Missed doses When used as an oral contraceptive, the
following advice is recommended ‘If you forget a pill, take
it as soon as you remember and carry on with the next pill
at the right time. If the pill was more than 3 hours overdue
you are not protected. Continue normal pill-taking but you
must also use another method, such as the condom, for the
The Faculty of Sexual and Reproductive Healthcare
recommends emergency contraception if one or more
progestogen-only contraceptive tablets are missed or
taken more than 3 hours late and unprotected intercourse
has occurred before 2 further tablets have been correctly
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (February
2018) that levonorgestrel (Kyleena ®) is accepted for use
within NHS Scotland as a contraceptive device for up to
All Wales Medicines Strategy Group (AWMSG) decisions
The All Wales Medicines Strategy Group has advised
(September 2018) that levonorgestrel (Kyleena ®) is
recommended as an option for use within NHS Wales for
contraception for up to five years.
l EXCEPTIONS TO LEGAL CATEGORY Levonelle ® One Step can
be sold to women over 16 years; when supplying
emergency contraception to the public, pharmacists
should refer to guidance issued by the Royal
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Levonorgestrel 13.5 mg Jaydess 13.5mg intra-uterine device | 1 device P £69.22 DT = £69.22
Levonorgestrel 19.5 mg Kyleena 19.5mg intra-uterine device | 1 device P £76.00 DT = £76.00
▶ Levosert (Gedeon Richter (UK) Ltd)
Levonorgestrel 20 microgram per 24 hour Levosert
20micrograms/24hours intra-uterine device | 1 device P £66.00
Levonorgestrel 20 microgram per 24 hour Mirena
20micrograms/24hours intra-uterine device | 1 device P £88.00
▶ Levonorgestrel (Non-proprietary)
Levonorgestrel 1.5 mg Levonorgestrel 1.5mg tablets | 1 tablet P £3.74–£5.20 DT = £5.20
▶ Emerres (Morningside Healthcare Ltd)
Levonorgestrel 1.5 mg Emerres 1.5mg tablets | 1 tablet P £3.65
Levonorgestrel 1.5 mg Ezinelle 1.5mg tablets | 1 tablet P £9.64
Levonorgestrel 1.5 mg Levonelle 1500microgram tablets | 1 tablet P £5.20 DT = £5.20
▶ Levonelle One Step (Bayer Plc)
Levonorgestrel 1.5 mg Levonelle One Step 1.5mg tablets | 1 tablet p £13.83 DT = £5.20
▶ Melkine (Crescent Pharma Ltd)
Levonorgestrel 1.5 mg Melkine 1.5mg tablets | 1 tablet P £4.16
Levonorgestrel 30 microgram Norgeston 30microgram tablets |
▶ Upostelle (Consilient Health Ltd)
Levonorgestrel 1.5 mg Upostelle 1500microgram tablets | 1 tablet P £3.75 DT = £5.20
Other drugs used for Contraception, parenteral
progestogen-only Norethisterone, p. 764
Contraception (no hormonal contraceptive use in previous
▶ Females of childbearing potential: 1 implant inserted
during first 5 days of cycle, implant should be removed
▶ Females of childbearing potential: 1 implant to be
inserted 21–28 days after delivery (delay until 28 days
postpartum if breast-feeding), implant should be
removed within 3 years of insertion
Contraception following abortion or miscarriage in the
▶ Females of childbearing potential: 1 implant to be
inserted 21–28 days after abortion or miscarriage,
implant should be removed within 3 years of insertion
Contraception following abortion or miscarriage in the
▶ Females of childbearing potential: 1 implant to be
inserted within 5 days after abortion or miscarriage,
implant should be removed within 3 years of insertion
Contraception (changing from other hormonal
▶ Females of childbearing potential: Implant should be
removed within 3 years of insertion (consult product
l UNLICENSED USE Nexplanon ® not licensed for use in
females outside of the age range 18–40 years.
