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    / Boehringer Ingelheim


    Active Ingredient
    Ipratropium Bromide 0.25 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Solution

    20 ml x 0.25 mg/ml

    full basket chart 49689 9695

    Related information


    Dosage

    The dosage should be adapted to the individual requirements of the patient; patients should also be kept under medical supervision during treatment. It is advisable not to greatly exceed the recommended daily dose during both acute and maintenance treatment. If therapy does not produce a significant improvement or if the patient’s condition worsens, medical advice must be sought in order to determine a new regimen of therapy. In the case of acute or rapidly worsening dyspnea, a doctor should be consulted immediately. Ipratropium bromide Respirator Solution is not recommended for use in children under 3 years of age. Note: Ipratropium bromide and disodium cromoglycate inhalation solutions should not be simultaneously administered in the same nebulizer as precipitation may occur. Ipratropium bromide Respirator Solution may be administered from an intermittent positive pressure ventilator or from suitable nebulizers. The recommended dosage is as follows:

    Adults

    0.1 – 0.5 mg (0.4 – 2.0 ml = 8-40 drops) up to 4 times daily.

    Children

    6-12 Years: 0.25 mg (20 drops, i.e., 1 ml) 3 to 4 times daily.

     

    Children < 6 years of age:

    As only limited information is available for this age group, the following dose schedule should only be given under regular medical supervision:

    The single inhaled dose is 0.1 – 0.25 mg ipratropium bromide, (8-20 drops, i.e.: 0.4-1.0 ml)

     

    N.B. For ease of administration, the dose may need to be diluted in order to obtain a final volume suitable for the nebulizer being used. If dilution is necessary, only normal saline should be used.      


    Indications

    For the relief of symptoms of reversible bronchospasm associated with asthma, chronic bronchitis and emphysema. Ipratropium bromide Respirator Solution is of particular benefit in relieving acute bronchospasm when used concomitantly with inhaled beta agonists.


    Contra-Indications

    Hypersensitivity to the drug, to atropine and its derivatives. Hypersensitivity to any other ingredient of the preparation.


    Special Precautions

    Immediate hypersensitivity reactions may occur following the use of ipratropium bromide, such as rare cases of rash, urticaria, angioedema, oropharyngeal oedema, bron­chospasm and anaphylaxis.

    Paradoxical bronchospasm

    As with other inhaled medications, ipratropium bromide may cause paradoxical bronchospasm, which may be life-threatening. If paradoxical bronchospasm occurs, ipratropium bromide must be discontinued immediately and replaced with an alternative therapy.

    Ocular complications

    Care should be taken not to allow the solution or mist to enter into the eyes.

    ipratropium bromide should be used with caution in patients with a predisposition for narrow-angle glaucoma.

    If the product accidentally comes into contact with the eyes during use, mild, rev­ersible ocular comp­lications may occur. There is a risk of an acute glaucoma attack, particularly in patients with narrow-angle glaucoma; the characteristic symptoms are eye pain, blurred vision, visual halos or coloured ima­ges, red eyes and corneal oedema.

    If mydriasis and mild accommodation disturbances occur, treatment with miotic drops may be given. In the event of severe ocular complications, an ophthalmologist should also be consulted.

    In these patients, a mouthpiece rather than a face mask should ideally be used for inhalation in order to prevent the product from getting into the eyes.

    Effect on the kidneys and urinary tract

    In patients with micturition disorders (such as in prostatic hypertrophy or bladder neck obstruction), the benefit of treatment with ipratropium bromide must be carefully weighed against the potential risk of aggravating urinary reten¬tion.

    Gastrointestinal motility disorders

    Patients with cystic fibrosis are more likely to develop gastrointestinal motility disorders.

    Local effects

    This product contains the preservative benzalkonium chloride and the stabilising agent sodium edetate dihydrate. In susceptible patients with hyperreactive airways, this substance may cause bronchospasm on inha¬lation.

    See prescribing information for full details. 


    Side Effects

    Headache, dizziness, taste disturbance, Cough, irritation in the throat, Dry mouth, disturbed gastrointestinal motility, nausea

    See prescribing information for full details. 


    Drug interactions

    Chronic use of inhaled Ipratropium bromide.together with other anticholinergic drugs has not been studied and is therefore not recommended.

    b-Adrenergic agents and xanthine derivatives (such as theophylline) may enhance the therapeutic eff­ect.

    Other anticholinergic medications, such as those containing pirenzepi­ne, may increase both the thera­peutic and undesirable effects.

    The risk of acute glaucoma in patients with a history of narrow-angle glaucoma may be increased when Ipratropium bromide. and b-m imetics are administered simultaneously.


    Pregnancy and Lactation

    Pregnancy and breast-feeding

    There are no data from use in pregnant or breast-feeding women.

    Although no teratogenic effects have been identified to date, ipratropium bromide should not be used during pregnancy (especially the first trimester) or while breast-feeding unless considered necessary by the treating physician after careful benefit/risk assessment.The risks of inadequate treatment should be given due weight in this assessment.

    Fertility

    Clinical data on fertility are not available for ipratropium bromide. Non-clinical studies performed with ipratropium bromide showed no adverse effect on fertility.


    Overdose

    No symptoms specific to overdose have been encountered to date. In view of the wide therapeutic range and topical route of administration of ipratropium bromide inhalation, however, no serious anticholinergic symptoms are to be expected. Mild systemic anticholinergic effects such as dry mouth, ocular accommodation disturbances and increase in heart rate are possible.


    Important notes

    Pharmaceutical Precautions: Store below 25°C. Do not freeze. Once the bottle has been opened, the contents should not be kept for longer than one month. A fresh solution should be prepared before each usage and any residual diluted solution should be discarded.


    Manufacturer
    Instituto De Angeli S.R.L. Italy
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