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Naphazoline (drops)

Use in children The drug is contraindicated in children under 6 years of age. The use of the drug in children under 12 years of age is not recommended. The duration of use of the drug in children should not exceed 3 days.

Use during pregnancy and breastfeeding When used during pregnancy or breastfeeding, do not exceed the recommended dosage. The drug should be used only after a careful assessment of the risk-benefit ratio for the mother and fetus. The drug is contraindicated in the first trimester of pregnancy.

Effect on the ability to drive a car and operate machinery. With long-term use or use in a dosage exceeding the recommended one, systemic effects of naphazoline on the cardiovascular system may occur. In these cases, the ability to drive a car and operate machinery may be impaired.

Pharmacokinetic properties

Naphazoline

exhibits a vasoconstrictor effect after a few minutes, the effect of the drug continues for several hours. Along with tetrizoline and indanazoline, it is a short-acting alpha-adrenergic agonist with an effect lasting up to 4-6 hours.

Xylometazoline

is the only imidazoline with an average duration of action, reaching 8–10 hours. In all likelihood, the longer-lasting effect is explained by the slow elimination of alpha2-adrenergic agonists from the nasal cavity due to the decrease in blood flow in the mucous membrane caused by them. Rhinamometry data show that xylometazoline reduces airflow resistance in the nasal cavity for 8 hours with a maximum reduction of 33% [2, 3].

According to research, 0.1% and 0.05% solutions of xylometazoline have a comparable vasoconstrictor effect, so some experts recommend starting treatment with lower concentrations of the drug [2].

Naphazolin-RUBICON nasal drops 1 mg/ml 15 ml No. 1

Name

Naphazolin-RUBICON

Description

Transparent, colorless or yellowish solution.

Main active ingredient

Naphazoline nitrate.

Release form

Nasal drops.

Dosage

Naphazoline nitrate - 1.00 mg.

pharmachologic effect

Means for eliminating inflammatory edema (decongestants) and other means for topical use in rhinology. Sympathomimetics.

Indications for use

To reduce swelling of the nasal mucosa in acute rhinitis, as an adjuvant for sinusitis, otitis media.

Directions for use and doses

Adults and adolescents from 12 years of age: 2-4 drops in each nasal passage 3 times a day. The medicine can be used for up to 5 days. If breathing becomes free, the use of the drug can be stopped earlier. Repeated use of the drug is possible only a few days after its discontinuation. If the patient forgot to use the drug, he can use it immediately, and the subsequent dose should be used at a prescribed interval. Do not use two doses at once. Performing the instillation procedure: before using the drug and 5 minutes after its use, it is necessary to clean the nasal passages. Remove the cap from the bottle before use. Tilt your head back while sitting or lying down, carefully insert the tip of the nozzle of the bottle turned upside down into one half of the nose, drip the drug into each half of the nose, and gently tilt your head from side to side several times. After use, clean the tip of the nozzle and close the bottle with a lid. The vial should only be used by one person due to the risk of infection transmission.

Use during pregnancy and lactation

During pregnancy and breastfeeding, it is not recommended to use the drug due to the risk of naphazoline entering the systemic circulation.

Precautionary measures

The use of the drug for chronic atrophic rhinitis is not recommended. If it is necessary to use naphazoline solution for a long time, be sure to interrupt treatment for several days every 5 days to avoid the development of tolerance. The drug should be used with caution in patients suffering from pheochromocytoma, porphyria and prostatic hyperplasia, severe diseases of the cardiovascular system (arterial hypertension, coronary heart disease (CHD), metabolic disorders (diabetes mellitus, hyperteriosis) and with simultaneous treatment with MAO inhibitors and other drugs that increase blood pressure. It is also necessary to be careful during general anesthesia with the use of anesthetics that increase the sensitivity of the myocardium to sympathomimetics (for example, halothane) in patients with bronchial asthma. The drug contains benzalkonium chloride, which may cause irritation or swelling of the nasal mucosa , especially with long-term use. Continuous use of anti-edematous drugs can lead to chronic swelling and atrophy of the mucous membrane. Long-term use and overdose of the drug should be avoided. Patients who take high doses of the drug should be under medical supervision due to the possible occurrence of cardiovascular vascular and neurological side effects (hypertension, arrhythmia, palpitations, headaches, dizziness, drowsiness or insomnia).

Interaction with other drugs

Naphazoline may interact with MAO inhibitors due to inhibition of the catabolism of vasopressor amines. Naphazoline may enhance the effect of alpha-adrenergic stimulation in combination with other drugs that contain sympathomimetic amines or beta-blockers (especially non-selective beta-1 blockers).

Contraindications

-Children up to 12 years old. -Hypersensitivity, severe diseases of the cardiovascular system (arterial hypertension, coronary heart disease, severe atherosclerosis), metabolic disorders (diabetes mellitus, increased thyroid function), chronic rhinitis, severe eye diseases, angle-closure glaucoma, adrenal tumor (pheochromocytoma), bronchial asthma, simultaneous use of monoamine oxidase inhibitors (MAOIs) and a period of up to 10 days after the end of their use. -Atrophic rhinitis with dryness of the nasal mucosa. -First trimester of pregnancy. - Condition after transsphenoidal hypophysectomy or other surgical procedures that could lead to damage to the dura mater.

Compound

1 ml of solution contains: Active substance: naphazoline nitrate - 1.00 mg; Excipients: boric acid, disodium edetate, sodium chloride, benzalkonium chloride, sodium hydroxide, purified water.

