Freenosol, spray 15 ml

A combined anti-allergic agent (H₁-histamine receptor blocker + alpha-adrenomimetic).

ATX code

R01AB01

Pharmacological action

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Pharmacodynamics

Pharmacodynamics

Combined drug for local intranasal use for pathogenetic and symptomatic treatment with vasoconstrictor and anti-allergic action.

Phenylephrine is an alpha 1-adrenergic receptor agonist (sympathomimetic), causes narrowing of blood vessels of the nasal cavity mucosa, reduces mucosal edema and tissue hyperemia, congestion in the nasal mucosa. Restoration of nasopharyngeal air permeability improves the patient’s well-being and reduces the risk of possible complications caused by mucous secretion stasis.

Cetirizine is a blocker of H1-histamine receptors, it has anti-allergic activity, reduces capillary permeability, prevents development of edema of the mucous membrane of the nasal cavity and its accessory sinuses.

The drug contains an auxiliary humectant glycerol which promotes moisture retention and helps provide hydration in case of dryness and irritation of the nasal mucosa.

Pharmacokinetics

The drug is intended for topical intranasal use and its activity is independent of plasma concentrations of active ingredients.

Indications

• acute rhinitis (including “colds” diseases);
• allergic rhinitis (including hay fever);
• vasomotor rhinitis;
• chronic rhinitis;
• acute and chronic sinusitis;
• preparation for nasal surgery and liquidation of edema of mucous membrane of nasal cavity and sinuses after surgical interventions in this area.

Active ingredient

Phenylephrine, Cetirizine

Composition

1 ml of the preparation contains:
active ingredients: phenylephrine hydrochloride – 2.5 mg, cetirizine dihydrochloride – 2.5 mg;
excipients: glycerol – 40.0 mg, sodium hydrophosphate (anhydrous) – 2.5 mg, potassium dihydrophosphate – 1.5 mg, edetate disodium – 0.2 mg, benzalkonium chloride solution 50% – 0.1 mg in terms of 100%, purified water – up to 1 ml.

How to take, the dosage

Intranasally.

In adults, the recommended daily dose is 1-2 injections into each nasal passage 2-3 times a day.

The drug should not be used continuously for more than 7 days.

The bottle should be held vertically with the sprayer up. Tilt your head, insert the tip of the bottle into your nasal passage and press the sprayer briefly and sharply once. During injection, it is recommended that you breathe in through your nose lightly.

The nasal passages should be thoroughly cleaned before injecting.

Interaction

The drug should not be used concomitantly with tri- and tetracyclic antidepressants, beta-adrenoblockers, monoamine oxidase inhibitors (procarbazine, selegiline), maptiline, guanedrel, guanethidine. Thyroid hormones with systemic absorption of phenylephrine increase (mutually) the associated risk of coronary artery disease (especially in coronary atherosclerosis).

Special Instructions

The drug should not be used continuously for more than 7 days. Prolonged or excessive use of the drug may cause tachyphylaxis and a “ricochet” effect associated with recurrent development of nasal congestion (medically-induced rhinitis), leading to development of systemic vasoconstrictor action.

As with other vasoconstrictors, the recommended doses of the drug should not be exceeded. Otherwise, the development of systemic effects of the drug is possible, especially in elderly patients.

Phenylephrine should not be used in patients for 2 weeks after withdrawal of monoamine oxidase inhibitors, because they may increase the adrenergic effects of sympathomimetic agents and increase the risk of cardiovascular side effects.

The drug is for topical intranasal use only.

Influence on driving and operating ability

Cautiousness should be exercised when driving vehicles and operating machinery as well as performing other activities requiring concentration and quick psychomotor reactions, as there is a possibility of dizziness when using the drug.

Synopsis

Transparent colorless or light yellow solution.

Contraindications

• hypersensitivity to phenylephrine, cetirizine or other drug components;
• atrophic rhinitis;
• taking monoamine oxidase inhibitors (concomitantly or in the previous 14 days);
• closed angle glaucoma;
• children under 18 years of age (no data on efficacy or safety in children);
• pregnancy, breastfeeding period.

