The US Food and Drug Administration is requiring labeling changes to clarify the risk of mental health side effects of fluoroquinolones, a class of antibiotics that includes levofloxacin (Levaquin
), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin, gemifloxacin (Factive), delafloxacin (Baxdela), and more than 60 generic versions.
Fluoroquinolones include levofloxacin (Levaquin
), ciprofloxacin (Cipro), moxifloxacin (Avelox), gemifloxacin (Factive), and delafloxacin (Baxdela), and there are more than 60 generic versions.
Called fluoroquinolones, they are better known under the names Cipro and Levaquin
(as well as four others).
The company said the Levofloxacin Oral Solution USP in 25 mg/ml is the therapeutic equivalent to the reference listed drug, Levaquin
Oral Solution in 25 mg/ml of Janssen Pharmaceuticals Inc.
PAST DISAPPOINTMENT:Shares of Tetraphase dropped precipitously in the fall of 2015 when the company said that in Ignite2, its phase-three clinical trial against complicated urinary tract infections, eravacycline did not compare well with standard treatment levofloxacin, known as Johnson & Johnson's (JNJ) Levaquin
. RECENT RESULTS: According to Friday's Contagion Live report, Tetraphase's Ignite 4 phase 3 trial study "successfully met its primary efficacy endpoint, which was to demonstrate non-inferiority of eravacycline to meropenem for the treatment of cIAI.
CSF culture Resistance Initial Profile Antibiotic Case 1 Staphylococcus Oxacillin, Cefazolin epidermidis Penicillin G Erythromycin, Cefazolin, Case 2 Staphylococcus Oxacillin, Amoxicillin/ epidermidis Penicillin G, clavulanate Clindamycin Case 3 Staphylococcus Erythromycin, Cefazolin haemolyticus Oxacillin, Penicillin G, TMP-SMZ Antibiotic Duration Indication IVH IT tPA change to of drain Case 1 Ceftazidime, 14 days ICH Yes Yes Vancomycin, Metronidazole Ceftazidime, Case 2 Vancomycin, 15 days Cerebral No No Levaquin
edema (pneumonia) Case 3 Vancomycin, 11 days Aneurysm No No Meropenem, rupture Ceftriaxone (concurrent UTI) Table 4: Sputum cultures for nosocomial pneumonia.
Cipro Zosyn Levaquin
67.2% 90.6% 66.1% Note: Cipro is ciprofloxacin: Zosyn is piperacillin-tazobactam: Levaquin
Aripiprazole * Ability Bupropion * Wellbutrin Chlorpromazine * Thorazine Citalopram * Celexa Clonazepam * Klonopin Cydobenzaprine * Flexeril Dexamethasone * Decadron Docusate * Colace Enoxaparin * Lovenox Fluoxetine * Prozac Gabapentin * Neurontin Haloperidol * Haldol Hydromorphone * Dilaudid Levofloxacin * Levaquin
Lidocaine ointment * Xylocaine Methadone * Dolophine Mirtazapine * Remeron Olanzapine * Zyprexa Omeprazole * Prilosec Ondansetron * Zofran Risperidone * Risperdal Tamsulosin * Flomax Trazodone * Desyrel Topiramate * Topamax Zolpidem * Ambien
The patient was started on Aztreonam (due to her penicillin allergy) and Levaquin
. Repeat blood culture 48 hours later was negative for any growth.
He was thereafter treated with Levaquin
for persistent febrile episodes, later requiring hospitalization during which work-up revealed pancytopenia and hyperferritinemia.
The adsorbate Levofloxacin (drug), Chemical formula = C18H20FN3O4, M.W = 361.36 g/mol, Trade name = Levaquin
, Chemical class = Fluoroquinolone) was purchased from commercially available source.