NAZOL SPRAY NASAL 25MCG/DOSE 10ML

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NAZOL SPRAY NASAL 25MCG/DOSE 10ML

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International non-proprietary name

Oxymetazoline.

Dosage Form

Spray nasal dosed.

Composition 100ml contain:

1 dose contains:

active substance:

oxymetazoline hydrochloride

0.05 g

0.025 mg

Excipients:

benzalkonium chloride

0.02 g

0.01 mg

macrogol 400

7.5 g

3.75 mg

povidone

0.4 g

0.2 mg

propylene glycol

7.5 g

3.75 mg

sodium hydrogen phosphate dihydrate

0,006 g

0.003 mg

sodium dihydrophosphate dihydrate

0.65 g

0.325 mg

disodium edetate dihydrate

0.1 g

0.05 mg

hydrochloric acid conc.

0.003 g

0.0015 mg

purified water

86,571 g

43.2855 mg

Description

Transparent, colorless, odorless solution.

Pharmacotherapeutic group

Decongestant - alpha adrenomimetic.

Pharmacological properties

Oxymetazoline belongs to the group of alpha stimulants for topical use. Has a vasoconstrictor effect. With the introduction of intranasal reduces swelling of the mucous membrane of the upper respiratory tract, which leads to the relief of nasal breathing and the opening of the mouths of the paranasal sinuses and Eustachian tubes. The effect of the drug is manifested in 10-15 minutes after application and lasts for 10-12 hours.

Indications for use

For relief of nasal breathing in case of “cold” diseases and viral infections of the upper respiratory tract, sinusitis, rhinitis of any etiology.

Contraindications

Hypersensitivity to the drug or its components, atrophic rhinitis, angle-closure glaucoma, severe atherosclerosis, conditions after transsphenoidal hypophysectomy, simultaneous use of monoamine oxidase inhibitors (including a period of 14 days after their withdrawal), children under 6 years of age, pregnancy, lactation period.

Carefully

The drug should be used in patients with diseases of the cardiovascular system (arterial hypertension, coronary heart disease, chronic heart failure, tachycardia, arrhythmias), carbohydrate metabolism disorders (diabetes mellitus), hyperthyroidism, pheochromocytoma, chronic renal failure, prostate hyperplasia (urinary retention), with an increase in intraocular pressure, taking tricyclic antidepressants.

Use during pregnancy and during breastfeeding

Use during pregnancy and breastfeeding is possible only when the intended benefits to the mother outweigh the possible risk to the fetus or infant.

Dosage and administration

Intranasal.

1 dose contains 0,025 mg oxymetazoline hydrochloride.

Adults and children over 12 years old - 2-3 doses in each nasal passage 2 times a day.

Children from 6 to 12 years old - 1 dose in each nasal passage 2 times a day.

Do not use the drug more than 2 times a day.

Duration of treatment:

Do not use the drug for more than 3 days.With frequent or long-term use of the drug, a feeling of difficulty in nasal breathing may appear again or worsen. If these symptoms appear, you should stop treatment and consult a doctor.

When injecting, do not tilt the head back and do not spray in the “lying” position.

Side effect

Burning or dryness of the nasal mucosa, dryness in the mouth and throat, sneezing, an increase in the volume of secretions released from the nasal cavity. After the effect of using the drug passes, a strong feeling of nasal congestion (reactive hyperemia).

Side effects caused by the systemic action of the drug: increased blood pressure, headache, dizziness, heartbeat, anxiety, nausea, insomnia. With prolonged use of the drug (more than 7 days) are possible: reactive hyperemia of the mucous membrane of the nasal cavity, atrophy of the mucous membrane of the nasal cavity, tachyphylaxis (a rapid decrease in therapeutic effect with repeated use). Benzalkoniya chloride, which is part of the drug, can cause irritation of the nasal mucosa.

Overdose

In case of overdose or accidental ingestion of the drug, the following symptoms may develop: nausea, vomiting, cyanosis, fever, tachycardia, arrhythmia, increased blood pressure, shortness of breath, mental disorders, depression of the central nervous system (drowsiness, decrease in body temperature, bradycardia, decrease in blood pressure, respiratory arrest and coma). Treatment is symptomatic; in case of accidental ingestion - gastric lavage, intake of Activated carbon.

Interaction with other drugs

With simultaneous use with MAO inhibitors (including the period within 14 days after their cancellation) and tricyclic antidepressants, an increase in blood pressure may be observed. The drug slows down the absorption of local anesthetic drugs, lengthens their action. Co-administration of other vasoconstrictor drugs increases the risk of side effects.

special instructions

In the recommended dosage without consultation with the doctor, use no more than 3 days. Avoid contact with eyes. The drug has an effect on vision, possibly reducing the reaction rate.

To avoid the spread of infection, you must use the drug individually. With prolonged use (more than one week), the symptoms of nasal congestion may resume.

Influence on ability to drive machinery and other vehicles

During treatment, you should refrain from driving and practicing other potentially hazardous activities that require increased concentration or psychomotor speed, as the drug may cause dizziness and other side effects that may affect these abilities.

Release form

Spray nasal dosage of 0.025 mg / dose. On 10 ml (150 doses) in a bottle from high-density polyethylene with the batcher, a spray from polypropylene and a polyethylene protective cap.Label on the bottle. The bottle together with the instruction on a medical use is placed in a cardboard pack.

Storage conditions

At a temperature not higher than 25 ºС.

Keep out of the reach of children.

Shelf life

3 years.

Do not use after expiration date.

Vacation conditions

Over the counter.

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