Fastum, gel 2.5%, 50g

Composition

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of 100 g of gel contains: Active ingredient: ketoprofen – 2.50 g. Auxiliary substances: carbomer,96% ethanol, neroli flavor, lavender flavor, trollamine (triethanolamine), purified water.

Pharmacological action

Pharmacotherapy group: nonsteroidal anti-inflammatory drugs (NSAIDs) for topical use

ATX code: M 02 AA 10 Pharmacological properties

Pharmacodynamics mechanism of action of the drug is associated with inhibition of prostaglandin synthesis. Ketoprofen has analgesic and anti-inflammatory effects. Ketoprofen, penetrating through the skin, reaches the focus of inflammation, making it possible to locally treat lesions (joints, tendons, ligaments and muscles) accompanied by pain.

Pharmacokinetics When applied topically, ketoprofen penetrates the inflammatory site through the skin, absorption of ketoprofen from the inflammatory site is extremely slow (bioavailability of the gel is about 5%). After applying ketoprofen at a dose of 50-150 mg, the concentration in blood plasma after 5-8 hours is 0.08-0.15 mcg / ml. Practically does not accumulate in the body. The elimination half-life is 1-3 hours. Binding to plasma proteins is 60-90%. It is mainly excreted via the kidneys in the form of glucuronide; approximately 90% of the administered dose is eliminated within 24 hours.

Indications

-pain of traumatic origin (injuries, bruises, sprains of ligaments and muscles); – tension and stiffness of the neck muscles; – lumbago (pain in the lumbosacral spine);- muscular and osteoarticular pain of rheumatic origin.

Use during pregnancy and lactation

In the first and second trimester of pregnancy, the study in mice and rats did not reveal any teratogenic or embryotoxic effects of the drug. In a rabbit study, there was a small embryotoxic effect, probably related to maternal toxicity. Since no safety studies have been conducted on the use of ketoprofen in pregnant women, its use in the first and second trimester of pregnancy should be avoided.

In the third trimester of pregnancy, all prostaglandin synthesis inhibitors, including ketoprofen, cause toxic damage to the fetal cardiopulmonary system and kidneys. At the end of pregnancy, both the mother and the child may have a longer bleeding time. In this regard, ketoprofen is contraindicated in the third trimester of pregnancy.

Breast-feeding There are no data on the penetration of ketoprofen into the mother’s milk. Ketoprofen is not recommended for use in nursing mothers.

Contraindications

-hypersensitivity to ketoprofen or other components of the drug, thiaprofenic acid, fenofibrate, acetylsalicylic acid or other NSAIDs (indications in the anamnesis of asthma symptoms, urticaria or rhinitis caused by taking the drugs);- a history of hypersensitivity of the skin to solar radiation (photosensitization) ;- a history of skin allergies to ketoprofen, thiaprofenic acid, fenofibrate, sunscreens or perfumes; – sun exposure to the treated areas, including indirect sunlight and tanning beds during the course of the drug and 2 weeks after application, pathological skin changes such as acne, eczema, infected abrasions, wounds (at the site of gel application);- children under 12 years of age (efficacy and safety have not been studied);- third trimester of pregnancy.

With caution-impaired liver and kidney function; – heart failure;- elderly age (elderly patients are more susceptible to adverse reactions when using nonsteroidal anti-inflammatory drugs).

Side effects

Possible side effects of Fastum® are listed by descending frequency of occurrence: very common (≥ 10%), often (≥ 1%, <10%), infrequently (≥ 0,1%, <1%), rarely (≥ 0,01%, <0,1%), very rare (

From the skin Often: erythema, pruritus, eczema, burning sensation; Rarely: photosensitization, bullous dermatitis, urticaria; Very rarely: contact dermatitis, angioedema.

From the gastrointestinal tract Very rarely: peptic ulcer, gastrointestinal bleeding, diarrhea.

From the immune system Very rarely: anaphylactic reactions, hypersensitivity reactions.

From the urinary system Very rarely: renal failure or aggravation of existing renal insufficiency.

Interaction

With external use of ketoprofen in the form of a gel, it is possible to increase the effect of drugs that cause photosensitization. No other interactions have been established. However, regular monitoring of the international normalized ratio (INR) is recommended for patients taking coumarin-type anticoagulants.

How to take, course of use and dosage

For external use. A strip of gel 5-10 cm long is applied in a thin layer to the affected area or skin over the focus of inflammation 1-3 times a day and lightly rubbed. Fastum® may be used in combination with physical therapy (phonophoresis and iontophoresis).

Overdose

Extremely low systemic absorption of the Active ingredient of the drug with external use makes overdose unlikely. If large amounts of the drug are accidentally ingested, systemic side effects may occur. Treatment should be symptomatic, as with an overdose of NSAIDs for oral use.

Description

colorless, almost transparent gel with a viscous consistency, with a characteristic smell.

Special instructions

Do not apply the gel on damaged (including open wounds) and inflamed skin!Avoid contact with mucous membranes and eyes (risk of conjunctival irritation). It is recommended to wash your hands thoroughly after each application of the drug. Do not apply in the form of hermetic dressings. Do not exceed the recommended duration of treatment, as the risk of contact dermatitis and photosensitization reactions increases with increasing application time. To avoid any signs of hypersensitivity or photosensitivity, avoid direct sunlight (including tanning beds) during the treatment period and within two weeks after applying the drug, it is recommended to cover the treated areas with clothing. Patients with renal, cardiac or hepatic insufficiency should exercise caution when using Fastum®; isolated cases of systemic side effects associated with kidney damage have been reported. You should stop using the drug in case of any skin reaction, including reactions when applying sunscreens or other cosmetics containing the organic sunscreen filter octocrylene to the skin at the same time. When the drug is used externally in large quantities, it is possible to develop systemic side effects (hypersensitivity, bronchial asthma, disorders of the gastrointestinal tract and kidneys). Local skin reactions have been reported that may subsequently extend beyond the application site. Rare events include cases of more pronounced reactions, such as bullous or flictenular eczema, which can spread and become generalized. The risk of systemic side effects increases depending on the amount of gel applied, the area of the treated area of the skin, the condition of the skin, and the duration of treatment (therefore, do not exceed the maximum recommended duration of treatment). Avoid exposure to sunlight or UV rays on the treated areas during the treatment period and for two weeks after treatment. Patients with asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyps have a higher risk of developing allergic reactions to aspirin and / or NSAIDs than other people.

Influence on the ability to drive vehicles and mechanisms Fastum® does not affect the ability to drive vehicles and mechanisms.

Form of production

Gel for external use,2.5%.30 g,50 g or 100 g of the drug in tubes made of soft aluminum, coated on the inside with an epoxy-phenolic varnish, with a screw-on punch cap (polyethylene/polypropylene).1 tube with instructions for use of the drug in a cardboard box.

Storage conditions

Store at a temperature not exceeding 30 °C. Keep the medicine out of the reach of children!

Shelf

life is 5 years. Do not use after the expiration date indicated on the package!

Active ingredient

Ketoprofen

Dosage form

gel for external use

Purpose

Children over 12 years old, For adults

Indications

Sciatica, Osteochondrosis, Myositis, Osteoarthritis, Bruises, Swelling after injuries and operations, Dislocations and sprains, Lumbago, Osteoarthritis and arthritis, Rheumatoid arthritis, Sciatica