MOXIFLOXACIN HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Novel Laboratories, Inc.

INN (International Name):

MOXIFLOXACIN HYDROCHLORIDE

Composition:

MOXIFLOXACIN 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Moxifloxacin hydrochloride is 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 hydrochloride is 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 hydrochloride is indicated in ad

Product summary:

Moxifloxacin hydrochloride tablets are available as pink, biconvex, capsule shaped tablets containing moxifloxacin hydrochloride equivalent to 400 mg moxifloxacin. The tablet is debossed with "n" on one side and "034" on the other side. Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature] . Avoid high humidity.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MOXIFLOXACIN HYDROCHLORIDE- MOXIFLOXACIN HYDROCHLORIDE TABLET
Novel Laboratories, Inc.
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MEDICATION GUIDE
Moxifloxacin hydrochloride
(mox" i flox' a sin hye" droe klor' ide) Tablets
Read the Medication Guide that comes with moxifloxacin hydrochloride
tablets before you start taking it
and each time you get a refill. There may be new information. This
Medication Guide does not take the
place of talking to your healthcare provider about your medical
condition or your treatment.
What is the most important information I should know about
moxifloxacin hydrochloride tablets?
Moxifloxacin hydrochloride tablets belongs to a class of antibiotics
called fluoroquinolones.
Moxifloxacin hydrochloride tablets can cause serious side effects that
can happen at the same time and
could result in death. If you get any of the following serious side
effects, you should stop taking
moxifloxacin hydrochloride tablets and get medical help right away.
Talk with your healthcare provider
about whether you should continue to take moxifloxacin hydrochloride
tablets.
1. Tendon rupture or swelling of the tendon (tendinitis).
Tendon problems can happen in people of all ages who take moxifloxacin
hydrochloride tablets. Tendons
are tough cords of tissue that connect muscles to bones. Symptoms of
tendon problems may include:
•
Pain, swelling, tears and inflammation of tendons including the back
of the ankle (Achilles),
shoulder, hand, or other tendon sites.
The risk of getting tendon problems while you take moxifloxacin
hydrochloride tablets is higher if you:
Are over 60 years of age
Are taking steroids (corticosteroids)
Have had a kidney, heart or lung transplant
Tendon problems can happen in people who do not have the above risk
factors when they take
moxifloxacin hydrochloride tablets. Other reasons that can increase
your risk of tendon problems can
include:
Physical activity or exercise
Kidney failure
Tendon problems in the past, such as in people with rheumatoid
arthritis (RA).
Stop taking moxifloxacin hydrochloride tablets immedia

Summary of Product characteristics

MOXIFLOXACIN HYDROCHLORIDE- MOXIFLOXACIN HYDROCHLORIDE TABLET
NOVEL LABORATORIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MOXIFLOXACIN HYDROCHLORIDE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MOXIFLOXACIN HYDROCHLORIDE
TABLETS.
MOXIFLOXACIN HYDROCHLORIDE 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 (5.1–5.13 ), 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
Boxed Warning 7/2016
Indications and Usage, Acute Bacterial Sinusitis (1.6) 7/2016
Indications and Usage, Acute Bacterial Exacerbation of Chronic
Bronchitis (1.7) 7/2016
Dosage and Administration, Dosage in Adult Patients (2.1) 7/2016
Warnings and Precautions (5) 7/2016
INDICATIONS AND USAGE
Moxifloxacin hydrochloride is a flu