▶ Rare or very rare Pulmonary oil microembolism . sperm
apnoea . urinary tract obstruction
SIDE-EFFECTS, FURTHER INFORMATION Stop treatment or
reduce dose if severe polycythaemia occurs.
l PREGNANCY Avoid—causes masculinisation of female
l HEPATIC IMPAIRMENT Avoid if possible—fluid retention
l RENAL IMPAIRMENT Caution—potential for fluid
▶ Monitor haematocrit and haemoglobulin before
treatment, every three months for the first year, and yearly
▶ Monitor prostate and PSA in men over 45 years.
Androgenic effects in women Women should be advised to
report any signs of virilisation e.g. deepening of the voice
Hypogonadism due to androgen deficiency in men
▶ Adult: Apply 23 mg once daily; increased in steps of
23 mg, adjusted according to response; maximum
DOSE EQUIVALENCE AND CONVERSION
▶ For Testavan®: One pump actuation delivers 1.15 g of
gel containing 23 mg of testosterone.
Hypogonadism due to testosterone deficiency in men
▶ Adult: Apply 50 mg once daily, subsequent application
adjusted according to response; maximum 100 mg per
DOSE EQUIVALENCE AND CONVERSION
▶ For Testim®: One tube of 5 g contains 50 mg
Hypogonadism due to androgen deficiency in men
▶ Adult: Apply 40.5 mg once daily; increased in steps of
20.25 mg, adjusted according to response; maximum
DOSE EQUIVALENCE AND CONVERSION
▶ For Testogel® 16.2mg/g: One pump actuation delivers
1.25 g of gel containing 20.25 mg of testosterone.
Hypogonadism due to androgen deficiency in men
▶ Adult: Apply 50 mg once daily; increased in steps of
25 mg, adjusted according to response; maximum
DOSE EQUIVALENCE AND CONVERSION
▶ For Testogel® 50mg/5g: One sachet of 5 g contains
Hypogonadism due to testosterone deficiency in men
▶ Adult: Apply 60 mg once daily, subsequent application
adjusted according to response; maximum 80 mg per
DOSE EQUIVALENCE AND CONVERSION
▶ For Tostran®: 1 g of gel contains 20 mg testosterone.
l CAUTIONS Thrombophilia—increased risk of thrombosis
▶ Common or very common Hypertriglyceridaemia
l DIRECTIONS FOR ADMINISTRATION Avoid skin contact with
gel application sites to prevent testosterone transfer to
other people, especially pregnant women and children—
TOSTRAN ® Apply gel on clean, dry, intact skin of abdomen
or both inner thighs, preferably in the morning. Gently rub
in with a finger until dry before dressing. Wash hands with
soap and water after applying gel; avoid washing
application site for at least 2 hours. Not to be applied on
TESTOGEL ® 50MG/5G Apply thin layer of gel on clean, dry,
healthy skin such as shoulders, arms or abdomen,
immediately after sachet is opened. Not to be applied on
genital area as high alcohol content may cause local
irritation. Allow to dry for 3–5 minutes before dressing.
Wash hands with soap and water after applying gel, avoid
shower or bath for at least 6 hours.
TESTIM ® Squeeze entire content of tube on to one palm
and apply as a thin layer on clean, dry, healthy skin of
shoulder or upper arm, preferably in the morning after
washing or bathing (if 2 tubes required use 1 per shoulder
or upper arm); rub in and allow to dry before putting on
clothing to cover site; wash hands with soap after
application; avoid washing application site for at least
TESTOGEL ® 16.2MG/G Apply thin layer of gel on clean, dry,
healthy skin over right and left upper arms and shoulders.
Not to be applied on genital area as high alcohol content
may cause local irritation. Allow to dry for 3–5 minutes
before dressing. Wash hands with soap and water after
applying gel, and cover the site with clothing once gel
dried; avoid shower or bath for at least 2 hours.
TESTAVAN ® Manufacturer advises apply one pump
actuation of gel evenly onto clean, dry, intact skin over
upper arm and shoulder using the applicator, without
getting any gel on the hands—repeat on opposite upper
arm and shoulder if two pump actuations are required, and
repeat again on initial upper arm and shoulder if three
pump actuations are required. Allow to dry completely
before dressing and cover application site with clothing.
Wash hands with soap and water immediately if gel was
touched during application; avoid shower or bath for at
768 Sex hormone responsive conditions BNF 78
l PATIENT AND CARER ADVICE Patient or carer should be
given advice on how to administer testosterone gel.
