Pharmazolin 0.05% 10 ml nasal drops
- $3.90
The instruction for medical use
of PHARMAZOLIN® medicine
the Trade name
of Pharmazolin®
the International unlicensed
name Xylomethazolinum Form of release
of the Drop nasal 0.05%, 0.1%
Structure
of 1 ml of drug contains
active agent - xylomethazolinum a hydrochloride in terms of 100% substance - 0.5 mg or 1.0 mg,
excipients: sodium hydrophosphate dodecahydrate, sodium dihydrophosphate a dihydrate, sorbite (E 420), decamethoxynum, dinatrium edetat, water for injections
the Description
Transparent colourless liquid.
Pharmacotherapeutic group
Nasal drugs. Antikongenstanta and other nasal drugs for topical administration. Sympathomimetics. Xylomethazolinum.
The ATX R01A A07 code
the Pharmacological
Pharmacokinetics At properties topical administration is practically not absorbed, concentration of xylomethazolinum in blood plasma is so small that it cannot be determined by modern analytical methods.
The pharmacodynamics
of Pharmazolin® belongs to non-selective α-adrenomimetika which locally narrow vessels of a mucous membrane, eliminating swelled also hyperaemia of a mucous membrane. When drawing has antiedematous effect on a mucous membrane of a nose that promotes simplification of nasal breath.
Effect of drug begins in 5–10 minutes and continues within 5-6 hours.
Indications
- the acute rhinitis of a virus or bacterial etiology, allergic rhinitis, a pollinosis, sinusitis which are followed by difficulty of nasal breath
- prevention of hypostasis of a mucous membrane of a nasopharynx at diagnostic and surgical manipulations in the nasal courses.
The route of administration and doses
When using a bottle polyethylene before the first use as much as possible screw up a cap. At the same time the thorn which is on the cap interior punctures an opening. The cap is unscrewed, removed and, slightly pressing on the bottle body, solution is dug in in a nose.
When using a bottle of opening, polyethylene with control, just before use the bottle needs to be taken in a palm to warm up it to body temperature. After burying it is dense to screw up a cap.
Before administration of drug it is necessary to clean a nasal cavity carefully.
Фармазолин®, drops nasal 0.05%, apply to children from 2 to 11 years.
Фармазолин®, drops nasal 0.1%, apply to adults and children from 12 years.
Drops nasal 0.05%:
to children from 2 to 5 years (under observation of adults) on 1-2 drops in each nasal course 1-2 times a day, but no more than 3 times a day,
to children from 6 to 11 years (under observation of adults) on 2-3 drops in each nasal course 1-3 times a day.
To apply no more than 3 times a day.
Duration of treatment depends on a course of the disease and should not exceed 5 days in a row if the doctor did not appoint differently.
Drops nasal 0.1%:
apply to adults and children from 12 years on 1-2 drops in each nasal course 3 times a day.
To apply no more than 3 times a day.
Duration of treatment is 5 days.
Side effects
from the immune system: reactions of hypersensitivity, including a Quincke's disease, rash, an itching.
From nervous system: a headache, concern, insomnia, fatigue (drowsiness, slackness), hallucinations (especially at children), a depression.
From organs of sight: temporary deterioration in sight, increase in intraocular pressure is possible.
From a cardiovascular system: the accelerated heartbeat, tachycardia, the increased arterial blood pressure, arrhythmia.
From respiratory organs, a thorax and mediastinum: xeromycteria and nasopharynxes, sneezing, increase in a rhinedema after decrease in effect of drug, nasal bleeding, disturbance of sense of smell up to an atrophy mucous a nose (is more often at prolonged use).
From a gastrointestinal system: nausea.
From a skeletal and muscular system, connective tissues and bones: spasms (especially at children).
The general disorders and reactions in the injection site of drug: burning sensation in the injection site, pricking.
