Simdax Dosage/Direction for Use

Simdax is for in-hospital use only. It should be administered in a hospital setting where adequate monitoring facilities and expertise with the use of inotropic agents are available.
Method of administration: Simdax is to be diluted prior to administration (see Special precautions for disposal and other handling under Cautions for Usage).
The infusion is for intravenous use only and can be administered by the peripheral or central route.
Posology: The dose and duration of treatment should be individualised according to the patient's clinical condition and response.
The treatment should be initiated with a loading dose of 6-12 microgram/kg infused over 10 minutes followed by a continuous infusion of 0.1 microgram/kg/min (see Pharmacology: Pharmacodynamics under Actions). The lower loading dose of 6 microgram/kg is recommended for patients on concomitant intravenous vasodilators or inotropes or both at the start of the infusion. Higher loading doses within this range will produce a stronger haemodynamic response but may be associated with a transient increased incidence of adverse reactions. The response of the patient should be assessed with the loading dose or within 30 to 60 minutes of dose adjustment and as clinically indicated. If the response is deemed excessive (hypotension, tachycardia), the rate of the infusion may be decreased to 0.05 microgram/kg/min or discontinued (see Precautions). If the initial dose is tolerated and an increased haemodynamic effect is required, the rate of the infusion can be increased to 0.2 microgram/kg/min.
The recommended duration of infusion in patients with acute decompensation of severe chronic heart failure is 24 hours. No signs of development of tolerance or rebound phenomena have been observed following discontinuation of Simdax infusion. Haemodynamic effects persist for at least 24 hours and may be seen up to 9 days after discontinuation of a 24-hour infusion (see Precautions).
Experience of repeated administration of Simdax is limited. Experience with concomitant use of vasoactive agents, including inotropic agents (except digoxin) is limited. In the REVIVE programme, a lower loading dose (6 micrograms/kg) was administered with baseline concomitant vasoactive agents (see Precautions, Interactions and Pharmacology: Pharmacodynamics under Actions).
Monitoring of treatment: Consistent with current medical practice, ECG, blood pressure and heart rate must be monitored during treatment and the urine output measured. Monitoring of these parameters for at least 3 days after the end of infusion or until the patient is clinically stable is recommended (see Precautions). In patients with mild to moderate renal or mild to moderate hepatic impairment monitoring is recommended for at least 5 days.
Elderly: No dose adjustment is required for elderly patients.
Renal impairment: Simdax must be used with caution in patients with mild to moderate renal impairment. Simdax should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/min) (see Contraindications, Precautions and Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: Simdax must be used with caution in patients with mild to moderate hepatic impairment although no dose adjustment appears necessary for these patients. Simdax should not be used in patients with severe hepatic impairment (see Contraindications, Precautions and Pharmacology: Pharmacokinetics under Actions).
Children: Simdax should not be administered to children and adolescents under 18 years of age (see Precautions and Pharmacology: Pharmacokinetics under Actions).
The following table provides detailed infusion rates for both the loading and maintenance infusion doses of a 0.05 mg/ml preparation of Simdax infusion: (See Table 1.)

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The following table provides detailed infusion rates for both the loading and maintenance infusion doses for a 0.025 mg/ml preparation of Simdax infusion: (See Table 2.)

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