Dutasteride
دوتاستراید
🚻 Genito Urinary System And Sex Hormones5-alpha-reductase inhibitor
Market / country: 🇺🇸 USA
Avodart (US)
🧮 Dose calculator
Benign prostatic hyperplasia (BPH) · Regimen source: FDA Avodart · 2.1FDA Avodart · 2.2
- • Do not open or chew (oropharyngeal irritation). Pregnant women or those who may become pregnant must not handle capsules (skin absorption). FDA Avodart · 2FDA Avodart · 16
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Pregnancy; clinically significant hypersensitivity to dutasteride or other 5-alpha-reductase inhibitors. FDA Avodart · 4
Warnings
- • Lowers PSA by about 50%; evaluate any confirmed PSA rise. May increase high-grade prostate cancer. Do not donate blood until 6 months after the last dose. FDA Avodart · 5
Formulations
- 0.5 mg soft capsule (swallow whole) — capsule 🇺🇸 USA FDA Avodart · 3
👥 Special populations
- 🤰 PregnancyContraindicated
Label: contraindicated in pregnancy. FDA Avodart · 4
“AVODART is contraindicated for use in: • Pregnancy.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Avodart · 8.2
“Risk Summary AVODART is not indicated for use in women.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Avodart · 8.4
“Safety and effectiveness in pediatric patients have not been established.”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Avodart · 8.5
“No overall differences in safety or efficacy were observed between these subjects and younger subjects.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Avodart · 8.3
“Infertility Males: The effects of dutasteride 0.5 mg/day on semen characteristics were evaluated in normal volunteers aged 18 to 52 years (n = 27 dutasteride, n = 23 placebo) throughout 52 weeks of treatment and 24 weeks of post-treatment follow-up.”
🔗 Reference links
- FDA (approval record)NDA021319
- DailyMed (FDA label)FDA Avodart
- MedlinePlus (NIH)Dutasteride
- WHO ATC/DDDG04CB02
- Darooyab (Iran)Dutasteride
🇮🇷 Registered in Iran Darooyab · G-3248/Dutasteride
Dosage forms with Iranian generic codes, per Darooyab.
- 06735 · DUTASTERIDE 0.5MG CAP · کپسول دوتاستراید ۰٫۵ میلیگرم
- 06617 · DUTASTERIDE 0.5MG TAB · قرص دوتاستراید ۰٫۵ میلیگرم
- 17497 · DUTASTERIDE 15MG TAB · قرص دوتاستراید ۱۵ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Avodart · 3FDA Avodart · 2.1FDA Avodart · 2.2FDA Avodart · 2FDA Avodart · 16FDA Avodart · 4FDA Avodart · 5FDA Avodart · 8.2FDA Avodart · 8.4FDA Avodart · 8.5FDA Avodart · 8.3FDA Avodart · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-3248/Dutasteride
- Clinical review⚠ Unverified