l PRESCRIBING AND DISPENSING INFORMATION
Orodispersible tablets not suitable for initiation of therapy
in patients taking alpha-blockers.
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (October
2011) that vardenafil orodispersible tablets (Levitra ®) are
accepted for restricted use within NHS Scotland for
treatment of erectile dysfunction in men for whom an
orodispersible tablet is an appropriate formulation.
NHS restrictions Levitra ® is not prescribable in NHS
primary care for the treatment of erectile dysfunction
except in men who meet the criteria listed in part XVIIIB of
the Drug Tariff (Part XIb of the Northern Ireland Drug
Tariff, Part 12 of the Scottish Drug Tariff). The prescription
must be endorsed ’SLS’. For more information see Prices in
the BNF, under How to use the BNF.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Aspartame
Vardenafil (as Vardenafil hydrochloride trihydrate) 10 mg Levitra
10mg orodispersible tablets sugar-free | 4 tablet P £19.67 DT =
▶ Vardenafil (Non-proprietary)
Vardenafil (as Vardenafil hydrochloride trihydrate)
5 mg Vardenafil 5mg tablets | 4 tablet P £6.24–£12.04 DT =
£8.31 | 8 tablet P £14.97–£24.08
Vardenafil (as Vardenafil hydrochloride trihydrate)
10 mg Vardenafil 10mg tablets | 4 tablet P £11.09–£21.41 DT =
£14.77 | 8 tablet P £26.61–£42.82
Vardenafil (as Vardenafil hydrochloride trihydrate)
20 mg Vardenafil 20mg tablets | 4 tablet P £18.23–£35.20 DT =
£24.29 | 8 tablet P £42.52–£70.40
Vardenafil (as Vardenafil hydrochloride trihydrate) 5 mg Levitra
5mg tablets | 4 tablet P £8.32 DT = £8.31
Vardenafil (as Vardenafil hydrochloride trihydrate) 10 mg Levitra
10mg tablets | 4 tablet P £14.78 DT = £14.77 | 8 tablet P £29.57
Vardenafil (as Vardenafil hydrochloride trihydrate)
20 mg Levitra 20mg tablets | 4 tablet P £24.30 DT = £24.29 | 8 tablet P £48.60
Erectile dysfunction (initiated under specialist
▶ Adult: Initially 250 micrograms, adjusted according to
response; usual dose 0.125–1 mg; maximum 2 doses
per day; maximum 7 doses per week
816 Erectile and ejaculatory conditions BNF 78
Aid to diagnosis of erectile dysfunction
▶ Adult: 500 micrograms for 1 dose
▶ Adult: Apply 300 micrograms, to the tip of the penis,
5–30 minutes before sexual activity; max 1 dose in
24 hours not more than 2–3 times per week
▶ BY INTRACAVERNOSAL INJECTION
▶ Adult: Initially 2.5 micrograms for 1 dose (first dose),
followed by 5 micrograms for 1 dose (second dose), to
be given if some response to first dose, alternatively
7.5 micrograms for 1 dose (second dose), to be given if
no response to first dose, then increased in steps of
5–10 micrograms, to obtain a dose suitable for
producing erection lasting not more than 1 hour; if no
response to dose then next higher dose can be given
within 1 hour, if there is a response the next dose
should not be given for at least 24 hours; usual dose
5–20 micrograms (max. per dose 60 micrograms),
maximum frequency of injection not more than 3 times
per week with at least 24 hour interval between
Erectile dysfunction associated with neurological
▶ BY INTRACAVERNOSAL INJECTION
▶ Adult: Initially 1.25 micrograms for 1 dose (first dose),
then 2.5 micrograms for 1 dose (second dose), then
5 micrograms for 1 dose (third dose), increased in steps
of 5–10 micrograms, to obtain a dose suitable for
producing erection lasting not more than 1 hour; if no
response to dose then next higher dose can be given
within 1 hour, if there is a response the next dose
should not be given for at least 24 hours; usual dose
5–20 micrograms (max. per dose 60 micrograms),
maximum frequency of injection not more than 3 times
per week with at least 24 hour interval between
▶ BY INTRACAVERNOSAL INJECTION
▶ Adult: 10–20 micrograms for 1 dose (consult product
Aid to diagnosis where evidence of neurological
▶ BY INTRACAVERNOSAL INJECTION
▶ Adult: Initially 5 micrograms (max. per dose
10 micrograms) for 1 dose, (consult product literature)
▶ BY INTRACAVERNOSAL INJECTION
▶ Adult: Initially 2.5 micrograms for 1 dose (first dose),
followed by 5 micrograms for 1 dose (second dose), to
be given if some response to first dose, alternatively
7.5 micrograms for 1 dose (second dose), to be given if
no response to first dose, then increased in steps of
