AVELOX- moxifloxacin hydrochloride injection, solution AVELOX- 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:

Schering Plough Corporation

INN (International Name):

MOXIFLOXACIN HYDROCHLORIDE

Composition:

MOXIFLOXACIN 400 mg in 250 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

AVELOX is 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. AVELOX is 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 )]. AVELOX is indicated in adult patients for the treatment of Complicated Skin and Ski

Product summary:

AVELOX (moxifloxacin hydrochloride) tablets are available as oblong, dull red film-coated tablets containing 400 mg moxifloxacin. The tablet is coded with the word “BAYER” on one side and “M400” on the reverse side. NDC Code 0085-1733-01 Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature] . Avoid high humidity. AVELOX (moxifloxacin hydrochloride) in sodium chloride injection is available in ready-to-use 250 mL flexible bags containing 400 mg of moxifloxacin in 0.8% saline. The flexibag is not made with natural rubber latex. No further dilution of this preparation is necessary. NDC Code 0085-1737-01 Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature] . Do not refrigerate – product precipitates upon refrigeration.

Authorization status:

New Drug Application

Patient Information leaflet

AVELOX- MOXIFLOXACIN HYDROCHLORIDE INJECTION, SOLUTION
AVELOX- MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED
Schering Plough Corporation
----------
MEDICATION GUIDE
FDA-Approved Medication Guide
MEDICATION GUIDE
AVELOX® (AV-eh-locks)
(moxifloxacin hydrochloride)
Tablets
AVELOX® (AV-eh-locks)
(moxifloxacin hydrochloride)
Injection Solution for Intravenous use
Read the Medication Guide that comes with AVELOX® 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 AVELOX?
AVELOX belongs to a class of antibiotics called fluoroquinolones.
AVELOX 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 AVELOX and get medical help right
away. Talk with your healthcare
provider about whether you should continue to take AVELOX.
1. Tendon rupture or swelling of the tendon (tendinitis).
•
Tendon problems can happen in people of all ages who take AVELOX.
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 AVELOX 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
•
Tendon problems can happen in people who do not have the above risk
factors when they take
AVELOX.
•
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 AVELOX immediately and call your healthcare provider right
away at the first sign of
te

Summary of Product characteristics

AVELOX- MOXIFLOXACIN HYDROCHLORIDE INJECTION, SOLUTION
AVELOX- MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED
SCHERING PLOUGH CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AVELOX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR AVELOX.
AVELOX (MOXIFLOXACIN HYDROCHLORIDE) TABLETS, FOR ORAL USE
AVELOX (MOXIFLOXACIN HYDROCHLORIDE) INJECTION, FOR INTRAVENOUS 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._
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON
RUPTURE,
PERIPHERAL NEUROPATHY, CENTRIAL NERVOUS SYSTEM EFFECTS AND
EXACERBATION OF
MYASTHENIA GRAVIS
•
•
•
ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS (1.7)
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
AVELOX 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:
FLUOROQUINOLONES, INCLUDING AVELOX, HAVE BEEN ASSOCIATED WITH
DISABLING AND POTENTIALLY
IRREVERSIBLE SERIOUS ADVERSE REACTIONS THAT HAVE OCCURRED TOGETHER
(5.1) INCLUDING:
o
o
o
TENDINITIS AND TENDON RUPTURE (5.2)
PERIPHERAL NEUROPATHY (5.3)
CENTRAL NERVOUS SYSTEM EFFECTS (5.4)
DISCONTINUE AVELOX IMMEDIATELY AND AVOID THE USE OF FLUOROQUINOLONES,
INCLUDING AVELOX, IN
PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS ADVERSE REACTIONS (5.1)
FLUOROQUINOLONES, INCLUDING AVELOX, MAY EXACERBATE MUSCLE WEAKNESS IN
PATIENTS WITH MYASTHENIA
GRAVIS. AVOID AVELOX IN PATIENTS WITH KNOWN HISTORY OF MYASTHENIA
GRAVIS (5.5).
BECAUSE FLUOROQUINOLONES, INCLUDING AVELOX, HAVE BEEN ASSOCIATED WITH
SERIOUS ADVERSE REACTIONS
(5.1–5.13), RESERVE AVELOX FOR USE IN PATIENTS WHO HAVE NO
ALTERNATIVE TREATMENT OPTIONS FOR THE
FOLLOWING INDICATIONS:
o
ACUTE BACTERIAL SINUSITIS (1.6)
Boxed