Otrivin

Otrivin (xylometazoline hydrochloride) is a vasoconstrictor-decongestant for use in otorhinolaryngological practice for rhinitis (including allergic origin), sinusitis, and otitis. Method of application: intranasal. The group of nasal decongestants is united by the property of constricting the blood vessels of the nasal mucosa. As a result, nasal breathing is facilitated and excessive mucus secretion is eliminated. A feature of vasoconstrictors is that their use is limited to five to seven days (primarily this applies to nasal drops, which are more difficult to dose than sprays). One of the most popular drugs in this group among domestic consumers is Otrivin, which, in addition to xylometazoline, contains moisturizing ingredients - sorbitol, which normalizes the degree of hydration of the mucous membrane and prevents it from drying out, as well as methylhydroxypropylcellulose, which potentiates the effects of sorbitol and has its own moisturizing effect due to changes in rheological properties solution. Otrivin is an effective drug that facilitates nasal breathing without irritating the mucous membrane and without disrupting the functioning of the ciliated epithelium lining it. Unlike its “colleagues” in the pharmacological group, it has a long-lasting (up to 10-12 hours) effect and is indicated for use within 14 days (as opposed to other decongestants, which cannot be used for more than one week). These features of the drug distinguish it from the general series and allow it to be considered a leader among other vasoconstrictor-decongestants.

It is well tolerated, incl. in persons with hypersensitive mucous membranes, and its acid-base balance corresponds to the physiological values characteristic of the nasal cavity. Menthol and cineol, which are part of the drug, have a cooling effect and bring a feeling of freshness to the mucous membrane. When used in doses recommended by the manufacturer, it does not irritate the mucous membrane and does not increase blood flow to the blood vessels located near it. The therapeutic effect of the drug is noted already in the second minute of its instillation into the nasal cavity. When used intranasally in therapeutic doses, it is not absorbed into the systemic circulation. Contraindicated in persons with arterial hypertension, individual intolerance to xylometazoline and auxiliary components of the drug, advanced atherosclerosis, hyperthyroidism, glaucoma, as well as pregnant and lactating women. The drug can be used in pediatric practice under the supervision of a doctor (for children under one year old), adults (for children under 6 years old). Otrivin should be used with caution in elderly patients. If the recommended duration of use of the drug is exceeded, the development of so-called “rebound effect” (increased signs of rhinitis).

Otrivin nasal spray 0.1% fl 10ml eucalyptus-menthol

Registration Certificate Holder

GlaxoSmithKline Healthcare (Russia)

Dosage form

Medicine - Otrivin® (Otrivin®)

Description

Dosed nasal spray (with menthol and eucalyptus) 0.1%

in the form of a colorless opalescent solution with a characteristic odor of menthol and eucalyptus.

1 ml

xylometazoline hydrochloride 1 mg

Excipients

: sodium dihydrogen phosphate dihydrate - 2 mg, sodium hydrogen phosphate dodecahydrate - 2.8 mg, sodium chloride - 5 mg, benzalkonium chloride 50% solution - 0.1 mg (in terms of benzalkonium chloride - 0.05 mg), sorbitol 70% - 14 mg, disodium edetate - 0.5 mg, levomenthol (menthol) - 0.3 mg, cineole (eucalyptol) - 0.2 mg, macrogol glyceryl hydroxystearate - 2.5 mg, purified water - up to 1 ml.

10 ml - bottles made of high-density polyethylene (1) with a pump dispenser, tip and protective cap made of polyethylene - cardboard packs.

Indications

acute respiratory diseases with symptoms of rhinitis;
acute allergic rhinitis;
hay fever;
sinusitis;
eustachitis;
otitis media (to reduce swelling of the nasopharyngeal mucosa);
preparing the patient for diagnostic manipulations in the nasal passages.

Contraindications for use

hypersensitivity to xylometazoline and other components of the drug;
arterial hypertension;
tachycardia;
severe atherosclerosis;
glaucoma;
dry rhinitis or atrophic rhinitis;
hyperthyroidism;
condition after transsphenoidal hypophysectomy;
surgical interventions on the meninges (history);
children's age up to 12 years.

Carefully:

diabetes; pheochromocytoma; cardiovascular diseases (including ischemic heart disease, angina pectoris); prostatic hyperplasia; with increased sensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure.

pharmachologic effect

Xylometazoline has an alpha-adrenomimetic effect: it causes a constriction of the blood vessels of the nasal mucosa, eliminating swelling and hyperemia of the nasopharyngeal mucosa. Xylometazoline also reduces the accompanying hypersecretion of mucus and facilitates the drainage of nasal passages blocked by secretions and thus improves nasal breathing during nasal congestion.

Otrivin® is well tolerated by patients with sensitive mucous membranes; its effect does not interfere with mucus secretion. 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, giving a feeling of freshness.

In therapeutic concentrations, the drug does not irritate the mucous membrane and does not cause hyperemia.

The effect occurs 2 minutes after application and continues for 12 hours.

In vitro studies have shown that in humans, xylometazoline inhibits the infectious activity of rhinovirus, which causes the common cold.

