OLOPATADINE HYDROCHLORIDE solution/ drops

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM)

Disponible des:

Teva Pharmaceuticals USA, Inc.

Vía de administración:

OPHTHALMIC

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Olopatadine hydrochloride ophthalmic solution is indicated for the treatment of ocular itching associated with allergic conjunctivitis. None. Teratogenic Effects Pregnancy Category C Olopatadine was found not to be teratogenic in rats and rabbits. However, rats treated at 600 mg/kg/day, or 150,000 times the MROHD and rabbits treated at 400 mg/kg/day, or approximately 100,000 times the MROHD, during organogenesis showed a decrease in live fetuses. In addition, rats treated with 600 mg/kg/day of olopatadine during organogenesis showed a decrease in fetal weight. Further, rats treated with 600 mg/kg/day of olopatadine during late gestation through the lactation period showed a decrease in neonatal survival and body weight. There are, however, no adequate and well- controlled studies in pregnant women. Because animal studies are not always predictive of human responses, this drug should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the embryo or fetus. Olopa

Resumen del producto:

Olopatadine hydrochloride ophthalmic solution USP 0.2% is a clear, colorless to light yellow solution supplied in a white, low density polyethylene (LDPE) bottle with a white dropper tip, and a high density polyethylene cap. 2.5 mL fill in 5 mL bottle (NDC 0093-7684-32) Storage Store at 2° to 25°C (36° to 77°F) KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

OLOPATADINE HYDROCHLORIDE- OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS
TEVA PHARMACEUTICALS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OLOPATADINE HYDROCHLORIDE
OPHTHALMIC SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR OLOPATADINE
HYDROCHLORIDE OPHTHALMIC SOLUTION.
OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION 0.2%
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Olopatadine hydrochloride ophthalmic solution is a mast cell
stabilizer indicated for the treatment of ocular itching
associated with allergic conjunctivitis. (1)
DOSAGE AND ADMINISTRATION
The recommended dose is one drop in each affected eye once a day. (2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution 0.2%: each mL contains 2.22 mg of olopatadine
hydrochloride. (3)
WARNINGS AND PRECAUTIONS
For topical ocular use only. Not for injection or oral use. (5.1)
ADVERSE REACTIONS
Symptoms similar to cold syndrome and pharyngitis were reported at an
incidence of approximately 10%. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TEVA PHARMACEUTICALS
USA, INC. AT 1-866-832-8537 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 2/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 For Topical Ocular Use Only
5.2 Contamination of Tip and Solution
5.3 Contact Lens Use
6 ADVERSE REACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Topical Ophthalmic Use Only
17.2 Sterility of Dropper Tip
17.3 Concomitant Use of Contact Lenses
Olopatadine Hydrochloride Ophthalmic Solutio