MOXIFLOXACIN solution/ drops

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE (UNII: B8956S8609) (MOXIFLOXACIN - UNII:U188XYD42P)

Disponible des:

Advanced Rx Pharmacy of Tennessee, LLC

Vía de administración:

OPHTHALMIC

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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. 8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies with moxifloxacin ophthalmic solution in pregnant women to inform any drug-associated risks. Oral administration of moxifloxacin to pregnant rats and monkeys and int

Resumen del producto:

Moxifloxacin ophthalmic solution, USP is supplied as a sterile ophthalmic solution in a white translucent 5 mL LDPE bottle with an LDPE dropper tip, and a tan HDPE cap. 3 mL in a 5 mL bottle - NDC 80425-0239-01 Storage: Store at 2°C to 25°C (36°F to 77°F).

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

MOXIFLOXACIN- MOXIFLOXACIN SOLUTION/ DROPS
ADVANCED RX PHARMACY OF TENNESSEE, LLC
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MOXIFLOXACIN 0.5% SOLUTION
1. INDICATIONS AND USAGE
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.
2. DOSAGE AND ADMINISTRATION
Instill one drop in the affected eye 3 times a day for 7 days.
Moxifloxacin is for topical
ophthalmic use.
3. DOSAGE FORMS AND STRENGTHS
5 mL bottle filled with 3 mL sterile ophthalmic solution of
moxifloxacin 0.5%
4. 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.
5. WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
In patients receiving systemically administered quinolones, including
moxifloxacin,
serious and occasionally fatal hypersensitivity (anaphylactic)
reactions have been
reported, some following the first dose. Some reactions were
accompanied by
cardiovascular collapse, loss of consciousness, angioedema (including
laryngeal,
pharyngeal or facial edema), airway obstruction, dyspnea, urticaria,
and itching. If an
allergic reaction to moxifloxacin occurs, discontinue use of the drug.
Serious acute
hypersensitivity reactions may require immediate emergency treatment.
Oxygen and
airway management should be administered as clinically indicated.
5.2 Growth of Resistant Organisms With Prolonged Use
As with other anti-infectives, prolonged use may result in overgrowth
of non-susceptible
organisms, including fungi. If superinfection occurs, discontinue use
a