Silodosin
سیلودوزین
🚻 Genito Urinary System And Sex HormonesAlpha-1A blocker
Market / country: 🇺🇸 USA
Rapaflo (US)
🧮 Dose calculator
Benign prostatic hyperplasia (BPH) · Regimen source: FDA Silodosin · 2.1
- • If swallowing is difficult, the capsule may be opened onto applesauce. FDA Silodosin · 2.1
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Severe renal impairment (CrCl <30); severe hepatic impairment (Child-Pugh ≥10); strong CYP3A4 inhibitors; hypersensitivity. FDA Silodosin · 4
Warnings
- • Postural hypotension and syncope; exclude prostate cancer first; intraoperative floppy iris syndrome (IFIS) in cataract surgery. FDA Silodosin · 5
Renal adjustment
- • eGFR < 50: CrCl 30–50: 4 mg once daily; below 30 contraindicated. FDA Silodosin · 2.2
Formulations
- 8 mg capsule — capsule 🇺🇸 USA FDA Silodosin · 3
- 4 mg capsule — capsule 🇺🇸 USA FDA Silodosin · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Silodosin · 8.1
“Risk Summary Silodosin is not indicated for use in females.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Silodosin · 8.2
“Silodosin is not indicated for use in females.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Silodosin · 8.4
“Safety and effectiveness in pediatric patients have not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Silodosin · 8.5
“In double-blind, placebo-controlled, 12-week clinical studies of silodosin, 259 (55.6%) were under 65 years of age, 207 (44.4%) patients were 65 years of age and over, while 60 (12.9%) patients were 75 years of age and over.Orthostatic hypotension was reported in 2.3% of silodosin patients < 65 years of age (1.2% for …”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Silodosin · 8.3
“Infertility Males Possible effects on male fertility could be observed based on findings in rats at exposures that were at least two times higher than at the MRHD (based on AUC).”
🔗 Reference links
- FDA (approval record)ANDA210687
- DailyMed (FDA label)FDA Silodosin
- MedlinePlus (NIH)Silodosin
- WHO ATC/DDDG04CA04
- Darooyab (Iran)Silodosin
🇮🇷 Registered in Iran Darooyab · G-5335/Silodosin
Dosage forms with Iranian generic codes, per Darooyab.
- 53409 · SILODOSIN 8 mg CAPSULE · کپسول سیلودوسین ۸ میلیگرم
- 53408 · SILODOSIN 4 mg CAPSULE · کپسول سیلودوسین ۴ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Silodosin · 3FDA Silodosin · 2.1FDA Silodosin · 4FDA Silodosin · 5FDA Silodosin · 2.2FDA Silodosin · SPL approval / marketing categoryFDA Silodosin · 8.1FDA Silodosin · 8.2FDA Silodosin · 8.4FDA Silodosin · 8.5FDA Silodosin · 8.3
- 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-5335/Silodosin
- Clinical review⚠ Unverified