Active substanceTramadolTramadol
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  • Dosage form: & nbsp
    Suppositories.
    Composition:
    1 suppository contains:
    100 mg of tramadol hydrochloride.
    Auxiliary substances: Witepsol W 35, Witepsol E 75.
    Description:
    Suppositories of the classical form, homogeneous structure, white color with slightly yellowish shade, almost without a smell. The length of the suppository is about 26.0 mm, the diameter is about 10.0 mm.

    Pharmacotherapeutic group: An analgesic opioid.
    ATX: & nbsp

    N.02.A.X.02   Tramadol

    Pharmacodynamics:
    Tramal is a highly effective analgesic of the central action. The analgesic effect is based on the interaction of the drug with specific receptors of the pain sensitivity regulating system, with the so-called opiate receptors.
    Pharmacodynamics. Tramadol hydrochloride is a synthetic opioid. It is a racemate of (+) and (-) isomers of 50%, which are involved in various ways in the analgesic effect. The isomer (+) is an antagonist of opioid receptors, has a low tropism and does not have a pronounced selectivity for various receptor subtypes. The isomer (-), inhibiting neuronal capture of norepinephrine, activates the central descending noradrenergic system. Thus, transmission of pain impulses to the gelatinous substance of the spinal cord is impaired. Both isomers act synergistically. There is no effect of oppression of the respiratory center after the administration of therapeutic doses. The drug has a sedative effect. The analgesic effect develops 5-10 minutes after administration and lasts for 3-5 hours.

    Pharmacokinetics:Absorption of the drug after oral administration is about 90%. Absolute bioavailability is about 65%. The maximum concentration of the active substance in the blood plasma is reached approximately 2 hours after the administration of the drug inside. The binding of the active substance with serum proteins is about 4%. The half-life period is 6 hours. 25-35% of the active substance administered is excreted by the kidneys unchanged.
    Indications:
    - Pain syndrome of moderate and strong intensity of different etiology:
    - postoperative period,
    - injuries,
    - myocardial infarction,
    - neuralgia,
    - pain in cancer patients,
    - anesthesia for painful diagnostic and therapeutic procedures.
    Contraindications:
    - hypersensitivity to tramadol hydrochloride or opiates;
    - acute poisoning with alcohol, sleeping pills, analgesic or psychotropic drugs (ie, drugs acting on the nervous system);
    - simultaneous use of MAO inhibitors and a two-week period after their cancellation;
    - pregnancy and lactation period (application is possible only once for life indications);
    - withdrawal syndrome;
    - children under the age of 14 years.
    Carefully:
    Tramal is used with extreme caution in opioid-dependent patients, in patients with head injuries, in shock or unconsciousness, in breathing disorders, with increased intracranial pressure. The drug is used with caution in patients with hypersensitivity to opiates.
    It is necessary to take into account the possibility of seizures in patients taking tramadol in the recommended dosages. The risk of seizures increases with exceeding the daily dose of the drug (400 mg). The administration of tramadol may increase the risk of seizures in patients taking drugs that reduce the convulsive threshold. Patients with epilepsy, or susceptible to developing seizures should take tramadol only for life indications.
    Tramadol has a low potential for dependence development. However, with prolonged use, addiction, physical and mental dependence can develop. In patients with a tendency to abuse drugs or who are drug addicted, tramadol treatment is performed with direct indications for a short time under a permanent medicalcontrol, Tramadol It is not used as a substitute for opioid-dependent patients. Tramadol It can not suppress the symptoms of morphine withdrawal, although it is an opioid agonist.
    Dosing and Administration:

    The dose of the drug should be selected depending on the intensity of pain and the individual sensitivity of the patient. If there are no special instructions, the following is recommended:

    Adults and teenagers over 14 years of age prescribe 1 suppository 100 mg twice a day, morning and evening. If the analgesic effect is insufficient, then after 1-2 hours a repeated dose of 100 mg may be prescribed. In severe pain, a higher dose can be given as an initial dose. 400 mg of tramadol hydrochloride per day is usually sufficient to relieve pain.

    Have elderly patients at the age of 75 years, excretion of the drug may be slowed down. In such cases, it is necessary to increase the interval between doses of the drug in accordance with the patient's state of health.

    With renal failure / dialysis and with liver failure the excretion of tramadol slows down. In such patients, it is necessary to individually select the interval between doses of the drug.

    Suppositories TPAMAJI enter into the rectum. Immediately after administration, approximately 30 minutes of rest in the supine position is recommended.

