Rinofliu (xylometazoline) nasal spray solution 0.05% 10 ml. vial

Description

Rinofliu (xylometazoline) nasal spray solution 0.05% 10 ml. vial

Composition

active substance: xylometazoline;

1 ml of solution contains 0.5 mg or 1 mg of xylometazoline hydrochloride;

auxiliary substances: eucalyptus oil; benzalkonium chloride (50% solution); sodium hydrogen phosphate, dodecahydrate; sodium dihydrogen phosphate, dihydrate; sorbitol (70% aqueous solution); sodium chloride; ethyl alcohol 96%; the water is purified.

Medicinal form

Nasal spray, solution.

Main physicochemical properties: transparent or slightly yellowish colorless liquid.

Pharmacotherapeutic group

Anti-edematous and other drugs for local use in diseases of the nasal cavity. Sympathomimetics, simple drugs.
ATX code R01A A07.

Pharmacological properties

Xylometazoline hydrochloride, a derivative of imidazole, is a sympathomimetic active substance with alpha-adrenergic action. The drug has a vasoconstrictive effect, thus reducing the swelling of the mucous membrane. The onset of action is usually observed in 5 – 10 minutes; the drug facilitates nasal breathing, reducing swelling of the mucous membrane and improving the excretion of secretions.
When administered nasally, the absorbed amount may sometimes be sufficient to cause systemic effects, ie manifestations of the central nervous system and cardiovascular system.

Indication

To reduce swelling of the nasal mucosa in acute rhinitis, episodes of profuse nasal discharge (vasomotor rhinitis) and allergic rhinitis (allergic rhinitis).
To facilitate the excretion of secretions in the case of paranasal sinusitis and inflammation of the mucous membrane of the middle ear in combination with a cold.

Contraindication:

• Hypersensitivity to the active substance of xylometazoline hydrochloride or to any of the excipients of the drug;
• dry inflammation of the nasal membrane with the formation of crusts (dry rhinitis);
• concomitant treatment with monoamine oxidase inhibitors (MAOIs), treatment with MAOIs for two weeks before the start of Rinoflu, concomitant treatment with other drugs capable of
  raise blood pressure;
• contraindicated after hypophysectomy or surgery on the dura mater;
• angle-closure glaucoma;
• acute coronary heart disease;
• coronary asthma;
• hyperthyroidism.

Due to the content of benzalkonium chloride used as a preservative, Rinoflu should not be used in case of hypersensitivity to this substance.

Method of application and dosage

Doses

The dose depends on the individual sensitivity of the patient and the clinical effect.

Unless otherwise prescribed, children aged 6 to 12 years are prescribed 1 injection of Rinoflu (0.05% nasal spray) in each nostril up to 3 times a day. Children over 12 years of age and adults are prescribed 1 injection of Rinoflu (0.1% nasal spray) in each nostril up to 3 times a day.

Application method

To use Rinofliu, a nasal spray, the protective cap should first be removed. Before the first use, press the dispenser several times until a uniform stream appears. The dosed spray is ready for further use. The tip of the cap should be inserted into the nostril and pressed once, then repeat the insertion into the other nostril. While spraying, you should inhale slightly through the nose.

Do not spray from top to bottom or at an angle. For reasons of hygiene, the sprayer should be wiped after each use and the protective cap should be put on.

Duration of treatment

The drug should not be used for more than 3-5 days, except when it is recommended by a doctor.

Repeated use should be started only after a break of several days and after consulting a doctor. The duration of treatment for children is determined by the doctor individually.

In the case of a chronic runny nose, the drug can be used only under the supervision of a doctor due to the risk of atrophy of the nasal mucosa.

Children

The drug Rinofliu 0.05% is intended for the treatment of children aged 6 to 12 years. Rinoflu 0.1% is intended for the treatment of adults and children over 12 years of age.

Overdose

When used nasally, systemic effects are unlikely due to local vasoconstriction, which inhibits absorption. In the case of systemic absorption, xylometazoline, as an α2-adrenergic agonist, can be expected to have a clonidine-like effect: a brief increase in blood pressure followed by prolonged hypotension and sedation.
Symptoms of intoxication with imidazole derivatives may be clinically unclear, as periods of stimulation may alternate with periods of central nervous system and cardiovascular depression.
Symptoms of central nervous system stimulation include anxiety, agitation, hallucinations, and convulsions.
Symptoms of central nervous system depression include fever, lethargy, drowsiness, and coma.
Additional symptoms are possible: miosis, mydriasis, sweating, nausea, cyanosis, fever, pale skin, tachycardia, bradycardia, cardiac arrest, hypertension, shock hypotension, pulmonary edema, respiratory distress and apnea.
Overdose, especially in children, can significantly affect the central nervous system, causing spasms, coma, bradycardia, apnea and hypertension, which can change to hypotension.

Side effects:

• Respiratory, thoracic and mediastinal disorders: Xylometazoline may cause temporary mild signs of irritation (burning or dryness of the nasal mucosa), especially in sensitive patients. reactive redness, nosebleeds, sneezing.
• Prolonged or frequent use of higher doses of xylometazoline hydrochloride may cause burning, tingling, itching, tenderness, dryness or irritation of the nasal mucosa, as well as reactive congestion and medical rhinitis. This effect may occur after 7 days of treatment and after prolonged use of the drug may be irreversible damage to the nasal mucosa with the formation of crusts (dry rhinitis).
• Occasionally, nausea, headache, and temporary visual disturbances may occur.
• There was a return of nasal congestion after discontinuation of treatment, in particular after prolonged use of xylometazoline.
• From the nervous system: headache, insomnia, fatigue.
• From the cardiovascular system: systemic effects of sympathomimetics (rapid heartbeat, rapid pulse, increased blood pressure).
• From the musculoskeletal system and connective tissue: convulsions, especially in children.
• From the immune system: hypersensitivity reactions (angioneurotic edema, rash, itching).