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Instruction
on medical application of preparation
TRAMADOL
(pills, capsules)
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Registracistracionnyy number: P-8-242-№ 010255
Point-of-sale name of preparation: Tramadol
International unpatent name: tramadol (tramadol)
Chemical name: : (Rr,ss0-2-(dimetilaminometil)-1-(3-metoksifenil)ciklogeksanola gidrokhlorid
Medicinal forms: pills, capsules |
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Composition:
- Pills
a 1 pill contains 50 mgs of tramadola gidrokhlorida.
Auxiliary matters:
Lactose, microcrystalline cellulose, magnesium stearat, krospovidon, the macropoor 4000, saccharin of sodium, colloid anhydride of silicon, flavour.
Description: white or practically white rounded biconvex pills with a notch on one side and characteristic smell of strawberry.
- Capsules
a 1 capsule contains 50 mgs of tramadola gidrokhlorida.
Auxiliary matters:
Lactose, Calcium of gidrogenfosfat, glikolyat of sodium starch, magnesium stearat, gelatin, dye of E 132, E 171, E 172.
Description: hard gelatinous capsules, lid of green color, corps of yellow. Content of capsules is powder of white or practically white color odourless. |
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Pharmacological properties:
Farmakoterapevticheskaya group: opioidnyy anal'getik with the mixed mechanism of action. N02akh02
Pharmacodynamics:
Behaves to anal'geticheskim facilities of central action. Renders the expressed anaesthetic effect.
Unselective antagonist of opioidnykh myu-, del'ta- and kappa-receptorov in CNS with most affinity to the mus-receptors. Oppresses the reverse neyronal'nyy capture of Noradrenalinum and strengthens freeing of serotonin. Renders an antitussive action also, does not violate motoriku stomach – intestinal highway. Duration of action – about 4-8 hours.
Pharmakokinetics:
Suction: After the reception of tramadol quickly and almost fully sucked in from a stomach – intestinal highway (about 90%). A maximal concentration in plasma of blood is determined approximately in 2 hours. The size of biological availability makes about 70%, does not depend on eating and increased at the nonexpendable of preparation.
Distributing: Binding to the squirrel of plasma makes about 20 %. Tramadol penetrates through gemato-encefallicheskiy and placenta barriers. Approximately 0,1 % selected with pectoral milk.
Metabolism: Metaboliziruetsya by a demethylation and kon'yugacii to 11 metabolitov, only one of which (O-demetiltramadol) possesses the expressed pharmacological activity (in 2-4 times exceeds activity of tramadola).
Leadingout: Tramadol and him metabolity hatch mainly buds (to 90%) and through an intestine (about 10%). The period of poluvyvedeniya, regardless of way of introduction, makes about 6 hours.
For patients in a sear and yellow leaf, with a hepatocirrhosis and at kidney insufficiency the size of period of poluvyvedeniya is increased. |
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Testimonies to application:
Pain syndrome of middle and strong intensity of different etiology (posleoperacionnyy period, traumas, pains for oncologic patients).
With the purpose of anaesthetizing during the leadthrough of sickly diagnostic or medical manipulations. |
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Contra-indications:
Enhanceable sensitiveness to preparation.
States, breathings attended with oppressing or the expressed oppressing of cns (poisoning an alcohol, somnolent preparations, narcotic anal'getikami, psikhotropnymi facilities). Simultaneous application of inhibitirs of MAO (and two weeks after their abolition). Pregnancy and period of lactation (application is possible only on vital testimonies). Age to 14 years.
Pregnancy and period of suckling:
At pregnancy it is necessary to avoid the protracted application of tramadola from the risk of development of privykaniya at a fruit and origin of syndrome of abolition in a neonatal'nom period.
At a necessity a reception it is necessary to take into account in the period of lactation, that tramadol in a negligible quantity selected with pectoral milk. |
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Method of application and dose:
The dose of preparation sneaks up a doctor individually depending on intensity and character of pains.
Adults and teenagers in age a chief 14 years.
Usually initial dose - for to a 1 pill or capsule ( 50 mgs ) inward with the two-bit of liquid regardless of time of eating; in default of effect during 30 - 60 minutes it is possible to accept a 1 pill or capsule; at great pains a single dose can at once make 100 mgs ( 2 pills or capsule ). An effect, depending on the degree of expressed of pains, is saved during 4-8 hours. It is not necessary to exceed the daily dose of tramadola 400 mgs (8 pills or capsules).
Children.
It is not necessary to accept this medicinal form children with mass of body less than 25 kg and in age less than 14 years.
Elderly patients, patients with parafunctions liver and buds.
At a necessity a reception it is necessary to increase an interval between the receptions of preparation.
Duration and chart of application is determined a treating doctor
Capsules it is necessary to swallow not chewing, washing down the necessary amount of liquid, regardless of eating.
Pills it is possible to swallow not chewing, washing down the necessary amount of liquid, regardless of eating, or preliminary to dissolve in 1/2 glass of water. |
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Side actions:
Dizziness, nausea, locks, head pain, somnolence (these side effects meet at 30 - 15% patients, accepting tramadol), vomiting, skin itch, symptoms of psikhostimuliruyuschego action, asthenia, potlivost', dyspepsia, is most characteristic, dryness in to the mouth, diarrhoea ( meet at 15 - 5% patients ).
With frequency less than 5% the loss of weight, hypotension and takhikardiya, paresthesias, hallucinations, tremor, pains in area of stomach, paropsiss, delay of urination, is possible.
