Atrovent 250 mg/2 ml

Trade Name:

Atrovent 250 mg/2 ml

Solution for inhalation

Nebulizer solution

Composition:

Active substance:

Ipratropium bromide

Inactive ingredients:

Sodium chloride, 3,6% hydrochloric acid ( for pH adjustment), purified water

Properties:

Atrovent 250 mg/2ml solution for inhalation is a medicine specifically for the prevention and treatment of dyspnoea in chronic obstructive pulmonary disease (COPD), mild to moderate bronchial asthma and as a supplement to beta²-agonists in an acute asthma attack. Due to the site of action of the active substance in Atrovent solution for inhalation, which is an anticholinergic agent, spasms of the bronchial muscles, triggered by the vagus nerve, are inhibited. This differentiates it from most other antispasmodic inhaled preparations.

Indications:

Prevention and treatment of dyspnoea in

• Chronic obstructive pulmonary disease
• Mild to moderate bronchial asthma in adults and children, as a supplement to beta² agonists in an acute asthma attack.

Dosage and administration:

Always use this medicine exactly as your doctor has told you. 

Atrovent solution for inhalation is intended for inhalation with a nebulizer only.

The dosage must be adapted to each individual case. Unless otherwise prescribed, the following dosage recommendations generally apply:

• Adults (including the elderly) and adolescents > 12 years of age:

250 – 500 micrograms (i.e. one vial of 250 micrograms in 1 ml or 1 vial of 500 micrograms in 2 ml) 3 to 4 times daily.

For treatment of acute bronchospasm, 500 micrograms.

• Children 6 – 12 years of age:

250 micrograms (i.e. one vial of 250 micrograms in 1ml) up to a total daily dose of 1mg (4 vials).

• Children 0 – 5 years of age (for treatment of acute asthma only):

125 – 250 micrograms (i.e. half to one vial of 250 micrograms in 1 ml) up to a total daily dose of 1 mg (4 vials).

! As the product contains no preservative, a fresh vial should be used for each dose and the vial should be opened immediately before administration. Any solution left in the vial should be discarded.

Side effects:

Hypersensitivity

Anaphylactic reaction

Angioedema of tongue, lips & face

Headache, Dizziness

Blurred vision

Mydriasis

Intraocular pressure increased

Glaucoma

Eye pain

Halo vision

Conjunctival hyperaemia

Corneal oedema

Supraventricular tachycardia

Atrial fibrillation

Heart rate increased

Throat irritation

Cough

Bronchospasm

Paradoxical bronchospasm

Laryngospasm

Pharyngeal oedema

Dry throat

Dry mouth

Nausea

Diarrhoea

Constipation

Vomiting

Stomatitis

Rash

Pruritus

Urticaria

Urinary retention

Contraindications:

Atrovent is contraindicated in patients with known hypersensitivity to atropine or its derivatives (such as the active substance ipratropium bromide) or to any other component of the product.

Warnings and precautions:

• Pregnancy

The safety of Atrovent during human pregnancy has not been established. The benefits of using Atrovent during a confirmed or suspected pregnancy must be weighed against the possible hazards to the unborn child. 

• Lactation

It is not known whether ipratropium bromide is excreted into breast milk. It is unlikely that ipratropium bromide would reach the infant to an important extent, however caution should be exercised when Atrovent is administered to nursing mothers.

• Fertility

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

Storage:

Store at a temperature not exceeding 25 °C.

Package:

Carton box contains 10,20 or 50 unit dose vials of 2 ml and insert leaflet.