Ipratropium Steri-Neb (Ipratropium Steri-Neb)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceIpratropium bromideIpratropium bromide
Similar drugsTo uncover
  • Atrovent®
    solution d / inhal. 
    Boehringer Ingelheim International GmbH     Germany
  • Atrovent® H
    aerosol d / inhal. 
    Boehringer Ingelheim International GmbH     Germany
  • Ipratropium Steri-Neb
    solution d / inhal. 
    AIVEX Pharmaceuticals Yukey Limited     United Kingdom
  • Ipratropium Aeronaut
    aerosol d / inhal. 
    NATIVA, LLC     Russia
  • Ipratropium-native
    solution d / inhal. 
    NATIVA, LLC     Russia
    • Dosage form: & nbspinhalation solution
    Composition:

    Per 1 ml:

    active substance: ipratropium bromide monohydrate (in terms of ipratropium bromide) 250 mcg;

    Excipients: sodium chloride 8.5 mg, hydrochloric acid to pH 3.4, water for injection up to 1 ml.

    Description:

    Transparent, colorless or almost colorless liquid.

    Pharmacotherapeutic group:M-holinoblokator
    ATX: & nbsp

    R.03.B.B.01   Ipratropium bromide

    Pharmacodynamics:

    The bronchodilator, blocks m-holinoretseptory smooth muscle tracheobronchial tree (mainly at the level of large and medium bronchi) and suppresses reflex bronchoconstriction. Having a structural similarity with the molecule of acetylcholine, it is its competitive antagonist.

    Effectively prevents narrowing of the bronchi,arising as a result of the action of various bronchospasmodiruyuschih agents, and also eliminates spasm of the bronchi associated with the influence of the vagus nerve.

    With inhalation, it practically does not have a resorptive effect.

    The bronchodilator effect develops after 5-15 minutes, reaches a maximum after 1-2 hours and lasts up to 6 hours (sometimes up to 8 hours).

    Pharmacokinetics:

    Absorption is extremely low. Up to 90% of the inhaled dose is swallowed, in the gastrointestinal tract it is practically not absorbed and is excreted mainly with feces (25% in unchanged form, the rest in the form of metabolites). The absorbed part (small) is metabolized in the liver in 8 inactive or weakly active anticholinergic metabolites, which are excreted by the kidneys. Being a derivative of quaternary nitrogen, it dissolves poorly in fats and weakly penetrates biological membranes. Do not cumulate. The half-life of the drug, caught in the bronchial tree, is 3.6 hours; 70% of this dose is excreted in the urine.

    Changes in pharmacokinetic parameters in patients with violations kidney, liver and elderly patients have no clinical significance and do not require dose adjustment.

    Indications:

    Reversible obstruction of the airways, including chronic obstructive pulmonary disease, bronchial asthma, chronic obstructive bronchitis, emphysema.

    Contraindications:

    - Hypersensitivity to atropine and its derivatives;

    - hypersensitivity to ipratropium bromide and other components of the drug;

    - pregnancy (I trimester).

    Carefully:

    Closed-angle glaucoma, obstruction of the urinary tract (prostatic hyperplasia), children under 6 years old.

    Pregnancy and lactation:

    The drug is contraindicated in the first trimester of pregnancy. Appointment of the drug in the II and III trimesters of pregnancy and lactation is possible only if the intended benefit of therapy for the mother exceeds the possible risk to the fetus or infant.

    Dosing and Administration:

    The preparation Ipratropium Steri-Neb is administered by inhalation with the help of inhalers-nebulizers (see the section "The technique of using the drug" of this instruction).

    Adults and children over 12 years of age

    By 2.0 ml solution (40 drops = 500 μg) 3-4 times a day. The maximum daily dose of 8 ml.

    Children from 6 to 12 years old

    For 1.0 ml of the solution (20 drops = 250 μg) 3-4 times a day. The maximum daily dose of 4 ml.

    Children up to 6 years old

    For 0.4-1.0 ml of the solution (8-20 drops = 100-250 μg) 3-4 times a day. The maximum daily dose - 4 ml.

    Treatment of children should be carried out under medical supervision.

    If necessary, the drug can be diluted with 0.9% sodium chloride solution.

    Side effects:

    Dry mouth, headache, nausea, increased viscosity of phlegm.

    Rarely: constipation, weakening motility of the gastrointestinal tract, urinary retention, paradoxical bronchospasm, cough, tachycardia (including supraventricular), atrial fibrillation, palpitation, paresis of accommodation.

    Allergic reactions: skin rash (including urticaria and multiforme erythema), edema of the tongue, lips and face, laryngospasm and other manifestations of anaphylaxis.

    When applied in therapeutic doses, side effects on bronchial secretion were not noted.

    Overdose:

    Due to the inhalation of a dose of 5 mg, tachycardia is observed, but single doses of 2 mg in adults and 1 mg in children do not cause side effects. A single oral dose of ipratropium bromide equal to 30 mg causes minor manifestations of systemic anticholinergic action, such as dry mouth, paresis of accommodation, increased heart rate.

    Treatment: symptomatic.

    Interaction:

    Strengthens the broncholytic effect of beta-adrenomimetics and xanthine derivatives.

    The anticholinergic effect is enhanced by antiparkinsonian drugs, quinidine, tricyclic antidepressants.

    With simultaneous application enhances the effect of other anticholinergic drugs - additive action.

    Special instructions:

    Care should be taken when using the drug for the first time through a nebulizer. There are data on rare cases of development of paradoxical bronchospasm.

    With a decrease in the effectiveness of the drug should consult a doctor.

    It is not recommended for emergency relief of an attack of asthma (the bronchodilator effect develops later than in beta-adrenostimulants).

    Patients should be able to correctly apply Ipratropium Steri-Neb.

    Avoid contact with the eyes.

    Patients who are predisposed to the development of glaucoma should be especially warned about the need to protect the eyes from getting the drug.

    Technique of drug use

    Before using the drug, it is necessary to read the instructions of the manufacturer of the nebulizer.

    Prepare the nebulizer according to the manufacturer's instructions.

    Separate STERI-HEB (ampoule with sterile solution) from the block, for this, turn and pull it as in Fig.

    While holding the ampoule vertically upwards with the cap, break off the cap (Fig.2).

    Extract the solution into the reservoir of your nebulizer (Fig. 3).

    Use a nebulizer according to the manufacturer's instructions.

    The solution left unused in the nebulizer chamber should be poured. Wash the nebulizer thoroughly.

    When using the drug, avoid contact with the solution in the eyes.

    Form release / dosage:

    Solution for inhalation, 0.25 mg / ml.

    Packaging:

    1 ml or 2 ml of the drug in a vial of low-density polyethylene.

    5 ampoules are welded to each other in the form of a block. Each block is placed in a laminated foil.

    By 4 or 12 blocks together with the instruction for use are placed in a cardboard box.

    Storage conditions:

    Store at a temperature of no higher than 25 ° C in a dark place. Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-005420/10
    Date of registration:10.06.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:AIVEX Pharmaceuticals Yukey LimitedAIVEX Pharmaceuticals Yukey Limited United Kingdom
    Manufacturer: & nbsp
    Representation: & nbspTeva Teva Israel
    Information update date: & nbsp27.11.2017
    Illustrated instructions
    Instructions
    Up