Overdose

Pediatric age: Rare cases of intoxication have been observed in children after accidental ingestion or use of too high doses. The toxic dose is 0.5 mg/10 kg body weight (single dose). Early symptoms include bradycardia and arrhythmia, and less commonly, tachycardia and increased blood pressure. If the overdose is severe, hypothermia, diaphoresis, loss of consciousness, coma, or respiratory depression may occur. Adults: Overdose is not observed in adults. In case of accidental ingestion, it is recommended to take activated charcoal and seek medical attention.

Side effect

The frequency of possible side effects listed below is determined as follows: very often (≥1/10) often (≥1/100 -

Storage conditions

At a temperature not exceeding 25 °C, in a place protected from light. Keep out of the reach of children!

Buy Naphazolin-RUBICON 1 mg/ml in 15 ml bottle in pack No. 1 in the pharmacy

Price for Naphazolin-RUBIKON 1 mg/ml in 15 ml bottle in pack No. 1

Instructions for use for Naphazolin-RUBIKON naz. 1 mg/ml in bottle 15 ml in pack No. 1

Naphazolin-K 0.1% 20 ml nasal drops.

APPROVED by the Order of the Chairman of the Committee for Control of Medical and Pharmaceutical Activities of the Ministry of Health of the Republic of Kazakhstan dated "______" __________ 201___ No. ________ Instructions for the medical use of the drug Naphazolin-K Trade name Naphazolin-K International nonproprietary name Naphazolin Dosage form Nasal spray 0.05% and 0.1% 10ml, 20 ml Composition 1 liter of the drug contains the active substance - naphazoline nitrate 0.5 g, 1.0 g excipients - boric acid, purified water. Description Transparent, colorless liquid Pharmacotherapeutic group Anticongestants and other nasal drugs for local treatment. Sympathomimetics ATC code R01AA08 Pharmacological properties Pharmacokinetics After application to the mucous membranes, it is quickly absorbed. Has a resorptive effect. Pharmacodynamics Alpha adrenergic agonist. Naphazoline has a pronounced vasoconstrictor effect. Naphazoline stimulates alpha2-adrenergic receptors, which leads to a narrowing of peripheral blood vessels, increases blood pressure, and dilates the pupils. Due to the vasoconstrictor effect, the drug reduces swelling, hyperemia, and exudation. Indications for use - acute rhinitis - allergic rhinitis - acute and chronic laryngitis - laryngeal edema of allergic origin - laryngeal edema due to irradiation - hyperemia and swelling of the mucous membranes of the upper respiratory tract after surgery - rhinoscopy Method of administration and dosage Nasal spray Adults 0.1% and 0.05% 1 injection into each nasal passage 1-2 times on day 2. Children 0.05% from 2 years to 6 years, 1 injection, from 6 to 15 years, 1 injection into each nasal passage 1-2 times a day. In case of swelling of the vocal cords, administer 1-2 ml of solution in the form of a spray or in small doses with a laryngeal syringe. As an adjuvant for superficial anesthesia - 2-4 drops per 1 ml of local anesthetic. The course of treatment is 5-6 days. Side effects - headache - increased blood pressure, tachycardia - nausea - irritation and reactive hyperemia of the mucous membrane - swelling of the mucous membrane (if used for more than 1 week), atrophic rhinitis Contraindications - children under 2 years of age (for 0.05% solution) - children under 12 years of age (for 0.1% solution) - arterial hypertension, tachycardia, severe atherosclerosis - severe eye diseases - hyperthyroidism - diabetes mellitus - chronic rhinitis - hypersensitivity to the components of the drug. - simultaneous use of MAO inhibitors (antidepressants) and a period of up to 14 days after the end of their use - angle-closure glaucoma Drug interactions Should not be used simultaneously with MAO inhibitors or within 10 days after the end of their use. Slows down the absorption of local anesthetic drugs (prolongs their effect during superficial anesthesia). Special instructions May have a resorptive effect. With prolonged use, the severity of the vasoconstrictor effect gradually decreases. With prolonged use, tolerance may develop. It is not recommended to use the drug for a long time without consulting a doctor. Pregnancy and lactation The use of the drug during pregnancy and lactation is possible only according to strict indications in cases where the expected therapeutic effect for the mother exceeds the potential risk of side effects in the fetus or child. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms Considering the side effects of the drug, care must be taken when driving vehicles or potentially dangerous mechanisms Overdose Symptoms - decreased body temperature, bradycardia, arterial hypertension Treatment - symptomatic Release form and packaging Spray: 0.05 % and 0.1% solution, 10 ml, 20 ml in bottles. 10 ml and 20 ml in high-density polyethylene bottles with a spray cap and a protective cap. The bottles, together with the appropriate number of instructions for use in the state and Russian languages, are placed in cardboard boxes, placing cardboard gaskets between the bottles. Storage conditions Store in a place protected from light, at a temperature not exceeding 30˚С. Keep out of the reach of children! Shelf life: 3 years After the expiration date, the medicinal product should not be used. Conditions for dispensing from pharmacies Without a prescription Name and address of the manufacturer: Pharmacia LLP 2010, Republic of Kazakhstan, 100019, Karaganda, st. Chkalova 7, tel. fax Name and country of the owner of the registration certificate Pharmacy 2010 LLP, Kazakhstan Name and country of the packaging organization Pharmacy 2010 LLP, Kazakhstan