Instructions for Fort-gel 2.5% tube 50 g
Composition
active ingredient: 1 g of gel contains 0.025 g of ketoprofen;
Excipients: ethanol 96%, carbomer, triethanolamine, lavender oil, purified water.
Dosage form
Gel 2.5%.
Main physicochemical properties: the gel is colorless, almost transparent, of uniform consistency, with a fragrant odor.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory drugs for topical use. Ketoprofen.
ATX code M02A A10.
Pharmacological properties
Pharmacodynamics.
Ketoprofen belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs), derivatives of propionic acid. It has analgesic and anti-inflammatory effects due to inhibition of cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2), inhibition of bradykinin activity, stabilization of lysosomal membranes and inhibition of macrophage migration. Ketoprofen has analgesic and anti-inflammatory effects at the early stage (vascular phase) and at the late stage (cellular phase) of the inflammatory reaction. Ketoprofen also inhibits platelet aggregation.
Pharmacokinetics.
When applied topically, ketoprofen gel is absorbed from the skin and penetrates locally into the inflamed tissues. Absorption into the systemic circulation is very low (only 5% of the applied dose).
The drug applied to the skin quickly penetrates the problem area and maintains a therapeutic concentration there. Absorption into the general circulation, on the contrary, occurs slowly. When applying a gel containing from 50 to 150 mg of ketoprofen to the skin, it forms after 5-8 hours in the blood plasma a concentration of the active substance of no more than 0.08-0.15 μg/ml, which has almost no clinically significant effect on the body.
Indication
Post-traumatic pain in muscles and joints, tendovaginitis.
Contraindication
Hypersensitivity to ketoprofen or to any other excipients of the drug, salicylates and other NSAIDs.
Hypersensitivity reactions, such as symptoms of bronchial asthma, allergic rhinitis or urticaria, have been reported after the use of ketoprofen, other NSAIDs, acetylsalicylic acid, fenofibrate, tiaprofenic acid. Exacerbation of gastric or duodenal ulcer.
History of gastrointestinal bleeding. Chronic dyspepsia (discomfort and pain in the upper abdomen). Severe renal failure. Skin damage and diseases, skin injuries, irritation, itching, acne, burns (rash, eczema, skin infections). The gel should not be applied to damaged skin (dermatoses, open and infected wounds). Do not use airtight dressings.
Any history of photosensitivity reactions. History of skin allergy to ketoprofen, other excipients, fenofibrate, tiaprofenic acid, ultraviolet (UV) blockers or perfumes. Exposure to sunlight (even on a foggy day), including indirect sunlight and UV exposure in a solarium during the entire treatment period and for 2 weeks after stopping treatment with the drug.
Third trimester of pregnancy, breastfeeding period.
Interaction with other medicinal products and other types of interactions
Monitoring of patients taking coumarin is recommended.
The simultaneous use of other topical formulations containing ketoprofen or other NSAIDs 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 blood 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 binding to proteins. Ketoprofen, like other NSAIDs, 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, as a result of which its toxicity is significantly increased.
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 - increased effect of the above drugs.
With simultaneous use of ketoprofen and cardiac glycosides, lithium preparations and cyclosporine, their toxicity increases due to reduced excretion. Ketoprofen may reduce the effect of diuretics and antihypertensive drugs, increase the effectiveness of oral hypoglycemic drugs - sulfonylurea derivatives, as well as some anticonvulsants (phenytoin).
Concomitant use of ketoprofen and diuretics or angiotensin converting enzyme inhibitors increases the risk of renal dysfunction.
Ketoprofen may reduce the effect of mifepristone, therefore at least 8 days should elapse between the course of mifepristone treatment and the start of ketoprofen therapy.
Application features
The drug should be used externally only. If you miss the time to apply the gel, do not double the dose when applying the drug again.
Despite the fact that systemic side effects of ketoprofen with topical application are practically absent, 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 renal damage have been reported.
Do not apply the gel to the anal or genital area.
The gel should not be used together with other topical agents on the same areas of skin.
Local application of large amounts of gel may 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). Avoid contact of the gel with mucous membranes, eyes and skin around the eyes. Do not use under occlusive dressings, on large areas of skin, in quantities larger than necessary and with a frequency greater than necessary, near an open flame (since the drug 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, and hairsprays, to delay their photodegradation.
If changes appear on the skin, treatment should be temporarily discontinued. If irritation is severe, it is not recommended to continue treatment. Wash hands thoroughly after each application of the gel. If prolonged rubbing of Fort-gel is necessary, surgical gloves should be used.
It is necessary to protect the treated skin areas from the sun (including UV rays in a solarium) during treatment and for 2 weeks after treatment to reduce any risk of photosensitization; immediately discontinue treatment if any skin reactions occur, including skin reactions after simultaneous use with products containing octocrylene (some cosmetics and hygiene products).
Direct sunlight and UV radiation, including tanning beds, should be avoided during treatment and for 2 weeks after its completion.
