Ipratropium Steri-Neb

General characteristics. Structure:

1 ml of 0,025% of solution for inhalations contains:
Active agent: a monohydrate bromide ipratropiya (in terms of an ipratropiya bromide) 250 mkg.
Excipients: sodium chloride, Acidum hydrochloricum of 1 N, water purified.

Description: Transparent, colourless or almost colourless liquid.

Pharmacological properties:

Bronkhodilatiruyushchy means, blocks m-holinoretseptory of smooth muscles of a tracheobronchial tree (preferential at the level of large and average bronchial tubes) and suppresses a reflex bronkhokonstriktion. Having structural similarity to acetylcholine molecule, is his competitive antagonist. Effectively prevents the narrowing of bronchial tubes resulting from inhalation of various bronkhospazmiruyushchy agents and also the spasm of bronchial tubes connected with influence of vagus nerves oppresses. At inhalation use has practically no resorptive effect. The Bronkhodilatiruyushchy effect develops in 5-15 minutes, reaching a maximum in 1-2 hours, and proceeds to 6 h (sometimes – to 8 h).

Pharmacokinetics. Absorption is extremely low. To 90% of an ingalatsionny dose it is swallowed, in digestive tract it is practically not absorbed and removed preferential with a stake (25% - in not changed form, other part - in the form of metabolites). The soaked-up part (small) is metabolized in 8 inactive or slaboaktivny anticholinergic metabolites (it is removed by kidneys). It does not kumulirutsya. The elimination half-life of the drug which got to a bronchial tree makes 3,6 hours; 70% of this dose are removed with urine. Changes of pharmacokinetic parameters at patients with renal failures, a liver and at elderly patients have no clinical value and do not demand dose adjustment.

Indications to use:

Reversible obstruction of respiratory tracts, including at chronic an obstructive pulmonary disease, bronchial asthma, chronic obstructive bronchitis, emphysema of lungs.

Route of administration and doses:

Drug Ipratropium Steri-Neb is used it is inhalation by means of inhalers – nebulizers (see the section "Technology of Use of Drug" of the present instruction).

The adult (including elderly) and to children 12 years are more senior: On 2,0 ml (40 drops = 500 mkg) 3-4 times a day. The maximum daily dose – 8,0

Children are from 6 to 12 years old: on 1,0 ml (20 drops = 250 mkg) 3-4 times a day. The maximum daily dose – 4 ml

To children up to 6 years: on 0,4-1,0 ml (8-20 drops = 100-250 mkg) 3-4 times a day. The maximum daily dose – 4 ml. Treatment of children should be carried out under medical observation.

If necessary drug it is possible to part 0,9% with chloride sodium solution.

Features of use:

It is necessary to be careful at the first uses of drug via the nebulizer. There is development of a paradoxical bronchospasm given about exceptional cases. At decrease in efficiency of drug follows will see a doctor. It is not recommended for the emergency stopping of an attack of suffocation (the broncholitic effect develops later, than at a beta adrenostimulyatorov).

Patients have to be able to use correctly drug Ipratropium Steri-NEB. It is necessary to avoid hit of solution in eyes. The patients predisposed to development of glaucoma should be warned about need of protection of eyes against drug hit especially.

Technology of use of drug
• Before use of medicine it is necessary to read the instruction of the producer of nebulizers.
• To prepare the nebulizer according to the instruction of his producer.
• To separate Steri-Neb (an ampoule with sterile solution) from the block, for this purpose to turn and pull it.
• Holding an ampoule vertically up a cap, to break off a cap.
• To squeeze out solution in a nebulizer tank
• To use the nebulizer according to the instruction of his producer.
• It is necessary to rinse a mouth after the end of inhalation.
• If the mask was used, it is necessary to wash out face skin.
• The solution which remained unused in the nebulizer camera should be poured out.
• To carefully wash up the nebulizer.

 

When using drug it is necessary to avoid hit of solution in eyes.

Side effects:

Dryness in a mouth, a headache, nausea, increase in viscosity of a phlegm. Seldom: lock, easing of motility of digestive tract, ischuria, paradoxical bronchospasm, cough, tachycardia (including supraventricular), ciliary arrhythmia, feeling heartbeat, accommodation paresis.

Allergic reactions – skin rash (including a small tortoiseshell and a multiformny erythema), a paraglossa, lips, persons, a laryngospasm and other displays of an anaphylaxis. At use in therapeutic doses of side effect on bronchial secretion it was not noted.

Interaction with other medicines:

Strengthens broncholitic effect β2-адреномиметиков and ksantinovy derivatives. The anticholinergic effect amplifies protivoparkinsonichesky medicines, quinidine, tricyclic antidepressants. At simultaneous use strengthens action of other anticholinergics – the additive action.

Contraindications:

• Hypersensitivity to atropine and its derivatives;
• Hypersensitivity to an ipratropiya to bromide or to other components of drug;

With care - closed-angle glaucoma, obstruction of urinary tract, a prostate hyperplasia; breastfeeding, children's age (up to 6 years).

Use at pregnancy and during breastfeeding
Drug is contraindicated in the I trimester of pregnancy. Purpose of drug in II and III trimesters of pregnancy and in the period of a lactation perhaps only if the estimated advantage for mother exceeds possible risk for a fruit or the baby.

Overdose:

Owing to inhalation of a dose of 5 mg tachycardia is observed, but single doses on 2 mg and on 1 mg at children did not cause side effect in adults. The single peroral dose an ipratropiya of bromide, equal 30 mg, causes insignificant manifestations of systemic antikholinegichesky action, such as dryness in a mouth, accommodation paresis, increase in heart rate. Symptomatic treatment.

Storage conditions:

To store at a temperature not above 25ºС in the protected place. Not to allow freezing. To store in the place, unavailable to children. Period of validity 3 years. Not to use after the expiry date specified on packaging.

Issue conditions:

According to the recipe

Packaging:

On 1 ml or 2 ml of drug in an ampoule from polyethylene of low density. 5 ampoules are soldered with each other in the form of the block. Each block is placed in the laminated foil. On 4 blocks together with the application instruction place in a cardboard pack. On 6 blocks together with the application instruction place in a cardboard pack and on the 2nd cardboard packs place in a cardboard box.