Contraindications
- hypersensitivity to any of drug components
- acute coronary diseases
- coronary asthma
- a hyperthyroidism
- closed-angle glaucoma
- transfenoidalny hypophysectomy, existence in the anamnesis of transfenoidalny hypophysectomy or surgical interventions with exposure of a firm meninx
- dry inflammation of a mucous membrane of a nose
- atrophic rhinitis
- tachycardia
- arterial hypertension
- the profound atherosclerosis
- pregnancy and the period of a lactation
- children under 2 years
- the accompanying treatment by MAO inhibitors and within 2 weeks after the termination of their use
Medicinal interactions
Xylomethazolinum can strengthen action of sympathomimetics and reduce influence of the drugs oppressing sympathetic nerves. When using together with beta-blockers can cause a bronchial spasm or a lowering of arterial pressure. Use together with tricyclic antidepressants, MAO inhibitors (including for 14 days after the termination of their use) can lead to strengthening of systemic action of xylomethazolinum, especially at overdose.
Special instructions
Drug should be used with care to patients with the increased arterial blood pressure, the coronary insufficiency increased by a thyroid gland, diabetes, a porphyria, a hypertrophy of a prostate and the existing pheochromocytoma in connection with possible system sympathomimetic effect.
With care patients should use drug with sensitivity to sympathomimetics which can cause such symptoms as a sleep disorder, dizziness and others.
It is impossible to use drug for a long time and to exceed a dosage as it can lead ing of the rhinitis provoked by effect of drug, dry rhinitis (mucosal atrophy), converse effect after the termination of treatment and to reduction of efficiency of effect of medicine.
For the purpose of infection avoidance with drug only one person can use each bottle.
Use in pediatric practice
of Pharmazolin®, drop of 0.05%, is not applied to children up to 2 years.
Фармазолин®, drops of 0.05%, to children from 2 to 11 years apply under observation of adults.
Фармазолин®, drops nasal 0.1%, do not apply to children up to 12 years.
Use during pregnancy or a lactation
As drug has vasoconstrictive action, its use during pregnancy or feeding by a breast is not recommended.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
does not influence.
Overdose
At introduction of more than 0.2 mg/kg of drug the emergence of such symptoms as fatigue, the accelerated heartbeat and increase in arterial blood pressure is possible. Very seldom at heavy overdose, especially at children (for example, at accidental ingestion of high doses of drug) stages of stimulation and oppression of the central nervous system and a cardiovascular system can alternate. The concern, excitement, hallucinations and in hard cases – spasms can be symptoms of stimulation of the central nervous system. Decrease in body temperature, slackness, drowsiness and in hard cases – a coma can be symptoms of oppression of the central nervous system. Emergence of such symptoms as narrowing or expansion of pupils, perspiration, pallor, cyanosis, nausea, tachycardia, bradycardia, arrhythmia, an asystolia, a lowering of arterial pressure, blood circulation disturbance, a fluid lungs, disturbance of breath and an apnoea is also possible. The overdose, especially at children, can have considerable influence on the central nervous system, including convulsions, a coma, bradycardia, an apnoea and increase in arterial blood pressure which changes its decrease subsequently.
It is desirable for ˃1 mg/kg to begin treatment of heavy overdose (that for children weighing 20 kg corresponds to contents of 4 bottles of the drug Pharmazolin®, drops of 0.05%, or 2 bottles of the drug Pharmazolin®, a drop of 0.1%) within 1 hour after the use. For treatment of convulsions to use anticonvulsive drugs of type of petroldiazepam, for a lowering of arterial pressure – non-selective alpha blockers (for example, docsazotsin, terazotsin). Use of vasoconstrictors is contraindicated. To apply atropine only in case of clinically apparent bradycardia which is followed by a lowering of arterial pressure.
A form of release and packing
On 10 ml in bottles polyethylene, corked with caps or in the bottles polyethylene with dosers corked with covers with seals (control of the first opening), or on 10 ml in bottles polyethylene, corked with traffic jams - droppers and caps.
On a bottle paste the label self-bonding.
Each bottle together with the instruction for medical use in the state and Russian languages is put in a pack from cardboard.
To Store storage conditions in original packing at a temperature not above 25 °C.
To store out of children's reach.
Period of storage
3 years. A period of storage after opening of a bottle – 28 days.
Not to use drug after the termination of the expiration date specified on packing.
Prescription status
Without prescription.
PJSC Pharmak producer, Ukraine, 04080, Kiev, st. of Frunze, 74.
The owner of the registration certificate
of PJSC Pharmak, Ukraine
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
Republic of Kazakhstan, 050012, Almaty, Amangelda St. 59 'A' Business center 'Shartas', the 9th floor.