5–10 micrograms, to obtain a dose suitable for
producing erection lasting not more than 1 hour; if no
response to dose then next higher dose can be given
within 1 hour, if there is a response the next dose
should not be given for at least 24 hours; usual dose
5–20 micrograms (max. per dose 60 micrograms),
maximum frequency of injection not more than 3 times
per week with at least 24 hour interval between
Erectile dysfunction associated with neurological
▶ BY INTRACAVERNOSAL INJECTION
▶ Adult: Initially 1.25 micrograms for 1 dose (first dose),
then 2.5 micrograms for 1 dose (second dose), then
5 micrograms for 1 dose (third dose), increased in steps
of 5–10 micrograms, to obtain a dose suitable for
producing erection lasting not more than 1 hour; if no
response to dose then next higher dose can be given
within 1 hour, if there is a response the next dose
should not be given for at least 24 hours; usual dose
5–20 micrograms (max. per dose 60 micrograms),
maximum frequency of injection not more than 3 times
per week with at least 24 hour interval between
▶ BY INTRACAVERNOSAL INJECTION
▶ Adult: 10–20 micrograms for 1 dose (consult product
Aid to diagnosis where evidence of neurological
▶ BY INTRACAVERNOSAL INJECTION
▶ Adult: Initially 5 micrograms (max. per dose
10 micrograms) for 1 dose, (consult product literature)
Neurogenic erectile dysfunction
▶ BY INTRACAVERNOSAL INJECTION
▶ Adult: Initially 1.25 micrograms, increased in steps of
2.5–5 micrograms, to obtain dose suitable for
producing erection not lasting more than 1 hour; usual
dose 10–20 micrograms (max. per dose
40 micrograms), maximum frequency of injection not
more than 3 times per week with at least 24 hour
interval between injections; reduce dose if erection
▶ BY INTRACAVERNOSAL INJECTION
▶ Adult: Initially 2.5 micrograms, increased in steps of
2.5–5 micrograms, to obtain dose suitable for
producing erection not lasting more than 1 hour; usual
dose 10–20 micrograms (max. per dose
40 micrograms), maximum frequency of injection not
more than 3 times per week with at least 24 hour
interval between injections; reduce dose if erection
Not for use in patients with penile implants or when sexual
activity medically inadvisable (e.g. orthostatic
hypotension, myocardial infarction, and syncope). not for
use with other agents for erectile dysfunction . predisposition to prolonged erection (as in
thrombocythemia, polycythemia, sickle cell anaemia,
multiple myeloma or leukaemia). urethral application
contra-indicated in urethral stricture . urethral application
contra-indicated in urethritis
▶ With topical use Balanitis . severe curvature . severe
hypospadia . urethral stricture . urethritis
l CAUTIONS Anatomical deformations of penis (painful
erection more likely)—follow up regularly to detect signs
of penile fibrosis (consider discontinuation if angulation,
erection lasting 4 hours or longer)
l INTERACTIONS → Appendix 1: alprostadil
BNF 78 Erectile dysfunction 817
dysfunction . urethral burning
▶ With intracavernosal use Asthenia . balanoposthitis . dry
▶ With urethral use Balanoposthitis . hyperhidrosis . increased
risk of infection . leg pain . nausea . pelvic pain . perineal
▶ With intracavernosal use Myocardial ischaemia . stroke
▶ With intravenous use Peripheral oedema
l CONCEPTION AND CONTRACEPTION
▶ With urethral use If partner is pregnant, barrier
contraception should be used. No evidence of harm to
▶ With topical use Condoms should be used to avoid exposure
to women of child-bearing age, pregnant or lactating
women. No evidence of harm to latex condoms.
l DIRECTIONS FOR ADMINISTRATION
▶ With intracavernosal use The first dose of the intracavernosal
injection must be given by medically trained personnel;
self-administration may only be undertaken after proper
▶ With urethral use During initiation of treatment the urethral
application should be used under medical supervision;
self-administration may only be undertaken after proper
l PATIENT AND CARER ADVICE Patients should be instructed
to report any erection lasting 4 hours or longer.
▶ With topical use Counsel patients that condoms should be
used to avoid local reactions and exposure of alprostadil to
women of childbearing age, pregnant, or lactating women.
