Overdose
No information provided.
Contraindications
This product is contraindicated in persons with known or
suspected hypersensitivity to any of its components. It should not be used while
soft contact lenses are being worn.
Undesirable effects
The most frequent adverse experiences reported with the use
of LIVOSTIN™ 0.05% (levocabastine hydrochloride ophthalmic suspension) were
mild, transient stinging and burning (29%) and headache (5%).
Other adverse experiences reported in approximately 1-3% of
patients treated with LIVOSTIN™ were visual disturbances, dry mouth, fatigue,
pharyngitis, eye pain/dryness, somnolence, red eyes, lacrimation/discharge, cough,
nausea, rash/erythema, eyelid edema, and dyspnea.
Therapeutic indications
LIVOSTIN™ 0.05% (levocabastine hydrochloride ophthalmic
suspension) is indicated for the temporary relief of the signs and symptoms of
seasonal allergic conjunctivitis.
Fertility, pregnancy and lactation
Teratogenic Effects - Pregnancy Category C
Levocabastine has been shown to be teratogenic (polydactyly)
in rats when given in doses 16,500 times the maximum recommended human ocular
dose. Teratogenicity (polydactyly, hydrocephaly, brachygnathia),
embryotoxicity, and maternal toxicity were observed in rats at 66,000 times the
maximum recommended ocular human dose. There are no adequate and
well-controlled studies in pregnant women. Levocabastine should be used during
pregnancy only if the potential benefit justifies the potential risk to the
fetus.
Qualitative and quantitative composition
LIVOSTIN™ 0.05% (levocabastine hydrochloride ophthalmic
suspension), 2.5 mL, 5 mL, and 10 mL is provided in white, polyethylene dropper
tip squeeze bottles.
Keep tightly closed when not in use.
Do not use if the suspension has discolored.
Store at controlled room temperature 15°to 30°C (59° to
86°F).
Protect from freezing.
NDC 58768-610-10 (10.0 mL)
NDC 58768-610-05 (5.0 mL)
NDC 58768-610-99 (2.5 mL)
Levocabastine hydrochloride is an original product of
Janssen Pharmaceutica Inc.
Mfd. by OMJ Pharmaceuticals, Inc., San Germán, P.R., 00683
for: Novartis Ophthalmics, Duluth, GA 30097
Special warnings and precautions for use
WARNINGS
For topical use only. Not for injection.
PRECAUTIONS
Carcinogenesis, Mutagenesis, Impairment of Fertility
Levocabastine was not carcinogenic in male or female rats or
in male mice when administered in the diet for up to 24 months. In female mice,
levocabastine doses of 5,000 and 21,500 times the maximum recommended ocular
human use level resulted in an increased incidence of pituitary gland adenoma
and mammary gland adenocarcinoma possibly produced by increased prolactin
levels.
The clinical relevance of this finding is unknown with
regard to the interspecies differences in prolactin physiology and the very low
plasma concentrations of levocabastine following ocular administration.
Mutagenic potential was not demonstrated for levocabastine
when tested in Ames' Salmonella reversion test or in Escherichia coli,
Drosophila melanogaster, a mouse Dominant Lethal Assay or in rat
Micronucleus test.
In reproduction studies in rats, levocabastine showed no
effects on fertility at oral doses of 20 mg/kg/day (8,300 times the maximum recommended
human ocular dose).
Pregnancy
Teratogenic Effects - Pregnancy Category C
Levocabastine has been shown to be teratogenic (polydactyly)
in rats when given in doses 16,500 times the maximum recommended human ocular
dose. Teratogenicity (polydactyly, hydrocephaly, brachygnathia),
embryotoxicity, and maternal toxicity were observed in rats at 66,000 times the
maximum recommended ocular human dose. There are no adequate and
well-controlled studies in pregnant women. Levocabastine should be used during
pregnancy only if the potential benefit justifies the potential risk to the
fetus.
Nursing Mothers
Based on determinations of levocabastine in breast milk
after ophthalmic administration of the drug to one nursing woman, it was calculated
that the daily dose of levocabastine in the infant was about 0.5 μg.
Pediatric Use
Safety and effectiveness in pediatric patients below the age
of 12 have not been established.
Dosage (Posology) and method of administration
SHAKE WELL BEFORE USING. The usual dose is one drop
instilled in affected eyes four times per day.
Interaction with other medicinal products and other forms of interaction
SIDE EFFECTS
The most frequent adverse experiences reported with the use
of LIVOSTIN™ 0.05% (levocabastine hydrochloride ophthalmic suspension) were
mild, transient stinging and burning (29%) and headache (5%).
Other adverse experiences reported in approximately 1-3% of
patients treated with LIVOSTIN™ were visual disturbances, dry mouth, fatigue,
pharyngitis, eye pain/dryness, somnolence, red eyes, lacrimation/discharge, cough,
nausea, rash/erythema, eyelid edema, and dyspnea.
DRUG INTERACTIONS
No information provided.
