chloramphenicol

REMS

IV: Management of the following serious infections when less toxic agents cannot be used:
- Skin and soft-tissue infections,
- Intra-abdominal infections,
- CNS infections (including meningitis),
- Bacteremia.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity.

Use Cautiously in:

Severe renal impairment;
Severe hepatic impairment;
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Geri: ↑risk of toxicity in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: rash, urticaria

EENT: blurred vision, optic neuritis

GI: bitter taste, diarrhea, enterocolitis, glossitis, nausea, stomatitis, vomiting

Hemat: bone marrow depression, APLASTIC ANEMIA, neutropenia, thrombocytopenia

Neuro: confusion, delirium, depression, headache, peripheral neuritis

Misc: ANGIOEDEMA, fever, GRAY SYNDROME(IN NEWBORNS)

Interactions ⬆ ⬇

Drug-drug:

May ↑ effects of oral hypoglycemic agents, warfarin, and phenytoin.
Phenobarbital or rifampin may ↓ levels and effectiveness.
May delay response to vitamin B or folic acid therapy.
Bone marrow depression may be additive with bone marrow–depressing agents (antineoplastics).

Availability ⬆ ⬇

(Generic available)

Powder for injection: 1 g/vial

Route/Dosage ⬆ ⬇

IV (Adults ): 12.5 mg/kg every 6 hr (up to 100 mg/kg/day).
IV (Children ): Most infections: 12.5 mg/kg every 6 hr (maximum daily dose = 4 g). Bacteremia/meningitis: 18.75 to 25 mg every 6 hr.
IV (Infants > 2 wk): Most infections: 12.5 mg/kg every 6 hr (maximum daily dose = 4 g).Bacteremia/meningitis: 18.75 to 25 mg every 6 hr.
IV (Neonates >7 days and >2 kg): 25 mg/kg every 12 hr.
IV (Neonates birth–7 days or ≤2 kg): 25 mg/kg once daily.

Action ⬆ ⬇

Inhibits protein synthesis in susceptible bacteria at the level of the 50S ribosome.

Therapeutic effects:

Bacteriostatic action.

Spectrum:

Wide variety of gram-positive aerobic organisms including:
- Streptococcus pneumoniae and other streptococci,
- Some enterococci (especially vancomycin-resistant).
Gram-negative pathogens:
- Haemophilus influenzae,
- Neisseria meningitidis,
- Salmonella,
- Shigella.
Anaerobes:
- Bacteroides fragilis,
- Prevotella melaninogenica.
Other organisms inhibited:
- Rickettsia,
- Chlamydia,
- Mycoplasma.

Classifications ⬆ ⬇

Therapeutic Classification: anti-infectives

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailabililty.

Distribution: Widely distributed to tissues. Crosses the blood-brain barrier with CSF levels 60% of serum values.

Metabolism/Excretion: Mostly metabolized by the liver; <10% excreted unchanged by the kidneys.

Half-Life: 1.5–3.5 hr.

Canadian Brand Names ⬆ ⬇

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	end of infusion	6–12 hr

Patient/Family Teaching ⬆ ⬇

Advise patient to contact health care professional immediately if signs of unusual bleeding; bruising; fever; sore throat; nausea; vomiting; diarrhea; or numbness, tingling, or burning pain or weakness in hands or feet occurs. Medication should be discontinued with the onset of these symptoms.
Reassure patient that bitter taste 15–20 sec following injection is limited to 2–3 min.
Instruct patient to report signs of superinfection (stomatitis, perianal itching, vaginal discharge, fever).
Emphasize the importance of follow-up exams. Bone marrow depression may develop wk to mo after drug therapy has been discontinued.
Rep: Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

63323- Fresenius Kabi USA, LLC
- 63323-011- Chloramphenicol Sodium Succinate
  - 63323-011-15- 10 VIAL in 1 TRAY (63323-011-15) > 10 mL in 1 VIAL

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Indications ⬇