MOXIFLOXACIN tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

RedPharm Drug, Inc.

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Moxifloxacin hydrochloride 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]), 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 tablets are indicated in adult patients for the treatment of Uncomplicated Skin and Skin Structure Infections caused by susceptible isolates of methicillin-susceptible

Περίληψη προϊόντος:

Moxifloxacin hydrochloride tablets 400 mg are available as Beige colored, capsule shaped, biconvex tablets debossed ‘112’ on one side and plain on other side. They are supplied in bottles of 30, 100, 500, and unit dose package of 50’s (5 x 10’s). Bottles of 30                                                   NDC 55111-112-30 Bottles of 100                                                 NDC 55111-112-01 Bottles of 500                                                 NDC 55111-112-05 Unit dose package of 50 (5 x 10’s)                NDC 55111-112-66  Store at 20-25°C (68-77°F); [see USP Controlled Room Temperature]. Avoid high humidity.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

MOXIFLOXACIN- MOXIFLOXACIN TABLET, FILM COATED
RedPharm Drug, Inc.
----------
FDA-Approved Medication Guide
MEDICATION GUIDE
Moxifloxacin Hydrochloride Tablets
(mox'' i flox' a sin hye'' droe klor' ide)
Read the Medication Guide that comes with moxifloxacin hydrochloride
tablets 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 tablets?
Moxifloxacin hydrochloride tablet belongs to a class of antibiotics
called fluoroquinolones. Moxifloxacin
hydrochloride 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 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
hydrochloridetablets 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 healthca

Αρχείο Π.Χ.Π.

MOXIFLOXACIN- MOXIFLOXACIN TABLET, FILM COATED
REDPHARM DRUG, INC.
----------
MOXIFLOXACIN 400MG
BOXED WARNING SECTION
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON
RUPTURE, PERIPHERAL NEUROPATHY, CENTRAI NERVOUS SYTEM EFFECTS and
EXACERBATION OF MYASTHENIA GRAVIS
• Fluoroquinolones, including moxifloxacin, have been associated
with disabling and potentially
irreversible serious adverse reactions that have occurred together
[see Warnings and Precautions
(5.1)], including:
• Tendinitis and tendon rupture [see Warnings and Precautions (5.2)]
• Peripheral neuropathy [see Warnings and Precautions (5.3)]
• Central nervous system effects [see Warnings and Precautions
(5.4)]
Discontinue moxifloxacin, immediately and avoid the use of
fluoroquinolones, including
moxifloxacin, in patients who experience any of these serious adverse
reactions [see Warnings
and Precautions (5.1)].
• Fluoroquinolones, including moxifloxacin, may exacerbate muscle
weakness in patients with
myasthenia gravis. Avoid moxifloxacin, in patients with known history
of myasthenia gravis [see
Warnings and Precautions (5.5)].
• Because fluoroquinolones, including moxifloxacin, have been
associated with serious adverse
reactions [see Warnings and Precautions(5.1-5.13)], reserve
moxifloxacin, for use in patients who
have no alternative treatment options for the following indications:
• Acute bacterial sinusitis [see Indications and Usage (1.6)]
• Acute bacterial exacerbation of chronic bronchitis [see
Indications and Usage (1.7)]
1 INDICATIONS AND USAGE
1.1 COMMUNITY ACQUIRED PNEUMONIA
Moxifloxacin hydrochloride 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]), _Haemophilus
influenzae, Moraxella catarrhalis, methicillin-_
_susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma
pneumoniae, or Chlamydophila_
_pneumoniae_ [see CLINICAL STUDIES