Sanetis®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SANEтIS® (SANETIS®)

Composition:

Active substance: oxymetazoline hydrochloride;

100 g of the preparation contain oxymetazoline hydrochloride, recalculated to 100% substance, 0.05 g;

Excipients: benzalkonium chloride, polyethylene glycol, disodium edetate, propylene glycol, povidone, sodium hydrogen phosphate dodecahydrate, potassium dihydrogen phosphate, purified water.

Pharmaceutical form. Nasal spray, metered.

Main physicochemical properties: the preparation is sprayed as an aerosol jet consisting of liquid particles dispersed in the air.

Pharmacotherapeutic group

Decongestants and other drugs for local use in nasal cavity disorders. Simple sympathomimetics. Oxymetazoline.

ATC code R01A A05.

Pharmacological Properties

Pharmacodynamics

Oxymetazoline hydrochloride is a synthetic adrenomimetic agent. By stimulating α-adrenergic receptors in blood vessels, it produces pronounced and prolonged vasoconstrictive effects. The vasoconstrictive action reduces blood flow, decreases swelling of the mucous membranes of the nose, paranasal sinuses, and Eustachian tube, thereby restoring nasal breathing impaired during influenza, colds, and allergic conditions.

Local vasoconstriction of the nasal and paranasal mucous membranes occurs within 5–10 minutes after intranasal administration of the drug. The anti-edema effect lasts up to 12 hours. The medicinal product exerts a soothing effect on the irritated nasal mucosa and protects it from excessive drying.

Pharmacokinetics

The elimination half-life of oxymetazoline hydrochloride is 5–8 hours. It is excreted mainly in unchanged form in urine and feces.

Clinical Characteristics

Indications. Use for symptomatic treatment of colds, influenza, allergic conditions (hay fever) accompanied by acute rhinitis, sinusitis (including frontal, ethmoidal), and other sinus infections; for treatment of acute otitis media.

Contraindications

Hypersensitivity to oxymetazoline, other adrenergic agents, or any excipients of the medicinal product; severe arterial hypertension, marked atherosclerosis, acute cardiovascular disorders or cardiac asthma, tachysystolic cardiac arrhythmias, angina pectoris, renal insufficiency, marked prostatic hyperplasia, pheochromocytoma, metabolic disorders (hyperthyroidism, diabetes mellitus), atrophic rhinitis, increased intraocular pressure, especially in angle-closure glaucoma, after transsphenoidal hypophysectomy or other surgical interventions involving opening of the dura mater; skin inflammation or injury in the nasal area or nasal mucosa; use of agents that increase blood pressure; concomitant use with monoamine oxidase inhibitors (MAOIs), or within 2 weeks after discontinuation of MAO inhibitor therapy.

Interaction with other medicinal products and other forms of interaction

Before using other medicinal products during treatment with oxymetazoline hydrochloride, consult a physician. Concurrent use with other vasoconstrictive agents (by any route of administration) or with other nasal decongestants, as well as with tricyclic antidepressants or maprotiline, should be done only after consulting a physician due to the potential for increased blood pressure.

Concomitant use of MAO inhibitors and oxymetazoline may lead to elevated blood pressure. Therefore, this medicinal product should not be used simultaneously with, or within 2 weeks after discontinuation of, MAO inhibitor therapy.

Concomitant use of oxymetazoline with tricyclic antidepressants may result in increased blood pressure and development of arrhythmias.

Oxymetazoline may reduce the effectiveness of β-adrenergic blockers, methyldopa, or other antihypertensive agents.

Concomitant use of sympathomimetic agents and antiparkinsonian drugs may result in additive toxic effects on the cardiovascular system.

Special precautions for use

When spraying into the nasal cavity, do not tilt the head back or invert the bottle. To avoid the spread of infection, it is not recommended that several individuals use the same bottle.

If nasal congestion does not resolve after three days of using the medicinal product, this may indicate the presence of a deviated nasal septum, purulent sinusitis, adenoids, allergic rhinitis, persistent bacterial infection, or other undiagnosed conditions requiring medical consultation and specialized comprehensive therapy.

Medical advice should be sought before starting treatment with this medicinal product in cases of high arterial pressure, cardiovascular disorders, liver or kidney impairment, or porphyria.

Prolonged use and overdosage of the product should be avoided. Long-term use of decongestants may lead to reduced effectiveness. Misuse of this product may cause atrophy of the mucous membrane and reactive hyperemia resulting in medicamentosa rhinitis, as well as damage to the mucosal epithelium and inhibition of epithelial activity. Doses higher than recommended should only be used under medical supervision. Recommended dosages must not be exceeded.

