Metronidazole ER

Class
Antibiotics
Subclass
Nitroimidazoles
Substance name
Metronidazole ER
Common formulations
Film-coated tablet
See also
Metronidazole (Flagyl®, Nuvessa®, Likmez®, Noritate®)
Dosage and administration
Adults patients
Treatment of bacterial vaginosis
•
750 mg PO daily for 7 days
Take on an empty stomach.
Indications for use
Labeled indications
Adults
•
Treatment of bacterial vaginosis
Safety risks
Boxed warnings
Malignancy
•
Maintain a high level of suspicion as animal studies have shown metronidazole to be carcinogenic in mice and rats. Use only when indicated.
Contraindications
Hypersensitivity to metronidazole or other nitroimidazole derivatives
Alcoholism or ethanol intoxication
Cockayne syndrome
Warnings and precautions
Encephalopathy, peripheral neuropathy, convulsion, seizure, aseptic meningitis
•
Maintain a high level of suspicion for various central and peripheral nervous system side effects. Discontinue if abnormal neurological signs present.
Exacerbation of alcohol intolerance
•
Use caution in the concurrent administration with alcoholic beverages.
Exacerbation of fungal infections
•
Use caution in patients with concurrent fungal infections, as they may present more prominently with concurrent use of metronidazole.
Prolonged QT interval
•
Use caution in patients with conditions that may increase the risk of QT prolongation or receiving medications known to prolong the QT interval or cause electrolyte imbalances.
Specific populations
Renal impairment
CrCl ≥ 30 mL/min
•
Use acceptable. No dose adjustment required.
CrCl < 30 mL/min
•
Use with caution. Monitor for signs of toxicity.
Renal replacement therapy
Continuous renal replacement
•
Use acceptable. No dose adjustment required.
Intermittent hemodialysis
•
Use with caution. Monitor for signs of toxicity.
Peritoneal dialysis
•
Use acceptable. No dose adjustment required. Monitor for signs of toxicity. Monitor for signs of toxicity due to potential accumulation of metronidazole metabolites.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required. Monitor for toxicity.
Child-Pugh B (moderate)
•
Use acceptable. No dose adjustment required. Monitor for toxicity.
Child-Pugh C (severe)
•
Avoid use.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B2
•
Use only if benefits outweigh potential risks. Evidence of fetal harm in animals.
Breastfeeding
Do not use during breastfeeding.
Low excretion in breastmilk (5-25%).
Low-moderate levels in breastfed infants (25-45%).
May potentially cause adverse effects in breastfed infants.
Adverse reactions
Very common > 10%
•
Candidiasis, headache, vaginal discharge, vaginitis
Common 1-10%
•
Acne vulgaris, breast enlargement, diaphoresis, gingivitis, hypertension, influenza virus infection, leukorrhea, menorrhagia, pharyngitis, abdominal pain, anal itching, back pain, constipation, depression, diarrhea, dizziness, dry mouth, dysgeusia, dysmenorrhea, dyspepsia, dysuria, flatulence, insomnia, itching, loss of appetite, metallic taste, nasal congestion, nausea, skin rash, urinary frequency, vomiting, rhinitis, sinusitis, urticaria
Unknown frequency
•
Acute liver failure, acute cystitis, acute pancreatitis, agranulocytosis, angioedema, aseptic meningitis, ataxia, contact dermatitis, DRESS syndrome, ↓ WBC count, ↓ blood neutrophil count, ↓ platelet count, dysarthria, encephalopathy, glossitis, hyperhidrosis, ↑ blood eosinophil count, ↑ liver enzymes, nystagmus, peripheral edema, peripheral neuropathy, phlebitis, proctitis, ↑QTc interval, psychosis, arthralgia, asthenia, chest pain, chills, confusion, ↓ libido, dyspareunia, dyspnea, fatigue, fever, hiccups, hypoesthesia, irritability, malaise, muscle cramps, myalgia, palpitations, paresthesia, polyuria, seizure, skin flushing, somnolence, syncope, urinary incontinence, vertigo, weakness, ST-segment changes, serum sickness, sinus tachycardia, skin dryness, skin erythema, Stevens-Johnson syndrome, stomatitis, toxic epidermal necrolysis, urine discoloration
Interactions
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