MOXIFLOXACIN solution/ drops

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

MOXIFLOXACIN HYDROCHLORIDE (UNII: C53598599T) (MOXIFLOXACIN - UNII:U188XYD42P)

Dostupné z:

Mylan Pharmaceuticals Inc.

Spôsob podávania:

OPHTHALMIC

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species* Micrococcus luteus* Staphylococcus aureus Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus warneri* Streptococcus pneumoniae Streptococcus viridans group Acinetobacter lwoffii* Haemophilus influenza Haemophilus parainfluenzae* Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections. Moxifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. Moxifloxacin was not teratogenic when administered to pregnant rats during organogenesis at oral doses as high as 500 mg/kg/day (approximately 21,700 times the highest recommended total daily human ophthalmic dose); however, decreased fetal body weights and slightly delayed fetal skeletal developmen

Prehľad produktov:

Moxifloxacin Ophthalmic Solution, USP is a sterile clear, greenish-yellow solution of 0.5% moxifloxacin. Each mL of Moxifloxacin Ophthalmic Solution USP, 0.5% contains 5.45 mg moxifloxacin hydrochloride, USP equivalent to 5 mg (0.5%) moxifloxacin. Moxifloxacin Ophthalmic Solution USP, 0.5% is supplied as a 3 mL solution in a 5 mL three piece container consisting of a natural low density polyethylene bottle, a natural low density polyethylene open nozzle and a tan high density polyethylene cap. 3 mL fill NDC 0378-5430-35 carton of one bottle Store at 2° to 25°C (36° to 77°F).

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

MOXIFLOXACIN- MOXIFLOXACIN SOLUTION/ DROPS
MYLAN PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MOXIFLOXACIN OPHTHALMIC
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MOXIFLOXACIN OPHTHALMIC
SOLUTION.
MOXIFLOXACIN OPHTHALMIC SOLUTION
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Moxifloxacin ophthalmic solution is a topical fluoroquinolone
anti-infective indicated for the treatment of bacterial
conjunctivitis caused by susceptible strains of the following
organisms:
_Corynebacterium_ species*, _Micrococcus luteus_*, _Staphylococcus
aureus_, _Staphylococcus epidermidis_, _Staphylococcus_
_haemolyticus_, _Staphylococcus hominis_, _Staphylococcus warneri_*,
_Streptococcus pneumoniae_, _Streptococcus viridans_ group,
_Acinetobacter lwoffii_*, _Haemophilus influenza_, _Haemophilus
parainfluenzae_*, _Chlamydia trachomatis_
*Efficacy for this organism was studied in fewer than 10 infections.
(1)
DOSAGE AND ADMINISTRATION
Instill one drop in the affected eye 3 times a day for 7 days. (2)
DOSAGE FORMS AND STRENGTHS
5 mL bottle filled with 3 mL sterile ophthalmic solution of
moxifloxacin 0.5%. (3)
CONTRAINDICATIONS
Moxifloxacin ophthalmic solution is contraindicated in patients with a
history of hypersensitivity to moxifloxacin, to other
quinolones, or to any of the components in this medication. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
The most frequently reported ocular adverse events were
conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular
discomfort, ocular hyperemia, ocular pain, ocular pruritus,
subconjunctival hemorrhage, and tearing. These events
occurred in approximately 1-6% of patients. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN PHARMACEUTICALS
INC. AT 1-877-446-3679 (1-877-
4-INFO-RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 10/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS