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FARMAZOLIN NASAL DROPS 0.05% 10ML

Instructions

active ingredient: xulomethazoline ;

1 ml of xylometazoline hydrochloride calculated as 100% substance 0.5 mg or 1 mg

Excipients: sodium phosphate, dodecahydrate; sodium dihydrogen phosphate, dihydrate; sorbitol (E 420) benzalkonium chloride, Trilon B; water for injections.

Dosage form

Nasal drops.

Basic physical and chemical properties: transparent, colorless liquid.

Pharmacological group

Medicines used for diseases of the nasal cavity. Decongestants for topical use for diseases of the nasal cavity. Sympathomimetics, simple drugs.

Pharmacological properties

Pharmacological.

Xylometazoline is a sympathomimetic agent acting on α-adrenergic receptors.

Farmazolin ® causes a narrowing of the nasal blood vessels, reducing swelling of the nasal mucosa and paranasal sinuses, thereby improving nasal breathing when the nose and paranasal sinuses are congested. The drug is well tolerated, including by patients with sensitive mucous membranes. The drug reduces mucociliary function. Thanks to moisturizing components (sorbitol), the drug helps with dryness and irritation of the mucous membrane of the nasal passages. Farmazolin ®, nasal drops, has a balanced pH value within the limits characteristic of the nasal cavity.

Pharmacokinetics.

The effect of the drug begins a few minutes after use and lasts until 12:00. When applied topically, the drug is practically not absorbed; the concentrations of xylometazoline in the blood plasma are so small that they cannot be determined by modern analytical methods.

readings

Symptomatic treatment of nasal congestion due to colds, hay fever, other allergic rhinitis, sinusitis.

To facilitate the outflow of secretions in diseases of the paranasal sinuses.

Auxiliary therapy for otitis media (to eliminate swelling of the mucous membrane).

To facilitate rhinoscopy.

Contraindications

Hypersensitivity to the components of the drug, acute coronary diseases, coronary asthma, hyperthyroidism, glaucoma, transsphenoidal hypophysectomy, a history of transsphenoidal hypophysectomy or surgical interventions with exposure of the dura mater, dry inflammation of the nasal mucosa, atrophic rhinitis. Concomitant treatment with MAO inhibitors and for 2 weeks after stopping their use.

Interaction with other drugs and other types of interactions

Xylometazoline may enhance the effect of sympathomimetics and reduce the effect of drugs that suppress sympathetic nerves. When used together with beta blockers, may cause bronchial spasm or decreased blood pressure. Use together with tricyclic antidepressants, MAO inhibitors (including within 14 days after stopping their use) may lead to increased systemic effect of xylometazoline, especially in overdose.

Features of application

The drug should be used with caution in patients with high blood pressure, coronary insufficiency, enlarged thyroid gland, diabetes mellitus, porphyria, prostatic hypertrophy and existing pheochromocytoma due to a possible systemic sympathomimetic effect.

The drug should be used with caution in patients with sensitivity to sympathomimetics, which can cause symptoms such as sleep disturbances, dizziness, etc.

Do not use the drug for a long time and exceed the dosage, as this can lead to rhinitis provoked by the action of the drug, dry rhinitis (atrophy of the mucous membrane), a reverse effect after stopping treatment and a decrease in the effectiveness of the drug.

In order to prevent infection, each bottle of the drug can only be used by one person.

The drug contains benzalkonium chloride, long-term use of which can cause swelling of the nasal mucosa.

Use during pregnancy or breastfeeding

Since the drug has a vasoconstrictor effect, its use during pregnancy and lactation is not recommended.

The ability to influence the reaction rate when driving vehicles or other mechanisms

Does not affect.

Directions for use and doses

When using a polyethylene bottle, screw the cap as far as possible before first use. In this case, the spike, which is located on the inside of the cap, pierces a hole. The cap is unscrewed, removed and, lightly pressing on the body of the bottle, the solution is instilled into the nose.

When using a polyethylene bottle with controlled opening, immediately before use, you need to hold the bottle in your palm to warm it up to body temperature. After instillation, screw the cap tightly.

Before administering the drug, you should thoroughly clean the nasal cavity.

Farmazolin ®, nasal drops 0.05%, is used for children aged 1 to 11 years.

Farmazolin ®, nasal drops 0.1%, is used for adults and children over 12 years of age.

