MOXIFLOXACIN HYDROCHLORIDE tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Teva Pharmaceuticals USA, Inc.

INN (Nama Antarabangsa):

MOXIFLOXACIN HYDROCHLORIDE

Komposisi:

MOXIFLOXACIN 400 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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 patie

Ringkasan produk:

Moxifloxacin tablets USP, 400 mg are available as pink, film-coated, unscored, oval-shaped tablets, debossed with “TEVA” on one side and “7387” on the other side. Tablets are supplied in bottles of 30 (NDC 0093-7387-56). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid high humidity. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

Teva Pharmaceuticals USA, Inc.
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MEDICATION GUIDE
Dispense with Medication Guide available at: www.tevausa.com/medguides
Moxifloxacin (mox″ i flox′ a sin)Tablets
Read the Medication Guide that comes with moxifloxacin tablets before
you start taking them 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 tablets 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).
•
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:
•
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
tablets is higher if you:
•
Are over 60 years of age.
•
Are taking steroids (corticosteroids).
•
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 tablets.
•
Other reasons that can increase your risk of tendon problems can
include:
•
Physical activity or exercise.
•
Kidney failure.
•
Tendon problems in the past, such as in people with rheumatoid
arthritis (RA).
•
Stop taking moxifloxacin tablets immediately and call your healthcare
provider right away at the first sign of tendon pain, swelling or
inflammation.St

Ciri produk

MOXIFLOXACIN HYDROCHLORIDE- MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM
COATED
TEVA PHARMACEUTICALS USA, INC.
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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, CENTRAL 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:
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 TO 5.14), RESERVE
MOXIFLOXACIN
HYDROCHLORIDE 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)
INDICATIONS AND USAGE
Moxifloxacin tablets are 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 (