Nazivin - instructions for use, doses, side effects, contraindications

citric acid monohydrate 27.4 μg, sodium citrate dihydrate 172.0 μg, glycerol (85%) 1095.66 μg, benzalkonium chloride (50% solution) 4.5 μg, purified water 44037 μg.

Total: 45,359.06 μg, equivalent to 45 μl.

Description:Almost transparent, from almost colorless to slightly yellow in color.

Pharmacotherapeutic group:Antitussive medication - alpha-adrenomimetic

ATX: & nbsp

S.01.G.A.04 Oxymetazoline

Pharmacodynamics:

The drug Nazivin® (oxymetazoline) has a vasoconstrictive effect. When applied locally to the inflamed mucous membrane of the nasal cavity reduces its swelling and discharge from the nose. Restores nasal breathing. Elimination of the edema of the mucous membrane of the nasal cavity facilitates the restoration of the aeration of the paranasal sinuses of the nasal cavity, the middle ear cavity, which prevents the development of bacterial complications (sinusitis, sinusitis, otitis media). With local intranasal use in therapeutic concentrations, it does not irritate and does not cause hyperemia of the mucous membrane of the nasal cavity.

The drug Nazivin® nasal spray 0.05% is effective from 25 seconds.

Duration of the drug up to 12 hours. The results of a double-blind, placebo-controlled study in patients with acute viral rhinitis at the age of 12-70 years showed that the use of the drug Nazivin® nasal spray 0.05% reduced the median duration of the common cold from 6 to 4 days.

Pharmacokinetics:

With topical intranasal application oxymetazoline does not have a systemic effect. The half-life of oxymetazoline with its intranasal administration is 35 hours. 2.1% of oxymetazoline is excreted in urine and about 1.1% with feces.

Indications:

- LTreatment of acute respiratory diseases accompanied by a runny nose;

- allergic rhinitis;

- vasomotor rhinitis;

- for restoration of drainage with inflammation of the paranasal sinuses of the nasal cavity, eustachiitis, otitis media;

- to eliminate the edema before the diagnostic manipulations in the nasal passages.

Contraindications:

- Atrophic rhinitis;

- an angle-closure glaucoma;

hypersensitivity to the components of the drug;

- Children under 6 years.

Carefully:

In patients taking monoamine oxidase inhibitors and other drugs,contributing to high blood pressure in the period up to 10 days after their use; with increased intraocular pressure, severe atherosclerosis, tachycardia, pheochromocytoma, during pregnancy and lactation, with severe forms of cardiovascular diseases (arterial hypertension, angina pectoris); with thyrotoxicosis and diabetes mellitus.

Pregnancy and lactation:

When used during pregnancy or breastfeeding, the recommended dosage should not be exceeded. The drug should only be used after a thorough assessment of the risk-benefit relationship for the mother and fetus.

Dosing and Administration:

Adults and children over 6 years: 1 injection in each nasal passage 2-3 times a day. If the symptoms increase or the improvement does not occur within 3 days, you should consult your doctor. In the recommended dose without consulting a doctor apply no more than 7 days.

Doses above recommended can be used only under the supervision of a doctor.

One 45 μl injection contains 22.5 μg of oxymetazoline hydrochloride.

Side effects:

Sometimes: burning or dry nasal membranes, sneezing.

In rare cases: after the effect of using Nazivin®, a strong sense of "stuffiness" of the nose (reactive hyperemia). Multiple overdose with local nasal use sometimes leads to such systemic sympathomimetic effects, as an increase in the pulse (tachycardia) and an increase in blood pressure.

In very rare cases anxiety, insomnia, fatigue, headaches and nausea.

Prolonged continuous use of vasoconstrictive drugs can lead to tachyphylaxis, atrophy of the nasal mucosa and recurrent edema of the nasal mucosa (medicamentous rhinitis).

Overdose:

After a significant overdose or accidental ingestion, the following may appear symptoms: narrowing of pupils, nausea, vomiting, cyanosis, increase temperature, tachycardia, arrhythmia, collapse, depression of cardiac activity, arterial hypertension, pulmonary edema, respiratory distress. In addition, mental disorders may occur, as well as depression of central nervous system functions, accompanied by drowsiness, lower body temperature, bradycardia, arterial hypotension, respiratory arrest and possible development of coma.

In case of an overdose associated with taking the drug inside, a gastric lavage is prescribed, Activated carbon.

Interaction:

At simultaneous appointment of blockers MAO and tricyclic antidepressants - increase of arterial pressure.

Co-administration of other vasoconstrictive drugs increases the risk of side effects.

Special instructions:

Avoid prolonged use and overdose of the drug, especially in children.

Effect on the ability to drive transp. cf. and fur:

After a prolonged use or intake of funds from the cold, containing oxymetazoline, in dosages exceeding the recommended, it is impossible to exclude the general effect on the cardiovascular system and the central nervous system. In these cases, the ability to drive a vehicle or equipment can be reduced.

Form release / dosage:

Spray nasal dosed with 22.5 μg / dose.

Packaging:

For 10 ml (not less than 143 doses / bottle) of the drug in a bottle of brown glass, III hydrolytic class with a dispenser made of polyethylene and stainless steel and a protective cover.

1 bottle with the instruction for use is placed in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N013921 / 01

Date of registration:27.12.2007 / 26.12.2017

Expiration Date:Unlimited

The owner of the registration certificate:Merck Selbstmedikation GmbHMerck Selbstmedikation GmbH Germany

Manufacturer: & nbsp

MERCK, KGaA Germany

Sofarimex Industria Quimica e Farmaceutica, Lda Portugal

Representation: & nbspDR REDDY'S LABORATORIS LTD. DR REDDY'S LABORATORIS LTD. India

Information update date: & nbsp30.05.2018

Illustrated instructions

Instructions

Nazivin® (Nasivin®)