Instructions Naphthyzin nasal drops 0.1% bottle 10 ml
Composition
active ingredient: naphazoline;
1 ml of the drug contains naphazoline nitrate 0.5 mg or 1 mg;
excipients: boric acid, purified water.
Dosage form
Nasal drops.
Main physicochemical properties: clear, colorless or slightly yellowish liquid.
Pharmacotherapeutic group
Anti-edematous and other drugs for local use in diseases of the nasal cavity. Sympathomimetics. ATX code R01A A08.
Pharmacological properties
Pharmacodynamics
Naphthyzin® has a pronounced vasoconstrictive effect on peripheral vessels due to its effect on α-adrenoreceptors. When applied to mucous membranes, it reduces edema, hyperemia, and exudation, which facilitates nasal breathing in rhinitis. Naphazoline helps open and dilate the outflow ducts of the paranasal sinuses and Eustachian tubes, which improves the outflow of secretions and prevents the deposition of bacteria.
Pharmacokinetics
The therapeutic effect occurs within 5 minutes and lasts 4–6 hours when administered intranasally.
Indication
Acute rhinitis. As an adjuvant for inflammation of the paranasal sinuses and middle ear.
To reduce mucosal swelling during diagnostic procedures.
Contraindication
Hypersensitivity to any components of the drug.
Dry inflammation of the nasal mucosa.
Interaction with other medicinal products and other types of interactions
The use of Naphthyzin® simultaneously with monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, maprotiline or within a few days after their withdrawal may cause an increase in blood pressure.
Application features
The drug should be used with great caution in severe diseases of the cardiovascular system (arterial hypertension, ischemic heart disease), diabetes mellitus, hyperthyroidism, pheochromocytoma, concomitant use of MAO inhibitors or other drugs that may have a hypertensive effect. Caution is required during general anesthesia with the use of anesthetics that increase the sensitivity of the myocardium to sympathomimetics (e.g. halothane), as well as in bronchial asthma.
When using high doses of the drug, the development of such side effects from the cardiovascular and nervous systems as palpitations, arterial hypertension, arrhythmia, headache, dizziness, drowsiness or insomnia is possible.
It is important to avoid long-term use and overdose, especially in children. Long-term use of medications intended to relieve nasal congestion can lead to nasal congestion and subsequent atrophy of the nasal mucosa.
Ability to influence reaction speed when driving vehicles or other mechanisms
The use of the drug Naphthyzin® in recommended doses does not affect the ability to drive vehicles or operate machinery. If the recommended doses are exceeded, dizziness and drowsiness are possible.
Use during pregnancy or breastfeeding
There is no data on the ability of naphazoline to penetrate the placental barrier or into breast milk. Therefore, before prescribing the drug to women during pregnancy or breastfeeding, all possible risks and benefits of treatment should be carefully considered and the drug should be prescribed only if absolutely necessary.
Method of administration and doses
Naphthyzin® is instilled into each nasal passage, tilting the head back slightly and tilting it to the right when instilling into the right nostril and to the left when instilling into the left nostril.
For therapeutic purposes. Adults and children over 15 years of age – 1–3 drops of 0.05%–0.1% solution in each nasal passage.
Children aged 3–6 years are instilled with a 0.05% solution, 1–2 drops in each nasal passage;
children aged 6–15 years – 2 drops in each nasal passage.
Naphthyzin® should be used 3 times a day, but not more often than every 4 hours.
Naphthyzin® should not be used for more than 5 days in adults and more than 3 days in children.
Naphthyzin® can be used again only after a few days.
In case of nosebleeds, use tampons moistened with a 0.05% solution of the drug.
For diagnostic purposes (e.g., for the diagnosis and treatment of nasal polyps). After cleaning the nasal cavity, instill 3–4 drops of a 0.05%–0.1% solution into each nasal passage or insert a swab moistened with a 0.05%–0.1% solution for 2–3 minutes.
In case of vocal cord swelling, inject 1–2 ml of the drug with a laryngeal syringe.
Children
Children aged 3 to 15 years can use Naphthyzin® 0.05%.
Children over 15 years of age can use Naphthyzin® 0.1%.
Overdose
The depressing effect on the central nervous system is manifested by symptoms such as decreased body temperature; bradycardia; increased sweating; drowsiness; shock similar to hypotensive; apnea; coma. The risk of overdose increases in children, who are more vulnerable to negative effects than adults.
Treatment is symptomatic.
Adverse reactions
When used in recommended doses, Naphthyzin® is usually well tolerated. In patients with hypersensitivity, the drug may occasionally cause burning and dryness of the nasal mucosa. In isolated cases, a feeling of severe nasal congestion may occur.
Only in rare cases does a systemic side effect occur (most often with overdose):
from the immune system: allergic reactions, including Quincke's edema, burning;
from the nervous system: nervousness, headache, tremor;
from the side of the cardiac system: tachycardia, palpitations;
from the vascular system: arterial hypertension;
Skin and subcutaneous tissue disorders: increased sweating.
Prolonged (more than 5 days for adults and more than 3 days for children) or frequent use of the drug may lead to addiction, accompanied by intense swelling of the nasal mucosa, which occurs in a relatively short period of time after use. Long-term use of the drug may lead to damage to the mucosal epithelium, inhibition of the activity of the epithelial cilia and cause irreversible damage to the mucosa and the development of dry rhinitis.
Expiration date
3 years.
After opening the bottle, the shelf life of the drug is 28 days.
Do not fasten the drug after closing the heat resistance indicated on the package.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
10 ml in a glass bottle. 1 bottle in a pack.
Vacation category
Without a prescription.
Producer
PJSC "Farmak".
Location of the manufacturer and its business address
Ukraine, 04080, Kyiv, Frunze St., 74.
