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  • Tienam
    / MSD


    Active Ingredient *
    Cilastatin (as sodium) 500 mg
    Imipenem (as monohydrate) 500 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    10 X 500 mg

    partial basket chart 35596 20727

    Dosage

    Adults: The dosage recommendations for TIENAM I.V. represent the quantity of imipenem to be administered. An equivalent amount of cilastatin is also present in the solution. Each 125 mg, 250 mg, or 500 mg dose should be given by intravenous administration over 20 to 30 minutes. Each 750 mg or 1000 mg dose should be infused over 40 to 60 minutes. In patients who develop nausea during the infusion, the rate of infusion may be slowed.
    The total daily dosage for TIENAM I.V. should be based on the type or severity of infection and given in equally divided doses based on consideration of degree of susceptibility of the pathogen(s), renal function, and body weight. Adult patients with impaired renal function, as judged by creatinine clearance ≤70 mL/min/1.73 m², require adjustment of dosage as described in the succeeding section of these guidelines.
    Intravenous Dosage Schedule for Adults with Normal Renal Function and Body Weight ≥70 kg: Doses cited in Table I (See prescribing information) are based on a patient with normal renal function and a body weight of 70 kg.
    These doses should be used for a patient with a creatinine clearance of ≥71 mL/min/1.73 m² and a body weight of ≥70 kg. A reduction in dose must be made for a patient with a creatinine clearance of ≤70 mL/min/1.73 m² and/or a body weight less than 70 kg.
    Dosage regimens in column A of Table I are recommended for infections caused by fully susceptible organisms which represent the majority of pathogenic species. Dosage regimens in column B of Table I are recommended for infections caused by organisms with moderate susceptibility to imipenem, primarily some strains of P. aeruginosa.
    Due to the high antimicrobial activity of TIENAM I.V., it is recommended that the maximum total daily dosage not exceed 50 mg/kg/day or 4.0 g/day, whichever is lower. There is no evidence that higher doses provide greater efficacy.
    See prescribing information for full details.


    Indications

    Polymicrobial infections. Hospital only.


    Contra-Indications

    Patients who have shown hypersensitivity to any component of this product.


    Special Precautions

    Before initiating therapy, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactams, and other allergens. If an allergic reaction occurs, treatment should be discontinued. In patients with CNS disorders, adverse experiences such as confusional states, myoclonic activity and seizures have been reported during treatment, especially when recommended dosages were exceeded. Patients with creatinine clearances of (5ml/min/1.73 m2 should not receive Tienam I.V. unless hemodialysis is instituted within 48 hours. For patients on hemodialysis, treatment is recommended only when the benefit outweighs the potential risk of seizures. Close adherence to the recommended dosage and dosage schedules is urged. Prolonged use may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient’s condition is essential. Periodic assessment of organ system functions, including renal, hepatic and hematopoietic, is advisable during prolonged therapy. Pregnancy and lactation: Should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus. Caution should be exercised when administered to a nursing woman.


    Side Effects

    Diarrhea, gastroenteritis, vomiting, rash, irritation at I.V. site, urine discoloration, phlebitis, oliguria/anuria, tachycardia, convulsions.
    See prescribing information for full details.


    Drug interactions

    Probenecid, ganciclovir.


    Manufacturer
    Laboratories Merck Sharp & Dohme, France
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