MOXIFLOXACIN- moxifloxacin hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

MOXIFLOXACIN HYDROCHLORIDE

Composition:

MOXIFLOXACIN 400 mg in 250 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Moxifloxacin Injection is indicated in adults (18 years of age or older) for the treatment of Community Acquired Pneumonia caused by susceptible isolates of Streptococcus pneumoniae (including multi-drug resistant isolates*), Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae . * MDRSP, Multi-drug resistant Streptococcus pneumoniae includes isolates previously known as PRSP (Penicillin-resistant S. pneumoniae ), and are isolates resistant to two or more of the following antibiotics: penicillin (minimum inhibitory concentrations [MIC] ≥ 2 mcg/mL), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole [see Clinical Studies (14.2)] . Moxifloxacin Injection is indicated in adults (18 years of age or older) for the treatment of Uncomplicated Skin and Skin Structure Infections caused by susceptible isolates of methicillin-susceptible

Product summary:

How Supplied Moxifloxacin Injection 400 mg/250 mL is a sterile solution available in a single-dose, ready-to-use flexible bag. No further dilution is necessary. Parenteral drug products should be inspected visually for particulate matter prior to administration. Samples containing visible particulates should not be used. Storage and Handling Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Do not refrigerate - Product precipitates upon refrigeration. Retain in overwrap to protect from light. Use immediately once removed from the overwrap. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP. Sterile.

Authorization status:

New Drug Application

Patient Information leaflet

Fresenius Kabi USA, LLC
----------
This Medication Guide has been approved by the U.S. Food and
Drug Administration
Revised:10/2022
Medication Guide
MOXIFLOXACIN
(mox i FLOX a sin) (in jek shun)
injection, for intravenous use
Read the Medication Guide that comes with moxifloxacin injection
before you start receiving it and each
time you receive it. 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 injection?
Moxifloxacin injection is in a class of antibiotics called
fluoroquinolones. Moxifloxacin injection 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 receiving moxifloxacin
injection and get medical help
right away. Talk with your healthcare provider about whether you
should continue to receive
moxifloxacin injection.
1. Tendon rupture or swelling of the tendon (tendinitis).
•
Tendon problems can happen in people of all ages who receive
moxifloxacin injection. 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 receive moxifloxacin
injection 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 receive
moxifloxacin injection.
•
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 receiving moxifloxacin injection immediately and call your
healthc

Summary of Product characteristics

MOXIFLOXACIN - MOXIFLOXACIN HYDROCHLORIDE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MOXIFLOXACIN INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MOXIFLOXACIN INJECTION.
MOXIFLOXACIN INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1999
RX ONLY
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, 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 INJECTION IMMEDIATELY AND AVOID THE USE OF
FLUOROQUINOLONES, INCLUDING MOXIFLOXACIN INJECTION, IN PATIENTS WHO
EXPERIENCE ANY OF
THESE SERIOUS ADVERSE REACTIONS.
FLUOROQUINOLONES, INCLUDING MOXIFLOXACIN, MAY EXACERBATE MUSCLE
WEAKNESS IN
PATIENTS WITH MYASTHENIA GRAVIS. AVOID MOXIFLOXACIN INJECTION IN
PATIENTS WITH KNOWN
HISTORY OF MYASTHENIA GRAVIS (5.5).
BECAUSE FLUOROQUINOLONES, INCLUDING MOXIFLOXACIN, HAVE BEEN ASSOCIATED
WITH SERIOUS
ADVERSE REACTIONS (5.1 TO 5.14), RESERVE MOXIFLOXACIN INJECTION FOR
USE IN PATIENTS
WHO HAVE NO ALTERNATIVE TREATMENT OPTIONS FOR THE FOLLOWING
INDICATIONS:
ACUTE BACTERIAL SINUSITIS (1.5)
ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS (1.6)
RECENT MAJOR CHANGES
Indications and Usage (1)
3/2020
Dosage and Administration (2)
3/2020
Warnings and Precautions (5)
3/2020
INDICATIONS AND USAGE
Moxifloxacin Injection is a fluoroquinolone antibacterial drug
indicated for treating infections in adults ≥ 18
years of age caused by designated, susceptible bacteria. (1, 12.4)
Community Acquired Pneumonia (1.1)
Skin and Skin Structure Infections: Uncomplicated (1.2) and
Complicated (1