Drug profile
Metronidazole
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- Trichomoniasis: Adult Female and Male Patients: One-day treatment: 2 g (20 mL) of
LIKMEZ, given either as a single oral dose or in 2 divided oral doses of 1 g (10
mL) each, given on the same day.
Source: US FDA label for metronidazole (LIKMEZ), section 'dosage and
administration', retrieved 2026-08-29
- ( 2.1 ) Seven-day course of treatment: 250 mg (2.5 mL) of LIKMEZ given three times
daily for 7 consecutive days.
Source: US FDA label for metronidazole (LIKMEZ), section 'dosage and
administration', retrieved 2026-08-29
- ( 2.1 ) Amebiasis: Adult Patients: For acute intestinal amebiasis (acute amebic
dysentery): 750 mg (7.5 mL) orally three times daily for 5 days to 10 days.
Source: US FDA label for metronidazole (LIKMEZ), section 'dosage and
administration', retrieved 2026-08-29
CHILD
- The safety and effectiveness of LIKMEZ for the treatment of amebiasis have been
established in pediatric patients. The safety and effectiveness of LIKMEZ for the
treatment of trichomoniasis and anaerobic bacterial infections have not been
established in pediatric patients.
Source: US FDA label for metronidazole (LIKMEZ), section 'pediatric use',
retrieved 2026-08-29
- Trichomoniasis: Adult Female and Male Patients: One-day treatment: 2 g (20 mL) of
LIKMEZ, given either as a single oral dose or in 2 divided oral doses of 1 g (10
mL) each, given on the same day. ( 2.1 ) Seven-day course of treatment: 250 mg
(2.5 mL) of LIKMEZ given three times daily for 7 consecutive days. ( 2.1 )
Individualize the dosing regimen.
Source: US FDA label for metronidazole (LIKMEZ), section 'dosage and
administration', retrieved 2026-08-29
- ( 2.2 ) Pediatric Patients : 35 mg/kg/24 hours to 50 mg/kg/24 hours, divided into
three doses, to a maximum dose of 2,250 mg/24 hours (maximum dose 750 mg/dose or
7.5 mL/dose),orally for 10 days.
Source: US FDA label for metronidazole (LIKMEZ), section 'dosage and
administration', retrieved 2026-08-29
RENAL IMPAIRMENT
- The clearance of metronidazole will depend on the type of dialysis membrane used,
the duration of the dialysis session, and other factors.
Source: US FDA label for metronidazole (LIKMEZ), section 'dosage and
administration', retrieved 2026-08-29
- No adjustment in LIKMEZ dose is needed in patients undergoing continuous
ambulatory peritoneal dialysis (CAPD) [ see Clinical Pharmacology (12.3) ] . 2.6
Important Administration Instructions Shake the bottle well before administering
the recommended dosage.
Source: US FDA label for metronidazole (LIKMEZ), section 'dosage and
administration', retrieved 2026-08-29
- Decreased liver function in geriatric patients can result in increased
concentrations of metronidazole that may necessitate adjustment of metronidazole
dosage [ see Dosage and Administration (2.4) ]. 8.6 Renal Impairment Patients with
end-stage renal disease may excrete metronidazole and metabolites slowly in the
urine, resulting in significant accumulation of metronidazole metabolites.
Source: US FDA label for metronidazole (LIKMEZ), section 'use in specific
populations', retrieved 2026-08-29
HEPATIC IMPAIRMENT
- ( 2.3 ) Patients with Severe Hepatic Impairment (Child-Pugh C) Reduce the dose of
LIKMEZ by 50%.
Source: US FDA label for metronidazole (LIKMEZ), section 'dosage and
administration', retrieved 2026-08-29
- Do not exceed a maximum of 4 g (40 mL) during a 24-hour period. 2.4 Recommended
Dosage in Patients with Severe Hepatic Impairment For patients with severe hepatic
impairment (Child-Pugh C), reduce the dose of LIKMEZ by 50% [ see Use in Specific
Populations (8.7) and Clinical Pharmacology (12.3) ].
Source: US FDA label for metronidazole (LIKMEZ), section 'dosage and
administration', retrieved 2026-08-29
- Monitor for LIKMEZ associated adverse reactions [ see Clinical Pharmacology (12.3)
] . 8.7 Hepatic Impairment Patients with hepatic impairment metabolize
metronidazole slowly, with resultant accumulation of metronidazole in the plasma.
Source: US FDA label for metronidazole (LIKMEZ), section 'use in specific
populations', retrieved 2026-08-29
PREGNANCY
- Risk Summary While available studies cannot definitively establish the absence of
risk, published data from case-control studies, cohort studies and meta-analyses
have not established an association with metronidazole use during pregnancy and
major birth defects, miscarriage or other adverse maternal or fetal outcomes (see
Data).
Source: US FDA label for metronidazole (LIKMEZ), section 'pregnancy', retrieved
2026-08-29
- The background risk of major birth defects and miscarriage for the indicated
population is unknown.
Source: US FDA label for metronidazole (LIKMEZ), section 'pregnancy', retrieved
2026-08-29
- All pregnancies have a background risk of birth defect, loss, or other adverse
outcomes.
Source: US FDA label for metronidazole (LIKMEZ), section 'pregnancy', retrieved
2026-08-29
BREASTFEEDING
- Lactation : A lactating woman may choose to pump and discard human milk for the
duration of LIKMEZ therapy and for 48 hours after the last dose and feed her
infant stored human milk or formula.
Source: US FDA label for metronidazole (LIKMEZ), section 'use in specific
populations', retrieved 2026-08-29
- There was no evidence of harm to the fetus due to metronidazole. 8.2 Lactation
Risk Summary Metronidazole is present in human milk at concentrations similar to
maternal serum levels, and infant serum levels can be close to or comparable to
infant therapeutic levels.
Source: US FDA label for metronidazole (LIKMEZ), section 'use in specific
populations', retrieved 2026-08-29
- The developmental and health benefits of breastfeeding should be considered along
with the mother’s clinical need for LIKMEZ and any potential adverse effects on
the breastfed infant from LIKMEZ or from the underlying maternal condition.
Source: US FDA label for metronidazole (LIKMEZ), section 'use in specific
populations', retrieved 2026-08-29