Sample Technical Information Leaflet: Epoprostenol

NHS PASA Purchasing for safety project – Manchester pilot

Sample technical information leaflet: Epoprostenol

Epoprostenol
(Flolan Injection)
Presentation of vial

Each 50ml vial contains 0.5mg (500 micrograms) of epoprostenol

Licensed indications

Is an anticoagulant indicted for use in haemofiltration or dialysis when use of heparin carries a high risk of causing or exacerbating bleeding or when heparin is otherwise contra-indicated.

Unlicensed indications

Primary pulmonary hypertension, peripheral vascular disease

Route and Method of Administration

Administration via port of Haemofiltration circuit.

Standard dose

Usual Adult Dose:

2.5 – 7 nanograms/kg/min. Start at 2.5 nanograms/kg/min and titrate to the lowest effective dose. The maximum dose is 10 nanograms/kg/min.

Calculation of infusion rate:-

The infusion rate may be calculated from the following formula:-

Infusion Rate = Dose (nanograms/kg/min) X Actual Bodyweight (kg)

(ml/minute)Concentration of solution (nanograms/ml)

To calculate infusion rate in ml/hour multiply infusion rate (ml/minute) by 60

The standard concentration of epoprostenol used is 5000 nanograms/ml

For a 70kg patient

Infusion rate at 2.5 nanograms/kg/min= 2.1mls/hr

Infusion rate at 7 nanograms/kg/min= 5.8mls/hr

Infusion rate at 10 nanograms/kg/min=8.4mls/hr

Compatibility

Sodium chloride 0.9%

Incompatibility

Incompatible with glucose or glucose/sodium chloride 0.9%

Instructions for preparation

1. Using aseptic technique withdraw 10ml of the sterile diluent into a sterile syringe.
2. Inject the content of the syringe into the vial containing epoprostenol and gently shake until the powder has dissolved.
3. Draw up all the epoprostenol solution into a syringe and re-inject the entire content into the residue of the original 50ml diluent and mix well. This solution has a concentration of 10,000 nanograms/ml (10 micrograms/ml or 500 micrograms/50ml).
4. Using the filter provided 25mls of this solution is then further diluted with sodium chloride 0.9 to make a final concentration of 5,000 nanograms/ml (250 micrograms/50ml)
5. Label the vial with the patient’s name, the date and the time prepared. This reconstituted vial can be stored in the fridge for 24hours

Renal / hepatic insufficiency

No special recommendations

Contraindications

Known hypersensitivity to epoprostenol

Special precautions

• Epoprostenol has high pH, therefore care should be taken to avoid extravasation
• Epoprostenol is a potent vasodilator. The cardiovascular effects disappear within 30 mins of the end of the administration

Side effects

Epoprostenol can cause profound hypotension and should never be used in an unresuscitated patient. Other side effects are anxiety, headache, tachycardia, facial flushing

Monitoring

• Blood pressure, heart rate
• Epoprostenol effect cannot be monitored with conventional coagulation tests, e.g. PT or APTT.

Pharmaceutical / handling precautions

Do not store above 25 degrees C, Discard any remaining reconstituted solution after 12 hours

References

1.SPC Flolan 0.5mg injection at accessed 29.01.2008

1. UCL Injectable Medicines Administration Guide 2nd edition. UCL Hospitals 2007

3.Handbook of Drugs in Intensive care 3rd edition 2006

1. BNF 54