MOXIFLOXACIN HYDROCHLORIDE- moxifloxacin hydrochloride tablet, film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

MOXIFLOXACIN HYDROCHLORIDE (UNII: C53598599T) (MOXIFLOXACIN - UNII:U188XYD42P)

Mevcut itibaren:

Alvogen, Inc.

INN (International Adı):

MOXIFLOXACIN HYDROCHLORIDE

Kompozisyon:

MOXIFLOXACIN 400 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Moxifloxacin Hydrochloride 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. Moxifloxacin Hydrochloride 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 )]. Moxifloxacin Hydrochloride is indicated in

Ürün özeti:

Moxifloxacin Hydrochloride (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.

Yetkilendirme durumu:

New Drug Application Authorized Generic

Bilgilendirme broşürü

MOXIFLOXACIN HYDROCHLORIDE- MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM
COATED
Alvogen, Inc.
----------
MEDICATION GUIDE
FDA-Approved Medication Guide
MEDICATION GUIDE
Moxifloxacin Hydrochloride
Tablets
Read the Medication Guide that comes with Moxifloxacin Hydrochloride®
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 Hydrochloride?
Moxifloxacin Hydrochloride belongs to a class of antibiotics called
fluoroquinolones. Moxifloxacin
Hydrochloride 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 Hydrochloride and
get medical help right away. Talk with your healthcare provider about
whether you should continue to
take Moxifloxacin Hydrochloride.
1. Tendon rupture or swelling of the tendon (tendinitis).
•
Tendon problems can happen in people of all ages who take Moxifloxacin
Hydrochloride. 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 Moxifloxacin
Hydrochloride 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
Moxifloxacin Hydrochloride.
•
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 Moxifloxacin Hydrochloride immediately and call your
healthcare provider

Ürün özellikleri

MOXIFLOXACIN HYDROCHLORIDE- MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM
COATED
ALVOGEN, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MOXIFLOXACIN HYDROCHLORIDE SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MOXIFLOXACIN
HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDE 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 Hydrochloride, 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 Moxifloxacin Hydrochloride immediately and avoid the use
of fluoroquinolones, including
Moxifloxacin Hydrochloride, in patients who experience any of these
serious adverse reactions (5.1)
Fluoroquinolones, including Moxifloxacin Hydrochloride, may exacerbate
muscle weakness in patients with
myasthenia gravis. Avoid Moxifloxacin Hydrochloride in patients with
known history of myasthenia gravis (5.5).
Because fluoroquinolones, including Moxifloxacin Hydrochloride, have
been associated with serious adverse
reactions (5.1–5.13), reserve Moxifloxacin Hydrochloride for use in
patients who have no alternative treatment
options for the following indications:
o
Acute bacterial sinusitis (1.6)
Acute bacterial exacerbation of chronic bronchitis (1.7)
•
o
o
o
•
•
o
o
FLUOROQUINOLONES, INCLUDING MOXIFLOXACIN HYDROCHLORIDE, HAVE BEEN
ASSOCIATED WITH DISABLING
AND POTENTIALLY IRREVERSIBLE SERIOUS ADVERSE REACTIONS THAT HAVE
OCCURRED TOGETHER _[SEE WARNINGS_
_AND PRECAUTIONS (5.1)]_, INCLUDING:
o
o
o
TENDINITIS AND TENDON RUPTURE _[SEE WARNINGS AND PRECAUTIONS (5.2)]_
PERIPHERAL NEUROPATHY _