Sinumax

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SINUMAX

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.

Anti-edematous and other preparations for local use in nasal cavity disorders. Sympathomimetics, simple preparations. Oxymetazoline.

ATC code R01A A05.

Pharmacological Properties

Pharmacodynamics

Xylometazoline hydrochloride is a synthetic adrenomimetic agent. By stimulating vascular α-adrenergic receptors, it produces a pronounced and prolonged vasoconstrictive effect. The vasoconstriction reduces blood flow, thereby decreasing swelling of the mucous membranes of the nose, paranasal sinuses, and Eustachian tube. As a result, nasal breathing, impaired during influenza, colds, and allergic conditions, is restored.

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

Pharmacokinetics

The elimination half-life is 5–8 hours. The drug is excreted mainly in unchanged form in urine and feces.

Clinical characteristics.

Indications.

Symptomatic treatment of colds, influenza, and allergic conditions (hay fever) associated with acute rhinitis, sinusitis, including sinusitis maxillaris, and other sinus infections (frontitis, ethmoiditis); treatment of acute otitis media.

Contraindications.

Hypersensitivity to oxymetazoline, other adrenomimetics, or any component of the preparation; severe forms of arterial hypertension; pronounced atherosclerosis; acute cardiovascular disorders or cardiac asthma; tachyarrhythmias; 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; inflammation or damage to the skin of 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 MAOI therapy.

Interaction with other medicinal products and other forms of interaction.

Consult a physician before using other medicinal products at the start of treatment with this preparation. Concomitant use with other vasoconstrictors (by any route of administration) or with other nasal decongestants, as well as with tricyclic antidepressants or maprotiline, should be performed only after consultation with a physician due to the possible increase in blood pressure.

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

Concomitant use of oxymetazoline with tricyclic antidepressants may lead to increased blood pressure and development of arrhythmias.

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

Concomitant use of sympathomimetics and antiparkinsonian agents 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. It is not recommended for several individuals to use the same bottle to avoid the spread of infection.

Persistent nasal congestion after the third day of use may indicate the presence of nasal septum deviation, 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 use of this medicinal product in the following cases: elevated arterial pressure, cardiovascular disorders, hepatic or renal impairment, porphyria.

Prolonged use and overdosing of the product must be avoided. Long-term use of a decongestant may lead to diminished effectiveness. Misuse of this medicinal product may cause atrophy of the mucous membrane and reactive hyperemia resulting in drug-induced rhinitis, as well as damage to the mucosal epithelium and inhibition of epithelial activity. Doses higher than recommended should be used only under medical supervision. The recommended dosage must not be exceeded.

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

Use during pregnancy or breastfeeding.

Oxymetazoline has not been associated with adverse pregnancy outcomes. The medicinal product should be used with caution in patients with arterial hypertension or signs of reduced placental perfusion. Frequent or prolonged use of high doses may reduce placental blood flow. Use during pregnancy is possible only if, in the opinion of the physician, the expected 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 during breastfeeding.

Ability to influence reaction speed when driving or operating machinery.

After prolonged use of the 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 into each nostril; for children aged 6 to 12 years: 1 spray into each 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 at a dose of 2 sprays per day may be possible under medical supervision.

Children.

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

Overdose.

With topical application, systemic adverse reactions usually do not occur.

Symptoms of oxymetazoline overdose vary and include stages of hyperactivity and depression. Stimulation of the central nervous system (CNS) clinically manifests as fear, excitation, 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 blood pressure, pulmonary edema, dyspnea, and physical discomfort.

CNS depression clinically presents as drowsiness, decreased body temperature, bradycardia, arterial hypotension, collapse, shock, respiratory disturbances, respiratory arrest, loss of consciousness, and coma.

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

Emergency measures. In case of suspected oxymetazoline overdose, immediate hospitalization to an intensive care unit is required. Administer activated charcoal and laxatives. Gastric lavage is necessary. To reduce elevated blood pressure, prescribe α-adrenergic blockers (phentolamine). Vasopressors should not be administered. Anticonvulsant therapy may be indicated if necessary. In severe cases, endotracheal intubation and artificial ventilation of the lungs may be required.

Adverse reactions.

With frequent and prolonged use, sensations of burning, tingling in the nose, facial flushing, sneezing, and dryness of the mucous membrane may occur. Rarely, after the effect of the medication has worn off, 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, serious adverse effects are not expected.

Cardiovascular system. Very rarely, tachycardia, palpitations, increased arterial pressure, chest pain may occur.

Eye disorders. Rarely, eye irritation, discomfort, redness of the eyes, or blurred vision may occur.

Gastrointestinal system. Rarely, nausea may occur.

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

Respiratory, thoracic and mediastinal disorders. Rarely, discomfort or irritation in the nose, mouth, and throat, as well as nasal bleeding, may occur.

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

Skin and subcutaneous tissue disorders. Rash.

Musculoskeletal and connective tissue disorders. Muscle cramps (especially in children).

General disorders. Weakness.

Reporting suspected adverse reactions

Reporting of suspected adverse reactions after registration of the medicinal product is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: 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. 1 bottle per carton.

Supply category.

Over-the-counter (without prescription).

Manufacturer.

MICROFARM LLC.

Manufacturer's address and location of business activity.

20 Shevchenka St., Kharkiv, 61013, Ukraine.

Marketing Authorization Holder.

VALARTIN PHARMA LLC.

Address of the Marketing Authorization Holder.

60 Hrushevskoho St., Chayky, Kyiv-Sviatoshynskyi District, Kyiv Oblast, 08135, Ukraine.