Atrovent (The solution for inhalations)

Active material: Ipratropiya bromide
When ATH: R03BB01
CCF: Bronchodilators – m-blocker holinoreceptorov
ICD-10 codes (testimony): J43, J44, J45
When CSF: 12.01.04
Manufacturer: BOEHRINGER Ingelheim International GmbH (Germany)

Pharmaceutical form, composition and packaging

The solution for inhalations clear, colorless or near colorless, virtually particle-free.

1 ml
ïpratropïya bromide monohydrate261 g,
calculated as ipratropium bromide anhydrous250 g

Excipients: benzalkonium chloride, disodium эdetat, sodium chloride, hydrochloric acid, Purified water.

20 ml – amber glass vials (1) with tube-dropper – packs cardboard.

 

Pharmacological action

Bronchodilators. Does m-cholinergic receptors of bronchial smooth muscle (mainly at the level of large and medium bronchi) and inhibits reflex bronchoconstriction. Having structural similarity with the molecule of acetylcholine, it is a competitive antagonist.

Warns bronchospasm, resulting from the inhalation of cigarette smoke, cold air, the effect of different drugs, and also eliminates bronchospasm, to the effects of the vagus nerve.

When inhalation use almost no resorptive action, while only 10% reaches the small airways and the alveoli, and the remainder is deposited in the mouth or pharynx and swallowed.

In patients with bronchospasm, associated with COPD (chronic bronchitis and emphysema), drug improves lung function: OFV1 and the mean forced expiratory volume rate25-75% increase by 15% or more after 15 minutes after administration. The maximum effect is achieved after 1-2 h and continuing until the majority of patients 6 hours after administration of Ipratropium bromide.

In 40% patients with asthma showed a significant improvement in external respiration (OFV1 increased 15% and more).

 

Pharmacokinetics

Absorption

The absorption of the drug is low. Almost not absorbed from the gastrointestinal tract.

Distribution

Poorly soluble in fats and loosely penetrates through biological membranes. Not accumulates.

Metabolism

It is metabolized to form 8 inactive or weakly active metabolites, having anticholinergic action.

Deduction

The unchanged output through the intestine. The metabolites are excreted in the urine.

 

Testimony

- Chronic obstructive pulmonary disease (incl. chronic obstructive bronchitis, emphysema);

- Asthma mild to moderate severity.

 

Dosage regimen

It should be taken into account, what 20 drops = 1 ml, 1 drop = 12.5 mcg ipratropium bromide anhydrous.

To maintenance treatment adult (incl. elderly patients) and children over 12 years appoint 2 ml (40 drops 500 g =) 3-4 times / day. The maximum daily dose – 8 ml (2 mg).

Treatment children should be under medical supervision.

Babies aged 6 to 12 years appoint 1 ml (20 drops 250 g =) 3-4 times / day. The maximum daily dose – 4 ml (1 mg).

Children up 6 years appoint 0.4-1 ml (8-20 drops = 100-250 mg) 3-4 times / day. The maximum daily dose – 4 ml (1 mg).

To treatment of acute bronchospasm adult (incl. elderly patients) and children over 12 years appoint 2 ml (40 drops 500 g =).

Treatment children should be under medical supervision.

Children from 6 to 12 years appoint 1 ml (20 drops 250 g =); Children up to 6 years – by 0.4-1 ml (8-20 drops = 100-250 mg). The possibility of reappointment to stabilize the patient's condition.

The interval between injections is determined individually by the attending physician. The simultaneous use of beta2-adrenomimetikov.

Terms of use of the drug

The recommended dose should be diluted with saline until the volume of the preparation 3-4 ml, pour into a nebulizer and make inhalation. The drug should be diluted with saline before each use. The remaining solution was poured after inhalation.

Dosing may depend on the method and type of inhalation nebulizer. The duration of inhalation can be controlled by spending diluted volume.

Atrovent® It can be applied using a variety of nebulizers, commercially available. By using a centralized oxygen system solution is best applied at a flow rate 6-8 l / min.

 

Side effect

The most frequent adverse events: headache, dry mouth, gastrointestinal dysmotility (nausea, vomiting, diarrhea, constipation).

