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Medicine guide

Ipratropium Bromide

.5 mg/2.5mL · Solution

  • Prescription only
  • Anticholinergic
Active substance
Ipratropium Bromide
Made by
Mylan Pharmaceuticals Inc.

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2013-06-24

What it is

Anticholinergic

Used for
  • Ipratropium Bromide Inhalation Solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm…
The label’s usual adult dose

The usual dosage of ipratropium bromide inhalation solution is 500 mcg (1 Unit-Dose Vial) administered three to four times a day by oral nebulization, with doses 6 to 8 hours apart.

Full directions ↓
Do not take it if

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

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
31other products contain Ipratropium Bromide — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • 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.

From the official label · 2013-06-24 · DailyMed

How it works

From this product’s own US prescribing label.

Ipratropium bromide is an anticholinergic (parasympatholytic) agent that, based on animal studies, appears to inhibit vagally mediated reflexes by antagonizing the action of acetylcholine, the transmitter agent released from the vagus nerve.

Anticholinergics prevent the increases in intracellular concentration of cyclic guanosine monophosphate (cyclic GMP) that are caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle.

Half-life1.6 h
Mostly cleared after≈ 8 hfive half-lives — our arithmetic
How the body breaks it down

It is partially metabolized.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2013-06-24

Do not take it if

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

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • The usual dosage of ipratropium bromide inhalation solution is 500 mcg (1 Unit-Dose Vial) administered three to four times a day by oral nebulization, with doses 6 to 8 hours apart.
  • Ipratropium bromide inhalation solution unit-dose vials contain 500 mcg ipratropium bromide, USP anhydrous in 2.5 mL normal saline.
  • Ipratropium bromide inhalation solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour.
  • Drug stability and safety of Ipratropium Bromide Inhalation Solution when mixed with other drugs in a nebulizer have not been established.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • 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 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.
  • General Ipratropium bromide should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction.
  • Information for Patients Patients should be advised that temporary blurring of vision, precipitation or worsening of narrow-angle glaucoma or eye pain may result if the solution comes into direct contact with the eyes.
  • Drug Interactions Ipratropium bromide has been shown to be a safe and effective bronchodilator when used in conjunction with beta adrenergic bronchodilators.
  • Carcinogenesis, Mutagenesis, Impairment of Fertility Two-year oral carcinogenicity studies in rats and mice have revealed no carcinogenic potential at dietary doses up to 6 mg/kg/day of ipratropium bromide.
  • Results of various mutagenicity studies (Ames test, mouse dominant lethal test, mouse micronucleus test and chromosome aberration of bone marrow in Chinese hamsters) were negative.
  • Fertility of male or female rats at oral doses up to 50 mg/kg/day was unaffected by ipratropium bromide administration.
  • At doses above 90 mg/kg increased resorption and decreased conception rates were observed.
  • Pregnancy TERATOGENIC EFFECTS Pregnancy Category B Oral reproduction studies performed in mice, rats and rabbits at doses of 10, 100, and 125 mg/kg respectively, and inhalation reproduction studies in rats and rabbits at doses of 1.5 and 1.8 mg/kg (or approximately 38 and 45 times the recommended human daily dose) respectively, have demonstrated no evidence of teratogenic effects as a result of ipratropium bromide.
  • Nursing Mothers It is not known whether ipratropium bromide is excreted in human milk.
  • Pediatric Use Safety and effectiveness in the pediatric population below the age of 12 have not been established.
  • General Ipratropium bromide should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • TERATOGENIC EFFECTS Pregnancy Category B Oral reproduction studies performed in mice, rats and rabbits at doses of 10, 100, and 125 mg/kg respectively, and inhalation reproduction studies in rats and rabbits at doses of 1.5 and 1.8 mg/kg (or approximately 38 and 45 times the recommended human daily dose) respectively, have demonstrated no evidence of teratogenic effects as a result of ipratropium bromide.
  • However, no adequate or well-controlled studies have been conducted in pregnant women.
  • Because animal reproduction studies are not always predictive of human response, ipratropium bromide should be used during pregnancy only if clearly needed.
  • It is not known whether ipratropium bromide is excreted in human milk.
  • Although lipid-insoluble quaternary bases pass into breast milk, it is unlikely that ipratropium bromide would reach the infant to a significant extent, especially when taken by inhalation since ipratropium bromide is not well absorbed systemically after inhalation or oral administration.
  • However, because many drugs are excreted in human milk, caution should be exercised when ipratropium bromide is administered to a nursing woman.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

