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OTRIZOL-DF

nasal drops 0.05%, 0.1%, 10 ml

Dispensing conditions: NO PRESCRIPTION 

Category: Nasal preparations

THERAPEUTIC INDICATIONS:

  • acute respiratory diseases with rhinitis (runny nose);

  • vasomotor rhinitis;

  • acute allergic rhinitis (hay fever, pollinosis);

  • sinusitis;

  • otitis media (as part of combined therapy - to reduce nasopharyngeal mucosal edema);

  • preparing the patient for diagnostic procedures in the nasal passages.

dwldDownload instructions for use

Composition

1 ml of the product contains:

active substance - xylometazoline hydrochloride 0.5 mg or 1 mg, excipients: hydrophosphate dodecahydrate, sodium dihydrophosphate dihydrate, sodium chloride, edetate disodium, benzalkonium chloride (as a 10% solution), purified water.

Pharmaceutical form

Otrizol-DF®, nasal drops 0.05%, 0.1%, 10 ml.

Pharmacotherapeutic group

Respiratory system. Nasal preparations. Decongestants and other nasal medications for topical use. Simple sympathomimetics. Xylometazoline.

ATC code R01AA07

Indications

  • acute respiratory diseases with rhinitis (runny nose);
  • vasomotor rhinitis;
  • acute allergic rhinitis (hay fever, pollinosis);
  • sinusitis;
  • otitis media (as part of combined therapy - to reduce nasopharyngeal mucosal edema);
  • preparing the patient for diagnostic procedures in the nasal passages.

Contraindications

  • hypersensitivity to the components of the product;
  • atrophic rhinitis;
  • closed angle glaucoma;
  • surgical interventions on the cerebral membranes (history);
  • hyperthyroidism;
  • diabetes mellitus;
  • pronounced atherosclerosis;
  • arterial hypertension;
  • tachycardia;
  • severe eye diseases;
  • pheochromacytoma;
  • porphyria
  • prostatic hyperplasia;
  • concomitant use of monoamine oxidase inhibitors and a period of up to 14 days after the end of their use;
  • children under 2 years of age (for Otrizol-DF 0.05%);
  • children under 12 years of age (for Otrizol-DF 0.1%);
  • pregnancy and lactation period.

Posology and method of administration

Intranasally.

  • 0.05% nasal drops for children over 2 years of age 1 drop in each nasal passage 1-2 times a day.
  • 0.1% nasal drops for adults and children over 12 years of age: 1-2 drops in each nasal passage 1-2 times a day.

Do not use more than 3 times a day.

The course of treatment is not more than 5-7 days.

Adverse reactions

Common:

  • with frequent or prolonged use, irritation or dryness of nasal mucosa, nasal mucous atrophy, burning, sneezing, dependence, hypersecretion, chronic rhinitis, headache are possible.

Uncommon:

  • palpitations;
  • heart rhythm disorder;
  • increased blood pressure
  • nausea;
  • vomiting;
  • allergic reaction (Quincke's edema, urticaria, itching);
  • depression (with prolonged use of high doses), visual impairment.

Very rare:

  • agitation;
  • fatigue;
  • drowsiness;
  • lethargy;
  • insomnia;
  • hallucinations and seizures (especially in children).

Overdose

Symptoms: anxiety, agitation, hallucinations and seizures; hypothermia, lethargy, somnolence, coma; miosis, mydriasis, increased sweating, fever, pale skin, cyanosis, nausea and vomiting, tachycardia, bradycardia, cardiac arrhythmia, cardiac arrest, palpitation, hypertension, shock-like hypotension, pulmonary edema, respiratory depression and apnea, psychiatric disorders. 

Treatment: immediately administer activated charcoal (absorbent), sodium sulfate (laxative) or gastric lavage. Non-selective alpha-blockers are prescribed for lowering blood pressure. 

Use during pregnancy or breastfeeding

None.

Pediatric population

Use in children only on doctor's recommendation.

Special warnings

With long-term use and overdose of anti-rhinological drugs, their effect can be decreased. As a consequence of the excessive influence on the nasal mucosa of rhinological drugs, manifestations are possible:

  • reactive hyperemia of nasal mucosa (drug-induced rhinitis);
  • atrophy of the mucous membrane.

Presentation and package

10 ml of the product in plastic dropper bottles, sealed with tamper-proof caps. Each bottle has a label made of label paper.

One bottle is with instruction for use in the state and Russian language are placed in a carton pack.

Storage conditions

Store in a place protected from light, at a temperature below 250С.

Keep out of the reach of children.

Shelf life

3 years

Do not use after expiration date.

Manufacturer

"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan, tel.: (727) 253-03-88.

Marketing authorization holder

"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan.

Name, address, contact information of the organization accepting claims (proposals) against quality of products from consumers in the territory of the Republic of Kazakhstan, which is responsible for post-authorization safety surveillance of the medicine:

"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan,

Tel./Fax: (727) 253-07-07, 253-03-88, e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

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