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:

Breckenridge Pharmaceutical, Inc.

INN (International Name):

MOXIFLOXACIN HYDROCHLORIDE

Composition:

MOXIFLOXACIN 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Moxifloxacin Tablets USP are available as pale red, capsule-shaped, film-coated tablets containing moxifloxacin hydrochloride equivalent to 400 mg moxifloxacin. The tablet is imprinted with "400" on one side. 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MOXIFLOXACIN HYDROCHLORIDE- MOXIFLOXACIN HYDROCHLORIDE TABLET
Breckenridge Pharmaceutical, Inc.
----------
MEDICATION GUIDE
Moxifloxacin Tablets
(MOX-i-FLOX-a-sin)
Read the Medication Guide that comes with Moxifloxacin 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 Tablets?
Moxifloxacin Tablets are in a class of antibiotics called
fluoroquinolones. Moxifloxacin 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
Tablets.
1. Tendon rupture or swelling of the tendon (tendinitis).
•
Tendon problems can happen in people of all ages who take Moxifloxacin
Tablets. Tendons are
tough cords of tissue that connect muscles to bones. Symptoms of
tendon problems may include:
o 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
Tablets is higher if you:
o Are over 60 years of age.
o Are taking steroids (corticosteroids).
o Have had a kidney, heart or lung transplant.
o Tendon problems can happen in people who do not have the above risk
factors when they take
Moxifloxacin Tablets.
•
Other reasons that can increase your risk of tendon problems can
include:
o Physical activity or exercise.
o Kidney failure.
o Tendon problems in the past, such as in people with rheumatoid
arthritis (RA).
•
Stop taking Moxifloxacin Tablets immediately and call your healthcare
provider right away at the
first sign of tendon pain, swelling or inflammation. Stop taking
Moxifloxacin Tab

Summary of Product characteristics

MOXIFLOXACIN HYDROCHLORIDE- MOXIFLOXACIN HYDROCHLORIDE TABLET
BRECKENRIDGE PHARMACEUTICAL, INC.
----------
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:
TENDINITIS AND TENDON RUPTURE ( 5.2)
PERIPHERAL NEUROPATHY ( 5.3)
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 ( 5.1-5.14), RESERVE MOXIFLOXACIN TABLETS
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 Infections: Uncomplicated ( 1.2) and
Complicated ( 1.3)
Complicated Intra-Abdo