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:

Major Pharmaceuticals

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). Carton of 30 tablets (10 tablets each blister pack x 3) NDC 0904-6406-04 Carton of 50 tablets (10 tablets each blister pack x 5) NDC 0904-6406-06 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
Major Pharmaceuticals
----------
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).
1.
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:
1.
Pain, swelling, tears and inflammation of tendons including the back
of the ankle (Achilles),
shoulder, hand, or other tendon sites.
1.
The risk of getting tendon problems while you take moxifloxacintablets
is higher if you:
1.
Are over 60 years of age .
2.
Are taking steroids (corticosteroids) .
3.
Have had a kidney, heart or lung transplant .
4.
Tendon problems can happen in people who do not have the above risk
factors when they take
moxifloxacin tablets.
1.
Other reasons that can increase your risk of tendon problems can
include:
1.
Physical activity or exercise .
2.
Kidney failure .
3.
Tendon problems in the past, such as in people with rheumatoid
arthritis (RA).
1.
Stop taking moxifloxacin tablets immediately and call your healthcare
provider right away at the first
sign of tendon pain, swelling or infl

Summary of Product characteristics

MOXIFLOXACIN- MOXIFLOXACIN TABLET, FILM COATED
MAJOR PHARMACEUTICALS
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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 Bacterial Sinusi