l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Ergometrine maleate (Non-proprietary)
Ergometrine maleate 500 microgram per 1 ml Ergometrine
500micrograms/1ml solution for injection ampoules |
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, ergometrine maleate p. 824, oxytocin p. 823.
Active management of the third stage of labour |
Postpartum haemorrhage caused by uterine atony
▶ Adult: No longer recommended
Bleeding due to incomplete miscarriage or abortion
▶ Adult: Adjusted according to response to, the patient’s
l INTERACTIONS → Appendix 1: ergometrine
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Syntometrine (Alliance Pharmaceuticals Ltd)
Ergometrine maleate 500 microgram per 1 ml, Oxytocin 5 unit
per 1 ml Syntometrine 500micrograms/1ml solution for injection
Other drugs used for Premature labour Indometacin,
p. 1143 . Nifedipine, p. 162 . Salbutamol, p. 252 . Terbutaline
Uncomplicated premature labour between 24 and
▶ INITIALLY BY INTRAVENOUS INJECTION
▶ Adult: Initially 6.75 mg over 1 minute, then (by
intravenous infusion) 18 mg/hour for 3 hours, then (by
intravenous infusion) reduced to 6 mg/hour for up to
45 hours. Maximum duration of treatment is 48 hours
l CONTRA-INDICATIONS Abruptio placenta . antepartum
30 weeks’ gestation . severe pre-eclampsia
l CAUTIONS Abnormal placental site . intra-uterine growth
▶ Uncommon Fever. insomnia . skin reactions
▶ Rare or very rare Uterine atony . uterine haemorrhage
▶ Frequency not known Dyspnoea . pulmonary oedema
l HEPATIC IMPAIRMENT Manufacturer advises caution—no
l RENAL IMPAIRMENT No information available.
l MONITORING REQUIREMENTS Monitor blood loss after
l DIRECTIONS FOR ADMINISTRATION For intravenous infusion
(Tractocile ® concentrate for intravenous infusion), give
continuously in Glucose 5% or Sodium chloride 0.9%.
Withdraw 10 mL infusion fluid from 100-mL bag and
replace with 10 mL atosiban concentrate (7.5 mg/mL) to
produce a final concentration of 750 micrograms/mL.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Atosiban (as Atosiban acetate) 7.5 mg per 1 ml Atosiban
6.75mg/0.9ml solution for injection vials | 1 vial P £18.41
▶ Tractocile (Ferring Pharmaceuticals Ltd)
Atosiban (as Atosiban acetate) 7.5 mg per 1 ml Tractocile
6.75mg/0.9ml solution for injection vials | 1 vial P £18.41
Atosiban (as Atosiban acetate) 7.5 mg per 1 ml Atosiban
37.5mg/5ml concentrate for solution for infusion vials | 1 vial P £50.18–£52.82 (Hospital only)
Atosiban 6.75mg/0.9ml solution for injection ampoules | 1 ampoule P £17.99 (Hospital only)
▶ Tractocile (Ferring Pharmaceuticals Ltd)
Atosiban (as Atosiban acetate) 7.5 mg per 1 ml Tractocile
37.5mg/5ml solution for infusion vials | 1 vial P £52.82 (Hospital
PROGESTERONE RECEPTOR MODULATORS
l DRUG ACTION Mifepristone, an antiprogestogenic steroid,
sensitises the myometrium to prostaglandin-induced
contractions and ripens the cervix.
Cervical ripening before mechanical cervical dilatation for
termination of pregnancy of up to 84 days gestation
(under close medical supervision)
▶ Adult: 200 mg for 1 dose, to be taken 36-48 hours
Labour induction in fetal death in utero where
prostaglandin or oxytocin inappropriate (under close
▶ Adult: 600 mg once daily for 2 days, if labour not
started within 72 hours of first dose, another method
Medical termination of intra-uterine pregnancy of up to
49 days gestation (under close medical supervision)
▶ Adult: 600 mg for 1 dose, dose followed 36–48 hours
later (unless abortion already complete) by gemeprost
1 mg by vagina or misoprostol 400 micrograms by
mouth, alternatively 200 mg for 1 dose, dose followed
36–48 hours later (unless abortion already complete)
by gemeprost 1 mg by vagina; observe for at least
3 hours (or until bleeding or pain at acceptable level);
follow-up visit within 2 weeks to verify complete
expulsion and to assess vaginal bleeding continued→
BNF 78 Termination of pregnancy 825
Medical termination of intra-uterine pregnancy of
50–63 days gestation (under close medical supervision)
▶ Adult: 600 mg for 1 dose, alternatively 200 mg for
1 dose, dose followed 36–48 hours later (unless
abortion already complete) by gemeprost 1 mg by
vagina; observe for at least 3 hours (or until bleeding or
pain at acceptable level); follow-up visit within 2 weeks
to verify complete expulsion and to assess vaginal
Termination of pregnancy of 13–24 weeks gestation (in
combination with a prostaglandin) (under close medical
▶ Adult: 600 mg for 1 dose, alternatively 200 mg for
1 dose, dose followed 36–48 hours later by gemeprost
1 mg by vagina every 3 hours up to max. 5 mg or
misoprostol; if abortion does not occur, 24 hours after
start of treatment repeat course of gemeprost 1 mg by
vagina up to max. 5 mg; follow-up visit after
appropriate interval to assess vaginal bleeding
l CONTRA-INDICATIONS Acute porphyrias p. 1058 . chronic
adrenal failure . suspected ectopic pregnancy (use other
specific means of termination). uncontrolled severe
l CAUTIONS Adrenal suppression (may require
corticosteroid). anticoagulant therapy . asthma (avoid if
l INTERACTIONS → Appendix 1: mifepristone
disorders . vaginal haemorrhage (sometimes severe). vomiting
▶ Rare or very rare Angioedema . chills . dizziness . erythema
nodosum . fever. headache . hot flush . malaise . skin
reactions .toxic epidermal necrolysis .toxic shock
l HEPATIC IMPAIRMENT Manufacturer advises avoid in
hepatic failure (no information available).
