MOXIFLOXACIN- moxifloxacin tablet, film coated

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Camber Pharmaceuticals, Inc.

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Moxifloxacin tablets are indicated in adult patients for the treatment of Community Acquired Pneumonia caused by susceptible isolates of Streptococcus pneumoniae (including multi-drug resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Clinical Studies ( 14.3)]. MDRSP isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [MIC] ≥ 2 mcg/mL), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. Moxifloxacin tablets are indicated in adult patients for the treatment of Uncomplicated Skin and Skin Structure Infections caused by susceptible isolates of  methicillin-susceptible Staphylococcus aureus or St

Резиме производа:

Moxifloxacin tablets, USP are pink colored, capsule shaped, biconvex, film coated tablets, debossed with ‘103’ on one side and ‘J’ on the other side. Bottle of 30 Tablets                                                                        NDC 31722-845-30 Bottle of 500 Tablets                                                                      NDC 31722-845-05 Store at 20º to 25º C (68º to 77ºF) [see USP Controlled Room Temperature]. Avoid high humidity.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

MOXIFLOXACIN - MOXIFLOXACIN TABLET, FILM COATED
CAMBER PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MOXIFLOXACIN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MOXIFLOXACIN TABLETS.
MOXIFLOXACIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING
TENDINITIS, TENDON RUPTURE, PERIPHERAL
NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF
MYASTHENIA GRAVIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
• FLUOROQUINOLONES, INCLUDING MOXIFLOXACIN TABLETS, HAVE BEEN
ASSOCIATED WITH
DISABLING AND POTENTIALLY IRREVERSIBLE SERIOUS ADVERSE REACTIONS THAT
HAVE OCCURRED
TOGETHER ( 5.1) INCLUDING:
O TENDINITIS AND TENDON RUPTURE ( 5.2)
O PERIPHERAL NEUROPATHY ( 5.3)
O CENTRAL NERVOUS SYSTEM EFFECTS ( 5.4)
DISCONTINUE MOXIFLOXACIN TABLETS IMMEDIATELY AND AVOID THE USE OF
FLUOROQUINOLONES,
INCLUDING MOXIFLOXACIN TABLETS, IN PATIENTS WHO EXPERIENCE ANY OF
THESE SERIOUS
ADVERSE REACTIONS ( 5.1)
• FLUOROQUINOLONES, INCLUDING MOXIFLOXACIN TABLETS, MAY EXACERBATE
MUSCLE WEAKNESS
IN PATIENTS WITH MYASTHENIA GRAVIS. AVOID MOXIFLOXACIN TABLETS IN
PATIENTS WITH KNOWN
HISTORY OF MYASTHENIA GRAVIS ( 5.5).
• BECAUSE FLUOROQUINOLONES, INCLUDING MOXIFLOXACIN TABLETS, HAVE
BEEN ASSOCIATED WITH
SERIOUS ADVERSE REACTIONS ( 5.1 TO 5.14), RESERVE MOXIFLOXACIN TABLETS
FOR USE IN
PATIENTS WHO HAVE NO ALTERNATIVE TREATMENT OPTIONS FOR THE FOLLOWING
INDICATIONS: O ACUTE BACTERIAL SINUSITIS ( 1.6) O ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS ( 1.7)
RECENT MAJOR CHANGES
Dosage and Administration ( 2.2) 5/2020
INDICATIONS AND USAGE
Moxifloxacin tablets are a fluoroquinolone antibacterial indicated for
treating infections in adults 18 years
of age and older caused by designated susceptible bacteria, in the
conditions listed below:
Community Acquired Pneumonia ( 1.1)
Skin and Skin Structure Infections: Uncomplicated ( 1.2) and
Complicated ( 1.3)
Complicated Intr