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  • Tramadol 100 mg Rotexmedica
    / Pharmalogic


    Active Ingredient
    Tramadol HCl 100 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Ampoule

    1 X 2 ml X 100 mg

    not in the basket chart 21039

    Dosage

    For Adults and Pediatric patients. For I.M, I.V, S.C use only.
    Adults: A single dose of 50 mg or 100 mg 4-6 hourly (1 or 2 ml of Tramadol solution for injection) is usually required. Intravenous injection must be given slowly over 2-3 minutes. For severe (postoperative) pain, administer an initial bolus of 100 mg during the 60 minutes following the initial bolus, further doses of 50 mg may be given every 10 to 20 minutes, up to a total dose of 250 mg including the initial bolus. Subsequent doses should be 50 or 100 mg administered every 4-6 hours. If the administration of Tramadol solution for injection has been forgotten, the pain may return. The dose should not be doubled. Administration should be continued as before. A total daily dose of 400 mg should not be exceeded except in special clinical circumstances. Tramadol solution for injection is injected into the veins (usually into blood vessels under the surface of the arms), muscle (usually the buttocks) or under the skin. Administration into the veins is slow, with 1 ml Tramadol solution for injection (equivalent to 50 mg tramadol hydrochloride)/minute. Alternatively Tramadol solution for injection may be diluted with a suitable infusion solution (0.9% physiological saline or 5% glucose solution) for I.V. infusion or for patient-controlled analgesia (PCA).
    Elderly Use: in subjects over the age of 75 years, serum concentrations are slightly elevated and the elimination half-life is slightly prolonged. Subjects in this age group are also expected to vary more widely in their ability to tolerate adverse drug effects. Daily doses as for adults but should not exceed 300 mg.
    Patients with renal insufficiency/dialysis: as elimination of tramadol may be prolonged in patients with renal impairment, the usual initial adult doses should be employed, but prolongation of the dosage interval should be carefully considered according to patient’s requirements. For creatinine clearance <30 ml/min the dosing should be increased to 12-hour intervals. For creatinine clearance <10 ml/min (severe renal impairment) tramadol is not recommended. Tramadol is removed very slowly by hemodialysis or hemofiltration and therefore post dialysis dosing to maintain analgesia is usually unnecessary.
    Patients with hepatic insufficiency: it should be noted that as the elimination of tramadol may be prolonged in severe hepatic impairment, although the usual initial adult dose should be used, prolongation of the dosing should be at 12-hour intervals.
    Paediatric Use: Over 14 years, dosage as for adults.
    Children aged 1 year to 14 years receive 1-2 mg tramadol/kg body weight as a single dose.
    Please refer to the license holder for further details.


    Indications

    Moderate severe to severe pain.


    Contra-Indications

    Hypersensitivity to Tramadol or any of the excipients; Acute intoxication with hypnotics centrally acting analgesics, opioids, psychotropic drugs or alcohol; Patients who are receiving monoamine oxidase (MAO) inhibitors or within 2 weeks of their withdrawal, with other opioids analgesics; Epilepsy, not adequately controlled by treatment.
    See prescribing information for full list of contraindications.


    Special Precautions

    Please refer to the license holder for further details.


    Side Effects

    Most common: nausea and dizziness, headache, muzziness, constipation, dry mouth, vomiting and sweating.
    For full details see prescribing information.


    Manufacturer
    Rotexmedica
    Licence holder
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