Drug profile
Moxifloxacin
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- ( 2.2 ) 2.1 Dosage in Adult Patients The dose of moxifloxacin injection is 400 mg
intravenously once every 24 hours.
Source: US FDA label for moxifloxacin (Moxifloxacin), section 'dosage and
administration', retrieved 2026-08-29
- Type of Infection Dose Every 24 hours Duration (days) Community Acquired Pneumonia
( 1.1 ) 400 mg 7 to 14 Uncomplicated Skin and Skin Structure Infections (SSSI) (
1.2 ) 400 mg 7 Complicated SSSI ( 1.3 ) 400 mg 7 to 21 Complicated Intra-Abdominal
Infections ( 1.4 ) 400 mg 5 to 14 Acute Bacterial Sinusitis ( 1.5 ) 400 mg 10
Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.6 ) 400 mg 5 No dosage
adjustment in patients with renal or hepatic impairment.
Source: US FDA label for moxifloxacin (Moxifloxacin), section 'dosage and
administration', retrieved 2026-08-29
CHILD
- Safety and effectiveness in pediatric patients and adolescents less than 18 years
of age have not been established. Moxifloxacin causes arthropathy in juvenile
animals [see Boxed Warning , Warnings and Precautions (5.11) , and Clinical
Pharmacology (12.3) ] .
Source: US FDA label for moxifloxacin (Moxifloxacin), section 'pediatric use',
retrieved 2026-08-29
RENAL IMPAIRMENT
- Therefore, moxifloxacin should be avoided in patients taking drugs that can result
in prolongation of the QT interval (for example, Class IA or Class III
antiarrhythmics) or in patients with risk factors for torsades de pointes (for
example, known QT prolongation, uncorrected hypokalemia) [see Warnings and
Precautions (5.6) , Drug Interactions (7.4) , and Clinical Pharmacology (12.3)] .
Source: US FDA label for moxifloxacin (Moxifloxacin), section 'use in specific
populations', retrieved 2026-08-29
- No dosage adjustment is necessary in patients with renal impairment, including
those patients requiring hemodialysis (HD) or continuous ambulatory peritoneal
dialysis (CAPD) [see Dosage and Administration (2) , and Clinical Pharmacology
(12.3) ] . 8.7 Hepatic Impairment No dosage adjustment is recommended for mild,
moderate, or severe hepatic insufficiency (Child-Pugh Classes A, B, or C).
Source: US FDA label for moxifloxacin (Moxifloxacin), section 'use in specific
populations', retrieved 2026-08-29
HEPATIC IMPAIRMENT
- Type of Infection Dose Every 24 hours Duration (days) Community Acquired Pneumonia
( 1.1 ) 400 mg 7 to 14 Uncomplicated Skin and Skin Structure Infections (SSSI) (
1.2 ) 400 mg 7 Complicated SSSI ( 1.3 ) 400 mg 7 to 21 Complicated Intra-Abdominal
Infections ( 1.4 ) 400 mg 5 to 14 Acute Bacterial Sinusitis ( 1.5 ) 400 mg 10
Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.6 ) 400 mg 5 No dosage
adjustment in patients with renal or hepatic impairment.
Source: US FDA label for moxifloxacin (Moxifloxacin), section 'dosage and
administration', retrieved 2026-08-29
- No dosage adjustment is necessary in patients with renal impairment, including
those patients requiring hemodialysis (HD) or continuous ambulatory peritoneal
dialysis (CAPD) [see Dosage and Administration (2) , and Clinical Pharmacology
(12.3) ] . 8.7 Hepatic Impairment No dosage adjustment is recommended for mild,
moderate, or severe hepatic insufficiency (Child-Pugh Classes A, B, or C).
Source: US FDA label for moxifloxacin (Moxifloxacin), section 'use in specific
populations', retrieved 2026-08-29
- However, due to metabolic disturbances associated with hepatic insufficiency,
which may lead to QT prolongation, moxifloxacin should be used with caution in
these patients [see Warnings and Precautions (5.6) , and Clinical Pharmacology
(12.3) ] .
Source: US FDA label for moxifloxacin (Moxifloxacin), section 'use in specific
populations', retrieved 2026-08-29
PREGNANCY [ CAUTION ]
The label allows it only when the benefit is judged to outweigh the risk. Read the
quote below.
- Because no adequate or well-controlled studies have been conducted in pregnant
women, moxifloxacin should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
Source: US FDA label for moxifloxacin (Moxifloxacin), section 'pregnancy',
retrieved 2026-08-29
- Moxifloxacin was not teratogenic when administered to pregnant rats during
organogenesis at oral doses as high as 500 mg/kg/day or 0.24 times the maximum
recommended human dose based on systemic exposure (AUC), but decreased fetal body
weights and slightly delayed fetal skeletal development (indicative of
fetotoxicity) were observed.
Source: US FDA label for moxifloxacin (Moxifloxacin), section 'pregnancy',
retrieved 2026-08-29
- Intravenous administration of 80 mg/kg/day (approximately 2 times the maximum
recommended human dose based on body surface area) to pregnant rats resulted in
maternal toxicity and a marginal effect on fetal and placental weights and the
appearance of the placenta.
Source: US FDA label for moxifloxacin (Moxifloxacin), section 'pregnancy',
retrieved 2026-08-29
BREASTFEEDING
- Moxifloxacin is excreted in the breast milk of rats.
Source: US FDA label for moxifloxacin (Moxifloxacin), section 'nursing mothers',
retrieved 2026-08-29
- Moxifloxacin may also be excreted in human milk.
Source: US FDA label for moxifloxacin (Moxifloxacin), section 'nursing mothers',
retrieved 2026-08-29
- Because of the potential for serious adverse reactions in infants who are nursing
from mothers taking moxifloxacin, a decision should be made whether to discontinue
nursing or to discontinue the drug, taking into account the importance of the drug
to the mother.
Source: US FDA label for moxifloxacin (Moxifloxacin), section 'nursing mothers',
retrieved 2026-08-29