Ph. +7 (727) 267-64-63, fax +7 (727) 267-63-73, e-mail address:
a.liadobruk@gmail.com
of PHARMAZOLIN® medicine
the Trade name
of Pharmazolin®
the International unlicensed
name Xylomethazolinum Form of release
of the Drop nasal 0.05%, 0.1%
Structure
of 1 ml of drug contains
active agent - xylomethazolinum a hydrochloride in terms of 100% substance - 0.5 mg or 1.0 mg,
excipients: sodium hydrophosphate dodecahydrate, sodium dihydrophosphate a dihydrate, sorbite (E 420), decamethoxynum, dinatrium edetat, water for injections
the Description
Transparent colourless liquid.
Pharmacotherapeutic group
Nasal drugs. Antikongenstanta and other nasal drugs for topical administration. Sympathomimetics. Xylomethazolinum.
The ATX R01A A07 code
the Pharmacological
Pharmacokinetics At properties topical administration is practically not absorbed, concentration of xylomethazolinum in blood plasma is so small that it cannot be determined by modern analytical methods.
The pharmacodynamics
of Pharmazolin® belongs to non-selective α-adrenomimetika which locally narrow vessels of a mucous membrane, eliminating swelled also hyperaemia of a mucous membrane. When drawing has antiedematous effect on a mucous membrane of a nose that promotes simplification of nasal breath.
Effect of drug begins in 5–10 minutes and continues within 5-6 hours.
Indications
- the acute rhinitis of a virus or bacterial etiology, allergic rhinitis, a pollinosis, sinusitis which are followed by difficulty of nasal breath
- prevention of hypostasis of a mucous membrane of a nasopharynx at diagnostic and surgical manipulations in the nasal courses.
The route of administration and doses
When using a bottle polyethylene before the first use as much as possible screw up a cap. At the same time the thorn which is on the cap interior punctures an opening. The cap is unscrewed, removed and, slightly pressing on the bottle body, solution is dug in in a nose.
When using a bottle of opening, polyethylene with control, just before use the bottle needs to be taken in a palm to warm up it to body temperature. After burying it is dense to screw up a cap.
Before administration of drug it is necessary to clean a nasal cavity carefully.
Фармазолин®, drops nasal 0.05%, apply to children from 2 to 11 years.
Фармазолин®, drops nasal 0.1%, apply to adults and children from 12 years.
Drops nasal 0.05%:
to children from 2 to 5 years (under observation of adults) on 1-2 drops in each nasal course 1-2 times a day, but no more than 3 times a day,
to children from 6 to 11 years (under observation of adults) on 2-3 drops in each nasal course 1-3 times a day.
To apply no more than 3 times a day.
Duration of treatment depends on a course of the disease and should not exceed 5 days in a row if the doctor did not appoint differently.
Drops nasal 0.1%:
apply to adults and children from 12 years on 1-2 drops in each nasal course 3 times a day.
To apply no more than 3 times a day.
Duration of treatment is 5 days.
Side effects
from the immune system: reactions of hypersensitivity, including a Quincke's disease, rash, an itching.
From nervous system: a headache, concern, insomnia, fatigue (drowsiness, slackness), hallucinations (especially at children), a depression.
From organs of sight: temporary deterioration in sight, increase in intraocular pressure is possible.
From a cardiovascular system: the accelerated heartbeat, tachycardia, the increased arterial blood pressure, arrhythmia.
From respiratory organs, a thorax and mediastinum: xeromycteria and nasopharynxes, sneezing, increase in a rhinedema after decrease in effect of drug, nasal bleeding, disturbance of sense of smell up to an atrophy mucous a nose (is more often at prolonged use).
From a gastrointestinal system: nausea.
From a skeletal and muscular system, connective tissues and bones: spasms (especially at children).
The general disorders and reactions in the injection site of drug: burning sensation in the injection site, pricking.
Contraindications
- hypersensitivity to any of drug components
- acute coronary diseases
- coronary asthma
- a hyperthyroidism
- closed-angle glaucoma
- transfenoidalny hypophysectomy, existence in the anamnesis of transfenoidalny hypophysectomy or surgical interventions with exposure of a firm meninx
- dry inflammation of a mucous membrane of a nose
- atrophic rhinitis
- tachycardia
- arterial hypertension
- the profound atherosclerosis
- pregnancy and the period of a lactation
- children under 2 years
- the accompanying treatment by MAO inhibitors and within 2 weeks after the termination of their use
Medicinal interactions
Xylomethazolinum can strengthen action of sympathomimetics and reduce influence of the drugs oppressing sympathetic nerves. When using together with beta-blockers can cause a bronchial spasm or a lowering of arterial pressure. Use together with tricyclic antidepressants, MAO inhibitors (including for 14 days after the termination of their use) can lead to strengthening of systemic action of xylomethazolinum, especially at overdose.
