Moxifloxacin Hydrochloride (Page 2 of 14)

1.6 Acute Bacterial Sinusitis

Moxifloxacin Tablets are indicated in adult patients for the treatment of acute bacterial sinusitis (ABS) caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae , or Moraxella catarrhalis [see Clinical Studies (14.1)] .

Because fluoroquinolones, including Moxifloxacin Tablets, have been associated with serious adverse reactions [see Warnings and Precautions (5.1-5.14)] and for some patients ABS is self-limiting, reserve Moxifloxacin Tablets for treatment of ABS in patients who have no alternative treatment options.

1.7 Acute Bacterial Exacerbation of Chronic Bronchitis

Moxifloxacin Tablets are indicated in adult patients for the treatment of Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus, or Moraxella catarrhalis [see Clinical Studies (14.2)].

Because fluoroquinolones, including Moxifloxacin Tablets, have been associated with serious adverse reactions [see Warnings and Precautions (5.1-5.14)] and for some patients ABECB is self-limiting, reserve Moxifloxacin Tablets for treatment of ABECB in patients who have no alternative treatment options.

1.8 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Moxifloxacin Tablets and other antibacterial drugs, Moxifloxacin Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Adult Patients

The dose of Moxifloxacin Tablets 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
Type of Infection * Dose Every 24 hours Duration (days)
*
Due to the designated pathogens [see Indications and Usage ( 1)] .
Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician
Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Community Acquired Pneumonia ( 1.1) 400 mg 7–14
Uncomplicated Skin and Skin Structure Infections (SSSI ) ( 1.2) 400 mg 7
Complicated SSSI ( 1.3) 400 mg 7–21
Complicated Intra-Abdominal Infections ( 1.4) 400 mg 5–14
Plague ( 1.5) 400 mg 10–14
Acute Bacterial Sinusitis (ABS) ( 1.6) 400 mg 10
Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) ( 1.7) 400 mg 5

Conversion of Intravenous to Oral 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 injection may be switched to Moxifloxacin Tablets when clinically indicated at the discretion of the physician.

2.2 Important Administration Instructions

Moxifloxacin Tablets

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 [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

With Food

Moxifloxacin Tablets can be taken with or without food, drink fluids liberally.

Missed DosesIf 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. Double doses should not be taken to compensate for a missed dose.

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