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medicalmeds.eu Medicines Non-steroidal anti-inflammatory drugs (NPVS) for topical administration. Fastomed

Fastomed

Препарат Фастомед. ООО «Фармтехнология» Республика Беларусь



General characteristics. Structure:

Active ingredient: 0,05 g of ketoprofen in 1 g of cream.

Excipients: propylene glycol, paraffin soft white, cetostearyl alcohol, a makrogolglitserin hydroxystearate, a macrogoal cetostearyl ether, a macrogoal 400, alcohol, a dimethyl sulfoxide, stearic acid, diethanol amide, methylparahydroxybenzoate, пропилпарагидроксибензоат, citric acid monohydrate, the water purified.

The non-steroidal anti-inflammatory drug for topical administration having antiinflammatory and analgetic effect.




Pharmacological properties:

Pharmacodynamics. Non-steroidal anti-inflammatory drug for topical administration, derivative propionic acid. Has antiinflammatory and analgetic effect. 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 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. At topical administration ketoprofen is soaked up extremely slowly and practically does not accumulate in an organism. Bioavailability makes about 5% that allows to reach local effect without impact on other bodies

Ketoprofen well gets into hypodermic cellulose, sheaves and muscles, synovial fluid and reaches therapeutic concentration there. Concentration of drug in plasma extremely low.


Indications to use:

- a symptomatic treatment of inflammatory, inflammatory and degenerative and traumatic defeats of a musculoskeletal system (the pseudorheumatism and a periarthritis ankylosing a spondylitis (Bekhterev's disease), psoriasis arthritis, reactive arthritis (a syndrome of Reuters), an arthrosynovitis, a tendinitis tendosinovit, a bursitis, a lumbago, a mialgiya, neuralgia, radiculitis, bruises of muscles and sheaves, sprains, ruptures of sheaves and sinews of muscles, dislocations, injuries of a meniscus of a knee joint, a wryneck);
-  as a part of a combination therapy of inflammatory diseases of veins, absorbent vessels, lymph nodes (phlebitis, a periphlebitis, a lymphangitis).


Route of administration and doses:

A small amount of cream (3-5 cm) is applied on the struck surface by 2-3 times a day, then is long and carefully rub to the inflamed and painful sites before full penetration of medicine into thickness of skin.

Duration of a course of treatment should not exceed 14 days.


Features of use:

Medicine is not recommended to be applied on open wound surfaces.

It is necessary to avoid hit of cream on mucous membranes. To carefully wash hands after putting cream of ketoprofen.

Not to subject the field of putting ketoprofen to impact of a sunlight (including in cloudy weather), and also radiation UF throughout the entire period of treatment and two weeks after medicine phase-out.

To provide protection of a zone of putting ketoprofen with clothes from impact of a sunlight.

Not to apply cream under occlusive bandages. To immediately stop putting ketoprofen at emergence of the first signs of skin reaction.

If you forgot to apply cream, to apply it when the following dose has to be put, but do not double it.

Do not mix Fastomed, cream with other components or medicines.

Ketoprofen does not influence ability to manage vehicles and to work with potentially dangerous mechanisms.

Pregnancy and period of a lactation. Safety of use of ketoprofen during pregnancy and feeding by a breast is not established. Ketoprofen can be applied in I and II trimesters of pregnancy only if the expected therapeutic effect for future mother exceeds potential risk for a fruit. NPVP is not recommended to appoint at pregnancy more than 36 weeks. At treatment by Fastomed it is necessary to refuse feeding by a breast.


Side effects:

Local side reactions: in 3% of cases - an erythema, an itch, slight tranzitorny dermatitis, it is rare – a photosensitization.

Cases of heavy contact dermatitis owing to bad hygiene and solar influence, also cases of heavy generalized dermatitis are described.


Interaction with other medicines:

As concentration of ketoprofen 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 of Fastomed.

Simultaneous use of other dosage forms of topical administration (ointments, gels) containing ketoprofen or other NPVS is not recommended.

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

Ketoprofen reduces removal of a methotrexate and promotes increase in its toxicity.

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

At Fastomed's appointment medical control is recommended to the patients receiving coumarins.


Contraindications:

- the becoming wet dermatosis, eczema;
- the infected grazes and wounds;
- hypersensitivity to ketoprofen and components of a ready dosage form, to salicylates and other NPVS;
- heavy abnormal liver functions and kidneys; at skin diseases (a dermatosis, eczema, infections, etc.)
- reactions of a photosensitization in the anamnesis;
- children's age up to 15 years.


Overdose:

Symptoms: irritation, erythema, itch.

Treatment: it is necessary to cancel drug and to see a doctor. Carry out symptomatic therapy.


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



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