FACTIVE- gemifloxacin mesylate tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

GEMIFLOXACIN MESYLATE (UNII: X4S9F8RL01) (GEMIFLOXACIN - UNII:OKR68Y0E4T)

थमां उपलब्ध:

Merus Labs International Inc.

INN (इंटरनेशनल नाम):

GEMIFLOXACIN MESYLATE

रचना:

GEMIFLOXACIN 320 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

FACTIVE is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below. (See DOSAGE AND ADMINISTRATION and CLINICAL STUDIES. ) Acute bacterial exacerbation of chronic bronchitis (ABECB) caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis . Because fluoroquinolones, including FACTIVE, have been associated with serious adverse reactions (see WARNINGS ) and for some patients ABECB is self-limiting, reserve FACTIVE for treatment of ABECB in patients who have no alternative treatment options. Community-acquired pneumonia (of mild to moderate severity) caused by Streptococcus pneumoniae (including multi-drug resistant strains [MDRSP])*, Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Klebsiella pneumoniae . *MDRSP: multi-drug resistant S

उत्पाद समीक्षा:

FACTIVE (gemifloxacin mesylate) is available as white to off-white, oval, film-coated tablets with breaklines and GE 320 debossed on both faces. Each tablet contains gemifloxacin mesylate equivalent to 320 mg of gemifloxacin. 320 mg Unit of Use (CR*) 5's             NDC 44001-321-05 320 mg Unit of Use (CR*) 7's             NDC 44001-321-07 *Child Resistant Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF) [see USP Controlled Room Temperature]. Protect from light.

प्राधिकरण का दर्जा:

New Drug Application

सूचना पत्रक

FACTIVE- GEMIFLOXACIN MESYLATE TABLET
Merus Labs International Inc.
----------
MEDICATION GUIDE
FACTIVE® [FAC-tiv]
(gemifloxacin)
320mg Tablets
Read the Medication Guide that comes with FACTIVE 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
FACTIVE?
FACTIVE, a fluoroquinolone antibacterial medicine, can cause serious
side effects. Some of these serious
side effects can happen at the same time and could result in death.
If you get any of the following serious side effects while you are
taking FACTIVE, you should stop
taking FACTIVE immediately and get medical help right away.
1. Tendon rupture or swelling of the tendon (tendinitis)
•
Tendon problems can happen in people of all ages who take FACTIVE.
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 FACTIVE 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
FACTIVE.
•
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 FACTIVE immediately and get medical help right away at the
first sign of tendon
pain, swelling or inflammation. Stop taking FACTIVE until tendinitis
or tendon rupture has been
ruled out by your healthcare provider. Avoid exercise and using the
affected area. The most
common area of pain and swelling is the Achilles tendon at t

उत्पाद विशेषताएं

FACTIVE- GEMIFLOXACIN MESYLATE TABLET
MERUS LABS INTERNATIONAL INC.
----------
FACTIVE
(GEMIFLOXACIN MESYLATE) TABLETS
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON
RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS
AND EXACERBATION OF MYASTHENIA GRAVIS
FLUOROQUINOLONES, INCLUDING FACTIVE , HAVE BEEN ASSOCIATED WITH WITH DISABLING AND
POTENTIALLY IRREVERSIBLE SERIOUS ADVERSE REACTIONS THAT HAVE OCCURRED
TOGETHER (SEE
WARNINGS) INCLUDING:
TENDINITIS AND TENDON RUPTURE
PERIPHERAL NEUROPATHY
CENTRAL NERVOUS SYSTEM EFFECTS
DISCONTINUE FACTIVE IMMEDIATELY AND AVOID THE USE OF FLUOROQUINOLONES,
INCLUDING
FACTIVE, IN PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS ADVERSE
REACTIONS (SEE
WARNINGS).
FLUOROQUINOLONES, INCLUDING FACTIVE, MAY EXACERBATE MUSCLE WEAKNESS IN
PERSONS
WITH MYASTHENIA GRAVIS. AVOID FACTIVE IN PATIENTS WITH KNOWN HISTORY
OF MYASTHENIA
GRAVIS (SEE WARNINGS ).
BECAUSE FLUOROQUINOLONES, INCLUDING FACTIVE, HAVE BEEN ASSOCIATED WITH
SERIOUS
ADVERSE REACTIONS (SEE WARNINGS), RESERVE FACTIVE FOR USE IN PATIENTS
WHO HAVE
NO ALTERNATIVE TREATMENT OPTIONS FOR ACUTE BACTERIAL EXACERBATION OF
CHRONIC BRONCHITIS
(SEE INDICATIONS AND USAGE).
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of FACTIVE and
other antibacterial drugs, FACTIVE should be used only to treat
infections that are proven or strongly
suspected to be caused by bacteria.
DESCRIPTION
FACTIVE (gemifloxacin mesylate) is a synthetic broad-spectrum
antibacterial agent for oral
administration. Gemifloxacin, a compound related to the
fluoroquinolone class of antibiotics, is
available as the mesylate salt in the sesquihydrate form. Chemically,
gemifloxacin is _(R,S_)-7-[(4Z)-3-
(aminomethyl)-4-(methoxyimino)-1-pyrrolidinyl]-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-1,8-
naphthyridine-3-carboxylic acid.
The mesylate salt is a white to light brown solid with a molecular
weight of 485.49. Gemifloxacin is
considered freely soluble at neutral pH (350 μg/mL at 37ºC, pH 7.0).
Its empirical formu