Composition, form of production and packaging
? Nasal drops in the form of an almost transparent solution from colorless to slightly yellowish in color.
1 ml
oxymetazoline hydrochloride 100 Ојg
Excipients: benzalkonium chloride 50% solution, disodium edetate dihydrate, sodium dihydrogen phosphate dihydrate, sodium hydrogen phosphate dihydrate, sodium hydroxide 1M solution, purified water.
5 ml - bottles of dark glass with a lid-pipette (1) - packs of cardboard.
? Nasal drops in the form of an almost transparent solution from colorless to slightly yellowish in color.
1 ml
oxymetazoline hydrochloride 250 Ојg
Excipients: benzalkonium chloride 50% solution, disodium edetate dihydrate, sodium dihydrogen phosphate dihydrate, sodium hydrogen phosphate dihydrate, sodium hydroxide 1M solution, purified water.
10 ml - bottles of dark glass with a lid-pipette (1) - packs of cardboard.
? Nasal drops in the form of an almost transparent solution from colorless to slightly yellowish in color.
1 ml
hydroxymetazoline hydrochloride 500 Ојg
Excipients: benzalkonium chloride 50% solution, disodium edetate dihydrate, sodium dihydrogen phosphate dihydrate, sodium hydrogen phosphate dihydrate, sodium hydroxide 1M solution, purified water.
10 ml - bottles of dark glass with a lid-pipette (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
Vasoconstrictive drug for topical use, alpha 2 -adrenomimetic.
When applied locally to inflamed mucous membranes, the nose reduces the swelling and the amount of secretion. Restores nasal breathing. Eliminating edema of the mucous membranes, the drug helps restore the aeration of the paranasal sinuses, the middle ear cavity and prevents the development of bacterial complications (sinusitis, sinusitis, otitis media).
With local intranasal use in therapeutic concentrations, oxymetazoline does not have a systemic effect, does not irritate the mucous membranes and does not cause hyperemia.
The drug begins to act for several minutes.
The duration of the action is up to 12 hours.
PHARMACOKINETICS
Data on the pharmacokinetics of Nazivin В® are not available.
INDICATIONS
- treatment of acute respiratory diseases accompanied by rhinitis;
- Allergic rhinitis;
- Vasomotor rhinitis;
- restoration of drainage with inflammation of the paranasal sinuses of the nasal cavity, eustachiitis, otitis media;
- elimination of edema before diagnostic manipulations in the nasal passages.
DOSING MODE
Nasivin В® drops are intended for intranasal use.
Adults and children over 6 years should be prescribed drops of 0.05% 1-2 drops in each nostril 2-3 times / day.
Children aged 1 to 6 years should be prescribed drops of 0.025% 1-2 drops in each nostril 2-3 times / day.
Children under the age of 1 year are prescribed drops of 0.01%.
Newborns (children under 4 weeks) are administered 1 drop in each nostril 2-3 times / day.
Children aged 1 month to 1 year are prescribed 1-2 drops in each nostril 2-3 times / day.
To ensure the accuracy of the dosage, the 0.01% drop bottle has a graduated pipette with the number of drops. If 1 drop is prescribed, the pipette should be filled with a solution to the mark 1.
The effectiveness of the following procedure is also proved: depending on the age of 1-2 drops 0.01% solution is applied to cotton wool and the nasal passages are wiped.
Nasivin В® should be used within 3-5 days. Doses in excess of those recommended are prescribed at the doctor's discretion.
SIDE EFFECT
Local reactions: sometimes - dryness and burning sensation of the nasal mucosa, sneezing, in rare cases (after the end of Nazivin's action) - a feeling of nasal congestion (reactive hyperemia).
From the side of the central nervous system: rarely - anxiety, insomnia, fatigue, headache.
From the digestive system: rarely - nausea.
From the side of the cardiovascular system: with multiple overdose possible arterial hypertension, tachycardia.
Prolonged continuous use of vasoconstrictive drugs can lead to tachyphylaxis, atrophy and recurrent edema of the mucous membranes of the nasal cavity (medicamentous rhinitis).
CONTRAINDICATIONS
- Atrophic rhinitis;
- an angle-closure glaucoma;
- Children's age to 6 years (drops and spray nasal 0.05%);
- Hypersensitivity to the components of the drug.
It is recommended to adhere to recommended concentrations of the drug, intended for different age categories.
With caution should be appointed while using MAO inhibitors and other drugs that promote blood pressure, and also up to 10 days after the withdrawal of these drugs; with increased intraocular pressure; during pregnancy and lactation; with severe forms of cardiovascular diseases (arterial hypertension, angina pectoris); with thyrotoxicosis and diabetes mellitus.
PREGNANCY AND LACTATION
The use of the drug during pregnancy and during lactation is possible only after a careful assessment of the relationship between use for the mother and the risk to the fetus or baby. It is inadmissible to exceed the recommended dose.
APPLICATION FOR CHILDREN
Avoid prolonged use and overdose of the drug in children.
Contraindicated in childhood to 6 years (drops and spray nasal 0.05%).
SPECIAL INSTRUCTIONS
Avoid prolonged use and overdose of the drug, especially in children.
Impact on the ability to drive vehicles and manage mechanisms.
After long-term use of drugs containing oxymetazoline, in doses exceeding the recommended, it is impossible to exclude the overall effect on the cardiovascular system and the central nervous system; in these cases, the ability to drive a vehicle or equipment can be reduced.
OVERDOSE
Symptoms: with a significant overdose or ingestion, pupils narrowing, nausea, vomiting, cyanosis, fever, tachycardia, arrhythmia, collapse, cardiac depression, arterial hypertension, pulmonary edema, respiratory distress may be observed. In addition, there may be mental disorders, as well as depression of the central nervous system, accompanied by drowsiness, lower body temperature, bradycardia, arterial hypotension, respiratory arrest and possible development of coma.
Treatment: gastric lavage, reception of activated charcoal.
DRUG INTERACTION
With the simultaneous use of Nazivin with MAO blockers or tricyclic antidepressants, there is an increase in blood pressure.
Co-administration of other vasoconstrictive 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
The drug should be stored out of the reach of children at a temperature of no higher than 25 В° C. Shelf life - 3 years.
