Fridifin (Spray, Drops) Instructions for Use

ATC Code

R01AB01 (Phenylephrine in combination with other drugs)

Active Substances

Phenylephrine (Rec.INN registered by WHO)

Dimetindene (Rec.INN registered by WHO)

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

A combined drug with vasoconstrictive and antiallergic action for topical use in diseases of the ENT organs.

Phenylephrine is a sympathomimetic; with topical application, it has a moderate vasoconstrictive effect (due to stimulation of α₁-adrenergic receptors located in the venous vessels of the nasal mucosa), eliminating edema of the nasal mucosa and its paranasal sinuses.

Dimetindene is an antiallergic agent – an antagonist of histamine H₁-receptors; it does not reduce the activity of the ciliated epithelium of the nasal mucosa.

Pharmacokinetics

For topical application.

Indications

Acute rhinitis (including with colds); allergic rhinitis (including with hay fever); vasomotor rhinitis; chronic rhinitis; acute and chronic sinusitis; acute otitis media (as an auxiliary agent); preparation for surgical interventions in the nasal area and elimination of edema of the nasal mucosa and paranasal sinuses after surgical intervention in this area.

ICD codes

Dosage Regimen

Administer the dosage individually, based on the indication, patient age, and clinical presentation.

For the nasal spray, prime the pump before first use. Tilt head slightly forward and insert tip into nostril. Spray into the nose while breathing in gently through the nose. Repeat for the other nostril.

For nasal drops, lie on a bed with head tilted back. Instill the prescribed number of drops into each nostril. Remain in position for a few minutes.

For adults and children over 6 years, use one to two sprays or two to four drops in each nostril. Do not exceed three to four applications per day.

For children aged 2 to 6 years, use only the nasal drops. Administer one to two drops into each nostril. Do not exceed three applications per day.

The maximum duration of continuous use is five to seven days. Prolonged use can lead to medication-induced rhinitis and loss of efficacy.

If symptoms persist beyond one week, discontinue use and consult a physician. Do not exceed the recommended dosage.

For preoperative use or to relieve post-operative edema, follow the specific instructions provided by the surgeon.

Adverse Reactions

From the respiratory system: rarely – discomfort in the nasal area, dryness in the nose, nosebleed.

Local reactions: rarely – burning at the application site.

Contraindications

Atrophic rhinitis (including with foul-smelling discharge – ozaena); simultaneous use of MAO inhibitors and the period up to 14 days after their withdrawal; children under 6 years of age; closed-angle glaucoma; hypersensitivity to phenylephrine, dimetindene maleate, or other components of the drug.

Use with caution in cardiovascular diseases (arterial hypertension, arrhythmias, generalized atherosclerosis), hyperthyroidism, prostate adenoma, diabetes mellitus, obstruction of the bladder neck (for example, due to prostate hypertrophy), epilepsy; in patients with severe reactions to sympathomimetics, manifested as insomnia, dizziness, tremor, cardiac arrhythmia, or increased blood pressure.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Pediatric Use

In children under 6 years of age, only nasal drops are used. If the recommended dose is exceeded, manifestations of the systemic action of the drug may develop.

Geriatric Use

If the recommended dose is exceeded, manifestations may develop in elderly patients.

Special Precautions

Long-term or excessive use of the drug may cause tachyphylaxis and a “rebound” effect, associated with the re-development of nasal congestion (medication-induced rhinitis), and lead to the development of a systemic vasoconstrictive action.

If the recommended dose is exceeded, manifestations of the systemic action of the drug may develop, especially in children and elderly patients.

Drug Interactions

Contraindicated in patients receiving MAO inhibitors at the present time or who have received them within the previous 2 weeks.

The drug should not be prescribed simultaneously with tri- and tetracyclic antidepressants, beta-blockers.

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.