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (April 2019)
that testosterone gel (Testavan ®) is accepted for restricted
use within NHS Scotland for the treatment of adult male
hypogonadism, when testosterone deficiency has been
confirmed by clinical features and biochemical tests, and
in patients who require a transdermal delivery system.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 15
EXCIPIENTS: May contain Butylated hydroxytoluene, propylene glycol
▶ Testavan (Ferring Pharmaceuticals Ltd)
Testosterone 20 mg per 1 gram Testavan 20mg/g transdermal gel
Testosterone 50 mg Testim 50mg/5g gel | 30 tube P £32.00 DT
Testosterone 50 mg Testogel 50mg/5g gel sachets | 30
Testosterone 16.2 mg per 1 gram
Testosterone 20 mg per 1 gram Tostran 2% gel | 60 gram P £28.63 DT = £28.67e
Testosterone decanoate, isocaproate,
phenylpropionate and propionate
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, testosterone propionate below.
▶ BY DEEP INTRAMUSCULAR INJECTION
▶ Adult: 1 mL every 3 weeks, adjusted according to
DOSE EQUIVALENCE AND CONVERSION
▶ Each 1 mL dose of Sustanon ® 250 solution for injection
contains 100 mg testosterone decanoate, 60 mg
testosterone isocaproate, 60 mg testosterone
phenylpropionate and 30 mg testosterone propionate.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Arachis (peanut) oil, benzyl alcohol
▶ Sustanon (Aspen Pharma Trading Ltd)
Testosterone propionate 30 mg per 1 ml, Testosterone
isocaproate 60 mg per 1 ml, Testosterone phenylpropionate
60 mg per 1 ml, Testosterone decanoate 100 mg per
1 ml Sustanon 250mg/1ml solution for injection ampoules | 1 ampoule P £2.45e
▶ BY SLOW INTRAMUSCULAR INJECTION
▶ Adult: Initially 250 mg every 2–3 weeks; maintenance
▶ BY SLOW INTRAMUSCULAR INJECTION
▶ Adult: 250 mg every 2–3 weeks
l UNLICENSED USE Not licensed for use in breast cancer.
l CAUTIONS Thrombophilia—increased risk of thrombosis
l SIDE-EFFECTS Bone formation increased . circulatory
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Testosterone enantate (Non-proprietary)
Testosterone enantate 250 mg per 1 ml Testosterone enantate
250mg/1ml solution for injection ampoules | 3 ampoule P £83.74–£87.73 DT = £85.74e
▶ Adult: 50 mg 2–3 times a week
▶ Adult: 100 mg 2–3 times a week
l CAUTIONS Thrombophilia—increased risk of thrombosis
l MEDICINAL FORMS Forms available from special-order
manufacturers include: solution for injection
▶ Adult: 120–160 mg daily for 2–3 weeks; maintenance
▶ BY DEEP INTRAMUSCULAR INJECTION
▶ Adult (male): 1 g every 10–14 weeks, to be given over
2 minutes, if necessary, second dose may be given after
6 weeks to achieve rapid steady state plasma
testosterone levels and then every 10–14 weeks.
l CAUTIONS Thrombophilia—increased risk of thrombosis
▶ Uncommon Diarrhoea . mood altered
infection . migraine . muscle complaints . musculoskeletal
▶ With intramuscular use Hair growth increased
BNF 78 Male sex hormone responsive conditions 769
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Testosterone undecanoate 250 mg per 1 ml Nebido 1000mg/4ml
solution for injection vials | 1 vial P £87.11 DT = £87.11e
CAUTIONARY AND ADVISORY LABELS 21, 25
▶ Restandol (Merck Sharp & Dohme Ltd)
Hyper-sexuality in males | Sexual deviation in males
▶ Adult: 50 mg twice daily, to be taken after food
Prevention of tumour flare with initial gonadorelin
▶ Adult (male): 200 mg daily in 2–3 divided doses for
5–7 days before initiation of gonadorelin analogue,
followed by 200 mg daily in 2–3 divided doses for
3–4 weeks after initiation of gonadorelin analogue;
Long-term palliative therapy where gonadorelin
analogues or orchidectomy contra-indicated, not
tolerated, or where oral therapy preferred
▶ Adult (male): 200–300 mg daily in 2–3 divided doses.
