Flolan® for inhalation (epoprostenol)

Use

· Pulmonary hypertension secondary to CDH

· Acute respiratory distress syndrome

Dosing

· Concentrations dispensed will vary according to the dose administered (up to 2400 ng/mL)

· A vial of 30 mL will be dispensed and must be stored in the refrigerator

· Usual doses: 20-100 ng/kg/min q4h; continuous nebulization may also be used

Administration

· Administer via ultrasonic or Mini-heart nebulizer over 30 minutes (these nebulizers are recommended to achieve ideal particle size of 2 to 5 microns)

· Solution is stable for 40 hours refrigerated and 8 hours at room temperature

· PROTECT FROM LIGHT

· Submit a “Missing Medication Form” when down to only 1-2 doses in the vial.

·

Monitoring

· Patients should be monitored more closely after initiation of therapy and changes in dose

· Monitoring parameters include vital signs, oxygen saturations, mean arterial pressure, bleeding (i.e.- from surgical sites, chest tubes, etc.)

· For intermittent dosing, recommend assessing patients prior to initiation of therapy, after 10 minutes of the nebulization treatment, at the end of the treatment, and 10 minutes after the end of the treatment

· For continuous nebulization, recommend monitoring every 15 minutes for the first hour of therapy and after any change in dose (due to the short half-life of epoprostenol, most adverse effects would occur within 15 minutes of the dose change)

Adverse Effects

· Adverse reactions to inhaled epoprostenol are thought to be minimal due to small extent of systemic absorption at usual doses; systemic effects are rarely seen at usual therapeutic doses but have been reported with doses >100-200 ng/kg/min

· Adverse events associated with intravenous epoprostenol include hypotension, tachycardia, decreased platelet aggregation and possible increased bleeding; these are not likely to occur with aerosolized administration at therapeutic doses

· No systemic adverse events have been reported after administration of inhaled epoprostenol

· Local effects of inhaled epoprostenol include bronchospasm, bronchoconstriction, bronchodilation, and tracheitis after exposure to high doses and concentrations

References:

· Haraldsson A, Kieler-Jensen N, et al. Chest 1998,114:780-786

· Hache M, Denault A, et al. J Thorac Carsiovasc Surg 2003;125:642-9

· Mikhail G, Gibbs JSR, et al. Eur Heart J 1997;18:1499-1504

· Lowson SM, Doctor A, et al. Crit Care Med 2002;30(12)

· Siobal MS, Kallet RH, et al. Respiratory Care 2003;48(8):742-753

· Carroll CL, Backer CL, et al. J Card Surg 2005;20:436-439

· Lowson SM. Crit Care Med 2005;33:S188-S195