Active substanceTramadolTramadol
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  • Dosage form: & nbsp
    Injection.

    Composition:
    each ampoule (2 ml) contains:
    The active substance is tramadol hydrochloride -100 mg
    Excipients: sodium acetate, water for injection.

    Description:
    A colorless liquid free from visible foreign particles.

    Pharmacotherapeutic group:An analgesic with a mixed mechanism of action.
    ATX: & nbsp

    N.02.A.X.02   Tramadol

    Pharmacodynamics:
    The drug belongs to the list of No. 1 potent substances of the Standing Committee on Drug Control of the Ministry of Health of the Russian Federation.
    Tramadol is an opioid synthetic analgesic with central action and action on the spinal cord (promotes the opening of K + and Ca2 + channels, causes hyperpolarization of membranes and inhibits pain impulses), enhances the action of sedatives. Activates opioid receptors (mu, delta, kappa) on the pre- and postsynaptic membranes of the afferent fibers of the nociceptive system in the brain and gastrointestinal tract.

    Pharmacokinetics:
    Absorption at intramuscular (IM) administration - 100%. The time to reach the maximum concentration after the / m introduction is 45 min. Penetrates through the hemoencephalic and placental barriers, excretion in breast milk is 0.1%. The volume of distribution is 203 liters with intravenous administration. Connection with plasma proteins - 20%.
    In the liver, it is metabolized by N- and O-desmethylation followed by conjugation with glucuronic acid. 11 metabolites have been identified, of which mono-O-desmethyltramadol (Ml) has pharmacological activity. The half-life (T1 / 2) in the second phase is -6h (tramadol), 7.9 hours (mono-O-desmethyltramadol); in patients older than 75 years - 7.4 (tramadol); with cirrhosis of the liver -13.3 ± 4.9 h (tramadol), 18.5 ± 9.4 h (mono-O-desmethyltramadol), in severe cases - 22.3 h and 36 h, respectively; with chronic renal failure (creatinine clearance less than 5 ml / min) - 11 ± 3.2 h (tramadol), 16.9 ± 3 h (mono-O-desmethyltramadol), in severe cases - 19.5 h and 43.2 h respectively.
    The drug is excreted by the kidneys (25-35% unchanged), the average cumulative index of renal excretion is 94%. About 7% is excreted by hemodialysis.
    Indications:
    Pain syndrome of strong and medium intensity including inflammatory, traumatic, vascular origin (postoperative period, trauma, pain in cancer patients, acute myocardial infarction, neuralgia).
    Anesthesia when performing painful diagnostic or therapeutic manipulations.
    Contraindications:
    - Hypersensitivity to the drug and other opioids.
    - Conditions accompanied by respiratory depression or severe central nervous system depression (alcohol poisoning, hypnotics, narcotic analgesics, psychotropic drugs).
    - Severe hepatic and / or renal failure (creatinine clearance less than 10 mL / min).
    - Simultaneous use of MAO inhibitors (including 2 weeks after their cancellation).
    - Children's age (up to 14 years).
    Carefully:With caution and under the supervision of a doctor, the drug should be used for patients with impaired renal and hepatic function, with craniocerebral trauma, increased intracranial pressure, with a disturbance of consciousness of different genesis, patients with epilepsy, and also persons with drug dependence for opioids, in patients with pain in the abdomen of an unclear genesis ("acute abdomen").
    Pregnancy and lactation:During pregnancy and during lactation, use is only possible according to vital indications, the application should be limited only to one-time use.
    Dosing and Administration:

    Tramaklosidol is used according to the doctor's prescription, the dosage regimen is selected individually depending on the severity of the pain syndrome and the sensitivity of the patient. Duration of treatment is determined individually, do not prescribe the drug beyond the term justified from a therapeutic point of view.

    Tramaclosidol is intended for intravenous (enter slowly!), intramuscular or subcutaneous injection. In the absence of other prescriptions, Tramaclosidol should be administered in the following dosages.

    For adults and teenagers over 14 years of age - single administration of 50-100 mg of tramadol hydrochloride (1-2 ml of solution for injection). If there is no satisfactory analgesia, after 30-60 minutes a repeated single dose of 50 mg (1 ml) may be prescribed. In severe pain, a higher dose (100 mg of tramadol hydrochloride) can be prescribed as the initial dose.