l NATIONAL FUNDING/ACCESS DECISIONS
NHS restrictions Caverject ®, Viridal ® Duo, Vitaros ® and
MUSE ® are not prescribable in NHS primary care for the
treatment of erectile dysfunction except in men who meet
the criteria listed in part XVIIIB of the Drug Tariff (Part XIb
of the Northern Ireland Drug Tariff, Part 12 of the Scottish
Drug Tariff). The prescription must be endorsed ’SLS’. For
more information see Prices in the BNF, under How to use
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Muse (Meda Pharmaceuticals Ltd)
Alprostadil 500 microgram Muse 500microgram urethral sticks |
1 applicator P £11.30 DT = £11.30 | 6 applicator P £67.79
▶ Vitaros (Ferring Pharmaceuticals Ltd)
Alprostadil 3 mg per 1 gram Vitaros 3mg/g cream | 4 applicator P £40.00 DT = £40.00
Powder and solvent for solution for injection
Alprostadil 10 microgram Caverject 10microgram powder and
solvent for solution for injection vials | 1 vial P £9.24 DT = £9.24
Caverject Dual Chamber 10microgram powder and solvent for solution
for injection | 2 pre-filled disposable injection P £14.70
Alprostadil 20 microgram Caverject Dual Chamber 20microgram
powder and solvent for solution for injection | 2 pre-filled disposable
Caverject 20microgram powder and solvent for solution for injection
vials | 1 vial P £11.94 DT = £11.94
Alprostadil 40 microgram Caverject 40microgram powder and
solvent for solution for injection vials | 1 vial P £21.58 DT =
Alprostadil 10 microgram Viridal Duo Starter Pack 10microgram
Viridal Duo Continuation Pack 10microgram powder and solvent for
solution for injection cartridges | 2 cartridge P £16.55
Alprostadil 20 microgram Viridal Duo Starter Pack 20microgram
Viridal Duo Continuation Pack 20microgram powder and solvent for
solution for injection cartridges | 2 cartridge P £21.39
Alprostadil 40 microgram Viridal Duo Starter Pack 40microgram
Viridal Duo Continuation Pack 40microgram powder and solvent for
solution for injection cartridges | 2 cartridge P £27.22
SYMPATHOMIMETICS › VASOCONSTRICTOR
Adrenaline/epinephrine 27-Sep-2017
l DRUG ACTION Acts on both alpha and beta receptors and
increases both heart rate and contractility (beta1 effects); it
can cause peripheral vasodilation (a beta2 effect) or
vasoconstriction (an alpha effect).
Priapism associated with alprostadil, if aspiration and
lavage of corpora are unsuccessful (alternative to
▶ BY INTRACAVERNOSAL INJECTION
▶ Adult: 10–20 micrograms every 5–10 minutes, using a
20 microgram/mL solution, Important: if suitable
strength of adrenaline not available may be specially
prepared by diluting 0.1 mL of the adrenaline 1 in 1000
(1 mg/mL) injection to 5 mL with sodium chloride 0.9%,
continuously monitor blood pressure and pulse;
maximum 100 micrograms per course
l UNLICENSED USE The use of adrenaline for the treatment
of priapism is an unlicensed indication.
l CAUTIONS Arteriosclerosis . arrhythmias . cerebrovascular
disorders . psychoneurosis . severe angina . susceptibility
CAUTIONS, FURTHER INFORMATION Cautions listed are only
for non-life-threatening situations.
l INTERACTIONS → Appendix 1: sympathomimetics,
▶ Rare or very rare Cardiomyopathy
▶ Frequency not known Angina pectoris . angle closure
818 Erectile and ejaculatory conditions BNF 78
l RENAL IMPAIRMENT Manufacturers advise use with
l MONITORING REQUIREMENTS Monitor blood pressure and
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: solution for
EXCIPIENTS: May contain Sulfites
▶ Adrenaline/epinephrine (Non-proprietary)
Adrenaline 100 microgram per 1 ml Adrenaline (base)
100micrograms/1ml (1 in 10,000) dilute solution for injection
ampoules | 10 ampoule P £76.34
Adrenaline (base) 1mg/10ml (1 in 10,000) dilute solution for injection
Adrenaline (as Adrenaline acid tartrate) 100 microgram per
1 ml Adrenaline (base) 1mg/10ml (1 in 10,000) dilute solution for
injection ampoules | 10 ampoule P £88.48
Adrenaline (base) 500micrograms/5ml (1 in 10,000) dilute solution for
injection ampoules | 10 ampoule P £81.33
Adrenaline 1 mg per 1 ml Adrenaline (base) 10mg/10ml (1 in 1,000)
solution for injection ampoules | 10 ampoule P £96.38
Adrenaline (base) for anaphylaxis 1mg/1ml (1 in 1,000) solution for
injection pre-filled syringes | 1 pre-filled disposable injection P £11.88 DT = £11.71
Adrenaline (base) 1mg/1ml (1 in 1,000) solution for injection pre-filled
syringes | 1 pre-filled disposable injection P £11.88 DT = £11.71
Adrenaline (as Adrenaline acid tartrate) 1 mg per 1 ml Adrenaline
(base) 5mg/5ml (1 in 1,000) solution for injection ampoules |
Adrenaline (base) 500micrograms/0.5ml (1 in 1,000) solution for
injection ampoules | 10 ampoule P £76.73 DT = £76.73
Adrenaline (base) 1mg/1ml (1 in 1,000) solution for injection ampoules
| 10 ampoule P £6.95 DT = £6.01
Priapism (alternative to intracavernosal injections of
▶ BY INTRACAVERNOSAL INJECTION
▶ Adult: 1 mg every 15 minutes
l UNLICENSED USE Use for priapism is an unlicensed
l CONTRA-INDICATIONS Hypertension
thrombosis . peripheral vascular thrombosis . Prinzmetal’s
variant angina . uncorrected hypovolaemia
l INTERACTIONS → Appendix 1: sympathomimetics,
▶ Common or very common Headache . hypertension
▶ Rare or very rare Skin exfoliation . soft tissue necrosis
▶ Frequency not known Abscess . arrhythmias . nausea . palpitations . peripheral ischaemia
l MONITORING REQUIREMENTS Monitor blood pressure and
l DIRECTIONS FOR ADMINISTRATION For intracavernosal
injection, dilute 1 mg (0.1 mL of 10 mg/mL) metaraminol
injection to 50 mL with Sodium chloride injection 0.9%
and give carefully by slow injection into the corpora in
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: solution for
▶ Metaraminol (Non-proprietary)
Metaraminol (as Metaraminol tartrate) 10 mg per
1 ml Metaraminol 10mg/1ml solution for injection ampoules |
Priapism associated with alprostodil, if aspiration and
lavage of the corpora are unsuccessful (alternative to
▶ BY INTRACAVERNOSAL INJECTION
▶ Adult: 100–200 micrograms every 5–10 minutes, dose
to be administered using a 200 micrograms/mL
solution; maximum 1 mg per course
l UNLICENSED USE Use of phenylephrine hydrochloride
injection in priapism is an unlicensed indication.