l RENAL IMPAIRMENT Manufacturer advises avoid.
l MONITORING REQUIREMENTS Careful monitoring of blood
pressure and pulse essential for 3 hours after
administration of gemeprost pessary (risk of profound
l PRESCRIBING AND DISPENSING INFORMATION Supplied to
NHS hospitals and premises approved under Abortion Act
l PATIENT AND CARER ADVICE Patient information leaflet to
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 10
▶ Mifepristone (Non-proprietary)
Mifepristone 200 mg Mifepristone 200mg tablets | 1 tablet P £9.48
▶ Mifegyne (Nordic Pharma Ltd)
Mifepristone 200 mg Mifegyne 200mg tablets | 3 tablet P £52.66 (Hospital only)
Cervical ripening prior to first trimester surgical abortion
▶ Adult: 1 mg, dose to be inserted into posterior fornix
▶ Adult: 1 mg every 3 hours for maximum 5
administrations, to be inserted into posterior fornix,
second course may begin 24 hours after start of
treatment (if treatment fails, pregnancy should be
Second trimester intra-uterine death
▶ Adult: 1 mg every 3 hours for maximum 5
administrations only, to be inserted into posterior
Medical termination of intra-uterine pregnancy of up to
49 days gestation following mifepristone | Medical
termination of intra-uterine pregnancy of 50–63 days
gestation following mifepristone
Termination of pregnancy of 13–24 weeks gestation (in
combination with a prostaglandin) following
▶ Adult: 1 mg every 3 hours, if abortion does not occur,
24 hours after start of treatment repeat course of
gemeprost 1 mg by vagina up to max. 5 mg; follow-up
visit after appropriate interval to assess vaginal
bleeding recommended, careful monitoring of blood
pressure and pulse essential for 3 hours after
administration of gemeprost pessary (risk of profound
hypotension); maximum 5 mg per course
l CONTRA-INDICATIONS Placenta praevia . unexplained
vaginal bleeding . uterine scarring
l SIDE-EFFECTS Back pain . chest pain . chills . coronary
l RENAL IMPAIRMENT Manufacturer advises avoid.
▶ If used in combination with mifepristone, carefully
monitor blood pressure and pulse for 3 hours.
▶ When used for second trimester intra-uterine death,
monitor for coagulopathy during treatment.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Gemeprost 1 mg Cervagem 1mg pessaries | 5 pessary P s
l DRUG ACTION Misoprostol is a synthetic prostaglandin
analogue that acts as a potent uterine stimulant.
Termination of pregnancy following mifepristone
▶ Adult: 400 micrograms for 1 dose, dose to be given
24–48 hours after mifepristone
Termination of pregnancy following mifepristone
▶ INITIALLY BY VAGINA, OR BY BUCCAL ADMINISTRATION, OR BY
▶ Adult: 800 micrograms for 1 dose, dose to be given
24–48 hours after mifepristone, if abortion has not
occurred 4 hours after first misoprostol dose a further
dose may be given, (by mouth or by vagina)
Termination of pregnancy following mifepristone
▶ Adult: 800 micrograms for 1 dose, dose to be given
36–48 hours after mifepristone, followed by (by vagina
or by mouth) 400 micrograms every 3 hours if required
Termination of pregnancy following mifepristone
▶ Adult: 800 micrograms for 1 dose, dose to be given
36–48 hours after mifepristone, followed by (by vagina
or by mouth) 400 micrograms every 3 hours if required
for a maximum of 4 doses, if abortion has not occurred
3 hours after the last dose of misoprostol, a further
dose of mifepristone may be given, and misoprostol
may be recommenced 12 hours later
MYSODELLE ® VAGINAL DELIVERY SYSTEM
Induction of labour (specialist supervision in hospital)
▶ Adult: 200 micrograms for 1 dose, to be inserted (in
vaginal delivery system) high into posterior fornix; if
oxytocin required, remove at least 30 minutes before
oxytocin administration, for information on when to
remove the delivery system—consult product literature
l UNLICENSED USE Misoprostol doses for termination of
pregnancy may differ from those in product literature.
