Active matter: Tramadol hydrochloride 150 mg

Auxiliary matters: starch potato (50/100mg), lactose monohydrate (milk sugar), magnesium stearate (2.5/5 mg).

Tablets, 50mg

By 10 pills in contour cellular pack from polyvinylchloride film and aluminic foil. By 1, 2, 3 or 5 contour cellular packs are placed in the pack from cardboard.

Tablets, 100mg

By 10 pills in contour cellular pack or 20 pills in jar of dimming glass. Every jar or 2 contour cellular packs are placed into the pack from cardboard.

Solution for injections, 50mg/ml

The ampules by 1 or 2 ml. By 5 ampules in contour cellular pack. 1 or 2 contour cellular packs are placed into the pack from cardboard. There are ampule knife or ampule scarifier in the pack (under usage of ampules with ring of fracture or cut and point the ampule knife or ampule scarifier isn’t applied).

Opioid analgetics. Code АТС N02A X02.

Pharmacological:

Tramadol is the powerful analgetic with central actions. The analgesic action is realized by two ways such as by the way of connecting with opioid receptors and thanks to this activity it is diminished the pain sensation and also by the way of noradrenalin’s reversible capture oppression and stimulation of the descending noradrenergic effects owing to it is decelerated the transmission of the painful impulses in the spinal cord. The analgetic effect is a result of the synergistic activity of both mechanisms of action. Tramadol doesn’t call any breathing suppression and damages of cardiovascular activity. The action begins quickly and it is prolonged during some hours.

Pharmacokinetics:

absorption

Tramadol is quickly and practically fully adsorbed from the gastrointestinal tract after its applying. The therapeutic concentration is reached over 2 hours and it reaches the maximum over 4 hours. The therapeutical effect is prolonged during 12 hours.

distribution

Connecting with proteins of blood plasma is 20%. Tramadol penetrates into placenta and its concentration in umbilical blood is 80% from concentration in mother’s blood.

metabolism

90% of Tramadol and its metabolites are taken away with kidneys and other parts are taken out with feces. The period of semiejection is 5-6 hours and it is similar for Tramadol and its metabolites.

Patients with renal insufficiency

Under some damages of kidneys’ function (including renal insufficiency) the speed and degree of excretion are decreased that’s why it is recommended the dosages lowering or increasing of interval between applications for patients with clearance of Creatinine less than 30 ml / min.

Aged patients

The maximal concentration of this preparation in blood by patient elder than 75 years is some increased and the period of semiejection is prolonged that’s why it is necessary to change the main dose a few.

Powerful and moderate pain of different origin (for example, pain owing to trauma (wounding, fracture), powerful neuralgia, pain owing to presence of the neoplasm, myocardial infarction, pain after the diagnostic and therapeutical procedures).

The main contraindication for Tramadol applying is hypersensibility to the main active component or other substances consisted into the structure of this medication. This medicine isn’t recommended to prescribe for children till one year. This drug isn’t also applied under the acutest intoxication by the inhibitors of the central nervous system (alcohol, antidepressants, neuroleptics, sedative agents, anxiolytics and hypnotic drugs) or under the treatment by the inhibitors of MAO.

It isn’t recommended to apply Tramadol medication together with MAO inhibitors. Under the synchronous application of Tramadol drug together with medications operated on the patient’s central nervous system (anesthetic drugs, antidepressants, neuroleptics, sedative agents, anxiolytics, hypnotic drugs) or together with alcohol drinks it is possibly the synergic action which is manifested in some increasing of sedative effect or some strengthening of analgetic effect. Under the synchronous application of Tramadol medicine together with Carbamazepine it is increased the metabolism of Tramadol that needs the preparation’s dosage increasing. The synchronous application of Tramadol and specific inhibitors of serotonin’s reversible capture, tricyclic antidepressants and neuroleptics may enlarge the risk of convulsions appearance.

Tramadol may be applied for treatment of the patients with heightened apprehensibility to different opioids but with prudence. It isn’t recommended to use this medical preparation for sick individuals who are inclined to abuse of alcohol, different medical agents and narcotic dugs.

During the medical curing and also during some times after the treatment by Tramadol preparation it is recommended the careful observation for sick persons with cerebral convulsions.

Tramadol drug isn’t taken in view of substitutive therapy under the opioid dependence.

Under the prolonged applying of Tramadol medication it is impossibly to exclude fully the possibility of officinal dependence development.

It is recommended at least in the beginning of treatment to increase the interval between Tramadol application for patients with renal insufficiency (the clearance of Creatinine less than 30 ml / min).

It is recommended to bring down or enlarge the interval between Tramadol application for ill persons with hepatic insufficiency over the lowered hepatic clearance, increased concentration in blood serum and enlarged period of partial ejection.

Tramadol may be applied by sick individuals with heightened intracranial pressure (for example, under the craniocerebral injuries) or with heaviest sicknesses of lungs but with some prudence and under the physician’s controlling.