Drug interactions

Xylometazoline is contraindicated in patients currently receiving MAO inhibitors or who have received them within the previous 2 weeks.

The simultaneous 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 be avoided.

Dosage regimen

Intranasally.

Adults and children over 12 years of age:

1 injection into each nasal passage 3 times a day.
Should not be used more than 3 times/day.
It is recommended to apply the last time just before bedtime.

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, a sharp decrease may be observed.

Treatment:

Appropriate supportive measures should be taken if overdose is suspected, and in some cases immediate symptomatic treatment under medical supervision is indicated. 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.

Side effect

Determination of the frequency of adverse reactions: very often ≥10); often (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rarely ( ≥

1/10,000, <1/1000); very rare (<1/10,000).

From the immune system:

very rarely - hypersensitivity reactions (angioedema, rash, itching).

From the nervous system:

often - headache; rarely - insomnia, depression (with long-term use in high doses).

From the senses:

very rarely - impaired clarity of visual perception.

From the cardiovascular system:

rarely - palpitations, 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 at the site of application.

If any of the above side effects worsen, or the patient notices any other side effects, he should inform the doctor.

special instructions

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

Recommended doses should not be exceeded, especially in children and elderly patients.

Long-term (more than 10 days) or excessive use of the drug may cause a rebound effect (rhinitis medicamentosa) and/or atrophy of the nasal mucosa.
Effect on the ability to drive vehicles and operate machinery
Xylometazoline does not affect the ability to drive vehicles and operate machinery.

Storage conditions

The drug in the form of an odorless spray should be stored at a temperature not exceeding 30°C.

Best before date

Shelf life – 3 years.

The drug in the form of a menthol-scented spray should be stored at a temperature not exceeding 25°C. Shelf life – 2.5 years.

The drug should be stored out of the reach of children.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - Contraindicated. Restrictions when breastfeeding - With caution.

The drug should not be used during pregnancy.

During lactation, use is possible only under the supervision of a physician and after a careful assessment of the risk-benefit ratio for the mother and fetus. Do not exceed the recommended dose.

Use in elderly patients

Restrictions for elderly patients - Use with caution.

The recommended dose and duration of use of the drug should not be exceeded, especially in elderly patients.

Use in children

Restrictions for children - Contraindicated. Contraindicated for children under 12 years of age.

Terms of sale

The drug is available without a prescription.

Contacts for inquiries

GlaxoSmithKline Healthcare JSC (Russia)

GlaxoSmithKline Healthcare AO

123112 Moscow, Presnenskaya embankment, 10, fl. 6, room III, room. 9 Tel.

Otrivin Baby Comfort disposable replaceable extra-soft nozzles No. 10

A country

France, Switzerland
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.

Compound

Polyvinyl chloride, melamine foam.

Product description

The package contains ten soft disposable nozzles with an absorbent filter for use with the Otrivin Baby Comfort nasal aspirator, which is purchased separately. The anatomical shape of the nozzle makes it easy to install into the child’s nasal passage, eliminating injury. Each nozzle contains an absorbent filter that traps mucus secretions, ensuring clean and hygienic use. Removing mucous secretions helps prevent further complications such as ear infections (otitis media), sinus infections (sinusitis), or coughs. To facilitate the procedure, before using the Otrivin Baby Comfort nasal aspirator, it is recommended to rinse your nose with a saline solution, for example, Otrivin Baby drops.

Indications for use

Nasal aspirator Otrivin Baby Comfort is intended for children (newborns, infants, young children). The aspirator helps cleanse your child's nose by gently removing mucous secretions that bother him. Replaceable soft nozzles are ideal for baby's nose; contain an absorbent filter that retains mucus. Disposable nozzles are hygienic to use.

Contraindications

Individual intolerance to the components of the drug.

Carefully

Before use, you should carefully read the information on the packaging. To avoid re-infection, the used nozzle should be thrown away.

Use during pregnancy and lactation

There are no contraindications for use during pregnancy and lactation.

Directions for use and doses

1. Attach the replacement tip (A) to the center body (B) of the aspirator. 2. Place the mouthpiece (C) in the mouth (for parents and caregivers) and insert the tip (A) into one of the child's nasal passages. 3. Gently draw in air through your mouth using even breaths through the mouthpiece (C). 4. If the tip becomes filled with secretions between breaths, remove the secretion from the tip into a tissue by blowing through the mouthpiece, or replace the tip. 5. Repeat the procedure for the other nasal passage. 6. Disconnect and discard used attachment (A). For hygiene reasons and to prevent re-infection, the attachments should only be used once

special instructions

Do not use the aspirator and attachments if you are allergic to the materials from which the product components are made. The aspirator should not be used if it is tampered with or damaged.

Release form

Replaceable soft nozzles for the nasal aspirator Otrivin Baby Comfort in the amount of 10 pieces. In cardboard packaging

Storage conditions

Keep out of the reach of children in the original packaging. Store at temperatures from O °C to 30 °C.

Best before date

3 years. Do not use after the expiration date stated on the packaging.