Flolan 1.5 mg injection
epoprostenol
Please read this leaflet carefully. Keep it safe, as you may want to read it again.
This leaflet contains important information about Flolan 1.5 mg injection. If you want to know more about your illness or medicine, please ask your doctor.
What is in Flolan?
Flolan is supplied as a sterile white to off-white powder in vials containing 1.5 mg of the active ingredient epoprostenol, as the sodium salt. There are some other ingredients in Flolan powder for solution and infusion. These are glycine, sodium chloride, mannitol and sodium hydroxide. Before Flolan is used it must be dissolved in a sterile diluent called GlaxoSmithKline Glycine Buffer Diluent. This contains the ingredients glycine, sodium chloride, sodium hydroxide and water for injections.
Flolan injection 1.5 mg comes in the following pack presentation:
- 1.5 mg vial of epoprostenol with 1 vial of GlaxoSmithKline Glycine Buffer Diluent and a filter
Who makes Flolan?
makes Flolan and
is licensed to sell it in the UK.
What is Flolan for?
Flolan has two separate uses.
It can be used during renal dialysis to stop your blood from clotting (known as an anticoagulant action), or it can be used to treat primary pulmonary hypertension - where Flolan widens the blood vessels in the lungs and so lowers the blood pressure in your lungs (known as a vasodilator action).
Is it alright for me to have Flolan?
This medicine suits most people, but there are a few people who, in some cases, it may not be suitable for.
Ask yourself these questions to check whether it is right for you:
- Have you previously had an allergic reaction to epoprostenol or any of the other ingredients used in a Flolan infusion listed above?
- Do you have water on the lungs (causing breathing difficulty especially at night)?
- Do you have haemophilia or any other type of bleeding tendency?
- Are you pregnant, trying to become pregnant or breast-feeding?
- Are you currently taking any medicine to prevent blood clots, such as heparin, warfarin, aspirin or other anti-inflammatory pain killers (NSAIDs)?
- Are you currently taking any other medicines that are used to treat high blood pressure, heart failure, any other heart or circulation problem or a group of medicines known as nitrates that are used to treat angina?
- Are you on a low sodium diet?
If the answer to any of these questions is "YES", or if you are not sure, please tell your doctor BEFORE you are given Flolan.
Flolan may cause drowsiness if it is being used to treat primary pulmonary hypertension. If you are affected do not drive or operate machinery.
How is Flolan given?
Flolan is given differently depending on the treatment you require.
When used in renal dialysis: Flolan will be given as an infusion (drip) either intravenously (into a blood vessel) or into the blood supplying the dialyser.
The dose of Flolan is based on your body weight. Your doctor will decide on the dose and duration of Flolan therapy which is right for you. The usual starting dose for adults is 4 nanograms of epoprostenol per kilogram of body weight per minute. The Flolan infusion is stopped at the end of dialysis.
When used to treat primary pulmonary hypertension: Flolan will be given as an intravenous infusion only, normally through a permanently fitted intravenous catheter (during initial treatment a 'peripheral line' may be used which is a non-permanent catheter).
Initial treatment with Flolan will be carried out in a hospital. Your doctor will start you on an infusion of 2 nanograms of epoprostenol per kilogram of your body weight per minute and then increase this slowly (every 15 minutes), to find the most effective or largest dose you can tolerate. During this part of the treatment you will also learn about how your body reacts to Flolan. If you develop pulmonary oedema (water on the lungs) during this time, your doctor may choose not to treat you with Flolan.
Your doctor will then continue the infusion based on this dose, and may increase or decrease your infusion rate depending on your response to the treatment. All changes should be done gradually and under the direction of a doctor, except in emergency situations. Your Flolan infusion will be given to you through a pump. There are only certain pumps which can be used. Your doctor will make sure you are using the right one. If you are unsure ask your doctor for advice.
Flolan should not be used for bolus administration (a direct injection).
There is no specific information available on the dose of Flolan in children or people over 65 years of age.
Can an overdose of Flolan be given?
In hospital the effects of Flolan are monitored carefully by your doctor and appropriate action, such as reducing the dose, can be taken promptly in the unlikely event that you receive too much. If you are using Flolan at home and you think you have used too much, do not delay, contact your doctor or nearest hospital casualty department. Receiving too much Flolan may cause very low blood pressure, which may possibly cause you to faint.
Does Flolan have side effects?
Flolan can cause side effects in some people. If you experience any of the following while you are receiving it please tell your doctor at once:
- facial flushing or redness
- speeding up or slowing of the heartbeat, quickening of the pulse
- headaches
- feeling or being sick (vomiting)
- wind or tummy discomfort
- a dry mouth
- tiredness and weakness
- paleness of the skin
- anxiety, nervousness and agitation
- dizziness, or feeling faint, especially on standing
- chest pain and tightness
- reddening and pain at the infusion site
- sweating
- jaw pain
You may also experience lower levels of certain blood cells (platelets) used in the clotting process.
Sometimes this may be noticeable as bruising or bleeding from the gums or nose.
Tell your doctor if you notice any other side effects from your medicine which are not mentioned here.
Flolan may affect your heart rate or blood pressure during infusion. Your doctor will monitor these.
If you have been fitted with an intravenous catheter, it is very important to keep this area clean, otherwise infection of the skin at the site of injection may result, which can then spread into your blood (known as septicaemia).
Your doctor or nurse will have shown you how to keep your catheter, and the area around it, clean and free from infection. They will also show you how to prepare and administer Flolan and how to stop treatment if necessary. It is very important you follow all their instructions carefully.
Storing Flolan
- Store Flolan in a dry place not above 25°C and protect from light by keeping Flolan in its carton until it is used.
When used for renal dialysis: once Flolan powder has been dissolved with the GlaxoSmithKline Glycine Buffer Diluent and further diluted with physiological saline (O.9%), any unused infusion solution can be stored at 25°C and used within 12 hours.
When used for primary pulmonary hypertension: once Flolan powder has been dissolved and diluted as instructed using only the GlaxoSmithKline Glycine Buffer Diluent, it should be infused immediately. Alternatively, it may be stored for up to 24 hours at 2-8°C and then infused immediately. If you have a 'cold pouch' with your infusion pump, then Flolan may be used over a 24-hour period as long as the cold pouch is changed as necessary throughout the day so that the Flolan solution is always kept between 2°C and 8°C. If the use of a cold pouch is not possible, the maximum time over which freshly prepared Flolan solutions can be given at 25°C is 12 hours. For solutions that have been made up and stored in the fridge, the maximum time is 8 hours.- Do not freeze Flolan at any time.
- As with any medication, keep Flolan safely away from children, where they cannot see or reach it.
- Do not use Flolan after the expiry date on the label.
Leaflet last updated: September 2006
The Information provided applies only to FLOLAN 1.5 mg injection
Flolan is a registered trademark of the GlaxoSmithKline group of companies
© 2006 GlaxoSmithKline group of companies
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