MHRA/CHM ADVICE (JUNE 2016): NEXPLANON ® (ETONOGESTREL)
CONTRACEPTIVE IMPLANTS: REPORTS OF DEVICE IN
There have been rare reports of Nexplanon ® implants
reaching the lung via the pulmonary artery. An implant
that cannot be palpated at its insertion site should be
located and removed as soon as possible; if unable to
locate implant within the arm, the MHRA recommends
using chest imaging. Correct subdermal insertion
reduces the risk of these events.
l CONTRA-INDICATIONS Acute porphyrias p. 1058 . history
of breast cancer but can be used after 5 years if no evidence
of disease and non-hormonal contraceptive methods
unacceptable . severe arterial disease . undiagnosed
l CAUTIONS Active trophoblastic disease (until return to
normal of urine- and plasma-gonadotrophin
pregnancy of deterioration of otosclerosis . history during
pregnancy of pruritus . history of jaundice in pregnancy .
BNF 78 Contraception, parenteral progestogen-only 809
erythematosus with positive (or unknown)
l INTERACTIONS → Appendix 1: etonogestrel
abnormalities . hypertrichosis . insomnia . myalgia . oedema . vomiting . vulvovaginal discomfort
▶ Frequency not known Abscess . angioedema . embolism and
thrombosis . haemorrhage . insulin resistance . neoplasms . paraesthesia . seborrhoea
SIDE-EFFECTS, FURTHER INFORMATION The benefits of
using progestogen-only contraceptives (POCs), such as
etonogestrel, should be weighed against the possible risks
There is a small increase in the risk of having breast
cancer diagnosed in women using a combined oral
contraceptive pill (COC); this relative risk may be due to an
earlier diagnosis, biological effects of the pill or a
combination of both. This increased risk is related to the
age of the woman using the COC rather than the duration
of use and disappears gradually within 10 years after
The risk of breast cancer in users of POCs is possibly of
similar magnitude as that associated with COCs, however
the evidence is less conclusive.
l PREGNANCY Not known to be harmful, remove implant if
l BREAST FEEDING Progestogen-only contraceptives do not
l DIRECTIONS FOR ADMINISTRATION The doctor or nurse
administering (or removing) the system should be fully
trained in the technique and should provide full
counselling reinforced by the patient information leaflet.
l PATIENT AND CARER ADVICE Full counselling backed by
patient information leaflet required before administration.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Nexplanon (Merck Sharp & Dohme Ltd)
Etonogestrel 68 mg Nexplanon 68mg implant | 1 device P £83.43 DT = £83.43
Medroxyprogesterone acetate 24-May-2017
Dysfunctional uterine bleeding
▶ Adult: 2.5–10 mg daily for 5–10 days, repeated for
2 cycles, begin treatment on day 16–21 of cycle
▶ Adult: 2.5–10 mg daily for 5–10 days, repeated for
3 cycles, begin treatment on day 16–21 of cycle
Mild to moderate endometriosis
▶ Adult: 10 mg 3 times a day for 90 consecutive days,
begin treatment on day 1 of cycle
Progestogenic opposition of oestrogen HRT
▶ Adult: 10 mg daily for the last 14 days of each 28-day
Endometrial cancer | Renal cell cancer
▶ BY DEEP INTRAMUSCULAR INJECTION
▶ Females of childbearing potential: 150 mg, to be
administered within the first 5 days of cycle or within
first 5 days after parturition (delay until 6 weeks after
parturition if breast-feeding)
▶ Females of childbearing potential: 104 mg, to be
administered within first 5 days of cycle or within
5 days postpartum (delay until 6 weeks postpartum if
breast-feeding), injected into anterior thigh or
abdomen, dose only suitable if no hormonal
contraceptive use in previous month
▶ BY DEEP INTRAMUSCULAR INJECTION
▶ Females of childbearing potential: 150 mg every
12 weeks, first dose to be administered within the first
5 days of cycle or within first 5 days after parturition
(delay until 6 weeks after parturition if breast-feeding)
▶ Females of childbearing potential: 104 mg every
13 weeks, first dose to be administered within first
5 days of cycle or within 5 days postpartum (delay until
6 weeks postpartum if breast-feeding), injected into
anterior thigh or abdomen, dose only suitable if no
hormonal contraceptive use in previous month
Contraception (when patient changing from other
▶ Females of childbearing potential: (consult product
Hot flushes caused by long-term androgen suppression in
▶ Adult: 20 mg once daily initially for 10 weeks, evaluate
effect at the end of the treatment period
l UNLICENSED USE g Medroxyprogesterone acetate is
used for the treatment of hot flushes caused by long-term
androgen suppression in men, hbut it is not licensed for
