SCHEDULE ‘H’ DRUG:
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
- Treatment of male pattern hair loss / androgenic alopecia in MEN ONLY
- It is not indicated for use in WOMEN
2.Mechanism of Action:
- Dutasteride, is a specific inhibitor of both Type I &Type II 5-alpha reductase enzyme. This blocks the peripheral conversion of testosterone to DHT (Dihydrotestosterone) resulting in significant reduction in tissue and serum DHT level. This interrupts the process of miniaturisation of hair by DHT.
3.Direction for Use:
- The recommended dose is 0.5mg tablet taken once daily
- It can be taken with or without food
4.Duration of Use and expected outcome:
- In general, regular use for three months or more is necessary before benefit is observed in mild to moderate hair loss and thinning but not in complete hair loss.
- Full benefit will take around a year.
- Continued use is recommended to sustain benefit, which should be re-evaluated periodically.
- Withdrawal of treatment leads to reversal of effect within 12 months.
5.Side Effects/Adverse Reaction:
- Most common (≥1% of patients)
Breast tenderness, enlargement or lump(neoplasm)
- Post marketing experience (causal relation not known)
Male breast cancer
If you see any of these side effects, stop the medicine and consult your doctor.
- Pregnancy – Category X
- Hypersensitivity to any component of this medicine
- It is not indicated in paediatric patients.
- Keep out of reach of children.
- Contraindicated in pregnancy and breastfeeding
- No clinical efficacy study in geriatric population above 65 years age.
- Patients with liver function abnormality need to be cautious and consult doctor.
- No dose adjustment needed in kidney disease.
8.Warning and Precautions:
- Exposure of women- It is not indicated in women. Women should not handle crushed or broken tablet when they are pregnant or potentially pregnant or expose themselves to semen of male partners .
- Effects on PSA (Prostate Specific Antigen)- PSA levels are affected by dutasteride. These findings should be taken into account for proper interpretation of serum PSA when evaluating men treated with finasteride. Any confirmed increase from the lowest PSA value while on dutasteride may signal the presence of prostate cancer and should be evaluated, even if PSA levels are still within the normal range.
- 5α-reductase inhibitors may increase the risk of development of high-grade prostate cancer.
- Consult your doctor on whether to start dutasteride if you are taking any of these following medications:
- Verapamil or diltiazem (for high BP)
- Ritonavir or indinavir (for HIV)
- Itraconazole or ketoconazole (for fungal infections)
- Nefazodone (an antidepressant)
PRACTICAL TIPS on DUMAN USE
- The sooner the medicine is started in patterned hair loss, the better the result.
- Works on top and crown area, but hairline and FT angles show poor response.
- Once the desired results are seen, dose can be reduced to twice a week to maintain the result.
- If the medicine is stopped, the effects are slowly reversed over 12 months.
- If you note any sexual side effects, stop medicine and consult your doctor.
- For married males, it is recommended to stop the medicine 3 months prior to planning conception.