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Basic Drug Info
Drug Name:Chloramphenicol Sodium Succinate
Manufacturer:Monarch Pharmaceuticals, Inc.
Other Info:



Clinical Trials:


Indications and Usage

In accord with the concepts in the Warning Box and this INDICATIONS AND USAGE section, chloramphenicolmust 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.

1.

Acute infections caused by Salmonella typhi*It is not recommended for the routine treatment of the typhoid carrier state.2.

Serious infections caused by susceptible strains in accordance with the concepts expressed above:a) Salmonella species b) H.

influenzae, specially meningeal infections c) Rickettsiad) Lymphogranuloma-psittacosis group e) Various gram-negative bacteria causing bacteremia, meningitis, or other serious gram-negative infectionsf) Other susceptible organisms which have been demonstrated to be resistant to all other appropriate antimicrobial agents.

3.

Cystic fibrosis regimens*In treatment of typhoid fever some authorities recommend that chloramphenicol be administered at therapeutic levels for 8 to 10 days after the patient has become afebrile to lessen the possibility of relapse.
Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Communicable Diseases -- broad class of diseases whose causative agents may be passed between individuals in many different ways.

Typhoid Fever -- acute systemic febrile infection caused by Salmonella typhi.

BACTEREMIA -- The presence of viable bacteria circulating in the blood. Fever, chills, tachycardia, and tachypnea are common acute manifestations of bacteremia. The majority of cases are seen in already hospitalized patients, most of whom have underlying diseases or procedures which render their bloodstreams susceptible to invasion.

Meningitis -- Inflammation of the coverings of the brain and/or spinal cord, which consist of the PIA MATER; ARACHNOID; and DURA MATER. Infections (viral, bacterial, and fungal) are the most common causes of this condition, but subarachnoid hemorrhage (HEMORRHAGES, SUBARACHNOID), chemical irritation (chemical MENINGITIS), granulomatous conditions, neoplastic conditions (CARCINOMATOUS MENINGITIS), and other inflammatory conditions may produce this syndrome. (From Joynt, Clinical Neurology, 1994, Ch24, p6)

Cystic Fibrosis -- An autosomal recessive genetic disease of the EXOCRINE GLANDS. It is caused by mutations in the gene encoding the CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR expressed in several organs including the LUNG, the PANCREAS, the BILIARY SYSTEM, and the SWEAT GLANDS. Cystic fibrosis is characterized by epithelial secretory dysfunction associated with ductal obstruction resulting in AIRWAY OBSTRUCTION; chronic RESPIRATORY INFECTIONS; PANCREATIC INSUFFICIENCY; maldigestion; salt depletion; and HEAT PROSTRATION.

Recurrent disease -- The return of signs and symptoms of cancer after a period of improvement.

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 infections.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Influenza -- acute viral infection involving the respiratory tract; marked by inflammation of the nasal mucosa, the pharynx, and conjunctiva, and by headache and severe, often generalized, myalgia.

Bacterial Infections -- Infections by bacteria, general or unspecified.

Warnings

Clostridium difficile associated with diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Chloromycetin Sodium Succinate, and may range in severity from mild diarrhea to fatal colitis.

Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C.

difficile.C.

difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C.

difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use.

Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.

difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C.

difficile, and surgical evaluation should be instituted as clinically indicated.
Branded Drugs
The following US Branded drugs contain Chloramphenicol Sodium Succinate


CHLORAMPHENICOL -- ELKINS SINN DIV AH ROBINS CO INC

CHLOROMYCETIN -- PARKEDALE PHARMACEUTICALS INC

MYCHEL-S -- ANGUS CHEMICAL CO


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