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DrugsLevel 4 LocalisationS5INJEML

Testosterone Cypionate

AndrogenHormone replacement therapy

Indications

Registered South African indications:

  • Hypogonadism

Cautions

Contraindications

  • Hypersensitivity to the active ingredient or any of its excipients 
  • Pregnancy
  • Breastfeeding
  • Severe renal impairment
  • Severe hepatic impairment
  • Male breast cancer 
  • Prostate cancer 
  • Hypercalcaemia
  • Cardiac decompensation
  • Prepubertal males

Cautions

  • Mild to moderate renal impairment
  • Mild to moderate hepatic impairment
  • Elderly
  • Breast cancer 
  • Immobilized patients 
  • Cardiovascular disease  
  • Congestive cardiac failure
  • Benign prostatic hypertrophy

Adult dosage

Forms avail. in SA and covered in this monograph: inj

Primary hypogonadism
Secondary hypogonadism

  • IM: 200-400mg, every 3-4 weeks

More frequent administration of divided doses (e.g. 100mg, weekly or 200mg, every 2 weeks) may be required in patients experiencing significant symptoms of hypogonadism before the next injection is due; Doses should be titrated to testosterone levels as well as clinical response to therapy


Do not administer intravenously

Paediatric dosage

Paed. forms avail. in SA and covered in this monograph: inj

Primary hypogonadism
Secondary hypogonadism

Prepubertal boys

  • IM: Not established for use in children prior to puberty

Pubertal boys

  • IM: See adult dosage

Do not administer intravenously

Special populations

Pregnancy

  • Contraindicated
  • Testosterone is not indicated for use in women and must not be used in pregnant women

Breastfeeding

  • Contraindicated
  • Testosterone is not indicated for use in women and must not be used in breastfeeding women

Fertility

  • In men, treatment with androgens can lead to fertility disorders by repressing sperm-formation
  • In women, treatment with androgens can lead to an infrequent or repressed menstrual cycle

Renal Impairment

Hepatic Impairment

Elderly

Porphyria Information

Drugs in Sport

  • Prohibited - At all times

Adverse reactions

Cardiovascular Disorders

  • Oedema
  • Dyslipidaemia
  • Venous thromboembolism

Endocrine and Metabolic Disorders

  • Hypercalcaemia
  • Virilization in females
  • Priapism
  • Excessive sexual stimulation
  • Oligospermia  
  • Reduced ejaculatory volume
  • Gynaecomastia

Skin and Subcutaneous Tissue Disorders

  • Acne
  • Local irritation

Immune, Blood and Lymphatic System Disorders

  • Hypersensitivity
  • Anaphylactoid reactions
  • Polycythemia

Interactions

  • Antidiabetic agents
  • Corticosteroids
  • Ciclosporin
  • Dehydroepiandrosterone
  • Warfarin

Monitoring

  • Full blood count 
  • Lipid profile
  • Hepatic function
  • Renal function
  • Serum testosterone

Specific cases may require

  • Prostate-specific antigen 
  • Bone mineral density
  • Serum calcium

Mechanism of action

The effects of testosterone occur by way of two main mechanisms: by activation of the androgen receptor (directly or as 5α-dihydrotestosterone) and by conversion to estradiol and activation of certain estrogen receptors.In the eunuch and eunuchoid male, androgens act to stimulate and maintain the secondary sexual characteristics associated with the adult male. Androgens influence closure of the epiphyseal lines in males and some females.

Dosage forms

  • Injection

Formulation

Injection (per ml) 100mg

  • Depo-testosterone (Pfizer) originator

Injection (per 2ml) 200mg

  • Depotrone (Adcock)

References

1. SAMF_12th Edition_Page 234 2. https://drive.google.com/drive/folders/0B27NqM_vidrmQ1hjLS1ZT2Z6WTQ (31/01/2006_Pfizer_Depo-Testosterone_100mg_inj) 3. https://www.uptodate.com/contents/testosterone-drug-information?search=Testosterone%20propionate&source=panel_search_result&selectedTitle=1~148&usage_type=panel&kp_tab=drug_general&display_rank=1 (date accessed: 21/12/2018) 4. https://www.drugs.com/pregnancy/testosterone.html 5. NAPOS The Drug Database for Acute Porphyria: G03BA03 Testosterone; Accessed online 21 Dec 2018 [http://www.drugs-porphyria.org/languages/UnitedKingdom/s3.php?atc_code=G03BA03&l=gbr] 6. South African Institute for Drug-Free Sport; Depo-testosterone; Accessed online 21 Dec 2018 [http://www.drugfreesport.org.za/online-medication-check/] 7. SmPC: Nebido 1000mg/4ml, solution for injection, Bayer plc: Last updated on eMC: 19 Oct 2018; Downloaded online 21 Jan 2019 [https://www.medicines.org.uk/emc/product/3873/smpc] 8. SmPC: Sustanon 250, 250mg/ml solution for injection, Aspen: Last updated 18 Sept 2018; updated 20 April 2020 [https://www.medicines.org.uk/emc/product/5373] 9. Dr Irhuma. Updates for testosterone cypionate [https://trello.com/c/rMS5bjHg/321-list-of-hot-monographs-1]. Dated 3 December 2019. Updated 20 April 2020. 10. Porphyria information: testosterone. Updated 20 April [http://porphyriadrugs.com/search/?q=testosterone] (APF)

Brands & products

2 products · cached snapshot
Trade names (2)
  • Depo-Testosterone
  • Depotrone

INJInjection· 2 products

from R279.96
ProductStrengthPackApplicantMin price
Depotrone Injection200 mg/2ml2Adcock Ingram LimitedR279.96
Depo-testosterone 100mg100 mg/ml10Pfizer Laboratories (Pty) LtdR556.94

Medical aid coverage

data not yet integrated
Discovery Health
not yet integrated
  • Comprehensive Series—
  • Executive Plan—
  • KeyCare Series—
  • Priority Series—
  • Saver Series—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

Bonitas Medical Fund
not yet integrated
  • BonClassic—
  • BonComprehensive—
  • BonEssential—
  • BonFit Select—
  • BonSave—
  • BonStart—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

GEMS — Government Employees Medical Scheme
not yet integrated
  • Beryl—
  • Emerald—
  • Onyx—
  • Ruby—
  • Sapphire—
  • Tanzanite One—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

POLMED — Police Medical Aid Scheme
not yet integrated
  • Aquarium Option—
  • Efficiency Option—
  • Marine Option—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

Interacts with 2 known drugs

Check against other drugs →

Cited in 4 documents

NeoHealth® ID 15255 · updated 10/15/2022