  • 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.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

  • Acute systemic overdosage by inhalation solution is unlikely since ipratropium bromide is not well absorbed after inhalation at up to four-fold the recommended dose, or after oral administration at up to forty-fold the recommended dose.
  • The oral LD 50 of ipratropium bromide ranged between 1001 and 2010 mg/kg in mice; between 1667 and 4000 mg/kg in rats; and between 400 and 1300 mg/kg in dogs.

Quoted from the official label, section “Overdosage”.

Use in children

Safety and effectiveness in the pediatric population below the age of 12 have not been established.

Quoted from the official label, section “Pediatric Use”.

Side effects

  • 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, mydriasis, and acute eye pain have been reported.
  • Lower respiratory adverse reactions (bronchitis, dyspnea and bronchospasm) were the most common events leading to discontinuation of ipratropium bromide therapy in the 12-week trials.
  • Headache, mouth dryness and aggravation of COPD symptoms are more common when the total daily dose of ipratropium bromide equals or exceeds 2,000 mcg.
  • Allergic-type reactions such as skin-rash, angioedema of tongue, lips and face, urticaria, laryngospasm and anaphylactic reaction have been reported.
  • Many of the patients had a history of allergies to other drugs and/or foods.
  • All Adverse Events, from a Double-blind, Parallel, 12-week Study of patients with COPD All adverse events, regardless of drug relationship, reported by three percent or more patients in the 12-week controlled clinical trials.
  • PERCENT OF PATIENTS Ipratropium Metaproterenol Ipratropium/Metaproterenol Albuterol Ipratropium/Albuterol (500 mcg t.i.d.) (15 mg t.i.d.) (500 mcg t.i.d./15 mg t.i.d.) (2.5 mg t.i.d.) (500 mcg t.i.d./2.5 mg t.i.d.) n = 219 n = 212 n = 108 n = 205 n = 100 Body as a Whole-General Disorders Headache 6.4 5.2 6.5 6.3
  • 9.0 Pain 4.1 3.3 0.9 2.9
  • 5.0 Influenza-like symptoms 3.7 4.7 6.5 0.5
  • 1.0 Back Pain 3.2 1.9 1.9 2.4
  • 0.0 Chest Pain 3.2 4.2 5.6 2.0
  • 1.0 Cardiovascular Disorders Hypertension/Hypertension Aggravated 0.9 1.9 0.9 1.5
  • 4.0 Central & Peripheral Nervous System Dizziness 2.3 3.3 1.9 3.9
  • 4.0 Insomnia 0.9 0.5 4.6 1.0
  • 1.0 Tremor 0.9 7.1 8.3 1.0
  • 0.0 Nervousness 0.5 4.7 6.5 1.0
  • 1.0 Gastrointestinal System Disorders Mouth Dryness 3.2 0.0 1.9 2.0
  • 3.0 Nausea 4.1 3.8 1.9 2.9
  • 2.0 Constipation 0.9 0.0 3.7 1.0
  • 1.0 Musculo-skeletal System Disorders Arthritis 0.9 1.4 0.9 0.5
  • 3.0 Respiratory System Disorders (Lower) Coughing 4.6 8.0 6.5 5.4
  • 6.0 Dyspnea 9.6 13.2 16.7 12.7
  • 9.0 Bronchitis 14.6 24.5 15.7 16.6
  • 20.0 Bronchospasm 2.3 2.8 4.6 5.4
  • 5.0 Sputum Increased 1.4 1.4 4.6 3.4
  • 0.0 Respiratory Disorder 0.0 6.1 6.5 2.0
  • 4.0 Respiratory System Disorders (Upper) Upper Respiratory Tract Infection 13.2 11.3 9.3 12.2
  • 16.0 Pharyngitis 3.7 4.2 5.6 2.9
  • 4.0 Rhinitis 2.3 4.2 1.9 2.4
  • 0.0 Sinusitus 2.3 2.8 0.9 5.4 4.0

