MOXIFLOXACIN HYDROCHLORIDE- 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:

AvPAK

INN (International Name):

MOXIFLOXACIN HYDROCHLORIDE

Composition:

MOXIFLOXACIN 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin hydrochloride tablets and other antibacterial drugs, moxifloxacin hydrochloride tablets 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. Moxifloxacin hydrochloride tablets are indicated for the treatment of adults (≥ 18 years of age) with infections caused by susceptible isolates 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  

Product summary:

Moxifloxacin Hydrochloride Tablets are available as modified capsule shaped, dull red film-coated tablets containing 400 mg moxifloxacin. The tablet is debossed with E-18 on one side and plain on the other side. NDC 50268-576-13   10 Tablets per card, 3 cards per carton. Dispensed in Unit Dose Package. For Institutional Use Only.                                                           Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid high humidity.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MOXIFLOXACIN HYDROCHLORIDE - MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM
COATED
AvPAK
----------
FDA-APPROVED MEDICATION GUIDE
MEDICATION GUIDE
Moxifloxacin Hydrochloride Tablets
(mox'' i flox' a sin hye'' droe klor' ide)
Rx only
Read the Medication Guide that comes with moxifloxacin hydrochloride
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 hydrochloride tablets?
Moxifloxacin hydrochloride tablets belong to a class of antibiotics
called fluoroquinolones. Moxifloxacin
hydrochloride tablets 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 moxifloxacin hydrochloride tablets.
1. Tendon rupture or swelling of the tendon (tendinitis).
•
Tendon problems can happen in people of all ages who take moxifloxacin
hydrochloride 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
hydrochloride 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
hydrochloride 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).
•
Call your healthcare provider right away at the first sign of tendo

Summary of Product characteristics

MOXIFLOXACIN HYDROCHLORIDE - MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM
COATED
AVPAK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
MOXIFLOXACIN HYDROCHLORIDE TABLETS
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MOXIFLOXACIN
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
MOXIFLOXACIN HYDROCHLORIDE TABLETS.
MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM-COATED FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
WARNING: TENDON EFFECTS AND MYASTHENIA GRAVIS
FLUOROQUINOLONES, INCLUDING MOXIFLOXACIN HYDROCHLORIDE, 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 MOXIFLOXACIN HYDROCHLORIDE, MAY EXACERBATE
MUSCLE
WEAKNESS IN PERSONS WITH MYASTHENIA GRAVIS. AVOID MOXIFLOXACIN
HYDROCHLORIDE 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 moxifloxacin
hydrochloride and other antibacterial drugs, moxifloxacin
hydrochloride 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
Warnings and Precautions ( 5.10) 11/14
INDICATIONS AND USAGE
Moxifloxacin hydrochloride tablets are 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 HOURSDURATION (DAYS)
Acute Bacterial Sinusitis (1.1)
400 mg
10