Expiration date: 02/2025

The composition and form of issue:

Drops 1 FL.

Phenylephrine hydrochloride 0,125 grams

auxiliary substances: benzalkonium chloride 50% solution of ethylenediaminetetraacetic acid disodium salt (disodium edetate) polyethylene glycol glycerine (glycerol) sodium disodium phosphate potassium phosphate odnosemjannyj purified water to 100 ml 

in plastic bottles with a conical dispenser or PE low density with screw cap for 5, 10, 15 and 30 ml cartons 1 a bottle.

Description pharmaceutical form:

Transparent solution from colorless to light yellow, odorless.

Pharmacokinetics:

The local application of systemic absorption is low.

Description pharmacological action:

Phenylephrine hydrochloride is an agonist of alpha1-adrenergic receptors (sympathomimetic), have a vasoconstrictor effect by stimulating alpha1-receptors in the nasal mucosa. Reduces swelling of mucous membranes and hyperemia of the tissues, congestion in the nasal mucosa, and improves the patency of the nasal Airways.

Indications:

To facilitate breathing through the nose:

• colds
  
• flu
  
• hay fever or other allergic diseases of the upper respiratory tract, accompanied by acute rhinitis or sinusitis.
  

Contraindications:

• increased individual sensitivity to the ingredients of the drug
  
• cardiovascular disease (including coronarosclerosis, angina)
  
• hypertensive crisis
  
• thyrotoxicosis
  
• diabetes.
  

With caution:

• children up to age 6 years
  
• pregnancy
  
• lactation.
  

Application of pregnancy and breast-feeding:

Sufficient experience in use of the drug during pregnancy is not. Perhaps the use for the treatment of pregnant and breastfeeding mothers by appointment the attending physician if the expected therapeutic effect exceeds the risk of possible side effects.

Side effects:

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

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

Drug interactions:

MAO inhibitors (procarbazine, Telegin), tricyclic antidepressants, maprotiline, guanadrel, guanetidin amplify the Pressor effect and aritmogennosti Phenylephrine (with systemic absorption).

When systemic absorption Phenylephrine thyroid hormones increase (mutually) the associated risk of coronary insufficiency (especially in coronary atherosclerosis).

Method of application and dose:

Intranasal, slightly squeeze the bottle, holding it upside down.

For children under 1 year: single dose — 1 drop not more often than every 6 hours.

For children aged 1 year to 6 years: single dose of 1-2 drops.

For children over the age of 6 years and adults: single dose of 3-4 drops.

After use, wipe dry dropper on the bottle.

The duration of treatment is not more than 3 days.

Overdose:

Data on overdose of the drug available.

Symptoms (with systemic absorption): a potential ventricular extrasystoles, short paroxysms of ventricular tachycardia, a feeling of heaviness in the head and limbs, excessive increased blood pressure, agitation.

Treatment: in/with the introduction of the Alfa-adrenoblokatorov short-acting (phentolamine) and beta-adrenoblokatorov (when violations of rhythm).

Special instructions:

Children up to 1 year to use strictly on prescription and not more frequently than every 6 h. in children, systemic absorption Phenylephrine and the associated risk of side effects is higher than in adults.

Should not be administered phenylephrine to patients for 2 weeks after discontinuation of MAO inhibitors because they may increase the severity of adrenergic effects simpatomimetikov and increase the risk of side effects from the cardiovascular system.