Neozolini (Xylometazoline) 0.05% and 0,1% N/D - 10ml
Alfa-adrenomimetic mean
Generic name: Xylometazoline;
ATС Code: R01AA07 .
Drug form:
0,1% and 0,05% nasal
drops.
0,1% and 0,05% nasal spray.
Pharmacological group: Alfa-adrenomimetic means.
Composition:
1 ml of “Neozolin” nasal drops and spray contains:
Xylomethazolin hydrochloride – 1mg (0,1%
solution) or 0,5 mg (0,5% solution);
Excipients: Benzalkonium chloride or Nipagin, edetate
disodium, sodium chlorides,
sodium dihydrogen dehydrate,
sodium hydrophosphate anhydrous, distilled water.
Pharmacological
operation:
Pharmacodynamics: Xylomethazolin belongs to local vasoconstrictor means with Alfa-adrenomimetic activity (nonselective
Alfa-adrenomimetic). It causes nasal mucosa vessels constriction, reduces nose
and gullet mucous tunic
edema, hyperemia, exudation. Restores nasal patency and facilitate nasal breath at time of cold. In
therapeutic concentration doesn't irritate mucous, doesn't cause a hyperemia. Action of the preparation starts in a few
minutes and proceeds within several hours (4-5 h). Long use of preparation
(more than 2 weeks) may cause secondary expansion of blood vessels
(medicamentous rhinitis), decrease
of arterial pressure, which is
related to the irritation of presynaptic alfa2-adrenoreceptors of brain vessels moving
center, mediators excretion lowering and reduction of
sympathetic impulses streams of the central nervous system.
Pharmacokinetics: At time of local use it isn't absorbed
practically and has no systemic operation.
Indications:
·
Acute
infectious
rhinitis;
·
Acute allergic rhinitis;
·
Acute respiratory disease with rhinitis
symptoms;
·
Pollinosis;
·
Sinusitis;
·
Middle
ear inflammation (in
complex therapy for reduction of rhinopharynx mucous membrane edema);
·
For
the sick preparation to carry out rhinoscopy.
Contraindications:
·
Hypersensitivity
toward compound components or acting substances;
·
Pregnancy and lactation period;
·
Arterial
hypertensia;
·
Tachycardia;
·
Expressed
atherosclerosis;
·
Surgical
interventions on brain covers (in the anamnesis);
·
Atrophic
rhinitis.
Order of intake and dosage: “Neozolin” is used intranasal;
0,05%
nasal drops for children from
2 to 12 years:
Children from 2 to 6 years - 1-2 drops in each
nostril, 1-2 times in a day (not more than 3 times in a day);
Children from 6 to 12 years - 1-3 drops in each
nostril, 2-3 times in a day (not more than 3 times in a day);
0,1%
nasal drops is used in adults
and children more than 12 years: 2-3 drops in each nostril (not more than 3
times in a day);
0,05%
nasal spray is used for
children from 6 to 12 years: 1 spray in each nostrils 1-3 times in a day.
0,1%
nasal spray is used for adults
more than 12 years: 1 spray in each nostrils 2-3 times in a day.
Preparation is used not more than 7 days.
Side effects: "Neozolin's" frequent and/or long
application has following side-effects: irritation of rhinopharynx mucous
membrane, dryness, and feeling of burning, sneezing, hypersecretion. Seldom –
nasal mucous membrane edema, increase of arterial pressure, arrhythmia,
dizziness, headaches, nausea, sleep disturbance; depression (at time of long
application with great doses).
Special instructions:
"Neozolin" is prescribed carefully at time of diabetes
mellitus, and also to those patients, having hypersensitivity toward adrenergic
means.
Its long use isn't recommended. The vial is
intended for individual use. It isn't allowed to transfer to other persons, for
the purpose of avoiding possible spread of infection.
Pregnancy and lactation: Use of "Neozolin" during pregnancy
and lactation isn't recommended. It is possible to intake only if the expected
effect for mother sharply exceeds potential risk of negative impact on the
fetus.
Interaction with other medicines or other sort interaction: "Neozolin" isn’t used with tricyclic
antidepressant, MAO inhibitors and sympathetic nervous system exciting
preparations, as it may cause increase of arterial pressure.
Overdose:
Symptoms: Reinforce of side effects;
Treatment: Treatment is symptomatic.
Influence of vehicle and mechanisms management skill: "Neozolin" may influence on vehicle and mechanisms management
skill. So, patients whose activity needs attention concentration and quick psychomotor action should be careful.
Package: 10
ml in glass or polymeric vials with dropper. The vial is put in a carton box.
15ml in polymeric vials with doser
and protecting cover. The vial is put in a carton box.
Storage conditions: Store on 15-25ºC temperature in a dark, dry
place and keep away from children.
After opening the bottle preparation is fit for
the 1st month.
In case of visual defects and expiry of
validity date, the preparation can not be used.
Issue: III group of a pharmaceutical product - issued without a doctor's prescription.
Validity: 10 ml nasal drops in glass and polyethylene bottles
- shelf life 3 years.
15 ml solution in polymer vial with dispenser - shelf life 2 years.
