Ipramol Steri-Neb

General characteristics. Structure:

Structure on 1 ampoule:
active agents: a bromide ipratropiya monohydrate (in recalculation on an ipratropiya bromide) 0,5mg, salbutamol sulfate – 3 mg (it is equivalent salbutamol 2,5mg).
excipients: sodium chloride, Acidum hydrochloricum, water for injections.

Description
Transparent liquid from colourless till pale yellow color.

Pharmacological properties:

Pharmacodynamics. The combined drug with the expressed broncholitic effect caused by action being a part an ipratropiya of bromide and salbutamol. Ipratropiya bromide is an anticholinergic. Blocks m-holinoretseptory of smooth muscles of a tracheobronchial tree (preferential large and average bronchial tubes), suppresses a reflex bronkhokonstriktion, reduces secretion of glands of a mucous membrane of respiratory tracts. Having structural similarity to acetylcholine molecule, is his competitive antagonist. Effectively prevents the narrowing of bronchial tubes resulting from inhalation of cigarette smoke, cold air, action of various bronkhospazmiruyushchy agents, and also eliminates the spasm of bronchial tubes connected with influence of a vagus nerve.

Salbutamol is β2адренергическим the means having effect on smooth muscles of respiratory tracts, causing its relaxation and preventing a bronchospasm. Reduces resistance in respiratory tracts, increases the vital capacity of lungs. Prevents allocation of a histamine, leukotrienes, D2 prostaglandin and other biologically active agents from mast cells. In the recommended therapeutic doses does not exert negative impact on warmly vascular system (CCC), does not cause increase in arterial pressure. To a lesser extent in comparison with medicines of this group, renders positive hrono-and inotropic action. Causes expansion of coronary arteries.

Joint inhalation an ipratropiya of bromide and salbutamol makes simultaneous local impact on muskarinovy and β2 adrenergic receptors of lungs therefore the effect amplifies broncholitic. System absorption at joint inhalation an ipratropiya of bromide and salbutamol does not increase.

Pharmacokinetics. Ipratropiya bromide is quickly absorbed after inhalation, however system bioavailability leaves less than 10% of the accepted dose. Communication with proteins of plasma (it is preferential with albumine and a glycoprotein) – 9%. 46% of drug are removed by kidneys. The elimination half-life (T1/2) makes about 1/6 hours later in / венного introductions. Ipratropiya bromide does not get through a blood-brain barrier.

Salbutamol is quickly and completely absorbed after inhalations. The maximum concentration of salbutamol in a blood plasma is observed in 3 hours. Communication with proteins of plasma - 10%. It is plunged to presistemny metabolism in a liver and an intestinal wall. The elimination half-life (T1/2) leaves 3-7 hours. It is removed by kidneys, it is preferential in an invariable look (30% of a dose within 24 hours) and in the form of an inactive fenolsulfatny metabolite within 72 hours and with bile. Salbutamol gets through a blood-brain barrier, creating the concentration equal to about 5% of concentration in a blood plasma.

Indications to use:

Bronkhospastichesky syndrome at are sick with the chronic obstructive pulmonary disease (COPD) and bronchial asthma.

Route of administration and doses:

It is inhalation by means of inhalers – nebulizers or system for noninvasive ventilation of the lungs in the mode of positive pressure in respiratory tracts.

Adults (including patients of advanced age and children are more senior than 12 years): 1 Steri-Neb (a nebula with sterile solution) – 3-4 times a day in the form of inhalation by means of the nebulizer.

Children up to 12 years: data on use drug Ipramol Steri-Neb at children up to 12 years are absent.

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.

Features of use:

In order to avoid overdose it is not recommended to exceed the most admissible daily dose. Patients need to be instructed about the correct use of drug Ipramol Steri-Neb by means of the nebulizer and to warn about inadmissibility of hit of solution or an aerosol in eyes.

At patients with bronchial asthma or the HOBL medium-weight forms the symptomatic treatment can be more preferable than regular use.

It is necessary to analyze in addition accession or strengthening of antiinflammatory therapy for control of an inflammation of respiratory tracts at patients with bronchial asthma and the HOBL steroidozavisimy forms.

Regular use of high dosages β2 adrenomimetik including as a part of drug Ipramol Steri-Neb, for control of symptoms of bronchial obstruction can worsen the course of a disease. At increase of bronchial obstruction simple increase in a dose of drug Ipramol Steri-Neb is higher recommended throughout a long span is inexpedient and even dangerous.

For prevention of life-threatening deterioration during a disease it is necessary to reconsider treatment planning of the patient and in particular degree of adequacy of antiinflammatory therapy of GKS with drugs. At use of solution for inhalation a bromide ipratropiya together with β2 adrenomimetikam seldom evolved cases of acute closed-angle glaucoma. Pain or discomfort in eyes, indistinct sight, emergence characteristic of glaucoma an areola in combination with reddening of eyes 6ot konyyuktevalny to corneal hypostasis can be regarded as signs of development of acute closed-angle glaucoma. If the specified symptoms do not disappear, it is necessary to begin treatment of a miotikama in the form of eye drops and to immediately have examination at the specialist.

It is necessary to explain to the patient that in case of the acute, fast-worsening asthma or explicit decrease in reaction to drug it is necessary will see a doctor.

Treatment β2 can lead adrenomimetikam to the expressed hypopotassemia. Extra care should be shown in cases of heavy obstruction of respiratory tracts as emergence of a hypopotassemia can promote the accompanying treatment by xanthine derivatives, diuretics and GKS. The hypopotassemia can result in the increased risk of arrhythmia at the patients accepting digoxin. Besides, the hypoxia can aggravate impact of a hypopotassemia on a cordial rhythm. In such situations it is recommended to check potassium concentration in blood serum.