The drug should be prescribed with caution to patients taking anticoagulants, diuretics and lithium salts. Regular monitoring of the condition of patients undergoing treatment with coumarin drugs is recommended.
Local application of large amounts of gel may provoke the appearance of systemic effects, including attacks of bronchial asthma and manifestations of hypersensitivity, such as contact dermatitis, urticaria and bronchospasm.
Elderly patients are more prone to adverse reactions when using NSAIDs.
Use during pregnancy or breastfeeding
There are no clinical data on the use of Forte-gel during pregnancy. Even if the systemic exposure to ketoprofen with topical application is lower compared to oral administration, it is not known whether it could be harmful to the embryo/fetus. During the first and second trimester of pregnancy, Forte-gel should not be used unless clearly necessary. If used, the dose should be as low as possible and the duration of treatment as short as possible.
During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors, including Fort-gel, may cause cardiopulmonary and renal toxicity in the fetus. At the end of pregnancy, prolonged bleeding may occur in both the mother and the child, and labor may be delayed. Therefore, Fort-gel is contraindicated during the last trimester of pregnancy (see section "Contraindications").
After systemic administration (oral, rectal, parenteral), traces of ketoprofen are found in breast milk. Ketoprofen should not be used during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
There is no data on the effect of Fort-gel on the ability to drive a car or use machines.
Method of administration and doses
Gel for external use. Apply the drug in a thin layer (3-5 cm of gel), gently rub in until completely absorbed 2 times a day. The duration of the course of treatment is determined by the doctor individually, but it is recommended to use the drug for no more than 10 days.
Fort-gel can be combined with other dosage forms of ketoprofen (capsules, tablets, rectal suppositories). The total maximum daily dose of ketoprofen should not exceed 200 mg, regardless of the dosage form used.
Hands should be washed after applying the gel, except when applying the gel directly to the hands. If prolonged rubbing into the skin is necessary, protective gloves should be used.
Children.
The safety and efficacy of the drug for this age group have not been established.
Overdose
In case of accidental ingestion of ketoprofen, the drug may cause drowsiness, dizziness, nausea, vomiting, epigastric pain. These symptoms usually disappear after appropriate symptomatic treatment. High doses of ketoprofen when used systemically can cause bradypnea, coma, convulsions, gastrointestinal bleeding, acute renal failure and increased or decreased 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 skin.
Symptoms: irritation, erythema and itching or increased manifestations of other adverse reactions.
Since the level of ketoprofen penetrating the skin in the blood plasma is low, 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 skin. If too much gel is applied to the skin, it should be washed with water.
Possible side effects typical of NSAIDs: heartburn, nausea, discomfort in the epigastric region, headache, dizziness.
Treatment: There is no specific antidote, symptomatic treatment is recommended along with maintaining vital body functions. Gastric lavage and administration of activated charcoal (the first dose should be administered together with sorbitol) are recommended, especially in the first 4 hours after overdose or when using a dose 5-10 times higher than the recommended dose. In case of irritation, erythema and itching, the skin surface should be thoroughly washed with running water.
Adverse reactions
Skin and subcutaneous tissue disorders: skin irritation, allergic skin reactions, flushing, erythema, burning sensation, itching, swelling, urticaria, contact dermatitis, rash, eczema, including vesicular, bullous and phlyctenulosis, which can spread and become generalized, bullous dermatitis, exfoliative dermatitis, Stevens-Johnson syndrome, increased sweating; photosensitivity, including serious skin reactions from exposure to the sun (photosensitization); purpura, erythema multiforme, lichen-like dermatitis, skin necrosis. Very rarely, with prolonged use of the drug in high doses or application to large areas of the skin, systemic adverse reactions are possible. There have been reports of local skin reactions that could subsequently extend beyond the site of application.
On the part of the immune system: hypersensitivity reactions, anaphylactic reactions, including angioedema, and anaphylaxis, observed with systemic and local use of ketoprofen, bronchospasm, attacks of bronchial asthma.
From the respiratory system: asthmatic attacks.
From the urinary system: deterioration of renal function, in rare cases interstitial nephritis occurs.
Gastrointestinal: 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 use of the drug and the use of airtight dressings, other adverse reactions of hypersensitivity, adverse reactions from the digestive tract and urinary system are possible.
Elderly patients are more prone to adverse reactions when using NSAIDs. Ketoprofen can cause attacks of bronchial asthma in patients with hypersensitivity to acetylsalicylic acid or its derivatives.
The use of the drug should be discontinued if skin lesions or any other adverse reactions occur at the site of gel application.
Reporting adverse reactions after registration of a medicinal product is of great importance. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of a medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
30 g or 50 g in tubes No. 1.
Vacation category
According to the recipe.
Manufacturer/Applicant
"Ternofarm" LLC.
Location of the manufacturer and address of its place of business/location of the applicant.
Ukraine, 46010, Ternopil, Fabrychna St., 4.
Phone/fax: (0352) 521-444, www.ternopharm.com.ua
