MOXIFLOXACIN HYDROCHLORIDE TABLETS, 400 MG tablet, film coated

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

MSN LABORATORIES PRIVATE LIMITED

INN (Tarptautinis Pavadinimas):

MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE

Sudėtis:

MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE 400 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 Streptococcus pyogenes [see  Clinical Studies (14.4)]. Moxifloxacin tablets are indicated in adult patients

Produkto santrauka:

Moxifloxacin Tablets, USP are available as dull red colored, caplet shaped, film coated tablets containing 400 mg moxifloxacin. The tablet is debossed with "M" on one side and "400" on other side. Package                                                                                   NDC Code Bottles of 30                                                                          69539-006-30 Bottles of 500                                                                        69539-006-05 Cartons of 50 (5 x 10 ) Unit-dose Tablets                             69539-006-31 Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [see USP Controlled Room Temperature]. Avoid high humidity.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

MOXIFLOXACIN HYDROCHLORIDE TABLETS, 400 MG - MOXIFLOXACIN
HYDROCHLORIDE
TABLETS, 400 MG TABLET, FILM COATED
MSN LABORATORIES PRIVATE LIMITED
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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 HYDROCHLORIDE, HAVE BEEN
ASSOCIATED WITH DISABLING AND
POTENTIALLY IRREVERSIBLE SERIOUS ADVERSE REACTIONS THAT HAVE OCCURRED
TOGETHER (5.1) INCLUDING:
TENDINITIS AND TENDON RUPTURE (5.2)
PERIPHERAL NEUROPATHY (5.3)
CENTRAL NERVOUS SYSTEM EFFECTS (5.4)
DISCONTINUE MOXIFLOXACIN HYDROCHLORIDE IMMEDIATELY AND AVOID THE USE
OF FLUOROQUINOLONES, INCLUDING
MOXIFLOXACIN HYDROCHLORIDE, IN PATIENTS WHO EXPERIENCE ANY OF THESE
SERIOUS ADVERSE REACTIONS (5.1)
FLUOROQUINOLONES, INCLUDING MOXIFLOXACIN HYDROCHLORIDE, MAY EXACERBATE
MUSCLE WEAKNESS IN PATIENTS
WITH MYASTHENIA GRAVIS. AVOID MOXIFLOXACIN HYDROCHLORIDE IN PATIENTS
WITH KNOWN HISTORY OF
MYASTHENIA GRAVIS (5.5)
BECAUSE FLUOROQUINOLONES, INCLUDING MOXIFLOXACIN HYDROCHLORIDE, HAVE
BEEN ASSOCIATED WITH SERIOUS
ADVERSE REACTIONS (5.1-5.14), RESERVE MOXIFLOXACIN HYDROCHLORIDE FOR
USE IN PATIENTS WHO HAVE NO
ALTERNATIVE TREATMENT OPTIONS FOR THE FOLLOWING INDICATIONS:
ACUTE BACTERIAL SINUSITIS (1.6)
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 Inf