l CONTRA-INDICATIONS Hypertension
l INTERACTIONS → Appendix 1: sympathomimetics,
l SIDE-EFFECTS Angle closure glaucoma . anxiety . appetite
l DIRECTIONS FOR ADMINISTRATION For intracavernosal
injection, if suitable strength of phenylephrine injection is
not available, it may be specially prepared by diluting
0.1 mL of the phenylephrine 1% (10 mg/mL) injection to
5 mL with sodium chloride 0.9%.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: solution for
▶ Phenylephrine hydrochloride (Non-proprietary)
Phenylephrine (as Phenylephrine hydrochloride) 50 microgram
per 1 ml Phenylephrine 500micrograms/10ml solution for injection
pre-filled syringes | 1 pre-filled disposable injection P £15.00 |
10 pre-filled disposable injection P £150.00
Phenylephrine hydrochloride 100 microgram per
1 ml Phenylephrine 1mg/10ml solution for injection ampoules | 10 ampoule P £40.00
Phenylephrine hydrochloride 10 mg per 1 ml Phenylephrine
10mg/1ml solution for injection ampoules | 10 ampoule P £99.12
BNF 78 Erectile dysfunction 819
VASODILATORS › PERIPHERAL VASODILATORS
Aviptadil with phentolamine mesilate
smooth muscle, resulting in vasodilatation; aviptadil is a
vasoactive intestinal polypeptide that acts as a smooth
▶ BY INTRACAVERNOSAL INJECTION
▶ Adult: 25/2000 micrograms, frequency of injection
should not exceed once daily or three times weekly,
duration of erection should not exceed 1 hour
DOSE EQUIVALENCE AND CONVERSION
▶ Dose expressed as x/y micrograms of
l CONTRA-INDICATIONS Anatomical deformation of the
penis (e.g. angulation, cavernosal fibrosis, Peyronie’s
disease). not for use with other agents for erectile
dysfunction . patients for whom sexual activity is
inadvisable . penile implants . predisposition to priapism
(e.g. in sickle cell anaemia or trait, multiple myeloma, or
l CAUTIONS Concomitant treatment with anticoagulants
(potential increased risk of bleeding). history of
▶ Common or very common Bruising . flushing
▶ Uncommon Dizziness . haematoma . headache . palpitations .tachycardia
l MONITORING REQUIREMENTS Manufacturer advises
monitor regularly (e.g. every 3 months), particularly in the
initial stages of self-injection therapy; careful examination
of the penis is recommended to detect signs of penile
fibrosis or Peyronie’s disease—discontinue treatment in
patients who develop penile angulation, cavernosal
fibrosis, or Peyronie’s disease.
l DIRECTIONS FOR ADMINISTRATION Manufacturer advises
that the initial injections of Invicorp ® must be
administered by medically trained personnel; selfadministration may only be undertaken after proper
l HANDLING AND STORAGE Manufacturer advises store in a
l PATIENT AND CARER ADVICE Manufacturer advises that
patients should be instructed to report any erection lasting
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (December
2017) that aviptadil with phentolamine (Invicorp ®) is
accepted for restricted use within NHS Scotland for the
symptomatic treatment of erectile dysfunction due to
neurogenic, vasculogenic, psychogenic, or mixed aetiology
in adult males who have failed on oral therapies (oral
phosphodiesterase type-5 inhibitors) and other noninjectable formulations of erectile dysfunction
All Wales Medicines Strategy Group (AWMSG) decisions
The All Wales Medicines Strategy Group has advised (July
2017) that aviptadil with phentolamine (Invicorp ®) is
recommended as an option for the symptomatic treatment
of erectile dysfunction in adult males due to neurogenic,
vasculogenic, psychogenic, or mixed aetiology that has not
responded to oral phosphodiesterase type-5 inhibitor
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Aviptadil 71.43 microgram per 1 ml, Phentolamine mesilate
5.71 mg per 1 ml Invicorp 25micrograms/2mg/0.35ml solution for
injection ampoules | 5 ampoule P £47.50 DT = £47.50
Premature ejaculation 01-Aug-2017
Premature ejaculation is a common male sexual disorder
characterised by brief ejaculatory latency, loss of control,
g Non-drug treatment (including psychosexual
counselling, education, and behavioural treatments) are
recommended in patients for whom premature ejaculation
causes few (if any) problems or in patients who prefer not to
take drug treatment. These techniques can also be used in
For patients with life-long premature ejaculation, drug
treatment is the recommended approach. hDapoxetine
p. 821, a short-acting selective serotonin re-uptake inhibitor,
is licensed to be used when required for this condition (not
g Other selective serotonin re-uptake inhibitors
(citalopram p. 364, fluoxetine p. 365, fluvoxamine maleate
p. 366, escitalopram p. 365, paroxetine p. 366, sertraline
p. 367 [unlicensed indications]) and the tricyclic
antidepressant clomipramine [unlicensed indication] have
been widely used as regular, daily treatment. Caution is
suggested in prescribing selective serotonin re-uptake
inhibitors for young adolescents with premature ejaculation,
and to men who also have a depressive disorder, particularly
when associated with suicidal ideation. Ejaculation delay
may start a few days after the start of treatment, but it is
more evident after 1 to 2 weeks, since receptor
desensitisation requires time to occur.