Hot flushes with gonadorelin analogue therapy or after
▶ Adult (male): Initially 50 mg daily, then adjusted
according to response to 50–150 mg daily in
Meningioma or history of meningioma
▶ When used for when used for hypersexuality Dubin-Johnson
tumours . Rotor syndrome . severe depression . severe
diabetes (with vascular changes). sickle-cell anaemia . wasting diseases
l CAUTIONS Diabetes mellitus . in prostate cancer, severe
(relevance to prostate cancer not known)
▶ Rare or very rare Galactorrhoea . neoplasms
SIDE-EFFECTS, FURTHER INFORMATION Direct hepatic
toxicity including jaundice, hepatitis and hepatic failure
have been reported (fatalities reported, usually after
several months, at dosages of 100 mg and above). If
hepatotoxicity is confirmed, cyproterone should normally
be withdrawn unless the hepatotoxicity can be explained
by another cause such as metastatic disease (in which case
cyproterone should be continued only if the perceived
l HEPATIC IMPAIRMENT Avoid (unless used for prostate
cancer)—dose-related toxicity.
▶ Monitor blood counts initially and throughout treatment.
▶ Monitor adrenocortical function regularly.
▶ Monitor hepatic function regularly—liver function tests
should be performed before and regularly during
treatment and whenever symptoms suggestive of
Driving and skilled tasks Fatigue and lassitude may impair
performance of skilled tasks (e.g. driving).
l MEDICINAL 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
CAUTIONARY AND ADVISORY LABELS 21
▶ Cyproterone acetate (Non-proprietary)
Cyproterone acetate 100 mg Cyproterone 100mg tablets |
84 tablet P £132.57 DT = £55.19
Cyproterone acetate 50 mg Androcur 50mg tablets | 60 tablet P £31.34
Cyproterone acetate 50 mg Cyprostat 50mg tablets | 160 tablet P £82.86
Cyproterone acetate 100 mg Cyprostat 100mg tablets | 80 tablet P £82.86
PITUITARY AND HYPOTHALAMIC HORMONES
AND ANALOGUES › THYROID STIMULATING
(Recombinant human thyroid stimulating
l DRUG ACTION Thyrotropin alfa is a recombinant form of
thyrotrophin (thyroid stimulating hormone).
Detection of thyroid remnants and thyroid cancer in postthyroidectomy patients, together with serum
thyroglobulin testing (with or without radioiodine
imaging)| To increase radio-iodine uptake for the
ablation of thyroid remnant tissue in suitable postthyroidectomy patients
▶ Adult: 900 micrograms every 24 hours for 2 doses, dose
to be administered into the gluteal muscle, consult
product literature for further information on
l CAUTIONS Presence of thyroglobulin autoantibodies may
▶ Common or very common Asthenia . dizziness . headache . nausea . vomiting
▶ Rare or very rare Atrial fibrillation . hyperthyroidism
l ALLERGY AND CROSS-SENSITIVITY Contra-indicated if
previous hypersensitivity to bovine or human
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Powder for solution for injection
▶ Thyrogen (Genzyme Therapeutics Ltd)
Thyrotropin alfa 900 microgram Thyrogen 900microgram powder
for solution for injection vials | 2 vial P £583.04
Antithyroid drugs are used for hyperthyroidism either to
prepare patients for thyroidectomy or for long-term
management. In the UK carbimazole below is the most
commonly used drug. Propylthiouracil p. 772 should be
reserved for patients who are intolerant of carbimazole or for
those who experience sensitivity reactions to carbimazole
(sensitivity is not necessarily displayed to both drugs), and
for whom other treatments are inappropriate. Both drugs act
primarily by interfering with the synthesis of thyroid
Over-treatment with antithyroid drugs can result in the
rapid development of hypothyroidism and should be avoided
particularly during pregnancy because it can cause fetal
A combination of carbimazole with levothyroxine sodium
p. 773 daily, may be used in a blocking-replacement regimen;
Iodine has been used as an adjunct to antithyroid drugs
for 10 to 14 days before partial thyroidectomy; however,
there is little evidence of a beneficial effect. Iodine should
not be used for long-term treatment because its antithyroid
Radioactive sodium iodide (131 I) solution is used
increasingly for the treatment of thyrotoxicosis at all ages,
particularly where medical therapy or compliance is a
problem, in patients with cardiac disease, and in patients
who relapse after thyroidectomy.
Propranolol hydrochloride p. 150 is useful for rapid relief
of thyrotoxic symptoms and may be used in conjunction with
antithyroid drugs or as an adjunct to radioactive iodine.
Beta-blockers are also useful in neonatal thyrotoxicosis and
in supraventricular arrhythmias due to hyperthyroidism.
