OLOPATADINE HYDROCHLORIDE solution/ drops

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Aurobindo Pharma Limited

Antoreitti:

OPHTHALMIC

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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

Tuoteyhteenveto:

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% is a clear, colorless to pale yellow solution supplied in a 5 mL white opaque LDPE bottle with LDPE nozzle and white color HDPE cap with a tamper-evident ring. 2.5 mL fill in 5 mL bottle                             NDC 59651-066-05 Storage Store at 2° to 25°C (36° to 77°F)

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

OLOPATADINE HYDROCHLORIDE - OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS
AUROBINDO PHARMA LIMITED
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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 AUROBINDO PHARMA USA
LLC AT 1-866-850-2876 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 3/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
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
*
Sections or subsections omitted from the full prescribing information
are not listed.
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
Olopatadine Hydrochloride Ophthalmic Solution is indicated for the
treatment of ocular itching
associated