Frinozol^® (Spray) Instructions for Use

Marketing Authorization Holder

Vertex, JSC (Russia)

ATC Code

R01AB01 (Phenylephrine in combination with other drugs)

Active Substances

Cetirizine (Rec.INN registered by WHO)

Phenylephrine (Rec.INN registered by WHO)

Dosage Form

Frinozol®

Nasal spray 2.5 mg/1 mL+2.5 mg/1 mL: 15 mL bottle with dispenser

Dosage Form, Packaging, and Composition

Nasal spray as a colorless or light yellow, transparent solution.

Excipients: glycerol – 40 mg, sodium phosphate, dibasic (anhydrous) – 2.5 mg, potassium phosphate, monobasic – 1.5 mg, disodium edetate – 0.2 mg, benzalkonium chloride solution 50% – 0.1 mg, purified water – up to 1 ml.

15 ml – bottles (1) with a dispenser – cardboard packs.

Clinical-Pharmacological Group

Drug with vasoconstrictive and antiallergic action for topical use in ENT practice

Pharmacotherapeutic Group

Drugs for the treatment of nasal diseases; decongestants and other drugs for topical use; sympathomimetics, combinations without corticosteroids

Pharmacological Action

Combined drug for intranasal use.

Phenylephrine is an agonist of α₁-adrenergic receptors (sympathomimetic), causes constriction of the blood vessels of the nasal mucosa, reduces swelling of the mucous membranes and tissue hyperemia, and congestion in the nasal mucosa.

Restoration of the air patency of the nasopharynx improves the patient’s well-being and reduces the risk of possible complications caused by stagnation of mucous secretions.

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

The preparation contains the excipient glycerol, which helps to retain moisture, which helps provide hydration for dryness and irritation of the nasal mucosa.

Pharmacokinetics

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

Indications

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 nasal mucosa and paranasal sinuses after surgical interventions in this area.

ICD codes

Dosage Regimen

Administer the drug intranasally.

Before first use, prime the pump by spraying several times into the air until a fine mist appears.

Before each administration, thoroughly clear the nasal passages.

For adults (18 years and older), administer one to two sprays into each nostril.

Repeat this dose two to three times per day, as needed for symptom relief.

Adhere to a minimum interval of 4-6 hours between doses.

Do not exceed six sprays in any single nostril within a 24-hour period.

Limit the total duration of continuous treatment to seven days.

Discontinue use and consult a physician if symptoms persist or worsen after this period.

Avoid exceeding the recommended dosage to prevent systemic effects and rebound congestion.

To administer, hold the bottle upright, insert the tip into the nostril, and spray while breathing in gently through the nose.

After use, wipe the spray tip clean and replace the protective cap.

Adverse Reactions

Cetirizine in combination with phenylephrine in the form of a spray is well tolerated in therapeutic doses, however, the following side effects may be observed.

Classification of the frequency of side effects according to WHO recommendations: very common (≥1/10); common (from ≥1/100 to <1/10); uncommon (from ≥1/1000 to <1/100); rare (from ≥1/10,000 to <1/1000); very rare (<1/10,000, including isolated reports); frequency unknown (cannot be estimated from the available data).

Blood and lymphatic system disorders very rare – thrombocytopenia.

Psychiatric disorders uncommon – agitation; rare – aggression, confusion, depression, hallucinations, sleep disorder; very rare – tic; frequency unknown – suicidal ideation, sleep disorders (including nightmares).

Nervous system disorders uncommon – paresthesia; rare – convulsions; very rare – taste perversion, dyskinesia, dystonia, syncope, tremor; frequency unknown – headache, dizziness, memory impairment, incl. amnesia.

Eye disorders very rare – accommodation disorder, blurred vision, nystagmus; frequency unknown – vasculitis.

Ear and labyrinth disorders frequency unknown – vertigo, deafness.

Cardiac disorders rare – tachycardia; frequency unknown – arrhythmia, increased blood pressure.

Respiratory, thoracic and mediastinal disorders rare – nasal discomfort, dryness or burning in the nose, tingling, sneezing; epistaxis; benzalkonium chloride, which is part of the drug, can cause irritation of the nasal mucosa; frequency unknown – swelling and hyperemia of the nasal mucosa, mucous and watery nasal discharge, difficulty in nasal breathing.

Gastrointestinal disorders uncommon – diarrhea; rare – hepatic failure with changes in liver function tests (increased activity of transaminases, ALP, GGT and bilirubin); frequency unknown – increased appetite.

Skin and subcutaneous tissue disorders uncommon – rash, itching.

Musculoskeletal and connective tissue disorders frequency unknown – arthralgia.

Renal and urinary disorders very rare – dysuria; frequency unknown – urinary retention.

Immune system disorders rare – hypersensitivity reactions, urticaria; very rare – anaphylactic shock, angioedema, fixed drug eruption.

General disorders and administration site conditions uncommon – asthenia, malaise.

Contraindications

Atrophic rhinitis; closed-angle glaucoma; pregnancy; lactation period; age under 18 years (data on efficacy and safety of use are lacking); use of MAO inhibitors (concurrent or within the preceding 14 days); hypersensitivity to phenylephrine, cetirizine or other components of the drug.

With caution cardiovascular diseases, incl. arterial hypertension, arrhythmias, generalized atherosclerosis; hyperthyroidism; prostate adenoma; chronic renal failure; increased seizure activity; angina pectoris; diabetes mellitus; obstruction of the bladder neck (e.g., due to prostatic hypertrophy); epilepsy; severe reactions to sympathomimetics, manifested as insomnia, dizziness, tremor, cardiac arrhythmia or increased blood pressure (as with the use of any topical decongestants), elderly age.

Use in Pregnancy and Lactation

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

Use in Renal Impairment

With caution chronic renal failure.

Pediatric Use

The use of the drug is contraindicated under the age of 18 years (data on efficacy and safety of use are lacking).

Geriatric Use

With caution elderly age.

Special Precautions

Long-term (more than 7 days) use of the drug may cause tachyphylaxis and a “rebound” effect associated with the re-development of nasal congestion (medication-induced rhinitis).

As with the use of other decongestants, the recommended doses of the drug should not be exceeded. Otherwise, manifestations of the systemic action of the drug may develop, especially in elderly patients.

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

Effect on ability to drive vehicles and operate machinery

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

Drug Interactions

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

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

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.