Universal reference book for medicines
Name of the drug: NAZOL ® BABY (NAZOL BABY)

Active substance: phenylephrine

Type: Vasoconstrictive drug for topical application in ENT practice

Manufacturer: BAYER (Russia) manufactured by ISTITUTO de ANGELI (Italy)
Composition, form of production and packaging
?
Nasal droplets 0.125% in the form of a clear solution, from colorless to light yellow color, odorless.
100 ml

phenylephrine hydrochloride 0.125 g

Excipients: benzalkonium chloride 0.018 g, glycerol 5 g, macrogol 1500 1.5 g, sodium hydrogen phosphate dihydrate 0.226 g, potassium dihydrogen phosphate 0.101 g, disodium edetate dihydrate 0.02 g, purified water 94.76 g.

5 ml - polyethylene bottles (1) - cardboard packs.

10 ml - polyethylene bottles (1) - cardboard packs.

15 ml - polyethylene bottles (1) - cardboard packs.

30 ml - polyethylene bottles (1) - cardboard packs.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

Vasoconstrictive drug for topical application in ENT-practice, is an agonist?
1- adrenoreceptors (sympathomimetic). Has vasoconstrictive effect due to stimulation? 1-adrenoreceptors in the nasal mucosa: reduces swelling, stagnation and flushing of tissues in the nasal mucosa, and improves the patency of the nasal airways.
PHARMACOKINETICS

With topical application of the drug, systemic absorption is low.

INDICATIONS

To facilitate breathing through the nose when:

- colds and flu;

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

DOSING MODE

The drug is administered intranasally.
The duration of treatment is no more than 3 days.
For children under the age of 1 year, a single dose - 1 drop is not more frequent than every 6 hours.

For children aged 1 to 6 years, a single dose is 1-2 drops.

For children over the age of 6 and adults, a single dose is 3-4 drops.

For instillation it is necessary to squeeze the bottle slightly, keeping it upside down.
After use, wipe the pipette on the vial dry.
SIDE EFFECT

From the side of the central nervous system: headache, dizziness, tremor, sleep disturbance.

From the cardiovascular system: palpitation, arrhythmia, increased blood pressure.

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

Other: sweating, pallor.

CONTRAINDICATIONS

- diseases of the cardiovascular system (including coronarosclerosis, angina pectoris);

- hypertensive crisis;

- thyrotoxicosis;

- diabetes;

- Hypersensitivity to the components of the drug.

With caution apply the drug in children younger than 6 years .

PREGNANCY AND LACTATION

Sufficient experience in the use of the drug in pregnancy is not.

The use of the drug during pregnancy and lactation (breastfeeding) is possible only if the intended benefit to the mother exceeds the potential risk to the fetus or child.

APPLICATION FOR CHILDREN

With caution apply the drug in children younger than 6 years


SPECIAL INSTRUCTIONS

In children under the age of 1 year, the drug should be administered strictly as prescribed by the doctor and not more often than every 6 hours. In children, the systemic absorption of phenylephrine and the associated risk of side effects are higher than in adults.

Do not prescribe phenylephrine to patients within 2 weeks after the abolition of MAO inhibitors, as they can increase the severity of adrenergic effects of sympathomimetics and increase the risk of cardiovascular side effects.

OVERDOSE

Data on drug overdose are absent.

Symptoms: possible with systemic absorption - ventricular extrasystole, short paroxysms of ventricular tachycardia, a sense of heaviness in the head and extremities, excessive increase in blood pressure, agitation.

Treatment: iv injection of short-acting alpha-blockers (phentolamine) and beta-blockers (in case of rhythm disturbances).

DRUG INTERACTION

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

Thyroid hormones increase (coupled with systemic absorption of phenylephrine) the associated risk of coronary insufficiency (especially in coronary atherosclerosis).

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored in a dry, protected from light, out of reach of children at a temperature of 15 ° to 30 ° C.
Shelf life - 2 years.
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