Home About

Spiriva Respimat

TIOTROPIUM BROMIDE INHALATION SPRAY

Manufacturer: Boehringer Ingelheim Pharmaceuticals, Inc.

Score: 141.0

Quick Summary

Spiriva Respimat is an anticholinergic inhalation spray used for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) and for reducing COPD exacerbations. It is also used for the long-term, once-daily, maintenance treatment of asthma in patients 6 years of age and older. The recommended dosage for patients with COPD is 2 inhalations of Spiriva Respimat 2.5 mcg per actuation once-daily, and for patients with asthma, it is 2 inhalations of Spiriva Respimat 1.25 mcg per actuation once-daily. Important safety information includes warnings about immediate hypersensitivity reactions, paradoxical bronchospasm, and worsening of narrow-angle glaucoma and urinary retention. Contraindications include hypersensitivity to tiotropium, ipratropium, or any component of the product.

Key Clinical Findings and Indications

  • Maintenance treatment of bronchospasm associated with COPD
  • Reducing COPD exacerbations
  • Maintenance treatment of asthma in patients 6 years of age and older

Important Safety Information

Warning

Risk of immediate hypersensitivity reactions, paradoxical bronchospasm, and worsening of narrow-angle glaucoma and urinary retention

Contraindications

  • Hypersensitivity to tiotropium, ipratropium, or any component of the product

Adverse Reactions

  • Pharyngitis
  • Cough
  • Dry mouth
  • Sinusitis
  • Headache
  • Bronchitis

Dosing Recommendations

General Guidance

No dosage adjustment is required for geriatric, hepatically-impaired, or renally-impaired patients

COPD

Adult Dose

2 inhalations of Spiriva Respimat 2.5 mcg per actuation once-daily

Pediatric Dose

Not applicable

Asthma

Adult Dose

2 inhalations of Spiriva Respimat 1.25 mcg per actuation once-daily

Pediatric Dose

2 inhalations of Spiriva Respimat 1.25 mcg per actuation once-daily for patients 6 years of age and older

Special Population Considerations

Pregnancy

  • The limited human data with Spiriva Respimat use during pregnancy are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes

Nursing Mothers

  • No information available

Pediatric Use

  • The safety and efficacy of Spiriva Respimat 2.5 mcg have been established in pediatric patients aged 6 to 17 years with asthma

Geriatric Use

  • No adjustment of Spiriva Respimat dosage in geriatric patients is warranted