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:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

MOXIFLOXACIN HYDROCHLORIDE

Composition:

MOXIFLOXACIN 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 indica

Product summary:

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. Bottles of 5: NDC 43063-585-05 Bottles of 10: NDC 43063-585-10 Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature] . Avoid high humidity.

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

MOXIFLOXACIN HYDROCHLORIDE- MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM
COATED
PD-Rx Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
1.
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:
•
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.
•
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 Hydrochloride immediately and

Summary of Product characteristics

MOXIFLOXACIN HYDROCHLORIDE- MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM
COATED
PD-RX PHARMACEUTICALS, 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
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.4, 5.11)
INDICATIONS AND USAGE
Moxifloxacin Hydrochloride 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:
Community Acquired Pneumonia ( 1.1)
Skin and Skin Structure Infections: Uncomplicated ( 1.2) and
Complicated ( 1.3)
Complicated Intra-Abdominal Infections ( 1.4)
Plague (1.5)
Acute Bacterial Sinusitis ( 1.6)
Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.7)
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. ( 1.8)
DOSAGE AND ADMINISTRATION
TYPE OF INFECTION
DOSE EVERY 24 HOURS
DURATIO N
(DAYS)
Community Acquired Pneumonia (1.1)
400 mg
7–14
Uncomplicated Skin and Skin Structure Infections (SSSI) (1.2)
400 mg
7
Complicated SSSI (1.3)
400 mg
7–21
Complicated Intra-Abdominal Infections (1.4)
400 mg
5–14
Plague (1.5)
400 mg
10–14
Acute Bacterial Sinusitis (1.6)
400 mg
10
Acute Bacterial Exacerbation of Chronic Bronchitis (1.7)
400 mg
5
No dosage adjustment in patients with renal or hepatic impairment. (
8.6, 8.7)
Do not mix with other medications in intravenous bag or in an
intravenous line. ( 2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: Moxifloxacin hydrochloride (equivalent to 400 mg
moxifloxacin) ( 3.1)
CONTRAINDICATIONS
Known hypersensitivity to Moxifloxacin Hydrochloride or