MHRA/CHM ADVICE: MISOPROSTOL VAGINAL DELIVERY SYSTEM
(MYSODELLE ®): REPORTS OF EXCESSIVE UTERINE CONTRACTIONS
(TACHYSYSTOLE) UNRESPONSIVE TO TOCOLYTIC TREATMENT
Mysodelle ® can cause excessive uterine tachysystole that
may not respond to tocolytic treatment. Monitor
patients closely and remove the vaginal delivery system
immediately in cases of excessive or prolonged uterine
contractions, at the onset of labour, or if there is clinical
Be prepared to administer tocolytic therapy—if
needed, it can be administered immediately after
MYSODELLE ® VAGINAL DELIVERY SYSTEM Before
36 weeks’ gestation . chorioamnionitis (unless adequate
prior treatment initiated). fetal malpresentation . placenta
▶ When used for termination of pregnancy Cardiovascular
disease .risk factors for cardiovascular disease
MYSODELLE ® VAGINAL DELIVERY SYSTEM Modified Bishop
▶ Common or very common Nausea . neonatal respiratory
depression .rash .transient tachypnoea of the newborn . vomiting
▶ Uncommon Genital pruritus . hypoxic-ischaemic
encephalopathy . uterine rupture
l BREAST FEEDING Manufacturer advises avoid—present in
milk, and may cause diarrhoea in nursing infants.g
Tertiary sources state present in milk but amount probably
too small to be harmful; to further reduce risk following
termination of pregnancy, consider interrupting
breastfeeding for 5 hours after a dose. k
MYSODELLE ® VAGINAL DELIVERY SYSTEM Manufacturer
advises store in a freezer (-10 to -25°C); no thawing
Driving and skilled tasks Manufacturer advises patients
should be cautioned on the effects on driving and
performance of skilled tasks—increased risk of dizziness.
l NATIONAL FUNDING/ACCESS DECISIONS
MYSODELLE ® VAGINAL DELIVERY SYSTEM
All Wales Medicines Strategy Group (AWMSG) decisions
The All Wales Medicines Strategy Group has advised (March
2018) that misoprostol (Mysodelle ®) is recommended as an
option for use within NHS Wales for the induction of
labour in women with an unfavourable cervix, from
36 weeks gestation, in whom induction is clinically
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 21
▶ Misoprostol (Non-proprietary)
Misoprostol 200 microgram Misoprostol 200microgram vaginal
tablets | 4 tablet P s (Hospital only)
▶ Topogyne (Nordic Pharma Ltd)
Misoprostol 400 microgram Topogyne 400microgram tablets | 16 tablet P £128.00 (Hospital only)
▶ Mysodelle (Ferring Pharmaceuticals Ltd)
Misoprostol 7 microgram per 1 hour Mysodelle 200micrograms
vaginal delivery system | 5 unit P £465.00
Symptoms are often restricted to the vulva, but infections
almost invariably involve the vagina which should also be
treated. Applications to the vulva alone are likely to give
only symptomatic relief without cure.
Aqueous medicated douches may disturb normal vaginal
Topical anaesthetic agents give only symptomatic relief and
may cause sensitivity reactions. They are indicated only in
cases of pruritus where specific local causes have been
BNF 78 Vaginal and vulval conditions 827
Systemic drugs are required in the treatment of infections
such as gonorrhoea and syphilis.
Topical HRT for vaginal atrophy
atrophic vaginitis. It is important to bear in mind that topical
oestrogens should be used in the smallest effective amount
to minimise systemic effects. Modified-release vaginal
tablets and an impregnated vaginal ring are now also
The risk of endometrial hyperplasia and carcinoma is
increased when systemic oestrogens are administered alone
for prolonged periods. The endometrial safety of long-term
or repeated use of topical vaginal oestrogens is uncertain;
treatment should be reviewed at least annually, with special
consideration given to any symptoms of endometrial
Topical oestrogens are also used in postmenopausal
women before vaginal surgery for prolapse when there is
Non-hormonal preparations for vaginal atrophy
Several non-hormonal vaginal moisturisers are available and
some are prescribable on the NHS (consult Drug Tariff).
Effective specific treatments are available for the common
Candidal vulvitis can be treated locally with cream, but is
almost invariably associated with vaginal infection which
should also be treated. Vaginal candidiasis is treated
primarily with antifungal pessaries or cream inserted high
into the vagina (including during menstruation). Single-dose
preparations offer an advantage when compliance is a
problem. Local irritation may occur on application of vaginal
Imidazole drugs (clotrimazole p. 829, econazole nitrate
p. 830, fenticonazole nitrate p. 830, and miconazole p. 830)
are effective against candida in short courses of 1 to 14 days
according to the preparation used; treatment can be
repeated if initial course fails to control symptoms or if
symptoms recur. Vaginal applications may be supplemented
with antifungal cream for vulvitis and to treat other
superficial sites of infection.
Oral treatment of vaginal infection with fluconazole p. 595
or itraconazole p. 597 is also effective.
Vulvovaginal candidiasis in pregnancy
Vulvovaginal candidiasis is common during pregnancy and
can be treated with vaginal application of an imidazole (such
as clotrimazole), and a topical imidazole cream for vulvitis.
Pregnant women need a longer duration of treatment,
usually about 7 days, to clear the infection. Oral antifungal
treatment should be avoided during pregnancy.
Recurrent vulvovaginal candidiasis
Recurrence of vulvovaginal candidiasis is particularly likely if
there are predisposing factors, such as antibacterial therapy,
pregnancy, diabetes mellitus, or possibly oral contraceptive
use. Reservoirs of infection may also lead to
recontamination and should be treated; these include other
skin sites such as the digits, nail beds, and umbilicus as well
as the gastro-intestinal tract and the bladder. The partner
may also be the source of reinfection and, if symptomatic,
should be treated with a topical imidazole cream at the same
Treatment against candida may need to be extended for
6 months in recurrent vulvovaginal candidiasis.
Trichomonal infections commonly involve the lower urinary
tract as well as the genital system and need systemic
treatment with metronidazole p. 542 or tinidazole p. 544.
Bacterial infections with Gram-negative organisms are
particularly common in association with gynaecological
operations and trauma. Metronidazole is effective against
certain Gram-negative organisms, especially Bacteroides spp.
and can be used prophylactically in gynaecological surgery.
