The recommended dosage and administration by infection is shown in the following table: See Table 1.
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The usual treatment duration of doripenem therapy is 5-14 days and should be guided by the severity, site of the infection and the patient's clinical response. Doripenem was given for up to 14 days in clinical studies and the safety of longer durations of therapy has not been established. After commencing treatment with the intravenous doripenem, a switch to appropriate oral therapy to complete the treatment course is possible once clinical improvement has been established.
Dosage in paediatric patients: Doripenem is not recommended for use in children below 18 years of age due to a lack of safety and efficacy data.
Dosage in patients with impairment of renal function: In patients with mild renal impairment (i.e. Creatinine clearance (CrCl) is 51-79 mL/min), no dosage adjustment is necessary. In patients with moderate renal impairment (CrCl 30 to <50 mL/min), the dosage of Doripenem should be 250 mg every 8 hours. In patients with severe renal impairment (CrCl <30 mL/min), the dosage of Doripenem should be 250 mg every 12 hours. Due to limited clinical data and an expected increased exposure of doripenem and its metabolite, Doripenem should be used with caution in patients with severe renal impairment.
Dosage in patients on dialysis: Doripenem is haemodialyzable; however, there is insufficient information to make dose adjustment recommendations in patients on dialysis. Therefore, Doripenem is not recommended for patients on any type of dialysis.
Dosage in elderly patients (≥65 years of age): No dosage adjustment is necessary in elderly patients, except in cases of moderate to severe renal insufficiency (see Dosage in patients with impairment of renal function previously mentioned).
Dosage in patients with impaired hepatic function: No dosage adjustment is necessary.
Method for administration: Doripenem is to be reconstituted and then further diluted (see Special Precautions for disposal and other handling under Cautions for Usage) prior to administration by intravenous infusion over a period of one or four hours.