Composition, form of production and packaging
Spray nasal dosed transparent, colorless.
1 dose
xylometazoline hydrochloride 0.1 mg
dexpanthenol 5 mg
Excipients: benzalkonium chloride 0.04 mg, potassium dihydrogen phosphate 0.853 mg, sodium hydrogen phosphate dodecahydrate 0.027 mg, purified water 93.98 mg.
10 ml (not less than 100 doses) - amber glass bottles (1) complete with a pump dispenser (in individual packaging) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with alpha-adrenomimetic activity, causes narrowing of the blood vessels of the nasal mucosa, restores the nasal passages, facilitates nasal breathing. The drug usually comes in a few minutes after its application and lasts up to 10 hours.
Dexpanthenol - a vitamin B group - a derivative of pantothenic acid. Dexpanthenol is converted in the body into pantothenic acid, which is an integral part of coenzyme A and participates in the processes of acetylation, carbohydrate and
fat metabolism, in the synthesis of acetylcholine, corticosteroids, porphyrins; stimulates the regeneration of the skin, mucous membranes
shells, normalizes cellular metabolism, accelerates mitosis and increases the strength of collagen fibers. It has a regenerating, metabolic and weak anti-inflammatory effect.
PHARMACOKINETICS
Xylometazoline with local application is practically not absorbed, plasma concentrations are so small that their
It is impossible to determine by modern analytical methods.
Dexpanthenol, when applied topically, is rapidly absorbed by the skin and converted to pantothenic acid, binds to plasma proteins (mainly with beta-globulin and albumin). Its concentration in the blood is 0.5-1 mg / l,
in the blood serum - 100 mcg / l. Pantothenic acid does not undergo metabolism in the body (except for inclusion in Ko-A), is excreted unchanged.
INDICATIONS
- acute respiratory diseases with phenomena of rhinitis;
acute allergic rhinitis;
- Vasomotor rhinitis;
- sinusitis;
- otitis media (as part of combination therapy to reduce edema of the nasopharyngeal mucosa);
- to facilitate the conduct of a rhinoscopy;
- to restore impaired nasal breathing after surgical interventions in the nasal cavity.
DOSING MODE
Intranasally. For adults and children over 6 years .
Remove the pump metering device from the packaging. Uncork the vial with the drug, screw the dispensing device onto the neck of the vial, remove the protective cap.
Before using the spray for the first time, press the pump dosing device several times until uniform spraying occurs.
When using a nasal spray, the bottle should be kept in an upright position. During the injection, it is easy to breathe in with your nose. One injection into each nostril 3-4 times a day.
Duration of therapy is 3-5 days.
SIDE EFFECT
With frequent and / or prolonged use, irritation and / or dryness of the nasopharyngeal mucosa, burning, tingling, sneezing, hypersecretion, allergic reactions, nasal congestion, vomiting, headache, dry rhinitis, palpitations, increased blood pressure, insomnia, impaired vision, depression (with prolonged use of high doses).
CONTRAINDICATIONS
- hypersensitivity to the components of the drug;
- arterial hypertension;
- tachycardia;
- severe atherosclerosis;
- Atrophic rhinitis;
- hyperthyroidism;
- porphyria;
- hyperplasia of the prostate;
- glaucoma;
- surgical interventions on the meninges (in the anamnesis);
- children's age till 6 years;
- simultaneous therapy with monoamine oxidase (MAO) inhibitors and tricyclic antidepressants.
With caution : diabetes, pheochromocytoma.
PREGNANCY AND LACTATION
Given that there is no data on the reproductive toxicity of the drug, during pregnancy and lactation it is not recommended to use it.
APPLICATION FOR CHILDREN
Contraindicated in children under 6 years.
SPECIAL INSTRUCTIONS
Before application, it is necessary to clean the nasal passages.
Do not use more than 5 days.
Impact on the ability to drive vehicles and manage mechanisms
During the period of application of the drug, precautions should be followed, or the management of vehicles should be avoided and other potentially hazardous activities requiring increased attention and speed of psychomotor reactions should be avoided.
OVERDOSE
AT cases of overdose or accidental oral administration, the following symptoms may occur : mydriasis,
nausea, vomiting, cyanosis, fever, convulsions, tachycardia, cardiac rhythm disorder, vascular insufficiency, cardiac arrest, hypertension, pulmonary edema, respiratory function, hallucinations. Patients may also have symptoms of CNS depression, accompanied by drowsiness, lower body temperature, bradycardia, shock, respiratory arrest and coma.
Treatment. The use of activated carbon, gastric lavage, oxygen ventilation of the lungs. To reduce blood pressure, 5 mg of phentolamine is prescribed in a 0.9% solution of sodium chloride by slow intravenous administration or 100 mg of phentolamine orally. Vasoconstrictors are contraindicated. If necessary, antipyretic and anticonvulsant drugs are used.
DRUG INTERACTION
With the simultaneous use of MAO inhibitors and tricyclic antidepressants, it is possible to enhance systemic action.
TERMS OF RELEASE FROM PHARMACY
Without recipe.
TERMS AND CONDITIONS OF STORAGE
At a temperature of no higher than 25 В° C. Shelf life - 3 years.