Effects, associated with anticholinergic drug: supraventricular tachycardia, heartbeat, atrial fibrillation, ccomodation, urinary retention (due to the low systemic absorption of the drug are rare, and are reversible). In patients with obstructive lesions of the urinary tract increases the risk of urinary retention.

The respiratory system: possible cough, Local irritation; rarely – paradoxical bronchospasm.

On the part of the organ of vision: In some cases when the product enters the eye observed mydriasis, Parez akkomodacii, increased intraocular pressure (especially in patients with narrow-angle glaucoma). Eye pain or discomfort, blurred vision, ghosting and color spots before the eyes, combined with conjunctival and corneal hyperemia may be symptoms of an attack of angle-closure glaucoma.

Allergic reactions: possible skin rash, angioedema language, lips, person, laringospazm, erythema multiforme, hives, anaphylactic reactions.

 

Contraindications

- I trimester of pregnancy;

- Hypersensitivity to atropine and its derivatives;

- Hypersensitivity to ipratropium bromide and other ingredients.

FROM caution should be prescribed the drug for angle-closure glaucoma, urinary tract obstruction (incl. prostatic hyperplasia), during breastfeeding, children under the age of 6 years.

 

Pregnancy and lactation

Safety of Atrovent® during pregnancy in humans has not been established.

Do not use this Atrovent® I trimester of pregnancy. The appointment of the drug in the II and III trimester of pregnancy is possible only in case, if the expected benefit of therapy to the mother outweighs the potential risk to the fetus.

The data on the allocation of ipratropium bromide in breast milk are absent. Although lipid-insoluble quaternary cations penetrate into breast milk, unlikely, that Atrovent® It will have a significant effect inhalation application. It should be used with caution during lactation (breast-feeding).

 

Cautions

Not recommended to prescribe the drug for emergency relief of asthma attacks (tk. bronchodilator effect develops later, than that of beta-agonists).

In patients with cystic fibrosis increased risk of slow GI motility.

It is not recommended to allow a significant excess of recommended doses as in the treatment of acute bronchospasm, and supportive care. The patient should be informed, if inhaled insufficiently effective or deteriorated condition, you should consult your doctor to change the treatment plan.

Atrovent® It can be used for inhalation combined simultaneously with Lazolvanom (solution for inhalation) and berotek (solution for inhalation).

Preparation soderzhit antibakterialynыy preservative benzalkonium chloride and stabilizer disodium эdetat, which can cause bronchoconstriction.

The patient should be taught the proper use of Atrovent®.

Patients, predisposed to glaucoma, should be particularly alert to the need to protect the eyes from getting the drug. In case of any symptom attack angle-closure glaucoma should appoint drops, causing constriction of the pupil, and immediately contact an ophthalmologist.

Inhalation nebulizer is recommended to use with the tip of mouth. If you use a nebulizer with a mask should be applied mask of appropriate size.

 

Overdose

Symptoms: specific symptoms of overdose have been identified. Given the breadth of therapeutic action, and how to use local Atrovent®, the emergence of any serious anticholinergic symptoms are unlikely. Slight manifestations of systemic anticholinergic action (incl. dry mouth, accommodation disturbances, increase in heart rate).

Treatment: symptomatic therapy.

 

Drug Interactions

With simultaneous use of beta2-agonists and xanthine derivatives potentiate the effect of bronchodilator Atrovent®.

With simultaneous use of Atrovent® with antiparkinsonian, xinidinom, tritsiklicheskimi antidepressantami usilivaetsya antiholinergicheskiy эffekt preparation.

With simultaneous use of Atrovent® other anticholinergics marked additive effect.

When using Atrovent® with inhaled beta2-agonists in patients with narrow-angle glaucoma increases the risk of an acute attack of glaucoma.

Atrovent® should not be administered simultaneously with the inhalation solution of disodium cromoglycate, Given the possibility of precipitation.

 

Conditions of supply of pharmacies

The drug is released under the prescription.

 

Conditions and terms

The drug should be stored out of reach of children at or above 30 ° C; Do not freeze. Shelf life – 5 years.

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