Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Ipratropium Bromide Inhalation Solution is a clear, colorless solution supplied in a unit-dose vial containing 2.5 mL. Supplied in cartons as listed below: 0.02% (0.5 mg/2.5 mL) NDC 65862-905-25 25 vials per carton / 25 vials per foil pouch NDC 65862-905-30 30 vials per carton / 30 vials per foil pouch NDC 65862-905-60 60 vials per carton / 30 vials per foil pouch NDC 65862-905-03 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 15° and 30°C (59° and 86°F). Protect from light. S tore in pouch until time of use. ATTENTION PHARMACIST: Detach “Patient’s Instructions for Use” from Package Insert and dispense with solution.; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Pouch Label (1 Vial) NDC 65862-905-01 Rx only Ipratropium Bromide Inhalation Solution 0.02% (0.5 mg/2.5 mL) For Oral Inhalation Only Not for Injection 1 x 2.5 mL Sterile Unit Dose Vial Each low density polyethylene vial contains: 2.5 mL Ipratropium Bromide USP 0.02%, preservative free, isotonic sterile aqueous solution containing sodium chloride. Adjusted to pH 3.4 (3 to 4) with hydrochloric acid. Usual Dosage: See accompanying prescribing information. Store between 15° and 30°C (59° and 86°F). Protect From Light. Store in pouch until time of use. ATTENTION PHARMACIST: Detach “Patient's Instructions for Use” from Package Insert and dispense with solution. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/13/2010 AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Pouch Label (1 Vial); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Pouch Label (25 Vials) NDC 65862-905-25 Rx only Ipratropium Bromide Inhalation Solution 0.02% (0.5 mg/2.5 mL) For Oral Inhalation Only Not for Injection 25 x 2.5 mL Sterile Unit Dose Vials Each low density polyethylene vial contains: 2.5 mL Ipratropium Bromide USP 0.02%, preservative free, isotonic sterile aqueous solution containing sodium chloride. Adjusted to pH 3.4 (3 to 4) with hydrochloric acid. Usual Dosage: See accompanying prescribing information. Store between 15° and 30°C (59° and 86°F). 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. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/13/2010 AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Pouch Label (25 Vials); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Pouch Label (30 Vials) NDC 65862-905-33 Rx only Ipratropium Bromide Inhalation Solution 0.02% (0.5 mg/2.5 mL) For Oral Inhalation Only Not for Injection 30 x 2.5 mL Sterile Unit Dose Vials Each low density polyethylene vial contains: 2.5 mL Ipratropium Bromide USP 0.02%, preservative free, isotonic sterile aqueous solution containing sodium chloride. Adjusted to pH 3.4 (3 to 4) with hydrochloric acid. Usual Dosage: See accompanying prescribing information. Store between 15° and 30°C (59° and 86°F). 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. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/13/2010 AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Pouch Label (30 Vials); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Container-Carton (30 Individually Wrapped Vials) Rx only NDC 65862-905-03 Ipratropium Bromide Inhalation Solution 0.02% (0.5 mg/2.5 mL) For Oral Inhalation Only Not for Injection 2.5 mL, Sterile Unit Dose Vial 30 Individually Wrapped Vials AUROBINDO PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Container-Carton (30 Individually Wrapped Vials); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Container-Carton (25 Vials) Rx only NDC 65862-905-25 Ipratropium Bromide Inhalation Solution 0.02% (0.5 mg/2.5 mL) For Oral Inhalation Only Not for Injection 25 x 2.5 mL Sterile Unit Dose Vials AUROBINDO PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Container-Carton (25 Vials); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Container-Carton (30 Vials) Rx only NDC 65862-905-30 Ipratropium Bromide Inhalation Solution 0.02% (0.5 mg/2.5 mL) For Oral Inhalation Only Not for Injection 30 x 2.5 mL Sterile Unit Dose Vials AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Container-Carton (30 Vials); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Container-Carton (2 x 30 Vial Pouches) Rx only NDC 65862-905-60 Ipratropium Bromide Inhalation Solution 0.02% (0.5 mg/2.5 mL) For Oral Inhalation Only Not for Injection 60 x 2.5 mL Sterile Unit Dose Vials (2 x 30 Vial Pouches) AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Container-Carton (2 x 30 Vial Pouches)
- HOW SUPPLIED Ipratropium Bromide Inhalation Solution is a clear, colorless solution supplied in a unit-dose vial containing 2.5 mL. Supplied in cartons as listed below: 0.02% (0.5 mg/2.5 mL) NDC 65862-905-25 25 vials per carton / 25 vials per foil pouch NDC 65862-905-30 30 vials per carton / 30 vials per foil pouch NDC 65862-905-60 60 vials per carton / 30 vials per foil pouch NDC 65862-905-03 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 15° and 30°C (59° and 86°F). Protect from light. S tore in pouch until time of use. ATTENTION PHARMACIST: Detach “Patient’s Instructions for Use” from Package Insert and dispense with solution.
