Iprimol Steri-Neb (Ipramol Steri-Neb)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceIpratropium bromide + SalbutamolIpratropium bromide + Salbutamol
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  • Iprimol Steri-Neb
    solution d / inhal. 
    AIVEX Pharmaceuticals Yukey Limited     United Kingdom
    • Dosage form: & nbspinhalation solution
    Composition:

    For 1 ampoule:

    active substances: ipratropium bromide monohydrate (in terms of ipratropium bromide) 0.5 mg, salbutamol sulfate 3 mg (equivalent to salbutamol 2.5 mg);

    Excipients: sodium chloride 22.5 mg, hydrochloric acid to pH 3.5, water for injection 2.5 ml.

    Description:

    Transparent liquid from colorless to pale yellow.

    Pharmacotherapeutic group:Bronchodilator combined (beta2-adrenomimetic selective + m-holinoblokator)
    ATX: & nbsp

    R.03.A.L.02   Salbutamol and ipratropium bromide

    Pharmacodynamics:

    Combined drug with a pronounced bronchodilator effect, caused by the action of ipratropium bromide and salbutamol.

    Ipratropium bromide is an anticholinergic agent. It blocks m-holinoretseptory smooth muscle tracheobronchial tree (mainly large and medium bronchi), inhibits reflex bronchoconstriction, reduces the secretion of the glands of the mucous membrane of the respiratory tract. Having a structural similarity with the molecule of acetylcholine, it is its competitive antagonist.Effectively prevents bronchoconstriction, resulting from the inhalation of cigarette smoke, cold air, the effects of various bronchospasmodiruyuschih agents, and also eliminates spasm of the bronchi associated with the influence of the vagus nerve.

    Salbutamol is a beta2-adrenergic agent that exerts an effect on the smooth muscles of the respiratory tract, causing its relaxation and preventing bronchoconstriction. Reduces resistance in the airways, increases the vital capacity of the lungs. Prevents the release of histamine, leukotrienes, prostaglandin D2 and other biologically active substances from mast cells. At recommended therapeutic doses, it does not adversely affect the cardiovascular system (CCC), does not cause an increase in blood pressure. To a lesser extent compared with the drugs of this group, it has a positive chrono- and inotropic effect. Causes the enlargement of the coronary arteries.

    Joint inhalation of ipratropium bromide and salbutamol has a simultaneous local effect on muscarinic and beta2-adrenergic receptors of the lungs, resulting in increased bronchodilator effect.Systemic absorption with simultaneous inhalation of ipratropium bromide and salbutamol does not increase.

    Pharmacokinetics:

    Ipratropium bromide It is rapidly absorbed after inhalation, but systemic bioavailability is less than 10% of the dose taken. The connection with plasma proteins (mainly with albumin and glycoprotein) is 9%. 46% of the drug is excreted by the kidneys. The half-life (T1/2) is about 1.6 hours after intravenous administration. Ipratropium bromide does not penetrate the blood-brain barrier.

    Salbutamol quickly and completely absorbed after inhalation. The maximum concentration of salbutamol in the blood plasma is observed after 3 hours. Connection with plasma proteins - 10%. It is subjected to presystemic metabolism in the liver and intestinal wall. The half-life (T1/2) is 3-7 hours. It is excreted by the kidneys, mostly unchanged (30% of the dose within 24 hours) and in the form of an inactive phenol sulfate metabolite for 72 hours and with bile. Salbutamol penetrates the blood-brain barrier, creating concentrations equal to about 5% of the concentration in the blood plasma.

    Indications:

    Bronchospastic syndrome in patients with chronic obstructive pulmonary disease (COPD) and bronchial asthma.

    Contraindications:

    - Hypersensitivity to salbutamol, ipratropium bromide, atropine or their derivatives;

    - hypertrophic obstructive cardiomyopathy;

    - tachyarrhythmia;

    - pregnancy (I trimester);

    - children under 12 years.

