Ipratropium Aeronativ, aerosol 20 mcg/dose 200 doses

Ipratropium aeronativ is a bronchodilator.

Blocks M-cholinoreceptors of smooth muscles of tracheobronchial tree (mainly at the level of large and medium bronchi) and suppresses reflex bronchoconstriction. Having structural similarity with acetylcholine molecule, it is its competitive antagonist.

It effectively prevents bronchoconstriction resulting from inhalation of cigarette smoke, cold air, the action of various bronchospasmic substances, and also inhibits bronchial spasm associated with the influence of the vagus nerve. When administered by inhalation it has almost no resorptive action – for the development of tachycardia about 500 doses are inhaled, with only 10% reaching the small bronchi and alveoli, and the rest is deposited in the throat or oral cavity and swallowed.

In patients with bronchospasm caused by chronic obstructive pulmonary diseases (chronic bronchitis and pulmonary emphysema) it improves indexes of external respiratory function: volume of forced expiratory volume in the first second (FEF1) and maximal mean expiratory flow (FEF25-75%) increase by 15% and more just in 15 minutes after the drug administration, the maximum effect is noted in 1-2 hours and lasts for most patients up to 6 hours.

In patients with bronchial asthma a significant improvement of external respiratory function was noted in 40% of patients (FEF1 increased by 15% or more).

Indications

Active ingredient

Composition

Active substance:

Ipratropium bromide monohydrate 0.021 mg (in terms of ipratropium bromide) (0.020 mg)

Associated substances:

ethanol (ethyl alcohol absolute) – 9.75 mg,

citric acid monohydrate – 0.005 mg,

triethylcitrate – 0.15 mg,

propellant R134a (1,1,1,1,2-tetrafluoroethane) – 55.08 mg.

How to take, the dosage

Ipratropium Aeronativ is intended for inhalation administration only.

The dosing regimen is individualized. Unless otherwise prescribed by a physician, the following dosing regimen is recommended for adults and children over 6 years of age: 2 inhaled doses (40 mcg) 4 times daily.

The need for higher doses may indicate the need to review the main treatment. The total daily dose should not exceed 12 inhalations (240 mcg) per day. If the inhalations are not effective enough, or if the patient’s condition worsens, a physician should be consulted to change the treatment plan. In case of sudden onset and rapid progression of dyspnea you should immediately consult a physician.

Children younger than 6 years of age: Due to the fact that information about the use of the drug in this age group is limited, the following dose is recommended (with medical supervision only): 1 inhaled dose (20 mcg) 3 times daily.

Interaction

In concomitant use β2-adrenomimetics and xanthine derivatives potentiate the bronchodilator effect of the drug. Anticholinergic effect is enhanced by antiparkinsonian agents, quinidine, tricyclic antidepressants. When concomitant use with other anticholinergic agents an additive effect is noted.

Special Instructions

It is not recommended to prescribe the drug for emergency relief of a bronchial asthma attack (because the bronchodilator effect develops later than that of β-adrenomimetics). Patients with cystic fibrosis have an increased risk of gastrointestinal motility disorders. Patients should know how to use Ipratropium aeronativ aerosol for metered dose inhalation correctly. The patient should be informed that if inhalation is not sufficiently effective or a worsening of the condition occurs, the patient should consult a physician to change the treatment plan. In case of sudden onset and rapid progression of dyspnea, the patient should also consult a physician immediately. If any of the symptoms of a closed-angle glaucoma attack (pain in the eye, discomfort, blurred vision, halo and colored spots in front of the eye, combined with conjunctival and corneal hyperemia) are present, constrictor drops should be prescribed and an ophthalmologist should be seen immediately.

Influence on the ability to drive and other vehicles, to operate moving machinery

There have been no studies to study the effect of the drug on the ability to drive and operate machinery. In case of side effects due to the use of the drug, patients should abstain from driving vehicles and operating machinery.

Contraindications

Side effects

Allergic reactions: infrequent – skin rash, itching, angioedema of the tongue, lips and face, urticaria, laryngospasm, bronchospasm, exudative erythema multiforme, anaphylactic reactions.

Effects associated with anticholinergic action of the drug: Rarely, supraventricular tachycardia, palpitations, accommodation disorders, decreased sweat gland secretion, gastrointestinal (GI) motility disorders, constipation, urinary retention (these effects are reversible). In patients with obstructive urinary tract disease the risk of urinary retention increases: very often – headache.

The digestive system: very often – nausea, often – dry mouth, rarely – diarrhea, abdominal pain, vomiting.

In the respiratory system: infrequent – cough; rarely – paradoxical bronchospasm.

Visual organs: very rare – in case of eye contact with aerosol there is dilation of the pupil (mydriasis), increased intraocular pressure (especially in patients with closed-angle glaucoma), closed-angle glaucoma, pain in the eye. Pain or discomfort in the eye, blurred vision, and the appearance of a halo and bright spots in front of the eye, combined with conjunctival and corneal hyperemia may be symptoms of an attack of closed angle glaucoma.

Others:very often, increased sputum viscosity.

Overdose

Symptoms:no specific symptoms of overdose have been identified. Given the breadth of the therapeutic action and the topical route of administration of Ipratropium aeronativ, the occurrence of any serious anticholinergic symptoms is unlikely. Minor manifestations of systemic anticholinergic effects such as dry mouth, impaired accommodation, and increased heart rate are possible.

Treatment:conducting symptomatic therapy.

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