Dosing & Uses
ADULTPEDIATRIC
Dosage Forms & Strengths
injectable solution
- 400mg/250mL
tablet
- 400mg
Acute Bacterial Sinusitis
400 mg PO/IV qDay for 5-10 days
Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute sinusitis
Community-Acquired Pneumonia
400 mg PO/IV qDay for 7-14 days
Acute Exacerbation of Chronic Bronchitis
Indicated for acute exacerbations of chronic bronchitis caused by bacterial infections
400 mg PO/IV qDay for 5 days
Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial exacerbation of chronic bronchitis
Skin & Skin Structure Infections
Uncomplicated: 400 mg PO/IV qDay for 7 days
Complicated: 400 mg PO/IV qDay for 7-21 days
Intra-abdominal Infections
Complicated: 400 mg PO/IV qDay for 5-14 days
Pneumonic & Septicemic Plague
Indicated in adults for the treatment of plague, including pneumonic and septicemic plague, caused by susceptible isolates of Yersinia pestis; it is also indicated for prophylaxis of plague in adults
400 mg PO/IV qDay x10-14 days
Begin administration as soon as possible after suspected or confirmed exposure to Yersinia pestis
Dosing Considerations
Initial IV administration may be changed to PO administration at same dosage to complete therapy, depending on patient's clinical status
Susceptible organisms
- Aeromonas hydrophila, Bacillus anthracis, Bacteroides fragilis, Bacteroides thetaiotaomicron, Campylobacter jejuni, Citrobacter diversus, Citrobacter freundii, Clostridium perfringens, Escherichia coli, Enterobacter spp, Haemophilus influenzae, Hafnia alvei, Klebsiella pneumoniae, Legionella pneumophila, Morganella morganii, Moraxella catarrhalis, Mycobacterium pneumoniae, Mycobacterium tuberculosis, Neisseria gonorrhoeae, Peptostreptococcus spp, Proteus mirabilis, Proteus vulgaris, Providencia spp, Pseudomonas aeruginosa, Salmonella typhi, Shigella spp, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus anginosus, Streptococcus constellatus, Streptococcus pneumoniae, Vibrio cholerae, Yersinia pestis
- First-line therapy: C jejuni; no unanimity on others (eg, L pneumophila, M morganii)
Adverse Effects
1-10%
Nausea (7%)
Diarrhea (6%)
Dizziness (3%)
Decreased amylase (2%)
Decreased basophils, eosinophils, hemoglobin, prothrombin time, red blood cells, neutrophils (2%)
Decreased serum glucose (2%)
Increased serum chloride (2%)
Increased serum ionized calcium (2%)
Immune hypersensitivity reaction (0.1-2%)
Prolonged QT interval (0.1-2%)
<1%
Acute renal failure
Agranulocytosis
Anaphylactoid reaction
Aplastic anemia
Extrinsic allergic alveolitis
Hemolytic anemia
Hepatic failure
Hepatic necrosis
Hepatitis
Pancytopenia
Seizure
Serum sickness due to drug
Stevens-Johnson syndrome
Tendon rupture, tendinitis
Thrombocytopenia
Torsades de pointes
Toxic epidermal necrolysis
Postmarketing Reports
Blood and lymphatic disorders: Agranulocytosis, pancytopenia
Vascular disorders: Aortic aneurysm and dissection
Cardiovascular disorders: Ventricular tachyarrhythmias (including in very rare cases cardiac arrest and torsade de pointes)
Ear and labyrinth disorders: Hearing impairment, including deafness (reversible in most cases)
Eye disorders: Vision loss (especially in the course of CNS reactions, transient in majority of cases)
Hepatobiliary disorders: Hepatitis, hepatic failure, jaundice, acute hepatic necrosis
Immune system disorders: Anaphylactic reactions including shock, angioedema (including laryngeal edema)
Musculoskeletal/connective tissue disorders: Tendon rupture, arthralgia, myalgia
Nervous system disorders: Exacerbation of myasthenia gravis symptoms, altered coordination, abnormal gait, muscle weakness, peripheral neuropathy, polyneuropathy
Central nervous system effects: Hallucinations, anxiety, depression, insomnia, severe headaches, and confusion
Psychiatric disorders: Psychotic reaction (very rarely culminating in self-injurious behavior, such as suicidal ideation/thoughts or suicide attempts)
Renal and urinary disorders: Renal dysfunction, interstitial nephritis
Respiratory disorders: Allergic pneumonitis
Skin and tissue disorders: Photosensitivity/phototoxicity reaction, Stevens-Johnson syndrome, Toxic epidermal necrolysis
Contraindications
Hypersensitivity to moxifloxacin or any member of the quinolone class of antibacterials
Pregnancy & Lactation
Pregnancy
There are no available human data establishing a drug associated risk; however, when moxifloxacin was administered to rats during pregnancy and throughout lactation at doses associated with maternal toxicity, decreased neonatal body weights, increased incidence of skeletal variations (rib and vertebra combined), and increased fetal loss were observed
Advise pregnant women of potential risk to fetus
Lactation
Not known if moxifloxacin is present in human milk
Based on animal studies in rats, moxifloxacin may be excreted in human milk
Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on the breastfed child from drug or from the underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.