Chloramphenicol sodium succinate: Difference between revisions

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* 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.
* 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.
|fdaLIADAdult===Indication==
|fdaLIADAdult===Indication==
In accord with the concepts in the warning box and this indications 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 concepts contained in the warning box above.
In accord with the concepts in the warning box and this indications 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 concepts contained in the warning box above.
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Adults should receive 50 mg/kg/day in divided doses at 6-hour intervals.  In exceptional cases patients with infections due to moderately resistant organisms may require increased dosage up to 100 mg/kg/day to achieve blood levels inhibiting the pathogen, but these high doses should be decreased as soon as possible.  Adults with impairment of hepatic or renal function or both may have reduced ability to metabolize and excrete the drug.  In instances of impaired metabolic processes, dosages should be adjusted accordingly.Precise control of concentration of the drug in the blood should be carefully followed in patients with impaired metabolic processes by the available microtechniques.
Adults should receive 50 mg/kg/day in divided doses at 6-hour intervals.  In exceptional cases patients with infections due to moderately resistant organisms may require increased dosage up to 100 mg/kg/day to achieve blood levels inhibiting the pathogen, but these high doses should be decreased as soon as possible.  Adults with impairment of hepatic or renal function or both may have reduced ability to metabolize and excrete the drug.  In instances of impaired metabolic processes, dosages should be adjusted accordingly.Precise control of concentration of the drug in the blood should be carefully followed in patients with impaired metabolic processes by the available microtechniques.
|offLabelAdultGuideSupport======Condition1=====
|offLabelAdultGuideSupport=* There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


* Developed by:


* Class of Recommendation:
|offLabelAdultNoGuideSupport=* There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


* Strength of Evidence:


* Dosing Information


:* Dosage
|fdaLIADPed=* There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.


=====Condition2=====


There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Non–Guideline-Supported Use (Adult)-->
|offLabelPedGuideSupport=* There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
|offLabelAdultNoGuideSupport======Condition1=====


* Dosing Information


:* Dosage
|offLabelPedNoGuideSupport=* There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


=====Condition2=====


There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
|contraindications=* Chloramphenicol is contraindicated in individuals with a history of previous [[hypersensitivity]] and/or toxic reaction to it.  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 infection.
 
|clinicalTrials='''Blood Dyscrasias'''
<!--Pediatric Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Off-Label Use and Dosage (Pediatric)-->
 
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Contraindications-->
* The most serious adverse effect of chloramphenicol is bone marrow depression.  Serious and fatal blood dyscrasias ([[aplastic anemia]], [[hypoplastic anemia]], [[thrombocytopenia]] and [[granulocytopenia]]) are known to occur after the administration of chloramphenicol. An irreversible type of marrow depression leading to [[aplastic anemia]] with a high rate of mortality is characterized by the appearance weeks or months after therapy of bone marrow aplastia or [[hypoplasia]].  Peripherally, pancytopenia is most often observed, but in a small number of cases only one or two of the three major cell types (erythrocytes, leukocytes, platelets) may be depressed.
|contraindications=* Chloramphenicol is contraindicated in individuals with a history of previous [[hypersensitivity]] and/or toxic reaction to it. 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 infection.  
|warnings=* Description


====Precautions====
* A reversible type of bone marrow depression, which is dose related, may occur.  This type of marrow depression is characterized by vacuolization of the erythroid cells, reduction of reticulocytes and [[leukopenia]], and responds promptly to the withdrawal of chloramphenicol.


* Description
* An exact determination of the risk of serious and fatal blood dyscrasias is not possible because of lack of accurate information regarding 1) the size of the population at risk, 2) the total number of drug-associated dyscrasias, 3) the total number of non-drug associated dyscrasias.


<!--Adverse Reactions-->
* In a report to the California State Assembly by the California Medical Association and the State Department of Public Health in January 1967, the risk of fatal aplastic anemia was estimated at 1:24,200 to 1:40,500 based on two dosage levels.


<!--Clinical Trials Experience-->
* There have been reports of [[aplastic anemia]] attributed to chloramphenicol which later terminated in [[leukemia]].
|clinicalTrials='''Blood Dyscrasias'''


* The most serious adverse effect of chloramphenicol is bone marrow depression.  Serious and fatal blood dyscrasias ([[aplastic anemia]], [[hypoplastic anemia]], [[thrombocytopenia]] and [[granulocytopenia]]) are known to occur after the administration of chloramphenicol.  An irreversible type of marrow depression leading to aplastic anemia with a high rate of mortality is characterized by the appearance weeks or months after therapy of bone marrow aplastia or hypoplasia.  Peripherally, pancytopenia is most often observed, but in a small number of cases only one or two of the three major cell types (erythrocytes, leukocytes, platelets) may be depressed.
* [[Paroxysmal nocturnal hemoglobinuria]] has also been reported.