Clindamycin below cream and metronidazole gel are
indicated for bacterial vaginosis.
Vaginal preparations intended to restore normal acidity
may prevent recurrence of vaginal infections and permit the
re-establishment of the normal vaginal flora.
The antiviral drugs aciclovir p. 633, famciclovir p. 635, and
valaciclovir p. 636 can be used in the treatment of genital
infection due to herpes simplex virus, the HSV type 2 being a
major cause of genital ulceration; they have a beneficial
effect on virus shedding and healing, generally giving relief
6.1 Vaginal and vulval infections
6.1a Vaginal and vulval bacterial
Other drugs used for Vaginal and vulval bacterial
infections Metronidazole, p. 542
▶ Adult: 1 applicatorful daily for 3–7 nights, dose to be
DOSE EQUIVALENCE AND CONVERSION
▶ 1 applicatorful delivers a 5 g dose of clindamycin 2%.
l INTERACTIONS → Appendix 1: clindamycin
▶ Common or very common Skin reactions
▶ Frequency not known Constipation . diarrhoea
SIDE-EFFECTS, FURTHER INFORMATION Clindamycin 2%
cream is poorly absorbed into the blood—low risk of
l CONCEPTION AND CONTRACEPTION
DALACIN ® 2% CREAM Damages latex condoms and
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Benzyl alcohol, cetostearyl alcohol (including
cetyl and stearyl alcohol), polysorbates, propylene glycol
Clindamycin (as Clindamycin phosphate) 20 mg per
1 gram Dalacin 2% cream | 40 gram P £10.86 DT = £10.86
828 Vaginal and vulval conditions BNF 78
Dequalinium chloride 13-Mar-2017
cell permeability and reducing enzyme activity.
▶ Adult 18–55 years: 10 mg once daily for 6 days, inserted
l CONTRA-INDICATIONS Vaginal ulceration
▶ Common or very common Increased risk of infection . vulvovaginal disorders
▶ Uncommon Haemorrhage . headache . nausea
▶ Frequency not known Cystitis . fever
l CONCEPTION AND CONTRACEPTION Does not affect efficacy
of latex condoms; however, manufacturer advises avoid
use of non-latex condoms and intravaginal devices—no
l PREGNANCY Manufacturer advises avoid unless
essential—limited information available.
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (November
2016) that dequalinium chloride (Fluomizin ®) is accepted
for restricted use within NHS Scotland for treatment of
bacterial vaginosis in patients for whom the initial
treatment is not effective or well tolerated.
All Wales Medicines Strategy Group (AWMSG) decisions
The All Wales Medicines Strategy Group has advised
(November 2016) that dequalinium chloride (Fluomizin ®)
is recommended as an option for restricted use within NHS
Wales for the treatment of bacterial vaginosis only after
initial treatment is ineffective or not tolerated, as an
alternative option to clindamycin vaginal cream.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Dequalinium chloride 10 mg Fluomizin 10mg vaginal tablets | 6 tablet P £6.95 DT = £6.95
Prevention of bacterial vaginosis
▶ Adult: 5 mL 1–2 times a week, insert the content of 1
Prevention of bacterial vaginosis
▶ Adult: 5 mL daily for 2–3 nights after menstruation,
insert the contents of one tube
Treatment of bacterial vaginosis
▶ Adult: 5 mL daily for 7 nights, insert the contents of
l ALLERGY AND CROSS-SENSITIVITY Contra-indicated in
l CONCEPTION AND CONTRACEPTION
RELACTAGEL ® GEL Not recommended if trying to
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Propylene glycol
▶ Balance Activ (BBI Healthcare Ltd)
Balance Activ BV vaginal pH correction gel | 7 device £5.25
▶ Relactagel (KoRa Healthcare)
Relactagel vaginal pH correction gel | 7 device £5.25
6.1b Vaginal and vulval fungal
Other drugs used for Vaginal and vulval fungal infections
Fluconazole, p. 595 . Itraconazole, p. 597
ANTIFUNGALS › IMIDAZOLE ANTIFUNGALS
Superficial sites of infection in vaginal and vulval
candidiasis (dose for 1% or 2% cream)
▶ Adult: Apply 2–3 times a day, to be applied to
Vaginal candidiasis (dose for 10% intravaginal cream)
▶ BY VAGINA USING VAGINAL CREAM
▶ Adult: 5 g for 1 dose, one applicatorful to be inserted
into the vagina at night, dose can be repeated once if
▶ Adult: 200 mg for 3 nights, course can be repeated once
if necessary, alternatively 100 mg for 6 nights, course
can be repeated once if necessary, alternatively 500 mg
for 1 night, dose can be repeated once if necessary
Recurrent vulvovaginal candidiasis
▶ Adult: 500 mg every week for 6 months, dose to be
administered following topical imidazole for
l INTERACTIONS → Appendix 1: antifungals, azoles
l SIDE-EFFECTS Abdominal pain . discomfort. genital
peeling . oedema . paraesthesia . pelvic pain . skin reactions . syncope . vaginal haemorrhage
l CONCEPTION AND CONTRACEPTION Cream and pessaries
may damage latex condoms and diaphragms.
Dose adjustments Pregnant women need a longer duration
of treatment, usually about 7 days, to clear the infection.
