The instruction for medical use
of APTOKCAH medicine
A trade name
Mezhdunarodnoye the unlicensed
name Tenoksikam Lekarstvennaya a form
the Lyophilized powder for preparation of solution for injections of 20 mg complete with
the Structure One Bottle solvent contains
active agent to tenoksika of 20 mg,
excipients: Mannitolum, dinatrium edetat, ascorbic acid, trometamin, sodium hydroxide, acid chlorohydrogen.
Solvent – water for injections of 2 ml.
the Lyophilized powder of greenish-yellow color.
Non-steroidal anti-inflammatory drugs. Oksikama.
The code of automatic telephone exchange M01AC02
Pharmacokinetics Communicates properties with proteins of plasma for 99%. Volume of distribution (Vd) of 0.15 l/kg. It is hydroxylated in a liver.
Easily passes through gistogematichesky barriers. Elimination half-life (T1/2) – 60-75 h. The main part is removed in the form of inactive metabolites with urine, other with bile.
It is characterized by high bioavailability of 100%.
Artoksan’s pharmacodynamics is effective non-steroidal anti-inflammatory drug (NPVP) with powerful anti-inflammatory, analgiziruyushchy and less significant febrifugal action. Properties of drug are caused by inhibition of both isoforms of enzyme of cyclooxygenase that leads to disturbance of metabolism of arachidonic acid and blockade of synthesis of prostaglandins.
The anti-inflammatory effect is caused by reduction of permeability of capillaries (limits exudation), stabilization of lizosomalny membranes (interferes with an exit of enzymes of the lysosomes causing damage of fabrics), oppression of synthesis or an inactivation of mediators of inflammation (prostaglandins, a histamine, bradykinin, lymphokines, complement factors). Reduces the number of free radicals in the inflammation center, the chemotaxis and phagocytosis oppresses.
Drug reduces painful sensitivity in the center of inflammation and affects the thalamic centers of pain, possesses the desensibilizing action (at prolonged use). In rheumatic diseases weakens a joint pain at rest and at the movement, reduces morning constraint and a swelling of joints, improves functions and increases the volume of movements of joints.
– a pseudorheumatism, the gouty arthritis ankylosing a spondylitis
– an osteoarthrosis, osteochondrosis
– tendinites, a bursitis, miozita, a periarthritis
– arthralgias, neuralgia, myalgias, a lumbago
– injuries, burns
the Route of administration and doses
Is intended for intramuscular or intravenous administration a dose makes 20 mg of 1 times/days. Maintenance dose: 10 mg a day.
At the expressed pain syndrome it is possible to increase a dose to 40 mg of 1 times a day.
At bad attacks of gouty arthritis: 20 mg 2 times a day during the first 2-3 days, then 20 mg of 1 times a day within 5 days.
– nausea, pains and unpleasant feelings in a stomach, a meteorism, diarrhea
– dizziness, a headache, insomnia, a depression, hyperexcitability
– allergic reactions in the form of an itching, a small tortoiseshell, an erythema, Stephens of Johnson and Layell’s syndrome
– increase in concentration in plasma of creatinine, urea, increase in activity of hepatic transaminases
– hypostasis and irritation of eyes
of the Contraindication
– hypersensitivity to a tenoksikam and other NPVP
– erozivno cankers zheludochno of an intestinal path
– zheludochno intestinal bleedings
– a serious illness of kidneys
– the planned anesthesia and surgeries
– the period of pregnancy and feeding by a breast
– the children’s and teenage age up to 18 years
of Artoksan increases expressiveness of effects of indirect anticoagulants. Interaction at simultaneous use with Cimetidinum, gipoglikemiziruyushchy means is not revealed, however implementation of the current control of effect of oral gipoglikemiziruyushchy drugs, especially in an initiation of treatment Artoksan is recommended. Simultaneous use of a probenitsid increases the speed of elimination of Artoksan.
At use with diuretics it is necessary to consider a possibility of a delay of sodium and water in an organism.
in the course of long-term treatment by Artoksan the control of function of a liver and kidneys is necessary.
Increase in a bleeding time is possible that should be considered at surgeries.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Should be careful at control of transport or potentially dangerous mechanisms.
Symptoms – strengthening of manifestations of the described side effects.
Treatment – symptomatic
the Form of release and packing
the Amounts of lyophilisate, equivalent 20 mg of a tenoksikam in colourless transparent glass bottles closed by rubber bungs, corked by an aluminum ring with the color latched cover.
On each bottle paste the self-adhesive label.
On 2 ml of solvent in ampoules of neutral glass.
On each ampoule paste the self-adhesive label or put marking with the fast-fixed paint for glass products.
3 bottles with the lyophilized powder and 3 ampoules with solvent put in blister strip packaging.
On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages put in a cardboard box.
To Store storage conditions at a temperature from 15 to 25 Pages.
To store out of children’s reach!
not to apply a period of storage after an expiration date.
According to the prescription
Producer E.I.P.I. To., Egypt
Tens ov City Ramadan,
the First B1 Industrial Zone, p.o. box 149 Tens
(E.I.P.I.CO. Egypt, Tenth of Ramadan City, First Industrial Area B1, P.O. box: 149 Tenth)
are made for Rotapharm, Great Britain
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of RK, Almaty, Suyunbaya 222 St. of B
Ph. / fax: 8 (7272) 529090