Loratek

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT LORATEK®

Composition:

Active substance: oxymetazoline hydrochloride;

100 g of the preparation contains oxymetazoline hydrochloride equivalent 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 dispersed as an aerosol jet consisting of fine liquid droplets suspended in air.

Pharmacotherapeutic group.
Anti-edematous and other agents 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 vascular α-adrenergic receptors, it induces pronounced and prolonged vasoconstrictive effects. The vasoconstriction 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 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 unchanged in urine and feces.

Clinical characteristics.

Indications.

Symptomatic treatment of colds, influenza, allergic conditions (hay fever), accompanied by acute rhinitis, sinusitis, including maxillary sinusitis and other types of sinusitis (frontitis, ethmoiditis); treatment of acute otitis media.

Contraindications.

Hypersensitivity to oxymetazoline, other adrenomimetics, or any component of the drug; severe forms of arterial hypertension; marked atherosclerosis; acute cardiovascular disorders or cardiac asthma; tachyarrhythmias; angina pectoris; renal insufficiency; marked benign prostatic hyperplasia; pheochromocytoma; metabolic disorders (hyperthyroidism, diabetes mellitus); atrophic rhinitis; increased intraocular pressure, especially in closed-angle glaucoma; following transsphenoidal hypophysectomy or other surgical interventions involving opening of the dura mater; skin inflammation or injury around nasal passages or nasal mucosa; use of agents that increase blood pressure; concomitant use with monoamine oxidase inhibitors (MAOIs), as well as within 2 weeks after discontinuation of MAOI therapy.

Interaction with other medicinal products and other types of interactions.

Prior to using other medicinal products, consultation with a physician is recommended. Concomitant use of this drug with other vasoconstrictive agents (regardless of route of administration), other nasal decongestants, tricyclic antidepressants, or mianserin should only be performed after consultation with 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 must not be used simultaneously with MAO inhibitors or within 2 weeks after discontinuation of MAOI 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 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 that several individuals use the same bottle to avoid the spread of infection.

Persistent nasal congestion after the third day of treatment 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.

Consult a physician before starting use of this medication in the following cases: high blood pressure, cardiovascular diseases, liver or kidney disorders, porphyria.

Prolonged use and overdosing 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 medication-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. Do not exceed the recommended dosage.

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. It should be used with caution in patients with 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 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 during breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

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

Method of Administration and Dosage.

For adults and children aged 12 years and older: 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 should not be performed earlier 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 is possible only 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. Stages of hyperexcitability and depression may be observed. Stimulation of the central nervous system (CNS) clinically manifests as fear, agitation, hallucinations, and seizures.

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

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

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

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

Side effects.

With frequent and prolonged use, sensations of burning, tingling in the nose, nasal congestion, sneezing, and dryness of the mucous membrane may occur. Rarely, after the effect of the medication wears off, a sensation 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 arterial pressure, chest pain.

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

Gastrointestinal disorders. Rarely: nausea.

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

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

Nervous system disorders. 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. Cramps (especially in children).

General disorders. Weakness.

Reporting of adverse reactions after drug registration is of great importance. It enables continuous 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 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 spray dispenser. 1 bottle per carton.

Supply category.

Over-the-counter (without prescription).

Manufacturer.

LLC "Micropharm".

Manufacturer's address and location of business activity.

20 Shevchenka Street, Kharkiv, Ukraine, 61013.

Marketing Authorization Holder.

LLC "VALARTIN PHARMA".

Address of the Marketing Authorization Holder.

60 Hrushevskoho Street, Chayky, Kyiv-Sviatoshynskyi district, Kyiv region, Ukraine, 08135.