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Active ingredients
Ketoprofen
Release form
Gel
Composition
100 g of gel contains: active ingredient: ketoprofen 2.50 g; ; excipients: carbomer 940 1.50 g, ethanol 96% 40.00 ml, non-nerve oil 0.05 g, lavender oil * 0.05 g, trolamine (triethanolamine) 2.80 g, purified water to 100.00 g ; * Hybrid lavender oil ("Lavender").
Pharmacological effect
For external use. The mechanism of action is related to the inhibition of prostaglandin synthesis. It has a local analgesic, anti-inflammatory, antiexudative effect. In the symptomatic treatment of diseases of the joints, tendons, ligaments, muscles, skin; with articular syndrome reduces pain in the joints at rest and when moving, morning stiffness and swelling of the joints.
Pharmacokinetics
When applied topically, penetrates into the inflammation through the skin, the absorption of ketoprofen from the inflammation occurs very slowly (gel bioavailability is about 5%). After administration of 50-150 mg ketoprofen at a dose of 5-8 hours, plasma concentration in plasma is 0.08-0.15 mcg / ml. Practically does not accumulate in the body. The half-life is 1-3 hours. Communication with proteins of blood plasma 60-90%. Excreted mainly through the kidneys in the form of glucuronide.
Indications
- pain of traumatic origin (bruises, sprains and muscles); - tension and stiffness of the neck muscles; - lumbago (pain in the lumbosacral spine); - muscular and osteo-articular pain of rheumatic origin (for example, osteoarthritis) .;
Contraindications
- individual hypersensitivity to ketoprofen or other components of the drug, acetylsalicylic acid or other NSAIDs (in the history of bronchospasm, urticaria or rhinitis caused by taking acetylsalicylic acid) and fenofibrate; - hypersensitivity of the skin to the effects of solar radiation (photosensitization) in history; - skin allergies in history of ketoprofen, tiaprofenic acid, fenofibrate, sunscreen and perfume; - exposure to the sun on the treated areas, including a tanning bed during the course of the drug use and 2 weeks after; - children's age up to 12 years (efficiency and safety are not studied); - pregnancy and lactation period .;
Use during pregnancy and lactation
The drug Fastum is contraindicated during pregnancy and during breastfeeding.
Dosage and administration
For external use .; When using a tube: a strip of gel with a length of 5-10 cm is applied with a thin layer on the affected area or the skin over the inflammation site 1-2 times a day and lightly rubbed .; When using the container with the dispenser (dispenser): press twice on the dome of the dispenser or on the base until the gel appears. It is recommended to keep the container in a horizontal position. Apply a thin layer of gel on the affected area or skin over the inflammation 1-2 times a day and slightly rubbed.; The amount of gel applied depends on the size of the treated area .; It is possible to use the drug Fastum in combination with physiotherapy (phonophoresis and iontophoresis) .; The course of treatment is 10 days.
Side effects
Possible side effects are listed by descending frequency of occurrence: very often (> 10%), often (> 1%,> 10%), infrequently (> 0.1%,> 1%), rarely (> 0.01%,> 0.1%), very rarely (> 0.01%) .; On the part of the skin: Infrequently: erythema, pruritus, eczema; ; Seldom: photosensitization, bullous dermatitis, urticaria; ; Very rare: contact dermatitis, angioedema .; On the part of the gastrointestinal tract: Very rare: peptic ulcer, bleeding, diarrhea; Immune system: Very rare: anaphylactic reactions, hypersensitivity reactions .; Urinary system: Very rare: aggravation of renal failure .;
Overdose
The extremely low systemic absorption of the active ingredients of the drug for external use makes overdosing almost impossible .; In case of accidental ingestion of large quantities of the drug may cause systemic side effects. Treatment should be symptomatic .;
Interaction with other drugs
With the external use of ketoprofen in the form of a gel, it is possible to enhance the action of drugs that cause photosensitization. Other interactions are not established. However, patients taking coumarin anticoagulants are advised to regularly monitor the international normalized ratio (INR).
special instructions
Do not apply on damaged (including open wounds) and inflamed skin !; Avoid contact with eyes (danger of irritation of the conjunctiva) .; It is recommended to thoroughly wash your hands after applying the drug .; Do not use in the form of hermetic dressings.Do not use in combination with tight clothing .; Prolonged use of topical agents may result in increased sensitivity or local irritation. In order to avoid any manifestations of hypersensitivity or photosensitivity, exposure to direct sunlight should be avoided (including visiting a tanning bed) during the treatment period and for two weeks after using the drug and it is recommended to cover the treated areas with clothing .; Patients with severe renal, cardiac or hepatic insufficiency should be careful when using the drug Fastum .; The drug should be discontinued in the event of any skin reaction, including the simultaneous application to the skin of sunscreen or other cosmetics containing the octocrylene organic sunscreen .; When using the drug in large quantities it is possible, in very rare cases, the development of systemic side effects (hypersensitivity, bronchial asthma, disorders of the gastrointestinal tract, worsening of the course of renal failure) .; The risk of systemic side effects increases depending on the amount of gel applied, the area of the treated skin area, the condition of the skin, the duration of treatment .; Avoid exposure of the sun or UV rays, including tanning beds, to the treated areas during the treatment period and for two weeks after the treatment .; The influence of the drug on the ability to drive vehicles and control mechanisms; The drug Fastum does not affect the ability to drive vehicles and work requiring increased concentration of attention .;