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:

RedPharm Drug Inc.

INN (International Name):

MOXIFLOXACIN HYDROCHLORIDE

Composition:

MOXIFLOXACIN HYDROCHLORIDE 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVELOX and other antibacterial drugs, AVELOX should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. AVELOX  Tablets and IV are indicated for the treatment of adults (≥ 18 years of age) with infections caused by susceptible strains of the designated microorganisms in the conditions listed below [see Dosage and Administration (2) and Use In Specific Populations (8.5)]. Culture and Susceptibility Testing Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin

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.   Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature] . Avoid high humidity. AVELOX IV (moxifloxacin hydrochloride in sodium chloride injection) is available in ready-to-use 250 mL latex-free flexible bags containing 400 mg of moxifloxacin in 0.8% saline. NO FURTHER DILUTION OF THIS PREPARATION IS NECESSARY.   Parenteral drug products should be inspected visually for particulate matter prior to administration. Samples containing visible particulates should not be used. Because the premix flexible containers are for single-use only, any unused portion should be discarded. 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 TABLET, FILM COATED
RedPharm Drug Inc.
----------
MEDICATION GUIDE
AVELOX® (AV-eh-locks)
(moxifloxacin hydrochloride)
Tablets
AVELOX® I.V. (AV-eh-locks)
(moxifloxacin hydrochloride in sodium chloride injection)
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 side effects that
may be serious or even cause death. If you get any of the following
serious side effects, get medical help
right away. Talk with your healthcare provider about whether you
should continue to take AVELOX.
•
Tendon rupture or swelling of the tendon (tendinitis)
•
Tendons are tough cords of tissue that connect muscles to bones.
•
Pain, swelling, tears and inflammation of tendons including the back
of the ankle
(Achilles), shoulder, hand, or other tendon sites can happen in people
of all ages who take
fluoroquinolone antibiotics, including AVELOX. The risk of getting
tendon problems is
higher if you:
•
Are over 60 years of age
•
Are taking steroids (corticosteroids)
•
Have had a kidney, heart or lung transplant
•
Swelling of the tendon (tendinitis) and tendon rupture (breakage) have
also happened in patients
who take fluoroquinolones who do not have the above risk factors.
•
Other reasons for tendon ruptures can include:
•
Physical activity or exercise
•
Kidney failure
•
Tendon problems in the past, such as in people with rheumatoid
arthritis (RA)
•
Call your healthcare provider right away at the first sign of tendon
pain, swelling or inflammation.
Stop taking AVELOX until tendinitis or tendon rupture has been ruled
out by your healthcare
provider. Avoid exercise and using the affected area. The most common
area of p

Summary of Product characteristics

AVELOX - MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED
REDPHARM DRUG INC.
----------
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.
INITIAL U.S. APPROVAL: 1999
WARNING:
FLUOROQUINOLONES, INCLUDING AVELOX , ARE ASSOCIATED WITH AN INCREASED
RISK OF TENDINITIS AND TENDON
RUPTURE IN ALL AGES. THIS RISK IS FURTHER INCREASED IN OLDER PATIENTS
USUALLY OVER 60 YEARS OF AGE, IN PATIENTS
TAKING CORTICOSTEROID DRUGS, AND IN PATIENTS WITH KIDNEY, HEART OR
LUNG TRANSPLANTS _[SEE WARNINGS AND_
_PRECAUTIONS (5.1)]_.
FLUOROQUINOLONES, INCLUDING AVELOX, MAY EXACERBATE MUSCLE WEAKNESS IN
PERSONS WITH MYASTHENIA
GRAVIS. AVOID AVELOX IN PATIENTS WITH KNOWN HISTORY OF MYASTHENIA
GRAVIS [SEE WARNINGS AND PRECAUTIONS
(5.2).]
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of AVELOX and other antibacterial
drugs, AVELOX should be used only to treat or prevent infections that
are proven or strongly suspected to be caused by
susceptible bacteria. (1)
RECENT MAJOR CHANGES
Boxed Warning 02/11
Warnings and Precautions (5.2) 02/11
INDICATIONS AND USAGE
AVELOX is a fluoroquinolone antibacterial indicated for treating
infections in adults ≥ 18 years of age caused by
designated, susceptible bacteria. (1, 12.4)
Acute Bacterial Sinusitis (1.1)
Acute Bacterial Exacerbation of Chronic Bronchitis (1.2)
Community Acquired Pneumonia (1.3)
Skin and Skin Structure Infections: Uncomplicated (1.4) and
Complicated (1.5)
Complicated Intra-Abdominal Infections (1.6)
DOSAGE AND ADMINISTRATION
TYPE OF INFECTION
DOSE EVERY 24
HO URS
DURATIO N
(DAYS)
Acute Bacterial Sinusitis (1.1)
400 mg
10
Acute Bacterial Exacerbation of Chronic Bronchitis (1.2)
400 mg
5
Community Acquired Pneumonia (1.3)
400 mg
7-14
Uncomplicated Skin and Skin Structure Infections (SSSI) (1.4)
400 mg
7
Complicated SSSI (1.5)
400 mg
7-21
Complicated Intra-Abdominal Infections (1.6)
400 mg
5-14
No dosage adjustment in patients