Frinozol nasal spray, 15ml

Composition

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1 ml of the drug contains: active ingredients: phenylephrine hcl is a 2.5 mg, cetirizine dihydrochloride 2.5 mg;excipients: glycerol – 40,0 mg, sodium hydrogen phosphate (anhydrous) 2.5 mg, potassium dihydrogen phosphate 1.5 mg, disodium edetate – 0.2 mg benzalkonium chloride solution 50% – 0.1 mg in terms of 100%, purified water – up to 1 ml.

Pharmacological action

Anti-allergic agent combined (_H1-histamine receptor blocker + alpha-adrenomimetic).

ATX

code

R01AB01 Pharmacological action

Pharmacodynamics

Pharmacodynamics

A combined drug for local intranasal use for pathogenetic and symptomatic treatment, which has a vasoconstrictor and anti-allergic effect.

Phenylephrine is an agonist of alpha-1-adrenergic receptors (sympathomimetic), causes narrowing of blood vessels of the nasal mucosa, reduces swelling of the mucous membranes and tissue hyperemia, congestion in the nasal mucosa. Restoration of nasopharyngeal air patency improves the patient’s well-being and reduces the risk of possible complications caused by stagnation of mucosal secretions.

Cetirizine is a blocker of H1-histamine receptors, has an anti-allergic effect, reduces capillary permeability, and prevents the development of edema of the nasal mucosa and its paranasal sinuses.

The composition of the preparation includes an auxiliary moisturizing substance glycerol, which helps to retain moisture, which helps to provide moisture when the nasal mucosa is dry and irritated.

Pharmacokinetics

The drug is intended for local intranasal use, and its activity does not depend on the concentration of active substances in the blood plasma.

Indications

• acute rhinitis (including the “common cold” diseases);
• allergic rhinitis (including hay fever);
• vasomotor rhinitis;
• chronic rhinitis;
• acute and chronic sinusitis,
• acute otitis media (as an auxiliary method of treatment);
• preparation for surgical interventions in the nasal area and elimination of edema of the mucous membrane of the nasal cavity and paranasal sinuses after surgery in this area.

Use during pregnancy and lactation

Due to the lack of data, the use of the drug is contraindicated during pregnancy and lactation.

Contraindications

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

With care

• cardiovascular disease, including hypertension, arrhythmia, generalized atherosclerosis;
• hyperthyroidism;
• benign prostatic hyperplasia;
• chronic renal failure;
• elderly age;
• patients with increased seizure activity;
• angina;
• diabetes mellitus;
• obstruction of the bladder neck (for example, due to prostatic hypertrophy);
• epilepsy;
• patients with severe reactions to sympathomimetics, manifested in the form of insomnia, dizziness, tremor, cardiac arrhythmia or high blood pressure (as in the case of the use of any local vasoconstrictor).

Side effects

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

Classification of the frequency of side effects according to the recommendations of the World Health Organization (WHO):

very common ≥ 1/10;

common ≥ 1/100 to < 1/10;

uncommon ≥ 1/1000 to < 1/100;

rare ≥ 1/10000 to < 1/1000;

very rare < 1/10000, including individual reports;

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

Disorders of the blood and lymphatic system:

very rare: thrombocytopenia.

Immune system disorders:

rare: hypersensitivity reactions;

very rare: anaphylactic shock.

Metabolic and nutritional disorders:

frequency unknown-increased appetite.

Mental disorders:

infrequently-agitation;

rarely-aggression, confusion, depression, hallucinations, sleep disorders;

very rarely-tic;

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

Nervous system disorders:

infrequently-paresthesia;

rarely-convulsions;

very rarely-taste distortion, dyskinesia, dystonia, syncope, tremor;

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

Visual disturbances:

very rarely-accommodation disorders, blurred vision, nystagmus;

frequency unknown-vasculitis.

Hearing and labyrinth disorders:

frequency unknown-vertigo.

Cardiac disorders:

rarely-tachycardia;

frequency unknown-arrhythmia.

Vascular disorders:

frequency unknown-increased blood pressure.

Gastrointestinal disorders:

infrequently – diarrhea.

Liver and biliary tract disorders:

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

Skin and subcutaneous tissue disorders:

infrequently-rash, pruritus;

rarely-urticaria;

very rarely-angioedema, persistent drug-induced erythema.

Musculoskeletal and connective tissue disorders:

frequency unknown: arthralgia.

Kidney and urinary tract disorders:

very rare: dysuria;

frequency unknown: urinary retention.

General disorders and reactions at the injectionsite:

infrequently-asthenia, malaise;

rarely-discomfort in the nose, dry or burning in the nose, tingling, sneezing; nosebleeds. Benzalkonium chloride, which is part of the drug, can cause irritation of the nasal mucosa;

the frequency is unknown-swelling and hyperemia of the nasal mucosa, mucous and watery discharge from the nose, difficulty in nasal breathing.

Interaction

Do not use the drug simultaneously with tri – and tetracyclic antidepressants, beta-blockers, monoamine oxidase inhibitors (procarbazine, selegiline), maprotilin, guanedrel, guanethidine. Thyroid hormones with systemic absorption of phenylephrine increase the (mutually) associated risk of coronary insufficiency (especially in coronary atherosclerosis).

How to take, course of use and dosage

Intranasally.

For adults, the recommended daily dose is 1-2 injections in 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, sprayed upwards. Tilt your head, insert the tip of the bottle into the nasal passage, and press the nebulizer 1 time with a short, sharp movement. During injection, it is recommended to take a light breath through the nose.

Before use of the drug, the nasal passages should be thoroughly cleaned.

Overdose

Extremely low systemic absorption of the drug when applied topically makes overdose almost impossible.

Symptoms

In case of accidental single oral use of cetirizine at a dose of 50 mg, the following symptoms may occur: confusion, diarrhea, dizziness, fatigue, headache, malaise, mydriasis, itching, restlessness, weakness, sedation, drowsiness, stupor, tachycardia, tremor, and urinary retention.

An overdose of phenylephrine can be manifested by cardiac arrhythmias, increased blood pressure, and agitation.

Treatment

Gastric lavage or stimulation of vomiting, use of activated charcoal, intake of large amounts of fluids; maintenance and symptomatic therapy. There is no specific antidote. Hemodialysis is ineffective. In case of overdose, you should consult a doctor.

Description

Transparent colorless or light yellow solution.

Special instructions

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

As with other vasoconstrictors, do not exceed the recommended dose of the drug. Otherwise, it is possible to develop manifestations of systemic action of the drug, especially in elderly patients.

Phenylephrine should not be used in patients within 2 weeks after discontinuation of monoamine oxidase inhibitors, as they may increase the severity of the adrenergic effects of sympathomimetic agents and increase the risk of side effects from the cardiovascular system.

The drug is intended only for local intranasal use.

Influence on the ability to drive vehicles and mechanisms

Caution should be exercised when driving vehicles and mechanisms, as well as performing other activities that require concentration of attention and speed of psychomotor reactions, since when using the drug, there is a possibility of dizziness.

Form of production

Nasal spray.

15 ml in a plastic (low-pressure polyethylene) bottle with a nasal spray.

Each bottle together with the instructions for use in a pack of cardboard.

Storage conditions

Store in a dark place at a temperature not exceeding 25 C. Keep out of reach of children.

Shelf

life is 2 years. Do not use after the expiration date.

Active ingredient

: Phenylephrine, Cetirizine

Dosage form

Capsules