If premature ejaculation is secondary to erectile
dysfunction p. 812, the erectile dysfunction should be
Topical anaesthetic preparations for the management of
premature ejaculation are available without prescription.
Other drugs used for Premature ejaculation Lidocaine
820 Erectile and ejaculatory conditions BNF 78
l DRUG ACTION Dapoxetine is a short-acting selective
serotonin re-uptake inhibitor.
Premature ejaculation in men who meet all the following
criteria: poor control over ejaculation, a history of
premature ejaculation over the past 6 months, marked
distress or interpersonal difficulty as a consequence of
premature ejaculation, and an intravaginal ejaculatory
latency time of less than two minutes
▶ Adult: Initially 30 mg, to be taken approximately
1–3 hours before sexual activity, subsequent doses
adjusted according to response; review treatment after
4 weeks (or 6 doses) and at least every 6 months
thereafter, not recommended for adults 65 years and
over; maximum 1 dose per day; maximum 60 mg per
DOSE ADJUSTMENTS DUE TO INTERACTIONS
▶ Manufacturer advises max. dose 30 mg with concurrent
use of moderate inhibitors of CYP3A4 except in
patients verified to be extensive CYP2D6 metabolisers
where manufacturer recommends max. dose 60 mg.
▶ Manufacturer advises avoid with concurrent use of
potent inhibitors of CYP3A4 except in patients verified
to be extensive CYP2D6 metabolisers where
manufacturer recommends max. dose 30 mg.
l CONTRA-INDICATIONS History of bipolar disorder. history
l CAUTIONS Bleeding disorders . epilepsy (discontinue if
convulsions develop). susceptibility to angle-closure
l INTERACTIONS → Appendix 1: SSRIs
▶ Common or very common Anxiety . asthenia . concentration
decreased . mydriasis . pruritus .taste altered .thinking
SIDE-EFFECTS, FURTHER INFORMATION Discontinue if
psychiatric disorder develops.
l HEPATIC IMPAIRMENT Manufacturer advises avoid in
moderate to severe impairment.
l RENAL IMPAIRMENT Use with caution if eGFR
l PRE-TREATMENT SCREENING Test for postural hypotension
l TREATMENT CESSATION The dose should preferably be
reduced gradually over about 4 weeks, or longer if
withdrawal symptoms emerge (6 months in patients who
have been on long-term maintenance treatment).
Postural hypotension and syncope Patients should be advised
to maintain hydration and to sit or lie down until
prodromal symptoms such as nausea, dizziness, and
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 2, 25
▶ Priligy (A. Menarini Farmaceutica Internazionale SRL)
Dapoxetine 30 mg Priligy 30mg tablets | 3 tablet P £14.71 DT =
£14.71 | 6 tablet P £26.48 DT = £26.48
Dapoxetine 60 mg Priligy 60mg tablets | 3 tablet P £19.12 DT =
£19.12 | 6 tablet P £34.42 DT = £34.42
Prostaglandins and oxytocics are used to induce abortion or
induce or augment labour and to minimise blood loss from
the placental site. They include oxytocin p. 823, carbetocin
p. 824, ergometrine maleate p. 824, and the prostaglandins.
All induce uterine contractions with varying degrees of pain
according to the strength of contractions induced.
Gemeprost p. 826, a prostaglandin administered vaginally as
pessaries, is suitable for the medical induction of late
therapeutic abortion; gemeprost is also used to ripen the
cervix before surgical abortion, particularly in primigravidas.
The prostaglandin misoprostol p. 827 is given by mouth,
buccally, sublingually, or vaginally, to induce medical
abortion [unlicensed indication]; intravaginal use ripens the
cervix before surgical abortion [unlicensed indication].
Extra-amniotic dinoprostone is rarely used nowadays.
