Ipratropium: uses, appearance and warnings

Ipratropium bromide inhalation solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

Ipratropium bromide inhalation solution USP is a clear, colorless solution containing 2.5 mL, packaged in cartons as listed below: NDC 64980-640-02, 25 vials per carton / 5 vials per foil pouch NDC 64980-640-03, 30 vials per carton / 5 vials per foil pouch NDC 64980-640-06, 60 vials per carton / 5 vials per foil pouch Each vial is made from a low density polyethylene (LDPE) resin. Storage and Handling Store between 15° C and 30° C (59° F and 86° F). Protect from light. Store in pouch until time of use. ATTENTION PHARMACIST: Detach “Patient’s Information for Use” from Package Insert and dispense with solution. Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured By: Nephron Pharmaceuticals Corporation West Columbia, SC 29172 For Customer Service, Call: 1-844-874-7464 IC 3017 Issued: 07/2024

Ipratropium bromide is contraindicated in known or suspected cases of hypersensitivity to ipratropium bromide, or to atropine and its derivatives.

The use of ipratropium bromide inhalation solution as a single agent for the relief of bronchospasm in acute COPD exacerbation has not been adequately studied. Drugs with faster onset of action may be preferable as initial therapy in this situation. Combination of ipratropium bromide inhalation solution and beta agonists has not been shown to be more effective than either drug alone in reversing the bronchospasm associated with acute COPD exacerbation. Immediate hypersensitivity reactions may occur after administration of ipratropium bromide, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal edema.

Adverse reaction information concerning ipratropium bromide inhalation solution is derived from 12-week active-controlled clinical trials. Additional information is derived from foreign post-marketing experience and the published literature. All adverse events, regardless of drug relationship, reported by three percent or more patients in the 12-week controlled clinical trials appear in the table below. Additional adverse reactions reported in less than three percent of the patients treated with ipratropium bromide include tachycardia, palpitations, eye pain, urinary retention, urinary tract infection and urticaria. Cases of precipitation or worsening of narrow-angle glaucoma and acute eye pain have been reported. …

Ipratropium bromide has been shown to be a safe and effective bronchodilator when used in conjunction with beta adrenergic bronchodilators. Ipratropium bromide has also been used with other pulmonary medications, including methylxanthines and corticosteroids, without adverse drug interactions.