Composition and release form
Drops - 1 ml:
- Active ingredient: Oxymetazoline hydrochloride - 0.1/0.25/0.5 mg;
- Excipients: Citric acid monohydrate - 0.6093 mg; Sodium citrate dihydrate - 3.823 mg; Glycerol (85%) - 24.348 mg; Benzalkonium chloride (50% solution) - 0.100 mg; Purified water - 979.020/978.870/978.600 mg.
Nasal drops 0.01%; 0.025% and 0.05%.
For Nazivin® 0.01%: 5 ml in a dark glass bottle with a pipette cap.
1 bottle with instructions for use is placed in a cardboard box.
For Nazivin® 0.025% and 0.05%: 10 ml in a dark glass bottle with a pipette cap.
1 bottle with instructions for use is placed in a cardboard box.
Analogs
Level 4 ATX code matches:
Xymelin Eco
Xymelin
Galazolin
Lazorin
Nazivin Sensitive for children
Otrivin
Naphthyzin
Sanorin
Knoxprey
For the nose
Lazolvan Rino
Afrin
Rhinorus
Eucazoline Aqua
Rinazolin
Grippostad Reno
Farmazolin
Xylometazoline
Nazol Advance
Nazol Baby
Drugs that have the same active ingredient: Nazol , Nazol Advance , Sanorinchik , Noxprey , Afrin , Nesopin , Fazin . Analogue drugs that have a similar effect: Galazolin , Xylometazoline , ForNos , Xymelin .
pharmachologic effect
Alpha 2 is an adrenergic agonist.
Pharmacokinetics
When administered locally intranasally, oxymetazoline does not have a systemic effect. The half-life of oxymetazoline when administered intranasally is 35 hours. 2.1% of oxymetazoline is excreted in the urine and about 1.1% in the feces.
Pharmacodynamics
The drug Nazivin® (oxymetazoline) has a vasoconstrictor effect. When applied topically to the inflamed mucous membrane of the nasal cavity, it reduces swelling and nasal discharge.
Restores nasal breathing.
Elimination of swelling of the nasal mucosa helps restore aeration of the paranasal sinuses and middle ear cavity, which prevents the development of bacterial complications (sinusitis, sinusitis, otitis media).
When used locally intranasally in therapeutic concentrations, it does not irritate or cause hyperemia of the nasal mucosa.
The drug begins to act quickly (within a few minutes).
The duration of action of the drug is up to 12 hours.
The results of a double-blind, placebo-controlled study in patients with acute viral rhinitis aged 12-70 years showed that the use of Nazivin® nasal drops 0.05% reduced the median duration of a runny nose from 6 to 4 days.
When is Nazivin shown?
It is necessary to use the drug to eliminate the symptoms of nasal breathing disorders:
- with a runny nose caused by an allergic reaction, infectious inflammatory processes during ARVI;
- with complications of otitis media;
- for sinusitis and inflammation of the Eustachian tubes.
Indications for the use of the drug include preparation for diagnostic and therapeutic ENT procedures to eliminate edema.
Contraindications to the use of Nazivin
Atrophic rhinitis; angle-closure glaucoma; hypersensitivity to the components of the drug.
You should adhere to the recommended concentrations of the drug intended for different age categories.
Carefully
In patients taking monoamine oxidase inhibitors and other drugs that increase blood pressure for up to 10 days after their use; with increased intraocular pressure, during pregnancy and lactation, with severe forms of cardiovascular diseases (hypertension, angina); with thyrotoxicosis and diabetes mellitus.
Interaction
The medicine slows down the absorption of local anesthetics and increases their duration of action.
When using Nazivin Sensitive for 2 weeks before using MAO inhibitors and for 2 weeks after completing their use, as well as during therapy with tricyclic antidepressants or other drugs that provoke an increase in blood pressure , a noticeable increase in blood pressure is observed.
Simultaneous administration of other vasoconstrictors increases the risk of adverse reactions.
Side effects
Sometimes: burning or dryness of the nasal membranes, sneezing. In rare cases: after the effect of using Nazivin® wears off, a strong feeling of “stuffiness” in the nose (reactive hyperemia). Repeated overdose with local nasal use sometimes leads to systemic sympathomimetic effects such as increased heart rate (tachycardia) and increased blood pressure. In very rare cases, anxiety, insomnia, fatigue, headaches and nausea have been observed.
Long-term continuous use of vasoconstrictor drugs can lead to tachyphylaxis, atrophy of the nasal mucosa and recurrent swelling of the nasal mucosa (rhinitis medicamentosa).
Nazivin dosage
Nazivin® 0.01%, 0.025% and 0.05% drops are intended for use in the nose.
Adults and children over 6 years of age: use Nazivin® 0.05% drops, 1 - 2 drops in each nasal passage 2 - 3 times a day.
Children from 1 year to 6 years: use Nazivin® 0.025% drops, 1 - 2 drops in each nasal passage 2 - 3 times a day.
Children under 1 year: children under 4 weeks of age are prescribed 1 drop of Nazivin® 0.01% in each nasal passage 2 - 3 times a day. From the 5th week of life to 1 year - 1 - 2 drops in each nasal passage 2 - 3 times a day.
To ensure dosage accuracy, the bottle of Nazivin® 0.01% drops has a graduated pipette with marks on the number of drops. For example, if 1 drop is prescribed, then the pipette should be filled with the solution to the 1 mark.
The following procedure has also been proven effective: depending on age, 1–2 drops of a 0.01% solution are applied to cotton wool and wiped over the nasal passages.
