METRO IV (metronidazole in sodium chloride)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Cockayne syndrome

There are 6 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
Optic neuropathy
Peripheral neuropathy

There are 7 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
Edema
Kidney disease with likely reduction in glomerular filtration rate (GFr)
Leukopenia
Neutropenic disorder

There are 21 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Abnormal hepatic function tests Agranulocytosis Anaphylaxis Angioedema DRESS syndrome Drug-induced psychosis Dyspnea Encephalopathy Eosinophilia Jaundice Leukopenia Neutropenic disorder Non-infective meningitis Optic neuropathy Pancreatitis Proctitis Seizure disorder Stevens-johnson syndrome Thrombocytopenic disorder Thrombophlebitis Toxic epidermal necrolysis

There are 50 less severe adverse reactions.

More Frequent	Less Frequent
Diarrhea Nausea	Alcohol intolerance Anorexia Dizziness Headache disorder Peripheral neuropathy Vomiting

Rare/Very Rare

Abnormal ECG Abnormal saccadic eye movement Acute abdominal pain Acute cognitive impairment Allergic dermatitis Arthralgia Ataxia Candidiasis Constipation Cystitis Depression Drowsy Drug fever Dysarthria Dysgeusia Dyspareunia Dysuria Erythema Flushing Furred tongue General weakness Glossitis Hiccups Hypoesthesia Insomnia Irritability Libido changes Myalgia Nasal congestion Palpitations Paresthesia Polyuria Pruritus of skin Skin rash Stomatitis Syncope Tachycardia Urinary incontinence Urine discoloration Urticaria Vulvovaginal candidiasis Xerostomia

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.

Drug/Drug Class	Severity	Precaution Description	Pregnancy Category Description
Metronidazole	2	Crosses placenta; recom when alternate treatment inadequate; insuff human data	No fda rating but may have precautions or warnings; may have animal and/or human studies or pre or post marketing information.

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.

Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.

Drug Name	Excretion Potential	Effect on Infant	Notes
Metronidazole	Excreted.This drug is known to be excreted in human breast milk.	It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data)	Manfact. states may discard breast milk during & for 48 hrs after treatment.

No enhanced Geriatric Use information available for this drug.

Precaution Exists
Geriatric management or monitoring precaution exists.

Drug Name	Narrative	REN	HEP	CARDIO	NEURO	PULM	ENDO
Metronidazole	Hepatic-May need to decrease dose with decreased hepatic function. Monitor for adverse events.	N	Y	N	N	N	N