CHLORAMPHENICOL SODIUM SUCCINATE- chloramphenicol sodium succinate injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHLORAMPHENICOL SODIUM SUCCINATE (UNII: 872109HX6B) (CHLORAMPHENICOL - UNII:66974FR9Q1)

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

CHLORAMPHENICOL SODIUM SUCCINATE

Composition:

CHLORAMPHENICOL 1 g in 10 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

In accord with the concepts in the   Warning Box   and this   INDICATIONS AND USAGE   section, chloramphenicol must be used only in those serious infections for which less potentially dangerous drugs are ineffective or contraindicated.  However, chloramphenicol may be chosen to initiate antibiotic therapy on the clinical impression that one of the conditions below is believed to be present; in vitro sensitivity tests should be performed concurrently so that the drug may be discontinued as soon as possible if less potentially dangerous agents are indicated by such tests.  The decision to continue use of chloramphenicol rather than another antibiotic when both are suggested by in vitro studies to be effective against a specific pathogen should be based upon severity of the infection, susceptibility of the pathogen to the various antimicrobial drugs, efficacy of the various drugs in the infection, and the important additional conce

Product summary:

Chloramphenicol Sodium Succinate for Injection, USP is freeze-dried in the vial.  When reconstituted as directed, each vial contains a sterile solution equivalent to 100 mg of chloramphenicol per mL (1 g/10 mL). Preservative Free. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLORAMPHENICOL SODIUM SUCCINATE - CHLORAMPHENICOL SODIUM SUCCINATE
INJECTION,
POWDER, LYOPHILIZED, FOR SOLUTION
FRESENIUS KABI USA, LLC
----------
CHLORAMPHENICOL SODIUM SUCCINATE FOR INJECTION, USP
Rx only
_FOR INTRAVENOUS ADMINISTRATION_
WARNING
SERIOUS AND FATAL BLOOD DYSCRASIAS (APLASTIC ANEMIA, HYPOPLASTIC
ANEMIA, THROMBOCYTOPENIA
AND GRANULOCYTOPENIA) ARE KNOWN TO OCCUR AFTER THE ADMINISTRATION OF
CHLORAMPHENICOL. IN
ADDITION, THERE HAVE BEEN REPORTS OF APLASTIC ANEMIA ATTRIBUTED TO
CHLORAMPHENICOL WHICH
LATER TERMINATED IN LEUKEMIA. BLOOD DYSCRASIAS HAVE OCCURRED AFTER
BOTH SHORT-TERM AND
PROLONGED THERAPY WITH THIS DRUG. CHLORAMPHENICOL MUST NOT BE USED
WHEN LESS POTENTIALLY
DANGEROUS AGENTS WILL BE EFFECTIVE, AS DESCRIBED IN THE INDICATIONS
AND USAGE
SECTION. _IT MUST NOT BE USED IN THE TREATMENT OF TRIVIAL INFECTIONS
OR WHERE IT IS NOT INDICATED, AS IN_
_COLDS, INFLUENZA, INFECTIONS OF THE THROAT; OR AS A PROPHYLACTIC
AGENT TO PREVENT BACTERIAL INFECTIONS._
PRECAUTIONS: IT IS ESSENTIAL THAT ADEQUATE BLOOD STUDIES BE MADE
DURING TREATMENT WITH THE
DRUG. WHILE BLOOD STUDIES MAY DETECT EARLY PERIPHERAL BLOOD CHANGES,
SUCH AS LEUKOPENIA,
RETICULOCYTOPENIA, OR GRANULOCYTOPENIA, BEFORE THEY BECOME
IRREVERSIBLE, SUCH STUDIES
CANNOT BE RELIED ON TO DETECT BONE MARROW DEPRESSION PRIOR TO
DEVELOPMENT OF APLASTIC
ANEMIA. TO FACILITATE APPROPRIATE STUDIES AND OBSERVATION DURING
THERAPY, IT IS DESIRABLE THAT
PATIENTS BE HOSPITALIZED.
IMPORTANT CONSIDERATIONS IN PRESCRIBING INJECTABLE CHLORAMPHENICOL
SODIUM SUCCINATE. CHLORAMPHENICOL SODIUM SUCCINATE IS INTENDED FOR
INTRAVENOUS USE ONLY. IT HAS BEEN DEMONSTRATED TO BE INEFFECTIVE
WHEN GIVEN INTRAMUSCULARLY.
Chloramphenicol sodium succinate must be hydrolyzed to its
microbiologically active form, and
there is a lag in achieving adequate blood levels compared with the
base given intravenously.
Patients started on intravenous chloramphenicol sodium succinate
should be changed to the oral
form of another appropriate antibiotic as soon as practicable.
DESCRIPTION:
Chlora