Chloramphenicol Sodium Succinate

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Overview

What is Chloramphenicol Sodium Succinate?

Chloramphenicol is an antibiotic that is clinically useful for, serious infections caused by organisms susceptible to its antimicrobial effects when less potentially hazardous therapeutic agents are ineffective or contraindicated. Sensitivity testing is essential to determine its indicated use, but may be performed concurrently with therapy initiated on clinical impression that one of the indicated conditions exists (see section).

When reconstituted as directed, each vial contains a sterile solution equivalent to 100 mg of chloramphenicol per mL (1 g/10 mL).

Each gram (10 mL of a 10% solution) of chloramphenicol sodium succinate contains approximately 52 mg (2.25 mEq) of sodium.

The chemical name for chloramphenicol sodium succinate is D-threo-(-)-2, 2-Dichloro-N-[β-hydroxy-α-(hydroxymethyl)-p-nitrophenethyl] acetamide α-(sodium succinate).

The structural formula is:

What does Chloramphenicol Sodium Succinate look like?

What are the available doses of Chloramphenicol Sodium Succinate?

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What should I talk to my health care provider before I take Chloramphenicol Sodium Succinate?

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How should I use Chloramphenicol Sodium Succinate?

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What interacts with Chloramphenicol Sodium Succinate?

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What are the warnings of Chloramphenicol Sodium Succinate?

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What are the precautions of Chloramphenicol Sodium Succinate?

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What are the side effects of Chloramphenicol Sodium Succinate?

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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 aplasia 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, and 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.

There have been reports of aplastic anemia attributed to chloramphenicol which later terminated in leukemia.

Paroxysmal nocturnal hemoglobinuria has been reported.

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Gastrointestinal Reactions

Nausea, vomiting, glossitis and stomatitis, diarrhea and enterocolitis may occur in low incidence.

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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.

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Hypersensitivity Reactions

Fever, macular and vesicular rashes, angioedema, urticaria, and anaphylaxis may occur. Herxheimer’s reactions have occurred during therapy for typhoid fever.

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"Gray Syndrome"

Toxic reactions including fatalities have occurred in the premature and neonate; 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 a neonate 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.

What should I look out for while using Chloramphenicol Sodium Succinate?

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

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

section.

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.

What might happen if I take too much Chloramphenicol Sodium Succinate?

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How should I store and handle Chloramphenicol Sodium Succinate?

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].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].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].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].

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Mechanism of Action

Chloramphenicol is a broad-spectrum antibiotic originally isolated from . It inhibits bacterial protein synthesis by interfering with the transfer of activated amino acids from soluble RNA to ribosomes. chloramphenicol exerts mainly a bacteriostatic effect on a wide range of gram-negative and gram-positive bacteria.

Antimicrobial Activity

Chloramphenicol has been shown to be active against most strains of the following microorganisms, both and in clinical infections as described in the section.

Aerobic gram-negative microorganisms

Haemophilus influenzae

Salmonella

Salmonella typhi

Other microorganisms

Lymphogranuloma-psittacosis group

Rickettsia

Non-Clinical Toxicology

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

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

section.

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.

Concurrent therapy with other drugs that may cause bone marrow depression should be avoided.

Repeated courses of chloramphenicol treatment should be avoided if at all possible. Treatment should not be continued longer than required to produce a cure with little or no risk or relapse of the disease.

Excessive blood levels may result from administration of the recommended dose to patients with impaired liver or kidney function. The dosage should be adjusted accordingly, or preferably, the blood concentration should be determined at appropriate intervals.

The use of this antibiotic, as with other antibiotics, may result in an overgrowth of nonsusceptible organisms, including fungi. If infections caused by nonsusceptible organisms appear during therapy, appropriate measures should be taken.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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