity, such as contact dermatitis, urticaria and bronchospasm. Use during pregnancy or lactation In the I and II trimesters, the use of the gel is possible only as directed by a doctor if the expected benefit to the mother outweighs the potential risk to the fetus. During treatment, breastfeeding should be stopped. All prostaglandin synthesis inhibitors, including ketoprofen, cause toxic damage to the cardiopulmonary system and fetal kidneys. At the end of pregnancy, both the mother and the baby may have an extended bleeding time. Non-steroidal anti-inflammatory drugs can cause delayed labor, so the use of the drug is contraindicated in the third trimester of pregnancy. The ability to influence the reaction rate when driving vehicles or working with other mechanisms There are no data on the effect of Fort-Gel on the ability to drive a car and mechanisms. Dosage and administrationGel for external use. The drug is applied to the skin 2-4 times a day, distributed in a thin layer (3-5 cm of gel), then gently and long-term rubbed into the inflamed and painful areas until completely absorbed. The duration of treatment is up to 7 days. Children Application is not recommended, because. the safety and efficacy of the drug in children has not been established. Overdose In case of accidental use of ketoprofen inside, the drug can cause drowsiness, dizziness, nausea, vomiting, pain in the epigastric region. These symptoms usually resolve with appropriate symptomatic treatment. High doses of ketoprofen when used systemically can cause bradypnea, coma, convulsions, gastrointestinal bleeding, acute renal failure and an increase or decrease in blood pressure. Systemic side effects may occur with prolonged use of Fort-gel, when used in high doses, or when applied to large areas of the skin. Symptoms: irritation, erythema and itching or increased manifestations of other adverse reactions. Since the level of ketoprofen, which penetrates the skin, is low in the blood plasma, an overdose is unlikely. The development of systemic adverse reactions is possible when using the drug for a long time, in high doses or on large areas of the skin. If too much gel is applied to the skin, it should be rinsed with water. Possible side effects characteristic of non-steroidal anti-inflammatory drugs: heartburn, nausea, discomfort in the epigastric region, headache, dizziness. Treatment: there is no specific antidote, symptomatic treatment is recommended along with the maintenance of vital body functions. Gastric lavage and activated charcoal (the first dose should be given with sorbitol) are recommended, especially in the first 4 hours after an overdose or when using a dose that is 5-10 times higher than recommended. In case of irritation, erythema and itching, thoroughly rinse the skin surface with running water. Adverse reactions From the side of the skin and subcutaneous tissue: skin irritation, allergic skin reactions, hyperemia, erythema, burning, itching, swelling, urticaria, contact dermatitis, rash, eczema, including vesicular, bullous and phlyctenular, which can spread and become generalized , bullous dermatitis, exfoliative dermatitis, Stevens-Johnson syndrome, increased sweating; photosensitivity, including serious skin reactions from sun exposure (photosensitivity); purpura, erythema multiforme, lichen-like dermatitis, skin necrosis. Very rarely, with prolonged use of the drug in high doses or applied to large areas of the skin, systemic adverse reactions are possible. There have been reports of local skin reactions, which could later extend beyond the areas of application of the drug. From the immune system: hypersensitivity reactions, anaphylactic reactions, including angioedema, and anaphylaxis, noted with systemic and local use of ketoprofen, bronchospasm, bronchial asthma attacks. From the respiratory system: asthmatic attacks. From the urinary system: deterioration of kidney function, in isolated cases, interstitial nephritis occurs. From the digestive tract: vomiting, dyspepsia, nausea, constipation, diarrhea, heartburn, peptic ulcers, bleeding or perforation. Neurological disorders: headache, dizziness, vertigo, mood changes, drowsiness or insomnia. Depending on the penetrating ability of the active substance, the amount of gel applied, the area of the treated area, the integrity of the skin, the duration of the drug and the use of hermetic dressings, other adverse hypersensitivity reactions, adverse reactions from the digestive tract and urinary system are possible. Elderly patients are most prone to adverse reactions when using non-steroidal anti-inflammatory drugs. Ketoprofen can cause asthma attacks in patients with hypersensitivity to acetylsalicylic acid or its derivatives. The use of the drug should be discontinued if skin lesions or any other undesirable reactions occur at the site of application of the gel. Shelf life 3 years. Do not use the drug after the expiration date indicated on the package! Storage conditionsStore at a temperature not exceeding 25 °C. Keep out of the reach of children! Packing 30 g or 50 g in a tube, placed together with a leaflet in a cardboard box. Vacation categoryBy prescription. 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