Acute porphyrias p. 1058 . severe arterial disease . undiagnosed vaginal bleeding
▶ With intramuscular use or subcutaneous use history of breast
cancer but can be used after 5 years if no evidence of
disease and non-hormonal contraceptive methods
▶ With oral use breast cancer (unless progestogens are being
used in the management of this condition). genital cancer
(unless progestogens are being used in the management of
this condition). history of liver tumours
GENERAL CAUTIONS Possible risk of breast cancer
▶ With intramuscular use or subcutaneous use history during
pregnancy in disturbances of lipid metabolism . history
during pregnancy of deterioration of otosclerosis . history
▶ With oral use Asthma . cardiac dysfunction . conditions that
may worsen with fluid retention . diabetes (progestogens
l INTERACTIONS → Appendix 1: medroxyprogesterone
▶ With parenteral use Anxiety . asthenia . gastrointestinal
discomfort. headaches . mood altered . pain . vulvovaginal
▶ With parenteral use Appetite abnormal . arthralgia . hot
flush . hypertension . ovarian cyst. painful sexual
intercourse . uterine haemorrhage . varicose veins . vertigo . vulvovaginal disorders
▶ With oral use Cerebral infarction . jaundice . malaise . myocardial infarction
▶ With parenteral use Breast cancer. lipodystrophy
papilloedema or retinal vascular lesions)
▶ With parenteral use Hepatic disorders . osteoporosis . osteoporotic fractures . seizure
SIDE-EFFECTS, FURTHER INFORMATION
With oral use In general, side effects may be more
common with high doses such as those used in malignant
With parenteral use Reduction in bone mineral
density is greater with increasing duration of use. The loss
is mostly recovered on discontinuation.
l CONCEPTION AND CONTRACEPTION
▶ With intramuscular use If interval between dose is greater
than 12 weeks and 5 days (in long-term contraception),
rule out pregnancy before next injection and advise
patient to use additional contraceptive measures (e.g.
barrier) for 14 days after the injection.
▶ With subcutaneous use If interval between dose is greater
than 13 weeks and 7 days (in long-term contraception),
rule out pregnancy before next injection.
▶ With oral use Avoid—genital malformations and cardiac
▶ With intramuscular use or subcutaneous use Not known to be
l BREAST FEEDING Present in milk—no adverse effects
reported. Progestogen-only contraceptives do not affect
▶ With intramuscular use or subcutaneous use The
birth; however, evidence suggests no harmful effect to
infant if given earlier. The benefits of using
medroxyprogesterone acetate in breast-feeding women
l HEPATIC IMPAIRMENT Avoid in liver tumour.
▶ With oral use Avoid in hepatic impairment.
▶ With intramuscular use or subcutaneous use Caution in severe
liver disease and recurrent cholestatic jaundice.
▶ When used for Mild to moderate endometriosis or Progestogenic
opposition of oestrogen HRT or Dysfunctional uterine bleeding or
Secondary amenorrhoea Use with caution.
▶ With intramuscular use or subcutaneous use Full counselling
backed by patient information leaflet required before
administration—likelihood of menstrual disturbance and
the potential for a delay in return to full fertility. Delayed
return of fertility and irregular cycles may occur after
discontinuation of treatment but there is no evidence of
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: oral suspension, oral
▶ Climanor (ReSource Medical UK Ltd)
Medroxyprogesterone acetate 5 mg Climanor 5mg tablets |
Medroxyprogesterone acetate 2.5 mg Provera 2.5mg tablets | 30 tablet P £1.84 DT = £1.84
Medroxyprogesterone acetate 200 mg Provera 200mg tablets | 30 tablet P £29.65 DT = £29.65
Medroxyprogesterone acetate 400 mg Provera 400mg tablets | 30 tablet P £58.67 DT = £58.67
Medroxyprogesterone acetate 150 mg per 1 ml Depo-Provera
150mg/1ml suspension for injection pre-filled syringes | 1 pre-filled
disposable injection P £6.01 DT = £6.01
Medroxyprogesterone acetate 160 mg per 1 ml Sayana Press
104mg/0.65 ml suspension for injection pre-filled disposable devices
| 1 pre-filled disposable injection P £6.90 DT = £6.90
3.6 Contraception, spermicidal
Spermicidal contraceptive in conjunction with barrier
methods of contraception such as diaphragms or caps
▶ Females of childbearing potential: (consult product
l SIDE-EFFECTS Genital erosion . increased risk of HIV
infection . pain . paraesthesia . skin reactions . vaginal
SIDE-EFFECTS, FURTHER INFORMATION High frequency use
of the spermicide nonoxinol-9 has been associated with
genital lesions, which may increase the risk of acquiring
sexually transmitted infections.
