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

Excipients: Benzalkonium chloride 0.1 mg or 0.15 mg or 0.15 mg; disodium edetate dihydrate 0.5 mg; sodium dihydrogen phosphate dihydrate - 1.29 mg; sodium hydrophosphate dodecahydrate - 1.76 mg; sodium hydroxide 0.1 M solution to pH 6.2-7.0; purified water - up to 1 ml.

Description:Pcolorless or slightly yellowish liquid.

Pharmacotherapeutic group:Antitussive medication - alpha-adrenomimetic

ATX: & nbsp

S.01.G.A.04 Oxymetazoline

Pharmacodynamics:

Oxymetazoline has a vasoconstrictive effect.

When applied locally to the inflamed mucous membrane of the nasal cavity reduces its swelling and discharge from the nose. 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 middle ear cavity, 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).

Duration of the drug up to 12 hours.

Pharmacokinetics:

With topical intranasal application oxymetazoline does not have a systemic effect. The half-life of oxymetazoline with its intranasal administration is 35 hours. 2.1% of oxymetazoline is excreted in the urine and about 1,1% with feces.

Indications:

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

- Allergic rhinitis;

- Vasomotor rhinitis;

- to restore drainage with inflammation of the paranasal sinuses of the nasal cavity, eustachiitis, otitis media;

- to eliminate the edema before the diagnostic manipulation in the nasal passages.

Contraindications:

- Hypersensitivity to the components of the drug;

- atrophic rhinitis;

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

- angle-closure glaucoma;

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

- 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%.

Carefully:

In patients with increased intraocular pressure, suffering from diseases of the cardiovascular system (arterial hypertension,ischemic heart disease, chronic heart failure, tachycardia, arrhythmia), disorders of carbohydrate metabolism (diabetes), impaired function of the thyroid gland (hyperthyroidism), pheochromocytoma, chronic renal failure, benign prostatic hyperplasia (urinary retention) expressed arteriosclerosis, porphyria, and in patients taking tricyclic antidepressants and bromocriptine.

Pregnancy and lactation:

Sufficient experience in the use of the drug during pregnancy, breast-feeding is not.

There is no data as to whether the oxymetazoline in mother's milk.

The use of the drug during pregnancy and lactation is possible only if the potential benefit to the mother exceeds the possible risk to the fetus and the baby.

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: 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:

When assessing the frequency of occurrence of various adverse reactions, the following grades are used: often 1-10%; infrequently, 0.1-1%; rarely - 0,01-0,1%.

From the respiratory system

Often: burning and dryness of the nasal mucosa, sneezing (especially in sensitive patients), hypersecretion.

Infrequently: increased edema of the nasal mucosa (reactive hyperemia), epistaxis.

From the central nervous system

Rarely: hallucinations, headache, insomnia, fatigue (drowsiness, loss of strength).

From the side of the cardiovascular system

Infrequent: palpitation, tachycardia, increased blood pressure.

Very rarely: arrhythmia

Side effects due to the systemic effect of the drug: dizziness, anxiety, irritability, sleep disturbance (in children), nausea, exanthema, visual impairment (eye contact), Quincke's edema, itching, seizures, respiratory arrest (in infants).

Prolonged or 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 side effects indicated in the manual are aggravated, or if you notice other side effects (not listed in the instructions), inform the doctor about it.

Overdose:

Symptoms

Dilation of the pupils, nausea, cyanosis, fever, convulsions, tachycardia, arrhythmia, cardiac arrest, arterial hypertension, pulmonary edema, shortness of breath, central nervous system depression (lowering of body temperature, lethargy, drowsiness and coma).

Treatment

In severe overdose, the inpatient intensive care is indicated. Such measures as the reception of activated carbon, sodium sulfate or gastric lavage (when taking large amounts) should be carried out without delay, since oxymetazoline absorbed quickly. With a decrease in blood pressure, selective alpha-blockers should not be used. Vasoconstrictors are contraindicated.

If necessary, use antipyretic,anticonvulsants and perform artificial ventilation with oxygen.

Interaction:

Slows the absorption of local anesthetic drugs, lengthens their action.

There is a risk of interactions with MAO inhibitors leading to increased blood pressure. The drug should not be used by patients taking MAO inhibitors within the previous 2 weeks and within 2 weeks after their withdrawal.

Interaction with tricyclic antidepressants with a possible increased risk of hypertension and arrhythmia is proved.

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

Special instructions:

Avoid contact with eyes.

The drug should not be used without a break for more than 7 days.

Do not exceed the recommended dosage.

With prolonged use and overdose of oxymetazoline, the therapeutic effect may be weakened, as well as the risk of reactive hyperemia (drug rhinitis) and atrophy of the nasal mucosa.

The preparation contains benzalkonium chloride, which can cause irritation and swelling of the nasal mucosa.

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

In therapeutic doses does not affect the ability to drive a car and to control machinery.

When developing unwanted reactions, it is advisable to take care when performing actions that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

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

Packaging:

5 ml in polyethylene bottles, hermetically sealed with stoppers-droppers and caps screwed (for a dosage of 0.01%).

For 5, 10 or 15 ml in polyethylene bottles, hermetically sealed with stoppers-droppers and caps screwed (for doses of 0,025% and 0,05%).

Each bottle, together with the instructions for use, is placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of 0 to 25 FROM.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-003988

Date of registration:01.12.2016

Expiration Date:01.12.2021

The owner of the registration certificate:VIPS-MED, LLC VIPS-MED, LLC Russia

Manufacturer: & nbsp

Firm VIPS-MED, LLC Russia

Information update date: & nbsp24.05.2017

Illustrated instructions

Instructions

Oxymetazoline (Oxymetazoline)