    Carefully:

    Closed-angle glaucoma, obstruction of the urinary tract (including against the background of prostatic hyperplasia), severe organic diseases SSS, pheochromocytoma, hyperthyroidism, insufficiently controlled diabetes mellitus, cystic fibrosis, myocardial infarction (recently transferred), pregnancy (II-III trimester), the period of lactation.

    Pregnancy and lactation:

    It is not recommended to prescribe the drug IPRAMOL STERI-HEB in the II and III trimesters of pregnancy and during breastfeeding, except when the expected benefit for the mother exceeds any possible risk to the fetus and infant.

    Dosing and Administration:

    Inhalation with nebulizer inhalers (see the "Drug Use Technique" section of this manual) or a system for non-invasive ventilation in positive airway pressure mode.

    Adults (including elderly patients and children over 12 years of age): 1 Steri-Neb (nebula with a sterile solution) - 3-4 times a day in the form of inhalation with the help of a nebulizer.

    Children under 12 years old: data on the use of the drug IPRAMOL STERI-NEB in children under 12 years are absent.

    TECHNIQUE OF USE OF THE PREPARATION:

    - 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 Figure 1).

    - While holding the ampoule vertically upwards with a 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.

    Side effects:

    Often (more than 1/100 and less than 1/10):

    Central nervous system: headache.

    The cardiovascular system: heart palpitations, tachycardia.

    Gastrointestinal tract: dry mouth, nausea.

    Airways: cough, dysphonia.

    Sense organs: disturbance of accommodation (in case of contact with eyes).

    Infrequently (more than 1/1000 and less than 1/100):

    Central nervous system: dizziness, excessive fatigue, tremor, paresthesia, insomnia, nervousness.

    The cardiovascular system: increased systolic blood pressure, arrhythmia.

    Gastrointestinal tract: vomiting, taste perversion, diarrhea.

    Musculoskeletal system: tremor.

    Genitourinary system: retention of urine, dysuria.

    Rarely (more than 1 / 10,000 and less than 1/1000):

    Central nervous system: disorders of coordination of movements, mental disorders and psychotic reactions such as dysphoria, memory disorders, fear, depression.

    Allergic reactions: angioedema, tongue, lips, face, skin rash (including hives, up to the giant), laryngospasm, bronchospasm, pruritus, anaphylactic shock.

    FROMcardiovascular system: lowering of diastolic blood pressure.

    Airways: nasal congestion, stridor, paradoxical bronchospasm, dyspnea.

    Metabolism: hypokalemia, hyperglycemia.

    Musculoskeletal system: myalgia, muscle cramps, muscle weakness, arthralgia.

    Sense organs: Eye contact may increase intraocular pressure, acute pain in the eye, visual acuity, mydriasis, scleral injection, conjunctival hyperemia, and closed angle glaucoma.

    Other: alopecia, sweating.

    Overdose:

    Manifestations of an overdose of ipratropium bromide are unlikely due to low systemic absorption after inhalation or ingestion. As a consequence, all manifestations of an overdose are mainly associated with the systemic action of salbutamol.

    Manifestations of a salbutamol overdose may include headache, nausea, vomiting, angina, hypertension, hypotension, hypokalemia, hyperglycemia, tachycardia, arrhythmia, chest pain, tremor, flushing, anxiety, hallucinations and dizziness.

    Treatment: symptomatic, including the introduction of cardioselective beta-blockers. However, it should be borne in mind that these drugs can enhance bronchospasm.

    Interaction:

    Joint use of additional beta2-adrenomimetikov, glucocorticosteroids, anticholinergics and xanthine derivatives can enhance the broncholytic effect of the drug IPRAMOL STERI-SKY on the respiratory tract and cause severe side effects.

    With concomitant treatment with beta-blockers, there may be a significant decrease in the effectiveness of the drug.

    Monoamine oxidase inhibitors and tricyclic antidepressants can increase the beta-adrenergic effect of salbutamol and lead to a sharp drop in blood pressure.

