Atrovent label

Atrovent

Atrovent Recall

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Side Effects & Adverse Reactions

Immediate hypersensitivity reactions may occur after administration of ipratropium bromide, as demonstrated by urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. If such a reaction occurs, therapy with ATROVENT Nasal Spray 0.03% should be stopped at once and alternative treatment should be considered.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

ATROVENT Nasal Spray 0.03% is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. ATROVENT Nasal Spray 0.03% does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis.

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History

There is currently no drug history available for this drug.

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Other Information

The active ingredient in ATROVENT Nasal Spray is ipratropium bromide (as the monohydrate). It is an anticholinergic agent chemically described as 8-azoniabicyclo[3.2.1]octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide monohydrate, (3-endo, 8-syn)-: a synthetic quaternary ammonium compound, chemically related to atropine. The structural formula is:

Atrovent Structure

C20H30BrNO3•H2O       ipratropium bromide       Mol. Wt. 430.4

Ipratropium bromide is a white to off-white crystalline substance, freely soluble in water and methanol, sparingly soluble in ethanol, and insoluble in non-polar media. In aqueous solution, it exists in an ionized state as a quaternary ammonium compound.

ATROVENT Nasal Spray 0.03% is a metered-dose, manual pump spray unit which delivers 21 mcg ipratropium bromide (on an anhydrous basis) per spray (70 μL) in an isotonic aqueous solution, pH-adjusted to 4.7 with hydrochloric acid and/or sodium hydroxide (if needed). It also contains benzalkonium chloride, edetate disodium, sodium chloride, and purified water. Each bottle contains 345 sprays.

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Atrovent Manufacturers

  • Physicians Total Care, Inc.
    Atrovent | Physicians Total Care, Inc.
    No Recall

    Atrovent | Physicians Total Care, Inc.

    Atrovent | Physicians Total Care, Inc.

    The recommended dose of ATROVENT Nasal Spray 0.03% is two sprays (42 mcg) per nostril two or three times daily (total dose 168 to 252 mcg/day) for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. Optimum dosage varies with the response of the individual patient.

    Initial pump priming requires seven sprays of the pump. If used regularly as recommended, no further priming is required. If not used for more than 24 hours, the pump will require two sprays, or if not used for more than seven days, the pump will require seven sprays to reprime. Avoid spraying into eyes.

  • Boehringer Ingelheim Pharmaceuticals, Inc.
    Atrovent | Boehringer Ingelheim Pharmaceuticals, Inc.
    No Recall

    Atrovent | Boehringer Ingelheim Pharmaceuticals, Inc.

    Atrovent | Boehringer Ingelheim Pharmaceuticals, Inc.

    The recommended dose of ATROVENT Nasal Spray 0.03% is two sprays (42 mcg) per nostril two or three times daily (total dose 168 to 252 mcg/day) for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. Optimum dosage varies with the response of the individual patient.

    Initial pump priming requires seven sprays of the pump. If used regularly as recommended, no further priming is required. If not used for more than 24 hours, the pump will require two sprays, or if not used for more than seven days, the pump will require seven sprays to reprime. Avoid spraying into eyes.

  • Boehringer Ingelheim Pharmaceuticals, Inc.
    Atrovent | Boehringer Ingelheim Pharmaceuticals, Inc.
    No Recall

    Atrovent | Boehringer Ingelheim Pharmaceuticals, Inc.

    Atrovent | Boehringer Ingelheim Pharmaceuticals, Inc.

    For Symptomatic Relief of Rhinorrhea Associated with the Common Cold

    The recommended dose of ATROVENT Nasal Spray 0.06% is two sprays (84 mcg) per nostril three or four times daily (total dose 504 to 672 mcg/day) in adults and children age 12 years and older. Optimum dosage varies with response of the individual patient. The recommended dose of ATROVENT Nasal Spray 0.06% for children age 5-11 years is two sprays (84 mcg) per nostril three times daily (total dose of 504 mcg/day).

    The safety and effectiveness of the use of ATROVENT Nasal Spray 0.06% beyond four days in patients with the common cold have not been established.

    For Symptomatic Relief of Rhinorrhea Associated with Seasonal Allergic Rhinitis

    The recommended dose of ATROVENT Nasal Spray 0.06% is two sprays (84 mcg) per nostril four times daily (total dose 672 mcg/day) in adults and children age 5 years and older.

    The safety and effectiveness of the use of ATROVENT Nasal Spray 0.06% beyond three weeks in patients with seasonal allergic rhinitis have not been established.

    Initial pump priming requires seven sprays of the pump. If used regularly as recommended, no further priming is required. If not used for more than 24 hours, the pump will require two sprays, or if not used for more than seven days, the pump will require seven sprays to reprime. Avoid spraying into eyes.

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