A reversible type of bone marrow depression, which is dose related, may occur.  This type of marrow depression is characterized by vacuolization of the erythroid cells, reduction of reticulocytes and leukopenia, and responds promptly to the withdrawal of chloramphenicol.
'''Gastrointestinal Reactions'''


An exact determination of the risk of serious and fatal blood dyscrasias is not possible because of lack of accurate information regarding 1) the size of the population at risk, 2) the total number of drug-associated dyscrasias, 3) the total number of non-drug associated dyscrasias.
* [[Nausea]], [[vomiting]], [[glossitis]] and [[stomatitis]], [[diarrhea]] and [[enterocolitis]] may occur in low incidence.


In a report to the California State Assembly by the California Medical Association and the State Department of Public Health in January 1967, the risk of fatal aplastic anemia was estimated at 1:24,200 to 1:40,500 based on two dosage levels.
'''Neurotoxic Reactions'''


There have been reports of aplastic anemia attributed to chloramphenicol which later terminated in leukemia.
* [[Headache]], mild [[depression]], mental confusion and [[delirium]] have been described in patients receiving chloramphenicol; optic and [[peripheral neuritis]] have been reported, usually following long-term therapy.  If this occurs, the drug should be promptly withdrawn.


Paroxysmal nocturnal hemoglobinuria has also been reported.
'''Hypersensitivity Reactions'''


Gastrointestinal Reactions
* [[Fever]], macular and vesicular [[rashes]], [[angioedema]], [[urticaria]] and [[anaphylaxis]] may occur.  Herxheimer reactions have occurred during therapy for typhoid fever.
Nausea, vomiting, glossitis and stomatitis, diarrhea and enterocolitis may occur in low incidence.


Neurotoxic Reactions
"'Gray Syndrome"'
Headache, mild depression, mental confusion and delirium have been described in patients receiving chloramphenicol; optic and peripheral neuritis have been reported, usually following long-term therapy.  If this occurs, the drug should be promptly withdrawn.


Hypersensitivity Reactions
* Toxic reactions including fatalities have occurred in the premature and newborn; the signs and symptoms associated with these reactions have been referred to as the gray syndrome.  One case of gray syndrome has been reported in an infant born to a mother having received chloramphenicol during labor.  One case has been reported in a 3-month old infant. The following summarizes the clinical and laboratory studies that have been made on these patients:
Fever, macular and vesicular rashes, angioedema, urticaria and anaphylaxis may occur.  Herxheimer reactions have occurred during therapy for typhoid fever.


"Gray Syndrome"
a) In most cases therapy with chloramphenicol had been instituted within the first 48 hours of life.
Toxic reactions including fatalities have occurred in the premature and newborn; the signs and symptoms associated with these reactions have been referred to as the gray syndrome.  One case of gray syndrome has been reported in an infant born to a mother having received chloramphenicol during labor.  One case has been reported in a 3-month old infant. The following summarizes the clinical and laboratory studies that have been made on these patients:


  a) In most cases therapy with chloramphenicol had been instituted within the first 48 hours of life.
b) Symptoms first appeared after 3 to 4 days of continued treatment with high doses of chloramphenicol.


  b) Symptoms first appeared after 3 to 4 days of continued treatment with high doses of chloramphenicol.
c)The symptoms appeared in the following order:


  c) The symptoms appeared in the following order:
1)Abdominal distension with or without emesis;


      1) abdominal distension with or without emesis;
2)Progressive pallid cyanosis;


      2) progressive pallid cyanosis;
3)Vasomotor collapse, frequently accompanied by irregular respiration;


      3) vasomotor collapse, frequently accompanied by irregular respiration;
4) Death within a few hours of onset of these symptoms.


