Трокситацин®

General characteristics. Structure:

Active ingredient: 1,2 g of indometacin, 0,8 g of a trokserutin.

Excipients: propylene glycol, macrogoal 400, карбопол 980, Natrium benzoicum E 211, alcohol of ethyl 96%.

Pharmacological properties:

Pharmacodynamics. HP of Troksitatsin® – the combined medicine which part are indometacin and троксерутин.

Indometacin shows the expressed antiinflammatory, analgetic and antiedematous action. It leads to reduction of pain, hypostasis and decrease in duration of dysfunction of joints and fabrics. Indometacin has more accurately expressed antiinflammatory action in comparison with salicylates and phenylbutazone.

Trokserutin reduces permeability of capillaries and shows venotoniziruyushchy action. Affects protivovospalitelno the fabrics surrounding veins reduces fragility of capillaries and shows a certain antiagregantny action. Reduces hypostasis, improves a trophicity at pathological changes which are connected with venous insufficiency. When drawing on skin of HP of Troksitatsin®, gel oppresses reactions of an inflammation and hypostasis, eliminates pain and temperature in places of an inflammation (outside and in deep fabrics, reaching the blood vessels placed there). Shows venotoniziruyushchy, kapillyaroprotektivny and haemo static action.

Pharmacokinetics. The used gel basis of drug is picked up so that to provide full solubility of active ingredients and their maximum release. The dosage form in the form of gel which part were indometacin and троксерутин provides good absorption from the surface of skin and therapeutic action at the different levels, forming necessary concentration in nearby fabrics and synovial fluid. Indometacin contacts proteins of plasma more than for 90% and is exposed to intensive biotransformation in a liver.

Indometacin is removed with urine (60%), bile and a stake (30%). Gets into breast milk, considering it, use of drug is not recommended during feeding by a breast. The most part rezorbirovany three - di - and monohydroxyethylrutosides is removed with bile, considerably smaller part – kidneys. Tetragidroksietilrutozid is brought preferential with urine.

Indications to use:

Symptomatic treatment:

· chronic venous insufficiency (swelled, feeling of weight and an onychalgia);

· superficial thrombophlebitis, phlebitis; posleflebitny states;

· in complex therapy of a hemorrhoidal disease;

· rheumatism of soft tissues: tendovaginitis, bursitis, fibrositis, periarthritis;

· at hypostases after surgical interventions, contusions, dislocations, stretchings.

Route of administration and doses:

Drug is intended for external use.

4–5 cm of gel apply 3–4 times a day with a thin layer on an affected area the easy massage movements. The total daily quantity should not exceed 20 cm. Treatment duration – no more than 10 days.

After application of drug it is necessary to wash up hands (except those cases when application is carried out on area of hands).

Children. It is not recommended to apply at children is younger than 14-year age as safety and efficiency of HP is not proved.

If you had impressions that HP of Troksitatsin®, gel works too poorly or too strongly, consult with the attending physician or the druggist.

Features of use:

It is not recommended to apply to children 14 years as there is no rather accumulated clinical experience are younger.

Medicine use is not recommended to persons with data in the anamnesis or the proved hypersensitivity to the substances which are a part of medicine, to patients with bronchial asthma, allergic rhinitis and other atopic reactions.

Long use of drug, especially on extensive sites of skin it is necessary to limit at patients with a serious illness of a liver and kidneys, and in the presence of a peptic ulcer.

In case of gel use more than 10 days laboratory control of level of leukocytes and thrombocytes is necessary.

Gel should be applied only on the unimpaired sites of skin, to avoid hit in eyes or on mucous membranes.

Use during pregnancy and feeding by a breast. Due to the lack of these controlled clinical tests to pregnant women and the nursing women of HP of Troksitatsin®, it is not necessary to apply gel. Its use is possible only after assessment by the doctor of a ratio advantage/risk.

Influence on ability of control of vehicles and works with the equipment. The HP of Troksitatsin®, gel does not exert impact on ability to drive the car and to work with the equipment.

Information on excipients. The HP of Troksitatsin®, gel contains Natrium benzoicum and propylene glycol as excipients which can render irritant action on skin.

Side effects:

Portability of drug usually good. Local reactions: emergence of symptoms of hypersensitivity from skin is possible – contact dermatitis, an itch, reddening, rash, feeling of heat and burning in a site of application.

System reactions: very seldom, at long use on extensive body parts, emergence of side effects is possible:

· Gastrointestinal disturbances – nausea, vomiting, stomach aches, increase in level of enzymes of a liver;

· Immune disturbances – supersensitivity symptoms (an anaphylaxis, an asthmatic attack, an angioedem).

Interaction with other medicines:

Simultaneous use with other nonsteroid antiinflammatory medicines and corticosteroid means, in view of a possibility of a potentsiirovaniye of their ulcerogenic action is not recommended.

Contraindications:

· Hypersensitivity to acting or to any excipient which is a part of the medicine (M).

· The HP of Troksitatsin®, gel should not be applied on open wounds, mucous membranes, an oral cavity, a conjunctiva of eyes.

· Medicine is not recommended to be applied in cases of manifestations of supersensitivity to any non-steroidal anti-inflammatory drugs (NPVS), for example, to acetylsalicylic acid.

· Pregnancy.

· Feeding by a breast.

· Children's age up to 14 years.

Overdose:

There are no data on overdose cases at drug use.

At long use (more than 10 days) observation of the patient since development of signs of a hepatotoxic and hemorrhages is possible is recommended laboratory control of level of leukocytes and thrombocytes is necessary.

As required intake the burning sensation in a mouth, a slyunovydeleniye, nausea, vomiting is possible. Measures which it is necessary to accept in that case – washing of an oral cavity and a stomach, if necessary – a symptomatic treatment.

At hit in eyes, on mucous membranes or open wound surfaces the local irritation – lachrymation, reddening, burning, pain is observed.

Necessary measures – washing of an affected area plentiful amount of the distilled water or normal saline solution before disappearance or reduction of complaints.

Storage conditions:

At a temperature not over 25 ºС. To store in the place, unavailable to children. A period of validity - 2 years. Not to use medicine after the termination of a period of validity.

Issue conditions:

Without recipe

Packaging:

On 40 g in tubas aluminum from bushona. Each tuba together with a leaf insert is located in a pack from a cardboard.