Drug profile
Tamsulosin
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- Tamsulosin hydrochloride capsules 0.4 mg once daily is recommended as the dose for
the treatment of the signs and symptoms of BPH.
Source: US FDA label for tamsulosin (Tamsulosin Hydrochloride), section 'dosage
and administration', retrieved 2026-08-29
- For those patients who fail to respond to the 0.4 mg dose after 2 to 4 weeks of
dosing, the dose of tamsulosin hydrochloride capsules can be increased to 0.8 mg
once daily.
Source: US FDA label for tamsulosin (Tamsulosin Hydrochloride), section 'dosage
and administration', retrieved 2026-08-29
- If tamsulosin hydrochloride capsules administration is discontinued or interrupted
for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started
again with the 0.4 mg once-daily dose. • 0.4 mg once daily taken approximately
one-half hour following the same meal each day.Tamsulosin hydrochloride capsules
should not be crushed, chewed or opened.
Source: US FDA label for tamsulosin (Tamsulosin Hydrochloride), section 'dosage
and administration', retrieved 2026-08-29
CHILD
- Tamsulosin hydrochloride capsules are not indicated for use in pediatric
populations. Efficacy and positive benefit/risk of tamsulosin hydrochloride was
not demonstrated in two studies conducted in patients 2 years to 16 years of age
with elevated detrusor leak point pressure (>40 cm H 2 O) associated with known
neurological disorder (e.g., spina bifida).
Source: US FDA label for tamsulosin (Tamsulosin Hydrochloride), section 'pediatric
use', retrieved 2026-08-29
RENAL IMPAIRMENT
- (8.5 , 12.3) • Renal Impairment: Has not been studied in patients with end-stage
renal disease.
Source: US FDA label for tamsulosin (Tamsulosin Hydrochloride), section 'use in
specific populations', retrieved 2026-08-29
- No overall differences in safety or effectiveness were observed between these
subjects and younger subjects, and the other reported clinical experience has not
identified differences in responses between the elderly and younger patients, but
greater sensitivity of some older individuals cannot be ruled out [see Clinical
Pharmacology (12.3) ] .
Source: US FDA label for tamsulosin (Tamsulosin Hydrochloride), section 'use in
specific populations', retrieved 2026-08-29
HEPATIC IMPAIRMENT
- (8.6 , 12.3) • Hepatic Impairment: Has not been studied in patients with severe
hepatic impairment.
Source: US FDA label for tamsulosin (Tamsulosin Hydrochloride), section 'use in
specific populations', retrieved 2026-08-29
- However, patients with end-stage renal disease (CL cr <10 mL/min/1.73 m 2 ) have
not been studied [see Clinical Pharmacology (12.3) ] . 8.7 Hepatic Impairment
Patients with moderate hepatic impairment do not require an adjustment in
tamsulosin hydrochloride capsules dosage.
Source: US FDA label for tamsulosin (Tamsulosin Hydrochloride), section 'use in
specific populations', retrieved 2026-08-29
- Tamsulosin hydrochloride has not been studied in patients with severe hepatic
impairment [see Clinical Pharmacology (12.3) ] .
Source: US FDA label for tamsulosin (Tamsulosin Hydrochloride), section 'use in
specific populations', retrieved 2026-08-29
PREGNANCY
- Teratogenic Effects, Pregnancy Category B.
Source: US FDA label for tamsulosin (Tamsulosin Hydrochloride), section
'pregnancy', retrieved 2026-08-29
- Administration of tamsulosin hydrochloride to pregnant female rats at dose levels
up to approximately 50 times the human therapeutic AUC exposure (300 mg/kg/day)
revealed no evidence of harm to the fetus.
Source: US FDA label for tamsulosin (Tamsulosin Hydrochloride), section
'pregnancy', retrieved 2026-08-29
- Administration of tamsulosin hydrochloride to pregnant rabbits at dose levels up
to 50 mg/kg/day produced no evidence of fetal harm.
Source: US FDA label for tamsulosin (Tamsulosin Hydrochloride), section
'pregnancy', retrieved 2026-08-29
BREASTFEEDING
- Tamsulosin hydrochloride capsules are not indicated for use in women.
Source: US FDA label for tamsulosin (Tamsulosin Hydrochloride), section 'nursing
mothers', retrieved 2026-08-29
- Tamsulosin hydrochloride capsules are not indicated for use in women. 8.3 Nursing
Mothers Tamsulosin hydrochloride capsules are not indicated for use in women. 8.4
Pediatric Use Tamsulosin hydrochloride capsules are not indicated for use in
pediatric populations.
Source: US FDA label for tamsulosin (Tamsulosin Hydrochloride), section 'use in
specific populations', retrieved 2026-08-29