    To alleviate pain in cancer and severe pain in the postoperative period higher doses may be used. As a rule, 400 mg (8 ml) of tramadol hydrochloride per day is sufficient to relieve pain.

    In elderly patients (at the age of 75 years and more) due to the possibility of delayed excretion, the interval between injections of the drug can be increased in accordance with individual characteristics.

    In patients with kidney and liver disease tramadol may last longer. For such patients, it may be recommended to increase the interval between single dose administration. Tramaclosydol should not be administered for longer than it is therapeutically necessary.

    Side effects:

    From the cardiovascular system: tachycardia, orthostatic hypotension, syncope, collapse.

    From the digestive system: dry mouth, nausea, vomiting, flatulence, abdominal pain, constipation, diarrhea, difficulty in swallowing.

    From the nervous system: sweating, dizziness, headache, weakness, fatigue, inhibition, paradoxical stimulation of the central nervous system (nervousness, agitation, anxiety, tremor, muscle spasms, euphoria, emotional lability, hallucinations), drowsiness, sleep disturbance, confusion, coordination of movement, convulsions of the central genesis (with intravenous administration in high doses or with the simultaneous administration of antipsychotic drugs), depression, amnesia, cognitive impairment, paresthesia, unsteadiness of gait.

    Allergic reactions: urticaria, itching, exanthema, bullous rash.

    From the side of the urinary system: dysuria, urinary retention.

    From the sense organs: impaired vision, taste.

    From the respiratory system: dyspnoea.

    Other: violation of the menstrual cycle.

    With prolonged use, it is possible to develop drug dependence.

    With a sharp cancellation - the development of the syndrome of "cancellation" is not ruled out.

    Overdose:

    Symptoms: miosis, vomiting, collapse, coma, convulsions, respiratory center depression, apnea.

    Treatment: ensuring airway patency, maintaining breathing and cardiovascular activity. Opiate-like effects can be stopped with naloxone, convulsions with benzodiazepine.

    Interaction:
    Tramadol is pharmaceutically incompatible with solutions of diclofenac, indomethacin, phenylbutazone, diazepam, flunitrazepam, nitroglycerin, midazolam.
    Strengthens the action of ethanol and drugs that have a depressing effect on the central nervous system.
    Inductors of microsomal oxidation (incl. carbamazepine, barbiturates) reduce the severity of the analgesic effect and the duration of action of tramadol. Long-term use of opioid analgesics or barbiturates stimulates the development of cross tolerance.
    Anxiolytics increase the severity of the analgesic effect of tramadol.
    Naloxone activates breathing, eliminating analgesia after the use of opioid analgesics.
    MAO inhibitors, furozolidone, procarbazine, antipsychotics increase the risk of seizures (reduction of the convulsive threshold).
    Quinidine increases the concentration of tramadol in the blood plasma and reduces the concentration of M1 metabolite due to competitive inhibition of isoenzyme CYP2D6.
    Special instructions:
    With increased time intervals apply Tramaklosidol in elderly patients. Under careful medical supervision and in reduced doses should be used Tramaklosidol against the background of the funds for anesthesia, hypnotics and psychotropic drugs.
    You should not drink alcohol while treating tramadol.
    Do not use for the treatment of the syndrome of "withdrawal" of drugs.
    In the case of a single use of the drug, there is no need to interrupt breastfeeding.
    Tramaklosidol in the form of injections can be addictive, so its long-term use in this dosage form should be avoided, and if necessary, assess tolerance, physical and mental dependence on the drug.

    Effect on the ability to drive transp. cf. and fur:When using the drug, it is necessary to refrain from driving motor vehicles and practicing potentially dangerous activities,requiring increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:Solution for injection 50 mg / ml.
    Packaging:2 ml each in glass ampoules (type I), 1 or 5 ampoules on a plastic pallet in a cardboard box with instructions for use.
    Storage conditions:
    In the dark place at a temperature of up to 25 ° C. Keep out of the reach of children!
    The drug belongs to the list of No. 1 potent substances of the Standing Committee on Drug Control of the Ministry of Health of the Russian Federation.
    Shelf life:3 years. Do not use the drug after the expiration date!
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-010620/08
    Date of registration:26.12.2008
    The owner of the registration certificate: Laboratorios Bago S.A. Laboratorios Bago S.A. Argentina
    Manufacturer: & nbsp
    Representation: & nbspBBC FARMA BV BBC FARMA BV Netherlands
    Information update date: & nbsp17.09.2015
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