BNF for Children (BNFC) 2018-2019

eiiiiF 481

Testosterone propionate

lINDICATIONS AND DOSE

Delayed puberty in males

▶BY INTRAMUSCULAR INJECTION

▶Child: 50 mg once weekly

Treatment of microphallus (specialist use only)

▶TO THE SKIN USING CREAM

▶Child:Apply 3 times a day for 3 weeks

lCAUTIONSThrombophilia—increased risk of thrombosis

lSIDE-EFFECTS

▶Rare or very rarePulmonary oil microembolism

lMEDICINAL FORMS

Forms available from special-order manufacturers include:

solution for injection, cream

eiiiiF 481

Testosterone undecanoate

lINDICATIONS AND DOSE

Induction and maintenance of sexual maturation in males

(specialist use only)

▶BY MOUTH

▶Child 12–17 years: 40 mg once daily on alternate days,

adjusted according to response to 120 mg daily

lCAUTIONSThrombophilia—increased risk of thrombosis

lSIDE-EFFECTS

▶UncommonDepression.diarrhoea.hypertension.mood

altered

▶Frequency not knownBenign prostatic hyperplasia.

epiphyses premature fusion.fluid imbalance.

gastrointestinal discomfort.hepatic function abnormal.

lipid metabolism change.myalgia.nervousness.penis

enlarged.precocious puberty.prostate cancer.sperm

abnormalities.urinary tract obstruction

lMEDICINAL FORMS

There can be variation in the licensing of different medicines

containing the same drug.

Capsule

CAUTIONARY AND ADVISORY LABELS21, 25

▶Restandol(Merck Sharp & Dohme Ltd)

Testosterone undecanoate 40 mgRestandol 40 mg Testocaps|

30 capsuleP£ 8. 55 e| 60 capsuleP£ 17. 10 DT =

£ 17. 10 e

7.2a Precocious puberty

Other drugs used for Precocious pubertyGoserelin, p. 471

.Leuprorelin acetate, p. 472 .Triptorelin, p. 472

ANTI-ANDROGENS

Cyproterone acetate

lINDICATIONS AND DOSE

Gonadotrophin-independent precocious puberty

(specialist use only)

▶BY MOUTH

▶Child:Initially 25 mg twice daily, adjusted according to

response

lUNLICENSED USEUnlicensed for use in children.

lCONTRA-INDICATIONSDubin-Johnson syndrome.history

of thromboembolic disorders.liver-disease.malignant

diseases.meningioma or history of meningioma.previous

or existing liver tumours.Rotor syndrome.severe

depression.severe diabetes (with vascular changes).

sickle-cell anaemia.wasting diseases.youths under

18 years (may arrest bone maturation and testicular

development)

lCAUTIONSDiabetes mellitus.in prostate cancer, severe

depression.in prostate cancer, sickle-cell anaemia

lSIDE-EFFECTS

▶Common or very commonDepressed mood.dyspnoea.

fatigue.gynaecomastia.hepatic disorders.hotflush.

hyperhidrosis.nipple pain.restlessness.weight change

▶UncommonSkin reactions

▶Rare or very rareGalactorrhoea.neoplasms

▶Frequency not knownAdrenocortical suppression.

anaemia.azoospermia.hair changes.hypotrichosis.

osteoporosis.sebaceous gland underactivity (may clear

acne).thromboembolism

SIDE-EFFECTS, FURTHER INFORMATIONDirect 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

benefit exceeds the risk).

lHEPATIC IMPAIRMENTAvoid—dose-related toxicity.

lMONITORING REQUIREMENTS

▶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

hepatotoxicity occur.

lPATIENT AND CARER ADVICE

Driving and skilled tasksFatigue and lassitude may impair

performance of skilled tasks (e.g. driving).

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, oral

solution

Tablet

CAUTIONARY AND ADVISORY LABELS 21

▶Cyproterone acetate (Non-proprietary)

Cyproterone acetate 50 mgCyproterone 50 mg tablets|

56 tabletP£ 48. 95 DT = £ 29. 00 | 168 tabletP£ 87. 00

Cyproterone acetate 100 mgCyproterone 100 mg tablets|

84 tabletP£ 132. 57 DT = £ 55. 19

▶Androcur(Bayer Plc)

Cyproterone acetate 50 mgAndrocur 50 mg tablets|

60 tabletP£ 31. 34

▶Cyprostat(Bayer Plc)

Cyproterone acetate 50 mgCyprostat 50 mg tablets|

160 tabletP£ 82. 86

Cyproterone acetate 100 mgCyprostat 100 mg tablets|

80 tabletP£ 82. 86

HORMONE ANTAGONISTS AND RELATED

AGENTS›AROMATASE INHIBITORS

Testolactone

lINDICATIONS AND DOSE

Gonadotrophin-independent precocious puberty

(specialist use only)

▶BY MOUTH

▶Child: 5 mg/kg 3 – 4 times a day; increased if necessary

up to 10 mg/kg 4 times a day

482 Sex hormone responsive conditions BNFC 2018 – 2019

Endocrine system

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