Pre-treatment with mifepristone p. 825 can facilitate the
process of medical abortion. It sensitises the uterus to
subsequent administration of a prostaglandin and, therefore,
abortion occurs in a shorter time and with a lower dose of
Induction and augmentation of labour
Dinoprostone is available as vaginal tablets, pessaries and
vaginal gels for the induction of labour. The intravenous
solution is rarely used; it is associated with more sideeffects.
Oxytocin (Syntocinon ®) is administered by slow
intravenous infusion, using an infusion pump, to induce or
augment labour, usually in conjunction with amniotomy.
Uterine activity must be monitored carefully and
hyperstimulation avoided. Large doses of oxytocin may
result in excessive fluid retention.
Misoprostol is given orally [unlicensed route] or vaginally
NICE Guidance, Induction of labour (updated July 2008),
available at www.nice.org.uk/guidance/CG70.
Prevention and treatment of haemorrhage
Bleeding due to incomplete miscarriage or abortion can be
controlled with ergometrine maleate and oxytocin
(Syntometrine ®) given intramuscularly, the dose is adjusted
according to the patient’s condition and blood loss. This is
commonly used before surgical evacuation of the uterus,
particularly when surgery is delayed. Oxytocin and
ergometrine maleate combined are more effective in early
pregnancy than either drug alone.
Active management of the third stage of labour reduces
the risk of postpartum haemorrhage; oxytocin is given by
intramuscular injection [unlicensed] on delivery of the
anterior shoulder or, at the latest, immediately after the baby
is delivered. Alternatively, ergometrine maleate with
oxytocin (Syntometrine ®) can be given by intramuscular
injection in the absence of hypertension; oxytocin alone
causes less nausea, vomiting, and hypertension than when
given with ergometrine maleate.
In excessive uterine bleeding, any placental products
remaining in the uterus should be removed. Oxytocic drugs
are used to treat postpartum haemorrhage caused by uterine
atony; treatment options are as follows:
. oxytocin by slow intravenous injection, followed in severe
cases by intravenous infusion of oxytocin at a rate that
. ergometrine by intramuscular injection or
. ergometrine by slow intravenous injection (use with
caution—risk of hypertension) or
. ergometrine with oxytocin (Syntometrine ®) by
Carboprost p. 824 has an important role in severe
postpartum haemorrhage unresponsive to ergometrine
Misoprostol [unlicensed] can be used in postpartum
haemorrhage when oxytocin, ergometrine maleate, and
carboprost are not available or are inappropriate.
For termination of pregnancy, a single dose of mifepristone
is followed by administration of a prostaglandin (gemeprost
Guidelines of the Royal College of Obstetricians and
Gynaecologists (November 2011) include [unlicensed]
regimens for inducing medical abortion.
Systemic methotrexate p. 913 [unlicensed indication] is used
for the management of ectopic pregnancy.
Tocolytic drugs postpone premature labour and they are used
with the aim of reducing harm to the child. However, there is
no satisfactory evidence that the use of these drugs reduces
mortality. The greatest benefit is gained by using the delay to
administer corticosteroid therapy or to implement other
measures which improve perinatal health (including transfer
to a unit with neonatal intensive care facility).
The oxytocin receptor antagonist, atosiban p. 825, is
licensed for the inhibition of uncomplicated premature
labour between 24 and 33 weeks of gestation. Atosiban may
be preferable to a beta2 agonist because it has fewer side
effects. The dihydropyridine calcium-channel blocker
nifedipine p. 162 also has fewer side-effects than a beta2
The beta2 agonists salbutamol p. 252 and terbutaline
sulfate p. 255 are licensed for inhibiting uncomplicated
premature labour between 22 and 37 weeks of gestation to
permit a delay in delivery of up to 48 hours. Use of high-dose
short acting beta2 agonists in obstetric indications has been
associated with serious, sometimes fatal cardiovascular
events in the mother and fetus, particularly when used for a
prolonged period of time. Oral therapy is no longer
recommended and parenteral therapy should be restricted to
a maximum duration of 48 hours, given under the
supervision of a specialist, and with close monitoring.
