Rhinostop Extra, nasal drops 0.01%, 10ml

Composition

Composition per 1 ml:

Pharmacological action

Pharmacodynamics .

Rhinostop®Cold remedy Extra (oxymetazoline) has a vasoconstrictive effect. When applied topically to the inflamed nasal mucosa, it reduces its puffiness, nasal congestion, and nasal discharge, eliminating the symptoms of rhinitis.

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

Glycerol included in Rhinostop® Extra, promotes moisture retention, which helps provide moisture to dry or irritated nasal mucosa.

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

Pharmacokinetics.

With local intranasal use, 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.

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 sinusitis, eustachiitis, otitis media;

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

Use during pregnancy and lactation

When used during pregnancy or lactation, do not exceed the recommended dose. The drug can only be used if the potential benefit to the mother exceeds the potential risk to the fetus and child.

Contraindications

• Atrophic rhinitis;
• hypersensitivity to the components of the drug;
• angle-closure glaucoma;
• condition after transsphenoidal pituitary
• surgery;dura mater surgery (in the anamnesis);
• children under 1 year of age – for drops 0.025%;
• children under 6 years of age – for drops 0.05%.

It is necessary to adhere to the recommended concentrations of the drug intended for different age categories (see methods of application). With caution: In patients taking monoamine oxidase (MAO) inhibitors and other drugs that increase blood pressure (including for up to 14 days after their withdrawal); in patients with concomitant severe forms of cardiovascular diseases (arterial hypertension, coronary heart disease, chronic heart failure, tachycardia, arrhythmias); in hyperthyroidism, diabetes mellitus, pheochromocytoma, prostatic hyperplasia with clinical manifestations (urinary retention), severe atherosclerosis, porphyria, during pregnancy and lactation, 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 taking 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; increased volume of secretions released from the nose; nosebleeds; after the effect of the drug passes, a feeling of nasal congestion (reactive hyperemia).

Side effects due to the systemic action of the drug (with accidental ingestion of the solution): increased blood pressure, headache, dizziness, palpitation, tachycardia, restlessness, anxiety, fatigue, drowsiness, sedation, irritability, sleep disturbance (in children), nausea, insomnia, exanthema, hallucinations, angioedema, itching, convulsions, respiratory arrest (in infants). Visual impairment (in case of contact with eyes).

Prolonged continuous use of vasoconstrictor drugs can lead to tachyphylaxis, atrophy of the nasal mucosa and recurrent swelling of the nasal mucosa (drug-induced rhinitis).

If you experience any of the side effects listed in the instructions or other side effects that are not listed in the instructions, contact your doctor.

The interaction

slows down the absorption of local anesthetic drugs (extends their effect during surface anesthesia).

The combined use of other vasoconstrictor drugs increases the risk of side effects.

Concomitant use of MAO inhibitors (including a period of 14 days after their withdrawal), tricyclic antidepressants and bromocriptine increases the risk of high blood pressure.

How to take, course of use and dosage

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 year to 6 years: apply-1-2 drops of 0.025% solution in each nasal passage 2-3 times a day.

Children under one year of age: children under 4 weeks of age – 1 drop of 0.01% solution in each nasal passage 2 – 3 times a day. From the 5th week of life to 1 year-1-2 drops in each nasal passage 2-3 times a day.

At the recommended dose, do not use for more than 5-7 days without consulting a doctor. If symptoms worsen or do not improve within 3 days, you should consult your doctor.

Overdose

If the drug is accidentally taken orally or overdosed, the following symptoms may occur: anxiety, restlessness, hallucinations, convulsions, low body temperature, lethargy, drowsiness, coma, constriction or dilation of the pupils, fever, sweating, pallor, cyanosis, palpitation, bradycardia, arrhythmia, cardiac arrest, increased blood pressure, decreased blood pressure, nausea, vomiting, respiratory depression, respiratory arrest.

Treatment: gastric lavage, taking activated charcoal; symptomatic.

Special instructions

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

Avoid contact with the eyes.

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

Influence on the ability to drive vehicles and mechanisms.

After long-term use of cold remedies containing oxymetazoline, and in doses exceeding the recommended ones, it is impossible to exclude the overall effect on the cardiovascular system and central nervous system. In these cases, it is recommended to use caution when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Nasal drops in the form of a clear, colorless or yellowish solution.

Storage conditions

Store at a temperature not exceeding 25 °C. Keep out of reach of children. Store in the original packaging.

Shelf

life is 3 years. Do not use the product after the expiration date.

Active ingredient

Oxymetazoline

Dosage form

nasal drops