MOXIFLOXACIN - moxifloxacin tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Moxifloxacin hydrochloride 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 hydrochloride 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 hydrochloride

Product summary:

Moxifloxacin hydrochloride tablets 400 mg are available as Beige colored, capsule shaped, biconvex tablets debossed ‘112’ on one side and plain on other side. They are supplied in bottles of 30, 100, 500, and unit dose package of 50’s (5 x 10’s). 55700-638-30 Store at 20-25°C (68-77°F); [see USP Controlled Room Temperature]. Avoid high humidity.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MOXIFLOXACIN - MOXIFLOXACIN TABLET, FILM COATED
Lake Erie Medical DBA Quality Care Products LLC
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FDA-Approved Medication Guide
MEDICATION GUIDE
Moxifloxacin Hydrochloride Tablets
(mox'' i flox' a sin hye'' droe klor' ide)
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 tablet 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 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
hydrochloridetablets 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

Summary of Product characteristics

MOXIFLOXACIN - MOXIFLOXACIN TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
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, CENTRIAL NERVOUS SYSTEM EFFECTS AND
EXACERBATION OF
MYASTHENIA GRAVIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
• FLUOROQUINOLONES, INCLUDING MOXIFLOXACIN, 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 IMMEDIATELY AND AVOID THE USE OF
FLUOROQUINOLONES, INCLUDING MOXIFLOXACIN, IN
PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS ADVERSE REACTIONS (5.1)
• FLUOROQUINOLONES, INCLUDING MOXIFLOXACIN, MAY EXACERBATE MUSCLE
WEAKNESS IN PATIENTS WITH
MYASTHENIA GRAVIS. AVOID MOXIFLOXACIN IN PATIENTS WITH KNOWN HISTORY
OF MYASTHENIA GRAVIS (5.5).
• BECAUSE FLUOROQUINOLONES, INCLUDING MOXIFLOXACIN, HAVE BEEN
ASSOCIATED WITH SERIOUS ADVERSE REACTIONS
(5.1–5.13), RESERVE MOXIFLOXACIN 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)
INDICATIONS AND USAGE
Moxifloxacin hydrochloride tablet is a fluoroquinolone antibacterial
indicated for treating infections