Dilephrin-Teva (Drops) Instructions for Use

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Rubicon, LLC (Republic of Belarus)

ATC Code

R01AB01 (Phenylephrine in combination with other drugs)

Active Substances

Phenylephrine (Rec.INN registered by WHO)

Dimetindene (Rec.INN registered by WHO)

Dosage Form

Dilephrin-Teva

Nasal drops 0.25 mg/ml+2.5 mg/ml

Dosage Form, Packaging, and Composition

Nasal drops

15 ml – bottles – carton packs – Over-the-Counter

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 ENT diseases.

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), it eliminates 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 in colds); allergic rhinitis (including in 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 drug intranasally. The dosage regimen is individual, determined by the indication, patient age, and clinical situation.

For children aged 6 to 12 years, instill 1 to 2 drops into each nostril. For adolescents from 12 years and adults, instill 2 to 4 drops into each nostril.

Apply the drops three to four times daily. The maximum frequency of application is every 4 hours.

Limit the duration of continuous use to 5 to 7 days. Prolonged use increases the risk of tachyphylaxis and medication-induced rhinitis (rebound congestion).

For pre-operative preparation or to manage post-operative edema, follow the specific regimen prescribed by the physician.

Do not exceed the recommended dosage, especially in children and elderly patients, to avoid systemic effects. If symptoms persist, discontinue use and consult a physician.

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 effect.

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.