Universal reference book for medicines
Product name: SANORIN (SANORIN)

Active substance: naphazoline

Type: Vasoconstrictive drug for topical application in ENT practice

Manufacturer: Teva Pharmaceutical Industries (Israel) manufactured by TEVA Czech Industries (Czech Republic)
Composition, form of production and packaging
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Spray nasal 0.1% in the form of a clear, colorless liquid, without visible particles, odorless.
1 ml of 1 fl.

naphazoline nitrate 1 mg 10 mg

[PRING] ethylenediamine - qs (about 400 μg), boric acid - 170 mg, methylparahydroxybenzoate - 10 mg, water - up to 10 ml.

10 ml - plastic bottles with mechanical dosing applicator (1) - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

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

PHARMACHOLOGIC EFFECT

Alpha 2 -adrenomimetic with direct stimulating effect on the? -adrenoceptors of the sympathetic nervous system.
When intranasal administration has a rapid, pronounced and prolonged vasoconstrictive effect on the vessels of the mucous membrane of the nasal cavity, the nasopharynx and the paranasal sinuses of the nasal cavity - reduces edema and hyperemia, which improves the patency of the nasal passages and facilitates nasal breathing. Along with this, the patency of eustachian tubes is restored.
The therapeutic effect occurs, usually within 5 minutes after the administration of the drug and persists for 4-6 hours. With prolonged use, the vasoconstrictor effect gradually decreases, therefore, after 5-7 days of treatment, a break should be made for several days.

PHARMACOKINETICS

There are no data on the distribution, metabolism and elimination of naphazoline in humans.

INDICATIONS

- Acute rhinitis of various etiologies;

- otitis media as an additional remedy for reducing the swelling of the mucous membrane of the nasopharynx;

- sinusitis;

- Eustachyte;

- laryngitis;

- to reduce the edema of the mucous membranes of the nasal cavity, nasopharynx and paranasal sinuses of the nasal cavity in diagnostic and therapeutic procedures;

- if necessary stopping nasal bleeding.

DOSING MODE

Apply intranasally.
1-3 doses of the drug are injected into each nasal passage 3-4 times / day.
Duration of use - no more than 1 week in adults and not more than 3 days in children.
If nasal breathing is facilitated, Sanorin can be used sooner. Repeated use of the drug is possible in a few days.
When using the spray for the first time, it is recommended that you press the dosing device several times until a compact aerosol cloud appears.

Before use, remove the protective cap, keep the bottle in a vertical position, insert the end of the dosing device into the nasal passage, then quickly and sharply push the applicator.
Immediately after injection, it is recommended that you inhale slightly with your nose.
After using the drug, close the applicator with a protective cap.

SIDE EFFECT

Local reactions: with increased sensitivity, a feeling of burning and dryness in the nasal cavity is possible;
in rare cases after the termination of exposure - reactive hyperemia and edema of the nasal mucosa. With prolonged and frequent use (more than 1 week) of Sanorin, chronic disruption of nasal passages and atrophy of the mucous membrane of the nasal cavity are possible.
From the side of the digestive system: very rarely - nausea.

From the cardiovascular system: very rarely - tachycardia, increased blood pressure.

From the side of the central nervous system: very rarely - headache, irritability.

Other: very rarely - excessive sweating, allergic reactions, rash.

In recommended doses, the drug is usually well tolerated.

CONTRAINDICATIONS

- chronic rhinitis;

- Atrophic rhinitis;

- an angle-closure glaucoma;

- severe eye diseases;

- arterial hypertension;

- severe atherosclerosis;

- tachycardia;

- hyperthyroidism;

- diabetes;

- simultaneous administration of MAO inhibitors and a period of up to 14 days after the end of their use;

- children and adolescence up to 15 years;

- Hypersensitivity to the components of the drug.

Caution should be used during pregnancy, lactation (breastfeeding), with IHD (angina pectoris), prostatic hyperplasia, pheochromocytoma.

PREGNANCY AND LACTATION

If you need to use the drug during pregnancy and lactation (breastfeeding), you should evaluate the expected benefit of therapy for the mother and the possible risk to the fetus.

Data on the penetration of naphazoline through the placental barrier, as well as in breast milk is not available.

APPLICATION FOR CHILDREN

Contraindicated in children and adolescents under 15 years.

SPECIAL INSTRUCTIONS

Care must be taken in general anesthesia with the use of anesthetics that increase the sensitivity of the myocardium to sympathomimetics (halothane), especially in patients with bronchial asthma.

Avoid prolonged use of the drug.

In view of the possible development of side effects from the cardiovascular system and the nervous system, the recommended dose of the drug should not be exceeded.

Impact on the ability to drive vehicles and manage mechanisms

The drug does not affect the ability to drive vehicles and engage in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions, taking into account the profile of side effects.

OVERDOSE

Symptoms: nervousness, excessive sweating, headache, tremor, tachycardia, palpitations, increased blood pressure, nausea, cyanosis, respiratory and mental disorders are also possible.
In the case of CNS depression, bradycardia, weakness, drowsiness, a decrease in body temperature, increased sweating, collapse, and extremely rare coma are observed.
Treatment: withdrawal of the drug, symptomatic therapy.

DRUG INTERACTION

With simultaneous use of the drug with MAO inhibitors or tricyclic antidepressants (and within 14 days after the end of their use), an increase in blood pressure is possible, which is due to the release of deposited catecholamines under the action of naphazoline.
Therefore, the use of the drug Sanorin is contraindicated simultaneously with MAO inhibitors and within 14 days after their cancellation.
Nafazoline slows the absorption of local anesthetics, which leads to an increase in the duration of their action.

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, protected from light at a temperature of 10 ° to 25 ° C.
Shelf life - 4 years.
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