Nafazolin nasal drops 0.5mg/ml 10ml №1

Name:
Naphazolin 0.5% 10ml
Description:
Clear, colorless or yellowish solution. The main active ingredient is phazolin nitrate Form of release drops Dosage 10 ml Pharmacological properties Alpha-adrenergic agonist. Due to the ability to excite predominantly α-adrenergic receptors, it causes vasoconstriction and has anti-edematous properties. When applied to the mucous membranes of the nose, it constricts blood vessels at the site of application, as well as in the mucous membranes of the eyes and nasopharynx, reduces blood flow to the venous sinuses, reduces exudation and swelling of the mucous membranes, facilitates nasal breathing, and reduces tearing. Naphazoline is well tolerated even when applied to sensitive mucous membranes. Nafazolin does not affect the function of the ciliated epithelium. With local application, the vasoconstrictive effect occurs after 10 minutes and lasts for 2-6 hours. With long-term administration, the effectiveness of the naphazoline solution gradually decreases due to the development of tolerance. Resorption of the drug with topical application practically does not occur if all recommendations for use are observed. In case of accidental ingestion, significant levels of the drug in the gastrointestinal tract can be created. However, the first pass through the liver and the effect of monoamine oxidase reduce blood concentrations to negligible levels, except in cases of large ingestion of the drug by mouth in children (see section “Overdose”). Indications for use For short-term symptomatic treatment of nasal congestion in rhinitis, sinusitis, otitis media. Dosage and administration Adults and children over 12 years of age are prescribed a solution of 1.0 mg / ml, 2-4 drops in each nostril 2-3 times a day. The volume of 1 drop is approximately 0.03 ml (equivalent to 0.03 mg of naphazoline nitrate). Do not use more than 24 drops per day (about 0.7 mg of naphazoline nitrate). Children over 7 years of age are prescribed a solution of 0.5 mg / ml, 2-4 drops in each nostril 2-3 times a day. The volume of 1 drop is approximately 0.03 ml (equivalent to 0.015 mg of naphazoline nitrate). Do not use more than 24 drops per day (about 0.35 mg of naphazoline nitrate). The drug should not be used for more than 5 days in a row. If breathing becomes free, the drug can be stopped earlier. Re-starting the use is possible only a few days after the drug is discontinued. Long-term treatment may cause headaches, insomnia, palpitations, nausea, especially in children and the elderly. Dryness and irritation of the mucous membranes of the nose may also occur. Performing the instillation procedure Before using the drug and 5 minutes after its use, it is necessary to clear the nose. Remove the cap from the vial before use. Tilt your head back in a sitting position or lie down, gently insert the tip of the nozzle of the bottle turned upside down into one of the nostrils, drip the solution into each half of the nose, gently tilt your head from side to side several times. After use, clean the tip of the nozzle, close the vial with a cap. The vial should only be used by one patient due to the risk of infection transmission. If you have taken an overdose of the drug or accidentally swallowed the solution, you should seek the advice of your doctor or the nearest medical facility. If you miss the use of the drug, it is not allowed to use a double dose in order to compensate for the missed one. You should continue to use the drug according to the recommendations of the leaflet. Use during pregnancy and lactation Use during pregnancy and breastfeeding is not recommended due to the risk of accidental entry of naphazoline nitrate into the systemic circulation. The use of the drug during pregnancy and breastfeeding is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus and breastfeeding child. Before use, a doctor’s consultation is necessary. Precautions The drug Naphazoline, nasal drops 0.5 mg / ml, is contraindicated in children under 7 years of age. The drug Nafazolin, nasal drops 1.0 mg / ml, is contraindicated in children under 12 years of age. The duration of the drug in children should not exceed 5 days. Influence on the ability to drive vehicles and work with other moving mechanisms The drug does not affect or slightly affects the ability to drive vehicles and work with moving mechanisms. With prolonged use and / or use at a dose exceeding the recommended one, it is possible to develop manifestations of the systemic action of naphazoline on the part of the cardiovascular system and other undesirable reactions (see also sections “Side effect” and “Overdose”). When driving and / or working with moving mechanisms, as well as when planning such activities, one should take into account the possibility of developing undesirable reactions that may affect attention and coordination of movements. Interaction with other drugs Simultaneous use of the drug with MAO inhibitors or tricyclic antidepressants (and even several days after their use) may increase blood pressure. Naphazoline may enhance the effect of alpha-adrenergic stimulation when used in combination with other drugs that contain sympathomimetic amines or ?-blockers (especially non-selective ?1-blockers). Special instructions and precautions As a first-line treatment, it is recommended to flush the nose with saline. This medicinal product is recommended for use as a second-line treatment for a maximum of 5 consecutive days. It is not allowed to use this drug for prophylactic purposes. Do not swallow. It is necessary to avoid prolonged use and the use of excessive doses of the drug, especially in children and the elderly. Long-term use of drugs that reduce swelling of the nasal mucosa can lead to chronic edema and atrophy of the mucous membrane, the development of drug-induced rhinitis. Patients who use high doses of the drug should be under medical supervision due to the possible occurrence of cardiovascular and neurological adverse reactions (hypertension, arrhythmia, palpitations, headaches, dizziness, drowsiness, insomnia). If it is necessary to use a solution of naphazoline for a long time, it is necessary to interrupt treatment for several days every 5 days in order to avoid the development of tolerance. Caution is necessary with the simultaneous use of drugs that can increase blood pressure. Care must also be taken when performing general anesthesia with the use of anesthetics that increase the sensitivity of the myocardium to sympathomimetics (for example, halothane). When combined with MAO inhibitors, there is a risk of a sharp increase in blood pressure, so it is allowed to start using naphazoline no earlier than 15 days after stopping the use of MAO inhibitors. 