LEVOFLOXACIN solution/ drops

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14)

Saadav alates:

Rising Pharma Holdings, Inc.

INN (Rahvusvaheline Nimetus):

LEVOFLOXACIN

Koostis:

LEVOFLOXACIN ANHYDROUS 5 mg in 1 mL

Manustamisviis:

TOPICAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Levofloxacin Ophthalmic Solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: AEROBIC GRAM-POSITIVE MICROORGANISMS Corynebacterium species* Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus (Groups C/F) Streptococcus (Group G) Viridans group streptococci AEROBIC GRAM-NEGATIVE MICROORGANISMS 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 of this medication.

Toote kokkuvõte:

Levofloxacin Ophthalmic Solution 0.5% is supplied in a natural, low density polyethylene bottle with a controlled dropper tip and a tan, high density polyethylene cap in the following size: Bottles of 5 mL    NDC 16571-150-50 Store at 20°-25°C (68°-77°F)  Rx Only Manufactured in India for: Rising Pharmaceuticals Inc. Allendale, NJ 07401 Distributed by: Pack Pharmaceuticals, LLC Allendale, NJ 07401

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

LEVOFLOXACIN- LEVOFLOXACIN SOLUTION/ DROPS
RISING PHARMA HOLDINGS, INC.
----------
LEVOFLOXACIN OPHTHALMIC SOLUTION 0.5%
STERILE
DESCRIPTION:
Levofloxacin Ophthalmic Solution 0.5% is a sterile topical ophthalmic
solution. Levofloxacin is a fluoroquinolone antibacterial active
against a broad spectrum
of Gram-positive and Gram-negative ocular pathogens. Levofloxacin is
the pure (-)-(s)-
enantiomer of the racemic drug substance, ofloxacin. It is more
soluble in water neutral
pH than ofloxacin.
Structural formula:
LEVOFLOXACIN HEMIHYDRATE
C
H
FN O · ½ H O Mol Wt. 370.38
CHEMICAL
NAME:(-)-(s)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-
oxo-7H pyrido [1,2,3-de]-1,4 benzoxazine-6-carboxylic acid
hemihydrate. Levofloxacin
(hemihydrate) is a yellowish-white crystalline powder. Each mL of
Levofloxacin
Ophthalmic Solution contains 5.12 mg of levofloxacin hemihydrate
equivalent to 5 mg
levofloxacin.
CONTAINS:
ACTIVE: Levofloxacin 0.5% ( mg/mL); PRESERVATIVE: benzalkonium
chloride 0.005%;
INACTIVES: sodium chloride and water for injection. May also contain
hydrochloric acid
and/or sodium hydroxide to adjust pH. Levofloxacin Ophthalmic Solution
is isotonic and
formulated at pH 6.5 with an osmolality of approximately 300 mOsm/kg.
Levofloxacin is
a fluorinated 4-quinolone containing a six-member (pyridobenzoxazine)
ring from
positions 1 to 8 of the basic ring structure.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS:
Levofloxacin concentration in plasma was measured in 15 healthy adult
volunteers at
various time points during a 15 day course of treatment with
Levofloxacin Ophthalmic
Solution. The mean levofloxacin concentration in plasma 1 hour
postdose, ranged from
18
20
3
4
2
0.86 ng/mL on Day 1 to 2.05 ng/mL on Day 15. The highest maximum mean
levofloxacin
concentration of 2.5 ng/mL was measured on Day 4 following 2 days of
dosing every 2
hours for a total of 8 doses per day. Maximum mean levofloxacin
concentrations
increased from 0.94 ng/mL on Day 1 to 2.15 ng/mL on Day 15, which is
more than
1,000 times lower th