In 1 ml of Tramadol solution (40 drops) is contained the sucrose in dosages as 200 mg. Under the applying of Tramadol medication according to the official instruction by every dose it is gotten into the organism of patient from 100 till 200 mg of sucrose. That’s why it isn’t followed to prescribe this official form of this medical preparation for sick individuals with intolerance of fructose, under the syndrome of disturbed absorption of glucose / galactose or deficit of sucrose-isomaltose.

The heightened dosages of glycerine may call the powerful headaches (migraine) and disorders of the gastrointestinal tract.

It can be worsened the symptomatology of painful syndromes and / or capability to some perception and formation of their development and increasing independently from applying of different pain0killers by sick persons with different painful syndromes. The risk of this fact stays during all time till remission beginning. As far as some improvement of condition cannot begin during the first weeks (or more) of the medical curing the patient must by under the observation with a goal of the reasons exposure of condition’s clinical worsening (including the appearance of the new symptoms) or painful syndromes development especially in the beginning if the treating course or under the dosages exchanging as increasing as diminishing ones. Taking into account the general clinical test it is considered that under all pain killers (opioid analgesics) using there is some risk of painful syndromes developing increased on the early stages of recovery.

The sick persons with different painful syndromes or oncological sicknesses in anamnesis and the young patients manifest in larger degree the capability to the formation and perception of pain increasing till the medical cure beginning. They are the group of big risk for painful syndromes and pain attempts that’s why they must be under the careful controlling during the treatment.

The patients must be anticipated about the necessity of the careful control for every worsening of their condition (including the new symptoms appearance) and / or appearance of new painful syndromes. In cases of such symptoms appearance it is followed to appeal for the medical helping immediately. It is followed to take into account that appearance of neuropsychic symptoms can be tied together such with main sickness as with preparation applying.

The sick persons with worsening of condition (including the development of new symptoms) and / or appearance of painful syndromes (especially if these symptoms have the heavy form) arise suddenly or not the part of the present symptoms needed in the substitute pf treatment’s therapeutic regime taken into account the medical cure stopping.

Fertility:

The influence of Tramadol on the human fertility isn’t established. The researches of the reproductive function by the rats didn’t reveal any influencing on the fertility.

Pregnancy:

After some epidemiological researches of influencing on the gestation it was reported about associated risk of the development of cardio-vascular system’s intrauterine pathology by fetus under Tramadol applying of pregnant woman in the first term. These data were identical ones in different researches. Physician must consider the possibility of the alternative treatment of the pregnant person or woman planned the gestation and he has to prescribe Tramadol only in cases when the waited benefit from the medical cure heightened the potential risk. According to the data of pregnancy international register the indicators of the inherent cardiac defects under Tramadol application in the first term are increased.

Breast-feeding:

As far as Tramadol hydrochloride and its metabolites are egested in the breast milk the women, who apply Tramadol drug or other medications from this category (analogs), must stop breast-feeding.

As other preparations influenced on the patients’ central nervous system the substance as Tramadol hydrochloride may influence on the capability to implement some tasks needed the heightened attention and movement coordination. That’s why the patients must observe some care under car driving and some other mechanisms controlling to make sure that Tramadol doesn’t disturb their functions.

Tramadol is used inward. It is followed to swallow the tablet wholly, not masticated and washed down by some quantity of water or preliminarily dissolved the pill in ½ of glass with water independently of food application. This medical preparation is applied only by the doctor’s prescribing. The dosing regime is picked up individually in dependence of painful syndrome intensity and apprehensibility of patient to this medicine.

adults

Under the absence of other orders this medication is followed to apply in following dosages^ adults and teens elder than 14 years (more than 25 kg) – 50 mg, under the necessity over 30-60 minutes they may take one pill. Under the powerful pains the single dosage may by 100 mg in one application. In dependence from intensity of painful syndrome the analgetic action is usually kept during the next 4-6 hours.

The daily norm may not be more than 400 mg per day.

For treatment of pains under the oncological sicknesses and expressed pain in post operative period it may be used higher dosages.

aged patients

The interval between Tramadol applying may be increased according to the individual properties of sick persons in connection with possibility of delayed removal by aged patients (elder than 75 years).

patients with damages of liver or kidneys’ function

Tramadol may operate more mg/kg by patients with some sicknesses of kidneys and/or liver. Under Cl Creatinine <30 ml/min and/or by patients with hepatic insufficiency it is necessary the interval in 12 hours between applications of the next dosages of Tramadol preparation. It is possibly some increasing of the interval between the applications of single doses. It isn’t followed to use the medication of Tramadol for patients with heavy renal (Cl Creatinine <10 ml/min) or hepatic insufficiency. It isn’t followed to use this medication over the time justified from the therapeutical point of view. Under tramadol prolonged application conditioned by the intensity or etiology of painful syndrome it is necessary the periodical control (if it is necessary – with some breaks in this preparations taking) for identification of the following therapy necessity and dosing optimization.

Children from 1 till 14 years

The single dosage is 1–2 mg/kg. The maximal daily norm is 8 mg/kg.

Under the applying of this medication in dosages considerably heightened the recommended ones it may appear some reasons of intoxication such as discomposing of consciousness (including coma), generalized convulsions, hypotension, tachycardia, narrowing or widening of pupils, breathing oppression and others.

