Sanorin - instructions for use, dose, side effects, contraindications

naphazoline nitrate 0.005 g (0.05% solution) and 0.01 g (0.1% solution); Excipients: Ethylenediamine q.s. (about 0.4 mg). boric acid (0.170 g), methyl parahydroxybenzoate (0.010 g), water (up to 10 ml).

Description:

A clear, colorless liquid.

Pharmacotherapeutic group:The anticongestive agent is alpha-adrenomimetic.

ATX: & nbsp

A.01.A.A.08 Naphazoline

Pharmacodynamics:

Naphazoline refers to alpha₂-adrenomimetics with direct stimulating effect on the alpha-adrenergic receptors of the sympathetic nervous system. With intranasal administration, it has a rapid, pronounced and prolonged vasoconstrictive effect on the vessels of the nasal mucous membranes, nasopharynx and paranasal sinuses - reduces swelling and hyperemia, which improves nasal passages and facilitates nasal breathing. Along with this, the patency of eustachian tubes is restored. The therapeutic effect occurs, as a rule, within 5 minutes after the administration of the drug and persists for 4-6 hours.

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 nasopharyngeal mucosa;

- sinusitis;

- eustachiitis;

- laryngitis;

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

- if necessary stopping nasal bleeding.

Contraindications:

- hypersensitivity to the components of the drug;

- chronic rhinitis;

- atrophic rhinitis;

- angle-closure glaucoma;

- severe eye diseases;

- arterial hypertension;

- severe atherosclerosis;

- tachycardia;

- hyperthyroidism;

- diabetes;

- simultaneous administration of monoamine oxidase inhibitors and a period of up to 14 days after the end of their use.

Sanorin 0,05% solution is contraindicated in children under 2 years.

Sanorin 0.1% solution is contraindicated in children under 15 years of age.

Carefully:

Pregnancy, lactation, ischemic heart disease (angina pectoris), prostatic hyperplasia, pheochromocytoma.

Pregnancy and lactation:

There is no data on the penetration of naphazoline through the placental barrier, as well as in breast milk.In connection with this, when prescribing the drug, it is necessary to correlate the possible risk to the child and the fetus and the expected therapeutic effect for the mother.

Dosing and Administration:

Adults and children over 15 years of age:

1-3 drops of 0.1% Sanorin solution in each nasal passage 3-4 times a day.

Children 2-15 years old:

1-2 drops of 0,05% Sanorin solution in each nasal passage 2-3 times a day with an interval of not less than 4 hours.

Apply for a short time, not 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.

In the case of epistaxis, a cotton swab moistened with 0.05% Sanorin solution can be placed in the nasal passage.

With a rhinoscope for the prolongation of surface anesthesia: 2-4 drops of 0.1% solution with 1 ml of anesthetic.

The drug is digested in each nasal passage with a slightly tilted back head. When instilled in left bow must tilt head to the right, and when instilled in right nasal passage - to the left.

Side effects:

In recommended doses, the drug is usually well tolerated.

People with hypersensitivity can experience burning and dryness in the nose.

Prolonged and frequent use (more than 1 week) of Sanorin can lead to chronic disruption of nasal passages and atrophy of the nasal mucosa.

Overdose:

When an overdose of the drug as a result of systemic effects on the body can develop such phenomena as nervousness, excessive sweating, headaches, tremor, tachycardia, palpitations and increased blood pressure. The possible signs of an overdose include nausea, cyanosis, fever, respiratory and mental disorders.

In the case of central nervous system depression, bradycardia, weakness, drowsiness, decreased body temperature, increased sweating, collapse, it is extremely rare for coma to develop.

The risk of overdose rises in children. Children are more sensitive to the effects of the drug than adults.

Treatment: symptomatic.

Interaction:

With the simultaneous use of the drug with monoamine oxidase inhibitors or tricyclic antidepressants (up to 14 days after their use), an increase in blood pressure is possible, which is due to the release of deposited catecholamines under the action of naphazoline.Therefore, simultaneous administration of the drug Sanorin with MAO inhibitors (and within 14 days after their cancellation) is contraindicated.

Nafazoline slows the absorption of local anesthetics (prolongs their effect).

Special instructions:

Care should be taken when conducting general anesthesia with the use of anesthetics that increase the sensitivity of the myocardium to sympathomimetics (halothane).

Rarely, ricochet hyperemia and swelling of the mucous membrane of the nasal cavity develop.

May have a resorptive effect. As a result of irritation of the sympathetic nervous system and general effects on the body, nausea, tachycardia, headache, irritability, excessive sweating, allergic reactions, rash, increased blood pressure are extremely rare.

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

The drug does not affect activities that require increased attention and response (transport management, maintenance mechanisms, high-altitude work).

Form release / dosage:

Nasal drops 0.05% and 0.1%.

10 ml of the preparation in a bottle of brown glass, equipped with a dropper SANO with a cap of polyethylene and a security tape control the first opening.One bottle is placed in a cardboard box along with instructions for use.

Packaging:bottle-dropper brown glass (1) - packs cardboard

Storage conditions:

Store at a temperature of 10 to 25 ° C, in a place protected from light.

Keep out of the reach of children.

Shelf life:

3 years.

Shelf life of the opened bottle is 4 weeks.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:П N011463 / 01

Date of registration:06.11.2009

The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel

Manufacturer: & nbsp

TEVA Czech Industries, s.r.o. Czech Republic

IVAX Pharmaceuticals, s.r.o. Czech Republic

Representation: & nbspTeva Teva Israel

Information update date: & nbsp31.07.2015

Illustrated instructions

Instructions

Sanorin (Sanorin)