NEODOSE

INDICATIONS

A wide-spectrum antimicrobial bacteriostatic agent. May be bactericidal to species such as H influenzae and Neisseria meningitidis .

• Anthrax: Chloramphenicol (for 32 weeks or more gestational age) Should only be used when other options are unavailable. Use as part of a triple regimen for systemic anthrax (meningitis or disseminated infection or meningitis cannot be ruled out). Duration: For anthrax, for 2 to 3 weeks or more until stable. Continue antimicrobial course of prophylaxis (usually oral therapy) for up to 60 days.
• Bacterial Meningitis: An alternative agent for bacterial meningitis due to Streptococcus pneumoniae when penicillin MIC is less than 0.1 mcg/mL, Neisseria meningitidis when penicillin MIC is less than 1 mcg/mL, and Haemophilus influenza (β-lactamase negative or positive).

ADVERSE EFFECTS

Reversible bone marrow suppression, irreversible aplastic anemia. Serum concentration greater than 50 mcg/mL has been associated with the “gray baby” syndrome (ie, abdominal distention, pallid cyanosis, vasomotor collapse; may lead to death within hours of onset). Fungal overgrowth.

BLACK BOX WARNING

According to the manufacturer’s BLACK BOX WARNING, serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia) are known to occur. There have been reports of aplastic anemia which later terminated in leukemia. Blood dyscrasias have occurred after both short-term and prolonged therapy with this drug. It is essential that adequate blood studies be made during treatment. If blood dyscrasias occur, therapy should be discontinued.

ADMINISTRATION

For IV intermittent infusion, dilute to a concentration of 20 to 25 mg/mL in compatible solution and infuse over 15 to 60 minutes. In the preparation and administration of injections, the National Institute for Occupational Safety and Health (NIOSH) recommends the use of double gloves and a protective gown. Prepare in a biological safety cabinet or a compounding aseptic containment isolator; eye/face and respiratory protection may be needed. Prepare compounds in a closed system drug transfer device. During administration, if there is a potential that the substance could splash or if the patient may resist, use eye/face protection. Administer certain dosage forms via a closed system drug transfer device.

MONITORING

Close monitoring of serum concentration is mandatory. Small changes in dose and interval can lead to disproportionately large changes in serum concentration. Therapeutic peak serum concentration: 10 to 25 mcg/mL. Monitor CBC and reticulocyte counts. Assess hepatic and renal function.