Pharmacological properties
Pharmacodynamics. The active substance of the drug f-gel - ketoprofen - belongs to the group of nonsteroidal anti-inflammatory drugs, derivatives of arylpropionic acid. Ketoprofen exhibits analgesic and anti-inflammatory effects due to inhibition of the action of COX-1, COX-2 and bradykinin, stabilization of lysosomal membranes and inhibition of macrophage migration. It has analgesic and anti-inflammatory activity both in the early (vascular phase) and in the late stage (cellular phase) of the inflammatory reaction. The drug also inhibits platelet aggregation.
Pharmacokinetics. When applied topically, ketoprofen is absorbed from the skin surface, penetrates locally into the inflamed tissues and maintains a therapeutic concentration in them for a long time. Absorption into the systemic circulation is very insignificant (only 5% of the dose) and occurs slowly. When applying a gel containing 50-150 mg of ketoprofen to the skin, the concentration of the active substance in the blood plasma after 5-8 hours is no more than 0.08-0.15 μg/ml, which has practically no clinically significant effect on the body.
Indication
Pain in muscles and joints caused by injuries or damage.
Tendovaginitis.
Application
The drug should be applied to the skin of the affected area with a thin layer - 3-5 cm of gel or more 1-2 times a day and gently rubbed until completely absorbed. The amount of gel depends on the size of the affected area: 5 cm of gel corresponds to 100 mg of ketoprofen, 10 cm - 200 mg of ketoprofen. After each use of the drug, wash your hands immediately.
The drug 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.
The duration of the course of treatment is determined individually, but not more than 10 days.
Contraindication
Known hypersensitivity reactions, such as symptoms of anaphylaxis, allergic rhinitis or urticaria, which have occurred with the use of ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs; hypersensitivity to any of the excipients; history of skin allergy to ketoprofen, fenofibrate, tiaprofenic acid, UV blockers or perfumes; history of photosensitivity reactions; exposure to sunlight, including indirect sunlight and UV exposure in a solarium during the entire period of treatment and for 2 weeks after discontinuation of treatment with the drug; violation of the integrity of the skin (damage, rash, eczema, trauma, skin infections).
Side effects
Immune system disorders: hypersensitivity reactions, including angioedema, bronchospasm, asthma attacks, anaphylactic reactions.
On the part of the skin and subcutaneous tissue: hyperemia, itching, burning sensation, edema, urticaria, photosensitivity reactions, dermatitis (contact, bullous), eczema, including bullous and phlyctenulosis, which can spread and become generalized, Stevens-Johnson syndrome.
Gastrointestinal tract: heartburn, nausea, vomiting, diarrhea, constipation, peptic ulcer, gastrointestinal bleeding.
On the part of the urinary system: increased renal dysfunction or renal failure, especially in patients with chronic renal failure, rarely - interstitial nephritis.
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, and the duration of use of the drug, other unpleasant sensations from the digestive tract and urinary system are possible.
Elderly patients are more prone to adverse reactions when using NSAIDs.
Special instructions
The drug is for external use only.
If you miss the time to apply the gel, double the dose the next time you use the drug.
After each use of the drug, hands should be washed immediately.
The drug should be discontinued in the event of skin reactions, including skin reactions when used simultaneously with products containing octocrylene (octocrylene is a component of some cosmetic and hygiene products, such as shampoos, aftershave gels, shower gels, creams, lipsticks, anti-aging creams, makeup removers, hairsprays, to delay their photodegradation). Treatment should be discontinued immediately after the development of any skin reaction after using the drug.
The drug should not be used on areas with acne, open wound areas and areas located near them, on mucous membranes, in areas around the eyes and in the eyes.
The gel should not be used under occlusive dressings.
Local application of large amounts of gel may cause systemic effects, including manifestations of hypersensitivity and asthma. The recommended dose and duration of treatment should not be exceeded, as the risk of developing contact dermatitis and photosensitivity reactions increases over time.
There have been isolated reports of systemic adverse reactions associated with renal damage.
The drug should be used with caution in patients with impaired renal or hepatic function, in the presence of concomitant heart failure.
The drug should be used with caution and under the supervision of a physician in patients taking anticoagulants, diuretics, and lithium salts.
The gel should not be used near an open flame because it contains ethanol.
Pregnancy and lactation. I and II trimesters of pregnancy. In studies on mice and rats, no teratogenic or embryotoxic effects were observed. In studies on rabbits, a slight embryotoxic effect was found, probably associated with maternal toxicity. Since safety studies of ketoprofen in pregnant women have not been conducted, the drug should be avoided in the I and II trimesters of pregnancy.
III trimester of pregnancy. All prostaglandin synthesis inhibitors, including ketoprofen, cause toxic damage to the cardiopulmonary system and kidneys of the fetus. At the end of pregnancy, bleeding time may be prolonged in both the mother and the child. Therefore, the use of the drug is contraindicated in the III trimester of pregnancy.
Breastfeeding. After systemic administration (oral, rectal, parenteral), traces of ketoprofen are detected in breast milk. The drug should not be used during breastfeeding.
Children. The drug should not be used in children under 15 years of age.
Ability to influence the reaction rate when driving vehicles or working with other mechanisms. There is no data on the negative effect of the drug on the reaction rate when driving vehicles or working with other mechanisms.
Interactions
Since the concentration of the drug in the blood plasma is extremely low, symptoms of interaction with other drugs (similar to symptoms with systemic use) are possible only with frequent and prolonged use:
with methotrexate, cardiac glycosides, lithium salts, cyclosporine - increased toxicity due to reduced excretion; with anticoagulants, antithrombotic agents, acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, corticosteroids, oral hypoglycemic agents, phenytoin - increased action of the above drugs; simultaneous use of the drug with other topical forms (ointments, gels) containing ketoprofen or other nonsteroidal anti-inflammatory drugs is not recommended; with antihypertensive agents, diuretics, mifepristone - weakening of the action of the above drugs. At least 8 days should elapse between the course of treatment with mifepristone and the start of ketoprofen therapy.
Overdose
Since the level of ketoprofen that penetrates the skin in the blood plasma is low, overdose is unlikely.
Main symptoms: irritation, erythema and itching.
Treatment: rinse the skin thoroughly under running water, stop using the gel and consult a doctor.
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.
Accidental oral use of the gel can cause drowsiness, dizziness, nausea, vomiting, epigastric pain, and taking high doses of ketoprofen can cause bradypnea, coma, convulsions, gastrointestinal bleeding, acute renal failure, and increased or decreased blood pressure.
Treatment: symptomatic therapy with support of vital functions of the body. Gastric lavage and administration of activated charcoal (the first dose should be administered together with sorbitol) may be useful, especially in the first 4 hours after overdose or when taking a dose 5-10 times higher than recommended.
Storage conditions
In original packaging at a temperature of 15-25 °C.