Treatment:

Under the powerful intoxication by Tramadol which may be accompanied by the loss of consciousness and surface breathing it is recommended the application of naloxone. The powerful convulsions are needed to remove with help of intravenous injection of diazepam.

By the results of clinical applying the side effects are systematized by the organs and systems and frequency of appearance. By the frequency of appearance all collateral results are divided into very often (≥ 1 on 10), often (≥ 1 on 100 and <1 on 10), not often (≥ 1 on 1000 and <1 on 100), seldom (≥ 1 on 10000 and <1 on 1000), very seldom <(1 on 10000), unknown (by having data the frequency is impossible to define).

The frequent side effects are different reactions from the side of gastrointestinal tract and central nervous system. They appear approximately by 5-30% of patients applied Tramadol in the therapeutical dosages.

The undesirable effects which are appeared and manifested in more than 5% patients are dizziness, nausea, constipation, headaches, sleepiness, vomiting, itching, asthenia, hyperhidrosis, breathlessness, dryness in mouth and diarrhea.

From the side of the central nervous system*

Very often: dizziness, headaches.

Often: taste discomposing, memory damages, nervousness, agitation, anxiety, myoclonus, dystonia, migraine, tremor.

Not often: disorders of the attention concentration, vertigo, acathisia, dysarthria.

Seldom: convulsions, damages of ECG.

Very seldom: dystonia, ataxia, parkinsonism, disorders of the movements’ coordination, memory discomposing, paresthesia, fainting fit.

Unknown: coma, delirium, damages of the apprehensibility, dyskinesia.

From the side of gastrointestinal tract*

Very seldom: heightening of the hepatic ferments’ level, jaundice, hepatitis.

Not often: toothaches, gums irritation.

Very often: dryness in mouth, gastrointestinal disorders including nausea and vomiting.

Often: some pains in stomach, constipation, dyspepsia.

Unknown: perforation of the bowels.

From the side of immune system*

Often: the reaction of hypersensibility such as nettle rush.

Very seldom: more heavy reaction of hypersensibility including the angioneurotic edema, breathlessness / bronchial spasm or anaphylactic shock.

Arthralgia, myalgia and fever are also appeared in connection with some precipitation and other symptoms of hypersensibility with moderated type. These symptoms can remind the serum sickness.

From the side of visual organs*

Often: visual disorders.

Not often: mydriasis, diplopia.

Unknown: heightening of eyes pressure.

From the side of hearing organs*

Often: ringing in the ears.

From the side of heart*

Seldom: myocardial infarction.

Very seldom: the strongest palpitation.

Not often: tachycardia, damages of the cardiac rhythm, some changes of ECG.

Unknown: heightening of the arterial pressure, edemas.

From the side of vessels*

Often: heightening of the arterial pressure (in some case it can be considerable one), reddening.

Very seldom: vasodilation, orthostatic hypotension.

From the side of metabolism and disorders of digestion*

Often: anorexia.

Not often: body weight decreasing. If the body weight decreasing is the largest symptom of patient’s depression it is followed to take into account such potentials of Wellbutrin SR as anorexia and / or body weight decreasing.

Very seldom: discomposing of the glucose level on blood.

From the side of psychics*

Often: excitation, stimulation, anxiety, insomnia.

Not often: depression, dysphoria, random orientation.

Very seldom: aggression, hostility, irritability, uneasiness, hallucinations, unusual dreams, depersonalization, delirium, paranoid thoughts.

Frequency is unknown: suicidal ideas and suicidal behavior, psychosis.

Unknown: sleeping damages, euphoria, mania, hypomania, some exchanges of the psychical condition.

From the side of skin and hypodermic tissue*

Often: precipitation, itching, hyperhidrosis.

Very often: polymorphous erythema, Stevens-Johnson syndrome, psoriasis sharpening.

Unknown: alopecia.

From the side of respiratory system*

Seldom: bronchitis, pulmonary embolism.

From the side of locomotive apparatus and connecting tissues*

Very seldom: vellication or muscle convulsions.

Often: arthritis, arthrosis.

From the side of kidneys and urogenital system*

Often: libido lowering, infections of the urogenital system.

Very seldom: increasing of the urination frequency and / or its delay.

Unknown: erectile dysfunction, damages of the menstrual cycle, gynecomastia, testicles edema, glycosuria, nocturia.

General disorders*

Often: weight loss, increasing of muscles tonus, swallowing damages, weight loss, fever, some pains in breast, asthenia.

From the side of blood*

Unknown: leukocytosis, leukocytopenia, thrombocytopenia.

Five years

It is followed to keep these medicines under the temperature not higher than 25°С in original package. Keep this drug in place too difficult for children.

By 10 pills in contour cellular pack from polyvinylchloride film and aluminic foil. By 1, 2, 3 or 5 contour cellular packs are placed in the pack from cardboard.

Tramadol hydrochloride, Tramadol-Zentiva, Tramadol Stada, Tramadol-M, Tramadol-ZN, Tramal, Toradol, Tramol, Tramalgin, Tramadol Retard, Tralgit СR 200