FLOLAN - Epoprostenol (Systemic) - MEDLINE ARTICLE
Some commonly used brand names are:
In the U.S.--Flolan
In Canada--Flolan
Other commonly used names are Prostacyclin, PGI 2,
and PGX .
Category
- Antihypertensive (pulmonary)
- vasodilator
Description
Epoprostenol (e-poe-PROST-en-ole) belongs to a
group of agents called prostaglandins. Prostaglandins occur naturally in the
body and are involved in many biological functions. Epoprostenol is used to
treat the symptoms of primary pulmonary hypertension, or the high blood
pressure that occurs in the main artery that carries blood from the right side
of the heart (the ventricle) to the lungs. When the smaller blood vessels in
the lungs become more resistant to blood flow, the right ventricle must work
harder to pump enough blood through the lungs. Epoprostenol works by relaxing
blood vessels and increasing the supply of blood to the lungs, reducing the
workload of the heart.
This medicine is available only with your
doctor's prescription, in the following dosage form(s):
Parenteral
- Injection (U.S. and Canada)
Before Using This Medicine
In deciding to use a medicine, the risks of
using the medicine must be weighed against the good it will do. This is a
decision you and your doctor will make. For epoprostenol, the following should
be considered:
Allergies--Tell your health
care professional if you are allergic to any other substances, such as foods,
preservatives, or dyes.
Pregnancy--Epoprostenol has
not been studied in pregnant women and, although epoprostenol has not been
shown to cause birth defects or other problems in animals, it is not
recommended for use in pregnant women unless absolutely necessary. Before
taking this medicine, make sure your doctor knows if you are pregnant or if
you may become pregnant.
Breast-feeding--It is not
known whether epoprostenol passes into breast milk. Although most medicines
pass into breast milk in small amounts, many of them may be used safely while
breast-feeding. Mothers who are taking this medicine and who wish to
breast-feed should discuss this with their doctor.
Children--Although there is no
specific information comparing use of this medicine in children with use in
other age groups, this medicine is not expected to cause different side
effects or problems in children than it does in adults.
Older adults--Many medicines
have not been studied specifically in older people. Therefore, it may not be
known whether they work exactly the same way they do in younger adults or if
they cause different side effects or problems in older people. There is no
specific information comparing use of epoprostenol in the elderly with use in
other age groups.
Other medicines--Although
certain medicines should not be used together at all, in other cases two
different medicines may be used together even if an interaction might occur.
In these cases, your doctor may want to change the dose, or other precautions
may be necessary. It is important that your health care professional know if
you are taking any prescription or nonprescription (over-the-counter [OTC])
medicines.
Other medical problems--The
presence of other medical problems may affect the use of epoprostenol. Make
sure you tell your doctor if you have any other medical problems, especially:
- Heart disease or
- Lung disease--Epoprostenol may make these
conditions worse
Proper Use of This
Medicine
Your doctor or nurse will teach you how to
prepare the medicine and use the pump for administering the medicine.
Epoprostenol must be administered continuously by a portable pump that is
operated by a small computer. The medicine will be delivered directly to the
heart through a catheter that will be inserted into a vein in the chest.
Epoprostenol should be reconstituted
only with the sterile diluent that is supplied with this medicine. The
reconstituted medicine should not be mixed with other solutions or medicines.
Use the following procedure for reconstituting your daily supply:
-
Clear an area to work in and clean the area
with alcohol. Gather your supplies. Wash your hands thoroughly with soap
and water and then open all packages. Remove the vial cap from the vial
containing the sterile diluent, clean the tops of the vials with alcohol
swabs, and let the vial tops dry before proceeding.
To withdraw the sterile diluent
- If not already attached, attach a needle to
the syringe. Gently pull the plunger out slightly and push it back to
break the syringe seal. Draw air into the syringe that is about equal to
the amount of sterile diluent you've been instructed to withdraw from the
vial. Insert the needle at an angle, completely through the rubber seal of
the vial. Turn the vial and syringe upside down (the syringe-vial unit is
now vertical) and carefully press the plunger, injecting some or all of
the air into the vial. Then aim the tip of the needle into the fluid and
carefully pull the plunger slowly back to withdraw the diluent and/or
allow the pressure to fill the syringe with the diluent. Continue pushing
the remaining air into the vial, allowing the liquid to enter the syringe
until the prescribed amount of diluent has been drawn into the syringe.
