Finished product reference
Dihydrotestosterone
Gel · Topical · 2.5 % · 80 g
- List code
- 50920
- Pharmacologic class
- Androgen (topical dihydrotestosterone, androstanolone)
What it is and how it works
Dihydrotestosterone (androstanolone) is the potent 5-alpha-reduced metabolite of testosterone that binds androgen receptors directly. Applied as a gel it is absorbed through the skin, producing androgenic effects; unlike testosterone it is not aromatised to oestradiol.
Indications
Male hypogonadism (androgen deficiency) where androgen replacement is indicated; in some markets also selected cases of micropenis and gynaecomastia under specialist supervision.
Dosage and administration (summary)
Dosing is individualised by the specialist according to the indication and serum androgen levels; applied once daily to clean, dry skin.
Contraindications
Known or suspected prostate or male breast cancer; hypersensitivity to the components.
Warnings and precautions
Monitor prostate (including PSA in older men), haematocrit and lipids during treatment; androgens may worsen sleep apnoea, oedema and heart failure. Secondary exposure of women and children through skin contact can cause virilisation, so the application site should be covered and hands washed. Not for use in women.
Pregnancy
Contraindicated in pregnancy; pregnant women must avoid contact with treated skin.
Storage and supply
Store below 25 °C.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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