AVELOX ABC PACK- 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:

Stat Rx USA

INN (International Name):

MOXIFLOXACIN HYDROCHLORIDE

Composition:

MOXIFLOXACIN HYDROCHLORIDE 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Following oral administration of 400 mg moxifloxacin for 10 days in 16 elderly (8 male; 8 female) and 17 young (8 male; 9 female) healthy volunteers, there were no age-related changes in moxifloxacin pharmacokinetics. In 16 healthy male volunteers (8 young; 8 elderly) given a single 200 mg dose of oral moxifloxacin, the extent of systemic exposure (AUC and Cmax ) was not statistically different between young and elderly males and elimination half-life was unchanged. No dosage adjustment is necessary based on age. In large phase III studies, the concentrations around the time of the end of the infusion in elderly patients following intravenous infusion of 400 mg were similar to those observed in young patients. The pharmacokinetics of moxifloxacin in pediatric subjects have not been studied. Following oral administration of 400 mg moxifloxacin daily for 10 days to 23 healthy males (19-75 years) and 24 healthy females (19-70 years), the mean AUC and Cmax were 8% and 16% higher, respectively, in fem

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 I.V. (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. Since 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 ABC PACK - MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED
Stat Rx USA
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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

Summary of Product characteristics

AVELOX ABC PACK - MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED
STAT RX USA
----------
AVELOX (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED
DESCRIPTION
AVELOX (moxifloxacin hydrochloride) is a synthetic broad spectrum
antibacterial agent and is
available as AVELOX Tablets for oral administration and as AVELOX I.V.
for intravenous
administration. Moxifloxacin, a fluoroquinolone, is available as the
monohydrochloride salt of 1-
cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3
quinoline carboxylic acid. It is a slightly yellow to yellow
crystalline substance with a molecular
weight of 437.9. Its empirical formula is C
H FN O *HCl and its chemical structure is as follows:
AVELOX Tablets are available as film-coated tablets containing
moxifloxacin hydrochloride
(equivalent to 400 mg moxifloxacin). The inactive ingredients are
microcrystalline cellulose, lactose
monohydrate, croscarmellose sodium, magnesium stearate, hypromellose,
titanium dioxide,
polyethylene glycol and ferric oxide.
AVELOX I.V. is available in ready-to-use 250 mL latex-free flexibags
as a sterile, preservative free,
0.8% sodium chloride aqueous solution of moxifloxacin hydrochloride
(containing 400 mg
moxifloxacin) with pH ranging from 4.1 to 4.6. The appearance of the
intravenous solution is yellow.
The color does not affect, nor is it indicative of, product stability.
The inactive ingredients are sodium
chloride, USP, Water for Injection, USP, and may include hydrochloric
acid and/or sodium hydroxide
for pH adjustment. AVELOX I.V. contains approximately 34.2 mEq (787
mg) of sodium in 250 mL.
CLINICAL PHARMACOLOGY
ABS ORPTION
Moxifloxacin, given as an oral tablet, is well absorbed from the
gastrointestinal tract. The absolute
bioavailability of moxifloxacin is approximately 90 percent.
Co-administration with a high fat meal (i.e.,
500 calories from fat) does not affect the absorption of moxifloxacin.
Consumption of 1 cup of yogurt with moxifloxacin does not
significantly affect the extent or rate of
s