Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
Olopatadine Hydrochloride (UNII: 2XG66W44KF) (Olopatadine - UNII:D27V6190PM)
Akorn
OPHTHALMIC
PRESCRIPTION DRUG
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% 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 fe
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% is supplied in a 10 mL white, low density polyethylene (LDPE) bottle with a dropper tip, and a white polypropylene cap in the following size: NDC 17478-305-12 2.5 mL in 10 mL bottle STORAGE: Store at 4° to 25°C (39° to 77°F).
Abbreviated New Drug Application
OLOPATADINE- OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS AKORN ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP, 0.2% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP, 0.2%. OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP, 0.2% INITIAL U.S. APPROVAL: 1996 INDICATIONS AND USAGE Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% 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 AKORN, INC. AT 1-800-932-5676 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 12/2017 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 * FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE Olopatadine Baca dokumen lengkapnya