Vicks active sinex

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VICKS ACTIVE SINEX (VICKS ACTIVE SINEX)

Composition:

Active substance: oxymetazoline hydrochloride;

1 ml of solution contains 0.5 mg of oxymetazoline hydrochloride;

Excipients: sodium citrate dihydrate, citric acid anhydrous, disodium edetate, polysorbate 80, benzalkonium chloride solution, benzyl alcohol, acesulfame potassium, sorbitol solution non-crystallizing (E 420), dry extract of aloe, eucalyptol, levomenthol, L-carvone, purified water.

Pharmaceutical form. Nasal spray.

Main physicochemical properties: clear colorless liquid or with a very faint yellowish tint, free from particles and suspended matter, which foams upon shaking.

Pharmacotherapeutic group. Decongestants and other agents for local use in nasal cavity disorders. Sympathomimetics. ATC code R01A A05.

Pharmacological properties.

Pharmacodynamics.

Oxymetazoline is a direct-acting sympathomimetic amine. It acts on α-adrenergic receptors of blood vessels in the nasal mucosa, causing vasoconstriction and reducing mucosal edema. Oxymetazoline constricts vessels at the site of application, reduces swelling of the nasal mucosa and upper respiratory tract. Reduction of nasal mucosal swelling promotes restoration of aeration of the paranasal sinuses and the middle ear cavity, thus preventing the development of bacterial complications.

Oxymetazoline exerts antiviral, anti-inflammatory, immunomodulatory, and antioxidant effects. Due to this combined mechanism of action, a faster and more effective reduction of nasal mucosal swelling caused by acute rhinitis has been demonstrated. The duration of the drug's effect is up to 12 hours.

Pharmacokinetics.

When applied topically to the nasal mucosa at therapeutic concentrations, it does not irritate the nasal mucosa or cause hyperemia. The elimination half-life is approximately 35 hours after administration. 2.1% of the drug is excreted by the kidneys, and about 1.1% is excreted in feces.

Clinical characteristics.

Indications.

Acute respiratory diseases accompanied by nasal congestion.

Allergic rhinitis.

Vasomotor rhinitis.

For restoration of drainage and nasal breathing in diseases of the nasal accessory sinuses, eustachitis.

For elimination of swelling prior to diagnostic procedures in the nasal passages.

Contraindications.

• Hypersensitivity to the active substance or to any of the excipients of the medicinal product;
• atrophic rhinitis;
• dry rhinitis;
• inflammation or damage of the nasal mucosa or skin around the nostrils;
• concomitant use of monoamine oxidase inhibitors (MAOIs) and within 2 weeks after discontinuation of MAOI therapy, as well as use of other medicinal products that may increase blood pressure;
• elevated intraocular pressure, especially closed-angle glaucoma;
• severe forms of cardiovascular diseases (e.g., ischemic heart disease, arterial hypertension);
• cardiac asthma;
• phaeochromocytoma;
• metabolic disorders (hyperthyroidism, diabetes mellitus, porphyria);
• patients after transsphenoidal hypophysectomy or other surgical interventions involving the dura mater;
• complicated urination due to enlarged prostate gland (prostatic hypertrophy).

Interaction with other medicinal products and other forms of interaction.

Do not use MAO inhibitors and other medicinal products with hypertensive effects due to the risk of increased blood pressure.

Concomitant use of other vasoconstrictive medicinal products increases the risk of adverse effects.

This medicinal product is known to interact with tricyclic antidepressants, which may manifest as an increased risk of arterial hypertension and arrhythmia.

The medicinal product should be used with caution in patients taking bromocriptine, as cardiovascular disorders may occur.

May reduce the effect of β-blockers or other antihypertensive agents, such as methyldopa, betanidine, debrisoquin, and guanethidine.

Special precautions for use.

Prolonged use and overdosing of the drug should be avoided. Prolonged use of a nasal decongestant may lead to diminished drug efficacy. Misuse of this product may cause atrophic rhinitis, mucosal atrophy, and reactive hyperemia with rebound congestion (rebound effect).

Special monitoring is required for patients with chronic rhinitis after administration of the drug. Doses higher than recommended should be used only under medical supervision.

If symptoms worsen or no improvement occurs within 3 days, medical advice must be sought.

Benzalkonium chloride contained in the drug may cause nasal mucosal swelling, especially with prolonged use. If such a reaction is suspected (persistent nasal congestion), a preservative-free medicinal product should be used. If a preservative-free product cannot be used, consideration should be given to switching to another dosage form.

Use during pregnancy or breastfeeding.

During pregnancy or breastfeeding, the drug should be used with particular caution, based on a careful benefit-risk assessment.

Recommended doses should not be exceeded.

Effect on ability to drive vehicles or operate machinery.

After prolonged use of the drug at doses exceeding the recommended levels, a systemic effect on the cardiovascular and nervous systems cannot be excluded. In such cases, the ability to drive vehicles or operate machinery may be impaired.

Dosage and Administration.

1 inhalation dose (50 µl) contains approximately 25 µg of oxymetazoline hydrochloride.

Adults and children aged 6 years and older: 1 spray into each nostril 2–3 times daily.

The drug should not be used for longer than 5–7 days. Do not exceed the recommended doses.

The drug may be used again only after several days.

Children.

The drug should not be used in children under 6 years of age.

Overdose.

After significant overdose or accidental ingestion, the following symptoms may occur: mydriasis, nausea, vomiting, cyanosis, elevated temperature, spasms, tachycardia, bradycardia, palpitations, arrhythmia, cardiovascular insufficiency, cardiac arrest, increased sweating, agitation, convulsions, arterial hypertension, pulmonary edema, respiratory disorders, pallor, miosis, hyposmia, psychiatric disorders, shock hypotension. Stimulation of the central nervous system may manifest as anxiety, excitement, hallucinations, and convulsions. In addition, depression of central nervous system function may occur, presenting as drowsiness, decreased body temperature, bradycardia, arterial hypotension, apnea, and possible progression to coma.

In children, overdose often leads to predominant central nervous system effects, including convulsions and coma, bradycardia, apnea, as well as arterial hypertension, which may follow an initial hypotensive phase.

Treatment: gastric lavage, administration of activated charcoal, lung ventilation. In case of decreased arterial pressure, phentolamine should be administered. Vasopressor agents should not be used. Anticonvulsant therapy, lung ventilation, and antipyretic measures may be required if necessary. Non-selective alpha-blockers may be used as an antidote.

Adverse reactions.

Immune system: hypersensitivity reactions, including rash, itching, angioedema.

Respiratory system: nasal discomfort, burning or dryness of the nasal mucosa, dryness and irritation in the mouth and throat, sneezing, nasal bleeding. After the effect of the medication wears off, a sensation of severe nasal congestion may occur (rebound hyperemia). Apnea in newborns and young children (especially in cases of overdose).

Eye disorders: eye irritation, redness, or discomfort.

Nervous system: headache, insomnia, anxiety, drowsiness, restlessness, tremor, sedative effect, irritability, seizures (mainly in children), hallucinations (especially in children), increased fatigue.

General disorders: rebound hyperemia, headache, nausea, exanthema, and visual disturbances.

Shelf life. 3 years.

Storage conditions. Store at a temperature not exceeding 25 °C, in a place inaccessible to children.

Packaging. 15 ml in a bottle with a spray device; 1 bottle per carton.

Availability. Over-the-counter (without prescription).

Manufacturer.

Procter & Gamble Manufacturing GmbH

Manufacturer's address and place of business.

Procter & Gamble Str. 1, 64521, Gross-Gerau, Hesse, Germany.