Indometacin p. 1143, a cyclo-oxygenase inhibitor, also
inhibits labour [unlicensed indication] and it can be useful in
situations where a beta2 agonist is not appropriate; however,
there are concerns about neonatal complications such as
transient impairment of renal function and premature
Other drugs used for Induction of labour Misoprostol,
Cervical ripening and induction of labour at term
▶ Adult: 1 pessary, insert pessary (in retrieval device)
high into posterior fornix and remove when cervical
ripening adequate; if oxytocin necessary, remove
30 minutes before oxytocin infusion; remove if cervical
ripening inadequate after 24 hours (dose not to be
▶ Adult: 1 mg, inserted high into the posterior fornix
(avoid administration into the cervical canal), followed
by 1–2 mg after 6 hours if required; maximum 3 mg per
Induction of labour (unfavourable primigravida)
▶ Adult: 2 mg, inserted high into the posterior fornix
(avoid administration into the cervical canal), followed
by 1–2 mg if required, after 6 hours; maximum 4 mg
▶ Adult: 3 mg, inserted high into the posterior fornix,
followed by 3 mg after 6–8 hours, to be given if labour
not established; maximum 6 mg per course
DOSE EQUIVALENCE AND CONVERSION
▶ Prostin E2 Vaginal tablets and Vaginal Gel are not
l CONTRA-INDICATIONS Active cardiac disease . active
pulmonary disease . avoid extra-amniotic route in
difficult or traumatic delivery . history of major uterine
surgery . major cephalopelvic disproportion . multiple
pregnancy . placenta praevia or unexplained vaginal
bleeding during pregnancy .ruptured membranes . untreated pelvic infection
disseminated intravascular coagulation . uterine rupture . uterine scarring
▶ Rare or very rare Disseminated intravascular coagulation
▶ Frequency not known Abdominal pain . diarrhoea . genital
oedema . nausea . uterine rupture . vomiting
l HEPATIC IMPAIRMENT Manufacturer advises avoid.
l RENAL IMPAIRMENT Manufacturers advise avoid.
▶ Monitor for disseminated intravascular coagulation after
▶ Monitor uterine activity and fetal status (particular care if
▶ Care needed in monitoring uterine activity when used in
l DIRECTIONS FOR ADMINISTRATION
▶ With intravenous use For intravenous infusion (Prostin E2 ®)
give continuously or intermittently in Glucose 5% or
l PRESCRIBING AND DISPENSING INFORMATION Important:
Do not confuse dose of Prostin E2 ®vaginal gel with that of
Prostin E2 ®vaginal tablets—not bioequivalent.
l LESS SUITABLE FOR PRESCRIBING Intravenous solution
rarely used and is considered less suitable for prescribing.
Extra-amniotic solution less commonly used and is
considered less suitable for prescribing.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Dinoprostone 3 mg Prostin E2 3mg vaginal tablets |
8 pessary P £106.23 (Hospital only)
Dinoprostone 400 microgram per 1 ml Prostin E2 1mg vaginal gel
| 2.5 ml P £13.28 (Hospital only)
Dinoprostone 800 microgram per 1 ml Prostin E2 2mg vaginal gel
| 2.5 ml P £13.28 (Hospital only)
▶ Propess (Ferring Pharmaceuticals Ltd)
Dinoprostone 10 mg Propess 10mg vaginal delivery system |
Induction of labour for medical reasons | Stimulation of
labour in hypotonic uterine inertia
▶ Adult: Initially 0.001–0.004 unit/minute, not to be
started for at least 6 hours after administration of
vaginal prostaglandin, dose increased at intervals of at
least 30 minutes until a maximum of 3–4 contractions
occur every 10 minutes (0.01 units/minute is often
adequate) up to max. 0.02 units/minute, if regular
contractions not established after a total 5 units, stop
induction attempt (may be repeated next day starting
again at 0.001–0.004 units/minute)
▶ BY SLOW INTRAVENOUS INJECTION
▶ Adult: 5 units immediately after delivery
Prevention of postpartum haemorrhage after delivery of
▶ BY SLOW INTRAVENOUS INJECTION
▶ Adult: 5 units, if infusion previously used for induction
or enhancement of labour, increase rate during third
▶ Adult: 10 units, can be used instead of oxytocin with
Treatment of postpartum haemorrhage
▶ BY SLOW INTRAVENOUS INJECTION
▶ Adult: 5 units, repeated if necessary
Treatment of severe cases of postpartum haemorrhage
(following intravenous injection)
▶ Adult: 40 units, given in 500 mL infusion fluid given at
a rate sufficient to control uterine atony
Incomplete, inevitable, or missed miscarriage
▶ INITIALLY BY SLOW INTRAVENOUS INJECTION
▶ Adult: 5 units, followed by (by intravenous infusion)
0.02–0.04 unit/minute if required, the rate of infusion
l UNLICENSED USE Oxytocin doses in the BNF may differ
from those in the product literature. Administration by
intramuscular injection is an unlicensed use.
Prolonged intravenous administration at high doses with
large volume of fluid (which is possible in inevitable or
missed miscarriage or postpartum haemorrhage) may
cause water intoxication with hyponatraemia. To avoid:
use electrolyte-containing diluent (i.e. not glucose),
increase oxytocin concentration to reduce fluid, restrict
fluid intake by mouth; monitor fluid and electrolytes.
