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

Active substance:	11.25 μg / dose	22.5 μg / dose
Oxymetazoline hydrochloride	11.25 μg	22.5 μg
Excipients:
Citric acid anhydrous	25,065 mkg
Sodium citrate dihydrate	172,035 mkg
Glycerol anhydrous	952.425 mkg
Water for injections	43.839 mg	43.828 mg

Description:

Transparent or almost transparent, from almost colorless to light yellow liquid.

Pharmacotherapeutic group:Antitussive medication - alpha-adrenomimetic

ATX: & nbsp

S.01.G.A.04 Oxymetazoline

Pharmacodynamics:

Oksimetazolin belongs to the group of alpha-adrenostimulators for topical application. Has vasoconstrictive effect. With intranasal administration reduces swelling of the mucous membrane of the upper respiratory tract 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 reduces the likelihood of bacterial complications (sinusitis, sinusitis, otitis). With local intranasal use in therapeutic concentrations, it does not irritate and does not cause hyperemia of the mucous membrane of the nasal cavity.

Oxymetazoline 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% 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;

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

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

Contraindications:

- Hypersensitivity to the components of the drug;

- atrophic (dry) rhinitis;

- angle-closure glaucoma;

- condition after transsphenoidal hypophysectomy;

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

- Children under 1 year of age - for oxyfrin, a nasal spray dosed with 11.25 μg / dose;

- Children under 6 years of age - for oxyfrin, a nasal spray dosed with 22.5 μg / dose.

Carefully:

Patients suffering from diseases of the cardiovascular system (arterial hypertension,ischemic heart disease, chronic heart failure, severe atherosclerosis, tachycardia, arrhythmias), a violation of carbohydrate metabolism (diabetes mellitus), thyroid disorders (hyperthyroidism), pheochromocytoma, chronic renal failure, prostatic hyperplasia with clinical symptoms (urinary retention), elevated intraocular pressure, porphyria, as well as in patients taking monoamine oxidase inhibitors within the previous 2 weeks and within 2 weeks after their cancellation, tricyclic of sul antidepressants bromocriptine.

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 or child.

Dosing and Administration:

Intranasally.

Children aged 1 to 6 years: for 1 injection Oxifreen, a nasal spray dosed 11.25 μg / dose in each nostril 2-3 times a day. The drug is applied 5-7 days. The drug can be re-administered only after a few days.

Adults and children over 6 years of age: for 1 injection Oxifreen, a nasal spray dosed with 22.5 μg / dose in each nostril 2-3 times a day.

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

Doses above recommended can be used only under the supervision of a doctor.

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.

One 45 μl injection contains:

- 11.25 μg of oxymetazoline hydrochloride - for oxyfrin, a nasal spray dosed with 11.25 μg / dose;

- 22.5 μg of oxymetazoline hydrochloride - for oxyfrin, a nasal spray dosed with 22.5 μg / dose.

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 using the drug has passed, the feeling of "stuffiness" of the nose (reactive hyperemia).

Side effects,the systemic effect of the drug: increased blood pressure, headache, dizziness, palpitations, tachycardia, anxiety, anxiety, fatigue, drowsiness, sedation, irritability, sleep disturbances (in children), nausea, insomnia, exanthema, impaired vision in the eyes), hallucinations, angioedema, itching, seizures, respiratory arrest (in infants).

Prolonged continuous use of vasoconstrictors may cause tachyphylaxis, atrophy of nasal mucosa and returnable edema nasal mucosa (rhinitis medicamentosa).

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

Overdose:

Symptoms: anxiety, anxiety, hallucinations, convulsions, lowered body temperature, lethargy, drowsiness, coma, narrowing or dilating pupils, fever, sweating, pallor, cyanosis, palpitations, bradycardia, arrhythmia, cardiac arrest, increased blood pressure, lowering blood pressure, nausea , vomiting, respiratory depression, respiratory arrest.

Treatment: gastric lavage, reception of activated charcoal (with accidental ingestion of the drug inside); symptomatic.

Interaction:

When used simultaneously with monoamine oxidase inhibitors (during the previous 2 weeks and within 2 weeks after their withdrawal), tricyclic antidepressants or other drugs that increase blood pressure may increase blood pressure.

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:

Avoid contact with 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, in doses exceeding the recommended, one can not exclude the general effect on the cardiovascular system and the central nervous system. In these cases, care should be taken when driving vehicles and engaging in other potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Spray nasal dosed, 11.25 mcg / dose and 22.5 mcg / dose.

Packaging:

For 10 ml (190 doses) per vial of polyethylene, completed with a metering nozzle.

For 10 ml (190 doses) or 15 ml (280 doses) per vial of plastic, completed with a metering nozzle.

1 bottle 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.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-003421

Date of registration:20.01.2016

Expiration Date:20.01.2021

The owner of the registration certificate:GROTEKS, LLC GROTEKS, LLC Russia

Manufacturer: & nbsp

GROTEKS, LLC Russia

Representation: & nbspGROTEKS, LLCGROTEKS, LLC

Information update date: & nbsp25.05.2017

Illustrated instructions

Instructions

Oxifrine (Oxyfrin)