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:

Dr. Reddy's Laboratories Limited

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

Product summary:

Moxifloxacin Tablets USP, 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). Bottles of 30                                                   NDC 55111-112-30 Bottles of 100                                                 NDC 55111-112-01 Bottles of 500                                                 NDC 55111-112-05 Unit dose package of 50 (5 x 10’s)                NDC 55111-112-66  Store at 20 to 25°C (68 to 77°F); [see USP Controlled Room Temperature]. Avoid high humidity.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MOXIFLOXACIN - MOXIFLOXACIN TABLET, FILM COATED
Dr. Reddy's Laboratories Limited
----------
FDA-Approved Medication Guide
MEDICATION GUIDE
Moxifloxacin Tablets, USP
(mox'' i flox' a sin hye'' droe klor' ide)
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 tablet 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 moxifloxacintablets
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 tendo

Summary of Product characteristics

MOXIFLOXACIN - MOXIFLOXACIN TABLET, FILM COATED
DR. REDDY'S LABORATORIES LIMITED
----------
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, 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– 5.14 ), 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
Dosage and Administration (2.2) 5/2020
INDICATIONS AND USAGE
Moxifloxacin tablet is 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-Abdominal Infections (1.4)
Plague (1.5)
Acute Bact