Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
levofloxacin (UNII: 6GNT3Y5LMF) (levofloxacin anhydrous - UNII:RIX4E89Y14)
Akorn
levofloxacin
levofloxacin anhydrous 5 mg in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
Levofloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Gram-positive bacteria Corynebacterium species* Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumonia Streptococcus (Groups C/F) Streptococcus (Group G) Viridans group streptococci* Gram-negative bacteria Acinetobacter lwoffii* Haemophilus influenzae Serratia marcescens* * Efficacy for this organism was studied in fewer than 10 infections. Levofloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to levofloxacin, to other quinolones, or to any of the components in this medication. Pregnancy Category C Teratogenic Effects: Levofloxacin at oral doses of 810 mg/kg/day in rats caused decreased fetal body weight and increased fetal mortality. No teratogenic effect was observed when rabbits were dosed orally as high as 50 mg/kg/day, at which systemic exposure was approximately 2,250 times that observed at t
Levofloxacin ophthalmic solution, 0.5% is supplied in a white, low density polyethylene bottle with a controlled dropper tip and a tan polypropylene cap in the following size: 5 mL fill in a 10 mL capacity bottle - NDC 17478-106-10 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
LEVOFLOXACIN- LEVOFLOXACIN SOLUTION AKORN ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LEVOFLOXACIN OPHTHALMIC SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVOFLOXACIN OPHTHALMIC SOLUTION. LEVOFLOXACIN OPHTHALMIC SOLUTION, FOR TOPICAL APPLICATION IN THE EYE INITIAL U.S. APPROVAL: 1996 INDICATIONS AND USAGE Levofloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: GRAM-POSITIVE BACTERIA Corynebacterium species* _Staphylococcus aureus_ _Staphylococcus epidermidis_ _Streptococcus pneumonia_ _Streptococcus_ (Groups C/F) _Streptococcus_ (Group G) Viridans group streptococci* GRAM-NEGATIVE BACTERIA _Acinetobacter lwoffii*_ _Haemophilus influenzae_ _Serratia marcescens*_ * Efficacy for this organism was studied in fewer than 10 infections (1) DOSAGE AND ADMINISTRATION DAYS 1 AND 2 Instill one to two drops in the affected eye(s) every 2 hours while awake, up to 8 times per day. DAYS 3 THROUGH 7 Instill one to two drops in the affected eye(s) every 4 hours while awake, up to 4 times per day. (2) DOSAGE FORMS AND STRENGTHS 10 mL bottle filled with 5 mL sterile ophthalmic solution of levofloxacin, 0.5% (3) CONTRAINDICATIONS Levofloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to levofloxacin, to other quinolones, or to any of the components in this medication. (4) WARNINGS AND PRECAUTIONS Hypersensitivity and anaphylaxis have been reported with systemic use of levofloxacin as well as topical use of other fluoroquinolones, including levofloxacin ophthalmic solution. (5.1) Prolonged use may result in the overgrowth of non-susceptible organisms, including fungi. (5.2) Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis. (5.3) ADVERSE REACTIONS The most frequently reported adverse reactions in the overall study population were transient decreased visio Прочитайте повний документ