Oral antifungal treatment should be avoided during
l EXCEPTIONS TO LEGAL CATEGORY Brands for sale to the
public include Canesten ® Internal Cream.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Benzyl alcohol, cetostearyl alcohol (including
cetyl and stearyl alcohol), polysorbates
▶ Canesten (clotrimazole) (Bayer Plc)
Clotrimazole 100 mg Canesten 100mg pessaries | 6 pessary p
Clotrimazole 200 mg Canesten 200mg pessaries | 3 pessary p
BNF 78 Vaginal and vulval fungal infections 829
Clotrimazole 500 mg Canesten Vaginal 500mg pessaries | 1 pessary P £2.00 DT = £4.71
EXCIPIENTS: May contain Benzyl alcohol, cetostearyl alcohol (including
cetyl and stearyl alcohol), polysorbates
▶ Clotrimazole (Non-proprietary)
▶ Canesten (clotrimazole) (Bayer Plc)
Clotrimazole 10 mg per 1 gram Canesten 1% cream | 20 gram p
£2.20 DT = £0.95 | 50 gram p £3.64 DT = £2.38
Canesten Antifungal 1% cream | 20 gram p £1.85 DT = £0.95
Clotrimazole 20 mg per 1 gram Canesten 2% thrush cream | 20 gram p £4.76 DT = £4.76
Clotrimazole 100 mg per 1 gram Canesten 10% VC cream | 5 gram P £4.50 DT = £6.23
Vaginal and vulval candidiasis
▶ Adult: 1 pessary for 1 dose, pessary to be inserted at
night, dose to be repeated once if necessary
Vaginal and vulval candidiasis
▶ INITIALLY BY VAGINA USING VAGINAL CREAM
▶ Adult: 1 applicatorful daily for at least 14 days, dose to
be inserted vaginally at night and (to the skin) apply
daily for at least 14 days, to be applied to vulva at
night, course can be repeated once if necessary
Vaginal and vulval candidiasis
▶ Adult: 1 pessary daily for 3 days, pessary to be inserted
at night, course can be repeated once if necessary
▶ Common or very common Skin reactions
▶ Frequency not known Angioedema
l CONCEPTION AND CONTRACEPTION Cream and pessaries
damage latex condoms and diaphragms.
l PREGNANCY Pregnant women need a longer duration of
treatment, usually about 7 days, to clear the infection.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Gyno-Pevaryl (Janssen-Cilag Ltd)
Econazole nitrate 150 mg Gyno-Pevaryl Once 150mg vaginal
Gyno-Pevaryl 150mg vaginal pessaries | 3 pessary P £4.17
EXCIPIENTS: May contain Butylated hydroxyanisole, fragrances
▶ Gyno-Pevaryl (Janssen-Cilag Ltd)
Econazole nitrate 10 mg per 1 gram Gyno-Pevaryl 1% cream | 15 gram P £2.11 | 30 gram P £3.78
▶ Adult: 200 mg daily for 3 days, alternatively 600 mg
daily for 1 dose, to be inserted at night
▶ Adult: 1 applicatorful twice daily for 3 days
DOSE EQUIVALENCE AND CONVERSION
▶ 1 applicatorful delivers a 5 g dose of fenticonazole 2 %.
l CONCEPTION AND CONTRACEPTION Intravaginal cream and
vaginal capsules damage latex condoms and diaphragms.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Cetostearyl alcohol (including cetyl and
stearyl alcohol), propylene glycol, woolfat and related substances
▶ Gynoxin (Recordati Pharmaceuticals Ltd)
Fenticonazole nitrate 20 mg per 1 gram Gynoxin 2% vaginal cream
EXCIPIENTS: May contain Hydroxybenzoates (parabens)
▶ Gynoxin (Recordati Pharmaceuticals Ltd)
Fenticonazole nitrate 200 mg Gynoxin 200mg vaginal capsules | 3 capsule P £2.42
Fenticonazole nitrate 600 mg Gynoxin 600mg vaginal capsules |
▶ Adult: Apply 1–2 times a day, to be applied to the
l CONTRA-INDICATIONS Acute porphyrias p. 1058
l INTERACTIONS → Appendix 1: antifungals, azoles
▶ Common or very common Skin reactions
▶ Uncommon Alopecia . angioedema
▶ Rare or very rare Taste altered
l CONCEPTION AND CONTRACEPTION Effect on latex
condoms and diaphragms not yet known.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Cetostearyl alcohol (including cetyl and
stearyl alcohol), polysorbates, propylene glycol
Ketoconazole 20 mg per 1 gram Nizoral 2% cream | 30 gram P £4.24 DT = £4.24
Vaginal and vulval candidiasis
▶ BY VAGINA USING VAGINAL CREAM
▶ Adult: 1 applicatorful once daily for 7 days, to be
inserted into the vagina before bedtime, course can be
Superficial sites of infection in vaginal and vulval
▶ BY VAGINA USING VAGINAL CREAM
▶ Adult: Apply twice daily, apply to the anogenital area
l CAUTIONS Avoid in Acute porphyrias p. 1058
l INTERACTIONS → Appendix 1: antifungals, azoles
▶ Common or very common Dysmenorrhoea . skin reactions . vulvovaginal disorders
830 Vaginal and vulval conditions BNF 78
infection . vaginal haemorrhage
l CONCEPTION AND CONTRACEPTION Gyno-Daktarin ®
damages latex condoms and diaphragms.
l PREGNANCY Pregnant women need a longer duration of
treatment, usually about 7 days, to clear the infection.