BNF 78 Contraception, spermicidal 811
l CONCEPTION AND CONTRACEPTION No evidence of harm to
l PREGNANCY Toxicity in animal studies.
l BREAST FEEDING Present in milk in animal studies.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Hydroxybenzoates (parabens), propylene
▶ Gygel (Marlborough Pharmaceuticals Ltd)
Nonoxinol-9 20 mg per 1 ml Gygel 2% contraceptive jelly | 81 gram G £11.00
Erectile dysfunction 06-Mar-2017
Erectile dysfunction (impotence) is the persistent inability to
attain and maintain an erection that is sufficient to permit
satisfactory sexual performance. It can have physical or
antipsychotics, cytotoxic drugs and recreational drugs
Risk factors for erectile dysfunction include sedentary
lifestyle, obesity, smoking, hypercholesterolaemia and
metabolic syndrome. Erectile dysfunction increases the risk
of cardiovascular disease. All men with unexplained erectile
dysfunction should be evaluated for the presence of
cardiovascular risk factors and any identified risk should be
g The recommended approach for the management of
erectile dysfunction is a combination of drug treatment and
lifestyle changes (including regular exercise, reduction in
body mass index, Smoking cessation p. 497, and reduced
An oral phosphodiesterase type-5 inhibitor is the first-line
drug treatment for erectile dysfunction, regardless of the
cause. hThese drugs act by increasing the blood flow to
the penis. They do not initiate an erection—sexual
The choice of oral phosphodiesterase type-5 inhibitor
depends on the frequency of intercourse and response to
treatment.g Avanafil below, sildenafil p. 813 and
vardenafil p. 816 are short-acting drugs and are suitable for
occasional use as required. Tadalafil p. 814 is a longer-acting
drug. It can be used as required, but can also be used as a
regular lower daily dose to allow for spontaneous (rather
than scheduled) sexual activity or in those who have
frequent sexual activity. A patient with erectile dysfunction
should receive six doses of an individual phosphodiesterase
type-5 inhibitor at the maximum dose (with sexual
stimulation) before being classified as a non-responder.
Patients who fail to respond to the maximum dose of at least
two different phosphodiesterase type-5 inhibitors should be
Intracavernosal, intraurethral or topical application of
alprostadil (prostaglandin E1) p. 816 is recommended as
second-line therapy under careful medical supervision.
Intracavernosal or intraurethral preparations can also be
Priapism associated with alprostadil
Manufacturers advise that patients should seek medical help
if a prolonged erection lasting four hours or more occurs;
application of an ice pack to the upper-inner thigh
(alternating between the left and right thighs every two
minutes for up to ten minutes) may result in reflex opening
If priapism has lasted more than six hours, treatment
should not be delayed; manufacturer advises management as
. Initial therapy by penile aspiration: using aseptic
technique, 20–50mL of blood should be aspirated using a
19–21 gauge butterfly needle inserted into the corpus
cavernosum; if necessary the procedure may be repeated on
. Lavage: if initial aspiration is unsuccessful, a second 19–21
gauge butterfly needle can be inserted into the opposite
corpus cavernosum; sterile physiological saline can be
injected through the first needle and drained through the
. If aspiration and lavage of are unsuccessful,
intracavernosal injection of a sympathomimetic with
action on alpha-adrenergic receptors can be given, with
continuous monitoring of blood pressure and pulse— see
phenylephrine hydrochloride p. 189 [unlicensed
indication], adrenaline/epinephrine p. 818 [unlicensed
indication], and metaraminol p. 187 [unlicensed
indication]. Extreme caution is required in patients with
coronary heart disease, hypertension, cerebral ischaemia
and in patients taking a monoamine-oxidase inhibitor
(facilities for managing hypertensive crisis should be
available when administered to patients taking MAOIs);
. If necessary the sympathomimetic injections can be
followed by further aspiration of blood through the same
. If administration of a sympathomimetic drug is
unsuccessful, urgent referral for surgical management is
Some drug treatments for erectile dysfunction may only be
prescribed on the NHS under certain circumstances; for
details see 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 Drug Tariffs can be accessed
online at: National Health Service Drug Tariff for England
and Wales: www.nhsbsa.nhs.uk/pharmacies-gp-practices-andappliance-contractors/drug-tariff.
