Chloramphenicol

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• CHLORAMPHENICOL/CITALOPRAM
• CHLORAMPHENICOL/FOSPHENYTOIN SODIUM
• CHLORAMPHENICOL/PHENYTOIN

This is not a complete list of Chloramphenicoldrug interactions. Ask your doctor or pharmacist for more information.

Take chloramphenicol exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Chloramphenicol dose your doctor recommends will be based on the following (use any or all that apply):

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Chloramphenicol is available in the following doses:

• Chloramphenicol 1000 Mg Injectable Powder For Injection
• Chloramphenicol 250 Mg Oral Capsule
• Chloramphenicol Compounding Powder
• Chloramphenicol Ophthalmic 0.5% Ophthalmic Solution
• Chloramphenicol Ophthalmic 1% Ophthalmic Ointment
• Chloramphenicol Ophthalmic 25 Mg Ophthalmic Powder For Reconstitution
• Chloramphenicol Otic 0.5% Otic Solution
• Chloramphenicol Palmitate Compounding Powder
• Chloramphenicol/fibrinolys/desoxyribo Topical Topical Ointment
• Chloramphenicol/hc/polymyxin B Ophthalmic 10 Mg-5 Mg-10,000 Units/g Ophthalmic Ointment

Antibacterial; broad-spectrum antibiotic used only in serious infections caused by susceptible bacteria when less hazardous anti-infectives are ineffective or contraindicated.132 a

Storage

Parenteral

15–25°C.a

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

• Advise patients that antibacterials (including chloramphenicol) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).a

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.a

• Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.a

• Importance of advising patients of other important precautionary information.a (See Cautions.)

• Antibiotic, Miscellaneous

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

Distribution

To most tissues and body fluids (Ambrose 1984); good CSF and brain penetration

CSF concentration with uninflamed meninges: 21% to 50% of plasma concentration

CSF concentration with inflamed meninges: 45% to 89% of plasma concentration

Vd: Chloramphenicol: 0.6 to 1 L/kg; Chloramphenicol succinate: 0.2 to 3.1 L/kg (Ambrose 1984)

Metabolism

Chloramphenicol: Hepatic to metabolites (inactive); Chloramphenicol succinate: Hydrolyzed in the liver, kidney and lungs to chloramphenicol (active) (Ambrose 1984)

Excretion

Urine (~30% as unchanged chloramphenicol succinate in adults, 6% to 80% in children; 5% to 15% as chloramphenicol) (Ambrose 1984; Powell 1982)

Half-Life Elimination

Neonates: 1 to 2 days: 24 hours; 10 to 16 days: 10 hours

Chloramphenicol: Infants: Significantly prolonged (Powell 1982); Children 4 to 6 hours; Adults: ~4 hours (Ambrose 1984)

Hepatic disease: Prolonged (Ambrose 1984)

Protein Binding

Chloramphenicol: ~60%; decreased with hepatic or renal dysfunction and 30% to 40% in newborn infants (Ambrose 1984)

Serious infections: Infants, Children, and Adolescents: IV:

Manufacturer’s labeling: 50 mg/kg/day in divided doses every 6 hours; severe infections (eg, bacteremia, meningitis) may require up to 100 mg/kg/day; decrease to 50 mg/kg/day as soon as possible. Note: In infants and children with suspected immature metabolic function, dose may be initiated at 25 mg/kg/day

Alternative dosing: 50 to 100 mg/kg/day in divided doses every 6 hours; maximum daily dose: 4 g/day (Red Book [AAP] 2015)

There are no specific dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment may be necessary. Use with caution; monitor serum concentrations.

Applies to chloramphenicol: compounding powder, injectable powder for injection, oral capsule

Hematologic

Hematologic side effects due to chloramphenicol-induced bone marrow depression are the most significant adverse reactions and have included aplastic anemia, hypoplastic anemia, thrombocytopenia, pancytopenia, and granulocytopenia. Idiosyncratic aplastic anemia occurs in approximately 1 in 20,000 to 1 in 40,000 cases, is fatal in 70% of affected patients, and resolves in only 10% of patients. Reversible bone marrow suppression is more common, and is dose-related. Paroxysmal nocturnal hemoglobinuria has also been reported. Hemolysis may occur in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.[Ref]

Aplastic anemia is idiosyncratic and dose-independent. It has been reported in patients who have received intravenous, oral, and topical (including ophthalmologic ointment) chloramphenicol 3 to 12 weeks after initiation of therapy.

Reversible bone marrow suppression may present as early as 5 days after therapy is begun as pancytopenia, is more common with plasma chloramphenicol levels of 25 mcg/mL or more, and may result in high serum iron levels due to lack of bone marrow clearance of iron.[Ref]

Hypersensitivity

Hypersensitivity side effects have included fever, macular and vesicular rashes, angioedema, urticaria, anaphylaxis, fever, hypersensitivity myocarditis, and angioedema. Herxheimer's reactions have been reported during treatment of typhoid fever. Extremely rare cases of contact dermatitis have been reported.[Ref]

Anaphylaxis may present with urticarial rash, bronchospasm, and angioedema, and is rare.[Ref]

Nervous system

Nervous system side effects have included headache, mental confusion, delirium, ototoxicity, sensorineural hearing loss, optic neuritis, peripheral neuritis, and encephalopathy.[Ref]

Sensorineural hearing loss has been reported after oral administration and after topical administration of chloramphenicol to the outer ear. The proposed mechanism is inhibition of mitochondrial protein synthesis in highly oxidative organs.[Ref]

Psychiatric

Psychiatric side effects have included mild depression.

Gastrointestinal

Gastrointestinal side effects have infrequently included nausea, vomiting, glossitis, stomatitis, and enterocolitis.[Ref]

Cardiovascular

Cardiovascular side effects have rarely included cardiomyopathy. The proposed mechanism is inhibition of mitochondrial protein synthesis in highly oxidative organs.[Ref]

Hepatic

Hepatic side effects have included rare cases of hepatitis.[Ref]

Other

Gray syndrome has been reported in neonates, premature infants, and infants. It usually appears after 3 to 4 days of chloramphenicol therapy and manifests as abdominal distension with or without vomiting, progressive pallid cyanosis, irregular respiration, vasomotor collapse, and death within a few hours after onset. In one case gray syndrome was reported in a neonate whose mother had received chloramphenicol during labor. High chloramphenicol serum levels (greater than 90 mcg/mL) have been associated with gray syndrome and large doses have been associated with a rapidly fatal course. Symptoms are frequently reversible with complete recovery if chloramphenicol is discontinued immediately.[Ref]

Some side effects of chloramphenicol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.