Bebifrin nasal drops 0.125%, 10ml

Composition

1 ml of the drug contains:

Active ingredient:

Phenylephrine hydrochloride 1.25 mg

Auxiliary substances:

Benzalkonium chloride 0.18 mg

Glycerol anhydrous 50,00 mg

Macrogol 1500 (polyethylene glycol 1500) 15.00 mg

Sodium hydrophosphate dihydrate 2.26 mg

Potassium dihydrophosphate 1.01mg

Disodium Edetate dihydrate (trilon B) 0.20 mg

Water for injection up to 1 ml.

Pharmacological effect

Anticongestive agent – alpha-adrenomimetic.

ATX Code: R01AA04

Pharmacological Properties

Pharmacodynamics

A drug for symptomatic local treatment of rhinitis. Phenylephrine hydrochloride is an agonist of alpha1-adrenergic receptors (sympathomimetics) that has a vasoconstrictive effect by stimulating alpha1-receptors in the mucous membranes of the nasal cavity, reduces swelling of the mucous membranes and tissue hyperemia, congestion in the nasal mucosa, and also improves the patency of the nasal airways.

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

Pharmacokinetics

When applied topically, systemic absorption is low.

Indications

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

Use during pregnancy and lactation

Is not recommended for use during pregnancy and during breastfeeding.

Contraindications

Increased individual sensitivity to the components of the drug; diseases of the cardiovascular system (including severe atherosclerosis, angina pectoris, tachycardia), thyroid diseases (thyrotoxicosis), diabetes mellitus, hypertension, simultaneous use of monoamine oxidase inhibitors (MAO) (as well as 2 weeks after their withdrawal), children under 4 years of age.

With caution

Children under 6 years of age; pheochromocytoma; with hypersensitivity to adrenergic drugs, accompanied by sleep disorders, dizziness, tremor of skeletal muscles, arrhythmia, increased blood pressure.

Side effects

Local reactions: burning sensation, tingling or tingling in the nose, irritation of the mucous membranes of the nasal cavity. Systemic effects: headache, dizziness, palpitation, arrhythmia, increased blood pressure, sweating, pallor, tremor, sleep disturbance. Benzalkonium chloride, which is part of the drug, can cause irritation of the nasal mucosa.

Interaction

MAO inhibitors (procarbazine, selegin), tricyclic antidepressants, maprotilin, guanedrel, guanetidine enhance the pressor effect and arrhythmogenicity of phenylephrine (with systemic absorption). Thyroid hormones with systemic absorption of phenylephrine increase the (mutually) associated risk of coronary insufficiency (especially with coronary atherosclerosis).

How to take, the course of use and dosage Intranasally. 1 dose contains 0.125 mg of phenylephrine hydrochloride. For children aged 4 to 6 years – 1-2 doses in each nasal passage, no more than every 6 hours; from 6 to 12 years – 2-3 doses in each nasal passage, no more than every 4 hours. The duration of treatment without consulting a doctor is no more than 3-5 days. Use the drug only according to the indications, the method of use and in the doses specified in the instructions.

Overdose

It can manifest itself as heart rhythm disorders, increased blood pressure, arousal. In case of overdose, it is necessary to consult a doctor. Treatment is symptomatic.

Special instructions

In children, systemic absorption of phenylephrine and the associated risk of side effects are higher than in adults. The duration of use of the drug should not exceed 3 days, while maintaining difficult nasal breathing, further use of the drug should be agreed with the doctor.

Phenylephrine should not be prescribed to patients within 2 weeks after the withdrawal of MAO inhibitors, since they can increase the severity of the adrenergic effects of sympathomimetic agents and increase the risk of side effects from the cardiovascular system. It is not recommended to use the same bottle to several persons in order to avoid the spread of infection.

Influence on the ability to drive vehicles and mechanisms

There is no data on the negative effect of the drug on the ability to drive a car and other vehicles. However, if symptoms of a side effect of the drug occur, one should refrain from driving vehicles and performing actions that require concentration of attention and speed of psychomotor reactions.

Storage conditions

Store at a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf life

2 years. Do not use after the expiration date!

Active ingredient

Phenylephrine

Dosage form

Nasal drops