Health and Personal Social Services for Northern Ireland
Drug Tariff: www.hscbusiness.hscni.net/services/2034.htm.
Scottish Drug Tariff: www.isdscotland.org/Health-Topics/
Prescribing-and-Medicines/Scottish-Drug-Tariff/.
Other drugs used for Erectile dysfunction: aviptadil with
PHOSPHODIESTERASE TYPE-5 INHIBITORS
▶ Adult: Initially 100 mg, to be taken approximately
15–30 minutes before sexual activity, then adjusted
according to response to 50–200 mg (max. per dose
200 mg), to be taken as a single dose as needed;
812 Erectile and ejaculatory conditions BNF 78
Erectile dysfunction in patients on alpha-blocker therapy
▶ Adult: Initially 50 mg, to be taken approximately
15–30 minutes before sexual activity, then adjusted
according to response to 50–200 mg (max. per dose
200 mg), to be taken as a single dose as needed;
DOSE ADJUSTMENTS DUE TO INTERACTIONS
▶ Manufacturer advises max. 100 mg once every 48 hours
with concurrent use of moderate inhibitors of CYP3A4.
l CONTRA-INDICATIONS Avoid if systolic blood pressure
below 90 mmHg (no information available). blood pressure
>170/100 mmHg . hereditary degenerative retinal
disorders . history of non-arteritic anterior ischaemic optic
neuropathy . life-threatening arrhythmia in previous
6 months . mild to severe heart failure . patients in whom
vasodilation or sexual activity are inadvisable .recent
history of myocardial infarction .recent history of stroke . recent unstable angina
l CAUTIONS Active peptic ulceration . anatomical
deformation of the penis (e.g. angulation, cavernosal
obstruction . predisposition to priapism (e.g. in sickle-cell
disease, multiple myeloma, or leukaemia)
l INTERACTIONS → Appendix 1: phosphodiesterase type-5
▶ Common or very common Headaches . nasal complaints . vasodilation
▶ Uncommon Asthenia . dizziness . drowsiness . dyspnoea
exertional . gastrointestinal discomfort. muscle
complaints . nausea . pain . palpitations .respiratory
disorders . vision blurred . vomiting
l HEPATIC IMPAIRMENT Manufacturer advises avoid in
Dose adjustments Manufacturer advises use lowest
effective initial dose in mild to moderate impairment and
adjust according to tolerance.
l RENAL IMPAIRMENT Avoid if eGFR less than
l PATIENT AND CARER ADVICE Onset of effect may be
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (September
2015) that avanafil (Spedra ®) is not recommended for use
within NHS Scotland, for treatment of erectile dysfunction
in men as the clinical and economic analysis presented
All Wales Medicines Strategy Group (AWMSG) decisions
The All Wales Medicines Strategy Group has advised (July
2015) that avanafil (Spedra ®) is recommended as an option
for use within NHS Wales for the treatment of erectile
NHS restrictions Spedra ® 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. The prescription must be endorsed ’SLS’.
For more information see Prices in the BNF, under How to
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Spedra (A. Menarini Farmaceutica Internazionale SRL)
Avanafil 50 mg Spedra 50mg tablets | 4 tablet P £10.94 DT =
£10.94 | 8 tablet P £19.70 DT = £19.70
Avanafil 100 mg Spedra 100mg tablets | 4 tablet P £14.08 DT =
£14.08 | 8 tablet P £26.26 DT = £26.26
Avanafil 200 mg Spedra 200mg tablets | 4 tablet P £21.90 DT =
£21.90 | 8 tablet P £39.40 DT = £39.40
Pulmonary arterial hypertension (initiated under
▶ Adult: 10 mg 3 times a day, use intravenous route when
the oral route is not appropriate
▶ Adult: Initially 50 mg, to be taken approximately 1 hour
before sexual activity, adjusted according to response
to 25–100 mg (max. per dose 100 mg) as required, to be
taken as a single dose; maximum 1 dose per day
Digital ulcers [associated with systemic sclerosis]
▶ Adult: 25 mg 3 times a day, increased to 50 mg 3 times
DOSE ADJUSTMENTS DUE TO INTERACTIONS
▶ When used for Erectile dysfunction Manufacturer advises a
starting dose of 25 mg with concurrent use of moderate
and potent inhibitors of CYP3A4. Manufacturer advises if
concurrent use of ritonavir is unavoidable, the max. dose
should not exceed 25 mg within 48 hours.