Without withdrawing the needle, tap the syringe gently so that any air
bubbles trapped in the syringe rise toward the top of the syringe. If air
bubbles appear, depress the plunger gently to force the air bubbles out
(into the vial) and then withdraw enough additional diluent to restore the
needed volume in the syringe. (Holding the syringe-vial as a unit in a
vertical position and keeping the needle tip in the fluid while
withdrawing the diluent may help minimize the amount of air drawn into the
syringe.) Once the required volume has been drawn into the syringe, let
the syringe-vial pressure equalize and slowly withdraw the needle from the
vial.
To reconstitute the epoprostenol
- Insert the same needle through the rubber
seal of the vial of epoprostenol and inject the sterile diluent gently
onto the side of the vial. The flow of the sterile diluent should be
directed toward the side of the vial and injected slowly in order to
prevent the medicine from foaming. Once the pressure has equalized,
withdraw the needle from the vial. Gently swirl the vial to mix the
epoprostenol. Turn the vial upside down to catch any undissolved powder
near the top of the vial. Never shake the vials. Repeat this process if
you need to mix more than one vial of epoprostenol.
To draw out the reconstituted epoprostenol
- Wipe the top of the reconstituted
epoprostenol vial with an alcohol swab and let it dry. Change the needle
on the syringe and then gently pull back the syringe plunger and fill the
syringe with the amount of air that is equal to the amount of
reconstituted epoprostenol you have been instructed to withdraw. Insert
the needle through the seal of the vial and inject the air into the vial.
Be sure to keep the needle tip below the fluid line and then pull the
plunger back gently to withdraw the reconstituted epoprostenol into the
syringe. Remove any air that may be trapped in the syringe as described
above. Withdraw the needle and replace the needle cap on the syringe.
To inject the reconstituted epoprostenol into
the cassette
- Remove the end cap from the cassette tubing.
Carefully remove the needle from the syringe (be sure to discard the
needle in an appropriate manner) and attach the syringe to the cassette
tubing. Hold the cassette in one hand and push the plunger to inject the
reconstituted solution into the cassette (alternatively, you may find it
useful to use a tabletop or other solid structure to steady the plunger
while pushing down on the syringe to inject the solution). When the
syringe is empty, clamp the cassette tubing near the syringe. Disconnect
the syringe and replace the cassette tubing end cap.
To inject the remaining diluent into the
partially filled cassette
- Using a 60 mL syringe, attach a new needle
to the syringe and follow the above procedures for breaking the syringe
seal and wiping the tops of the sterile diluent vials. Fill the syringe
with the amount of air that is equal to the amount of sterile diluent you
will remove from the first vial. Insert the needle through the rubber seal
and slowly inject some of the air into the vial, allowing the fluid to
flow into the syringe. Continue to push air gently into the vial until all
of the fluid in the vial has flowed into the syringe. Remove any air that
may be in the syringe as described above. Allow the pressure to equalize
before you pull the needle out or you may lose fluid from the syringe. (If
this occurs, the whole process needs to be repeated.) Withdraw the needle
and replace the needle cap on the syringe. You may find it easier to hold
the larger syringe in an upside down, vertical position while withdrawing
the fluid in the vial.
To inject the sterile diluent into the
cassette
- Uncap the clamped cassette tube and
carefully remove the needle from the syringe (discarding the needle in an
appropriate manner). Attach the syringe to the cassette tubing. Unclamp
the cassette tubing and carefully inject the solution into the cassette.
When the syringe is empty, clamp the cassette tube near the syringe and
disconnect the syringe. Replace the cap on the cassette tube. If more
diluent is needed to fill the cassette, repeat steps 6 and 7 with an
additional vial of diluent; however, after completing the transfer of all
of the required diluent, clamp the tubing, but leave the syringe attached
to the cassette tubing while you mix the solution. Gently turn the
cassette upside down at least 10 times to thoroughly mix the reconstituted
epoprostenol with the additional diluent.
To remove air from the cassette
- To remove the air from inside the cassette,
slowly turn the cassette until all of the small bubbles of air join to
form one air pocket. Tilt the cassette gently so that the air pocket is in
the corner where the tubing connects to the cassette. Unclamp the tube and
pull back the plunger of the syringe until you see fluid fill the tubing.
Clamp the tube near the connector and remove the syringe and replace the
cap on the tubing. Label the cassette with the current time and date.
Store the cassette in the refrigerator (preferably, on the top shelf to
avoid spilling any food or drink on it) until it is time to use it. Make
up a new cassette each day and use the cassette you refrigerated the day
before so that you will always have a back-up cassette.
