Rinostop Extra - instructions for use, dose, side effects, contraindications

	Dosage:
	0,01%	0,025 %	0,05 %
Active substance:
oxymetazoline hydrochloride	0.1 mg	0,25mg	0.5 mg
Excipients:
citric acid monohydrate	0.6093mg	0.6093mg	0.6093mg
sodium citrate dihydrate	3.8230mg	3.8230mg	3.8230mg
glycerol	24.3480mg	24.3480mg	24.3480mg
benzalkonium chloride 50% solution	0.1000 mg	0.1000 mg	0.1000 mg
purified water	up to 1 ml	up to 1 ml	up to 1 ml

Description:Transparent colorless or yellowish solution.

Pharmacotherapeutic group:An anticongestive agent (alpha-adrenomimetic)

ATX: & nbsp

S.01.G.A.04 Oxymetazoline

Pharmacodynamics:

Remedy for rhinostop® Extraoxymetazoline) has a vasoconstrictive effect. When applied locally to the inflamed mucous membrane of the nasal cavity reduces its swelling, nasal congestion, discharge from the nose, eliminating the symptoms of rhinitis. 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 cavity middle ear, which prevents the development 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. The drug starts to act quickly (within a few minutes).The duration of action of Rhinostop® Extra is up to 12 hours.

Pharmacokinetics:

With local intranasal use, the drug does not have a systemic effect. The half-life of oxymetazoline with its intranasal administration is 35 hours. 2.1% of oxymetazoline is excreted by the kidneys and about 1.1% through the intestine.

Indications:

- Treatment of acute respiratory diseases accompanied by rhinitis (runny nose);

- allergic rhinitis;

- vasomotor rhinitis;

- to facilitate the outflow of the discharge from the paranasal sinuses with sinusitis, eustachitis, average otitis media;

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

Contraindications:

- Atrophic rhinitis;

- hypersensitivity to the components of the drug;

- angle-closure glaucoma;

- condition after transsphenoidal hypophysectomy;

- surgical interventions on the dura mater (in the anamnesis);

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

- Children under 6 years old - for drops of 0.05%.

It is recommended to adhere to recommended concentrations of the drug, intended for different age categories (see methods of use).

Carefully:

In patients taking monoamine oxidase (MAO) inhibitors and other drugs that promote blood pressure (including up to 14 days after their cancellation); in patients with concomitant severe forms of cardiovascular diseases (arterial hypertension, ischemic heart disease, chronic heart failure, tachycardia, arrhythmias); with hyperthyroidism, diabetes, pheochromocytoma, prostatic hyperplasia with clinical manifestations (urinary retention), severe atherosclerosis, porphyria, during pregnancy and during breastfeeding, with increased intraocular pressure, chronic renal failure, in patients taking tricyclic antidepressants and bromocriptine, as well as other drugs that increase blood pressure.

If you have one or more of the diseases and conditions listed above, you should consult your doctor before you start taking the drug.

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 and the baby.

Dosing and Administration:

Intranasally.

Adults and children over 6 years of age: - Apply 1 to 2 drops of 0.05% solution in each nasal passage 2-3 times a day.

Children from 1 to 6 years: Apply - for 1 - 2 drops of 0.025% solution in each nasal passage 2-3 times a day.

Children up to one year: children under 4 weeks - 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.

In the recommended dose without consulting a doctor to apply no more than 5-7 days. If the symptoms increase or the improvement does not occur within 3 days, you should consult your 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; nose bleed; after the effect of the drug has passed, a sense of nasal congestion (reactive hyperemia).

Side effects caused by the systemic effect of the drug (with the occasional reception of the solution inside): increased blood pressure, headache,

dizziness, palpitations, tachycardia, anxiety, anxiety, fatigue, drowsiness, sedation, irritability, sleep disturbances (in children), nausea, insomnia, exanthema, hallucinations, angioedema, itching, seizures, respiratory arrest (in infants). Visual impairment (on contact with 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).

If any of the side effects indicated in the manual occur or other side effects not listed in the instructions, contact your doctor.

Overdose:

In case of accidental ingestion or overdose, the following symptoms may appear: anxiety, anxiety, hallucinations, convulsions, lowering of body temperature, lethargy, drowsiness, coma, narrowing or dilating pupils, fever, sweating, pallor, cyanosis, palpitations, bradycardia, arrhythmia, cardiac arrest, increased blood pressure, lower blood pressure, nausea, vomiting, respiratory depression, respiratory arrest.

Treatment: gastric lavage, reception of activated charcoal; symptomatic.

Interaction:

Slows the absorption of local anesthetic drugs (lengthens their action in the conduct of surface anesthesia).

Joint use of other vasoconstrictive drugs increases the risk of side effects.

With simultaneous use of MAO inhibitors (including the period within 14 days after their withdrawal), tricyclic antidepressants and bromocriptine - the risk of increasing blood pressure.

Special instructions:

Avoid prolonged use and overdose of the drug, especially in children.

Avoid contact with the eyes.

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

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

After a prolonged use of funds from the cold, containing oxymetazoline, and 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, it is recommended to use caution when driving vehicles and engaging in other potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

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

Packaging:

5 ml, 10 ml or 15 ml of the drug in a bottle - droppers polymer with a screw mouth, a stopper, a screw cap with a control ring of the first opening.

1 bottle-dropper polymer with instructions for use in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Keep in original packaging.

Conditions of transportation.

In accordance with GOST 17768-90.

Shelf life:

3 years. At the end of the expiration date the drug should not be used.

Terms of leave from pharmacies:Without recipe

Registration number:LP-004192

Date of registration:16.03.2017

Expiration Date:16.03.2022

The owner of the registration certificate:Otisipharm, PAO Otisipharm, PAO

Manufacturer: & nbsp

Pharmaceutical firm LEKKO, ZAO Russia

Information update date: & nbsp04.04.2017

Illustrated instructions

Instructions

Rhinostop® Extra (Rinostop® Extra)