Nazivin Sensitiv - instructions for use, dose, side effects, contraindications

Nazivin® Sensitive (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 reduces the likelihood 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 Sensitiv spray nasal dosed 11.25 μg / dose starts to act quickly, within a few minutes. Preparation Nazivin® Sensitive spray nasal dosed with 22.5 μg / dose is effective from 25 seconds.

The duration of action of Nasivin® Sensitive drugs is 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 Nasivin® Sensitive spray nasal dosage of 22.5 μg / dose 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:

- Pincreased diseases or viral infections of the upper respiratory tract, accompanied by a runny nose, sinusitis, eustachiitis, otitis media, rhinitis of any etiology;

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

Contraindications:

Atrophic rhinitis; angle-closure glaucoma; hypersensitivity to the components of the drug; surgical interventions on the dura mater (in the anamnesis).

For the drug Nasivin® Sensitive spray nasal dosed 11.25 mkg / dose - children under 1 year.

For the drug Nasivin® Sensitive spray nasal dosed 22.5 mcg / dose - children under 6 years of age.

Carefully:

With increased intraocular pressure, chronic heart failure, hypertension, angina pectoris; arrhythmias; chronic renal failure; in patients with prostatic hyperplasia with clinical symptoms (urinary retention); severe atherosclerosis; with hyperthyroidism; diabetes mellitus; pheochromocytoma; tachycardia; therapy with monoamine oxidase (MAO) inhibitors and tricyclic antidepressants, as well as with other drugs that increase blood pressure; porphyria.

Pregnancy and lactation:

When used during pregnancy or breastfeeding, the recommended dose should not be exceeded. The drug can only be used if the potential benefit to the mother exceeds the potential risk to the fetus and the baby.

Dosing and Administration:

Nasivin® Sensitive nasal spray with a dosage of 11.25 μg / dose and 22.5 μg / dose is for intranasal administration.

Children aged 1 to 6 years: for 1 injection of Nasivin® Sensitive nasal spray dosage of 11.25 μg / dose in each nostril 2-3 times per day. The drug is applied 5-7 days. The drug can be re-administered only after a few days.

Adults and children over 6 years of age: for 1 injection of Nasivin® Sensitive spray nasal dosed with 22.5 μg / dose in each nostril 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:

- 11.25 μg of oxymetazoline hydrochloride - for Nazivin® Sensitive nasal spray dosage of 11.25 μg / dose;

- 22.5 μg of oxymetazoline hydrochloride - for Nazivin® Sensitive spray nasal dosed with 22.5 μg / dose.

Side effects:

Infrequent: burning or dryness of the mucous membrane of the nasal cavity, sneezing, epistaxis, Quincke's edema, itching. In rare cases: after the effect of using the drug Nazivin® Sensitive, the sense of "stuffiness" of the nose (reactive hyperemia) will pass.

Rare: increase in blood pressure, headache, dizziness, palpitations, tachycardia, anxiety, irritability, sleep disturbance (in children), nausea, insomnia, rash, visual disturbances (Eye). Very rarely: fatigue, drowsiness, anxiety, hallucinations, convulsions, stopping breathing (in infants).

Prolonged continuous use of vasoconstrictors may cause tachyphylaxis, atrophy of nasal mucosa and returnable edema nasal mucosa (rhinitis medicamentosa).

Overdose:

Clinical signs of intoxication imidazole derivatives may be nonspecific and fuzzy, as phases hyperactivity phases alternate depression of the central nervous system, cardiovascular and respiratory systems. Symptoms: Anxiety, agitation, hallucinations, seizures, low body temperature, lethargy, drowsiness, coma, constriction or dilation of the pupils, fever, sweating, paleness, cyanosis, palpitations, bradycardia, arrhythmia, heart failure, high blood pressure, lowering blood pressure, nausea , vomiting, respiratory depression, respiratory arrest.

In children, an overdose can be the cause of the development of such symptoms from the central nervous system, such as: agitation, convulsions, coma, bradycardia, respiratory arrest, and increased blood pressure, followed by a possible reduction in blood pressure.

Treatment: gastric lavage, reception of activated charcoal (with accidental ingestion of the drug inside); symptomatic.

In severe overdose, intensive care is indicated in a hospital setting. The use of vasoconstrictor is contraindicated.

Interaction:

Slows the absorption of local anesthetic drugs, lengthens their action.

In patients taking monoamine oxidase inhibitors (MAO) for the previous 2 weeks and within 2 weeks after their withdrawal, tricyclic antidepressants or other drugs that increase blood pressure - increase blood pressure.

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

Special instructions:

Avoid contact with eyes.

To avoid the spread of infection, it is necessary to apply the drug individually.

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

After a prolonged use of funds from the cold, containing oxymetazoline, in doses exceeding the recommended, one can not exclude the general effect on the cardiovascular system and the central nervous system. In these cases, care should be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:

The nasal spray is 11.25 μg / dose and 22.5 μg / dose.

Packaging:

10 ml per bottle of polyethylene with a dosing device and with a protective cap made of polyethylene.

1 bottle with the instruction for use is placed in a cardboard box. At least 190 doses in the vial.

Storage conditions:

Store at a temperature not exceeding 30 ° 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:PL-000511

Date of registration:01.03.2011 / 15.12.2016

Expiration Date:Unlimited

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

Manufacturer: & nbsp

PHARMASTER France

Famar Health Care Services Madrid Spain

Representation: & nbspTakeda Pharmaceuticals Ltd.Takeda Pharmaceuticals Ltd.

Information update date: & nbsp30.05.2018

Illustrated instructions

Instructions

Nazivin® Sensitive (Nasivin® Sensitive)