The medicinal product contains propylene glycol and benzalkonium chloride, which may cause skin reactions.

Use during pregnancy or breastfeeding

Treatment with oxymetazoline has not been associated with adverse pregnancy outcomes. The medicinal product should be used with caution in patients with hypertension or signs of reduced placental perfusion. Frequent or prolonged use of high doses may lead to decreased placental blood flow. The use of this medicinal product in pregnant women is only recommended if, in the physician’s opinion, the benefit to the mother outweighs the potential risk to the fetus/child.

It is unknown whether oxymetazoline is excreted in breast milk. Due to lack of data, oxymetazoline should not be used in women who are breastfeeding.

Ability to affect reaction speed when driving or operating machinery

With prolonged use of the medicinal product at doses exceeding the recommended levels, a systemic effect on the cardiovascular system cannot be ruled out. In such cases, the ability to drive or operate machinery may be impaired.

Dosage and Administration

For adults and children aged 12 years and older: administer 2 sprays per nostril; for children aged 6 to 12 years: 1 spray per nostril. The bottle should be held vertically. Repeat spraying no sooner than every 12 hours.

Duration of treatment — no more than 3 days. Prolonged use up to 7–10 days with 2 sprays per day is possible only under medical supervision.

Children. Should not be used in children under 6 years of age.

Overdose

When oxymetazoline is used locally, systemic adverse reactions usually do not occur.

Symptoms of oxymetazoline overdose vary. Stages of hyperexcitability and depression are distinguished. Stimulation of the central nervous system (CNS) clinically manifests as fear, agitation, hallucinations, and seizures.

Symptoms of moderate or severe overdose include: miosis (pupil constriction), mydriasis (pupil dilation), nausea, vomiting, cyanosis, fever, sweating, spasms, tachycardia, arrhythmia, cardiac arrest, elevated arterial pressure, pulmonary edema, dyspnea, physical discomfort.

Depression of central nervous system functions clinically manifests as drowsiness, decreased body temperature, bradycardia, arterial hypotension, collapse, shock, respiratory disturbances and respiratory arrest, loss of consciousness, coma.

Clinical manifestations of overdose in children include CNS symptoms: seizures and coma, hallucinations, bradycardia, apnea, hypertension changing to hypotension.

Emergency measures. In case of suspected oxymetazoline overdose, immediate hospitalization to an intensive care unit is required. Activated charcoal and laxatives should be administered. Gastric lavage should be performed. To reduce elevated arterial pressure, α-adrenergic blockers (phentolamine) should be administered. Vasopressor agents should not be administered to the patient. Anticonvulsant therapy may be required. In severe cases, endotracheal intubation and artificial ventilation of the lungs may be necessary.

Adverse Reactions

With frequent and prolonged use of the medicinal product, sensations of burning, tingling in the nose, sneezing, and dryness of the mucous membrane may occur. Rarely, after the effect of the drug has subsided, a feeling of severe nasal congestion may occur (reactive hyperemia). Prolonged continuous use of vasoconstrictive agents may lead to tachyphylaxis or development of drug-induced rhinitis. Generally, severe adverse effects are not expected.

Cardiovascular system. Very rarely: tachycardia, palpitations, increased blood pressure, chest pain.

Eye disorders. Rarely: eye irritation, discomfort or redness, blurred vision.

Gastrointestinal tract. Rarely: nausea.

Immune system. In isolated cases: hypersensitivity reactions, including rash, itching, Quincke's edema (angioedema).

Respiratory system, thoracic organs and mediastinum. Rarely: discomfort or irritation in the nose, mouth, and throat, as well as nasal bleeding.

Nervous system. Restlessness, nervousness, anxiety, insomnia, drowsiness, tremor, hallucinations (especially in children), increased fatigue, headache, dizziness.

Skin and subcutaneous tissue. Rash.

Musculoskeletal and connective tissue. Convulsions (especially in children).

General disorders. Weakness.

Reporting of adverse reactions after drug registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of this medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of drug efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging

10 g in a bottle with a spray pump. One bottle per carton.

Availability. Over-the-counter.

Manufacturer. Limited liability company "Micropharm".

Manufacturer's address. 20 Shevchenka Street, Kharkiv, Kharkiv region, Ukraine, 61013.

Marketing Authorization Holder. LLC "VALARTIN PHARMA".

Address of the Marketing Authorization Holder.
60 Hrushevskoho Street, Chayky, Kyiv-Sviatoshyn district, Kyiv region, Ukraine, 08135.