Propranolol hydrochloride has been used in conjunction
with iodine to prepare mildly thyrotoxic patients for surgery
but it is preferable to make the patient euthyroid with
carbimazole. Laboratory tests of thyroid function are not
altered by beta-blockers. Most experience in treating
thyrotoxicosis has been gained with propranolol
hydrochloride but nadolol p. 149 is also used.
Thyrotoxic crisis (‘thyroid storm’) requires emergency
treatment with intravenous administration of fluids,
propranolol hydrochloride and hydrocortisone p. 676 (as
sodium succinate), as well as oral iodine solution and
carbimazole or propylthiouracil which may need to be
administered by nasogastric tube.
Antithyroid drugs in pregnancy
Radioactive iodine therapy is contra-indicated during
pregnancy. Propylthiouracil and carbimazole can be given
but the blocking-replacement regimen is not suitable.
Carbimazole is associated with congenital defects, including
aplasia cutis of the neonate, therefore propylthiouracil
remains the drug of choice during the first trimester of
pregnancy. In the second trimester, consider switching to
carbimazole because of the potential risk of hepatotoxicity
with propylthiouracil. Both propylthiouracil and carbimazole
cross the placenta and in high doses may cause fetal goitre
and hypothyroidism—the lowest dose that will control the
hyperthyroid state should be used (requirements in Graves’
disease tend to fall during pregnancy). See also Important
safety information in the carbimazole below drug monograph.
Patients with thyroid disorders may be eligible for the
Medicines Use Review service provided by a community
pharmacist. For further information, see Advanced Pharmacy
Services in Guidance on prescribing p. 1.
Other drugs used for Hyperthyroidism Metoprolol tartrate,
ANTITHYROID DRUGS › SULFUR-CONTAINING
▶ Adult: 15–40 mg daily continue until the patient
becomes euthyroid, usually after 4 to 8 weeks, higher
doses should be prescribed under specialist supervision
only, then reduced to 5–15 mg daily, reduce dose
gradually, therapy usually given for 12 to 18 months
Hyperthyroidism (blocking-replacement regimen) in
combination with levothyroxine
▶ Adult: 40–60 mg daily, therapy usually given for
DOSE EQUIVALENCE AND CONVERSION
▶ When substituting, carbimazole 1 mg is considered
equivalent to propylthiouracil 10 mg but the dose may
need adjusting according to response.
NEUTROPENIA AND AGRANULOCYTOSIS
Doctors are reminded of the importance of recognising
bone marrow suppression induced by carbimazole and
the need to stop treatment promptly.
. Patient should be asked to report symptoms and signs
suggestive of infection, especially sore throat.
. A white blood cell count should be performed if there
is any clinical evidence of infection.
. Carbimazole should be stopped promptly if there is
clinical or laboratory evidence of neutropenia.
MHRA/CHM ADVICE: CARBIMAZOLE: INCREASED RISK OF
CONGENITAL MALFORMATIONS; STRENGTHENED ADVICE ON
Carbimazole is associated with an increased risk of
congenital malformations when used during pregnancy,
especially in the first trimester and at high doses (daily
Women of childbearing potential should use effective
contraception during treatment with carbimazole. It
should only be considered in pregnancy after a thorough
benefit-risk assessment, and at the lowest effective dose
without additional administration of thyroid
hormones—close maternal, fetal, and neonatal
MHRA/CHM ADVICE: CARBIMAZOLE: RISK OF ACUTE
Cases of acute pancreatitis have been reported during
treatment with carbimazole. It should be stopped
immediately and permanently if acute pancreatitis
Carbimazole should not be used in patients with a
history of acute pancreatitis associated with previous
treatment—re-exposure may result in life-threatening
acute pancreatitis with a decreased time to onset.
l CONTRA-INDICATIONS Severe blood disorders
l INTERACTIONS → Appendix 1: carbimazole
▶ Rare or very rare Bone marrow disorders . haemolytic
anaemia . severe cutaneous adverse reactions (SCARs). thrombocytopenia
(discontinue permanently). salivary gland enlargement. skin reactions .taste loss
l CONCEPTION AND CONTRACEPTION The MHRA advises
that females of childbearing potential should use effective
contraception during treatment.
l PREGNANCY The MHRA advises consider use only after a
thorough benefit-risk assessment. See Important Safety
Information and Antithyroid drugs p. 771 for further
l BREAST FEEDING Present in breast milk but this does not
preclude breast-feeding as long as neonatal development
is closely monitored and the lowest effective dose is used.
Amount in milk may be sufficient to affect neonatal
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