The instruction for medical use
the Trade name
the International unlicensed
name Naphazoline Dosage Form
of the Drop nasal 0.05 and 0.1% 10 ml
of 1 ml of solution contains
active agent of naphazoline nitrate of 0.5 mg (0.05% solution) or 1 mg (0.1% solution)
excipients: boric acid, water for injections.
Transparent colourless or slightly yellowish liquid
of Antikongestanta and other drugs for topical administration. Sympathomimetics. Naphazoline.
ATX R01A A08 code.
Pharmacokinetics At properties topical administration naphazoline is completely soaked up.
Therapeutic action comes within 5 minutes and 4-6 hours at intranasal use last.
Naphthyzinum has the significant vasoconstrictive effect on peripheral vessels thanks to impact on alpha adrenoceptors. When drawing reduces by mucous membranes swelled, hyperaemia, exudation that promotes simplification of nasal breath in rhinitises. Naphazoline promotes opening and expansion of the removing channels of adnexal bosoms of a nose and Eustachian tubes that improves outflow of a secret and interferes with sedimentation of bacteria.
– acute rhinitis
– inflammation of adnexal bosoms of a nose
– an eustachitis
– for reduction of hypostasis at diagnostic and medical procedures.
The route of administration and doses
dig in Naphthyzinum in each nasal course, having thrown back the head a little back and having rejected it to the right at instillation in the left nostril and to the left – at instillation in the right nostril.
With the medical purpose. To adults and children aged from 15 years – on 1-3 drops of solution of 0.1% in each nasal course. To children aged from 2 up to 6 years apply solution of 0.05% – on 1 drop, children aged from 6 up to 15 years – on 2 drops in each nasal course.
Naphthyzinum is applied by 2-3 times a day, but is not more often than in 4-6 hours.
Adults cannot apply Naphthyzinum more than 1 week and more than 3 days – to children.
Repeatedly Naphthyzinum can be applied only in 7-14 days.
In case of bleeding to use tampons, the moistened 0.05% drug solution.
With the diagnostic purpose for reduction of hypostasis – after clarification of a nasal cavity in each nasal course dig in 0.05% of solution on 3-4 drops or enter the tampon moistened in 0.05% solution for 1-2 min.
Local effects of drug:
sensation of burning and dryness in a nasal cavity, a reactive hyperemia, at prolonged use a rhinedema, allergic reactions, extremely seldom a Quincke’s edema.
At use the accustoming to drug can cause more than 1 week.
Prolonged use can cause atrophic rhinitis.
Systemic action of drug:
from nervous system: weakness, a tremor, nausea, a headache, irritability, the increased perspiration,
from a cardiovascular system: in some cases predisposed patients have an increase in arterial blood pressure, tachycardia, arrhythmia
from skin and its appendages: pallor of integuments.
These side effects arise mainly after drug overdose.
– hypersensitivity to drug components
– dry inflammation of a mucous membrane of a nose
– children’s age up to 2 years for 0.05% of solution
– children’s age up to 15 years for 0.1% of solution
– a hyperthyroidism
– chronic rhinitis
– arterial hypertension
– coronary heart disease
– a pheochromocytoma
– the profound atherosclerosis
– closed-angle glaucoma
– simultaneous use of MAO inhibitors and the period up to 14 days after the end of their use
Naphthyzinum reduces therapeutic activity of the antihypertensives appointed orally, slows down absorption of anesthetics.
At the combined use with MAO inhibitors (Nialamidum, befol) and tricyclic antidepressants or for several days after their cancellation there is a risk of sharp increase in arterial blood pressure.
Non-selective inhibitors of the return capture of monoamines enhance vasoconstrictive effect of the drug Naphthyzinum.
Prolonged use of drug can result special instructions in chronic congestion of a nose and a mucosal atrophy.
It is necessary to use very carefully drug to people with a serious illness of a cardiovascular system, in bronchial asthma. The care is necessary at simultaneous use of anesthetics which increase sensitivity of a myocardium to sympathomimetics (for example, a halothane).
Naphthyzinum of 0.05% children under 2 years cannot apply use in pediatrics.
Children aged from 2 up to 15 years can apply Naphthyzinum of 0.05%.
Use during pregnancy or a lactation
Use of drug at pregnancy and feeding by a breast perhaps in case the expected advantage justifies potential risk for mother and the child.
The feature of influence of drug on ability to run transport and potentially dangerous mechanisms
At use in therapeutic doses does not affect ability to run vehicles and to work with other mechanisms.
Overdose or accidental ingestion of drug can be shown by symptoms of systemic action of drug: increase in arterial blood pressure, tachycardia, a headache, a tremor, irritability, the increased perspiration, heart consciousness, consciousness disturbance. Can arise – cyanosis, nausea, cardiac arrest, a fluid lungs, mental disturbances, fervescence. The oppressing action on the central nervous system is shown by such symptoms: drowsiness, bradycardia, decrease in body temperature, state of shock, apnoea, coma.
At accidental overdose it is necessary to stop use of drug and to see immediately a doctor.
A form of release and packing
On 10 ml in bottles polyethylene, corked by caps.
On bottles paste labels – self-bondings.
On 1 bottle together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in the place protected from light at a temperature from 15 With up to 25 C.
To store out of children’s reach!
The period of storage
After opening of a bottle drug is suitable 3 years for the use for 28 days.
It is not necessary to use drug after the termination of the expiration date specified on packing.
PJSC Pharmak Producer, Ukraine, 04080, Kiev, st. of Frunze, 63.
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)
the Republic of Kazakhstan, 050009 Almaty, st. of Abay 157, office 5
Ph. / fax: +7 (727) 250 66 23, the e-mail address: Djatlova88@mail.ru