Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
LEVOCABASTINE (LEVOCABASTINE HYDROCHLORIDE)
JANSSEN INC
R01AC02
LEVOCABASTINE
0.05MG
SUSPENSION
LEVOCABASTINE (LEVOCABASTINE HYDROCHLORIDE) 0.05MG
NASAL
15 ML
Prescription
ANTIALLERGIC AGENTS
Active ingredient group (AIG) number: 0124244002; AHFS:
CANCELLED POST MARKET
2020-12-22
LIVOSTIN 163978 APM.doc Page 1 of 22 PRODUCT MONOGRAPH PR LIVOSTIN ® levocabastine Nasal Spray 0.5 mg/mL as levocabastine hydrochloride Histamine H 1 -antagonist Janssen Inc. 19 Green Belt Drive Toronto, Ontario M3C 1L9 www.janssen.ca Date of Revision: July 15, 2013 SUBMISSION CONTROL NO: 163978 © 2013 Janssen Inc. All trademarks used under license. LIVOSTIN 163978 APM.doc Page 2 of 22 PRODUCT MONOGRAPH PR LIVOSTIN ® levocabastine Nasal Spray 0.5 mg/mL as levocabastine hydrochloride Histamine H 1 -antagonist CLINICAL PHARMACOLOGY LIVOSTIN ® levocabastine hydrochloride is a potent, fast-acting and highly selective histamine H 1 -antagonist with a sustained duration of action. Within 10 minutes of topical application to the nose, levocabastine inhibits sneezing, itchy nose and rhinorrhea induced by nasal provocation with allergens. Orally administered levocabastine provides a dose-dependent inhibition of skin reactions to intradermal histamine. After repeated topical application to the nose, topical and systemic antihistamine effects contribute to overall clinical outcome. Although systemic effects may contribute to the therapeutic effects of levocabastine nasal spray, this is not accompanied by any sedative effects. Levocabastine nasal spray (2 sprays/nostril t.i.d.), under acute and steady-state conditions, is devoid of CNS effects, as evaluated by objective and subjective psychoperformance tests and measures of general CNS activity. Following topical application to the nose, the absorption of levocabastine was incomplete and the absolute bioavailability of levocabastine administered in the nose could be estimated at 60-80% in healthy volunteers and in patients with allergic rhinitis. INDICATIONS AND CLINICAL USE LIVOSTIN ® levocabastine hydrochloride nasal spray is indicated for the symptomatic treatment of allergic rhinitis (sneezing, itchy nose, runny nose) in patients 12 years of age and older. CONTRAINDICATIONS LIVOSTIN ® levocabastine hydrochloride nasal spray is contraindicated in patients with hyper Baca dokumen lengkap