Composition, form of production and packaging
? Spray nasal 0.05% in the form of a clear, colorless solution, odorless.
oxymetazoline hydrochloride 0.05 g
Excipients: benzalkonium chloride - 0.02 g, macrogol 400 - 7.5 g, povidone 0.4 g, propylene glycol 7.5 g, sodium hydrogen phosphate dihydrate 0.006 g, sodium dihydrogen phosphate dihydrate 0.65 g, disodium edetate dihydrate 0.1 g, hydrochloric acid conc. - 0.003 g, purified water - 85.571 g.
15 ml - polyethylene bottles (1) with a spraying device - packs cardboard.
30 ml - polyethylene bottles (1) with a spraying device - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2008.
Oksimetazolin belongs to the group of alpha-adrenostimulators for topical application. Has vasoconstrictive effect. With intranasal administration reduces edema of the mucous membrane of the upper respiratory tract, which leads to the relief of nasal breathing and the opening of the mouths of the adnexal sinuses and Eustachian tubes. The effect of the drug manifests itself 10-15 minutes after application and lasts for 10-12 hours.
To facilitate nasal breathing with:
- Catarrhal diseases and viral infections of the upper respiratory tract
- sinusitis and rhinitis of any etiology.
Intranasally. Adults and children over 12 years of age - 2 - 3 injections into each nasal passage 2 times / day.
Children from 6 to 12 years - 1 injection in each nasal passage 2 times / day.
Do not use the drug more than 2 times / day. Duration of treatment: it is not recommended to use the drug for more than 3 days.
With frequent or prolonged use of the drug, a feeling of difficulty in nasal breathing may reappear or worsen. If these symptoms appear, discontinue treatment and consult a doctor.
When injecting, do not tilt the head back and do not spray in the prone position
Sometimes the burning or dryness of the nasal membranes, dryness in the mouth and throat, sneezing, an increase in the secretion secreted from the nose.
In rare cases, after the effect of using the drug has passed, a strong sense of "stuffiness" of the nose (reactive hyperemia).
Side effects due to the systemic effect of the drug : increased blood pressure, headache, dizziness, palpitations, increased anxiety, nausea, insomnia.
With prolonged use of the drug (more than 7 days) are possible: reactive hyperemia of the nasal mucosa, atrophy of the nasal mucosa, tachyphylaxis (rapid reduction of the therapeutic effect with repeated application).
- hypersensitivity to the drug or its components;
- Atrophic rhinitis;
- children's age till 6 years;
With caution should be used in patients with cardiovascular diseases (arterial hypertension, ischemic heart disease, chronic heart failure, tachycardia, arrhythmia), a violation of carbohydrate metabolism (diabetes mellitus), thyroid function (hyperthyroidism), pheochromocytoma, chronic renal failure, hyperplasia of the prostate (urinary retention) and angle-closure glaucoma, taking MAO inhibitors, tricyclic antidepressants.
PREGNANCY AND LACTATION
The drug is contraindicated for use in pregnancy and lactation (breastfeeding).
Application during pregnancy and breastfeeding is possible only if the intended benefit to the mother exceeds the possible risk to the fetus or baby.
APPLICATION FOR CHILDREN
Contraindicated: children under 6 years.
In the recommended dosage without consulting a doctor, use no more than 3 days. Avoid contact with eyes.
To avoid the spread of infection, it is necessary to use the drug individually.
Prolonged or frequent use of the drug in the nasal cavity can cause nausea, increased blood pressure, tachycardia, CNS depression.
When used simultaneously with MAO inhibitors (including the period within 14 days after their withdrawal) and tricyclic antidepressants, an increase in blood pressure may occur.
The drug slows the absorption of local anesthetic drugs, lengthens their effect.
Co-administration of other vasoconstrictor drugs increases the risk of side effects.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
At a temperature of 2 to 25 В° C in a dry, protected from light place. Keep out of the reach of children. Shelf life - 3 years. Do not use after expiry date.