CHLORAMPHENICOL SODIUM SUCCINATE
Chloromycetin Sodium Succinate
Classifications: antibiotic; Therapeutic: antibiotic
Pregnancy Category: C
250 mg capsules; 100 mg/mL injection; 5 mg/mL ophth solution; 10 mg/g ointment
Synthetic broad-spectrum antibiotic that is principally bacteriostatic but may be bactericidal in certain species (e.g.,
Haemophilus influenzae) or when given in higher concentrations. Believed to act by binding to the 50S ribosome of bacteria and thus interfering
with protein synthesis.
Effective against a wide variety of gram-negative and gram-positive bacteria and most anaerobic microorganisms.
Severe infections when other antibiotics are ineffective or are contraindicated. Particularly effective against Salmonella typhi and other Salmonella sp., Streptococcus pneumoniae, Neisseria, meningeal infections caused by H. influenzae, and infections involving Bacteroides fragilis and other anaerobic organisms, Rickettsia rickettsii (cause of Rocky Mountain spotted fever) and other rickettsiae, the lymphogranuloma-psittacosis group (Chlamydia), and Mycoplasma. Also used in cystic fibrosis antiinfective regimens and topically for infections of skin, eyes, and external auditory canal.
History of hypersensitivity or toxic reaction to chloramphenicol; treatment of minor infections, prophylactic use; typhoid
carrier state, history or family history of drug-induced bone marrow depression, concomitant therapy with drugs that produce
bone marrow depression; pregnancy (category C); lactation.
Impaired hepatic or renal function, premature and full-term infants, children; intermittent porphyria; patients with G6PD
deficiency; patient or family history of drug-induced bone marrow depression.
Route & Dosage
Adult: PO/IV 50 mg/kg/d in 4 divided doses.
Neonate: IV 2550 mg/kg/d divided q1224h
Infant/Child: PO/IV 5075 mg/kg/d divided q6h (max: 4 g/d)
Adult/Child: IV 75100 mg/kg/d divided q6h
- Give preferably with a full glass of water on an empty stomach, at least 1 h before or 2 h after a meal, to achieve optimum
- Apply light pressure to lacrimal duct after instillation for 12 min to prevent drainage into nasopharynx and systemic
absorption. This is an extremely important step to decrease absorption. Several cases of aplastic anemia have been associated
with use of ophthalmic preparations.
- IV administration to neonates, infants, children: Verify correct IV concentration and rate of infusion with physician.
PREPARE: Direct: Dilute each 1 g with 10 mL of sterile water or D5W. Intermittent: Further dilute in 50100 mL of D5W.
ADMINISTER: Direct: Give slowly over a period of at least 1 min. Intermittent: Give over 3060 min.
INCOMPATIBILITIES Solutions/additives: Chlorpromazine, glycopyrrolate, metoclopramide, polymyxin B, prochlorperazine, promethazine, tetracyclines, vancomycin. Y-site: Fluconazole.
- Solution for infusion may form crystals or a second layer when stored at low temperatures. Solution can be clarified by
shaking vial. Do not use cloudy solutions.
- Store topical ophthalmic, otic, and skin preparations, PO forms, and unopened ampuls at room temperature and protected from
light unless otherwise directed by manufacturer.
Adverse Effects (≥1%)Body as a Whole:
Hypersensitivity, angioedema, dyspnea
, fever, anaphylaxis,
superinfections, Gray syndrome
Nausea, vomiting, diarrhea
irritation, enterocolitis, glossitis, stomatitis
, unpleasant taste, xerostomia. Hematologic: Bone marrow depression
(dose-related and reversible): reticulocytosis, leukopenia
, granulocytopenia, thrombocytopenia
, increased plasma
reduced Hgb, hypoplastic anemia
, hypoprothrombinemia. Non-dose-related and irreversible pancytopenia, agranulocytosis, aplastic anemia,
paroxysmal nocturnal hemoglobinuria, leukemia. CNS:
Neurotoxicity: headache, mental depression
, confusion, delirium, digital paresthesias, peripheral neuritis
Urticaria, contact dermatitis, maculopapular and vesicular rashes, fixed-drug eruptions. Special Senses:
Visual disturbances, optic neuritis
, optic nerve atrophy, contact conjunctivitis
Diagnostic Test Interference
Possibility of false-positive results for urine glucose by copper reduction methods (e.g., Benedict's solution, Clinitest). Chloramphenicol may interfere with 17-OHCS (urinary steroid) determinations (modification of Reddy, Jenkins, Thorn procedure not affected), with urobilinogen excretion, and with responses to tetanus toxoid and possibly other active immunizing agents.
of chlorpropamide, dicumarol, phenytoin, tolbutamide
may be decreased, prolonging their activity. Phenobarbital
decreases chloramphenicol levels. The response to iron
preparations, folic acid,
and vitamin B12
may be delayed.
Rapidly from GI tract. Peak:
PO: 13 h; IV
: 1 h. Distribution:
Widely distributed to most body tissues including saliva and ascitic, pleural and synovial fluid; concentrates in liver
and kidneys; penetrates CNS
; crosses placenta. Metabolism:
Primarily inactivated in liver. Elimination:
Much longer in neonates; metabolite
and free drug excreted in urine; excreted in breast milk. Half-Life:
Assessment & Drug Effects
- Lab tests: Perform bacterial culture and susceptibility tests prior to first dose and periodically thereafter. Baseline
CBC, platelets, serum iron, and reticulocyte cell counts before initiation of therapy, at 48 h intervals during therapy,
and periodically. Monitor chloramphenicol blood levels weekly or more frequently with hepatic dysfunction and in patients
receiving therapy for longer than 2 wk. Desired concentrations: peak 1020 mcg/mL; through 510 mcg/mL.
- Monitor blood studies. Chloramphenicol should be discontinued upon appearance of leukopenia, reticulocytopenia, thrombocytopenia,
- Non-dose-related irreversible bone marrow depression may appear weeks or months after drug therapy is terminated. The potential
for this side effect is greatest in patients with impaired hepatic or renal function, infants, children, and premenopausal
- Observe the patient closely, because blood studies are not always reliable predictors of irreversible bone marrow depression.
- Check temperature at least q4h. Usually chloramphenicol is discontinued if temperature remains normal for 48 h.
- Monitor I&O ratio or pattern: Report any appreciable change.
- More frequent determinations of serum glucose are recommended in patients receiving oral antidiabetic agents.
- Monitor for S&S of gray syndrome, which has occurred 29 d after initiation of high dose chloramphenicol therapy in
premature infants and neonates and in children ≤2 y. Report early signs: abdominal
distention, failure to feed, pallor, changes in vital signs. Early detection and prompt termination of therapy can interrupt
a potentially fatal course.
Patient & Family Education
- A bitter taste may occur 1520 s after IV injection; it usually lasts only 23 min.
- Report immediately sore throat, fever, fatigue, petechiae, nose bleeds, bleeding gums, or other unusual bleeding or bruising,
or any other suspicious sign of symptom. Drug therapy should be discontinued if abnormal bleeding occurs.
- Watch for S&S of superinfection (see Appendix F).
- Follow dosage and duration of therapy as prescribed by physician.
- Avoid prolonged or frequent intermittent use of topical preparations because systemic absorption and toxicity can occur.
- Withhold medication and check with physician immediately if signs of hypersensitivity reaction (see Appendix F), irritation,
superinfection, or other adverse reactions appear.