At patients with a mucoviscidosis drug Ipramol Steri-Neb has to be appointed with care because emergence of symptoms of disturbance of motility of the gastrointestinal track (GT) is possible. Such patients have to be warned about need to report to the doctor about any changes of the GIT function.

If for stopping of symptoms of bronchial obstruction (or bronchospasms) high doses are required than it is recommended, it is necessary to reconsider treatment planning of the patient.

Influence on ability to drive the car and to work with the equipment.
Data on influence on ability to control of motor transport and/or other mechanisms are absent. However, considering a possibility of development of side effects from the central nervous system during treatment Ipramol Steri-Neb it is necessary to be careful at the driving of motor transport and occupations potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

Often (≥1/100> 1/10):
Central nervous system: headache.
Cardiovascular system: tachycardia, tachycardia.
Digestive tract: dryness in a mouth, nausea.
Respiratory tracts: cough, dysphonia.
Sense bodys: accommodation disturbance (at hit in eyes).

Infrequently (> 1/1000 <1/100)
Central nervous system: dizziness, excessive fatigue, tremor, paresthesias, sleeplessness, nervousness.
Cardiovascular system: increase in systolic arterial pressure, arrhythmia.
Digestive tract: vomiting, food faddism, diarrhea.
Skeletal and muscular system: tremor.
Urinogenital system: ischuria, dysuria

Seldom (> 1/10000> 1/1000)
Central nervous system: a lack of coordination of movements, disturbance from mentality and psychotic reactions, such as a dysphoria, memory disturbance, fear, a depression.
Allergic reactions: a Quincke's disease of language, lips, persons, skin rash (including a small tortoiseshell, up to huge), a laryngospasm, a bronchospasm, an itch, an acute anaphylaxis.
Cardiovascular system: decrease in distolichesky arterial pressure.
Respiratory tracts: nose congestion, stridor, paradoxical bronchospasm, asthma.
Metabolism: hypopotassemia, hyperglycemia.
Skeletal and muscular system: mialgiya, muscular spasms, muscular weakness, arthralgia.
Sense bodys: at hit in eyes increases in intraocular pressure, an acute pain in an eye, visual acuity disturbance, a mydriasis, a sclera injetsirovannost, a conjunctiva hyperemia, closed-angle glaucoma are possible.
Others: allopecia, perspiration.

Interaction with other medicines:

Combined use additional β2 adrenomimetik, glucocorticosteroids, anticholinergics and derivatives of xanthine can strengthen broncholitic effect of drug Ipramol Steri-Neb on respiratory tracts and cause heavy side effects. At the accompanying treatment β considerable decrease in efficiency of drug can be observed by adrenoblockers.

Monoamine oxidase inhibitors and tricyclic antidepressants can strengthen beta and adrenergic effect of salbutamol and lead to a sharp lowering of arterial pressure.

The inhalation anesthesia using the anesthetizing substances containing halogenated hydrocarbons, for example, a halothane, trichloroethylene and энфлуран, can aggravate side effects β2 adrenomimetik on cardiovascular system, in the investigation of what careful control of patients is required. As an alternative it is possible to stop drug use Ipramol Steri-Neb before carrying out operation.

Teufillin and other xanthines increase probability of development of takhiatrimiya.

Drug Ipramol Steri-Neb, in a consequence of gipokaliyemichesky effect of salbutamol can strengthen action of stimulators of the central nervous system, increase probability of glikozidny intoxication, strengthen kardiotropny effect of hormones of a thyroid gland.

Possible increase in number of cordial reductions and arterial pressure against the background of administration of drug Ipramol Steri-Neb can cause the necessity of dose adjustment of hypotensive and anti-anginal drugs.

Diuretics and glucocorticosteroids strengthen gipokaliyemichesky effect of salbutamol.

Anticholinergic medicines increase risk of increase in intraocular pressure.

Contraindications:

• Hypersensitivity to salbutamol, an ipratropiya to bromide, atropine or their derivatives;
• Hypertrophic subaortic stenosis;
• Takhiatrimiya;
• Pregnancy (I trimester);
• Children's age up to 12 years

With care
Closed-angle glaucoma
Obstruction of urinary tract (including against the background of a prostate hyperplasia), the expressed organic diseases of CCC, a pheochromocytoma, a hyperthyroidism, not enough controlled SD, a mucoviscidosis, the myocardial infarction which is recently postponed pregnancy (the II-III trimester), the lactation period.

Pregnancy and lactation
Ipramol Steri-Neb in II and the III trimester of pregnancy and during breastfeeding is not recommended to appoint drug unless the expected advantage for mother exceeds any possible risk for a fruit and the baby.

Overdose:

Overdose manifestations an ipratropiya of bromide are improbable because of low system absorption after inhalation or intake. Thereof all manifestations of overdose are connected with systemic action of salbutamol.

Manifestations of overdose of salbutamol can include: headache, nausea, vomiting, stenocardia, hypertensia, hypotension, hypopotassemia, hyperpotassemia, tachycardia, arrhythmia, stethalgia, tremor, hyperemia, concern, hallucinations and dizziness.

Treatment
Symptomatic, including administration of cardioselective beta adrenoblockers. However it is necessary to consider that these drugs can strengthen a bronchospasm.

Storage conditions:

At a temperature not above 25ºС, in the place protected from light not to freeze. To store in the place, unavailable to children. Period of validity 2 years. Not to use after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Solution for inhalations of 0.2 mg +1 mg/ml
On 2,5 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.