THERAPEUTIC INDICATIONS:
-
acute, allergic vasomotor rhinitis;
-
rhinosinusitis;
-
eustachyitis associated with rhinitis;
-
elimination of nasal cavity mucous membrane edema before diagnostic procedures.
Download instructions for use
Composition
1 ml of the product contains:
- active substance - oxymetazoline hydrochloride - 0.25 mg or 0.5 mg;
- excipients: benzalkonium chloride (as 10% solution), sodium chloride, sodium dihydrophosphate dihydrate, dodecahydrate phosphate dihydrate, purified water.
Pharmaceutical form
Nasal drops 0.025%, 0.05%, 10 ml
Pharmacotherapeutic group
Respiratory system. Nasal preparations. Anticongestants and other nasal medications for topical use. Simple sympathomimetics. Oxymetazoline.
ATC code R01AA05
Indications
- acute, allergic vasomotor rhinitis;
- rhinosinusitis;
- eustachyitis associated with rhinitis;
- elimination of nasal cavity mucous membrane edema before diagnostic procedures.
Contraindications
- hypersensitivity to the components of the product;
- atrophic rhinitis;
- pronounced atherosclerosis;
- chronic heart failure;
- arrhythmias;
- arterial hypertension;
- chronic renal failure;
- prostatic hyperplasia;
- concomitant use of monoamine oxidase inhibitors and a period of up to 14 days after the end of their use;
- conditions after transsphenoidal pituitaryectomy or other surgical interventions on the dura mater;
- diabetes mellitus;
- thyrotoxicosis, hyperthyroidism;
- closed angle glaucoma;
- severe eye diseases;
- pheochromacytoma;
- porphyria
- children under 1 year of age (for Oxyvin-DF® 0.025%);
- children under 8 years of age (for Oxyvin-DF® 0.005%);
Posology and method of administration
Intranasally.
Unscrew and remove the cap, and slightly press on the body of the bottle.
- 0.025% nasal drops for children of 1 to 8 years of age: 1-2 drops in each nasal passage 2-3 times a day;
- 0.05% nasal drops for children over 8 years of age and adults: 1-2 drops in each nasal passage 2-3 times a day;
The course of treatment is not more than 5-7 days.
Adverse reactions
Common:
- burning and dryness of the nasal mucosa;
- dry mouth and throat;
- sneezing.
Uncommon:
- dizziness, headache;
- insomnia;
- tiredness (fatigue);
- nausea;
- swelling and edema of the mucous membrane (nasal congestion);
- nasal bleeding;
- reactive hyperemia;
- atrophy of the mucous membrane;
- allergic reactions (Quincke's edema, urticaria, itching).
Very rare:
- increased pulse rate;
- arterial hypertension;
- tachycardia;
- tachyphylaxis;
- arrhythmias;
- apnea in infants and newborns;
- convulsions.
Overdose
Symptoms: if the recommended doses are exceeded or accidental ingestion, the following symptoms may occur: constriction of the pupils, nausea, vomiting, cyanosis, fever, tachycardia, arrhythmia, collapse, cardiac depression, arterial hypertension, pulmonary edema, respiratory distress. In addition, mental disorders may appear, as well as depression of the central nervous system, accompanied by drowsiness, decreased body temperature, bradycardia, arterial hypotension, respiratory failure, and possible development of a coma.
Treatment: immediately administer activated charcoal (absorbent), sodium sulfate (laxative) or gastric lavage. Non-selective alpha-adrenoblockers (phentolamine 5 mg in saline (physiological) solution slowly v/v or 100 mg orally) are prescribed to decrease blood pressure. The use of vasopressors is contraindicated.
Use during pregnancy or breastfeeding
Use of the product during pregnancy and lactation is possible only when the estimated benefit to the mother exceeds the potential risk to the child and fetus.
Pediatric population
Approved for children over 1 year of age.
Special warnings
Prolonged or frequent use of vasoconstrictors leads to decreased effectiveness of the product, also their improper use can cause atrophy and swelling of nasal mucous membranes.
When Oxyvin-DF® is prescribed for the treatment of chronic rhinitis, to avoid the risk of nasal mucosal atrophy, it may be used only under the supervision of a physician.
Presentation and package
10 ml of the product in plastic dropper bottles, sealed with tamper-proof caps, or in 10 ml plastic dropper bottles, sealed with caps. Each bottle has a label. 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.