lINTERACTIONS→Appendix 1 : hormone replacement
therapy
lSIDE-EFFECTSBreast abnormalities.cervical mucus
increased.cholelithiasis.contact lens intolerance.
depression.electrolyte imbalance.embolism and
thrombosis.erythema nodosum.feminisation.fluid
retention.headaches.hypertension.jaundice cholestatic
.metrorrhagia.mood altered.myocardial infarction.
nausea.neoplasms.skin reactions.stroke.uterine
disorders.vomiting.weight change
lPREGNANCYAvoid.
lBREAST FEEDINGAvoid until weaning or for 6 months
after birth (adverse effects on lactation).
lHEPATIC IMPAIRMENTAvoid in liver disease including
disorders of hepatic excretion (e.g. Dubin-Johnson or
Rotor syndromes), infective hepatitis (until liver function
returns to normal), and jaundice.
lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug. Forms available from special-order
manufacturers include: tablet, capsule, oral suspension
Tablet
▶Ethinylestradiol (Non-proprietary)
Ethinylestradiol 2 microgramEthinylestradiol 2 microgram tablets
| 100 tabletP£ 200. 00
Ethinylestradiol 10 microgramEthinylestradiol 10 microgram
tablets| 21 tabletP£ 200. 00 DT = £ 200. 00
Ethinylestradiol 50 microgramEthinylestradiol 50 microgram
tablets| 21 tabletP£ 200. 00 DT = £ 200. 00
Ethinylestradiol 1 mgEthinylestradiol 1 mg tablets| 28 tabletP
£ 200. 00 DT = £ 200. 00
PROGESTOGENS
Norethisterone
lINDICATIONS AND DOSE
Postponement of menstruation
▶BY MOUTH
▶Females of childbearing potential: 5 mg 3 times a day, to
be started 3 days before expected onset (menstruation
occurs 2 – 3 days after stopping)
Induction and maintenance of sexual maturation in
females (combined with an oestrogen after
12 – 18 months oestrogen therapy)
▶BY MOUTH
▶Child: 5 mg once daily for the last 7 days of 28 -day cycle
Short-term contraception
▶BY DEEP INTRAMUSCULAR INJECTION
▶Females of childbearing potential: 200 mg, to be
administered withinfirst 5 days of cycle or immediately
after parturition (duration 8 weeks). To be injected into
the gluteal muscle, then 200 mg after 8 weeks if
required
Contraception
▶BY MOUTH
▶Females of childbearing potential: 350 micrograms daily,
dose to be taken at same time each day, starting on day
1 of cycle then continuously, if administration delayed
for 3 hours or more it should be regarded as a‘missed
pill’lUNLICENSED USE
▶When used for Induction and maintenance of sexual maturation in
females or Postponement of menstruationNot licensed for use
in children.
▶When used for ContraceptionConsult product literature for
the licensing status of individual preparations.
lCONTRA-INDICATIONS
GENERAL CONTRA-INDICATIONSAvoid in patients with a
history of liver tumours.breast cancer (unlessprogestogens are being used in the management of this
condition).genital cancer (unless progestogens are being
used in the management of this condition).history during
pregnancy of idiopathic jaundice.history during
pregnancy of pemphigoid gestationis (non-contraceptive
indications).history during pregnancy of severe pruritus
(non-contraceptive indications).when used as a
contraceptive, history of breast cancer (can be used after
5 years if no evidence of disease and non-hormonal
contraceptive methods unacceptable)
SPECIFIC CONTRA-INDICATIONS
▶With oral useAcute porphyrias p. 603 .severe arterial
disease.undiagnosed vaginal bleeding
lCAUTIONS
GENERAL CAUTIONSAsthma.cardiac dysfunction.
conditions that may worsen withfluid retention.diabetes
(progestogens can decrease glucose tolerance—monitor
patient closely).epilepsy.history of depression.
hypertension.migraine.susceptibility to
thromboembolism (particular caution with high dose)
SPECIFIC CAUTIONS
▶When used for contraceptionActive trophoblastic disease
(until return to normal of urine- and plasma-
gonadotrophin concentration)—seek specialist advice.
arterial disease.functional ovarian cysts.history of
jaundice in pregnancy.malabsorption syndromes.past
ectopic pregnancy.sex-steroid dependent cancer.
systemic lupus erythematosus with positive (or unknown)
anti-phospholipid antibodies
▶With intramuscular use for contraceptionDisturbances of lipid
metabolism.history during pregnancy of deterioration of
otosclerosis.history during pregnancy of pruritus.
possible risk of breast cancer
CAUTIONS, FURTHER INFORMATION
▶Use as a contraceptive in co-morbiditiesThe product literature
advises caution in patients with history of
thromboembolism, hypertension, diabetes mellitus and
migraine; evidence for caution in these conditions is
unsatisfactory.
▶Breast cancer risk with contraceptive useThere is a small
increase in the risk of having breast cancer diagnosed in
women using, or who have recently used, a progestogen-
only contraceptive pill; this relative risk may be due to an
earlier diagnosis. The most important risk factor appears
to be the age at which the contraceptive is stopped rather
than the duration of use; the risk disappears gradually
during the 10 years after stopping and there is no excess
risk by 10 years. A possible small increase in the risk of
breast cancer should be weighed against the benefits.
lINTERACTIONS→Appendix 1 : norethisterone
lSIDE-EFFECTS
GENERAL SIDE-EFFECTS
▶Common or very commonMenstrual cycle irregularities
▶UncommonBreast tenderness.depression
▶Frequency not knownHepatic cancer.skin reactions.
thromboembolism.weight change
SPECIFIC SIDE-EFFECTS
▶Common or very common
▶With intramuscular useDizziness.haemorrhage.headache.
hypersensitivity.nausea
▶Uncommon
▶With intramuscular useAbdominal distension
▶Frequency not known
▶With oral useAppetite change.fatigue.gastrointestinal
disorder.headaches.hypertension.libido disorder.
nervousness
lPREGNANCYNot known to be harmful in contraceptive
doses. Avoid in other indications.
lBREAST FEEDINGProgestogen-only contraceptives do not
affect lactation.BNFC 2018 – 2019 Female sex hormone responsive conditions 479
Endocrine system6