FOR THE NOSE

Active material: Ksilometazolin
When ATH: R01AA07
CCF: Vasoconstrictor drugs for local application in an ENT-practice
When CSF: 24.05.01
Manufacturer: SANDOZ PRIVATE Limited (India)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Nasal drops for kids 0.05% as a clear, colorless solution, without smell.

1 ml
Xylometazoline hydrochloride500 g

Excipients: benzalkonium chloride, sodium dihydrogen phosphate dihydrate, sodium hydrogen phosphate dodecahydrate, disodium эdetat, sodium chloride, water distillirovannaya.

10 ml – vials of dark glass (1) complete with a cover-pipette – packs cardboard.

Spray nazalynыy 0.1% as a clear, colorless solution, without smell.

1 ml
Xylometazoline hydrochloride1 mg

Excipients: benzalkonium chloride, sodium dihydrogen phosphate dihydrate, sodium hydrogen phosphate dodecahydrate, disodium эdetat, sodium chloride, water distillirovannaya.

10 ml – plastic spray bottles (1) with plastic cover – packs cardboard.

 

DESCRIPTION OF ACTIVE SUBSTANCES.

Pharmacological action

Vasoconstrictors for local application in an ENT-practice. Alpha-agonists. When applied to the mucous membranes causes vasoconstriction, The resulting reduced local edema and hyperemia. In rhinitis nasal breathing easier.

 

Pharmacokinetics

When applied topically, virtually not absorbed, plasma concentrations are so small, that they can not be determined by modern analytical methods.

 

Testimony

Acute allergic rhinitis, sinusitis, pollen disease, otitis media (to reduce swelling of the mucous nasopharynx), Patient preparation for diagnostic procedures in the nasal passages.

 

Dosage regimen

Applied locally for 7-14 days. The dosage depends upon the dosage form and the patient's age.

 

Side effect

Frequent and / or long-term use: irritation, burning, pricking, chikhaniye, dryness of mucous membranes of the nose, hypersecretion.

Rarely: rhinedema (more prolonged use), heartbeat, abnormal heart rhythm, increased blood pressure, headache, vomiting, sleep disorders, visual impairment.

Prolonged use of high doses: depression.

 

Contraindications

Zakrыtougolynaya glaucoma, atrophic rhinitis, arterial hypertension, tachycardia, expressed atherosclerosis, hyperthyroidism, Surgical intervention in the meninges (history), Hypersensitivity to xylometazoline.

 

Pregnancy and lactation

During pregnancy and lactation should only be used after careful evaluation of the risks and benefits for mother and fetus, not to exceed the recommended doses.

 

Cautions

Should not be used for a long time, eg, in chronic rhinitis. For colds in cases, when the nose formed crust, preferably administered in the form of a gel.

Use in Pediatrics

Be wary appoint ksilometazolin children under the age of 2 years (Gel - up 7 years).

 

Drug Interactions

Incompatible with MAO inhibitors and tricyclic antidepressants.

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