Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
NEPAFENAC (UNII: 0J9L7J6V8C) (NEPAFENAC - UNII:0J9L7J6V8C)
Novartis Pharmaceuticals Corporation
OPHTHALMIC
PRESCRIPTION DRUG
NEVANAC® 0.1% is indicated for the treatment of pain and inflammation associated with cataract surgery. NEVANAC 0.1% is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other non-steroidal anti-inflammatory drugs (NSAIDs). Teratogenic Effects Pregnancy Category C: Reproduction studies performed with nepafenac in rabbits and rats at oral doses up to 10 mg/kg/day have revealed no evidence of teratogenicity due to nepafenac, despite the induction of maternal toxicity. At this dose, the animal plasma exposure to nepafenac and amfenac was approximately 260 and 2400 times human plasma exposure at the recommended human topical ophthalmic dose for rats and 80 and 680 times human plasma exposure for rabbits, respectively. In rats, maternally toxic doses greater than or equal to 10 mg/kg were associated with dystocia, increased post-implantation loss, reduced fetal weights and growth, and reduced fetal survival. Nepafenac has been shown to cross
NEVANAC® 0.1% is supplied in a white, oval, low density polyethylene dispenser with a natural low density polyethylene dispensing plug and gray polypropylene cap. The 1.7 mL fill is presented in an overwrap, which provides tamper evidence to the package. Tamper evidence for the 3 mL fill is provided with a shrink band around the closure and neck area of the package. 3 mL in a 4 mL bottle……………………………………………………………………………NDC 0078-0778-03 Storage: Store at 2°C to 25°C (36°F to 77°F).
New Drug Application
NEVANAC- NEPAFENAC SUSPENSION/ DROPS NOVARTIS PHARMACEUTICALS CORPORATION ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE NEVANAC SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NEVANAC. NEVANAC (NEPAFENAC OPHTHALMIC SUSPENSION) 0.1%, FOR TOPICAL OPHTHALMIC USE INITIAL U.S. APPROVAL: 2005 INDICATIONS AND USAGE NEVANAC is a nonsteroidal, anti-inflammatory prodrug indicated for the treatment of pain and inflammation associated with cataract surgery. (1) DOSAGE AND ADMINISTRATION One drop of NEVANAC should be applied to the affected eye three times daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the postoperative period. (2.1) DOSAGE FORMS AND STRENGTHS Sterile ophthalmic suspension 0.1% 3 mL in a 4 mL bottle (3) CONTRAINDICATIONS Hypersensitivity to any of the ingredients in the formula or to other non-steroidal anti-inflammatory drugs (NSAIDS). (4) WARNINGS AND PRECAUTIONS Increased bleeding time due to interference with thrombocyte aggregation (5.1) Delayed Healing (5.2) Corneal effects, including keratitis (5.3) ADVERSE REACTIONS Most common adverse reactions (5% to 10%) are capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure (IOP), and sticky sensation. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT NOVARTIS PHARMACEUTICALS CORPORATION AT 1-888-669-6682 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 9/2021 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosing 2.2 Use With Other Topical Ophthalmic Medications 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Increased Bleeding Time 5.2 Delayed Healing 5.3 Corneal Effects 5.4 Contact Lens Wear ® 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Us Izlasiet visu dokumentu