WARNING: POTENTIAL FOR CARCINOGENICITY Metronidazole has been shown to be carcinogenic in mice and rats [ see Warnings and Precautions (5.1) ] . Avoid unnecessary use of LIKMEZ. Reserve LIKMEZ for use in the following indications: trichomoniasis [see Indications and Usage (1.1) ] , amebiasis [ see Indications and Usage (1.2) ] and anaerobic bacterial infections [ see Indications and Usage (1.3) ]. WARNING: POTENTIAL FOR CARCINOGENICITY See full prescribing information for complete boxed warning. Metronidazole has been shown to be carcinogenic in mice and rats ( 5.1 ). Avoid unnecessary use of LIKMEZ. Reserve LIKMEZ for use in the following indications: trichomoniasis ( 1.1 ), amebiasis ( 1.2 ) and anaerobic bacterial infections ( 1.3 ).
Adult Dosing
General dosing
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. Seven-day course of treatment: 250 mg (2.5 mL) of LIKMEZ given three times daily for 7 consecutive days. Individualize the dosing regimen. Amebiasis:
For acute intestinal amebiasis (acute amebic dysentery): 750 mg (7.5 mL) orally three times daily for 5 days to 10 days.
amebic liver abscess
For amebic liver abscess: 500 mg (5 mL) or 750 mg (7.5 mL) orally three times daily for 5 days to 10 days.
General dosing
Adult Patients: 7.5 mg/kg every six hours (approx. 500 mg (5 mL) for a 70-kg adult) to a maximum dose of 4 g (40 mL) during a 24-hour period, orally for 7 to 10 days. Infections of the bone and joint, lower respiratory tract, and endocardium may require longer treatment. Patients with Severe Hepatic Impairment (Child-Pugh C) Reduce the dose of LIKMEZ by 50%. Patients Undergoing Hemodialysis: Consider a supplemental dose of LIKMEZ following the hemodialysis session, depending on the patient’s clinical situation. 2.1 Recommended Dosage for Trichomoniasis Adult Female and Male Patients : One-day Treatment – Administer 2 g (20 mL) of LIKMEZ, either as a single oral dose or in 2 divided oral doses of 1 g (10 mL) each, given on the same day. Seven-day Course of Treatment − Administer 250 mg (2.5 mL) of LIKMEZ orally 3 times daily for 7 consecutive days. The dosage regimen should be individualized. Single-dose treatment may help improve compliance, especially if administered under supervision, in those patients who cannot be relied on to continue the seven-day regimen.
Max: 4 g (40 mL) during a 24-hour period, orally for 7 to 10 days
For acute intestinal amebiasis (acute amebic dysentery): Administer 750 mg (7.5 mL) of LIKMEZ orally three times daily for 5 days to 10 days.
amebic liver abscess
For amebic liver abscess: Administer 500 mg (5 mL) or 750 mg (7.5 mL) of LIKMEZ orally three times daily for 5 days to 10 days.
General dosing
Adult Patients: Administer 7.5 mg/kg of LIKMEZ orally every six hours (approx. 500 mg (5 mL) for a 70 kg adult) for 7 days to 10 days. Infections of the bone and joint, lower respiratory tract, and endocardium may require longer treatment. 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 and Clinical Pharmacology ]. 2.5 Recommended Dosage in Patients Undergoing Hemodialysis Hemodialysis removes significant amounts of metronidazole and its metabolites from systemic circulation. The clearance of metronidazole will depend on the type of dialysis membrane used, the duration of the dialysis session, and other factors. If the administration of LIKMEZ cannot be separated from the hemodialysis session, consider a supplemental dose of LIKMEZ following the hemodialysis session, depending on the patient’s clinical situation [ see Clinical Pharmacology ] .
Pediatric Dosing
General dosing
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. Anaerobic Bacterial Infections: In the treatment of most serious anaerobic infections, intravenous metronidazole is usually administered initially.
Max: 750 mg/dose or 7
General dosing
Pediatric Patients: Administer 35 mg/kg/24 hours to 50 mg/kg/24 hours of LIKMEZ, divided into three doses, to a maximum dose of 2250 mg/24 hours (maximum dose 750 mg/dose or 7.5 mL/dose), orally for 10 days. 2.3 Recommended Dosage for Anaerobic Bacterial Infections In the treatment of most serious anaerobic infections, intravenous metronidazole is usually administered initially.
Max: 2250 mg/24 hours (maximum dose 750 mg/dose or 7
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