l BREAST FEEDING Manufacturer advises caution—no
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Butylated hydroxyanisole
▶ Gyno-Daktarin (Janssen-Cilag Ltd)
Miconazole nitrate 20 mg per 1 gram Gyno-Daktarin 2% vaginal
cream | 78 gram P £4.33 DT = £4.33
Postmenopausal urogenital conditions (not suitable for
vasomotor symptoms or osteoporosis prophylaxis)
▶ Adult: To be inserted into upper third of vagina and
worn continuously; replace after 3 months; max.
duration of continuous treatment 2 years
Improve the vaginal epithelium in menopausal atrophic
▶ Adult: 1 tablet daily for 2 weeks, then reduced to
l CONTRA-INDICATIONS Active arterial thromboembolic
disease (e.g. angina or myocardial infarction). active
thrombophlebitis .Dubin-Johnson syndrome (or monitor
closely). history of breast cancer. history of recurrent
venous thromboembolism (unless already on
myocardial infarction). Rotor syndrome (or monitor
closely).thrombophilic disorder. undiagnosed vaginal
bleeding . untreated endometrial hyperplasia . venous
l CAUTIONS Acute porphyrias p. 1058 . diabetes (increased
risk of heart disease). history of breast nodules—closely
monitor breast status (risk of breast cancer). history of
endometrial hyperplasia; factors predisposing to
thromboembolism . history of fibrocystic disease—closely
monitor breast status (risk of breast cancer). hypophyseal
tumours . increased risk of gall-bladder disease . interrupt
treatment periodically to assess need for continued
thrombotic events). prolonged exposure to unopposed
oestrogens may increase risk of developing endometrial
cancer.risk factors for oestrogen-dependent tumours (e.g.
breast cancer in first-degree relative). symptoms of
endometriosis may be exacerbated . uterine fibroids may
▶ Risk of breast cancer It is estimated that using all types of
HRT increases the risk of breast cancer within 1–2 years of
initiating treatment. The increased risk is related to the
duration of HRT use (but not to the age at which HRT is
started) and this excess risk disappears within 5 years of
Radiological detection of breast cancer can be made
more difficult as mammographic density can increase with
▶ Risk of endometrial cancer The increased risk of endometrial
cancer depends on the dose and duration of oestrogenonly HRT.
In women with a uterus, the addition of a progestogen
cyclically (for at least 10 days per 28-day cycle) reduces the
additional risk of endometrial cancer; this additional risk is
eliminated if a progestogen is given continuously.
However, this should be weighed against the increased risk
▶ Risk of ovarian cancer Long-term use of combined HRT or
oestrogen-only HRT is associated with a small increased
risk of ovarian cancer. This excess risk disappears within a
▶ Risk of venous thromboembolism Women using combined or
oestrogen-only HRT are at an increased risk of deep vein
thrombosis and of pulmonary embolism especially in the
In women who have predisposing factors (such as a
personal or family history of deep vein thrombosis or
pulmonary embolism, severe varicose veins, obesity,
trauma, or prolonged bed-rest) it is prudent to review the
need for HRT, as in some cases the risks of HRT may
Travel involving prolonged immobility further increases
the risk of deep vein thrombosis.
▶ Risk of stroke Risk of stroke increases with age, therefore
older women have a greater absolute risk of stroke.
Combined HRT or oestrogen-only HRT slightly increases
▶ Risk of coronary heart disease HRT does not prevent coronary
heart disease and should not be prescribed for this
purpose. There is an increased risk of coronary heart
disease in women who start combined HRT more than
10 years after menopause. Although very little information
is available on the risk of coronary heart disease in
younger women who start HRT close to the menopause,
studies suggest a lower relative risk compared with older
▶ Other conditions The product literature advises caution in
other conditions including hypertension, renal disease,
asthma, epilepsy, sickle-cell disease, melanoma,
otosclerosis, multiple sclerosis, and systemic lupus
erythematosus (but care required if antiphospholipid
antibodies present). Evidence for caution in these
conditions is unsatisfactory and many women with these
conditions may stand to benefit from HRT.
l INTERACTIONS → Appendix 1: hormone replacement
▶ Uncommon Hypertension . vulvovaginal fungal infection . weight increased
malignant. neoplasms . vaginismus
SIDE-EFFECTS, FURTHER INFORMATION Cyclical HRT
(where a progestogen is taken for 12–14 days of each
28-day oestrogen treatment cycle) usually results in
regular withdrawal bleeding towards the end of the
progestogen. Continuous combined HRT commonly
produces irregular breakthrough bleeding in the first
4–6 months of treatment. Bleeding beyond 6 months or
after a spell of amenorrhoea requires further investigation
to exclude serious gynaecological pathology.
l CONCEPTION AND CONTRACEPTION HRT does not provide
contraception and a woman is considered potentially
fertile for 2 years after her last menstrual period if she is
under 50 years, and for 1 year if she is over 50 years. A
woman who is under 50 years and free of all risk factors for
venous and arterial disease can use a low-oestrogen
combined oral contraceptive pill to provide both relief of
menopausal symptoms and contraception; it is
recommended that the oral contraceptive be stopped at
50 years of age since there are more suitable alternatives.
If any potentially fertile woman needs HRT, non-hormonal
contraceptive measures (such as condoms) are necessary.
Measurement of follicle-stimulating hormone can help to
determine fertility, but high measurements alone
(particularly in women aged under 50 years) do not
necessarily preclude the possibility of becoming pregnant.
VAGIFEM ® No evidence of damage to latex condoms and
l PREGNANCY Not known to be harmful.
l BREAST FEEDING Avoid; adverse effects on lactation.
l HEPATIC IMPAIRMENT Avoid in active liver disease
liver function returns to normal), and liver tumours.
