Otrivin Moisturizing Formula, nasal spray dispensed 0.1%, 10ml

Product description

Otrivin nasal spray dosed 0.1%. The moisturizing formula reduces the symptoms of irritation and dryness of the nasal mucosa. Relieves nasal congestion in 2 minutes, maintaining the effect for up to 12 hours*. * Instructions for medical use, RU no. P N011649 / 04 of 10.09.08

Composition

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1 ml contains:  

Active ingredient:  

Xylometazoline hydrochloride 1 mg.

Auxiliary substances:  

Sodium Dihydrogen Phosphate Dihydrate;Sodium hydrophosphate Dodecahydrate; Sodium chloride; Benzalkonium chloride (in the form of 50% solution); Sorbitol 70%; Disodium edetate; Levomentol (menthol); Cineol (eucalyptol); Macrogol glycerylhydroxystearate; Purified water.

Pharmacological action

Xylometazoline has an alpha-adrenomimetic effect: causes narrowing of the blood vessels of the nasal mucosa, eliminating edema and hyperemia of the nasopharyngeal mucosa. Xylometazoline also reduces concomitant mucus hypersecretion and facilitates drainage of blocked nasal passages, thus improving nasal breathing in nasal congestion. Otrivin® is well tolerated in patients with sensitive mucosa, its effect does not interfere with the separation of mucus. Otrivin ® has a balanced pH value characteristic of the nasal cavity. The menthol and eucalyptol contained in the preparation have a cooling effect on the nasal mucosa, which gives a feeling of freshness. In therapeutic concentrations, the drug does not irritate the mucous membrane, does not cause hyperemia. The action occurs 2 minutes after application and lasts for 12 hours. In vitro studies have shown that in humans, xylometazoline suppresses the infectious activity of the rhinovirus that causes the “common cold”.

Clinical pharmacology

When applied topically at the recommended doses, it is practically not absorbed, and plasma concentrations are below the detection limit.

Indications

• Acute respiratory diseases with rhinitis (runny nose);
• acute allergic rhinitis, pollinosis, sinusitis, eustachiitis, otitis media (to reduce the swelling of the nasopharyngeal mucosa);
• preparation of the patient for diagnostic manipulations in the nasal passages.

Use during pregnancy and lactation

The drug should not be used during pregnancy. During lactation, use is possible only under the supervision of a doctor and after careful assessment of the risk-benefit ratio for the mother and fetus. Do not exceed the recommended dose.

Contraindications

• Hypersensitivity to the components of the drug; 
• arterial hypertension;
• tachycardia;
• severe atherosclerosis;
• glaucoma;
• atrophic rhinitis;
• hyperthyroidism;
• surgical interventions on the meninges (in the anamnesis);
• children under 6 years of age.

Use with caution in patients with diabetes mellitus, cardiovascular diseases, hypersensitivity to adrenergic drugs, accompanied by symptoms of insomnia, dizziness, cardiac arrhythmia, tremor, increased blood pressure.

Side effects

Determination of the frequency of adverse reactions: very common ≥10); common (≥1/100, <1/10); infrequent (≥1/1000, <1/100); rare (≥1/10 000, <1/1000); very rare (Immune system disorders: very rarely – hypersensitivity reactions (angioedema, rash, pruritus). From the nervous system: often-headache; rarely-insomnia, depression (with prolonged use in high doses). From the side of the senses: very rarely – violation of the clarity of visual perception. From the cardiovascular system: rarely-palpitation, increased blood pressure; very rarely-tachycardia, arrhythmia. From the respiratory system: often-irritation and / or dryness of the nasopharyngeal mucosa, burning, tingling, sneezing, hypersecretion of the nasopharyngeal mucosa. From the digestive system: often-nausea; rarely-vomiting. Local reactions: often-burning sensation at the site of application. If any of the above side effects get worse, or the patient notices any other side effects, they should inform their doctor.

Interaction

Xylometazoline is contraindicated in patients who are currently receiving MAO inhibitors or who have received them for the previous 2 weeks. Concomitant use of tri-or tetracyclic antidepressants and sympathomimetic drugs may lead to an increase in the sympathomimetic effect of xylometazoline, so this combination is recommended to avoid.

How to take, course of use and dosage

Intranasally.

 Adults and children over 12 years of age — 1 injection in each nasal passage 3 times a day.

Do not use more than 3 times a day.

Overdose

Symptoms: xylometazoline, when applied topically in an excessive dose or accidentally ingested, can cause severe dizziness, increased sweating, a sharp decrease in body temperature, headache, bradycardia, increased blood pressure, respiratory depression, coma and convulsions. Following an increase in blood pressure, there may be a sharp decrease in it. Treatment: Appropriate supportive measures should be taken in case of any suspected overdose, in some cases immediate symptomatic treatment is indicated under the supervision of a doctor. These measures should include monitoring the patient for several hours. In case of severe poisoning with cardiac arrest, resuscitation measures should last at least 1 hour.

Description

Nasal spray dosed 0.1% in the form of a clear colorless solution, practically odorless.

Special instructions

It is not recommended to use continuously for more than 10 days.

Do not exceed the recommended dose, especially in children and the elderly.

Prolonged (more than 10 days) or excessive use of the drug can cause a rebound effect (drug-induced rhinitis).

Product form

10 ml-high-density polyethylene bottles (1) with pump metering device-cardboard packs.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C.

Shelf life

3 years

Active ingredient

Xylometazoline

Dosage form

nasal spray

Description

Children over 12 years of age, For adults, Nursing mothers as prescribed by a doctor

Indications

Hay Fever, Cold, Sinusitis, Runny Nose, Sinusitis, Otitis Media, Allergic Rhinitis, Flu, Allergy