Available EU DMF/CEP
EU DMF
CEP
API Status
Commercial
Pipeline
Therapeutic Category
Alimentary tract & metabolism
Anti-infectives for systemic use
Antipyretic, analgesic and anti-inflammatory
Antineoplastic & immunomodulating agents
Blood & blood forming organs
Cardiovascular system
Genito-urinary system & sex hormones
Injectable forms
Musculo-skeletal system
Nervous system
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Respiratory system
Available US DMF
US DMF
Available Japanese/Chinese DMF
Japanese DMF
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Xylometazoline hydrochloride*

CAS No.

1218-35-5

Innovator/marketer

Otrivin

Polymorphic form

Therapeutic Area

Respiratory system

Status

Commercial

EU DMF readiness

CEP

Drug description:

Xylometazoline is a nasal vasoconstricting decongestant drug.
It is indicated for the temporarily relieves nasal congestion due to cold, hay fever or other respiratory allergies. It is indicated in treatment of acute allergic rhinitis, sinusitis, pollinosis, otitis media (to reduce edema of the nasopharyngeal mucosa).
It is formulated as spray for nasal route of administration.

Mechanism of action:

Xylometazoline is a direct acting sympathomimetic adrenergic alpha-agonist.
It induces systemic vasoconstriction, thereby decreasing nasal congestion. The sympathomimetic action of xylometazoline constricts the smaller arterioles of the nasal passages, producing a prolonged decongesting effect.

* IPOCHEM API Manufacturing Site

DISCLAIMER
Products protected by valid patents are not offered for commercial sale in countries where the sale of such products constitutes patent infringement but are offered solely for uses reasonably related to the development and submission of information under a law regulating the manufacture, use or sale of drugs. It is within the buyer’s responsibility and liability to check the patent situation of the product in the imported market(s).

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