▶ History of breast nodules or fibrocystic disease—closely
monitor breast status (risk of breast cancer).
▶ The endometrial safety of long-term or repeated use of
topical vaginal oestrogens is uncertain; treatment should
be reviewed at least annually, with special consideration
given to any symptoms of endometrial hyperplasia or
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Estradiol 10 microgram Vagifem 10microgram vaginal tablets | 24 pessary P £16.72 DT = £16.72
CAUTIONARY AND ADVISORY LABELS 10
Estradiol (as Estradiol hemihydrate) 7.5 microgram per
24 hour Estring 7.5micrograms/24hours vaginal delivery system | 1 device P £31.42 DT = £31.42
Improve the vaginal epithelium in menopausal atrophic
▶ Adult: Apply 1 applicatorful daily for 2–3 weeks, then
reduced to 1 applicatorful twice weekly, discontinue
every 2–3 months for 4 weeks to assess need for further
Vaginal surgery for prolapse when there is epithelial
atrophy in postmenopausal women (before surgery)
▶ Adult: Apply 1 applicatorful daily for 2 weeks before
surgery, resume 2 weeks after surgery
l CONTRA-INDICATIONS Active arterial thromboembolic
disease (e.g. angina or myocardial infarction). active
thrombophlebitis .Dubin-Johnson syndrome (or monitor
closely). history of breast cancer. history of recurrent
venous thromboembolism (unless already on
anticoagulant treatment). oestrogen-dependent cancer.
recent arterial thromboembolic disease (e.g. angina or
myocardial infarction). Rotor syndrome (or monitor
closely).thrombophilic disorder. undiagnosed vaginal
bleeding . untreated endometrial hyperplasia . venous
l CAUTIONS Acute porphyrias p. 1058 . diabetes (increased
risk of heart disease). factors predisposing to
thromboembolism . history of breast nodules—closely
monitor breast status (risk of breast cancer). history of
endometrial hyperplasia . history of fibrocystic disease—
disease . interrupt treatment periodically to assess need for
continued treatment. migraine (or migraine-like
headaches). presence of antiphospholipid antibodies
(increased risk of thrombotic events). prolonged exposure
to unopposed oestrogens may increase risk of developing
endometrial cancer.risk factors for oestrogen-dependent
▶ Risk of breast cancer It is estimated that using all types of
HRT increases the risk of breast cancer within 1–2 years of
initiating treatment. The increased risk is related to the
duration of HRT use (but not to the age at which HRT is
started) and this excess risk disappears within 5 years of
Radiological detection of breast cancer can be made
more difficult as mammographic density can increase with
▶ Risk of endometrial cancer The increased risk of endometrial
cancer depends on the dose and duration of oestrogenonly HRT.
In women with a uterus, the addition of a progestogen
cyclically (for at least 10 days per 28-day cycle) reduces the
additional risk of endometrial cancer; this additional risk is
eliminated if a progestogen is given continuously.
However, this should be weighed against the increased risk
▶ Risk of ovarian cancer Long-term use of combined HRT or
oestrogen-only HRT is associated with a small increased
risk of ovarian cancer. This excess risk disappears within a
▶ Risk of venous thromboembolism Women using combined or
oestrogen-only HRT are at an increased risk of deep vein
thrombosis and of pulmonary embolism especially in the
In women who have predisposing factors (such as a
personal or family history of deep vein thrombosis or
pulmonary embolism, severe varicose veins, obesity,
trauma, or prolonged bed-rest) it is prudent to review the
need for HRT, as in some cases the risks of HRT may
Travel involving prolonged immobility further increases
the risk of deep vein thrombosis.
▶ Risk of stroke Risk of stroke increases with age, therefore
older women have a greater absolute risk of stroke.
Combined HRT or oestrogen-only HRT slightly increases
▶ Risk of coronary heart disease HRT does not prevent coronary
heart disease and should not be prescribed for this
purpose. There is an increased risk of coronary heart
disease in women who start combined HRT more than
10 years after menopause. Although very little information
is available on the risk of coronary heart disease in
younger women who start HRT close to the menopause,
studies suggest a lower relative risk compared with older
▶ Other conditions The product literature advises caution in
other conditions including hypertension, renal disease,
asthma, epilepsy, sickle-cell disease, melanoma,
832 Vaginal and vulval conditions BNF 78
otosclerosis, multiple sclerosis, and systemic lupus
erythematosus (but care required if antiphospholipid
antibodies present). Evidence for caution in these
conditions is unsatisfactory and many women with these
conditions may stand to benefit from HRT.
l INTERACTIONS → Appendix 1: hormone replacement
l SIDE-EFFECTS Breast abnormalities . cervical mucus
increased . dementia . erythema nodosum . gallbladder
disorder. headache . increased risk of coronary artery
disease . increased risk of ischaemic stroke . increased risk
of venous thromboembolism . nausea . neoplasms . skin
reactions . vaginal haemorrhage . vaginal spotting . vomiting
l CONCEPTION AND CONTRACEPTION
OVESTIN ® Effect on latex condoms and diaphragms not
l PREGNANCY Not known to be harmful.
l BREAST FEEDING Avoid; adverse effects on lactation.
l HEPATIC IMPAIRMENT Avoid in active liver disease
liver function returns to normal), and liver tumours.
l RENAL IMPAIRMENT Manufacturer advises caution in renal
disease. Evidence for caution is unsatisfactory and many
women with these conditions may stand to benefit from
▶ Closely monitor breast status if history of breast nodules
or fibrocystic disease (risk of breast cancer).
