Rhinostop Extra, drops 0.025% 10 ml

Pharmacodynamics.

The rhinostop ^® Extra (oxymetazoline) has a vasoconstrictor effect. When applied topically to the inflamed nasal mucosa it reduces nasal swelling, nasal congestion and nasal discharge, eliminating the symptoms of rhinitis.

Restores nasal breathing. Elimination of nasal mucous membrane edema restores aeration of paranasal sinuses, middle ear cavity which prevents development of bacterial complications (maxillary sinusitis, sinusitis, otitis media). When used locally intranasally in therapeutic concentrations it does not irritate and does not cause nasal mucous membrane hyperemia.

Glycerol, which is part of Rinostop^® Extra, helps retain moisture, which helps provide hydration to dry or irritated nasal mucosa.

The drug takes effect quickly (within minutes). The duration of action of Rinostop^® Extra is up to 12 hours.

Pharmacokinetics.

In local intranasal administration the drug has no systemic action.

The elimination half-life of oxymetazoline when administered intranasally is 35 h. 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 discharge from the paranasal sinuses in case of sinusitis, eustachitis, otitis media;

– to eliminate swelling before diagnostic manipulations in the nasal passages.

Pharmacological effect

Pharmacodynamics.

The cold remedy Rinostop® Extra (oxymetazoline) has a vasoconstrictor effect. When applied topically to the inflamed mucous membrane of the nasal cavity, it reduces swelling, nasal congestion, and nasal discharge, eliminating the symptoms of rhinitis.

Restores nasal breathing. Elimination of swelling of the nasal mucosa helps restore aeration of the paranasal sinuses and middle ear cavity, which prevents the development of bacterial complications (sinusitis, sinusitis, otitis media). When used locally intranasally in therapeutic concentrations, it does not irritate or cause hyperemia of the nasal mucosa.

Glycerol, which is part of Rinostop® Extra, promotes moisture retention, which helps provide hydration to dry or irritated nasal mucosa.

The drug begins to act quickly (within a few minutes). The duration of action of Rinostop® Extra is up to 12 hours.

Pharmacokinetics.

When administered locally intranasally, the drug does not have a systemic effect.

The half-life of oxymetazoline when administered intranasally is 35 hours. 2.1% of oxymetazoline is excreted by the kidneys and about 1.1% through the intestines.

Special instructions

Long-term use and overdose of the drug should be avoided, especially in children.

Avoid contact of the drug with the eyes.

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

Impact on the ability to drive vehicles. Wed and fur.:

After long-term use of cold remedies containing oxymetazoline, and in doses exceeding the recommended ones, a general effect on the cardiovascular system and central nervous system cannot be excluded.

In these cases, it is recommended to be careful when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Active ingredient

Oxymetazoline

Composition

Composition per 1 ml:

Dosage:

0.01%

0.025%

0.05%

Active ingredient:

oxymetazoline hydrochloride

0.1 mg

0.25 mg

0.5 mg

Excipients:

citric acid monohydrate

0.6093 mg

0.6093 mg

0.6093 mg

sodium citrate dihydrate

3.8230 mg

3.8230 mg

3.8230 mg

glycerol

24.3480 mg

24.3480 mg

24.3480 mg

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

Pregnancy

When used during pregnancy or breastfeeding, do not exceed the recommended dose. The drug can only be used in cases where the potential benefit to the mother outweighs the potential risk to the fetus and child.

Contraindications

Atrophic rhinitis;
hypersensitivity to the components of the drug;
angle-closure glaucoma;
condition after transsphenoidal hypophysectomy;
surgical interventions on the dura mater (history);
children under 1 year of age – for drops 0.025%;
children under 6 years of age – for drops of 0.05%.
You should adhere to the recommended concentrations of the drug intended for different age categories (see methods of use).

With caution:

In patients taking monoamine oxidase inhibitors (MAO) and other drugs that increase blood pressure (including for up to 14 days after their discontinuation); in patients with concomitant severe forms of cardiovascular diseases (arterial hypertension, coronary heart disease, chronic heart failure, tachycardia, arrhythmias); with hyperthyroidism, diabetes mellitus, 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 starting to take the drug.

Side Effects

Burning or dryness of the mucous membranes of the nasal cavity, dryness of the mucous membranes of the mouth and throat; sneezing; an increase in the volume of secretions released from the nose; nosebleeds; after the effect of the drug wears off, a feeling of nasal congestion (reactive hyperemia).

Side effects caused by the systemic effect of the drug (if the solution is accidentally taken orally): increased blood pressure, headache, dizziness, palpitations, tachycardia, restlessness, anxiety, fatigue, drowsiness, sedation, irritability, sleep disturbance (in children), nausea, insomnia, exanthema, hallucinations, Quincke’s edema, itching, convulsions, respiratory arrest (in infants). Visual impairment (if in contact with eyes).

Long-term continuous use of vasoconstrictor drugs can lead to tachyphylaxis, atrophy of the nasal mucosa and recurrent swelling of the nasal mucosa (rhinitis medicamentosa).

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

Interaction

Slows down the absorption of local anesthetic drugs (prolongs their effect during superficial anesthesia).

Concomitant use of other vasoconstrictor 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 – there is a risk of increased blood pressure.

Overdose

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

Treatment: gastric lavage, taking activated carbon; symptomatic.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Store in original packaging.

Shelf life

3 years. After the expiration date, do not use the drug.

Manufacturer

Lecco CJSC, Russia