Skip to Content



PDF options:  View Fullscreen   Download PDF

PDF Transcript

Process 2385 structure


Prostin® E2 Vaginal Gel 1 mg/2 mg


Prostin® E2 Vaginal Gel 1 mg/ 2 mg
Translucent, thixotropic gel containing 1 or 2 mg
dinoprostone per 3 g (2.5 ml).
Oxytocic. Prostin E2 Vaginal Gel is indicated for the
induction of labour, when there are no fetal or
maternal contra-indications.
Dosage and administration
In primigravida patients with unfavourable induction
features (Bishop score of 4 or less), an initial dose of
2 mg should be administered vaginally. In other
patients an initial dose of 1 mg should be administered
In both groups of patients, a second dose of 1 mg or
2 mg may be administered after 6 hours as follows:
1 mg should be used where uterine activity is
insufficient for satisfactory progress of labour.
2 mg may be used where response to the initial dose
has been minimal.
Maximum dose 4 mg in unfavourable primigravida
patients or 3 mg in other patients (see "Precautions").
The syringe should be assembled by following the
sequence in the diagram.
The gel should be inserted high into the posterior
fornix avoiding administration into the cervical canal.
The patient should be instructed to remain recumbent
for at least 30 minutes.
Contra-indications, warnings, etc.
Contra-indications: Prostin E2 Vaginal Gel should not
be used where the patient is sensitive to
Prostin E2 Vaginal Gel is not recommended in the
following circumstances:
1. For patients in whom oxytocic drugs are generally
contra-indicated or where prolonged contractions
of the uterus are considered inappropriate such as:
Cases with a history of Caesarean section or major
uterine surgery;
Cases where there is cephalopelvic disproportion;
Cases in which fetal malpresentation is present;
Cases in which there is clinical suspicion or definite
evidence of pre-existing fetal distress;
Cases in which there is a history of difficult labour
and/or traumatic delivery;
Grand multiparae with six or more previous term
2. Patients with ruptured membranes.

3. In patients with a past history of, or existing, pelvic
inflammatory disease, unless adequate prior
treatment has been instituted.
4. In patients where there is clinical suspicion or
definite evidence of placenta praevia or unexplained
vaginal discharge and/or abnormal bleeding during
this pregnancy.
5. Patients with active cardiac, pulmonary, renal or
hepatic disease.

The Clinician should be alert that the intracervical
placement of dinoprostone gel may result in
inadvertent disruption and subsequent embolization
of antigenic tissue causing in rare circumstances the
development of Anaphylactoid Syndrome of
Pregnancy (Amniotic Fluid Embolism).
Interactions with other medicaments and other forms
of interaction: Since it has been found that
prostaglandins potentiate the effect of oxytocin, it is
not recommended that these drugs are used
together. If used in sequence, the patient’s uterine
activity should be carefully monitored.
Effects on ability to drive and to use machines:
Not applicable.
Other undesirable effects:
Cardiac disorders: Cardiac arrest
Vascular disorders: Hypertension
Gastrointestinal disorders: Diarrhoea, nausea, vomiting
General disorders and administration site conditions:
Immune system disorders: Hypersensitivity reactions
such as anaphylactoid reactions and anaphylactic
reactions including anaphylactic shock.
Musculoskeletal and connective tissue disorders: Back
Pregnancy, Puerperium and Perinatal conditions:
Maternal-related conditions: uterine hypertonus,
uterine rupture, abruptio placenta, pulmonary
amniotic fluid embolism, rapid cervical dilatation
Foetus-related conditions: uterine hypercontractility
with/without fetal bradycardia fetal distress/altered
fetal heart rate (FHR)
Neonatal conditions: neonatal distress, neonatal death,
stillbirths, low Apgar score
Reproductive system and breast disorders: Warm
feeling in vagina, irritation, pain
Respiratory, thoracic and mediastinal disorders:
Asthma, bronchospasm