Nasal drops 0.05%:

children aged 1 to 5 years (under adult supervision) 1-2 drops in each nasal passage 1-2 times a day, but not more than 3 times a day

children aged 6 to 11 years (under adult supervision) 2-4 drops in each nasal passage 2-3 times a day.

Use no more than 3 times a day.

The duration of treatment depends on the course of the disease and should not exceed 7 days, unless the doctor prescribes otherwise.

Nasal drops 0.1%:

adults and children over 12 years old, 2-4 drops in each nasal passage 3 times a day.

Use no more than 3 times a day.

The duration of treatment depends on the course of the disease and should not exceed 10 consecutive days.

Children

Farmazolin ®, drops 0.05%, is not used in children under 1 year of age.

Farmazolin ®, drops 0.05%, is used for children from 1 to 11 years old under adult supervision.

Farmazolin ®, nasal drops 0.1%, not for use in children under 12 years of age.

Overdose

When more than 0.2 mg/kg of the drug is administered, symptoms such as fatigue, rapid heartbeat and increased blood pressure may occur. Very rarely, in case of severe overdose, especially in children (for example, in case of accidental ingestion of high doses), stages of stimulation and depression of the central nervous system and cardiovascular system may alternate. Symptoms of central nervous system stimulation may include restlessness, agitation, hallucinations, and in severe cases, seizures. Symptoms of central nervous system depression may include decreased body temperature, lethargy, drowsiness, and in severe cases, coma. Symptoms such as constriction or dilation of the pupils, sweating, pallor, cyanosis, nausea, tachycardia, bradycardia, arrhythmia, asystole, decreased blood pressure, circulatory disorders, pulmonary edema, respiratory failure and apnea are also possible.

Overdose, especially in children, can have significant effects on the central nervous system, including convulsions, coma, bradycardia, apnea and an increase in blood pressure, modified by a decrease over time.

Treatment of severe overdose (˃1 mg / kg, which for children weighing 20 kg corresponds to the content of 4 bottles of the drug Farmazolin ®, drops 0.05%, or 2 bottles of the drug Farmazolin ®, drops 0.1%) should preferably be started within 1:00 after use . To treat seizures, use anticonvulsants such as benzodiazepam; to lower blood pressure, use non-selective alpha blockers (for example, doxazocine, terazocine). The use of vasoconstrictors is contraindicated. Atropine should be used only in cases of clinically significant bradycardia, accompanied by a decrease in blood pressure.

Adverse reactions

From the immune system: hypersensitivity reactions, including angioedema, rash, itching.

From the nervous system: headache, anxiety, insomnia, fatigue (drowsiness, lethargy), hallucinations (mainly in children).

On the part of the organ of vision: temporary visual impairment.

From the cardiovascular system: palpitations, tachycardia, high blood pressure, arrhythmia.

From the respiratory system, chest and mediastinum: dryness of the mucous membrane of the nose and nasopharynx, sneezing, increased swelling of the nasal mucosa after the effect of the drug decreases, nosebleeds.

From the gastrointestinal tract: nausea.

From the musculoskeletal system, connective tissue and bones: cramps (especially in children).

General disorders and reactions at the injection site: burning sensation at the injection site.

Best before date

3 years.

After opening the bottle, the drug is suitable for use for 28 days.

Do not use after the expiration date stated on the packaging.

Storage conditions

Store in original packaging at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Package

10 ml in a polyethylene bottle or in a polyethylene bottle with controlled opening. 1 bottle per pack.

Vacation category

Over the counter.

Farmazolin price, where to buy

The average price of Farmazolin 0.1% in Russia is close to 82 rubles, and in Ukraine the price of this form of release starts from 12.5 hryvnia.

Online pharmacies in UkraineUkraine
Online pharmacies in KazakhstanKazakhstan

Pharmacy24

Farmazolin N 0.1% 15 ml nasal spray PAT "Farmak", Ukraine
30 UAH. order
Farmazolin 0.05% 10ml nasal drops PAT "Farmak", Ukraine
20 UAH order
Farmazolin 0.1% 10 ml nasal drops PAT "Farmak", Ukraine
23 UAH order
Farmazolin 1mg/ml 10ml nasal spray mint with eucalyptus
39 UAH order

PaniPharmacy

Farmazolin liquid Farmazolin nasal drops 0.05% 10ml Ukraine, Farmak OJSC
22 UAH order
Farmazolin liquid Farmazolin nasal drops 0.1% 10ml Ukraine, Farmak OJSC
23 UAH order
Farmazolin N liquid Farmazolin N spray called. 0.1% 15ml Ukraine, Farmak OJSC
31 UAH order
Farmazolin spray mint/eucalyptus 1 mg/ml fl 10 ml No. 1 Ukraine, Farmak
43 UAH order

special instructions

The drug should be used with caution in patients with coronary insufficiency, high blood pressure, porphyria, diabetes mellitus, prostate hypertrophy , enlarged thyroid gland, pheochromocytoma.

