Dawaa Reference

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