LIVOSTIN EYE DROPS

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

LEVOCABASTINE (LEVOCABASTINE HYDROCHLORIDE)

Fáanlegur frá:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC númer:

S01GX02

INN (Alþjóðlegt nafn):

LEVOCABASTINE

Skammtar:

0.5MG

Lyfjaform:

DROPS

Samsetning:

LEVOCABASTINE (LEVOCABASTINE HYDROCHLORIDE) 0.5MG

Stjórnsýsluleið:

OPHTHALMIC

Einingar í pakka:

5ML

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ANTIALLERGIC AGENTS

Vörulýsing:

Active ingredient group (AIG) number: 0124244001; AHFS:

Leyfisstaða:

CANCELLED POST MARKET

Leyfisdagur:

2011-06-27

Vara einkenni

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