Drug Efficacy: Hearings Before a Subcommittee of the Committee on Government Operations, House of Representatives, Ninety-first Congress, First Session, Teil 1
United States. Congress. House. Committee on Government Operations. Intergovernmental Relations Subcommittee
U.S. Government Printing Office, 1970 - 415 Seiten
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action adequate administration antibiotic appears apply approved asked August base basis believe blood level BROWN Bureau of Medicine capsules certification Chairman chloramphenicol succinate Chloromycetin clinical Commissioner concentrations concerning CONGRESS continuing copy correct Davis decision Director discussion disease Documentation dosage dose drug effective efficacy evidence fact fever files firm Food and Drug FOUNTAIN give given going GOLDBERG GOODRICH gram GRAY Hodges hospital indicated injection insert intramuscular intravenous January JENNINGS July KIRK labeling Laboratories letter LIBRARY LOCKHART March material matter meeting memorandum MINCHEW obtained Office oral parenteral Parke patients period preparation present problem question Rachelle reason recall received recommended record referred regard requested response revised route September sodium succinate solution staff standard statement stocks studies subcutaneous submitted supply tion warning
Seite 66 - ... 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. (See discussion under Newborn Infants.) Precise control of concentration of the drug in the blood should be carefully followed in patients with impaired metabolic processes by the available microtechniques (information available on request).
Seite 63 - 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.
Seite 64 - Warning Box and this Indications section, chloramphenicol must be used only in those serious Infections for which less potentially dangerous drugs are ineffective or contraindlcated.
Seite 113 - Chloramphenicol should not be used when other less potentially dangerous agents will be effective, or in the treatment of trivial infections such as colds, influenza, or viral infections of the throat, or as a prophylactic agent.
Seite 57 - 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...
Seite 65 - 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 nondrugassociated dyscrasias. In a report to the California State Assembly by the California Medical Association and the State Department of Public Health...
Seite 65 - ... 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...
Seite 63 - 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 Indications section).
Seite 65 - ... Treatment should not be continued longer than required to produce a cure with little or no risk of relapse of the disease. 3. Concurrent therapy with other drugs that may cause bone marrow depression should be avoided. 4. Excessive blood levels may result from administration of the recommended dose to patients with impaired liver or kidney function, including that due to immature metabolic processes in the infant.
Seite 62 - 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.