NEODOSE

INDICATION

• Anaerobic Infections: Metronidazole is effective for anaerobic infections and protozoal parasites but it is not approved in infants. Common uses in premature infants are for the treatment of anaerobic bacteremia and central nervous system infections.
• Clostridium difficileinfection: Young children and infants may be asymptomatically colonized, but are unlikely to be infected with C difficile. Routine testing for C difficile in neonates or infants 12 months or younger with diarrhea is not recommended.
• Necrotizing enterocolitis: The recommended IV broad-spectrum antibiotics are acombination of ampicillin, gentamicin, and metroNIDAZOLE; ampicillin, cefotaxime, and metroNIDAZOLE; or meropenem. Vancomycin is an alternative to ampicillin when MRSA or ampicillin-resistant enterococcal infection is suspected.

CONTRAINDICATIONS

• Alcohol (or products containing propylene glycol) use during and for at least 3 days after metroNIDAZOLE use (oral, Flagyl(R) IV)
• Concomitant use with or within the last 2 weeks of disulfiram (oral, Flagyl(R) IV)
• Hypersensitivity to metroNIDAZOLE or any other component of the product or to other nitroimidazole agents

PRECAUTIONS

• Cardiovascular :
  • Sodium retention may occur in patients who are predisposed to edema
• Hematological:
  • Mild leukopenia has been observed during drug administration; use cautiously in patients with evidence or history of blood dyscrasia and monitoring recommended (IV, oral).
• Hepatic:
  • Accumulation of metroNIDAZOLE in patients with hepatic impairment may occur; dose adjustment recommended for severe impairment, monitoring for mild or moderate impairment (IV, oral)
• Immunological:
  • Use in absence of bacterial or parasitic infection, active or suspected, or prophylactic indication may result in increased risk of drug-resistant bacteria or parasites (IV, oral) .
  • Candidiasis, known or previously unrecognized, including vaginal candidiasis, may present with more prominent symptoms during treatment (IV, oral)
• Laboratory Test Interface:
  • May occur with some serum chemistry values (eg, AST,ALT, lactate dehydrogenase, triglycerides, glucose hexokinase); values of zero may be observed (IV, oral)
• Neurologic :
  • Encephalopathy, associated with cerebellar toxicity characterized by ataxia, dizziness, and dysarthria, has been reported (IV, oral); if abnormal neurologic signs occur, evaluate benefit to risk ratio for continued therapy; prompt discontinuation may be required
  • Peripheral neuropathy, including optic neuropathy, has been reported (IV, oral); if abnormal neurologic signs occur, evaluate benefit to risk ratio for continued therapy; prompt discontinuation may be required
  • Convulsive seizures have been reported (IV, oral); if abnormal neurologic signs occur, evaluate benefit to risk ratio for continued therapy; prompt discontinuation may be required.
  • Aseptic meningitis has been reported (IV, oral); if abnormal neurologic signs occur, evaluate benefit to risk ratio for continued therapy; prompt discontinuation may be required.
• Renal :
  • Drug or metabolites may accumulate in patients with renal disease or ESRD; monitoring recommended (IV, oral)
• Special Population :
  • Increased risk of hepatotoxicity, including fatal cases, after initiation of treatment in patients with Cockayne syndrome. Use in these patients only after careful risk/benefit assessment and discontinue use if liver function tests are elevated .

ADVERSE EFFECTS

The most common adverse reactions are related to the gastrointestinal tract, particularly nausea, sometimes accompanied by headache, anorexia, and occasionally vomiting, diarrhea, epigastric distress, abdominal cramping, and constipation

ADMINISTRATION

• Intravenous:
  • Infuse over 30 to 60 minutes at a final concentration not to exceed 8 mg/mL (administer by slow IV drip infusion only, either as a continuous or intermittent infusion).
  • Do NOT use equipment containing aluminum (eg, needles, cannulae) that would come in contact with the drug solution.
  • Do not introduce additives into injection; if used with a primary IV fluid system, discontinue the primary solution during infusion.

BLACK BOX WARNING

MetroNIDAZOLE has been shown to be carcinogenic in mice and rats. Unnecessary use of the drug should be avoided. Its use should be reserved for the conditions described in the Indications and Usage section of the package insert.

MONITORING

• Consider culture and susceptibility information before treatment initiation and with therapy modifications whenever possible.
• Confirm trichomonad infection with wet smears, cultures, or both before treatment initiation. Repeat cultures or smears after treatment cessation to confirm eradication and before repeated treatment.
• Perform total and differential leukocyte counts both before and after therapy and in patients who require prolonged or repeated treatment.
• Monitor patients with ESRD or hepatic impairment for drug-associated adverse events.Monitor geriatric patients for drug-associated adverse events.
• In patients with Cockayne syndrome, obtain a liver function test prior to therapy initiation, within the first 2 to 3 days after initiation, frequently during therapy, and after discontinuing therapy.
• Observe patients with Cockayne syndrome for signs and symptoms for potential liver injury (eg, abdominal pain, nausea, change in stool color, or jaundice)