Chloramphenicol 250 mg

Neonates

Pregnant Women

Nursing Women

Contraindications

Chloramphenicol is contraindicated in individuals with a history of previous hypersensitivity or toxic reaction to it.

Warnings

Serious and sometimes fatal reactions have occurred in patients taking chloramphenicol, even during short-term systemic therapy and possibly after long-term local application. These include blood dyscrasias such as aplastic anemia, hypoplastic anemia, thrombocytopenia and granulocytopenia. Two forms of bone marrow suppression are known to occur; a rare idiosyncratic, non-dose-related, irreversible reaction (aplastic anemia) with a high mortality rate (>50%) and a common, dose-related, reversible type. While hematologic studies may detect early peripheral blood changes, they are not useful in predicting irreversible bone marrow depression which precedes the development of aplastic anemia. Most cases of aplastic anemia have occurred weeks or months after completion of therapy. This reaction has limited its usefulness as an antimicrobial agent in current therapies.

A severe and potentially fatal reaction known as the gray baby syndrome has occurred in premature and newborn infants receiving large doses of chloramphenicol. Most commonly, chloramphenicol therapy had been initiated in the first 48 hours after birth; however, it has occurred in children as old as 2 years and in infants born to mothers who received chloramphenicol in the final stages of labor. Symptoms include failure to feed, abdominal distention, vomiting, blue-gray skin color, hypothermia, irregular breathing and cardiovascular collapse. Death can occur within hours. The syndrome has been attributed to excessive serum concentrations of chloramphenicol due to immature hepatic and renal elimination processes. If the syndrome is detected early and chloramphenicol is stopped, the infant may recover completely.

Chloramphenicol must not be used when less toxic agents can be expected to be effective.

Adverse Effects

Gastrointestinal

Central Nervous System

Hypersensitivity

Hematologic

Local

Gray Baby Syndrome

Overdose

Symptoms

Treatment

Dosage

When given iv direct, chloramphenicol should be administered as a 10 g/100 mL solution over at least 1 minute. Alternatively, it may be given as an iv infusion at a concentration of ≤20 mg/mL over 10–30 minutes. Oral preparations of chloramphenicol are no longer available. The iv solution chloramphenicol sodium succinate can be given orally. The bitter taste can be masked by first dissolving the iv solution in water, then diluting in milk.

Chloramphenicol has a narrow therapeutic index and ideally plasma concentrations should be monitored. For most infections peak concentrations should be between 10 and 20 µg/mL and trough concentrations between 5 and 10 µg/mL. For meningitis, peak and trough concentrations should be maintained between 15 and 25 µg/mL and 5 and 15 µg/mL, respectively. Serum samples should be drawn 0.5 to 1.5 hours after completion of iv administration for peak serum levels.

Oral and IV: Adults: 50 mg/kg/day in divided doses at 6-hour intervals. Patients with infections due to moderately resistant organisms or CNS infections may require higher doses of up to 100 mg/kg/day to achieve therapeutic serum or CSF levels, but the dose should be decreased as soon as possible to 50 mg/kg daily. Maximum daily dose is 4 g. Adults with impairment of hepatic or renal function may have reduced ability to metabolize and excrete the drug. In instances of impaired metabolic processes, dosages should be adjusted appropriately (see Precautions).

Children and infants over 4 weeks of age: Dosage of 50 mg/kg/day divided at 6-hour intervals is effective against most susceptible organisms. Severe infections (e.g., septicemia or meningitis): up to 100 mg/kg/day divided at 6-hour intervals. Dose should be decreased as soon as possible to 50 mg/kg daily. Maximum daily dose is 4 g.

Children with impaired hepatic or renal function require dosage adjustment based on serum chloramphenicol levels when possible (see Precautions).

Dose in Neonates: See Table 2.

IM administration is controversial and generally should not be used, because studies have reported varying serum levels.

Local: Ophthalmic: Preparations (e.g., a thin strip of ointment approximately 1 cm long or 1 drop of solution) may be applied in the conjunctival sac every 3 hours for the first 48 hours, at which time the dosing interval may be increased.

Otic: Instil 2 or 3 drops into the ear canal every 6 to 8 hours.

Your Shopping Cart

You currently have no items in your cart.

Customer Support

• Call Toll Free: 1-888-254-3038
• Live Chat Help:
  
  

90 Day Risk Free Refund
Buy with confidence, your satisfaction is guaranteed

Urgent: Compounded Prescription Recall

This is to inform you of a product recall involving: All Sterile Human and Veterinary Prescriptions Distributed by...

Honeyville Honey Farm Issues Allergy Alert on Undeclared Anchovy in Honeyville Honey Barbecue Sauce

Honeyville Honey Farm of Durango, CO is voluntarily recalling bottles of Honeyville Honey Barbecue Suace manufactured...

Now Hiring

Are you an energetic, self starter, looking to succeed? Call us today @ 1-888-254-3038 and set up an interview.