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Pouch Label (1 Vial) NDC 65862-905-01 Rx only Ipratropium Bromide Inhalation Solution 0.02% (0.5 mg/2.5 mL) For Oral Inhalation Only Not for Injection 1 x 2.5 mL Sterile Unit Dose Vial Each low density polyethylene vial contains: 2.5 mL Ipratropium Bromide USP 0.02%, preservative free, isotonic sterile aqueous solution containing sodium chloride. Adjusted to pH 3.4 (3 to 4) with hydrochloric acid. Usual Dosage: See accompanying prescribing information. Store between 15° and 30°C (59° and 86°F). Protect From Light. Store in pouch until time of use. ATTENTION PHARMACIST: Detach “Patient's Instructions for Use” from Package Insert and dispense with solution. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/13/2010 AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Pouch Label (1 Vial)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Pouch Label (25 Vials) NDC 65862-905-25 Rx only Ipratropium Bromide Inhalation Solution 0.02% (0.5 mg/2.5 mL) For Oral Inhalation Only Not for Injection 25 x 2.5 mL Sterile Unit Dose Vials Each low density polyethylene vial contains: 2.5 mL Ipratropium Bromide USP 0.02%, preservative free, isotonic sterile aqueous solution containing sodium chloride. Adjusted to pH 3.4 (3 to 4) with hydrochloric acid. Usual Dosage: See accompanying prescribing information. Store between 15° and 30°C (59° and 86°F). 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. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/13/2010 AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Pouch Label (25 Vials)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Pouch Label (30 Vials) NDC 65862-905-33 Rx only Ipratropium Bromide Inhalation Solution 0.02% (0.5 mg/2.5 mL) For Oral Inhalation Only Not for Injection 30 x 2.5 mL Sterile Unit Dose Vials Each low density polyethylene vial contains: 2.5 mL Ipratropium Bromide USP 0.02%, preservative free, isotonic sterile aqueous solution containing sodium chloride. Adjusted to pH 3.4 (3 to 4) with hydrochloric acid. Usual Dosage: See accompanying prescribing information. Store between 15° and 30°C (59° and 86°F). 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. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/13/2010 AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Pouch Label (30 Vials)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Container-Carton (30 Individually Wrapped Vials) Rx only NDC 65862-905-03 Ipratropium Bromide Inhalation Solution 0.02% (0.5 mg/2.5 mL) For Oral Inhalation Only Not for Injection 2.5 mL, Sterile Unit Dose Vial 30 Individually Wrapped Vials AUROBINDO PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Container-Carton (30 Individually Wrapped Vials)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Container-Carton (25 Vials) Rx only NDC 65862-905-25 Ipratropium Bromide Inhalation Solution 0.02% (0.5 mg/2.5 mL) For Oral Inhalation Only Not for Injection 25 x 2.5 mL Sterile Unit Dose Vials AUROBINDO PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Container-Carton (25 Vials)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Container-Carton (30 Vials) Rx only NDC 65862-905-30 Ipratropium Bromide Inhalation Solution 0.02% (0.5 mg/2.5 mL) For Oral Inhalation Only Not for Injection 30 x 2.5 mL Sterile Unit Dose Vials AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Container-Carton (30 Vials)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Container-Carton (2 x 30 Vial Pouches) Rx only NDC 65862-905-60 Ipratropium Bromide Inhalation Solution 0.02% (0.5 mg/2.5 mL) For Oral Inhalation Only Not for Injection 60 x 2.5 mL Sterile Unit Dose Vials (2 x 30 Vial Pouches) AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.02% (0.5 mg/2.5 mL) - Container-Carton (2 x 30 Vial Pouches)
Overview
The active ingredient in Ipratropium Bromide Inhalation Solution is ipratropium bromide monohydrate, USP. It 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 USP is a white to off-white crystalline powder, soluble in water, freely soluble in methanol and slightly soluble in ethanol. It is a quaternary ammonium compound and thus exists in an ionized state in aqueous solutions. It is insoluble in isopropyl alcohol, chloroform, methylene chloride and benzene. Ipratropium Bromide Inhalation Solution is administered by oral inhalation with the aid of a nebulizer. Each mL 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. Ipratropium Bromide Monohydrate Chemical Structure
Indications & Usage
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.
Dosage & Administration
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.
Warnings & Precautions
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 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.
Contraindications
Ipratropium bromide is contraindicated in known or suspected cases of hypersensitivity to ipratropium bromide, or to atropine and its derivatives.
Adverse Reactions
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. 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* PERCENT OF PATIENTS Ipratropium Bromide (500 mcg t.i.d.) n = 219 Metaproterenol (15 mg t.i.d.) n = 212 Ipratropium Bromide/ Metaproterenol (500 mcg t.i.d./15 mg t.i.d.) n = 108 Albuterol (2.5 mg t.i.d.) n = 205 Ipratropium Bromide/Albuterol (500 mcg t.i.d./2.5 mg t.i.d.) 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 Sinusitis 2.3 2.8 0.9 5.4 4.0 *All adverse events, regardless of drug relationship, reported by three percent or more patients in the 12-week controlled clinical trials
Drug Interactions
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.
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