Label: IPRATROPIUM BROMIDE solution
- NDC Code(s): 68071-3769-2
- Packager: NuCare Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0378-7970
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 13, 2025
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTIONPrescribing Information - Rx Only
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DESCRIPTIONThe active ingredient, ipratropium bromide monohydrate, USP, is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]- octane ...
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CLINICAL PHARMACOLOGYIpratropium bromide is an anticholinergic (parasympatholytic) agent that, based on animal studies, appears to inhibit vagally mediated reflexes by antagonizing the action of acetylcholine, the ...
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INDICATIONS AND USAGEIpratropium Bromide Inhalation Solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of ...
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CONTRAINDICATIONSIpratropium bromide is contraindicated in known or suspected cases of hypersensitivity to ipratropium bromide, or to atropine and its derivatives.
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WARNINGSThe 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 ...
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PRECAUTIONSGeneral - Ipratropium bromide should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction. Information for Patients - Patients should ...
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ADVERSE REACTIONSAdverse reaction information concerning ipratropium bromide inhalation solution is derived from 12-week active-controlled clinical trials. Additional information is derived from foreign ...
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OVERDOSAGEAcute 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 ...
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DOSAGE AND ADMINISTRATIONThe 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 ...
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HOW SUPPLIEDIpratropium Bromide Inhalation Solution Unit Dose Vial is supplied as a 0.02% clear, colorless solution containing 2.5 mL. NDC 68071-3769-2 - 25 vials per carton/25 vials per foil ...
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SPL UNCLASSIFIED SECTIONRx Only - Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 - Manufactured by: The Ritedose Corporation - Columbia, SC 29203 - TRC:IPBRIS:R3 - MAY 2013
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Patient's Instructions for UseIpratropium Bromide - Inhalation Solution, 0.02% Read complete instructions carefully before using. Twist open the top of one unit dose vial and squeeze the contents into the nebulizer ...
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PRINCIPAL DISPLAY PANEL - 2.5 mL Pouch Carton
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INGREDIENTS AND APPEARANCEProduct Information