Frinosol spray, 15 ml

• acute rhinitis (including with colds);

• 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 surgical interventions in this area.

The drug is administered intranasally.

The recommended dose for adults is 1-2 injections into each nasal passage 2-3 times / day.

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

Nasal spray in the form of a transparent, colorless or light yellow solution.

In 1 ml:

phenylephrine hydrochloride 2.5 mg

cetirizine dihydrochloride 2.5 mg

Excipients: glycerol - 40 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% substance, purified water - up to 1 ml ...

• atrophic rhinitis;

• angle-closure glaucoma;

• taking MAO inhibitors (concurrently or in the previous 14 days);

• pregnancy;

• lactation period (breastfeeding);

• age up to 18 years (there are no data on efficacy and safety in children);

• hypersensitivity to phenylephrine, cetirizine or other components of the drug.

With care: cardiovascular diseases, incl. arterial hypertension, arrhythmias, generalized atherosclerosis; angina pectoris; hyperthyroidism; prostate adenoma; obstruction of the bladder neck (eg, due to prostatic hypertrophy); chronic renal failure; increased seizure activity; diabetes; epilepsy; patients with severe reactions to sympathomimetics, manifested in the form of insomnia, dizziness, tremors, cardiac arrhythmias or increased blood pressure (as in the case of the use of any local vasoconstrictor drugs); elderly patients.

pharmachologic effect

Combined drug for intranasal use for pathogenetic and symptomatic treatment, with a vasoconstrictor and antiallergic effect.

Phenylephrine is an agonist of ? 1-adrenergic receptors (sympathomimetic), it causes narrowing of the blood vessels of the nasal mucosa, reduces edema of the mucous membranes and tissue hyperemia, congestion in the nasal mucosa. Restoring air permeability of the nasopharynx improves the patient's well-being and reduces the risk of possible complications caused by stagnation of mucous secretions.

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

The preparation contains an auxiliary moisturizing substance glycerol, which helps to retain moisture, which helps to provide moisture in case of dryness and irritation of the nasal mucosa.

Indications of the drug FrinosolЃ

• acute rhinitis (including with colds);

• 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 surgical interventions in this area.

Dosage regimen

The drug is administered intranasally.

The recommended dose for adults is 1-2 injections into each nasal passage 2-3 times / day.

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

Mode of application

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

The bottle should be held vertically with the spray upwards.

Tilt your head, insert the tip of the bottle into the nasal passage, press the spray bottle once with a short sharp movement.

During the injection, it is recommended to take a light breath through the nose.

Side effect

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

Classification of the incidence of side effects according to the WHO recommendations: very often (? 1/10); often (from? 1/100 to <1/10); infrequently (from? 1/1000 to <1/100); rarely (from? 1/10 000 to <1/1000); very rare (<1/10 000, including isolated messages); the frequency is unknown (according to available data, it is not possible to establish the frequency of occurrence).

From the hematopoietic system: very rarely - thrombocytopenia.

Mental disorders: infrequently - agitation; rarely - aggression, confusion, depression, hallucinations, sleep disturbances; very rarely - tick; frequency unknown - suicidal ideation, sleep disturbances (including nightmares).

From the nervous system: infrequently - paresthesia; rarely - convulsions; very rarely - taste perversion, dyskinesia, dystonia, fainting, tremor; frequency unknown - headache, dizziness, memory impairment, incl. amnesia.

From the side of the organ of vision: very rarely - violation of accommodation, blurred vision, nystagmus.

On the part of the organ of hearing and the labyrinth: the frequency is unknown - vertigo, deafness.

From the side of the cardiovascular system: rarely - tachycardia; the frequency is unknown - arrhythmia, increased blood pressure, vasculitis.

From the respiratory system: rarely - discomfort in the nose, dryness or burning sensation in the nose, tingling, sneezing; nose bleed; benzalkonium chloride, which is part of the drug, can cause irritation of the nasal mucosa; frequency unknown - edema and hyperemia of the nasal mucosa, mucous and watery nasal discharge, difficulty in nasal breathing.

From the digestive system: infrequently - diarrhea; rarely - liver failure with changes in liver function tests (increased activity of transaminases, alkaline phosphatase, GGT and bilirubin); frequency unknown - increased appetite.

From the urinary system: very rarely - dysuria; frequency unknown - urinary retention.

From the musculoskeletal system: the frequency is unknown - arthralgia.

Skin and subcutaneous tissue disorders: infrequently - rash, itching.

Allergic reactions: rarely - hypersensitivity reactions, urticaria; very rarely - angioedema, anaphylactic shock, persistent drug erythema.

Others: infrequently - asthenia, malaise.

Contraindications for use

• atrophic rhinitis;

• angle-closure glaucoma;

• taking MAO inhibitors (concurrently or in the previous 14 days);

• pregnancy;

• lactation period (breastfeeding);

• age up to 18 years (there are no data on efficacy and safety in children);

• hypersensitivity to phenylephrine, cetirizine or other components of the drug.

With care: cardiovascular diseases, incl. arterial hypertension, arrhythmias, generalized atherosclerosis; angina pectoris; hyperthyroidism; prostate adenoma; obstruction of the bladder neck (eg, due to prostatic hypertrophy); chronic renal failure; increased seizure activity; diabetes; epilepsy; patients with severe reactions to sympathomimetics, manifested in the form of insomnia, dizziness, tremors, cardiac arrhythmias or increased blood pressure (as in the case of the use of any local vasoconstrictor drugs); elderly patients.

Application during pregnancy and lactation

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

Application for impaired renal function

The drug should be used with caution in patients with chronic renal failure.

Application in children

The use of the drug under the age of 18 is contraindicated (there are no data on efficacy and safety in children).

Use in elderly patients

The drug should be prescribed with caution to elderly patients.

special instructions

For local intranasal use only.

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 re-development of nasal congestion (rhinitis medicamentosa), leading to the development of a systemic vasoconstrictor effect.

As with the use of other vasoconstrictors, the recommended dose of the drug should not be exceeded. Otherwise, the development of manifestations of the systemic action of the drug, especially in elderly patients, is possible.

Phenylephrine should not be used in patients within 2 weeks after discontinuation of MAO inhibitors, since they can increase the severity of the adrenergic effects of sympathomimetic drugs and increase the risk of side effects from the cardiovascular system.

Influence on the ability to drive vehicles and use mechanisms

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

Overdose

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

Symptoms

With an accidental single ingestion of cetirizine at a dose of 50 mg, confusion, diarrhea, dizziness, fatigue, headache, malaise, mydriasis, itching, anxiety, weakness, sedation, drowsiness, stupor, tachycardia, tremor, urinary retention may occur.

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

Treatment: gastric lavage or stimulation of vomiting, administration of activated charcoal, intake of large amounts of fluids; supportive and symptomatic therapy. There is no specific antidote. Hemodialysis is ineffective. In case of an overdose, the patient should consult a doctor.

Drug interactions

The drug should not be used simultaneously with tri- and tetracyclic antidepressants, beta-blockers, MAO inhibitors (procarbazine, selegiline), maprotiline, guanedrel, guanethidine.

Thyroid hormones with systemic absorption of phenylephrine increase the (mutually) associated risk of coronary insufficiency (especially in coronary atherosclerosis).