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.
Compound
- 1 ml of Nazivin Sensitive in the form of drops for children contains 100 mcg of oxymetazoline hydrochloride . Additional substances: citric acid monohydrate, glycerol 85%, water, sodium citrate dihydrate.
- 1 ml of Nazivin Sensitive in the form of a spray for children contains 250 mcg of oxymetazoline hydrochloride. One dose contains 11.25 mcg of oxymetazoline hydrochloride . Additional substances: citric acid monohydrate, glycerol 85%, water, sodium citrate dihydrate.
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.
Nazivin Sensitive nasal spray 11.25 mcg/dose 10 ml
Compound
Active substance: oxymetazoline hydrochloride 11.25 mcg (1 dose), 250 mcg (1 ml).
Excipients: citric acid monohydrate - 27.40 mcg, sodium citrate dihydrate - 172.03 mcg, glycerol 85% - 1121.44 mcg, purified water - 44027.86 mcg.
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.
Indications for use
- Colds or viral infections of the upper respiratory tract, accompanied by a runny nose, sinusitis, eustachitis, otitis media, rhinitis of any etiology;
- to eliminate swelling before diagnostic manipulations in the nasal passages.
Contraindications
- Atrophic rhinitis;
- angle-closure glaucoma;
- hypersensitivity to the components of the drug;
- surgical interventions on the dura mater (history).
For the drug Nazivin® Sensitive nasal spray dosed 11.25 mcg/dose - children under 1 year of age.
Carefully:
With increased intraocular pressure, chronic heart failure, arterial hypertension, angina pectoris; arrhythmias; chronic renal failure; in patients with prostatic hyperplasia with clinical symptoms (urinary retention); severe atherosclerosis; with hyperthyroidism; diabetes mellitus; pheochromocytoma; tachycardia; therapy with monoamine oxidase inhibitors (MAO) and tricyclic antidepressants, as well as other drugs that increase blood pressure; porphyria.
Directions for use and doses
Nazivin® Sensitive nasal spray dosed 11.25 mcg/dose is intended for intranasal administration.
Children aged 1 to 6 years: 1 injection of Nazivin® Sensitive nasal spray dosed 11.25 mcg/dose in each nostril 2-3 times a day. The drug is used for 5-7 days. The drug can be re-prescribed only after a few days.
If symptoms worsen or improvement does not occur within 3 days, you should consult your doctor. Use the recommended dose for no more than 7 days without consulting a doctor.
Doses higher than recommended can only be used under medical supervision.
Storage conditions
Store at a temperature not exceeding 30 °C. Keep out of the reach of children.
Best before date
3 years. Do not use after the expiration date.
special instructions
Avoid getting the drug into your eyes.
To avoid the spread of infection, it is necessary to use the drug individually.
Description
Anticongestant - alpha-adrenergic agonist.
Use in children
Contraindicated in children under 1 year of age.
Pharmacodynamics
Nazivin® Sensitive (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 reduces the likelihood 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 Nazivin Sensitive nasal spray dosed 11.25 mcg/dose begins to act quickly, within a few minutes.
The duration of action of Nazivin® Sensitive drugs is up to 12 hours.
Side effects
Uncommon: burning or dryness of the nasal mucosa, sneezing, nosebleeds, Quincke's edema, itching. In rare cases: after the effect of using the drug Nazivin® Sensitive wears off, a feeling of nasal “stuffiness” (reactive hyperemia).
Rarely: increased blood pressure, headache, dizziness, palpitations, tachycardia, anxiety, irritability, sleep disturbance (in children), nausea, insomnia, exanthema, blurred vision (if it gets in the eyes). Very rare: fatigue, drowsiness, restlessness, hallucinations, convulsions, respiratory arrest (in infants).
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).
Use during pregnancy and breastfeeding
When used during pregnancy or breastfeeding, do not exceed the recommended dose. The drug can only be used in cases where the potential benefit to the mother outweighs the potential risk to the fetus and child.