▶ The endometrial safety of long-term or repeated use of
topical vaginal oestrogens is uncertain; treatment should
be reviewed at least annually, with special consideration
given to any symptoms of endometrial hyperplasia or
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Arachis (peanut) oil, cetostearyl alcohol
(including cetyl and stearyl alcohol), polysorbates
▶ Ovestin (Aspen Pharma Trading Ltd)
Estriol 1 mg per 1 gram Ovestin 1mg cream | 15 gram P £4.45
l DRUG ACTION Prasterone is biochemically and biologically
identical to endogenous dehydroepiandrosterone (DHEA),
and is converted to oestrogens and androgens.
Vulvar and vaginal atrophy [in postmenopausal women
with moderate to severe symptoms]
▶ Adult: 6.5 mg once daily, at bedtime. Treatment should
be reassessed at least every 6 months
l CONTRA-INDICATIONS Active or recent arterial
thromboembolic disease (e.g. angina or myocardial
infarction). acute liver disease . acute porphyrias . history
of breast cancer. history of liver disease (where liver
vaginal bleeding . untreated endometrial hyperplasia . venous thromboembolism
l CAUTIONS Assess need for continued treatment at least
every 6 months . cholelithiasis . diabetes mellitus . factors
predisposing to thromboembolism . history of endometrial
hyperplasia . hypertriglyceridaemia . liver disorders
(discontinue if jaundice or deterioration in liver function
occurs during treatment). migraine (or migraine-like
headaches). prolonged exposure to unopposed oestrogens
may increase risk of developing endometrial cancer.risk
factors for oestrogen-dependent tumours (e.g. breast
cancer in first-degree relative). symptoms of
endometriosis may be exacerbated . uterine fibroids may
▶ Risk of breast cancer It is estimated that using all types of
HRT increases the risk of breast cancer within 1–2 years of
initiating treatment. The increased risk is related to the
duration of HRT use (but not to the age at which HRT is
started) and this excess risk disappears within 5 years of
Radiological detection of breast cancer can be made
more difficult as mammographic density can increase with
▶ Risk of endometrial cancer The increased risk of endometrial
cancer depends on the dose and duration of oestrogenonly HRT.
Bleeding or spotting occurring during treatment should
For oestrogen products for vaginal application, where
systemic exposure to oestrogen remains within the normal
postmenopausal range, it is not recommended to add a
▶ Risk of ovarian cancer Long-term use of combined HRT or
oestrogen-only HRT is associated with a small increased
risk of ovarian cancer. This excess risk disappears within a
▶ Risk of venous thromboembolism Women using combined or
oestrogen-only HRT are at an increased risk of deep vein
thrombosis and of pulmonary embolism especially in the
In women who have predisposing factors (such as a
personal or family history of deep vein thrombosis or
pulmonary embolism, severe varicose veins, obesity,
trauma, major surgery or prolonged bed-rest) it is prudent
to review the need for HRT, as in some cases the risks of
Travel involving prolonged immobility further increases
the risk of deep vein thrombosis.
▶ Risk of stroke Risk of stroke increases with age, therefore
older women have a greater absolute risk of stroke.
Combined HRT or oestrogen-only HRT slightly increases
▶ Other conditions The product literature advises caution in
other conditions including hypertension, asthma,
epilepsy, otosclerosis, and systemic lupus erythematosus.
Evidence for caution in these conditions is unsatisfactory
and many women with these conditions may stand to
▶ Common or very common Cervical abnormalities . weight
▶ Uncommon Breast neoplasm benign . uterine polyp
l CONCEPTION AND CONTRACEPTION Manufacturer advises
avoid use with condoms, diaphragms or cervical caps made
l PREGNANCY Manufacturer advises avoid—no information
l BREAST FEEDING Manufacturer advises avoid—no
Missed doses Manufacturer advises if a dose is more than
16 hours late, the missed dose should not be taken and the
next dose should be taken at the normal time.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Intrarosa (Theramex HQ UK Ltd) A
Prasterone 6.5 mg Intrarosa 6.5mg pessaries | 28 pessary P £15.94
l DRUG ACTION Ospemifene is a selective oestrogen
receptor modulator that has an oestrogen-like effect in the
vagina, increasing the cellular maturation and
mucification of the vaginal epithelium.
Moderate to severe symptomatic vulvar and vaginal
atrophy [in post-menopausal women who are not
candidates for local vaginal oestrogen therapy]
l CONTRA-INDICATIONS Breast cancer (suspected or actively
treated). endometrial hyperplasia . history of venous
thromboembolism . sex-hormone dependent malignancy
(suspected or active). unexplained vaginal bleeding
l CAUTIONS Risk factors for stroke .risk factors for venous
thromboembolism (discontinue if prolonged
l INTERACTIONS → Appendix 1: ospemifene
▶ Uncommon Endometrial thickening . hypersensitivity . tongue swelling
l PREGNANCY Manufacturer advises avoid—toxicity in
l HEPATIC IMPAIRMENT Manufacturer advises avoid in
severe impairment—no information available.
l PATIENT AND CARER ADVICE Manufacturer advises
patients and their carers should be advised to seek
immediate medical attention if they experience symptoms
of thromboembolism (such as sudden chest pain, dyspnoea
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 21
Ospemifene 60 mg Senshio 60mg tablets | 28 tablet P £39.50
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