Frequency of development of side effects rises with the increase of duration of reception of preparation. At the protracted application possibility of development of medicinal dependence is not eliminated in large doses.
About all of side effects, including not indicated higher, it is necessary to reveal to the treating doctor. |
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Overdose (intoxication) by preparation:
The most hazard effects of overdose of tramadolom are narrowing of pupils, vomiting, oppressing of breathing and cramp. At suspicion on poisoning it is necessary immediately to appeal for a medical help.
The first aid at poisoning is maintenance of adequate pulmonary ventilation and symptomatic therapy in the conditions of the specialized separation. Washing of stomach suffices in easy cases. Application of Naloxonum does not have a decision value, as does not allow to remove all of symptoms of poisoning and can cause cramps. Gemodializ is little effective. At cramps intravenous introduction of Diazepamum is expedient. |
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Special pointing:
With megascopic time domains tramadol apply at patients of superannuated. With a carefulness and under the supervision of doctor it is necessary to utillize preparation patients with the broken function of buds and liver, at craniocerebral traumas, enhanceable intracraneal pressure, to the patients by epilepsy, and also to the persons with medicinal dependence to opioidam.
Under a careful medical supervision and in the diminished doses it is necessary to apply tramadol on a background the action of facilities for anesthesia, somnolent and psikhotropnykh facilities. It is not necessary to combine preparation with narcotic anal'getikami from bad predictableness of effect of co-operation.
On a background the protracted application the karbamazepina effect of tramadola can be weaker. It is not recommended to use an alcohol at treatment of tramadolom.
At application of tramadola it is not necessary to lead a car or execute other work, requiring enhanceable attention. |
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Co-operating with other facilities:
At simultaneous application of tramadola with preparations, rendering oppressive influence on a cns, and also with an ethanol, strengthening of their action is possible.
At simultaneous application of trmadola with karbamazepinom and other inductors of metabolic enzymes weakening of anal'geziruyuschego action of tramadola is possible.
At the systematic reception of barbituratov, especially phenobarbital, there is probability of diminishing of anaesthetic action of opioidnykh anal'getikov. The protracted application of opioidnykh anal'getikov or barbituratov is stimulated by development of cross tolerance.
Naloxonum is activated by breathing, removing anal'geziyu after application of opioidnykh anal'getikov. |
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Forms of issue:
For 10 pills or capsules, containing for 50 mgs of tramadola g/kh, in blisterakh from Pvkh/alyuminievoy of foil. For 1, 2, 3 or 5 blisterov together with instruction on application in the cardboard packing. |
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Shelf-life:
Shelf-life makes 5 years.
It is not necessary to utillize medication after expiration of the shelf-life indicated on packing. |
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Terms of storage:
To keep at a temperature not higher 25oh With in an inaccessible for children place. |
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Terms of vacation from pharmacies:
TRAMADOL (Tramadolum)
(#)-транс-2-[(Dimetilamino) marked] 1-(m-metoksifenil) ciklogeksanola of gidrokhlorida.
Possesses strong analgeziruyuschey activity, gives a rapid and protracted effect. Yields, however, on activity to Morphinum at identical doses (used accordingly in large doses).
Behaves to the group of agonists-antagonists. Effective at introduction inward and parenterally.
At intravenous introduction renders an analgeziruyuschee action through 5 - 10 mines, at introduction inward - through 30 - 40 mins Operates during 3 - 5 ch.
Apply at great sharp and chronic pains: in a posleoperacionnom period, at traumas, for oncologic patients and other, and also before operations. At easy pains, applying preparation is not recommended.
To the adults and children more senior 14 years enter intravenously (slowly tiny) for 50 - 100 mgs (1 - 2 ampoules), to 400 mg (0,4 g) in days. In the same dose the intramuscular enter or hypodermic. Inward appoint (with the two-bit of liquid) in capsules for 50 mgs - to 8 capsules (0,4 g) in days or as drops - for 20 drops (contain 50 mgs of tramadola) on a reception in the two-bit of water to 8 times per days.
It is possible to appoint tramadol as rektal'nykh candles, containing for 0,1 g (100 mgs), for to a 1 candle to 4 times per days.
To the children under age 14 years preparation is not appointed because of insufficient studied (preparation relatively is recently entered in medical practice). It is not necessary to apply preparation protractedly (in order to avoid privykaniya).
Tramadol relatively carried well, does not cause in ordinary doses the expressed oppressing of breathing and substantially does not influence on circulation of blood and gastroenteric highway. Maybe, however, to turn a stomach, vomiting, dizziness, potlivost'; an enhanceable arteriotony can a few to go down.
It is impossible to appoint tramadol during sharp alcoholic intoxication; to the patients with an enhanceable sensitiveness to narcotic analgetikam; to the patients, to accepting the inhibitirs of MAO. Setting must pregnant be made with the special carefulness.
Forms of issue: capsules with maintenance of 0,05 g (50 mgs) of preparation for 10 and 20 things are in packing; drops (with maintenance in 1 ml 100 mgs of preparation) in small bottles for 10 things in packing; ampoules by the capacity of 1 ml with maintenance 50 mgs (0,05 g) in 1 ml and by a capacity 2 ml with maintenance 50 mgs in 1 ml (in all in an ampoule 100 mgs) for 5 and 50 things in packing; rektal'nye candles with maintenance 100 mgs (0,1 g) in packing for 5 things.
Storage: with an observance governed for narcotic analgetikov.
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