Composition
Per 1 ml: Active ingredient: Oxymetazoline hydrochloride-0.1 mgm Auxiliary substances: benzalkonium chloride-0.1 mg disodium edetate (Trilon B)Â – 0.5 m sodium hydroxide-up to pH 6.0-7.0 sodium dihydrogen phosphate dihydrate-1.29 m sodium hydrophosphate dodecahydrate-1.76 mg purified water-0.1 ml
Pharmacological action
Oxymetazoline belongs to the group of alpha-adrenostimulants for topical use. It has a vasoconstrictive effect. When administered intranasally, it reduces swelling of the upper respiratory tract mucosa and nasal discharge.
Restores nasal breathing. Elimination of edema of the nasal mucosa helps restore aeration of the paranasal sinuses of the nasal cavity, the middle ear cavity, which reduces the likelihood of bacterial complications (sinusitis, sinusitis, otitis media).
When applied topically intranasally in therapeutic concentrations, it does not irritate or cause hyperemia of the nasal mucosa. The drug begins to act quickly, within a few minutes. The duration of action of the drug is up to 12 hours.
Pharmacokinetics
When applied topically intranasally, oxymetazoline does not have a systemic effect. The half-life of oxymetazoline when administered intranasally is 35 hours. 2.1% of oxymetazoline is excreted in the urine and about 1.1% in the feces.
Indications
- Treatment of acute respiratory diseases accompanied by a runny nose;
- allergic rhinitis;
- vasomotor rhinitis;
- to restore drainage in case of inflammation of the paranasal sinuses, eustachiitis, otitis media;
- to eliminate edema before diagnostic manipulations in the nasal passages.
Contraindications
- Hypersensitivity to the components of the drug;
- atrophic (dry) rhinitis;
- taking monoamine oxidase inhibitors during the previous 2 weeks and within 2 weeks after their withdrawal;
- angle-closure glaucoma;
- dura mater surgery (in the anamnesis);
- condition after transsphenoidal pituitary surgery;
With caution
In patients with increased intraocular pressure, suffering from diseases of the cardiovascular system (arterial hypertension, ischemic heart disease, chronic heart failure, tachycardia, arrhythmias), carbohydrate metabolism disorders (diabetes mellitus), thyroid function disorders (hyperthyroidism), pheochromocytoma, chronic renal failure, prostatic hyperplasia (urinary retention), severe atherosclerosis, porphyria, pregnancy, lactation breast-feeding disorders, as well as patients taking tricyclic antidepressants and bromocriptine.
Side effects
Burning or dryness of the mucous membranes of the nasal cavity, dryness of the mucous membranes of the mouth and throat; sneezing; increased volume of secretions released from the nose, nosebleeds; after the effect of the drug passes, a strong feeling of “stuffy” nose (reactive hyperemia).
Side effects due to the systemic action of the drug: increased blood pressure, headache, dizziness, palpitation, tachycardia, anxiety, restlessness, fatigue, drowsiness, sedation, irritability, sleep disorders (in children), nausea, insomnia, exanthema, visual impairment (in contact with the eyes), hallucinations, angioedema, itching, convulsions, respiratory arrest (in infants). With prolonged use – tachyphylaxis, reactive hyperemia of the mucous membrane and atrophy of the nasal mucosa.
The preservative benzalkonium chloride, which is part of the drug, can cause swelling of the nasal mucosa. If this happens, you need to change the drug to another one that does not contain preservatives.
If you experience any of the side effects listed in the instructions or if they get worse, or if you notice any other side effects not listed in the instructions, tell your doctor.
Interaction
When used concomitantly with monoamine oxidase inhibitors (including a period of 14 days after their withdrawal), tricyclic antidepressants, or other drugs that contribute to an increase in blood pressure, an increase in blood pressure may occur. The drug slows down the absorption of local anesthetics, prolongs their effect.
Co-use of other vasoconstrictor drugs increases the risk of side effects.
If you are using the above or other medications (including over-the-counter medications), please consult your doctor before using Cialor ® reno.
How to take, course of use and dosage
Intranasally.
- Adults and children over 6 years of age: apply 1-2 drops of 0.05% solution in each nasal passage 2-3 times a day.
It is not recommended to use the drug for more than 7 days. With frequent and prolonged use of the drug, the feeling of “stuffy” nose may reappear or worsen. If these symptoms occur, you should stop treatment and consult a doctor.
Overdose
If the drug is accidentally taken orally or overdosed, the following symptoms may occur: anxiety, restlessness, hallucinations, convulsions, low body temperature, lethargy, drowsiness, coma, constriction or dilation of the pupils, fever, sweating, pallor, cyanosis, palpitation, bradycardia, arrhythmia, cardiac arrest, increased blood pressure, decreased blood pressure, nausea, vomiting, respiratory depression, respiratory arrest.
Treatment: symptomatic. In case of accidental ingestion-gastric lavage, taking activated charcoal. Vasopressor drugs are contraindicated.
Special instructions
At the recommended dose, do not use for more than 7 days without consulting a doctor. If symptoms worsen or do not improve within 3 days, you should consult your doctor. Avoid contact with eyes.
To avoid the spread of infection, it is necessary to use the drug individually. After opening, use within 14 days.
With prolonged use and overdose of oxymetazoline, the therapeutic effect may weaken, as well as the risk of reactive hyperemia (drug-induced rhinitis) and atrophy of the nasal mucosa increases.
Influence on the ability to drive vehicles and mechanisms
After long-term use of cold remedies containing oxymetazoline, in doses exceeding the recommended ones, it is impossible to exclude the overall effect on the cardiovascular system and central nervous system. In these cases, it is recommended to use caution when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.
Form of production
Nasal drops.
Active ingredient
Oxymetazoline
Dosage form
nasal drops
Description
Children’s forms
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Side effects of Sialor Rhino Renewal nasal drops 0.01% tube-dropper 1ml, 5pcs.
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