Ipratropium

FDA label

Read the full label on DailyMed ↗

Renal Undefined

Hepatic Undefined

Doses must be 6-8 hours apart; headache, dry mouth and worsening COPD symptoms become more common once the total daily dose reaches or exceeds 2,000 mcg.

Instructions

• Give by oral nebulization only; each unit-dose vial contains 500 mcg anhydrous ipratropium bromide in 2.5 mL of normal saline.
• Space doses 6 to 8 hours apart.
• May be mixed in the nebulizer with albuterol or metaproterenol if used within one hour; stability and safety with other drugs in a nebulizer have not been established.

Contraindications

• Known or suspected hypersensitivity to atropine or its derivatives

Cautions

• Not adequately studied as a single agent for relief of bronchospasm in acute COPD exacerbation - faster-onset drugs may be preferable as initial therapy; adding a beta-agonist has not been shown more effective than either drug alone in this setting.
• Immediate hypersensitivity reactions (urticaria, angioedema, rash, bronchospasm, oropharyngeal edema); many affected patients had other drug or food allergies.
• Use with caution in narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction.
• Avoid eye contact with the nebulized solution - temporary blurred vision, precipitation or worsening of narrow-angle glaucoma, or eye pain can result; a nebulizer with mouthpiece rather than face mask may be preferable.
• Urinary retention and urinary tract infection reported.
• Paradoxical bronchospasm and worsening dyspnea were the most common reasons for discontinuation in the 12-week trials.
• Headache, dry mouth and aggravation of COPD symptoms increase at total daily doses at or above 2,000 mcg.

Adverse reactions

• Bronchitis (14.6%), upper respiratory tract infection (13.2%), dyspnea (9.6%)
• Headache (6.4%)
• Cough (4.6%), bronchospasm (2.3%)
• Nausea (4.1%), dry mouth (3.2%)
• Pain, back pain, chest pain, influenza-like symptoms
• Dizziness, insomnia
• Pharyngitis, rhinitis, sinusitis
• Less common: tachycardia, palpitations, eye pain, urinary retention, urinary tract infection, urticaria
• Narrow-angle glaucoma precipitation/worsening, mydriasis

Pregnancy Oral and inhalation animal reproduction studies showed no teratogenicity; there are no adequate, well-controlled studies in pregnant women - use only if clearly needed (former Pregnancy Category B).

Lactation Undefined