▶ With oral use for Pulmonary arterial hypertension
Manufacturer advises reduce dose to 20 mg twice daily
with concurrent use of moderate inhibitors of CYP3A4.
Manufacturer advises reduce dose to 20 mg once daily with
concurrent use of some potent inhibitors of CYP3A4 (avoid
with ketoconazole, itraconazole and ritonavir).
▶ With intravenous use for Pulmonary arterial hypertension
Manufacturer advises reduce dose to 10 mg twice daily
with concurrent use of moderate inhibitors of CYP3A4.
Manufacturer advises reduce dose to 10 mg once daily with
concurrent use of some potent inhibitors of CYP3A4 (avoid
with ketoconazole, itraconazole and ritonavir).
l UNLICENSED USE g Sildenafil is used for the treatment
of digital ulcer, lbut is not licensed for this indication.
history of myocardial infarction .recent history of stroke
▶ When used for erectile dysfunction Avoid if systolic blood
inadvisable .recent unstable angina
▶ When used for pulmonary arterial hypertension Sickle-cell
GENERAL CAUTIONS Active peptic ulceration . bleeding
disorders . cardiovascular disease . left ventricular outflow
BNF 78 Erectile dysfunction 813
▶ When used for erectile dysfunction Anatomical deformation of
the penis (e.g. angulation, cavernosal fibrosis, Peyronie’s
disease). predisposition to priapism (e.g. in sickle-cell
disease, multiple myeloma, or leukaemia)
▶ When used for pulmonary arterial hypertension Anatomical
90 mmHg). intravascular volume depletion . predisposition to priapism . pulmonary veno-occlusive
l INTERACTIONS → Appendix 1: phosphodiesterase type-5
complaints . nausea . night sweats . pain . skin reactions . tremor. vasodilation . vision disorders
impairment occurs). oral hypoaesthesia . priapism .retinal
occlusion . scleral discolouration . seizure . severe
cutaneous adverse reactions (SCARs). sudden cardiac
death . syncope .throat tightness
l PREGNANCY Use only if potential benefit outweighs risk—
no evidence of harm in animal studies.
l BREAST FEEDING Manufacturer advises avoid—no
l HEPATIC IMPAIRMENT Manufacturer advises caution in
mild to moderate impairment; avoid in severe impairment
▶ With intravenous use for Pulmonary arterial
hypertension Manufacturer advises if usual dose not
tolerated, consider dose reduction to 10 mg twice daily in
▶ With oral use for Pulmonary arterial hypertension
Manufacturer advises if usual dose not tolerated, consider
dose reduction to 20 mg twice daily in mild to moderate
▶ When used for Erectile dysfunction Manufacturer advises
consider initial dose reduction to 25 mg in mild to
moderate impairment; adjust according to response.
Dose adjustments Use initial dose of 25 mg in erectile
dysfunction if eGFR less than 30 mL/minute/1.73 m2
In pulmonary hypertension, if usual dose not tolerated,
reduce oral dose to 20 mg twice daily and intravenous dose
▶ When used for Pulmonary arterial hypertension Consider
▶ When used for Erectile dysfunction Onset of effect may be
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (February
2010) that sildenafil tablets (Revatio ®) is accepted for
restricted use within NHS Scotland and should be initiated
for patients with pulmonary arterial hypertension only by
specialists in the Scottish Pulmonary Vascular Unit or
The Scottish Medicines Consortium has advised (March
2011) that sildenafil injection (Revatio ®) is accepted for
restricted use within NHS Scotland for patients with
pulmonary arterial hypertension who are currently
prescribed oral sildenafil and are temporarily unable to
take oral medicine, and should be prescribed only on the
advice of specialists in the Scottish Pulmonary Vascular
Unit or the Scottish Adult Congenital Cardiac Service.
