MOXIFLOXACIN HYDROCHLORIDE injection, solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Mylan Institutional LLC

INN (Kansainvälinen yleisnimi):

MOXIFLOXACIN HYDROCHLORIDE

Koostumus:

MOXIFLOXACIN 400 mg in 250 mL

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Moxifloxacin 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 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 is indicated in adult patients for the treatment of Complic

Tuoteyhteenveto:

Moxifloxacin hydrochloride in sodium chloride injection is available in ready-to-use single-dose 250 mL single-dose flexible bags containing moxifloxacin hydrochloride, USP (equivalent to 400 mg of moxifloxacin) in 0.8% sodium chloride aqueous solution. The flexible bag is not made with natural rubber latex. No further dilution of this preparation is necessary. Discard unused portion. Package NDC Code 67457-323-25 Store at 25°C (77°F); excursions permitted to 15ºC to 30°C (59ºF to 86°F). [See USP Controlled Room Temperature.] Do not refrigerate – product precipitates upon refrigeration.

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

MOXIFLOXACIN HYDROCHLORIDE- moxifloxacin hydrochloride injection,
solution
Mylan Institutional LLC
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MEDICATION GUIDE
Moxifloxacin Hydrochloride
(moxʺ i floxʹ a sin hyeʺ droe klorʹ ide)
in Sodium Chloride Injection, for intravenous use
Read the Medication Guide that comes with moxifloxacin hydrochloride
injection 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 injection?
Moxifloxacin hydrochloride injection is in a class of antibiotics
called fluoroquinolones. Moxifloxacin
hydrochloride 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 taking moxifloxacin hydrochloride
injection and get medical help right away. Talk with your healthcare
provider about whether you should
continue to take moxifloxacin hydrochloride injection.
1.Tendon rupture or swelling of the tendon (tendinitis).
•
Tendon problems can happen in people of all ages who take moxifloxacin
hydrochloride injection.
Tendons are tough cords of tissue that connect muscles to bones.
Symptoms of tendon problems may
include:
o
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 injection 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.
o
Tendon problems can happen in people who do not have the above risk
factors when they take
moxifloxacin hydrochloride injection.
•
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

Valmisteyhteenveto

MOXIFLOXACIN HYDROCHLORIDE- MOXIFLOXACIN HYDROCHLORIDE INJECTION,
SOLUTION
MYLAN INSTITUTIONAL LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MOXIFLOXACIN
HYDROCHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
MOXIFLOXACIN HYDROCHLORIDE INJECTION.
MOXIFLOXACIN HYDROCHLORIDE INJECTION, FOR INTRAVENOUS 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._
•
•
•
•
•
INDICATIONS AND USAGE
Moxifloxacin is 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:
•
•
•
•
•
•
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of moxifloxacin and
other antibacterial drugs. Moxifloxacin should be used only to treat
or prevent infections that are proven or
strongly suspected to be caused by susceptible bacteria. (1.8)
DOSAGE AND ADMINISTRATION
TYPE OF INFECTION
DOSE EVERY
24 HOURS
DURATION (DAYS)
Community Acquired Pneumonia (1.1)
400 mg
7 to 14
Uncomplicated Skin and Skin Structure Infections (SSSI) (1.2)
400 mg
7
FLUOROQUINOLONES, INCLUDING MOXIFLOXACIN, 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 IMMEDIATELY AND AVOID THE USE OF
FLUOROQUINOLONES,
INCLUDING MOXIFLOXACIN, IN PATIENTS WHO EXPERIENCE ANY OF THESE
SERIOUS ADVERSE
REACTIONS (5.1)
FLUOROQUINOLONES, INCLUDING MOXIFLOXACIN, MAY EXACERBATE MUSCLE
WEAKNESS IN
PATIENTS WITH MYASTHENIA GRAVIS. AVOID MOXIFLOXACIN IN PATIENTS WITH
KNOWN HISTORY
OF MYASTHENIA GRAVIS (5.5).
BEC