1 ml of the drug contains 0.1 mg of benzalkonium chloride. Benzalkonium chloride may cause irritation and/or swelling of the nasal mucosa, especially with prolonged use. The composition of the drug includes boric acid and sodium tetraborate. One drop (0.03 ml) contains about 0.369 mg of boric acid (equivalent to 0.065 mg of boron) and about 0.015 mg of sodium tetraborate (equivalent to 0.003 mg of boron). Thus, in total, 1 drop contains about 0.068 mg of boron. Nasal drops 0.5 mg/ml and 1.0 mg/ml contain equal amounts of boric acid and sodium tetraborate per unit volume. The maximum recommended daily dose for children is 24 drops of the drug 0.5 mg / ml, for adults – 24 drops of the drug 1 mg / ml. 24 drops contain about 1.632 mg of boron. Fertility, pregnancy and lactation Use during pregnancy and breastfeeding is not recommended due to the risk of accidental entry of naphazoline nitrate into the systemic circulation. The use of the drug during pregnancy and breastfeeding is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus and breastfeeding child. Before use, a doctor’s consultation is necessary. Contraindications Nafazolin, nasal drops 0.5 mg/ml: children under 7 years of age. Nafazolin, nasal drops 1.0 mg / ml: children under 12 years of age. Known individual hypersensitivity to the active substance and / or to any of the excipients that make up the medicinal product. Severe diseases of the cardiovascular system (arterial hypertension, coronary heart disease, severe atherosclerosis, arrhythmias). Metabolic disorders (diabetes mellitus, increased thyroid function). Severe eye diseases, angle-closure glaucoma. Tumor of the adrenal glands (pheochromocytoma). Bronchial asthma. Simultaneous reception of MAO inhibitors and a period of up to 15 days after the end of their use. Chronic rhinitis. atrophic rhinitis. Conditions after transsphenoidal hypophysectomy or other surgical procedures that may have resulted in damage to the dura mater. Composition 1 ml of the drug contains 0.5 mg or 1.0 mg of naphazoline nitrate as an active substance. Excipients: boric acid, sodium tetraborate, benzalkonium chloride, sodium chloride, disodium edetate, purified water. OverdoseChildren Rare cases of intoxication have been reported in children after accidental ingestion or topical application of too high doses. The toxic dose is 0.5 mg/10 kg body weight (single dose administration). Symptoms: early – bradycardia and cardiac arrhythmias, less often – tachycardia, increased blood pressure. In severe overdose, hypothermia, sweating, loss of consciousness, coma or respiratory depression may develop. Adults Cases of overdose are not registered. Treatment In case of overdose, stop using the drug and consult a doctor immediately. If necessary, emergency therapy is carried out in a specialized department of the hospital, ensuring that adequate respiratory function is maintained. Activated charcoal can be taken as an emergency first aid. Side effects Undesirable reactions that may occur when using the drug are classified by frequency of occurrence and by organ systems. The frequency of occurrence of side effects is estimated according to the following scheme: very often (? 1/10); often (?1/100 to <1/10); infrequently (?1/1000 to <1/100); rarely (?1/10000 to <1/1000); very rarely (< 1/10000); unknown (frequency cannot be estimated from the available data). Nervous system disorders: rarely - headache, insomnia, fatigue. Cardiac disorders: infrequently - palpitations, rapid pulse; very rarely - arrhythmia. Vascular disorders: infrequently - increased blood pressure. General disorders and disorders at the injection site: often - burning and dryness of the nasal mucosa, after the termination of the action of naphazoline - an increase in the feeling of "nasal congestion" caused by reactive hyperemia; infrequently - nosebleeds. Immune system disorders', infrequently - allergic reactions (Quincke's edema, urticaria, itching). Prolonged or frequent use or the use of high doses of naphazoline may cause burning or dryness of the mucous membranes, as well as secondary (reactive) drug-induced rhinitis, which may occur after using naphazoline for more than 5 days. With prolonged use of naphazoline, damage to the epithelium of the mucous membrane may develop with inhibition of the activity of ciliary transport. In some cases, irreversible damage and dryness of the mucous membrane develop, which are characteristic of atrophic rhinitis. If side effects occur, you should consult your doctor about the advisability of further use of the drug. Reporting adverse reactions If you experience any adverse reactions, it is recommended that you consult your doctor. This recommendation applies to any possible adverse reactions, including those not listed in the package insert for the use of the medicinal product. You can also report adverse reactions to the Adverse Drug Reactions Information Database. By reporting adverse reactions, you help to get more information about the safety of the medicine. In addition, you can report the ineffectiveness of the drug. Storage conditions Store in a place protected from light at a temperature of 15 ° C to 25 ° C. Keep out of the reach of children. Buy Nafazolin nasal drops 0.5 mg/ml 10ml No. 1