l CONTRA-INDICATIONS Any condition where spontaneous
labour inadvisable . any condition where vaginal delivery
uterine inertia . avoid rapid intravenous injection (may
transiently reduce blood pressure). fetal distress
(discontinue immediately if this occurs). hypertonic
uterine contractions (discontinue immediately if this
occurs). severe cardiovascular disease . severe preeclamptic toxaemia
l CAUTIONS Avoid large infusion volumes and restrict fluid
intake by mouth (risk of hyponatraemia and waterintoxication). enhancement of labour—presence of
borderline cephalopelvic disproportion (avoid if
significant) . history of lower-uterine segment caesarean
section . induction of labour—presence of borderline
cephalopelvic disproportion (avoid if significant). mild
pregnancy-induced cardiac disease . mild pregnancyinduced hypertension . moderate pregnancy-induced
cardiac disease . moderate pregnancy-induced
hypertension .risk factors for disseminated intravascular
coagulation . secondary uterine inertia . women over
▶ Common or very common Arrhythmias . headache . nausea . vomiting
▶ Rare or very rare Dyspnoea . hypotension .rash
▶ Frequency not known Angioedema . disseminated
SIDE-EFFECTS, FURTHER INFORMATION Avoid rapid
intravenous injection (may transiently reduce blood
Uterine hyperstimulation -usually with excessive
doses—may cause fetal distress, asphyxia, and death, or
may lead to hypertonicity, tetanic contractions, soft-tissue
Overdose Placental abruption and amniotic fluid embolism
▶ Careful monitoring of fetal heart rate and uterine motility
▶ Monitor for disseminated intravascular coagulation after
l DIRECTIONS FOR ADMINISTRATION For intravenous infusion
(Syntocinon ®), give continuously in Glucose 5% or Sodium
chloride 0.9%. Preferably given via a variable-speed
infusion pump in a concentration appropriate to the
pump; if given by drip infusion for induction or
enhancement of labour, dilute 5 units in 500 mL infusion
fluid or for higher doses, 10 units in 500 mL; for treatment
of postpartum uterine haemorrhage dilute 40 units in
500 mL; if high doses given for prolonged period (e.g. for
inevitable or missed abortion or for postpartum
BNF 78 Induction of labour 823
concentration than for induction or enhancement of
labour; close attention to patient’s fluid and electrolyte
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: infusion, solution
Oxytocin 5 unit per 1 ml Oxytocin 5units/1ml solution for injection
ampoules | 5 ampoule P s (Hospital only)
Oxytocin 10 unit per 1 ml Oxytocin 10units/1ml solution for infusion
ampoules | 5 ampoule P £15.00 | 10 ampoule P £20.00
Oxytocin 10units/1ml concentrate for solution for infusion ampoules |
5 ampoule P £4.55 | 10 ampoule P £9.00
Oxytocin 10units/1ml solution for injection ampoules | 5 ampoule P s (Hospital only)
Oxytocin 5 unit per 1 ml Syntocinon 5units/1ml solution for injection
ampoules | 5 ampoule P £4.01 (Hospital only)
Oxytocin 10 unit per 1 ml Syntocinon 10units/1ml solution for
injection ampoules | 5 ampoule P £4.53 (Hospital only)
Other drugs used for Postpartum haemorrhage Oxytocin,
Prevention of uterine atony after caesarean section
▶ BY SLOW INTRAVENOUS INJECTION
▶ Adult: 100 micrograms for 1 dose, to be given over
1 minute, administer as soon as possible after delivery,
preferably before removal of placenta
l CONTRA-INDICATIONS Eclampsia . epilepsy . pre-eclampsia
l CAUTIONS Asthma . cardiovascular disease (avoid if
severe). hyponatraemia . migraine
▶ Frequency not known Hyperhidrosis .tachycardia
l HEPATIC IMPAIRMENT Manufacturer advises avoid in
l RENAL IMPAIRMENT Manufacturer advises avoid.
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (January
2018) that carbetocin (Pabal ®) is not recommended for
use within NHS Scotland for the prevention of uterine
atony following delivery of the infant by Caesarean section
under epidural or spinal anaesthesia as the economic case
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Pabal (Ferring Pharmaceuticals Ltd)
Carbetocin 100 microgram per 1 ml Pabal 100micrograms/1ml
solution for injection vials | 5 vial P £88.20 (Hospital only)
Postpartum haemorrhage due to uterine atony in patients
unresponsive to ergometrine and oxytocin
▶ BY DEEP INTRAMUSCULAR INJECTION
▶ Adult: 250 micrograms, repeated if necessary, to be
given at intervals of not less than 15 minutes. Total
dose should not exceed 2 mg (8 doses)
l CONTRA-INDICATIONS Cardiac disease . pulmonary disease . untreated pelvic infection
l HEPATIC IMPAIRMENT Manufacturer advises avoid in
l RENAL IMPAIRMENT Manufacturer advises avoid.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Carboprost (as Carboprost trometamol) 250 microgram per
1 ml Hemabate 250micrograms/1ml solution for injection ampoules
| 10 ampoule P £182.01 (Hospital only)
Ergometrine maleate 14-Jul-2018
Postpartum haemorrhage caused by uterine atony
▶ BY INTRAMUSCULAR INJECTION, OR BY SLOW INTRAVENOUS
cardiac disease . severe hypertension . vascular disease
associated with intravenous administration
l INTERACTIONS → Appendix 1: ergometrine
l HEPATIC IMPAIRMENT Manufacturer advises caution in
mild to moderate impairment; avoid in severe impairment.
l RENAL IMPAIRMENT Manufacturer advises caution in mild
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