Nazivin® 0.01%, 0.025% and 0.05% drops should be used for 3 to 5 days. Doses higher than recommended can only be used under medical supervision.
Nazivin nasal spray 0.05% 10 ml for children over 6 years old and adults
Indications for use of the drug NAZIVIN® - treatment of acute respiratory diseases accompanied by rhinitis;
- allergic rhinitis;
- vasomotor rhinitis;
— restoration of drainage in case of inflammation of the paranasal sinuses, eustachitis, otitis media;
— elimination of edema before diagnostic manipulations in the nasal passages.
pharmachologic effect
Vasoconstrictor drug for topical use, alpha2-adrenergic agonist.
When applied topically to inflamed nasal mucous membranes, it reduces their swelling and the amount of discharge. Restores nasal breathing. By eliminating swelling of the mucous membranes, the drug helps restore aeration of the paranasal sinuses and middle ear cavity and prevents the development of bacterial complications (sinusitis, sinusitis, otitis media).
When administered locally intranasally 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 within a few minutes.
Duration of action up to 12 hours.
Pharmacokinetics
Data on the pharmacokinetics of the drug Nazivin ® are not provided.
Dosage regimen
Nazivin drops are intended for administration into the nose.
Adults and children over 6 years old
drops of 0.05% should be prescribed, 1-2 drops in each nostril 2-3 times a day.
Children aged 1 to 6 years
drops of 0.025% should be prescribed, 1-2 drops in each nostril 2-3 times a day.
Children under 1 year of age
drops of 0.01% are prescribed.
Newborns
(children under 4 weeks of age) administer 1 drop into each nostril 2-3 times a day.
Children aged 1 month to 1 year
Prescribe 1-2 drops in each nostril 2-3 times a day.
To ensure dosage accuracy, the bottle of 0.01% drops has a graduated pipette with markings on the number of drops. If 1 drop is prescribed, then the pipette should be filled with the solution to the 1 mark.
The following procedure has also been proven effective: depending on age, 1-2 drops of a 0.01% solution are applied to cotton wool and wiped over the nasal passages.
Nazivin should be used for 3-5 days. Doses higher than recommended are prescribed at the discretion of the physician.
Side effect
Local reactions:
sometimes - dryness and burning sensation of the nasal mucosa, sneezing, in rare cases (after the end of the action
of Nazivin ) - 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 cardiovascular system:
with repeated overdose, arterial hypertension and tachycardia are possible.
Long-term continuous use of vasoconstrictor drugs can lead to tachyphylaxis, atrophy and recurrent swelling of the mucous membranes of the nasal cavity (rhinitis medicamentosa).
Contraindications to the use of the drug NAZIVIN®
- atrophic rhinitis;
- angle-closure glaucoma;
- hypersensitivity to the components of the drug.
You should adhere to the recommended concentrations of the drug intended for different age categories (see methods of use).
Carefully _
should be prescribed with the simultaneous use of MAO inhibitors and other drugs that increase blood pressure, as well as for up to 10 days after discontinuation of these drugs;
with increased intraocular pressure; during pregnancy and lactation; in severe forms of cardiovascular diseases (arterial hypertension, angina pectoris); with thyrotoxicosis and diabetes mellitus. Use of the drug NAZIVIN® during pregnancy and lactation
The use of the drug during pregnancy and lactation is possible only after a careful assessment of the balance of benefit for the mother and risk for the fetus or infant. Exceeding the recommended dose is unacceptable.
special instructions
Long-term use and overdose of the drug should be avoided, especially in children.
Influence on the ability to drive vehicles and operate machinery.
After long-term use of drugs containing oxymetazoline in dosages exceeding the recommended ones, a general effect on the cardiovascular system and central nervous system cannot be excluded (in these cases, the ability to drive a vehicle or operate equipment may be reduced).
Overdose
Symptoms:
with a significant overdose or ingestion, constriction of the pupils, nausea, vomiting, cyanosis, increased body temperature, tachycardia, arrhythmia, collapse, cardiac depression, arterial hypertension, pulmonary edema, and respiratory disorders may be observed. In addition, mental disorders may be observed, as well as depression of central nervous system function, accompanied by drowsiness, decreased body temperature, bradycardia, arterial hypotension, respiratory arrest and possible development of coma.
Treatment:
gastric lavage, taking activated carbon.
Drug interactions
When Nazivin with MAO blockers or tricyclic antidepressants, an increase in blood pressure is observed.
Co-administration of other vasoconstrictor drugs increases the risk of side effects.
Conditions for dispensing from pharmacies
The drug is approved for use as a means of OTC.
Storage conditions and periods
The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life: 3 years.
Overdose
After a significant overdose or accidental ingestion, the following symptoms may appear: constriction of the pupils, nausea, vomiting, cyanosis, fever, tachycardia, arrhythmia, collapse, cardiac depression, arterial hypertension, pulmonary edema, respiratory disorders. In addition, mental disorders may appear, as well as depression of the functions of the central nervous system, accompanied by drowsiness, decreased body temperature, bradycardia, arterial hypotension, respiratory arrest and possible development of coma.
In case of overdose associated with oral administration of the drug, gastric lavage and activated charcoal are prescribed.
Precautionary measures
Long-term use and overdose of the drug should be avoided, especially in children.
Impact on the ability to drive vehicles and operate machinery
After long-term use or administration of cold remedies containing oxymetazoline in dosages exceeding the recommended ones, a general effect on the cardiovascular system and central nervous system cannot be excluded. In these cases, the ability to operate a vehicle or equipment may be impaired.