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

  • Patients should be advised that temporary blurring of vision, precipitation or worsening of narrow-angle glaucoma or eye pain may result if the solution comes into direct contact with the eyes.
  • Use of a nebulizer with mouthpiece rather than face mask may be preferable, to reduce the likelihood of the nebulizer solution reaching the eyes.
  • Patients should be advised that ipratropium bromide inhalation solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour.
  • Drug stability and safety of Ipratropium Bromide Inhalation Solution when mixed with other drugs in a nebulizer have not been established.
  • Patients should be reminded that ipratropium bromide inhalation solution should be used consistently as prescribed throughout the course of therapy.

Quoted from the official label, section “Patient Counseling Information”.

What it looks like and how it is packed

  • Ipratropium Bromide Inhalation Solution Unit Dose Vial is supplied as a 0.02% clear, colorless solution containing 2.5 mL.
  • NDC 0378-7970-52 25 vials per carton/25 vials per foil pouch NDC 0378-7970-93 30 vials per carton/30 vials per foil pouch NDC 0378-7970-91 60 vials per carton/30 vials per foil pouch NDC 0378-7970-55 30 vials per carton / 1 vial per foil pouch Each vial is made from a low density polyethylene (LDPE) resin.
  • Vials are supplied in a foil pouch.
  • Store between 59°F (15°C) and 86°F (30°C).
  • Protect from light.
  • Store unused vials in the foil pouch.
  • ATTENTION PHARMACIST:
  • Detach "Patient's Instructions for Use" from Package Insert and dispense with solution.

Quoted from the official label, section “How Supplied”.

How to store it

  • Store between 59°F (15°C) and 86°F (30°C). Protect from light. Store unused vials in the foil pouch. ATTENTION PHARMACIST:
  • Detach "Patient's Instructions for Use" from Package Insert and dispense with solution.

Quoted from the official label, section “Storage and Handling”.

What is in it

  • The active ingredient, ipratropium bromide monohydrate, USP, is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]- octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. Ipratropium Bromide Monohydrate C 20 H 30 BrNO 3
  • H 2 O Mol.Wt. 430.4 Ipratropium bromide is a white crystalline substance, freely soluble in water and lower alcohols. It is a quaternary ammonium compound and thus exists in an ionized state in aqueous solutions. It is relatively insoluble in non-polar media. Ipratropium Bromide Inhalation Solution is administered by oral inhalation with the aid of a nebulizer. It contains ipratropium bromide, USP 0.02% (anhydrous basis) in a sterile, preservative-free, isotonic saline solution, pH-adjusted to 3.4 (3 to 4) with hydrochloric acid. Chemical Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (12)

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Same active substance, strength and form in other countries

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Every strength and form (11)

Details

Made byMylan Pharmaceuticals Inc.
Active substanceIpratropium Bromide
Strength.5 mg/2.5mL
FormSolution
RouteRespiratory (inhalation)
Packs1 POUCH in 1 CARTON / 25 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE · 30 POUCH in 1 CARTON / 1 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE
NDC0378-7970

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

31 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Atrovent Hfa17 ugPrescription onlyAerosol, Metered Boehringer Ingelheim Pharmaceuticals, Inc. · Ipratropium BromideIpratropium Bromide21 ugPrescription onlySpray Hikma Pharmaceuticals USA Inc. · Ipratropium BromideIpratropium Bromide42 ugPrescription onlySpray Hikma Pharmaceuticals USA Inc. · Ipratropium BromideIpratropium Bromide.5 mg/2.5mLPrescription onlySolution Nephron Pharmaceuticals Corporation · Ipratropium BromideIpratropium Bromide21 ugPrescription onlySpray, Metered NORTHSTAR RX LLC · Ipratropium BromideIpratropium Bromide42 ugPrescription onlySpray, Metered NORTHSTAR RX LLC · Ipratropium Bromide

See every product with Ipratropium Bromide