WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS Fluoroquinolones, including moxifloxacin hydrochloride, 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 hydrochloride immediately and avoid the use of fluoroquinolones, including moxifloxacin hydrochloride, in patients who experience any of these serious adverse reactions [see Warnings and Precautions (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 [see Warnings and Precautions (5.5) ]. Because fluoroquinolones, including moxifloxacin hydrochloride, have been associated with serious adverse reactions [see Warnings and Precautions (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 [see Indications and Usage (1.6) ] Acute bacterial exacerbation of chronic bronchitis [see Indications and Usage (1.7) ] 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: Tendinitis and tendon rupture (5.2) Peripheral Neuropathy (5.3) 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)
Adult Dosing
General dosing
Type of Infection Dose Every 24 hours Duration (days) Community Acquired Pneumonia 400 mg 7 to 14 Uncomplicated Skin and Skin Structure Infections (SSSI) 400 mg 7 Complicated SSSI 400 mg 7 to 21 Complicated Intra-Abdominal Infections 400 mg 5 to 14 Plague 400 mg 10 to 14 Acute Bacterial Sinusitis 400 mg 10 Acute Bacterial Exacerbation of Chronic Bronchitis 400 mg 5 No dosage adjustment in patients with renal or hepatic impairment. ( 8.6 , 8.7 ) 2.1
General dosing
Dosage in Adult Patients The dose of moxifloxacin is 400 mg (orally) once every 24 hours. The duration of therapy depends on the type of infection as described in Table 1. Table 1: Dosage and Duration of Therapy in Adult Patients a) Due to the designated pathogens . b) Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician c) Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis . Type of Infection a Dose Every 24 hours Duration b (days) Community Acquired Pneumonia 400 mg 7 to 14 Uncomplicated Skin and Skin Structure Infections (SSSI) 400 mg 7 Complicated SSSI 400 mg 7 to 21 Complicated Intra-Abdominal Infections 400 mg 5 to 14 Plague C 400 mg 10 to 14 Acute Bacterial Sinusitis (ABS) 400 mg 10 Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) 400 mg 5 Conversion of Intravenous to Oral
General dosing
Dosing in Adults Intravenous formulation is indicated when it offers a route of administration advantageous to the patient (for example, patient cannot tolerate an oral dosage form). When switching from intravenous to oral formulation, no dosage adjustment is necessary. Patients whose therapy is started with moxifloxacin hydrochloride injection may be switched to moxifloxacin tablets when clinically indicated at the discretion of the physician. 2.2 Important Administration Instructions With Multivalent Cations Administer moxifloxacin tablets at least 4 hours before or 8 hours after products containing magnesium, aluminum, iron or zinc, including antacids, sucralfate, multivitamins and didanosine buffered tablets for oral suspension or the pediatric powder for oral solution . With Food Moxifloxacin tablets can be taken with or without food, drink fluids liberally. Missed Doses If a dose is missed, it should be taken anytime but not later than 8 hours prior to the next scheduled dose. If less than 8 hours remain before the next dose, the missed dose should not be taken and treatment should be continued as prescribed with the next scheduled dose.
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