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Description
Instruction for medical use
of RINOZOL medicine – ФОРТЕ®
the Trade name
of RINOZOL – ФОРТЕ®
the International unlicensed name
Is not present
the Dosage form
Nasal drops of 15 ml
Structure
1 ml of solution contains
active agents: Neomycinum (in the form of sulfate Neomycinum) 1.0 mg, a difengidramina a hydrochloride of 1.0 mg, naphazoline a hydrochloride of 0.5 mg,
excipients: sodium chloride, phosphate dinatrium dodecahydrate, water for injections
the Description
Colourless or slightly yellow transparent liquid
Pharmacotherapeutic group
Nasal drugs. Antikongenstanta and other nasal drugs for topical administration. Sympathomimetics in a combination with other drugs. Naphazoline
the ATX R01AB02 Code
the Pharmacological
Pharmacokinetics Therapeutic Effect properties of naphazoline develops in 5 min. after burying drug and proceeds up to 8 h, at frequent use of drug duration of action can be reduced to 6 h. At topical administration, naphazoline can be soaked up in a system blood stream and have systemic action. Development of system effects in children up to 6 years and elderly people is the most probable.
At topical administration system absorption of a difengidramin and Neomycinum low.
A pharmacodynamics
the Combined drug possessing the significant vasoconstrictive, anti-inflammatory, antimicrobial and antiallergenic action. It is caused by existence sympathomimetic, hydrochloride naphazoline vasoconstrictor (Naphthyzinum), means with pronounced antihistaminic properties of a difengidramin of a hydrochloride (Dimedrol) and an antibiotic of a broad spectrum of activity from group of aminoglycosides – sulfate Neomycinum.
Naphazoline the alpha stimulates 2 adrenoceptors that leads to narrowing of peripheral blood vessels, increases arterial blood pressure, expands pupils. Owing to vasoconstrictive action drug reduces puffiness, hyperaemia, exudation.
Difengidramin is an antagonist of H1 receptors 1 generations. By competitive blockade of histamine H1 receptor, drug brakes such allergic symptoms as the expansion and increases in permeability of blood vessels in particular connected with release of a histamine has antiallergic effect, reducing hypostasis, an itching and dacryagogue.
Neomycinum has bactericidal effect. The mechanism of action is connected with direct influence on ribosomes and oppression of synthesis of protein of a bacterial cell. Shigella spp., Proteus spp., Staphylococcus aureus, Streptococcus pneumoniae is active concerning many gram-negative and gram-positive microorganisms, including concerning Esherichia coli.
It is a little active concerning Pseudomonas aeruginosa and Streptococcus spp.
It is not active concerning a pathogenic fungi, viruses, anaerobic bacteria.
Resistance of microorganisms to Neomycinum develops slowly and in small degree
Indications
– rhinitises, antritises and sinusitis of infectious and inflammatory origin, including with the accompanying allergic manifestations
the Route of administration and doses
to Adults and children at the age of 6 years and are more senior dig in 1-2 drops in each nasal course 3-4 times a day within 5-7 days.
It is not recommended to use drug longer than an established period, without consultation of the attending physician
Side effects
– perhaps quickly passing feeling of pain or burning in a nasopharynx (in the first seconds after burying)
– a reactive hyperemia, swelling of a mucous membrane of a nose, light dryness of a mucous membrane of a nasal cavity, the strengthened growth of microorganisms, including mushrooms, irresponsive to an antibiotic (at long use)
Contraindications
– the increased individual sensitivity to drug and its
making chronic rhinitis
– atrophic rhinitis
– a concomitant use of monoamine oxidase inhibitors or tricyclic antidepressants and the period up to 14 days after their cancellation
– the lactation period
– children’s age up to 6 years
Medicinal interactions
Naphazoline slows down absorption of local anesthetics (extends their action when carrying out surface anesthesia).
It is incompatible with tricyclic antidepressants (Maprotilinum) and MAO inhibitors (Nialamidum, befol) – increase in arterial blood pressure is possible that is caused by release of the deposited catecholamines under the influence of naphazoline.
Strengthens action of stimulators of the central nervous system.
Reduces therapeutic activity of the antihypertensives appointed orally.
Perhaps mutual reduction of effects of a difengidramin and the medicines stimulating the central nervous system.
System absorption of Neomycinum after topical administration so low that risk of any interaction minimum.
At the accompanying therapy using ophthalmologic drugs it is necessary to adhere to an interval of 10-15 min. between their use.
Special instructions
in order to avoid solution pollution, you store a bottle densely closed and avoid contact of a tip of the pipette with any surface.
At prolonged use of drug the tolerance develops.
With care appoint drug to patients with arterial hypertension, the profound atherosclerosis, disturbances of a warm rhythm, hypersensitivity to sympathomimetics (including in a hyperthyroidism, diabetes, closed-angle glaucoma, a prostatauxe), bronchial asthma and also to elderly people.
Use in pediatrics
the Data on efficiency and safety of medicine at children up to 6 years are absent.
Pregnancy
Use of drug during pregnancy is possible only if the expected effect exceeds risk of development of complications at a fruit.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
does not influence.
Overdose
At the usual mode of topical administration of overdose it was not noted
the Form of release and packing
On 15 ml of drug so far spill in bottles droppers polyethylene, hermetically corked by the screwing-up covers with control of the first opening
On 1 bottle together with the instruction for medical use in the state and Russian languages place in a pack from cardboard
Storage conditions
to Store at a temperature from 15 wasps up to 25 wasps, in the place protected from light.
To store out of children’s reach!
A period of storage
2.5 years
a drug Period of storage after opening of a bottle – 4 weeks
not to apply after an expiration date
Prescription status from drugstore
Without prescription
LeKos LLP Producer 050000, Almaty, Kabangbai St. of the batyr, 114-13, ph.: 308-10-67.
The owner of the registration certificate
of LeKos LLP,
Republic of Kazakhstan 050000, Almaty, Kabangbai St. of the batyr, 114-13.
The address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products
050000, Almaty, Kabangbai St. of the batyr, 114-13, ph.: 308-10-67.
e-mail: lecos1@mail.ru, www.lecos.kz
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