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

Excipients: Benzalkonium chloride 0.1 mg / 0.15 mg / 0.15 mg, disodium edetate (Trilon B) 0.5 mg / 0.5 mg / 0.5 mg, sodium hydroxide (0.1 M sodium hydroxide solution) to pH 6.0-7.0, sodium dihydrogen phosphate dihydrate (sodium phosphate monosubstituted 2-water) 1.29 mg / 1.29 mg / 1.29 mg, sodium hydrogen phosphate dodecahydrate (sodium phosphate disubstituted 12-water) 1.76 mg / 1.76 mg / 1.76 mg, purified water up to 1 ml.

Description:Transparent colorless or slightly colored liquid.

Pharmacotherapeutic group:anticonvulsant - alpha-adrenomimetic

ATX: & nbsp

S.01.G.A.04 Oxymetazoline

Pharmacodynamics:

Oxymetazoline belongs to the group of alpha-adrenostimulators for topical application. Has vasoconstrictive effect. With intranasal administration reduces the swelling of the mucous membrane of the upper respiratory tract, which leads to the relief of nasal breathing and the opening of the mouth of the paranasal sinuses and Eustachian tubes. The drug appears after 5 minutes after application and lasts for 8-12 hours.

Pharmacokinetics:

With topical application oxymetazoline practically not absorbed.

Indications:

- Treatment of acute respiratory diseases accompanied by a runny nose;

- allergic rhinitis;

- vasomotor rhinitis;

- for restoration of drainage with inflammation of the paranasal sinuses of the nasal cavity, eustachiitis, otitis media;

- for elimination of edema before diagnostic manipulations in the nasal passages.

Contraindications:

- Hypersensitivity to the components of the drug;

- atrophic (dry) rhinitis;

- administration of monoamine oxidase inhibitors during the previous 2 weeks and within 2 weeks after their withdrawal;

- angle-closure glaucoma;

- condition after transsphenoidal hypophysectomy;

- children's age to 1 year - for drops of 0.025%;

- children under 6 years old - for drops of 0.05%;

- pregnancy;

- lactation period.

Carefully:

Patients suffering from cardiovascular diseases (arterial hypertension, ischemic heart disease, chronic heart failure, tachycardia, arrhythmias), a violation of carbohydrate metabolism (diabetes mellitus), thyroid disorders (hyperthyroidism), pheochromocytoma, chronic renal failure, prostatic hyperplasia (retention of urine) and taking tricyclic antidepressants and bromocriptine.

Pregnancy and lactation:

The drug should only be used after a thorough assessment of the risk-benefit relationship for the mother and fetus.

Dosing and Administration:

Intranasally.

Adults and children over 6 years of age: Apply 1-2 drops of 0,05% solution in each nasal passage 2-3 times a day.

Children from 1 to 6 years: Apply 1-2 drops of 0,025% solution in each nasal passage 2-3 times a day.

Children under 1 year old: Children under 4 weeks are prescribed 1 drop of 0.01% solution in each nasal passage 2-3 times a day. From the 5th week of life and up to 1 year - 1-2 drops in each nasal passage 2-3 times a day.

It is not recommended to use the drug for more than 7 days. With frequent and prolonged use of the drug, the sensation of "congestion" of the nose may appear again or worsen. If these symptoms appear, discontinue treatment and consult a doctor.

Side effects:

Burning or dryness of the mucous membranes of the nasal cavity, dryness of the mucous membranes of the mouth and throat; sneezing; increase in the amount of secretion secreted from the nose; after the effect of using the drug has passed, a strong sense of "stuffiness" of the nose (reactive hyperemia). Side effects,caused by the systemic action of the drug: increased blood pressure, headache, dizziness, severe palpitation, tachycardia, increased anxiety, sedation, irritability, sleep disturbances (in children), nausea, insomnia, exanthema, visual impairment (eye contact). With prolonged use - tachyphylaxis, reactive hyperemia of the mucosa and atrophy of the mucous membrane of the nasal cavity.

Preservative benzalkonium chloride, which is part of the drug, can cause swelling of the mucous membrane of the nasal cavity. If this happens, it is necessary to change the drug to another, which does not contain preservatives.

Overdose:

Symptoms: nausea, increased blood pressure, tachycardia, depression of the central nervous system.

Treatment: symptomatic.

Interaction:

When used simultaneously with monoamine oxidase inhibitors (including the period within 14 days after their withdrawal) and tricyclic antidepressants, an increase in blood pressure may be observed. The drug slows the absorption of local anesthetic drugs, lengthens their action.

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

Special instructions:

In the recommended dose without consulting a doctor, use no more than 7 days. If the symptoms increase or the improvement does not occur within 3 days, you should consult your doctor.

Avoid contact with eyes.

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

After opening, use within 14 days.

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

When oxymetazoline is used in dosages exceeding the recommended levels, there may be an increase in blood pressure, tachycardia, or depression of the central nervous system. In these cases, the ability to drive a vehicle or equipment can be reduced.

Form release / dosage:

Nasal drops, 0.01%, 0.025% and 0.05%.

Packaging:

1 ml each in a dropper with a valve (for a concentration of 0.01%) or 2 ml in a tubing with a valve (for a concentration of 0.025%) or 10 ml in a polymer vial (for a concentration of 0.05%).

On a tube-droppers, ampoules, vials glue labels.

2, 5 tubes for 1 ml (for concentration 0.01%) or 2, 5 tubes for 2 ml (for a concentration of 0.025%) with instructions for use are placed in a pack of cardboard.

1 ampoule of polymer for 10 ml (for a concentration of 0.05%) complete with a bottle of dark glass with a screw mouth, sealed with a nozzle-sprayer, with instruction for use put in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001418

Date of registration:11.01.2012

The owner of the registration certificate:UPDATE OF PFC, CJSC UPDATE OF PFC, CJSC Russia

Manufacturer: & nbsp

UPDATE, PFC CJSC Russia

Representation: & nbspUPDATE OF PFC, CJSCUPDATE OF PFC, CJSC

Information update date: & nbsp11.08.2015

Illustrated instructions

Instructions

Siallor® Rhino (Sialor® rino)