MOXIFLOXACIN HYDROCHLORIDE tablet
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Patient Information leaflet
(PIL)
03-04-2023
Summary of Product characteristics
(SPC)
03-04-2023
Active ingredient:
MOXIFLOXACIN HYDROCHLORIDE (UNII: C53598599T) (MOXIFLOXACIN - UNII:U188XYD42P)
Available from:
Torrent Pharmaceuticals Limited
INN (International Name):
MOXIFLOXACIN HYDROCHLORIDE
Composition:
MOXIFLOXACIN 400 mg
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
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]), Homophiles 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 Stre
Product summary:
Moxifloxacin tablets, USP 400 mg are available as light pink colored, capsule shaped biconvex film-coated tablets debossed with '1201' on one side and '400' on other side. Package NDC Code Bottles of 30 NDC 13668-201-30 Bottles of 100 NDC 13668-201-01 Bottles of 500 NDC 13668-201-05 Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature ]. Avoid high humidity.
Authorization status:
Abbreviated New Drug Application
Patient Information leaflet
MOXIFLOXACIN HYDROCHLORIDE- MOXIFLOXACIN HYDROCHLORIDE TABLET
Torrent Pharmaceuticals Limited
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MEDICATION GUIDE
Moxifloxacin
(MOX-i-FLOX-a-sin)
Tablets, USP for oral use
Read the Medication Guide that comes with moxifloxacin tabletsbefore
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 tablets?
Moxifloxacin tablets are 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:
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
tablets 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 tablets.
•
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 in people with rheumatoid
arthritis (RA).
•
Stop taking moxifloxacin tabletsimmediately and call your healthcare
provider right away at the
first sign of tendon pain, swelling or inflammation. Stop taki
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Summary of Product characteristics
MOXIFLOXACIN HYDROCHLORIDE- MOXIFLOXACIN HYDROCHLORIDE TABLET
TORRENT PHARMACEUTICALS LIMITED
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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: º TENDINITIS AND TENDON RUPTURE (5.2) º PERIPHERAL NEUROPATHY (5.3) º 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)
RECENT MAJOR CHANGES
Dosage and Administration ( 2.2)
5/2020
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
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