Sopifrin (Spray, Drops) Instructions for Use

ATC Code

R01AA04 (Phenylephrine)

Active Substance

Phenylephrine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Vasoconstrictor drug for topical use in ENT practice

Pharmacotherapeutic Group

Decongestant – alpha-adrenomimetic

Pharmacological Action

Alpha₁-adrenomimetic (sympathomimetic). It has a direct stimulating effect predominantly on alpha-adrenergic receptors.

It has a vasoconstrictive effect by stimulating alpha₁-adrenergic receptors in the nasal mucosa, reduces swelling of the mucous membrane and tissue hyperemia, congestion in the nasal mucosa, and also improves the patency of the nasal airways.

Pharmacokinetics

With topical application, systemic absorption is low.

Indications

Symptomatic treatment: to facilitate nasal breathing in colds, influenza, hay fever or other allergic diseases of the upper respiratory tract, accompanied by acute rhinitis or sinusitis.

ICD codes

Dosage Regimen

Administer intranasally only. Use the spray or drops at intervals of 6-8 hours.

For adults and children 12 years and older, apply 1-2 sprays or instill 2-3 drops into each nostril. Do not exceed 4 doses in any 24-hour period.

For children 6 to under 12 years, apply 1 spray or instill 1-2 drops into each nostril. Use with caution in this age group.

For children 1 to under 6 years, instill 1 drop into each nostril. Use only under direct medical supervision.

For infants 0 to under 1 year, use strictly as prescribed by a physician. Do not administer more frequently than every 6 hours.

Limit the total duration of treatment to 3 consecutive days. Do not exceed the recommended dosage.

Before initial use, prime the spray pump by pressing it several times. Tilt head slightly forward for administration. Avoid contact between the dropper or spray tip and the nasal passages.

Consult a physician if symptoms persist beyond 3 days or worsen. Discontinue use immediately and seek medical advice if symptoms of systemic adverse reactions occur.

Adverse Reactions

Local reactions: sometimes burning, tingling or prickling in the nose.

Systemic reactions: headache, dizziness, sensation of palpitations, arrhythmia, increased blood pressure, sweating, pallor, tremor, sleep disturbance.

Contraindications

Hypersensitivity to phenylephrine; diseases of the cardiovascular system (including coronary sclerosis, angina pectoris), hypertensive crisis, thyrotoxicosis, diabetes mellitus, simultaneous use of MAO inhibitors (and also 2 weeks after their discontinuation).

With caution

Children under 6 years of age.

Use in Pregnancy and Lactation

There is insufficient experience with use during pregnancy. It is possible to use for the treatment of pregnant and breastfeeding mothers if the potential benefit to the mother outweighs the possible risk to the fetus or child.

Pediatric Use

Use with caution in children under 6 years of age.

In children aged 0 to 1 year, use strictly as prescribed by a doctor and no more often than every 6 hours.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

In children aged 0 to 1 year, use strictly as prescribed by a doctor and no more often than every 6 hours.

In children, the systemic absorption of phenylephrine and the associated risk of developing side effects is higher than in adults.

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 sympathomimetics and increase the risk of side effects from the cardiovascular system.

The duration of use of phenylephrine should not exceed 3 days; if difficult nasal breathing persists, a doctor should be consulted for further use of phenylephrine.

Effect on the ability to drive vehicles and mechanisms

However, if symptoms of side effects of the drug appear, you should refrain from driving vehicles and performing activities that require concentration and speed of psychomotor reactions.

Drug Interactions

MAO inhibitors (procarbazine, selegiline), tricyclic antidepressants, maprotiline, guanadrel, guanethidine enhance the pressor effect and arrhythmogenicity of phenylephrine (with systemic absorption).

Thyroid hormones increase (mutually with systemic absorption of phenylephrine) 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.