    Side effects:
    The most characteristic are dizziness, nausea, headache, vomiting, constipation. Seldom there is an effect on the cardiovascular system (palpitation, tachycardia, hypotension and orthostatic collapse). Rare complications from the gastrointestinal tract (eg, abdominal pain, a feeling of fullness of the stomach) are sometimes manifested Skin reactions (prurit, rash, urticaria).
    In very rare cases, motor weakness, changes in appetite, blurred vision, impaired urination develop. Very rarely there are various side effects from the mental sphere, which individually vary in intensity and manifestation (depending on the nature of the patient and the duration of therapy). This includes a change in mood (often an improvement, less often a dysphoria), a change in activity (often suppression, rarely-rising) and impaired perception (behavioral reactions, impaired sensations). Very little chance of allergic reactions (i.e.violation of respiration, bronchospasm, asthmatic component, angioedema, edema) and anaphylactic manifestations.
    Very rarely develop epileptiform cramps. They are possible mainly after the administration of high doses of tramadol, or with the simultaneous administration of drugs that can lower the seizure potential (ie antidepressants or anti-psychotic drugs). Increased blood pressure and bradycardia manifest themselves in very rare cases. The possibility of worsening asthmatic conditions is not ruled out. Sometimes a respiratory depression is noted, usually in the case of a significant excess of recommended doses, or when combined with other central depressants.
    It is extremely rare with long-term administration of high doses of tramadol, addiction and withdrawal reactions may develop: agitation, agitation, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal disturbances. In a number of cases there is an increase in liver enzyme levels when taking tramadol.
    Overdose:

    Symptoms of overdose. From unconscious to unconsciousness (coma); epileptic seizures; miosis; vomiting; cardiovascular collapse; fall in blood pressurepressure; palpitation (tachycardia); narrowing or dilating pupils; difficulty breathing until stop.

    Treatment of overdose. The usual emergency measures are applied. It is necessary to provide airway patency (aspiration!), Maintain breathing and cardiovascular activity depending on the symptoms. It is necessary to clean the stomach by vomiting or rinsing. Tramadol is poorly excreted in hemodialysis and hemofiltration. Therefore, only these measures for overdose therapy are ineffective.

    Tramadol is an opiate agonist. In this regard, opioid-like effects can be stopped with the help of morphine antagonists (for example, nalaxone). Seizures that occur with toxic doses can be eliminated with drugs from the benzodiazepine group (diazepam).

    Interaction:
    Suppositories of TPAMAL should not be given to patients taking MAO inhibitors, or taking these drugs in less than 14 days. When the drug is administered together with other drugs that also affect the central nervous system (for example, tranquilizers or hypnotics), and when taking alcohol, the side effects characteristic of tramadol can be more pronounced.Concurrent or previous reception of carbamazepine (enzyme inducer) may reduce the analgesic effect of tramadol or shortened period. Combination analgesics tramadol group agonists / antagonists (i.e., buprenorphine, nalbuphine, pentazocine) is not recommended, because The analgesic effect of a pure agonist can theoretically decrease.
    Tramadol may induce convulsions and increase the potential of the convulsive selective serotonin reuptake inhibitors, tricyclic antidepressants, anti-psychotic drugs and other agents that reduce the seizure threshold. Drugs that inhibit CYP3A4, such as ketoconazole and erythromycinCan slow the metabolism of tramadol (N-demethylation) and metabolism of the active O-demethylated metabolite.
    Effect on the ability to drive transp. cf. and fur:During treatment with Tramal should abandon all activities requiring increased attention and quick response (driving, working at the bench, etc.), as tramadol can exert a strong enough influence on psychophysical abilities (loss of attention, slowing of reactions, etc.).
    Form release / dosage:
    Suppositories of 100 mg.


    Packaging:5 suppositories per package.
    Storage conditions:
    List B.
    Suppositories Tramal must be stored in a dry place at a temperature of no higher than 25 ° C.
    KEEP THE MEDICATIONS OUT OF THE REACH OF CHILDREN!
    Shelf life:5 years. Do not use the drug after the expiration date!
    Terms of leave from pharmacies:On prescription
    Registration number:P N001543 / 01
    Date of registration:19.12.2008
    The owner of the registration certificate:"EPMPP FGU" "RKNPK RosMedTechnologies" """EPMPP FGU" "RKNPK RosMedTechnologies" "" Russia
    Manufacturer: & nbsp
    Representation: & nbspFGU RKNPK ROSZDRAVA - EPMPP FGU RKNPK ROSZDRAVA - EPMPP Russia
    Information update date: & nbsp17.09.2015
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