Generic Name

Drug Description

Presentation

Indications

Adult Dosage

1 capsule three or four times daily. This dose may be doubled safely in patients who are less responsive.

A total daily dose of 8 capsules should not be exceeded.

Administration

The capsules are only intended for use in the AEROHALER and should not be swallowed. The AEROHALER pierces the AEROCAP so that you can breathe the powder it contains into your lungs. The instructions for use of the AEROHALER should be read carefully to ensure correct administration.

The magazine allows you to load up to six capsules at a time. When using the AEROHALER you will be breathing the medicine (powder) in from one capsule at a time. This means that you will be breathing in an exact dose each time. You can use your AEROHALER for up to one year to take your medication.

1. Remove the inhaler from the protective pouch provided.

2. Opening the inhaler. Open the mouthpiece (white part).

3. Magazine. Load the magazine according to the manufacturer's instructions as detailed on the Patient Information Leaflet. It is important to only load the number of capsules you will need for that day. Close the inhaler by pushing down the mouthpiece until it clicks.

4. Preparing for inhalation. Hold the mouthpiece upwards. Push the white button until it clicks and release it immediately. This pierces the capsule, making the medicine available for inhalation.

5. Inhalation. Breathe out fully, then raise the AEROHALER to your mouth and close your lips around the mouthpiece. Next breathe in slowly but deeply through the AEROHALER. While holding your breath for as long as is comfortable, remove the mouthpiece from your mouth. Finally, breathe out slowly, preferably through your nose, not your mouth. It is important not to breathe out through the AEROHALER.

6. Preparing for the next dose. Follow the manufacturer's instructions as detailed on the Patient Information Leaflet.

7. Removing the capsules. When you have used the last capsule, open up the mouthpiece. Turn the AEROHALER upside down and shake out all the used capsules. Then close, or refill, the inhaler.

8. The AEROHALER should be cleaned from time-to-time following the manufacturer's instructions as detailed on the Patient Information Leaflet.

Child Dosage

There is limited experience of the use of ATROVENT AEROCAPS in children, therefore the product is not recommended for use in children.

If therapy does not produce a significant improvement or if the patient's condition gets worse, medical advice must be sought. In the case of acute or rapidly worsening dyspnoea (difficulty in breathing) a doctor should be consulted immediately.

Contra Indications

Known hypersensitivity to atropine or its derivatives, or to any other component of the product.

Special Precautions

This product contains 39.7 mg of glucose per maximum recommended daily dose.

Patients with rare glucose–galactose malabsorption should not take this medicine

Caution is advocated in the use of anticholinergic agents in patients predisposed to or with narrow-angle glaucoma, or with prostatic hyperplasia or bladder-outflow obstruction.

As patients with cystic fibrosis may be prone to gastro-intestinal motility disturbances, ATROVENT, as with other anticholinergics, should be used with caution in these patients.

Immediate hypersensitivity reactions following the use of ATROVENT have been demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, oropharyngeal oedema and anaphylaxis.

There have been isolated reports of ocular complications (i.e. mydriasis, increased intraocular pressure, narrow-angle glaucoma, eye pain) when aerosolised ipratropium bromide, either alone or in combination with an adrenergic beta₂-agonist, has come into contact with the eyes.

Patients must be instructed in the correct administration of ATROVENT AEROCAPS and care must be taken not to allow the powder to enter into the eyes. However, since the inhaler device used to aerosolise the powder is breath-actuated, there should be little risk of the powder entering the eyes.

Eye pain or discomfort, blurred vision, visual halos or coloured images in association with red eyes from conjuctival congestion and corneal oedema may be signs of acute narrow-angle glaucoma. Should any of these symptoms develop, treatment with miotic drops should be initiated and specialist advice sought immediately.

Interactions

There is evidence that the administration of ATROVENT with beta-adrenergic drugs and xanthine preparations may produce an additive bronchodilatory effect.

Adverse Reactions

The following side effects have been reported. The frequencies given below are based on clinical trials involving 3250 patients who have been treated with ATROVENT (ipratropium bromide).

Frequencies

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

Immune system disorders

Urticaria⁽¹⁾ :Uncommon

Anaphylactic reaction: Rare

Angio-oedema of tongue, lips, face: Rare

Nervous system disorders

Headache: Common

Dizziness: Common

Eye disorders

Ocular accommodation disturbances: Uncommon

Angle closure glaucoma⁽²⁾: Uncommon

Intraocular pressure increased⁽²⁾: Rare

Eye pain ⁽²⁾:Rare

Mydriasis⁽²⁾: Rare

Cardiac Disorders

Tachycardia: Uncommon

Palpitations: Rare

Supraventricular tachycardia: Rare

Atrial fibrillation: Rare

Respiratory, Thoracic and Mediastinal Disorders

Cough: Very Common

Local irritation: Very Common

Laryngospasm: Uncommon

Inhalation induced bronchospasm: Rare

Gastro-intestinal Disorders

Dryness of mouth : Common

Vomiting: Common

Gastro-intestinal motility disorder ⁽⁴⁾: Common

Nausea: Rare

Skin and Subcutaneous Disorders

Skin rash: Uncommon

Pruritus: Uncommon

Renal and Urinary Disorders

Urinary retention ⁽⁴⁾: Rare

⁽¹⁾including giant urticaria

⁽²⁾ocular complications have been reported when aerolised ipratropium bromide, either alone or in combination with an adrenergic beta₂-agonist, has come into contact with the eyes.

⁽³⁾e.g. constipation, diarrhoea

⁽⁴⁾the risk of urinary retention may be increased in patients with pre-existing urinary outflow tract obstruction.

Manufacturer

Drug Availability

Updated