Cautions

• hyperthyroidism;
• adenoma of the prostate;
• chronic renal failure;
older age;
• patients with increased seizure activity;
• stenocardia;
• diabetes mellitus;
• bladder neck obstruction (e.g., due to prostate hypertrophy);
• epilepsy;
• patients with significant reactions to sympathomimetics manifested by insomnia, dizziness, tremor, cardiac arrhythmia, or increased blood pressure (as with any topical vasoconstrictors).

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Side effects

Cetirizine in combination with phenylephrine spray in therapeutic doses is well tolerated, but the following side effects may occur.

The frequency of side effects is classified according to the recommendations of the World Health Organization (WHO):

very often ≥ 1/10;

often from ≥ 1/100 to < 1/10;

infrequently from ≥ 1/1000 to < 1/100;

rarely from ≥ 1/10000 to < 1/1000;

very rarely < 1/10000, including individual reports;

frequency unknown – it is not possible to determine the frequency of occurrence from the available data.

Blood and lymphatic system disorders:

very rare: thrombocytopenia.

Disorders of the immune system:

really: hypersensitivity reactions;

very rarely: anaphylactic shock.

Metabolic and nutritional disorders:

frequency unknown: increased appetite.

Psychiatric disorders:

infrequent – agitation;

rare – aggression, confusion, depression, hallucinations, sleep disturbance;

very rare – tics;

frequency unknown – suicidal ideation, sleep disturbances (including nightmares).

Nervous system disorders:

infrequent – paresthesias;

rare – seizures;

very rare – perversion of taste, dyskinesia, dystonia, syncope, tremor;

frequency unknown-headache, dizziness, memory impairment, including amnesia;

frequency unknown-headache, dizziness, memory impairment, including amnesia.including amnesia, deafness.

Visual disorders:

very rarely – accommodation disorder, blurred vision, nystagmus;

frequency unknown – vasculitis.

Hearing and labyrinth disorders:

frequency unknown – vertigo.

Cardiac disorders:

rarely – tachycardia;

frequency unknown – arrhythmia.

vascular disorders:

frequency unknown – increase in blood pressure.

Gastrointestinal disorders:

infrequent – diarrhea.

Hepatic and biliary tract disorders:

rarely – hepatic failure with changes in functional liver function tests (increased activity of transaminases, alkaline phosphatase, gamma-glutamyltransferase and bilirubin).

Dermatological and subcutaneous tissue disorders:

infrequent – rash, itching;

rare – urticaria;

very rare – angioedema, persistent erythema drug.

Muscle, skeletal and connective tissue disorders:

frequency unknown: arthralgia.

Renal and urinary tract disorders:

very rare: dysuria;

frequency unknown: urinary retention.

General disorders and reactions at the site of administration:

infrequent: asthenia, malaise;

rare: nasal discomfort, dryness or burning in the nose, tingling, sneezing; nasal bleeding. Benzalkonium chloride, which is part of the drug, may cause irritation of the nasal mucosa;

incidence unknown – swelling and hyperemia of the nasal mucosa, mucous and watery nasal discharge, difficulty in nasal breathing.

Overdose

The extremely low systemic absorption of the drug when administered topically makes overdose almost impossible.

Symptoms

In an accidental single oral dose of 50 mg of cetirizine, there may be: Confusion, diarrhea, dizziness, increased fatigue, headache, malaise, mydriasis, itching, restlessness, weakness, sedation, drowsiness, stupor, tachycardia, tremor, urinary retention.

Phenylephrine overdose may manifest as abnormal heart rhythm, increased blood pressure, and agitation.

Treatment

Gastric lavage or vomiting stimulation, administration of activated charcoal, taking plenty of fluids; supportive and symptomatic therapy. There is no specific antidote. Hemodialysis is ineffective. In case of overdose it is necessary to consult a physician.

Pregnancy use

Due to the lack of data, the use of the drug is contraindicated in pregnancy and during breast-feeding.