Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
LEVOCABASTINE (LEVOCABASTINE HYDROCHLORIDE)
NOVARTIS PHARMACEUTICALS CANADA INC
S01GX02
LEVOCABASTINE
0.5MG
DROPS
LEVOCABASTINE (LEVOCABASTINE HYDROCHLORIDE) 0.5MG
OPHTHALMIC
5ML
Prescription
ANTIALLERGIC AGENTS
Active ingredient group (AIG) number: 0124244001; AHFS:
CANCELLED POST MARKET
2011-06-27
PRODUCT MONOGRAPH Pr LIVOSTIN* EYE DROPS (levocabastine hydrochloride ophthalmic suspension) 0.5 mg/mL levocabastine Histamine H 1 -antagonist Novartis Pharmaceuticals Canada Inc. Date of Revision: 385 Bouchard Boulevard June 17, 2010 Dorval, QC H9S 1A9 Control No. 137284 3 PRODUCT MONOGRAPH PR LIVOSTIN* EYE DROPS levocabastine hydrochloride ophthalmic suspension 0.5 mg/mL levocabastine THERAPEUTIC CLASSIFICATION Histamine H 1 -antagonist ACTION AND CLINICAL PHARMACOLOGY LIVOSTIN* (levocabastine hydrochloride) is a potent, fast-acting and highly selective histamine H 1 -antagonist with a sustained duration of action. Within 10-15 minutes of topical application to the eyes, levocabastine inhibits: itching, redness and chemosis induced by conjunctival provocation with histamine; itching, redness, chemosis, eyelid swelling, and tearing induced by conjunctival provocation with allergens; and itching and redness induced by conjunctival provocation with compound 48/80. Orally-administered levocabastine provides a dose dependent inhibition of skin reactions to intradermal histamine. After topical application to the eyes levocabastine did not produce clinically significant systemic antihistamine effects in patients. Levocabastine eye drops (2 drops/eye t.i.d.), under acute and steady state conditions, are devoid of CNS effects, as evaluated by objective and subjective psychoperformance tests and measures of general CNS activity. Following topical application to the eyes, the absorption of levocabastine was incomplete and the absolute bioavailability of levocabastine instilled in the eyes could be estimated at approximately 30% in patients with allergic conjunctivitis and up to 60% in healthy volunteers. 4 INDICATIONS AND CLINICAL USE LIVOSTIN* (levocabastine hydrochloride) eye drops are indicated in the symptomatic management of seasonal allergic conjunctivitis. CONTRAINDICATIONS LIVOSTIN* (levocabastine hydrochloride) eye drops are contraindicated in patients with hypersensitivity to any of the ingredients. WARNINGS Use Soma hati kamili