ATROVENT

What it is

ATROVENT is a pressurised inhalation aerosol containing ipratropium bromide monohydrate 21 micrograms per actuation, equivalent to 20 micrograms of ipratropium bromide. ATROVENT is an anticholinergic bronchodilator. It appears to inhibit vagally mediated reflexes by antagonising the action of acetylcholine, the transmitter agent released from the vagal nerve. Although the onset of bronchodilator response is seen within 3–5 minutes of administration, peak response is not reached until 1.5–2 hours after inhalation, with duration of significant bronchodilator action up to 6 hours.

Approved indications

— Maintenance treatment of bronchospasm associated with asthma. — Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD).

Dosing overview

Adults: two puffs 3 to 4 times daily, although some patients may need up to 4 puffs at a time to obtain maximum benefit during early treatment. Children aged 6–12 years: one or two puffs 3 to 4 times daily. Children under 6 years: one puff 3 times daily. Patients with poor inhaler technique will benefit from the consistent use of a spacer device, which also decreases the amount of drug deposited in the mouth and back of the throat and therefore reduces the incidence of local irritation.

Key safety warnings

Immediate hypersensitivity reactions may occur after administration of ATROVENT, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, oropharyngeal oedema and anaphylaxis. ATROVENT may result in paradoxical bronchospasm that may be life-threatening; if paradoxical bronchospasm occurs ATROVENT should be discontinued immediately and substituted with an alternative therapy. ATROVENT should be used with caution in patients predisposed to narrow-angle glaucoma, as isolated reports of ocular complications including mydriasis, increased intraocular pressure, acute angle glaucoma and eye pain have resulted from direct eye contact; patients must be instructed in the correct administration and warned not to allow the aerosol to enter the eyes, and those predisposed to glaucoma should be specifically warned to protect their eyes. Eye pain or discomfort, blurred vision, visual halos or coloured images in association with red eyes from conjunctival congestion and corneal oedema 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. Like other drugs with anticholinergic activity, ipratropium bromide should be avoided or used with caution in patients where atropine-like effects may precipitate or exacerbate a pre-existing clinical condition; patients at particular risk are those with eyes with narrow iridocorneal angles or patients with a tendency towards urinary retention or constipation.

Contraindications

ATROVENT is contraindicated in patients with known hypersensitivity to atropine or its derivatives such as ipratropium bromide, or to any of the other ingredients of ATROVENT.

Key safety information for specific populations

Care is recommended during pregnancy, particularly in the first trimester; the safety of ATROVENT during pregnancy has not been established, and the benefits of using ATROVENT when pregnancy is confirmed or suspected must be weighed against possible hazards to the foetus. Caution should be exercised when ATROVENT is administered to breastfeeding mothers as many drugs are excreted into breast milk.

Regulatory history

ATROVENT was first registered on the ARTG on 5 May 2003 as ipratropium bromide monohydrate 21 micrograms per metered dose inhalation aerosol can (ARTG 91129).