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(KLOR-am-FEN-ih-kahl)
AK-Chlor, Chloromycetin Otic, Chloromycetin Sodium Succinate, Chloroptic S.O.P.,  Diochloram, Ophtho-Chloram, Sopamycetin
Chloramphenicol Sodium Succinate
Chloromycetin Sodium Succinate
Chloramphenicol Palmitate
Chloromycetin Palmitate
Class: Antibiotic

 Action Interferes with or inhibits microbial protein synthesis.

 Indications Systemic: Treatment of following types of infections caused by susceptible strains of specific microorganisms: serious systemic infections for which less potentially dangerous drugs are ineffective or contraindicated. Topical: Treatment of cystic fibrosis, superficial ocular infections, superficial infections involving external auditory canal, superficial skin infections; infection prophylaxis for minor cuts, wounds, burns and skin abrasions and for various gram-negative bacteria causing bacteremia and meningitis.

 Contraindications

Oral use: Trivial infections (eg, colds, influenza, throat infections) or infections other than indicated; prophylaxis of systemic bacterial infections. Ophthalmic use: Epithelial herpes simplex keratitis; vaccinia; varicella; fungal disease of ocular structure; mycobacterial infections of eye; after uncomplicated removal of corneal foreign body. Otic use: Perforated tympanic membrane; when less potentially dangerous agents would be expected to be ineffective.

 Route/Dosage

Systemic Infections

ADULTS: PO/IV 50 mg/kg/day in divided doses q 6 hr; may require up to 100 mg/kg/day initially for CNS infections. CHILDREN: PO/IV 50–75 mg/kg/day in divided doses q 6 hr; 50–100 mg/kg/day for meningitis. INFANTS & CHILDREN WITH IMMATURE METABOLIC PROCESSES: PO/IV 25 mg/kg/day. NEWBORNS: PO/IV Usually 25 mg/kg/day in 4 doses q 6 hr. NEONATES > 7 DAYS (> 2 KG): PO/IV 50 mg/kg/day in divided doses q 12 hr. NEONATES < 2 KG AND BIRTH-7 DAYS (> 2 KG): PO/IV 25 mg/kg qd.

Ophthalmic Infections

ADULTS & CHILDREN: Ophthalmic 1–2 gtt q 15–30 min initially for acute infections; then reduce frequency as infection is controlled.

Otic Infections

ADULTS & CHILDREN: Otic 2–3 gtt in ear tid.

Topical Infections

ADULTS & CHILDREN: Topical Apply 1–4 times daily to affected area.

 Interactions

Anticoagulants: May enhance anticoagulation action. Barbiturates: May reduce effectiveness of chloramphenicol while barbiturate effects may be enhanced; effects may last days after barbiturates are withdrawn. Ferrous salts: May increase serum iron levels. Hydantoins (eg, phenytoin): May increase serum hydantoin levels, with possible toxicity; chloramphenicol levels may increase or decrease. Rifampin: May reduce chloramphenicol serum levels; effect may last days after rifampin is withdrawn. Sulfonylureas: May cause clinical manifestations of hypoglycemia. Vitamin B12: May decrease hematologic effects of vitamin B12 in patients with pernicious anemia.

 Lab Test Interferences None well documented.

 Adverse Reactions

CNS: Headache; mental confusion; delirium; mild depression; optic neuritis; peripheral neuritis. DERM: Topical use: Itching or burning; urticaria; angioneurotic edema; dermatitis. GI: Diarrhea; nausea; vomiting; glossitis; stomatitis. HEMA: Bone marrow depression; aplastic anemia; hypoplastic anemia; thrombocytopenia; granulocytopenia. OTHER: Hypersensitivity reactions (eg, fever, rash, angioedema, urticaria, anaphylaxis); Gray syndrome. Topical use may produce same adverse reactions seen with systemic use.