To use the pump
- The instructions for the use of the pump
may vary depending on the particular make and model of the pump.
Your doctor
or nurse will give detailed instructions on how to use and care for
the particular pump and accessories that you will use for administering
your
medicine. These instructions should include how to change the pump
battery, cassette, and tubing. Remember to change the gel packs every
12 hours or every 8 hours if the surrounding temperature approaches
86 °F.
- Maintain sterile technique at all times. If
you suspect that you have contaminated anything, throw away the
accessories and begin again.
Dosing--The dose of epoprostenol will be
different for different patients and will be determined by your doctor. The
amount of medicine you take may have to be increased gradually by your doctor.
It must never be stopped suddenly. Follow your doctor's orders or the
directions on the label . The following information includes only the
average doses of epoprostenol. If your dose is different, do not change it
unless your doctor tells you to do so.
The amount of medicine that you take depends on
the concentration of the reconstituted medicine and the rate at which the
infusion pump delivers the medicine.
- For injection dosage form:
- For primary pulmonary hypertension and
pulmonary hypertension secondary to scleroderma spectrum of disease:
- Adults--Initially, 2 nanograms per
kilogram (kg) (0.9 nanogram per pound) of body weight per minute.
Your doctor may increase your dose as necessary.
- Children--Use and dose must be
determined by your doctor.
Missed dose--Epoprostenol has to be
administered by a continuous intravenous infusion and it must never be stopped
suddenly.
Storage--To store this medicine:
- Keep out of the reach of children.
- Do not keep outdated medicine, or medicine
no longer needed. Be sure that any discarded medicine is out of the reach
of children.
Unopened vials
- Store unopened vials away from heat and
direct light.
- Keep the medicine and the diluent from
freezing.
- Do not store unopened vials in the bathroom,
near the kitchen sink, or in other damp places. Heat or moisture may cause
the medicine to break down.
Reconstituted injection
- Store the reconstituted injection in
the refrigerator, away from direct light. However, keep the medicine
from
freezing. Any medicine that has been frozen should be thrown away.
Reconstituted solutions should be kept either in the refrigerator
or in a cold pouch, or a combination of the two, for no more than
48 hours. Do not
expose reconstituted solution to temperatures higher than 25 °C (77 °F).
- If the reconstituted solution has particles
in it or is discolored, it should be discarded.
Precautions While Using Flolan
It is important that your doctor check your
progress at regular visits. This will allow your doctor to make sure the
medicine is working properly and to change the dosage if needed.
Be sure to report any signs of infection at
the catheter site to your doctor. Also, if you develop a sudden fever, contact
your doctor as soon as possible .Avoid the use of saunas, hot baths, or
sunbathing, or other situations that may cause blood vessels to dilate,
resulting in low blood pressure and increasing the possibility of dizziness,
light-headedness, or fainting.
Do not suddenly stop using this medicine.
Stopping suddenly may bring on symptoms of your condition and can be dangerous.
Check with your doctor before stopping completely .
Your doctor may want you to carry a medical
identification card stating that you are using this medicine.
Flolan Side Effects
Along with its needed effects, a medicine may
cause some unwanted effects. Although not all of these side effects may occur,
if they do occur they may need medical attention.
Check with your doctor immediately if
any of the following side effects occur:
Signs and symptoms that can occur with
initial dosage adjustments and/or dosage excess
Diarrhea; fast heartbeat; headache;
light-headedness or fainting; nausea; redness of face or neck (flushing);
vomiting
Check with your doctor as soon as possible if any
of the following side effects occur with the use of Flolan
More common
Anxiety and/or nervousness; diarrhea;
dizziness; flu or infection-like symptoms, such as chills, confusion,
delirium, light-headedness or fainting, fast heartbeat, fever, and/or rapid,
shallow breathing; headache; jaw pain (when chewing); local infection at the
catheter site; pain at injection site; pain in muscles or bones; redness of
face (flushing); unusual bleeding such as nosebleeds or bleeding gums or
bruising
If you stop using this medicine abruptly or your
dosage is reduced suddenly, symptoms of your condition may recur. If your
medicine is suddenly stopped or reduced, check with your doctor immediately
, especially if any of the following side effects occur:
Difficult or labored breathing; dizziness;
fainting; weakness
NOTE: THIS IS A MEDLINE MEDICAL
ARTICLE ON FLOLAN THERAPY FOR PPH PATIENTS. It is not medical advice. Follow
your doctors advise. There are side effects not listed above may also occur in
some patients. If you notice any other effects, check with your doctor.
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