Prostin® E2 Vaginal Gel 1 mg/2 mg

Read all of this leaflet carefully before you start
taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor,
midwife or pharmacist.
This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor, midwife or pharmacist.
In this leaflet:
1. What Prostin E2 Vaginal gel is and what it is used for
2. Before you are given Prostin E2 Vaginal gel
3. How Prostin E2 Vaginal gel is given to you
4. Possible side effects
5. How to store Prostin E2 Vaginal gel
6. Further information
1. What Prostin E2 Vaginal Gel is and what it is
used for
Prostin E2 Vaginal Gel contain the prostaglandin
dinoprostone and is used to “induce” labour. This
means that the medicine will help your uterus (womb)
to start contracting and you will go into labour.
Dinoprostone is similar to the natural ‘E2’, type of
prostaglandins which are made in your body when
labour starts. Your doctor would have satisfied
himself/herself that there are no conditions making
the induction unsafe. It will only be given to you in a
hospital or clinic which has an obstetric and maternity
2. Before you are given Prostin E2 Vaginal Gel
Most women can be treated with Prostin E2 Vaginal
Gel. Some women may need extra checks during
treatment and for some women a different treatment
may be better. Your doctor or midwife will ask you
questions before giving you Prostin E2 Vaginal Gel to
make sure it is safe for you. If you do not understand
any of the questions, ask your doctor or midwife to

Process Black


Do not use Prostin E2 Vaginal gel:
• If you have had an allergic reaction (e.g.wheezing,
breathlessness, swelling of the hands, face, itchy
rash or redness of the skin) to dinoprostone or any
other prostaglandin or any of the other ingredients
in the gel, which are listed in Section 6 below.
Your doctor or midwife will not use Prostin E2 to start
or strengthen your labour in certain circumstances if:
• you have heart, lung, kidney or liver disease
• you have had a Caesarean section or any major
surgery to your womb.
• the size of your baby’s head means there may be a
problem with the delivery.
• there has been or there is suspected fetal distress
(your baby is short of oxygen).
• you had a difficult labour or traumatic delivery in a
previous pregnancy.
• you have already had six or more full-term
• your waters have broken.
• you have a past history or existing infection of your
womb, ovaries or tubes (pelvic inflammatory disease)
unless you are receiving treatment for these, or if
you have ever had such an infection in the past.
• you have been told that you have or might have
placenta praevia (where the placenta lies across the
entrance to the womb, rather than being high up
and out of the way during birth). This causes
bleeding from the vagina during pregnancy and may
require that your baby is delivered by Caesarean
• during your pregnancy you have had bleeding from

the vagina and the cause of the bleeding is not
• your baby is not lying with his or her head down.
Take special care with Prostin E2:
Tell your doctor or midwife if you have or have had in
the past any of the following conditions as they may
want to monitor you more closely.
• heart, lung, kidney or liver disease
• glaucoma (raised pressure in the eye)
• epilepsy
• suffered from asthma
• hypertension (high blood pressure) at any time,
including during this or any previous pregnancy
• been told you had abnormally strong contractions of
your womb during a previous labour
• scarring of your womb from a previous operation
• Are you 35 years or older?
• Is your pregnancy over 40 weeks?
• Do you have any complications related to this
Your doctor or midwife will ask you questions before
giving you Prostin E2 Vaginal Gel to make sure they are
safe for you.
If you do not understand any of the questions, ask
your doctor or midwife to explain.
Taking other medicines:
Prostin E2 Vaginal Gel can make you more sensitive to
another medicine called oxytocin which is used to
strengthen contractions. Medical staff will normally try
not to use this medicine at the same time as Prostin
E2 Vaginal gel. If you need this medicine, your doctor
or midwife will make sure they are not given to you
close together and will watch over the contractions
very carefully.
Please tell your doctor if you are taking or have
recently taken any other medicines, including
medicines obtained without a prescription.
Pregnancy and breastfeeding
Prostin E2 Vaginal gel will only be given to you in the
late stages of pregnancy to induce labour.
Although prostaglandins are present in breast milk
they will not harm your baby and you may breastfeed
as normal after delivery.
Driving and using machinery
No effect on your ability to drive or use machinery is
expected after being given Prostin E2 Vaginal gel
3. How Prostin E2 Vaginal gel is given to you
Prostin E2 Vaginal Gel can only be used in a hospital or
a clinic with a specialist obstetric unit. Before you are
given this medicine, you will be examined by your
doctor or midwife. They need to know the position of
your baby’s head and how dilated (wide) your cervix
(neck of the womb) is.
You will be given a numbered score after you have
been examined. This is known as the Bishop score. The
lower your Bishop score, the less ready you are to go
into labour without any help. In this case, a higher
dose of Prostin E2 Vaginal Gel is given.
Prostin E2 Vaginal Gel will be inserted into the
posterior fornix (an area high up in your vagina) while
you are lying down. You will then be asked to stay lying
down for at least 30 minutes.


