Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
GEMIFLOXACIN MESYLATE (UNII: X4S9F8RL01) (GEMIFLOXACIN - UNII:OKR68Y0E4T)
Merus Labs International Inc.
GEMIFLOXACIN MESYLATE
GEMIFLOXACIN 320 mg
ORAL
PRESCRIPTION DRUG
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
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.
New Drug Application
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 Lue koko asiakirja
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 Lue koko asiakirja