Pregnancy & Lactation : הריון/הנקה

Use in Pregnancy
The safety of ipratropium during human pregnancy has not been established. The benefits of using ipratropium bromide during a confirmed or suspected pregnancy must be weighed against possible hazards to the unborn child. Preclinical studies have shown no embryotoxic or teratogenic effects following inhalation or intranasal application at doses considerably higher than those recommended in man.

Use During Lactation
It is not known whether ipratropium is secreted into breast milk. Although lipid- insoluble quaternary cations pass into breast milk, it is unlikely that ipratropium bromide would reach the infant to an important extent, when administered by inhalation. However, because many drugs are secreted into breast milk, caution should be exercised when ipratropium bromide is administered to nursing mothers.
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Use in Pediatrics
Aerovent Respirator Solution is not recommended for use in children under 3 years of age.

Adverse Reactions
Like all drugs, Aerovent Respirator Solution can cause undesirable effects.

a) General description
Many of the undesirable effects listed can be attributed to the anticholinergic properties of ipratropium bromide.
b) Table of undesirable effects
The undesirable effects listed are based on data from clinical trials and post- marketing surveillance.
Frequencies are defined as follows:

Very common                                        (≥ 1/10)
Common                                             (≥ 1/100, < 1/10) Uncommon                                           (≥ 1/1,000, < 1/100) Rare                                               (≥ 1/10,000, < 1/1,000) Very rare                                          : (< 1/10,000)
None known                                         (cannot be estimated from the available data) 

Immune system disorders
Uncommon:                                   Anaphylactic reactions, hypersensitivity 
Nervous system disorders
Common                                      Headache, dizziness

Eye disorders
Uncommon                                    Blurred vision, mydriasis, increase in intra-ocular pressure,
glaucoma, eye pain, blurred vision and rainbow
colours (halos),
hyperaemia of the conjunctiva, corneal oedema.
Rare                                        Accommodation disturbances 
Cardiac disorders
Uncommon                                    Palpitations, supraventricular tachycardia 
Rare                                        Atrial fibrillation, increase in heart rate 
Respiratory, thoracic and mediastinal
disorders
Common:                               Cough, irritation in the throat Uncommon                              Inhalation-induced      (paradoxical) bronchospasm, bronchospasm,
laryngospasm, pharyngeal oedema, dry pharynx

Gastrointestinal disorders
Common                                      Dry mouth, disturbed gastrointestinal motility, nausea Uncommon                                    Constipation, diarrhoea, stomach ache, vomiting, stomatitis, mouth oedema

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Skin    and      subcutaneous       tissue
disorders
Uncommon                                     Rash, pruritus, angioedema Rare                                         Urticaria

Renal and urinary disorders
Uncommon:                                    Urinary retention

c) Note on common undesirable effects
As with all aerosol therapy, Aerovent can also induce signs of local irritation in the throat. The most common undesirable effects reported in clinical trials included headache, irritation of the pharynx, cough, dry mouth, disturbed gastrointestinal motility (e.g. constipation, diarrhoea and vomiting), nausea and dizziness 
Precautions
Note: Immediate hypersensitivity reactions may occur after administration of Aerovent, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, oropharyngeal edema, and anaphylaxis.
Aerovent should be used with caution in patients predisposed to narrow-angle glaucoma, or with pre-exisiting outflow tract obstructions (e.g, with prostatic hyperplasia, or bladder-neck obstruction).
Patients should be reminded that Aerovent is not intended for occasional use, but rather, in order to be maximally effective, must be used consistently as prescribed throughout the course of therapy.

Ocular complications
There have been isolated reports of ocular complications (i.e. mydriasis, increased intraocular pressure, angle-closure glaucoma, eye pain) when aerosolized ipratropium bromide either alone or in combination with an adrenergic β2 -agonist, has escaped into the eyes. Thus patients must be instructed in the correct administration of Aerovent.
Eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema may be signs of acute angle-closure glaucoma. Should any combination of these symptoms develop, treatment with miotic drops should be initiated and specialist advice sought immediately.
Patients must be instructed in the correct administration of Aerovent inhalation solution. Care must be taken not to allow the solution or mist into the eyes. It is recommended that the nebulized solution be administered via a mouth piece. If this is not available and a nebulizer mask is used, it must fit properly. Patients who may be predisposed to glaucoma should be warned specifically to protect their eyes.
Patients with cystic fibrosis may be more prone to gastrointestinal motility disturbances.
The patient should be instructed to seek medical advice should a reduced response become apparent.
Because of occasional reports of bronchospasm associated with the use of Aerovent Respirator Solution, due to the preservative (benzalkonium chloride) and the stabilizer (sodium edetate), it is recommended that the patient be subject to medical supervision during the first week of treatment.


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Drug Interactions
Additive effect has been reported when ipratropium bromide is used in patients treated with β 2-adrenergic stimulants and xanthine preparations.

The therapeutic and adverse effects of Aerovent may become more pronounced if other anticholinergic medications, such as those containing pirenzepine, are given concomitantly.

The risk of acute glaucoma in patients with a history of narrow-angle glaucoma may be increased when nebulized ipratropium bromide and beta sympathomimetics are administered simultaneously.