Skin and subcutaneous tissue disorders: Rash
Blood and lymphatic system disorders: An increased
risk of post-partum disseminated intravascular
coagulation has been described in patients whose
labour was induced by pharmacological means, either
with dinoprostone or oxytocin. The frequency of this
adverse event, however, appears to be rare (<1 per
1,000 labours).
Post-marketing surveillance:
Use in pregnancy and lactation: Prostin E2 Vaginal Gel
is only used during pregnancy, to induce labour.
Prostaglandins are excreted in breast milk. This is not
expected to be a hazard given the circumstances in
which the product is used.

Other special warnings and precautions: This product is
available only to hospitals and clinics with specialised
obstetric units and should only be used where 24-hour
resident medical cover is provided.
Use the total contents of the syringe for one patient
only. Discard after use. Use caution in handling this
product to prevent contact with skin. Wash hands
thoroughly with soap and water after administration.
Prostin E2 Vaginal Gel and Prostin E2 Vaginal Tablets
are not bioequivalent.
Caution should be exercised in the administration of
prostaglandin E2 in patients with:
i. asthma or a history of asthma;
ii. epilepsy or a history of epilepsy;
iii. glaucoma or raised intra-ocular pressure;
iv. compromised cardiovascular, hepatic, or renal
v. hypertension.
As with any oxytocic agent, Prostin E2 Vaginal Gel
should be used with caution in patients with
compromised (scarred) uteri.
In labour induction, cephalopelvic relationships should
be carefully evaluated before use of prostaglandin E2.
During use, uterine activity, fetal status and the
progression of cervical dilation should be carefully
monitored to detect possible evidence of undesired
responses, e.g. hypertonus, sustained uterine
contractions, or fetal distress.
In cases where there is a known history of hypertonic
uterine contractility or tetanic uterine contractions, it
is recommended that uterine activity and the state of
the fetus should be continuously monitored
throughout labour.
The possibility of uterine rupture should be borne in
mind where high-tone uterine contractions are
Animal studies lasting several weeks at high doses have
shown that prostaglandins of the E and F series can
induce proliferation of bone. Such effects have also
been noted in newborn infants who have received
prostaglandin E1 during prolonged treatment. There is
no evidence that short-term administration of
prostaglandin E2 can cause similar bone effects.

Pharmaceutical precautions
Store at 2-8°C. Keep out of reach and sight of children.
The contents of one syringe to be used for one
patient. Do not use after the expiry/use by date on the
carton and syringe label. Discard after use.

Women aged 35 years or older, those with
complications during pregnancy and those with a
gestational age over 40 weeks have been shown to
have an increased risk of post-partum disseminated
intravascular coagulation. In addition, these factors
may further increase the risk associated with labour

3. Insert syringe cap into barrel of syringe.

Therefore, in these women, use of dinoprostone
should be undertaken with caution. Measures should
be applied to detect as soon as possible an evolving
fibrinolysis in the immediate post-partum phase.

The usual dose is 1 mg. If this is your first pregnancy
and you have a low Bishop score, you will be given
2 mg.
Your doctor or midwife may decide to give you a
second dose of gel if you do not start having
contractions or if you are only having weak
contractions. Because this treatment can take a long
time to have an effect in some women, your doctor or
midwife will not give you a second dose until they are
sure that this is needed. You should not have a second
dose for at least six hours and many doctors and
midwives will wait much longer than this. This means
that you could even have your second dose the
following day. You should not be given more than
4 mg.
Your doctor or midwife should be keeping a very close
eye on you during your treatment. They should be
able to act quickly if you have side-effects or if your
womb reacts too strongly to the dose you are given.
Your doctor or midwife will do internal checks to make
sure that your cervix is opening enough. They will also
check your contractions (to make sure that they are
not too strong) and your baby (to make sure he or she
does not get distressed).
4. Possible side effects
Like all medicines Prostin E2 Vaginal gel can cause side
effects, although not everybody gets them.
If you have asthma, Prostin E2 Vaginal gel could cause
you to have an asthmatic attack. You must tell your
doctor or midwife if you suffer from asthma or if
you have difficulty breathing.
Rare side effects
Rare but serious side effects which can sometimes
happen include the following:
• tearing or bursting of the wall of your womb (uterine
• heart attack
• allergic / anaphylactic reactions, including
anaphylactic shock (serious allergic reactions which
can include skin rash, itching, wheezing, shortness of
breath, swollen face, lips, hands, fingers, neck and
throat, sudden drop in blood pressure, abdominal
pain and collapse ).
If you get any of these symptoms please tell your
doctor or midwife straight away.


