LEVOFLOXACIN solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

levofloxacin (UNII: 6GNT3Y5LMF) (levofloxacin anhydrous - UNII:RIX4E89Y14)

Boleh didapati daripada:

Akorn

INN (Nama Antarabangsa):

levofloxacin

Komposisi:

levofloxacin anhydrous 5 mg in 1 mL

Laluan pentadbiran:

OPHTHALMIC

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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

Ringkasan produk:

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].

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

LEVOFLOXACIN- LEVOFLOXACIN SOLUTION
AKORN
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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
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