Yes

Antibiotic, Ophthalmic; Antibiotic, Otic; Antibiotic, Miscellaneous

Treatment of serious infections due to organisms resistant to other less toxic antibiotics or when its penetrability into the site of infection is clinically superior to other antibiotics to which the organism is sensitive; useful in infections caused by Bacteroides, H. influenzae, Neisseria meningitidis, Salmonella, and Rickettsia; active against many vancomycin-resistant enterococci

C

Hypersensitivity to chloramphenicol or any component

Use with caution in patients with impaired renal or hepatic function and in neonates; reduce dose with impaired liver function; use with care in patients with glucose 6-phosphate dehydrogenase deficiency. Serious and fatal blood dyscrasias have occurred after both short-term and prolonged therapy; should not be used when less potentially toxic agents are effective; prolonged use may result in superinfection.

<1%: Nightmares, headache, rash, diarrhea, stomatitis, enterocolitis, nausea, vomiting, bone marrow suppression, aplastic anemia, peripheral neuropathy, optic neuritis, gray syndrome

Aplastic anemia, an idiosyncratic reaction which can occur with any route of administration; usually occurs 3 weeks to 12 months after initial exposure to chloramphenicol

Bone marrow suppression is thought to be dose-related with serum concentrations >25 mg/mL and reversible once chloramphenicol is discontinued; anemia and neutropenia may occur during the first week of therapy

Gray syndrome is characterized by circulatory collapse, cyanosis, acidosis, abdominal distention, myocardial depression, coma, and death; reaction appears to be associated with serum levels greater than or equal to 50 mg/mL; may result from drug accumulation in patients with impaired hepatic or renal function

Symptoms of overdose include anemia, metabolic acidosis, hypotension, hypothermia

Treatment is supportive following GI decontamination

CYP2C9 enzyme inhibitor

Increased toxicity: Chloramphenicol inhibits the metabolism of chlorpropamide, phenytoin, oral anticoagulants

Refrigerate ophthalmic solution; constituted solutions remain stable for 30 days; use only clear solutions; frozen solutions remain stable for 6 months

Reversibly binds to 50S ribosomal subunits of susceptible organisms preventing amino acids from being transferred to growing peptide chains thus inhibiting protein synthesis

Distribution: Readily crosses placenta; appears in breast milk; distributes to most tissues and body fluids

Ratio of CSF to blood level (%): Normal meninges: 66; Inflamed meninges: 66+

Protein binding: 60%

Metabolism: Extensive in the liver (90%) to inactive metabolites, principally by glucuronidation, chloramphenicol palmitate is hydrolyzed by lipases in the GI tract to the active base; chloramphenicol sodium succinate is hydrolyzed by esterases to active base

Half-life: (Prolonged with markedly reduced liver function or combined liver/kidney dysfunction):

Normal renal function: 1.6-3.3 hours

End-stage renal disease: 3-7 hours

Cirrhosis: 10-12 hours

Neonates: Postnatal: 1-2 days: 24 hours; 10-16 days: 10 hours

Elimination: 5% to 15% excreted as unchanged drug in the urine, 4% excreted in bile; in neonates, 6% to 80% may be excreted unchanged in urine

Meningitis: I.V.: Infants >30 days and Children: 50-100 mg/kg/day divided every 6 hours

Other infections: I.V.:

Infants >30 days and Children: 50-75 mg/kg/day divided every 6 hours; maximum daily dose: 4 g/day

Adults: 50-100 mg/kg/day in divided doses every 6 hours; maximum daily dose: 4 g/day

Ophthalmic: Children and Adults: Instill 1-2 drops or 1.25 cm (1/2 " of ointment every 3-4 hours); increase interval between applications after 48 hours to 2-3 times/day

Otic solution: Instill 2-3 drops into ear 3 times/day

Topical: Gently rub into the affected area 1-4 times/day

Dosing adjustment/comments in hepatic impairment: Avoid use in severe liver impairment as increased toxicity may occur

Hemodialysis: Slightly dialyzable (5% to 20%) via hemo- and peritoneal dialysis; no supplemental doses needed in dialysis or continuous arteriovenous or veno-venous hemofiltration (CAVH/CAVHD)

Folic acid, iron salts, vitamin B₁₂: May decrease intestinal absorption of vitamin B₁₂; may have increased dietary need for riboflavin, pyridoxine, and vitamin B₁₂; monitor hematological status

CBC with reticulocyte and platelet counts, periodic liver and renal function tests, serum drug concentration

Therapeutic levels: 15-20 mg/mL; Toxic concentration: >40 mg/mL; Trough: 5-10 mg/mL

Timing of serum samples: Draw levels 1.5 hours and 3 hours after completion of I.V. or oral dose; trough levels may be preferred; should be drawn less than or equal to 1 hour prior to dose

May rarely cause nightmares

May cause bone marrow suppression; use caution with clozapine and carbamazepine

No information available to require special precautions

No effects or complications reported

Oral: Take as directed, at regular intervals around-the-clock, with a large glass of water. Maintain adequate hydration (2-3 L/day of fluids unless instructed to restrict fluid intake). During I.V. administration, a bitter taste may occur; this will pass. Diabetics: Drug may cause false-positive test with Clinitest® glucose monitoring; use alternative glucose monitoring. This drug may interfere with effectiveness of oral contraceptives. You may experience nausea, vomiting (frequent small meals, frequent mouth care, sucking lozenges, or chewing gum may help). Report persistent rash, diarrhea; pain, burning, or numbness of extremities; petechiae; sore throat; fatigue; unusual bleeding or bruising; vaginal itching or discharge; mouth sores; yellowing of skin or eyes; dark urine or stool discoloration (blue); CNS disturbances (nightmares acute headache); or lack or improvement or worsening of condition.

Ophthalmic: Wash hands before instilling. Sit or lie down to instill. Open eye, look at ceiling, and instill prescribed amount of medication. Close eye and apply gentle pressure to inner corner of eye. Do not let tip of applicator touch eye or contaminate tip of applicator. Temporary stinging or burning may occur. Report persistent pain, burning, vision disturbances, swelling, itching, rash, or worsening of condition.

Otic: Wash hands before instilling. Tilt head with affected ear upward. Gently grasp ear lobe and lift back and upward. Instill prescribed drops into ear canal. Do not push dropper into ear. Remain with head tilted for 2 minutes. Report ringing in ears, discharge, or worsening of condition.

Topical: Wash hands before applying or wear gloves. Apply thin film to affected area. May apply porous dressing. Report persistent burning, swelling, itching, or worsening of condition.

Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Breast-feeding is not recommended.

Draw peak level 2 hours post oral dose or draw peak levels 90 minutes after the end of a 30-minute infusion; trough levels should be drawn just prior to the next dose; can be administered IVP over 5 minutes at a maximum concentration of 100 mg/mL, or I.V. intermittent infusion over 15-30 minutes at a final concentration for administration of less than or equal to 20 mg/mL

Capsule: 250 mg

Ointment, ophthalmic: 1% [10 mg/g] (3.5 g)

AK-Chlor®, Chloromycetin®, Chloroptic® S.O.P.: 1% [10 mg/g] (3.5 g)

Powder for injection, as sodium succinate: 1 g

Powder for ophthalmic solution (Chloromycetin®): 25 mg/vial (15 mL)

Solution: 0.5% [5 mg/mL] (7.5 mL, 15 mL)

Ophthalmic (AK-Chlor®, Chloroptic®): 0.5% [5 mg/mL] (2.5 mL, 7.5 mL, 15 mL)

Otic (Chloromycetin®): 0.5% (15 mL)

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