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Uses
To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin hydrochloride tablets and other antibacterial drugs, moxifloxacin hydrochloride 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.
Moxifloxacin hydrochloride tablets are indicated for the treatment of adults (≥ 18 years of age) with infections caused by susceptible isolates of the designated microorganisms in the conditions listed below [see Dosage and Administration (2) and Use In Specific Populations (8.5)].
Culture and Susceptibility Testing
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin [see Clinical Pharmacology (12.4)]. Therapy with moxifloxacin hydrochloride tablets may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.
Moxifloxacin hydrochloride tablets are indicated for the treatment of Acute Bacterial Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies (14.4)].
Moxifloxacin hydrochloride tablets are indicated for the treatment of Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus, or Moraxella catarrhalis [see Clinical Studies (14.1)].
Moxifloxacin hydrochloride tablets are indicated for the treatment of Community Acquired Pneumonia caused by Streptococcus pneumoniae (including multi-drug resistant isolates*), Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae.
* MDRSP, Multi-drug resistant Streptococcus pneumoniae includes isolates previously known as PRSP (Penicillin-resistant S. pneumoniae), and are isolates resistant to two or more of the following antibiotics: penicillin (minimum inhibitory concentrations [MIC] ≥ 2 mcg/mL), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole [see Clinical Studies (14.2)].
Moxifloxacin hydrochloride tablets are indicated for the treatment of Uncomplicated Skin and Skin Structure Infections caused by methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes[see Clinical Studies (14.5)].
Moxifloxacin hydrochloride tablets are indicated for the treatment of Complicated Skin and Skin Structure Infections caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae [see Clinical Studies (14.6)].
Moxifloxacin hydrochloride tablets are indicated for the treatment of Complicated Intra-Abdominal Infections including polymicrobial infections such as abscess caused by Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron, or Peptostreptococcus species [see Clinical Studies (14.7)].
History
There is currently no drug history available for this drug.
Other Information
Moxifloxacin hydrochloride is a synthetic broad spectrum antibacterial agent and is available as tablets for oral administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid. It is a slightly yellow to yellow crystalline substance. Its chemical structure is as follows:
C21H24FN3O4•HCl M.W. 437.9
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- Moxifloxacin hydrochloride tablets are available as pink, film-coated, oval-shaped tablets containing moxifloxacin hydrochloride (equivalent to 400 mg moxifloxacin).
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- The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.
Sources
Olio Activ Mouthwash Spearmint Manufacturers
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Kleen Test Products Corporation
Olio Activ Mouthwash Spearmint | Teva Pharmaceuticals Usa Inc
2.1 Dosage in Adult PatientsThe dose of moxifloxacin hydrochloride tablets, 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 * Due to the designated pathogens [see Indications and Usage (1)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physicianType of Infection*
Dose Every 24 hours
Duration (days)†
Acute Bacterial Sinusitis (1.1)
400 mg
10
Acute Bacterial Exacerbation of Chronic Bronchitis (1.2)
400 mg
5
Community Acquired Pneumonia
400 mg
7 to 14
Uncomplicated Skin and Skin Structure Infections (SSSI) (1.4)
400 mg
7
Complicated SSSI (1.5)
400 mg
7 to 21
Complicated Intra-Abdominal Infections (1.6)
400 mg
5 to 14
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 IV may be switched to moxifloxacin hydrochloride tablets when clinically indicated at the discretion of the physician.
2.2 Drug Interactions With Multivalent CationsOral doses of moxifloxacin hydrochloride tablets should be administered at least 4 hours before or 8 hours after products containing magnesium, aluminum, iron or zinc, including antacids, sucralfate, multivitamins and VIDEX® (didanosine) chewable/buffered tablets or the pediatric powder for oral solution [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
2.3 Administration InstructionsMoxifloxacin Hydrochloride Film-Coated Tablets
Moxifloxacin hydrochloride tablets can be taken with or without food, drink fluids liberally.
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