FLOLAN

Posology Epoprostenol is only indicated for continuous infusion by intravenous route. Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension.

Short-term (acute) dose ranging:

This procedure should be conducted in a hospital with adequate resuscitation equipment. A short-term dose-ranging procedure administered via either a peripheral or central venous line is required to determine the long-term infusion rate.

The infusion rate is initiated at 2 nanograms/kg/min and increased by increments of 2 nanograms/kg/min every 15 min or longer until maximum haemodynamic benefit or dose-limiting pharmacological effects are elicited. If the initial infusion rate of 2 nanograms/kg/min is not tolerated, a lower dose which is tolerated by the patient should be identified.

Long-term continuous infusion:

Long-term continuous infusion of Flolan should be administered through a central venous catheter. v. infusions may be used until central access is established. Long-term infusions should be initiated at 4 nanograms/kg/min less than the maximum tolerated infusion rate determined during short-term dose-ranging.

If the maximum tolerated infusion rate is 5 nanograms/kg/min or less, then the long-term infusion should be started at 1 nanograms/kg/min.

Dosage adjustments:

Changes in the long-term infusion rate should be based on persistence, recurrence or worsening of the patient’s symptoms of pulmonary arterial hypertension or the occurrence of adverse reaction due to excessive doses of Flolan. In general, the need for increases in dose from the initial long-term dose should be expected over time.

Increases in dose should be considered if symptoms of pulmonary arterial hypertension persist, or recur after improving. The infusion rate should be increased by 1 to 2 nanograms/kg/min increments at intervals sufficient to allow assessment of clinical response; these intervals should be of at least 15 min.

Following establishment of a new infusion rate, the patient should be observed, and erect and supine blood pressure and heart rate monitored for several hours to ensure that the new dose is tolerated. During long-term infusion, the occurrence of dose-related pharmacological events similar to those observed during the dose-ranging period may necessitate a decrease in infusion rate, but the adverse reactions may occasionally resolve without dosage adjustment.

Adverse events are listed below by system organ class and frequency. 01%) and not known (cannot be estimated from the available data). g. v. catheter*, lassitude, chest tightness Investigations Unknown Blood glucose increased * Associated with the delivery system for Flolan 1 Catheter-related infections caused by organisms not always considered pathogenic (including micrococcus) have been reported.

2 Tachycardia has been reported as a response to Flolan at doses of 5 nanograms/kg/min and below. 3 Bradycardia, sometimes accompanied by orthostatic hypotension, has occurred in healthy volunteers at doses of Flolan greater than 5 nanograms/kg/min.

v. administration of a dose of Flolan equivalent to 30 nanograms/kg/min in healthy conscious volunteers. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Because of the high pH of the final infusion solutions, care should be taken to avoid extravasation during their administration and consequent risk of tissue damage. Flolan is a potent pulmonary and systemic vasodilator. The cardiovascular effects during infusion disappear within 30 min of the end of administration.

5). If excessive hypotension occurs during administration of Flolan, the dose should be reduced or the infusion discontinued. 9). Blood pressure and heart rate should be monitored during administration of Flolan. Flolan may either decrease or increase heart rate.

The change is thought to depend on both the basal heart rate and the concentration of Flolan administered. The effects of Flolan on heart rate may be masked by concomitant use of drugs which affect cardiovascular reflexes. Extreme caution is advised in patients with coronary artery disease.

8). The solvent contains no preservative; consequently a vial should be used once only and then discarded. Sodium content This medicinal product contains sodium, which should be taken into consideration by patients on a controlled sodium diet.

The amount of sodium present in the reconstituted concentrate solution equals 73 mg approximately, equivalent to approximately 4 % of the WHO recommended maximum daily dietary intake of 2 g of sodium for an adult. 2 % of the WHO recommended maximum daily dietary intake of 2 g of sodium for an adult.

The amount of sodium present in the solvent for parenteral use equals 70 mg approximately per vial, equivalent to approximately 4 % of the WHO recommended maximum daily dietary intake of 2 g of sodium for an adult. Some patients with pulmonary arterial hypertension have developed pulmonary oedema during dose- ranging, which may be associated with pulmonary veno-occlusive disease.

3). Abrupt withdrawal or interruption of infusion must be avoided, except in life-threatening situations. 2). Flolan is infused continuously through a permanent indwelling central venous catheter via a small, portable infusion pump. Thus, therapy with Flolan requires commitment by the patient to sterile drug reconstitution, drug administration, care of the permanent central venous catheter, and access to intense and ongoing patient education.

1. • with congestive heart failure arising from severe left ventricular dysfunction. • Flolan must not be used chronically in patients who develop pulmonary oedema during dose-ranging.