    Inhalation anesthesia using anesthetics containing halogenated hydrocarbons, for example, halothane, trichlorethylene and enflurane, can aggravate the side effects of beta2-adrenomimetics on the cardiovascular system, which requires careful monitoring of patients. Alternatively, you can stop the use of the preparation IPRAMOL STERI-NEBA before carrying out operations.

    Theophylline and other xanthines increase the likelihood of developing tachyarrhythmias.

    The drug IPRAMOL STERI-NEB, due to the hypokalemic effect of salbutamol, can enhance the effect of stimulants of the central nervous system, increase the likelihood of glycosidic intoxication, enhance the cardiotropic action of thyroid hormones.

    Possible increase in the number of heartbeats and blood pressure on the background of taking the drug IPRAMOL STERI-NEB cancause the need to correct the dose of antihypertensive and antianginal drugs.

    Diuretics and glucocorticosteroids increase the hypokalemic effect of salbutamol.

    Anticholinergic drugs increase the risk of increased intraocular pressure.

    Special instructions:

    To avoid overdose, do not exceed the maximum daily allowable dose.

    Patients should be instructed about the correct use of the drug IPRAMOL STERI-NEB using a nebulizer and warn about the inadmissibility of getting a solution or aerosol into the eyes.

    In patients with bronchial asthma or moderate-severe COPD, symptomatic treatment may be preferable to regular use.

    It is necessary to further analyze the attachment or enhancement of anti-inflammatory therapy to control inflammation of the respiratory tract in patients with bronchial asthma and steroid-dependent forms of COPD.

    Regular use of high-dosage beta2-adrenomimetics, incl. as part of the preparation IPRAMOL STERI-NEB, to control the symptoms of bronchial obstruction can worsen the course of the disease.With the increase of bronchial obstruction, a simple increase in the dose of IPramol Steri-NEB above the recommended dose over a long period of time is unreasonable and even dangerous. To prevent life-threatening deterioration during the course of the illness, the patient's treatment plan should be reviewed, and in particular the degree of adequacy of anti-inflammatory therapy with glucocorticosteroid drugs.

    When using a solution for inhalations based on androgenic bromide together with beta2- Adrenomimetics rarely occurred cases of acute closed-angle glaucoma. Pain or discomfort in the eyes, fuzzy vision, the appearance of a characteristic halo in combination with reddening of the eyes from conjunctival edema to corneal edema can be regarded as signs of development of acute closed-angle glaucoma. In case these symptoms do not disappear, it is necessary to begin treatment with myotics in the form of eye drops and immediately undergo an examination with a specialist.

    It should be explained to the patient that in the case of acute, rapidly worsening shortness of breath or an obvious decrease in the response to the drug, you should consult a doctor.

    Treatment of beta2-adrenomimetics can lead to severe hypokalemia. Particular caution should be exercised in cases of severe airway obstruction, since the occurrence of hypokalemia can be facilitated by concomitant treatment with xanthine derivatives, diuretics and glucocorticosteroids. Hypokalemia can lead to an increased risk of arrhythmia in patients taking digoxin. In addition, hypoxia can aggravate the effect of hypokalemia on the heart rhythm. In such situations it is recommended to check the concentration of potassium in the blood serum.

    In patients with cystic fibrosis, the drug IPRAMOL STERI-NEB should be administered with caution, because there may be symptoms of gastrointestinal motility disorder (GI). Such patients should be warned about the need to inform the doctor about any changes in the function of the digestive tract.

    If the relief of symptoms of bronchial obstruction (or bronchospasm) requires larger doses than recommended, the treatment plan of the patient should be reviewed.

    Effect on the ability to drive transp. cf. and fur:

    Data on the impact on the ability to manage motor vehicles and / or other mechanisms are not available.However, given the possibility of developing side effects from the central nervous system, care should be taken during the treatment of IPRAMOL STERI-NEB when driving vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Solution for inhalation, 0.2 mg + 1 mg / ml.

    Packaging:

    For 2.5 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 place protected from light, 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-005421/10
    Date of registration:10.06.2010 / 10.02.2015
    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
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