 Precautions

Pregnancy: Pregnancy category undetermined. Lactation: Excreted in breast milk. Children: Use drug with caution and in reduced dosages in premature and term infants to avoid Gray syndrome toxicity (toxic and potentially fatal reaction in premature infants and newborns). Symptoms of Gray syndrome generally appear in this sequence: abdominal distention with or without emesis; progressive pallid cyanosis; vasomotor collapse, frequently accompanied by irregular respiration; death within a few hours of onset (death occurs in 40% of patients within 2 days of initial symptoms). Other initial symptoms of Gray syndrome may include refusal to suck, loose green stools, flaccidity, ashen gray color, decreased temperature and refractory lactic acidosis. Blood dyscrasias: Serious and fatal blood dyscrasias can occur. Inner ear infections: Use systemic antibiotic therapy. Ophthalmic ointment: May retard corneal epithelial healing. Renal or hepatic impairment: Excessive blood levels of drug may occur; dosage adjustment may be required. Preexisting liver dysfunction may be significant risk factor for Gray syndrome. Special risk patients: Use drug with caution in patients with acute intermittent porphyria or G-6-PD deficiency. superinfection: Use of antibiotics may result in bacterial or fungal overgrowth. Serious infections may need systemic treatment in addition to local treatment.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

  • Parenteral

  • Chloramphenicol sodium succinate is intended for IV use only; it is ineffective when given via IM route.
  • Give direct IV as 10% solution in Water for Injection or 5% Dextrose Injection over at least 1 min. Do not administer if cloudy. May also be diluted in 50–100 ml of D5W and administered over 30 min.
  • Substitute oral administration as soon as possible.

Oral

  • Administer orally in capsules and oral suspension with full glass of water on empty stomach at least 1 hr before or 2 hr after meals at evenly spaced intervals (q 6 hr) around clock.
  • Administer with food if GI upset occurs.

Ophthalmic

  • Have patient tilt head back. Place medication in conjunctival sac and close patient’s eyes. Apply light finger pressure to lacrimal sac for 1 min after instillation.
  • Do not touch tip of cap to eye, fingers or other surface.

Otic

  • Avoid contact with eyes; for use in ear only.
  • If ear drops are kept refrigerated, hold container in hand for a few minutes to warm to near body temperature.
  • If drops are in suspension, shake well for 10 sec before using.
  • Have patient lie on side or tilt affected ear up for ease of administration. Allow drops to run in, and keep ear tilted for about 2 min.
  • Do not touch tip of cap to ear, fingers or other surface.

Topical

  • Do not use in eyes. Topical preparation is for external use only.
  • Cleanse affected area of skin prior to application unless otherwise instructed.
  • Cover with sterile bandage if needed.
  • Administer around clock at even intervals.

 Assessment/Interventions

  • Obtain patient history, including drug history and any known allergies. Note any renal or hepatic impairment.
  • Determine baseline of infectious state: measure temperature; assess vital signs; examine appearance of wound, eye, ear, urine and stool; perform blood studies.
  • Confirm diagnosis from cultures prior to administration of drug.
  • Determine baseline CBC and platelet count and monitor every 2 days.
  • Avoid concurrent therapy with other drugs that suppress bone marrow.
  • Avoid repeat course of therapy if possible.
  • Monitor serum levels of medication weekly. Therapeutic level peak is 5–20 mcg/ml; if level is higher, notify physician.
  • If signs of anemia, leukopenia, reticulocytopenia or thrombocytopenia develop, notify physician.
  • Observe patient daily for signs of bone marrow depression (eg, fatigue, sore throat, bleeding, aplastic anemia, hypoplastic anemia, thrombocytopenia, agranulocytosis) and Gray syndrome in infants.
  • Discontinue drug at first sign of hematologic disorders attributable to chloramphenicol.
OVERDOSAGE: SIGNS & SYMPTOMS
  Nausea, vomiting, unpleasant taste, diarrhea

 Patient/Family Education

  • Advise patient to take drug orally 1 hr before or 2 hr after meals. Explain that medication may be taken with food to avoid GI upset.
  • Instruct patient to complete entire regimen even if feeling better.
  • Emphasize importance of follow-up examinations because of possible complications from drug that can occur up to months after therapy is completed.
  • Caution patient about not sharing prescription medications because of danger of side effects.
  • Inform patient that ophthalmic solution may cause blurred vision or stinging for a few minutes after administration.
  • Instruct patient that bitter taste that occurs after IV administration will subside 2–3 min after injection.
  • Instruct patient to report these symptoms to physician: bleeding, fever, sore throat, itching, nausea, vomiting, diarrhea, bruising or numbness and weakness of hands or feet.
  • Advise parents to report these symptoms to physician if they occur in infants: failure to feed, abdominal distention, drowsiness, blue or gray skin color or any problems in breathing.
  • Instruct patient to report signs of further infection or worsening of current infection to physician.

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