      4) death within a few hours of onset of these symptoms.
d) The progression of symptoms from onset to exitus was accelerated with higher dose schedules.


  d) The progression of symptoms from onset to exitus was accelerated with higher dose schedules.
e) Preliminary blood serum level studies revealed unusually high concentrations of chloramphenicol (over 90 mcg/mL after repeated doses).


  e) Preliminary blood serum level studies revealed unusually high concentrations of chloramphenicol (over 90 mcg/mL after repeated doses).
f) Termination of therapy upon early evidence of the associated symptomatology frequently reversed the process with complete recovery.
 
  f) Termination of therapy upon early evidence of the associated symptomatology frequently reversed the process with complete recovery.
|postmarketing=* There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=* There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|drugInteractions=* Drug
:* Description
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
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|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
|administration=* Intravenous
|administration=* Intravenous


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:*Intravenously as a 10% (100 mg/mL) solution to be injected over at least a one-minute interval.  This is prepared by the addition of 10 mL of an aqueous diluent such as Water for Injection or 5% Dextrose Injection.
:*Intravenously as a 10% (100 mg/mL) solution to be injected over at least a one-minute interval.  This is prepared by the addition of 10 mL of an aqueous diluent such as Water for Injection or 5% Dextrose Injection.
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.  
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
|IVCompat=* There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
|overdose=* There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.




|overdose=* There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.


<!--Drug box 2-->
|structure=*
|PD=* There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.




<!--Drug box 2-->
|PK=* There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
|drugBox=<!--Mechanism of Action-->
|mechAction=*


<!--Structure-->
|structure=*


: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
|nonClinToxic=* There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.


<!--Pharmacodynamics-->
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.


<!--Pharmacokinetics-->
|clinicalStudies=* There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.


<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.


<!--Clinical Studies-->
|howSupplied=* 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 (1g/10mL).
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.


<!--How Supplied-->
[[File:XXXXX.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
|howSupplied=*
|packLabel=<!--Patient Counseling Information-->
|packLabel=<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
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<!--Look-Alike Drug Names-->
<!--Look-Alike Drug Names-->
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
|drugShortage=
|drugShortage=
}}
}}

Revision as of 13:16, 16 April 2015

Chloramphenicol sodium succinate
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

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Black Box Warning

Warning
See full prescribing information for complete Boxed 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 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.

Overview

Chloramphenicol sodium succinate is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indication

In accord with the concepts in the warning box and this indications 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 concepts contained in the warning box above.

  • Acute infections caused by Salmonella typhi*
  • It is not recommended for the routine treatment of the typhoid carrier state.
  • Serious infections caused by susceptible strains in accordance with the concepts expressed above:
 a) Salmonella species

 b) H. influenzae, specifically meningeal infections

 c) Rickettsia

 d) Lymphogranuloma-psittacosis group

 e) Various gram-negative bacteria causing bacteremia, meningitis or other gram-negative infections.

 f) Other susceptible organisms which have been demonstrated to be resistant to all other appropriate antimicrobial agents.
  • Cystic fibrosis regimens

Dosage

Adults should receive 50 mg/kg/day in divided doses at 6-hour intervals. In exceptional cases patients with infections due to moderately resistant organisms may require increased dosage up to 100 mg/kg/day to achieve blood levels inhibiting the pathogen, but these high doses should be decreased as soon as possible. Adults with impairment of hepatic or renal function or both may have reduced ability to metabolize and excrete the drug. In instances of impaired metabolic processes, dosages should be adjusted accordingly.Precise control of concentration of the drug in the blood should be carefully followed in patients with impaired metabolic processes by the available microtechniques.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

  • There is limited information regarding Off-Label Guideline-Supported Use of Chloramphenicol sodium succinate in adult patients.

Non–Guideline-Supported Use

  • There is limited information regarding Off-Label Non–Guideline-Supported Use of Chloramphenicol sodium succinate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

  • There is limited information regarding FDA-Labeled Use of Chloramphenicol sodium succinate in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

  • There is limited information regarding Off-Label Guideline-Supported Use of Chloramphenicol sodium succinate in pediatric patients.

Non–Guideline-Supported Use

  • There is limited information regarding Off-Label Non–Guideline-Supported Use of Chloramphenicol sodium succinate in pediatric patients.

Contraindications

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

Warnings

Warning
See full prescribing information for complete Boxed 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 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.

There is limited information regarding Chloramphenicol sodium succinate Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

Blood Dyscrasias

  • The most serious adverse effect of chloramphenicol is bone marrow depression. Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia and granulocytopenia) are known to occur after the administration of chloramphenicol. An irreversible type of marrow depression leading to aplastic anemia with a high rate of mortality is characterized by the appearance weeks or months after therapy of bone marrow aplastia or hypoplasia. Peripherally, pancytopenia is most often observed, but in a small number of cases only one or two of the three major cell types (erythrocytes, leukocytes, platelets) may be depressed.
  • A reversible type of bone marrow depression, which is dose related, may occur. This type of marrow depression is characterized by vacuolization of the erythroid cells, reduction of reticulocytes and leukopenia, and responds promptly to the withdrawal of chloramphenicol.
  • An exact determination of the risk of serious and fatal blood dyscrasias is not possible because of lack of accurate information regarding 1) the size of the population at risk, 2) the total number of drug-associated dyscrasias, 3) the total number of non-drug associated dyscrasias.
  • In a report to the California State Assembly by the California Medical Association and the State Department of Public Health in January 1967, the risk of fatal aplastic anemia was estimated at 1:24,200 to 1:40,500 based on two dosage levels.

