LIKMEZ (metronidazole)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Cockayne syndrome

There are 5 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Alcohol intoxication
Alcohol use disorder
Child-pugh class C hepatic impairment
Disease of liver
Peripheral neuropathy

There are 5 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Child-pugh class A hepatic impairment
Child-pugh class B hepatic impairment
Chronic kidney disease stage 5 (failure) GFr<15 ml/min
Kidney disease with likely reduction in glomerular filtration rate (GFr)
Neutropenic disorder

There are 21 severe adverse reactions.

More Frequent	Less Frequent
None.	Peripheral neuropathy

Rare/Very Rare
Acute generalized exanthematous pustulosis Acute hepatic failure Acute pancreatitis Ataxia Cystitis DRESS syndrome Encephalopathy Erythema Hearing loss Hepatocellular damage Leukopenia Neutropenic disorder Non-infective meningitis Optic neuropathy Seizure disorder Skin rash Stevens-johnson syndrome Thrombocytopenic disorder Toxic epidermal necrolysis Urticaria

There are 36 less severe adverse reactions.

More Frequent	Less Frequent
Abdominal pain with cramps Anorexia Diarrhea Headache disorder Nausea	Alcohol intolerance Dysgeusia Vaginal dryness Xerostomia

Rare/Very Rare
Acute cognitive impairment Constipation Depression Dizziness Dysarthria Dyspareunia Dysuria Fever Flushing Furred tongue General weakness Glossitis Insomnia Irritability Libido changes Nasal congestion Polyuria Proctitis Pruritus of skin Stomatitis Syncope Tinnitus Urinary incontinence Urine discoloration Vertigo Vomiting Vulvovaginal candidiasis

There was no evidence of fetotoxicity when metronidazole was administered orally at a dosage of 20 mg/kg daily (approximately 1.5 times the usual human dosage based on mg/kg of body weight) or at a dosage of 60 mg/m2 daily (approximately 10% of the usual human dosage) to pregnant mice; however, fetotoxicity did occur when the drug was administered intraperitoneally to pregnant mice at doses approximately equal to the usual human dose. There are no adequate or well-controlled studies to date using metronidazole in pregnant women, and the drug should be used during pregnancy only when clearly needed. The manufacturers, the CDC, and other experts state that use of the drug during the first trimester of pregnancy is contraindicated.

Although evidence from case-controlled studies, pooled analysis of cohort and case-controlled studies, and other information, including some experience during first-trimester exposure, suggests that metronidazole is not associated with a clinically important teratogenic or fetotoxic risk, conflicting evidence potentially implicating an association between the drug and certain fetal effects (e.g., cleft palate) also has been reported. Because of conflicting data and theoretical concerns regarding the mutagenic and carcinogenic potentials of the drug, use of metronidazole during the first trimester remains controversial and is considered contraindicated by the manufacturers and others. Because no therapy other than metronidazole currently has been shown to produce adequate response in the treatment of trichomoniasis, the manufacturers, CDC, and other experts state that oral metronidazole should be used to treat this infection in pregnant women only when severe symptoms cannot be controlled with local palliative treatment and only during the second or third trimester.

In addition, the manufacturers state that because the single-dose regimen may result in slightly higher serum concentrations of the drug, the 7-day regimen (see Dosage and Administration: Dosage) should be used to treat trichomoniasis during pregnancy. However, the CDC suggests the single-dose regimen when therapy with the drug is considered necessary. It has been suggested that 100 mg of clotrimazole administered intravaginally at bedtime for 7 days may produce symptomatic improvement but only occasionally cures in pregnant women with trichomoniasis; therefore, such therapy generally should be considered palliative.

Screening and/or treatment for bacterial vaginosis in pregnant women as clinically indicated (see Bacterial Vaginosis: Pregnant Women, in Uses) should be conducted early in the pregnancy (i.e., first prenatal visit for women at high-risk). For the treatment of bacterial vaginosis and reduction in the incidence of adverse pregnancy outcomes associated with bacterial vaginosis (e.g., preterm birth), particularly in pregnant women at high risk for complications of pregnancy, a 7-day regimen of oral metronidazole currently is preferred. the manufacturer and some experts state that the single-dose regimen of metronidazole should not be used in pregnant women because it may result in slightly higher serum concentrations of the drug, which can reach the fetal circulation. The safety and efficacy of oral metronidazole administered as extended-release tablets for the treatment of bacterial vaginosis have not been established in pregnant women.

Metronidazole is distributed into milk. Because of the tumorigenic potential of metronidazole in mice and rats, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman. The AAP states that, if a single 2-g dose of oral metronidazole is indicated in the mother, breast-feeding should be interrupted for 12-24 hours following the dose.

No enhanced Geriatric Use information available for this drug.