Moxifloxacin Hydrochloride (Page 2 of 17)

1.8 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Moxifloxacin Hydrochloride and other antibacterial drugs, Moxifloxacin Hydrochloride 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 Hydrochloride is 400 mg (orally or as an intravenous infusion) once every 24 hours. The duration of therapy depends on the type of infection as described in Table 1.The dose of Moxifloxacin Hydrochloride is 400 mg (orally or as an intravenous infusion) 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 a

Dose Every 24 hours

Duration b (days)

Community Acquired Pneumonia ( ) Community Acquired Pneumonia ( 1.1)

400 mg400 mg

7–147–14

Uncomplicated Skin and Skin Structure Infections (SSSI ) ( ) Uncomplicated Skin and Skin Structure Infections (SSSI ) ( 1.2)

400 mg400 mg

77

Complicated SSSI ( ) Complicated SSSI ( 1.3)

400 mg400 mg

7–217–21

Complicated Intra-Abdominal Infections ( ) Complicated Intra-Abdominal Infections ( 1.4)

400 mg400 mg

5–14 5–14

Plague ( ) Plague ( 1.5) C

400 mg400 mg

10–14 10–14

Acute Bacterial Sinusitis (ABS) ( 1.6)

400 mg

10

Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) ( 1.7)

400 mg

5

  1. Due to the designated pathogens [see Indications and Usage ( 1)].
  2. Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician
  3. Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.

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 Hydrochloride Injection may be switched to Moxifloxacin Hydrochloride Tablets when clinically indicated at the discretion of the physician.

2.2 Important Administration Instructions

With Multivalent Cations

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

3 DOSAGE FORMS AND STRENGTHS

Oblong, dull red, film-coated tablets imprinted with “BAYER” on one side and “M400” on the other containing moxifloxacin hydrochloride (equivalent to 400 mg moxifloxacin).

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