Interaction
Slows down the absorption of local anesthetic drugs and prolongs their effect.
In patients taking monoamine oxidase inhibitors (MAOIs) during the previous 2 weeks and within 2 weeks after their discontinuation, tricyclic antidepressants or other drugs that increase blood pressure - increased blood pressure.
Co-administration of other vasoconstrictor drugs increases the risk of side effects.
Overdose
Clinical signs of intoxication with imidazole derivatives can be nonspecific and unclear, since phases of hyperactivity are replaced by phases of depression of the central nervous system, cardiovascular and respiratory systems. Symptoms: anxiety, restlessness, hallucinations, convulsions, decreased body temperature, lethargy, drowsiness, coma, constriction or dilation of pupils, fever, sweating, pallor, cyanosis, palpitations, bradycardia, arrhythmia, cardiac arrest, increased blood pressure, decreased blood pressure, nausea, vomiting, respiratory depression, respiratory arrest.
In children, an overdose can cause the development of symptoms from the central nervous system, such as: agitation, convulsions, coma, bradycardia, respiratory arrest, as well as an increase in blood pressure with a subsequent possible decrease in blood pressure.
Treatment: gastric lavage, taking activated carbon (in case of accidental ingestion of the drug); symptomatic.
In case of severe overdose, intensive therapy in a hospital setting is indicated. The use of vasoconstrictors is contraindicated.
Impact on the ability to drive vehicles and operate machinery
After long-term use of cold remedies containing oxymetazoline in doses higher than recommended, a general effect on the cardiovascular system and central nervous system cannot be excluded. In these cases, care should be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
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.
Contraindications
- angle-closure glaucoma;
- hypersensitivity to the components of the drug;
- atrophic rhinitis;
- age less than 1 year (for all forms of the drug except Nazivin Sensitive in the form of drops);
- age less than 6 years (for the drug in the form of a spray with a dosage of 500 mcg/ml).
It is necessary to prescribe the drug with caution in case of increased intraocular pressure, arterial hypertension , heart failure or chronic renal failure, angina pectoris, pheochromocytoma , severe atherosclerosis , arrhythmia , prostatic hyperplasia with signs of urinary retention, diabetes mellitus , hyperthyroidism , as well as in persons taking MAO inhibitors over the past 2 weeks (and another 2 weeks after stopping their use), Bromocriptine , tricyclic antidepressants .
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).
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.
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.
Analogs
Level 4 ATX code matches:
Xymelin Eco
Xymelin
Nazivin
Galazolin
Lazorin
Otrivin
Naphthyzin
Sanorin
Knoxprey
For the nose
Lazolvan Rino
Afrin
Rhinorus
Eucazoline Aqua
Rinazolin
Grippostad Reno
Farmazolin
Xylometazoline
Nazol Advance
Nazol Baby
Vicks Active Sinex, Afrin Extra, Nazol Advance, 4-Way, Nazol Baby, Afrin, Nazol Kids, Nazospray, Nesopin, Oxymetazoline, Noxprey, Nazol, Fazin, Sanorinchik, Fervex.
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.
How to use Nazivin spray
The Nazivin form is indicated for the treatment of runny nose in children 1–6 years old. The bottle with the drug must first be shaken and a test spray into the air.
- Before use, the nasal passages are cleared of mucus clots with a cotton swab, the child is allowed to blow his nose, and if possible, the sinuses are washed with a special saline solution or water.
- Throwing your head up, carefully bring the dispenser to your nostrils and inject the drug once.
- The procedure is repeated up to three times a day.
The general course of treatment is up to 7 days.
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.
special instructions
Avoid contact of this product with eyes.
It is recommended to use the drug individually to avoid the spread of a viral or bacterial infection.
After prolonged use of drugs for the common cold, including oxymetazoline in large doses, the appearance of effects on cardiovascular and nervous activity cannot be ruled out. In these cases, patients should be careful when driving.
