Tiotropium Bromide

DRUG INFORMATION

  ADULT
    - Treatment of COPD: 2 inhalations of SPIRIVA RESPIMAT 2.5 mcg once-daily.
      Source: US FDA label for tiotropium bromide (Spiriva Respimat), section 'dosage
      and administration', retrieved 2026-08-29
    - ( 2 ) Treatment of asthma patients 6 years and older: 2 inhalations of SPIRIVA
      RESPIMAT 1.25 mcg once-daily.
      Source: US FDA label for tiotropium bromide (Spiriva Respimat), section 'dosage
      and administration', retrieved 2026-08-29
    - ( 2 ) 2.1 Chronic Obstructive Pulmonary Disease The recommended dosage for
      patients with COPD is 2 inhalations of SPIRIVA RESPIMAT 2.5 mcg per actuation
      once-daily; total dose equals 5 mcg of SPIRIVA RESPIMAT. 2.2 Asthma The
      recommended dosage for patients with asthma is 2 inhalations of SPIRIVA RESPIMAT
      1.25 mcg per actuation once-daily; total dose equals 2.5 mcg of SPIRIVA RESPIMAT.
      Source: US FDA label for tiotropium bromide (Spiriva Respimat), section 'dosage
      and administration', retrieved 2026-08-29

  CHILD
    - The safety and efficacy of SPIRIVA RESPIMAT 2.5 mcg have been established in
      pediatric patients aged 6 to 17 years with asthma in 6 clinical trials up to 1
      year in duration. In three clinical trials, 327 patients aged 12 to 17 years with
      asthma were treated with SPIRIVA RESPIMAT 2.5 mcg; in three additional clinical
      trials, 345 patients aged 6 to 11 years with asthma were treated with SPIRIVA
      RESPIMAT 2.5 mcg.
      Source: US FDA label for tiotropium bromide (Spiriva Respimat), section 'pediatric
      use', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - However, patients with moderate to severe renal impairment given SPIRIVA RESPIMAT
      should be monitored closely for anticholinergic effects [see Warnings and
      Precautions (5.6) , Use in Specific Populations (8.5 , 8.6 , 8.7) , and Clinical
      Pharmacology (12.3) ] .
      Source: US FDA label for tiotropium bromide (Spiriva Respimat), section 'dosage
      and administration', retrieved 2026-08-29
    - Patients with moderate to severe renal impairment should be monitored closely for
      potential anticholinergic side effects.
      Source: US FDA label for tiotropium bromide (Spiriva Respimat), section 'use in
      specific populations', retrieved 2026-08-29
    - The adverse drug reaction profiles were similar in the older population compared
      to the patient population overall. 8.6 Renal Impairment Patients with moderate to
      severe renal impairment (creatinine clearance of <60 mL/min) treated with SPIRIVA
      RESPIMAT should be monitored closely for anticholinergic side effects [see Dosage
      and Administration (2) , Warnings and Precautions (5.6) , and Clinical
      Pharmacology (12.3) ].
      Source: US FDA label for tiotropium bromide (Spiriva Respimat), section 'use in
      specific populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - The adverse drug reaction profiles were similar in the older population compared
      to the patient population overall. 8.6 Renal Impairment Patients with moderate to
      severe renal impairment (creatinine clearance of <60 mL/min) treated with SPIRIVA
      RESPIMAT should be monitored closely for anticholinergic side effects [see Dosage
      and Administration (2) , Warnings and Precautions (5.6) , and Clinical
      Pharmacology (12.3) ].
      Source: US FDA label for tiotropium bromide (Spiriva Respimat), section 'use in
      specific populations', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary The limited human data with SPIRIVA RESPIMAT use during pregnancy are
      insufficient to inform a drug-associated risk of adverse pregnancy-related
      outcomes.
      Source: US FDA label for tiotropium bromide (Spiriva Respimat), section
      'pregnancy', retrieved 2026-08-29
    - There are risks to the mother and the fetus associated with poorly controlled
      asthma in pregnancy (see Clinical Considerations ) .
      Source: US FDA label for tiotropium bromide (Spiriva Respimat), section
      'pregnancy', retrieved 2026-08-29
    - Based on animal reproduction studies, no structural abnormalities were observed
      when tiotropium was administered by inhalation to pregnant rats and rabbits during
      the period of organogenesis at doses 790 and 8 times, respectively, the maximum
      recommended human daily inhalation dose (MRHDID).
      Source: US FDA label for tiotropium bromide (Spiriva Respimat), section
      'pregnancy', retrieved 2026-08-29

  BREASTFEEDING
    - Such effects were not observed at approximately 5 and 95 times the MRHDID,
      respectively (on a mcg/m 2 basis at inhalation doses of 9 and 88 mcg/kg/day in
      rats and rabbits, respectively). 8.2 Lactation Risk Summary There are no data on
      the presence of tiotropium in human milk, the effects on the breastfed infant, or
      the effects on milk production.
      Source: US FDA label for tiotropium bromide (Spiriva Respimat), section 'use in
      specific populations', retrieved 2026-08-29
    - Tiotropium is present in milk of lactating rats; however, due to species-specific
      differences in lactation physiology, the clinical relevance of these data are not
      clear (see Data ) .
      Source: US FDA label for tiotropium bromide (Spiriva Respimat), section 'use in
      specific populations', retrieved 2026-08-29
    - The developmental and health benefits of breastfeeding should be considered along
      with the mother's clinical need for SPIRIVA RESPIMAT and any potential adverse
      effects on the breastfed child from SPIRIVA RESPIMAT or from the underlying
      maternal condition.
      Source: US FDA label for tiotropium bromide (Spiriva Respimat), section 'use in
      specific populations', retrieved 2026-08-29