Drugs
Zvezdochka NOZ, this is xylometazoline hydrochloride in the form of a nasal spray 0.1%, used to relieve swelling of the nasal mucosa and facilitate new breathing in rhinitis
Composition
Active ingredient: xylometazoline hydrochloride 1,0 mg; Excipients: benzalkonium chloride 0.1 mg; sodium dihydrogen phosphate dihydrate 0.84 mg; disodium hydrogen phosphate dodecahydrate 1.5 mg; sodium chloride 1.0 mg; disodium edetate dihydrate 0.5 mg; purified water to 1.0 ml.
Indications / Application Notes
Acute allergic rhinitis; symptomatic therapy of acute respiratory diseases (ARI) with rhinitis (runny nose), sinusitis, hay fever; eustachitis, otitis media (to reduce swelling of the mucous membrane of the nasopharynx). Preparing the patient for diagnostic manipulations in the nasal passages.
Contraindications
Hypersensitivity to the components of the drug, arterial hypertension, tachycardia, severe atherosclerosis, glaucoma, atrophic rhinitis, surgical interventions on the meninges (history), the state after transsphenoid hypophysectomy, hyperthyroidism, pregnancy; simultaneous therapy with monoamine oxidase inhibitors and tri- and tetracyclic antidepressants (including the period of 14 days after their withdrawal), other local vasoconstrictors (decongestants) and other drugs that increase blood pressure; inflammatory diseases of the skin or mucous membrane of the vestibule of the nose, children's age (up to 6 years). Carefully: The period of breastfeeding, coronary heart disease (angina pectoris III - IV functional class), prostatic hyperplasia, diabetes mellitus, pheochromocytoma. Use with caution in case of hypersensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, and high blood pressure.
Mode of application
Intranasally. Adults and children over the age of 6 years: 1 injection in each nasal passage 3 times a day; should not be used more than 3 times a day. The duration of therapy is no more than 7 days without consulting a doctor. During the administration of the drug, the vial should be kept upright with the spray, and after injection it is recommended to take a light breath with the nose.
Side effects
Classification of the frequency of side effects (according to WHO recommendations): very often (1/10 or more), often (> 1/100 and <1/10), infrequently (> 1/1000 and <1/100), rarely (> 1/10000 and <1/1000), very rarely (<1/10000, including single messages). Local reactions: often - burning sensation at the site of use. Benzalkonium chloride, which is part of the drug, can cause irritation of the nasal mucosa and bronchospasm. On the part of the immune system: infrequently - hypersensitivity reactions (angioedema, skin rash, itching). From the gastrointestinal tract: rarely - vomiting. From the nervous system: often - nausea, rarely - headache, very rarely - anxiety, insomnia, fatigue, paresthesia, hallucinations and convulsions (mainly in children). Violations of the organ of vision: very rarely - blurred visual perception. From the cardiovascular system: rarely - palpitations, tachycardia, increased blood pressure; very rarely - arrhythmia. From the respiratory system: often - irritation and / or dryness of the nasal mucosa, burning, tingling in the nose, sneezing, hypersecretion of the mucous membrane of the nasopharynx; infrequently - increased swelling of the nasal mucosa (reactive hyperemia), nosebleeds. If the above symptoms occur, stop using the drug and consult a doctor.
Special instructions
Before use it’s recomended to clear the nasal passages. Before use, remove the protective cap of the metering pump. With a light touch of your fingers, do 2 test injections (not in the nose), and then do the injection in the nose in the quantity indicated in the section “Mode of application and doses”. After use, always cover the metering pump with a protective cap. Long-term (more than 7 days) use or chronic overdose of xylometazoline can cause a weakening of the therapeutic effect (tachyphylaxis), and also increases the risk of reactive hyperemia of the nasal mucosa (drug rhinitis) and atrophy of the nasal mucosa (ozena). The effect of a medicinal product for medical use on the ability to drive vehicles, mechanisms The drug does not affect the ability to drive vehicles or mechanisms. With prolonged use in excess of the recommended doses, the possibility of its systemic effect cannot be ruled out. In such cases, be careful.
Release form
Nasal spray 0.1% for 15 ml of the drug in a plastic bottle with a nebulizer and with a protective cap made of polyethylene. 1 plastic bottle together with instructions for medical use in a cardboard box.
Storage conditions
In a dark place at the temperature 15-30 °С. Keep out of the reach of children.
Shelf life
3 years
Manufacturer
DANAFA PHARMACY JOINT STOCK COMPANY st. Dung Xi Thanh The 253, Da Nang City, Vietnam