Universal reference book for medicines
Name of the drug: NAZIVIN ® SENSITY (NASIVIN ® SENSITIVE)

Active substance: oxymetazoline

Type: Vasoconstrictive drug for topical application in ENT practice

Manufacturer: MERCK SELBSTMEDIKATION GmbH (Germany) manufactured by URSAPHARM Arzneimittel (Germany)
Composition, form of production and packaging
?
Spray nasal dosed in the form of a clear or almost transparent solution from almost colorless to slightly yellow.
1 dose of 1 ml

oxymetazoline hydrochloride 11.25 μg 250 μg

Excipients: citric acid monohydrate - 27.40 μg, sodium citrate dihydrate - 172.03 μg, glycerol 85% - 1121.44 μg, purified water - 44027.86 μg.

10 ml (not less than 190 doses) - polyethylene bottles with dosing device (1) - packs cardboard.

?
Spray nasal dosed in the form of a clear or almost transparent solution from almost colorless to slightly yellow.
1 dose of 1 ml

oxymetazoline hydrochloride 22.5 μg 500 μg

Excipients: citric acid monohydrate - 27.40 μg, sodium citrate dihydrate - 172.03 μg, glycerol 85% - 1121.44 μg, purified water - 44016.6 μg.

10 ml (not less than 190 doses) - polyethylene bottles with dosing device (1) - packs cardboard.

?
Nasal drops 0.01% in the form of a clear or almost transparent solution from almost colorless to slightly yellow in color.
1 ml

oxymetazoline hydrochloride 100 μg

Excipients: citric acid monohydrate - 0.609 mg, sodium citrate dihydrate - 3.823 mg, glycerol 85% - 24.921 mg, purified water - 978.547 mg.

5 ml - polyethylene bottles with a dispenser (1) - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

Vasoconstrictive drug for topical application.
When applied 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.
With local intranasal application, oxymetazoline does not have a systemic effect.

Oxymetazoline starts to act quickly, within a few minutes.
The duration of action of the drug Nazivin ® Sensitive - up to 12 hours.
PHARMACOKINETICS

T 1/2 oximetazoline with its intranasal administration is 35 hours. Withdrawal with urine is 2.1%, with feces - about 1.1%.

INDICATIONS

- colds or viral infections of the upper respiratory tract, accompanied by a runny nose;

- rhinitis of any etiology;

- sinusitis;

- Eustachyte;

- otitis media;

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

DOSING MODE

Apply intranasally.

Nasal drops

Nasivin ® Sensitive nasal drops 0.01% are intended for use in the nose of children under 1 year of age .

Children under 4 weeks are prescribed 1 drop of Nazivin ® Sensitive in each nostril 2-3 times / day.
From the 5th week of life and up to 1 year , 1-2 drops are prescribed per nostril 2-3 times / day.
1 drop Nazivin ® Sensitiv 0.01% contains 2.8 μg of oxymetazoline hydrochloride.

Before use, the vial should be turned over.
The drug should be instilled, throwing back the child's head.
The effectiveness of the following procedure is also proven: depending on the age of 1-2 drops, Nazivin ® Sensitive is applied to cotton wool and each nostril is rubbed.

In the recommended dose without consulting a doctor, the drug can be used no more than 5-7 days.
If symptoms increase or the improvement does not occur within 3 days, you should consult your doctor.
The drug in doses above recommended can be used only under the supervision of a doctor.

Spray nasal

Children aged 1 to 6 years: 1 injection of Nazivin ® Sensitive spray nasal dosed 11.25 μg / dose in each nostril 2-3 times / day.
The drug is used for 5-7 days. The drug can be re-administered only after a few days.
Adults and children over 6 years of age: 1 injection of Nazivin ® Sensitive spray nasal dosed 22.5 mcg / dose in each nostril 2-3 times / day.

If 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. The drug in doses exceeding recommended, can be used only under the supervision of a doctor.
One 45 μl injection contains:

- 11.25 μg of oxymetazoline hydrochloride - for the drug Nazivin ® Sensitive spray nasal dosed 11.25 μg / dose;

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

SIDE EFFECT

Local reactions: from? 1% to <10% - burning or dryness of the mucous membrane of the nasal cavity, sneezing, a strong sense of nasal congestion (reactive hyperemia) after the effect of using the drug Nazivin ® Sensitive, visual impairment (in the eyes) .
Prolonged continuous use of vasoconstrictive drugs can lead to tachyphylaxis, atrophy of the nasal mucosa and recurrent edema of the nasal mucosa (medicamentous rhinitis).
From the cardiovascular system: from? 0.1% to <1% - increased blood pressure, tachycardia;
perhaps - a feeling of palpitations.
From the nervous system: from? 0.01% to <0.1% - headache, insomnia;
possibly - dizziness, anxiety, irritability, sleep disturbance (in children).
Other: possible - nausea, exanthema.

CONTRAINDICATIONS

- Atrophic rhinitis;

- an angle-closure glaucoma;

- Children under 1 year of age (for the drug Nazivin ® Sensitive spray nasal dosed 11.25 μg / dose);

- Children under 6 years of age (for the drug Nazivin ® Sensitive Spray nasal dosed with 22.5 μg / dose);

- Hypersensitivity to the components of the drug.

With caution should be used with increased intraocular pressure, chronic heart failure, arterial hypertension, angina pectoris, arrhythmia, chronic renal failure, in patients with prostatic hyperplasia with clinical symptoms (retention of urine), severe atherosclerosis, hyperthyroidism, diabetes, pheochromocytoma, as well as in patients who received MAO inhibitors during the previous 2 weeks and within 2 weeks after their withdrawal, tricyclic antidepressants, bromocript
n.
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 or infant.
APPLICATION FOR FUNCTIONS OF THE LIVER

Caution should be applied to the drug in chronic kidney failure.

APPLICATION FOR CHILDREN

Contraindicated in childhood to 1 year (for the drug Nazivin ® Sensitive spray nasal dosed 11.25 μg / dose), in children under 6 years (for the drug Nazivin ®Sensitive spray nasal dosed with 22.5 μg / dose).

SPECIAL INSTRUCTIONS

Avoid contact with the eyes.

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

Impact on the ability to drive vehicles and manage mechanisms

After long-term use of colds containing oxymetazoline, in doses exceeding the recommended, it is impossible to exclude the overall effect on the cardiovascular system and the central nervous system.
In these cases, patients should be cautious when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
OVERDOSE

Symptoms: nausea, increased blood pressure, tachycardia, CNS depression.

Treatment: symptomatic therapy.

DRUG INTERACTION

The drug slows the absorption of local anesthetic drugs, lengthens their action.

When using the drug Nazivin ® Sensitive for 2 weeks prior to the appointment of MAO inhibitors and for 2 weeks after their withdrawal, against the background of treatment with tricyclic antidepressants or other drugs that promote blood pressure, there is an increase in blood pressure.

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

TERMS OF RELEASE FROM PHARMACY

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

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 30 ° C.
Shelf life - 3 years.
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