MOXIFLOXACIN HYDROCHLORIDE 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:

American Health Packaging

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 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

Product summary:

Moxifloxacin Tablets, USP are available as modified capsule shaped, dull red film-coated tablets containing 400 mg moxifloxacin. The tablet is debossed with E-18 on one side and plain on the other side. Unit dose packages of 50 (5 x 10) NDC 68084-722-65 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid high humidity. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MOXIFLOXACIN HYDROCHLORIDE- MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM
COATED
American Health Packaging
----------
MEDICATION GUIDE
8272265/0522F
Moxifloxacin Tablets, USP
(mox'' i flox' a sin)
Rx only
Read the Medication Guide that comes with moxifloxacin tablets before
you start taking them 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 is 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:
•
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:
•
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 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 tablets immediately and call your healthcare
provider right away at the first
sign of tendon pain, sw

Summary of Product characteristics

MOXIFLOXACIN HYDROCHLORIDE- MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM
COATED
AMERICAN HEALTH PACKAGING
----------
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 TO 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 Acquir