Common side effects
• vomiting (being sick)
• nausea (feeling sick)
• diarrhoea.
These have seldom been bad enough for the woman
to stop the treatment.

Process Black

Overdosage (symptoms, emergency procedures,
antidotes): Overdosage may be expressed by uterine
hypercontractility and uterine hypertonus. During use,
uterine activity, fetal status and the progression of
cervical dilation should be carefully monitored to
detect possible evidence of undesired responses, e.g.
hypertonus, sustained uterine contractions, or fetal
distress. Because of the transient nature of
PGE2-induced myometrial hyperstimulation,
non-specific, conservative management was found to
be effective in the vast majority of cases: i.e. maternal
position change and administration of oxygen to the
mother. If conservative management is not effective,
ß-adrenergic drugs may be used as a treatment of
hyperstimulation following administration of PGE2 for
cervical ripening, in appropriate patients.

Other side effects
As prostaglandins make the body go into labour in the
same way as it would happen naturally, anything that
can happen in a natural labour can also happen if you
have been given Prostin E2 Gel. Talk to your midwife or
doctor about this if you want to know more, as they
will be able to give you the information that you need.
• sudden blockage of a blood vessel with amniotic
fluid (the fluid which surrounds the baby) or by a
blood clot in the lungs. This could cause chest pain
and shortness of breath.
• placenta becoming detached
• stillbirth or death of the newborn baby
• abnormally strong, frequent or long contractions of
the womb
• slowing or quickening of the baby’s heart rate and
distress in the baby
• itching, soreness, rash or feeling of warmth of the
vaginal area
• high blood pressure in the mother
• very quick opening of the cervix
• running a high temperature
• backache
• rash
• baby born with an Apgar score lower than seven.
(The Apgar score, which is measured on a scale of
one to ten, is used to describe the baby’s condition
at birth. A low Apgar Score means that the baby’s

Legal category
Package quantities
Prostin E2 Vaginal Gel is available in single packs of l mg
or 2 mg.
Further information
Unlike other oxytocics, prostaglandin E2 exhibits the
capacity of the prostaglandins to influence uterine
activity at any stage of gestation. Other Prostin E2
dosage forms are available for induction of labour
(oral, vaginal and IV. routes), fetal death in utero (IV.
route), therapeutic termination of pregnancy (IV. and
extra-amniotic routes), missed abortion and
hydatidiform mole (IV. route).
Marketing Authorisation numbers
PL 00057/1029 PA 16/1/5 Prostin E2 Vaginal Gel 1 mg
PL 00057/1025 PA 16/1/6 Prostin E2 Vaginal Gel 2 mg
Holder of Marketing Authorisation
Pfizer Limited, Ramsgate Road, Sandwich, Kent,
CT13 9NJ, UK.
Date of preparation or last review
® Prostin is a Registered Trademark:
1. Remove from packaging.

2. Remove the syringe cap from the syringe.

PR 4_0

heart or lungs are not working properly.)
Studies have shown proliferation (thickening) of bone
in new-born infants who have been treated with
prostaglandins for a long time. There is no evidence
that this occurs following short-term treatment with
Prostin E2 Vaginal Gel.
A higher risk of a generalised bleeding disorder
following delivery (post-partum disseminated
intravascular coagulation-DIC) has been described in
women who are aged 35 and above, whose
pregnancies are more than 40 weeks and who have
pregnancy-related complications.
If you think you may be having any of the above side
effects, or you are worried about anything unusual
happening during your labour, please tell your doctor
or midwife.
5. How to store Prostin E2 Vaginal gel
The medicine will be kept out of the reach and sight of
Prostin E2 Vaginal gel will not be given to you after the
expiry date. The expiry date refers to the last day of
that month.
Your hospital pharmacist will store this medicine in a
refrigerator at 2 to 8 °C before use.
6. Further information
What Prostin E2 Vaginal Gel contains:
The active substance is called dinoprostone.
The other ingredients are Triacetin and colloidal silicon
What Prostin E2 Vaginal gel looks like and
contents of the pack
Prostin E2 Vaginal gel is packed in syringes that contain
1 mg or 2 mg of dinoprostone in 3 grams of gel. Each
pack contains one pre-filled syringe and the syringes
are for single use only.
Marketing Authorisation Holder:
Pfizer Limited
Ramsgate Road
CT13 9NJ
Pfizer Manufacturing Belgium NV
Rijksweg 12
B-2870 Puurs
For further information on this medicine, please
contact Pfizer Medical Information on: 01304 616161.
This leaflet was last revised in 02/2014
PR 4_0


+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.