The drug should also be used with caution in persons with sensitivity to sympathomimetics due to the possibility of sleep disturbances and dizziness.

Do not use the drug for a long time and exceed the recommended dosage, as this can lead to the development of atrophy of the nasal mucosa, rhinitis , reverse action after cessation of therapy and addiction to xylometazoline.

In order to prevent infection, each bottle of the product can only be used by one patient.

Overdose

When administered above 0.2 mg/kg body weight, rapid heartbeat, fatigue and increased blood pressure may occur. Rarely, when a severe overdose occurs, periods of excitation and depression of the brain and circulatory system may alternate. Signs of nervous system excitation are emotional agitation, hallucinations and convulsions , and symptoms of nervous system depression are decreased temperature, drowsiness, lethargy and coma . The following symptoms are also likely to occur: changes in pupil size, pallor, sweating , cyanosis, tachycardia , nausea, bradycardia, asystole, arrhythmia , circulatory disorders, decreased blood pressure, pulmonary edema , apnea .

It is advisable to start treatment of a severe overdose (over 1 mg/kg body weight) in the first hour after its occurrence. For the treatment of seizures, it is recommended to use anticonvulsants , and to lower blood pressure - non-selective alpha-blockers . The use of vasoconstrictor drugs is contraindicated. Atropine should be used only in cases of severe bradycardia due to low blood pressure.

Side effects

Immune reactions : rash, Quincke's edema , itching .
Reactions from the visual side: transient visual impairment.
Reactions from nervous activity: insomnia , headache , lethargy, drowsiness , hallucinations .
Circulatory reactions: increased blood pressure, tachycardia, arrhythmia.
Digestive reactions: nausea.
Reactions from breathing: sneezing, dryness of the mucous membranes of the nose and nasopharynx, nosebleeds, increased swelling of the nasal mucosa after the effect of the drug wears off.
Reactions from the musculoskeletal system: cramps .
Local reactions: burning in the area of application.

Contraindications

Sensitization to the components of the drug, acute vascular diseases of the heart, glaucoma, hyperthyroidism, transsphenoidal hypophysectomy , a history of surgical operations with exposure of the dura mater of the brain, atrophic rhinitis .
Combination therapy with MAO inhibitors and a two-week period after stopping their use.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

A sympathomimetic agent that acts only on α-adrenergic receptors .

Farmazolin constricts the blood vessels of the nose, weakening the swelling of the mucous membranes of the nose and its paranasal sinuses, facilitating nasal breathing. Well tolerated by patients with sensitive mucous membranes. Does not suppress mucociliary function.

The moisturizing components of the drug help with irritation and dryness of the nasal mucosa. Farmazolin drops have a balanced pH characteristic of the nasal cavity.

Pharmacokinetics

The action begins a few minutes after instillation and lasts up to 12 hours. When applied locally, the drug is almost not absorbed, and the content of xylometazoline in the blood is so insignificant that it is impossible to determine it using modern methods.

Analogs

Level 4 ATX code matches:
Xymelin Eco

Xymelin

Nazivin

Galazolin

Lazorin

Nazivin Sensitive for children

Otrivin

Naphthyzin

Sanorin

Knoxprey

For the nose

Lazolvan Rino

Afrin

Rhinorus

Eucazoline Aqua

Rinazolin

Grippostad Reno

Xylometazoline

Nazol Advance

Nazol Baby

Brizolin, Grippostad Rino, Galazolin, Dlynos, Doctor Theiss, Influrin, Asterisk NOS, Xylene, Xylobene, Xylometazoline, Xylometazoline bufus, Ximelin, Nosolin, Ximelin Eco, Otrivin, Olint, Tizin xylo, Rinomaris, Rinorus, Rinonorm, Rinostop, Snoop, Sanorin-Xylo, Suprima-NOZ, Espazolin.