Gastrointestinal Reactions

Neurotoxic Reactions

  • Headache, mild depression, mental confusion and delirium have been described in patients receiving chloramphenicol; optic and peripheral neuritis have been reported, usually following long-term therapy. If this occurs, the drug should be promptly withdrawn.

Hypersensitivity Reactions

"'Gray Syndrome"'

  • Toxic reactions including fatalities have occurred in the premature and newborn; the signs and symptoms associated with these reactions have been referred to as the gray syndrome. One case of gray syndrome has been reported in an infant born to a mother having received chloramphenicol during labor. One case has been reported in a 3-month old infant. The following summarizes the clinical and laboratory studies that have been made on these patients:

a) In most cases therapy with chloramphenicol had been instituted within the first 48 hours of life.

b) Symptoms first appeared after 3 to 4 days of continued treatment with high doses of chloramphenicol.

c)The symptoms appeared in the following order:

1)Abdominal distension with or without emesis;

2)Progressive pallid cyanosis;

3)Vasomotor collapse, frequently accompanied by irregular respiration;

4) Death within a few hours of onset of these symptoms.

d) The progression of symptoms from onset to exitus was accelerated with higher dose schedules.

e) Preliminary blood serum level studies revealed unusually high concentrations of chloramphenicol (over 90 mcg/mL after repeated doses).

f) Termination of therapy upon early evidence of the associated symptomatology frequently reversed the process with complete recovery.

Postmarketing Experience

  • There is limited information regarding Postmarketing Experience of Chloramphenicol sodium succinate in the drug label.

Drug Interactions

There is limited information regarding Chloramphenicol sodium succinate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Chloramphenicol sodium succinate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Chloramphenicol sodium succinate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Chloramphenicol sodium succinate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Chloramphenicol sodium succinate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Chloramphenicol sodium succinate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Chloramphenicol sodium succinate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Chloramphenicol sodium succinate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Chloramphenicol sodium succinate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Chloramphenicol sodium succinate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Chloramphenicol sodium succinate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Chloramphenicol sodium succinate in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Intravenous
  • Chloramphenicol, like other potent drugs, should be prescribed at recommended doses known to have therapeutic activity. Administration of 50 mg/kg/day in divided doses will produce blood levels of the magnitude to which the majority of susceptible microorganisms will respond.
  • As soon as feasible an oral dosage form of chloramphenicol should be substituted for the IV form because adequate blood levels are achieved with chloramphenicol by mouth.
  • The following method of administration is recommended:
  • Intravenously as a 10% (100 mg/mL) solution to be injected over at least a one-minute interval. This is prepared by the addition of 10 mL of an aqueous diluent such as Water for Injection or 5% Dextrose Injection.

Monitoring

There is limited information regarding Monitoring of Chloramphenicol sodium succinate in the drug label.

IV Compatibility

  • There is limited information regarding IV Compatibility of Chloramphenicol sodium succinate in the drug label.

Overdosage

  • There is limited information regarding Chronic Overdose of Chloramphenicol sodium succinate in the drug label.

Pharmacology

There is limited information regarding Chloramphenicol sodium succinate Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Chloramphenicol sodium succinate Mechanism of Action in the drug label.

Structure

Pharmacodynamics

  • There is limited information regarding Pharmacodynamics of Chloramphenicol sodium succinate in the drug label.

Pharmacokinetics

  • There is limited information regarding Pharmacokinetics of Chloramphenicol sodium succinate in the drug label.

Nonclinical Toxicology

  • There is limited information regarding Nonclinical Toxicology of Chloramphenicol sodium succinate in the drug label.

Clinical Studies

  • There is limited information regarding Clinical Studies of Chloramphenicol sodium succinate in the drug label.

How Supplied

  • 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 (1g/10mL).
File:XXXXX.png
This image is provided by the National Library of Medicine.

Storage

There is limited information regarding Chloramphenicol sodium succinate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Chloramphenicol sodium succinate in the drug label.

Precautions with Alcohol

  • Alcohol-Chloramphenicol sodium succinate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • CHLORAMPHENICOL SODIUM SUCCINATE ®[1]

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ "CHLORAMPHENICOL SODIUM SUCCINATE- chloramphenicol sodium succinate injection, powder, lyophilized, for solution".
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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