NHS restrictions Viagra ® is not prescribable in NHS
primary care for 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. Forms available
from special-order manufacturers include: oral suspension, oral
▶ Sildenafil (Non-proprietary)
Sildenafil (as Sildenafil citrate) 20 mg Sildenafil 20mg tablets | 90 tablet P £446.33 DT = £446.33
Sildenafil (as Sildenafil citrate) 100 mg Sildenafil 100mg tablets |
4 tablet P £23.50 DT = £0.80 | 8 tablet P £1.44–£46.99 | 12 tablet P £3.69
▶ Granpidam (Accord Healthcare Ltd)
Sildenafil (as Sildenafil citrate) 20 mg Granpidam 20mg tablets | 90 tablet P £424.01 DT = £446.33
Sildenafil (as Sildenafil citrate) 20 mg Mysildecard 20mg tablets | 90 tablet P £379.38 DT = £446.33
Sildenafil (as Sildenafil citrate) 20 mg Revatio 20mg tablets |
90 tablet P £446.33 DT = £446.33
▶ Viagra (Pfizer Ltd, Pfizer Consumer Healthcare Ltd)
▶ Vizarsin (Consilient Health Ltd)
Sildenafil (as Sildenafil citrate) 25 mg Vizarsin 25mg tablets |
Sildenafil (as Sildenafil citrate) 50 mg Vizarsin 50mg tablets | 4 tablet P £18.07 DT = £0.71
Sildenafil (as Sildenafil citrate) 100 mg Vizarsin 100mg tablets | 4 tablet P £19.97 DT = £0.80
Sildenafil (as Sildenafil citrate).8 mg per 1 ml Revatio
10mg/12.5ml solution for injection vials | 1 vial P £45.28
Sildenafil (as Sildenafil citrate) 10 mg per 1 ml Revatio 10mg/ml
oral suspension sugar-free | 112 ml P £186.75 DT = £186.75
Pulmonary arterial hypertension (initiated under
814 Erectile and ejaculatory conditions BNF 78
▶ Adult: Initially 10 mg (max. per dose 20 mg), to be
taken at least 30 minutes before sexual activity,
subsequent doses adjusted according to response, the
effect of intermittent dosing may persist for longer
than 24 hours, continuous daily use not recommended;
Erectile dysfunction; for patients who anticipate sexual
activity at least twice a week
▶ Adult: 5 mg once daily, reduced to 2.5 mg once daily,
adjusted according to response
History of non-arteritic anterior ischaemic optic
▶ When used for benign prostatic hyperplasia hypotension (avoid
if systolic blood pressure below 90 mmHg). mild to severe
heart failure . myocardial infarction . patients in whom
vasodilation or sexual activity are inadvisable .recent
stroke . uncontrolled arrhythmias . uncontrolled
hypertension . unstable angina
▶ When used for erectile dysfunction hypotension (avoid if
systolic blood pressure below 90 mmHg). mild to severe
heart failure . myocardial infarction . patients in whom
vasodilation or sexual activity are inadvisable .recent
stroke . uncontrolled arrhythmias . uncontrolled
hypertension . unstable angina
▶ When used for pulmonary arterial hypertension acute
myocardial infarction in past 90 days
▶ When used for benign prostatic hyperplasia anatomical
deformation of the penis (e.g. angulation, cavernosal
fibrosis, Peyronie’s disease). cardiovascular disease . left
ventricular outflow obstruction . predisposition to
priapism (e.g. in sickle-cell disease, multiple myeloma, or
▶ When used for erectile dysfunction anatomical deformation of
the penis (e.g. angulation, cavernosal fibrosis, Peyronie’s
disease). cardiovascular disease . left ventricular outflow
obstruction . predisposition to priapism (e.g. in sickle-cell
disease, multiple myeloma, or leukaemia)
▶ When used for pulmonary arterial hypertension Anatomical
(avoid if systolic blood pressure below 90 mmHg). left
l INTERACTIONS → Appendix 1: phosphodiesterase type-5
▶ Common or very common Flushing . gastrointestinal
discomfort. headaches . myalgia . nasal congestion . pain
neuropathy (discontinue if sudden visual impairment
loss (discontinue drug and seek medical advice). syncope
l PREGNANCY Manufacturer advises avoid.
l BREAST FEEDING Manufacturer advises avoid—present in
▶ When used for Pulmonary arterial hypertension Manufacturer
advises caution in mild to moderate impairment (limited
information available); avoid in severe impairment (no
▶ When used for Benign prostatic hyperplasia or Erectile
impairment for intermittent use (limited information
▶ When used for Pulmonary arterial hypertension Manufacturer
advises consider initial dose reduction to 20 mg once daily
in mild to moderate impairment.
