Fastomed

General characteristics. Structure:

Active ingredient: 25 mg of ketoprofen in 1 g of gel.

Excipients: a macrogoal 400, alcohol of 96%, propylene glycol, carbomer, diethanol amide, lavender oil, the water purified.

The non-steroidal anti-inflammatory drug for external use having antiinflammatory and analgeziruyushchy effect.

Pharmacological properties:

Pharmacodynamics. Non-steroidal anti-inflammatory drug for external use, derivative propionic acid. The mechanism of action is connected with oppression of activity of cyclooxygenase – the main enzyme of metabolism of arachidonic acid, being the predecessor of prostaglandins which play a major role in a pathogeny of an inflammation and pain.

The expressed analgeziruyushchy effect of ketoprofen is caused by two mechanisms: peripheral (indirectly, through suppression of synthesis of prostaglandins) and central (the caused inhibition of synthesis of prostaglandins in the central and peripheral nervous system, and also action on biological activity of other neurotropic substances playing a key role in release of mediators of pain in a spinal cord). Besides, ketoprofen has antibradikininovy activity, stabilizes lizosomalny membranes, causes considerable braking of activity of neutrophils in patients with a pseudorheumatism. Suppresses aggregation of thrombocytes.

Pharmacokinetics. Plasma and fabric levels of ketoprofen were studied at 24 patients after surgical intervention on a knee joint.

After repeated cutaneous use of gel of ketoprofen, its plasma level was 60 times less (9-39 ¡ú/g), than that after single oral dose of ketoprofen (490-3300 ¡ú/g).

Fabric ketoprofen level, in the field of application after gel use, was in the same range of concentration, as well as at oral administration, though some variability connected with specific features of an organism was observed.

At external use bioavailability of active agent makes about 5% of the level observed after use inside that is established according to excretion with urine. Linkng with proteins of plasma makes about 99%. Ketoprofen is removed by kidneys, mainly in the form of glucuronides.

Indications to use:

- the acute painful manifestations arising at uncomplicated injuries, including sports; at stretchings or ruptures of sheaves and sinews, muscles; tendinites; bruises of muscles and sheaves;
- posttraumatic pains and hypostases without symptoms of serious arthritis.

Route of administration and doses:

Medicine is intended for use on skin.

Adults: medicine is applied on the struck surface by 2-4 times a day, distribute a uniform thin layer, then is long and carefully rub to the inflamed and painful sites before full absorption. Duration of treatment is up to 7 days. The recommended dose of 15 g a day (7,5 g correspond to 14 cm of gel).

Children: it is not recommended since safety and efficiency of use of medicine at children is not established.

People of advanced age: dose adjustment and duration of treatment is not required.

Features of use:

It is necessary to wash carefully hands after each putting medicine. At emergence of skin reactions, including, developed at combined use with the oktokrilen-containing medicines, it is necessary to stop treatment immediately.

For reduction of risk of development of photosensitivity it is recommended to protect the leather processed by gel sites clothes from impact of ultra-violet radiation (Ural federal district) throughout the entire period of treatment and two more weeks after phase-out.

Not to apply in the form of occlusive bandages.

Medicine should be applied with care at patients with an abnormal liver function and/or kidneys, a digestive tract erosive canker, a blood disease, bronchial asthma, chronic heart failure.

Sites the leather processed by medicine should not be affected by direct sunshine or Ural federal district in a sunbed throughout the entire period of treatment and two more weeks after the treatment termination by medicine.

At emergence of skin rash it is necessary to stop use.

To store medicine far from fire.

Use at pregnancy and feeding by a breast. Contraindicated at pregnancy and breastfeeding.

Influence on ability to drive the car and to work with mechanisms. About influence on ability to manage motor transport and to service mechanisms it was not reported.

Side effects:

— local side reactions – an erythema, an itch, a burning sensation, eczema;
— allergic reactions;
— dermatological reactions: photosensitization, small tortoiseshell;
— seldom: heavier skin reactions, such as violent and pustular eczema which can extend and become generalized.

Interaction with other medicines:

As concentration of medicine in plasma extremely low, manifestations of symptoms of interaction with other medicines (similar to symptoms at system use) are possible only at frequent and prolonged use. Simultaneous use of other topical forms (ointments, gels) containing ketoprofen or other NPVP is not recommended.

Interaction with other medicines and influence on their removal are not significant.

Ketoprofen, as well as other NPVP, can reduce removal of a methotrexate and promote increase in its toxicity.

The concomitant use of acetylsalicylic acid reduces extent of linkng of ketoprofen with proteins of plasma.

To the patients accepting coumarin - the containing anticoagulative medicines, treatment under observation of the doctor is recommended to carry out.

Contraindications:

— reactions of photosensitivity in the anamnesis;
— the known reactions of hypersensitivity, such as asthma symptoms, the allergic rhinitis caused by ketoprofen or other components of medicine, fenofibraty, thiapro-foehn acid, acetylsalicylic acid, other nonsteroid protivovospaliteny medicines (NPVP);
— data in the anamnesis on skin reaction to ketoprofen, thiapro-foehn acid, фенофибрат, blockers of UV rays, fragrances;
— impact of a sunlight, including direct and indirect sunshine, ultra-violet radiation in a sunbed throughout the entire period of treatment and two more weeks after the treatment termination by medicine;
— disturbances of integrity of integuments (eczema, an acne, the becoming wet dermatitis, an open or contaminated wound).

It is necessary to avoid hit of gel in eyes and on other mucous membranes or to use with an occlusive bandage.

Overdose:

About overdose of medicine at topical administration it was not reported.

In case of a proglatyvaniye or hit inside medicine can cause system side reactions. In this case carry out the symptomatic and supporting treatment.

At hit in eyes can cause an itch, irritation, reddening and lachrymation. It is necessary to rinse an eye(s) plentiful amount of cool boiled water.

Storage conditions:

To store at a temperature not above + 25 °C. To store in the place, unavailable to children. Period of validity 2 years.

Issue conditions:

According to the recipe

Packaging:

On 30,0 g, 40,0 g and 50,0 g in the tubas placed together with a leaf insert for the consumer in packs from a cardboard.