Special instructions
Drug should be used with care to patients with the increased arterial blood pressure, the coronary insufficiency increased by a thyroid gland, diabetes, a porphyria, a hypertrophy of a prostate and the existing pheochromocytoma in connection with possible system sympathomimetic effect.
With care patients should use drug with sensitivity to sympathomimetics which can cause such symptoms as a sleep disorder, dizziness and others.
It is impossible to use drug for a long time and to exceed a dosage as it can lead ing of the rhinitis provoked by effect of drug, dry rhinitis (mucosal atrophy), converse effect after the termination of treatment and to reduction of efficiency of effect of medicine.
For the purpose of infection avoidance with drug only one person can use each bottle.
Use in pediatric practice
of Pharmazolin®, drop of 0.05%, is not applied to children up to 2 years.
Фармазолин®, drops of 0.05%, to children from 2 to 11 years apply under observation of adults.
Фармазолин®, drops nasal 0.1%, do not apply to children up to 12 years.
Use during pregnancy or a lactation
As drug has vasoconstrictive action, its use during pregnancy or feeding by a breast is not recommended.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
does not influence.
Overdose
At introduction of more than 0.2 mg/kg of drug the emergence of such symptoms as fatigue, the accelerated heartbeat and increase in arterial blood pressure is possible. Very seldom at heavy overdose, especially at children (for example, at accidental ingestion of high doses of drug) stages of stimulation and oppression of the central nervous system and a cardiovascular system can alternate. The concern, excitement, hallucinations and in hard cases – spasms can be symptoms of stimulation of the central nervous system. Decrease in body temperature, slackness, drowsiness and in hard cases – a coma can be symptoms of oppression of the central nervous system. Emergence of such symptoms as narrowing or expansion of pupils, perspiration, pallor, cyanosis, nausea, tachycardia, bradycardia, arrhythmia, an asystolia, a lowering of arterial pressure, blood circulation disturbance, a fluid lungs, disturbance of breath and an apnoea is also possible. The overdose, especially at children, can have considerable influence on the central nervous system, including convulsions, a coma, bradycardia, an apnoea and increase in arterial blood pressure which changes its decrease subsequently.
It is desirable for ˃1 mg/kg to begin treatment of heavy overdose (that for children weighing 20 kg corresponds to contents of 4 bottles of the drug Pharmazolin®, drops of 0.05%, or 2 bottles of the drug Pharmazolin®, a drop of 0.1%) within 1 hour after the use. For treatment of convulsions to use anticonvulsive drugs of type of petroldiazepam, for a lowering of arterial pressure – non-selective alpha blockers (for example, docsazotsin, terazotsin). Use of vasoconstrictors is contraindicated. To apply atropine only in case of clinically apparent bradycardia which is followed by a lowering of arterial pressure.
A form of release and packing
On 10 ml in bottles polyethylene, corked with caps or in the bottles polyethylene with dosers corked with covers with seals (control of the first opening), or on 10 ml in bottles polyethylene, corked with traffic jams - droppers and caps.
On a bottle paste the label self-bonding.
Each bottle together with the instruction for medical use in the state and Russian languages is put in a pack from cardboard.
To Store storage conditions in original packing at a temperature not above 25 °C.
To store out of children's reach.
Period of storage
3 years. A period of storage after opening of a bottle – 28 days.
Not to use drug after the termination of the expiration date specified on packing.
Prescription status
Without prescription.
PJSC Pharmak producer, Ukraine, 04080, Kiev, st. of Frunze, 74.
The owner of the registration certificate
of PJSC Pharmak, Ukraine
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
Republic of Kazakhstan, 050012, Almaty, Amangelda St. 59 'A' Business center 'Shartas', the 9th floor.
Ph. +7 (727) 267-64-63, fax +7 (727) 267-63-73, e-mail address:
a.liadobruk@gmail.com
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