▶ When used for Erectile dysfunction Manufacturer advises
dose of 10 mg for intermittent use (no information
▶ When used for Pulmonary arterial hypertension Manufacturer
advises avoid in severe impairment.
▶ When used for Erectile dysfunction or Benign prostatic
hyperplasia Manufacturer advises avoid regular once-daily
▶ When used for Pulmonary arterial hypertension Manufacturer
▶ When used for Erectile dysfunction Manufacturer advises
maximum dose of 10 mg for intermittent use in severe
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (July 2012)
that tadalafil (Adcirca ®) is accepted for restricted use
within NHS Scotland for adults with pulmonary arterial
hypertension and should be initiated only by specialists in
the Scottish Pulmonary Vascular Unit or other similar
specialists. This advice is contingent upon the continuing
availability of the Patient Access Scheme in NHS Scotland.
NHS restrictions Cialis ® 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.
Tadalafil 2.5 mg Tadalafil 2.5mg tablets | 28 tablet P £54.99 DT
Tadalafil 5 mg Tadalafil 5mg tablets | 28 tablet P £54.99 DT =
Tadalafil 10 mg Tadalafil 10mg tablets | 4 tablet P £28.88 DT =
Tadalafil 20 mg Tadalafil 20mg tablets | 4 tablet P £54.99 DT =
£1.95 | 8 tablet P £3.90–£109.98 | 56 tablet P £372.11–
▶ Adcirca (Eli Lilly and Company Ltd)
Tadalafil 20 mg Adcirca 20mg tablets | 56 tablet P £491.22
▶ Cialis (Eli Lilly and Company Ltd)
Tadalafil 2.5 mg Cialis 2.5mg tablets | 28 tablet P £54.99 DT =
BNF 78 Erectile dysfunction 815
Tadalafil 5 mg Cialis 5mg tablets | 28 tablet P £54.99 DT =
Tadalafil 10 mg Cialis 10mg tablets | 4 tablet P £28.88 DT =
Tadalafil 20 mg Cialis 20mg tablets | 4 tablet P £28.88 DT =
Tadalafil 20 mg Talmanco 20mg tablets | 56 tablet P £417.54
▶ Adult: Initially 10 mg (max. per dose 20 mg), to be
taken approximately 25–60 minutes before sexual
activity, subsequent doses adjusted according to
response, onset of effect may be delayed if taken with
high-fat meal; maximum 1 dose per day
▶ BY MOUTH USING ORODISPERSIBLE TABLET
▶ Adult: 10 mg, to be taken approximately
25–60 minutes before sexual activity; maximum 10 mg
Erectile dysfunction (patients on alpha-blocker therapy)
▶ Adult: Initially 5 mg (max. per dose 20 mg), to be taken
approximately 25–60 minutes before sexual activity,
subsequent doses adjusted according to response,
onset of effect may be delayed if taken with high-fat
DOSE EQUIVALENCE AND CONVERSION
▶ Levitra ® 10 mg orodispersible tablets and Levitra ® 10 mg
film coated tablets are not bioequivalent.
l CONTRA-INDICATIONS Avoid if systolic blood pressure
l CAUTIONS Active peptic ulceration . anatomical
deformation of the penis (e.g. angulation, cavernosal
obstruction . predisposition to priapism (e.g. in sickle-cell
disease, multiple myeloma, or leukaemia). susceptibility
to prolongation of QT interval
l INTERACTIONS → Appendix 1: phosphodiesterase type-5
congestion . skin reactions . sleep disorder.tinnitus . vertigo . vision disorders . vomiting
reaction . priapism . seizure . syncope
▶ Frequency not known Haematospermia . optic neuropathy
(discontinue if sudden visual impairment occurs). QT
interval prolongation . sudden hearing loss
l HEPATIC IMPAIRMENT For film-coated tablets,
manufacturer advises caution in mild to moderate
impairment; avoid in severe impairment.
For orodispersible tablets, manufacturer advises caution
in mild impairment; avoid in moderate to severe
Dose adjustments For film-coated tablets, manufacturer
advises initial dose reduction to 5 mg in mild to moderate
impairment, increase according to response; max. 10 mg in
For orodispersible tablets, manufacturer advises initial
dose reduction to 5 mg using film-coated tablets in mild
impairment, increase according to response.
l RENAL IMPAIRMENT Orodispersible tablets not suitable if
eGFR less than 30 mL/minute/1.73 m2
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