Sanorin

General characteristics. Structure:

1 bottle (10 ml) contains:
active agent: naphazoline nitrate of 0,01 g;
excipients: q.s ethylene diamine. (about 0,4 mg), boric acid of 0,170 g, methylparahydroxybenzoate of 0,010 g, water to 10 ml.

Description
Transparent, colourless liquid, without visible particles, inodorous.

Pharmacological properties:

Pharmacodynamics. Naphazoline belongs to alfa2-adrenomimetika with the direct stimulating impact on alpha adrenoceptors of a sympathetic nervous system. At intranasal introduction renders the bystry, expressed and long vasopressor action concerning vessels of mucous membranes of a nasal cavity, a nasopharynx and adnexal bosoms of a nasal cavity - reduces puffiness and a hyperemia thanks to what passability of the nasal courses improves and nasal breath is facilitated. Along with it passability of Eustachian tubes is recovered.

The therapeutic effect occurs, as a rule, within 5 minutes after administration of drug and remains for 4-6 hours.

At prolonged use the vasoconstrictive effect gradually decreases in this connection in 5-7 days of treatment it is necessary to take a break for several days.

Pharmacokinetics. Concerning distribution, the person has metabolism and elimination of naphazoline of no data.

Indications to use:

• acute rhinitis of various etiology;
• average otitis - as an additional tool for reduction of hypostasis of a mucous membrane of a nasopharynx;
• sinusitis;
• eustachitis;
• laryngitis;
• for reduction of hypostasis of mucous membranes of a nasal cavity, a nasopharynx and adnexal bosoms of a nasal cavity at diagnostic and medical procedures;
• in need of a stop of nasal bleedings.

Route of administration and doses:

Intranazalno. On 1-3 doses of drug in each nasal course 3-4 times a day.

At the first use of spray it is recommended to press several times the portioning device, the compact cloudlet of an aerosol will not appear yet. Before direct use remove a protective cap, you keep a bottle in vertical position, enter a trailer part of the portioning device into the nasal course then quickly and sharply press the applicator. Directly right after injection it is recommended to make an easy breath a nose.

After drug use close the applicator a protective cap.

To apply quickly, no more than 1 week is at adult and no more than 3 days at children.
If nasal breath is facilitated, then use of the drug Sanorin can be finished earlier.
Repeated use of drug is possible in several days.

Features of use:

The combined use with monoamine oxidase inhibitors strengthens hypertensive effect.

It is necessary to show care when carrying out the general anesthesia using the anesthetics increasing sensitivity of a myocardium to sympathomimetics (halothane), especially at patients with bronchial asthma.

It is necessary to avoid long administration of drug.

In view of possible development of by-effects from cardiovascular and nervous systems it is not necessary to exceed the drug Sanorin doses recommended for use.

Influence on control of vehicles and other mechanisms
 Drug does not influence ability to manage vehicles and to be engaged in other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions taking into account a profile of side effects.

Side effects:

In the recommended doses drug usually well is transferred.

Persons with special sensitivity can have a burning sensation and dryness in a nasal cavity.

In rare instances after the termination of influence of drug the reactive hyperemia and swelling of a mucous membrane of a nasal cavity develops.

As a result of irritation of a sympathetic nervous system and the general impact on an organism nausea, tachycardia, a headache, irritability, the increased perspiration, allergic reactions, rash, increase in arterial pressure are extremely seldom possible.

Prolonged and frequent use (more than 1 week) of the drug Sanorin can lead to chronic disturbance of passability of the nasal courses and a mucosal atrophy of a nasal cavity.

Interaction with other medicines:

At simultaneous use of drug with monoamine oxidase inhibitors or tricyclic antidepressants (and within 14 days after the end of their use) increase in arterial pressure is possible that is caused by release of the deposited catecholamines under the influence of naphazoline. Therefore the concomitant use of the drug Sanorin with MAO inhibitors (and within 14 days after their cancellation) is contraindicated.
Naphazoline slows down absorption of local anesthetics (extends their action).

Contraindications:

• hypersensitivity to drug components;
• chronic rhinitis;
• atrophic rhinitis;
• closed-angle glaucoma;
• serious illness of eyes;
• arterial hypertension;
• the expressed atherosclerosis;
• tachycardia;
• hyperthyroidism;
• diabetes mellitus;
• a concomitant use of monoamine oxidase inhibitors and the period up to 14 days after the end of their use.

Sanorin of 0,1% solution is contraindicated to children up to 15 years.
With care
Pregnancy, lactation period, coronary heart disease (stenocardia), prostate hyperplasia, pheochromocytoma.

Pregnancy and lactation
 There are no data on penetration of naphazoline through a placental barrier, and also in breast milk. In this regard, at purpose of drug it is necessary to correlate possible risk for the child and a fruit and the expected therapeutic effect for mother.

Overdose:

At overdose of drug as a result of system impact on an organism such phenomena as nervousness, the increased perspiration, headache, tremor, tachycardia, heart consciousness, increase in arterial pressure can develop.

Also nausea, cyanosis, respiratory and mental disorders belong to possible signs of overdose.

In case of oppression of the central nervous system bradycardia, weakness, drowsiness, decrease in body temperature, increase in sweating, a collapse are observed, development of a coma is extremely seldom possible.

Treatment: symptomatic.

Storage conditions:

At a temperature from 10 to 25 °C in protected from light and the place, unavailable to children. Period of validity 4 years. Not to apply after the period of validity specified on packaging.

Issue conditions:

Without recipe

Packaging:

Spray of nasal 0,1%.
 10 ml of drug in the opaque translucent plastic bottle supplied with the dosing applicator which is screwing on mechanical with a protective cap and a plastic protective half ring for protection from accidental pressing.
Each bottle together with the application instruction is placed in a cardboard pack.