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At least 127 records · Page 7Linked to original sources
PubMed2001

Label and extra label drug use in small ruminants.

The small ruminant practitioner has a small arsenal of approved drugs in the United States, so the practitioner must be familiar with the laws and regulations related to extra label use. Drugs can be used extra label in food animals only under specific circumstances and can be used only for therapeutic purposes. Drugs that are illegal in small ruminants include chloramphenicol; clenbuterol; diethylstilbestrol; dimetridazole, ipranidazole, and other nitroimidazoles such as metronidazole; dipyrone; fluoroquinolones; glycopeptides; nitrofurans; furazolidone; and extra label use of medication in feed. It is also illegal to use any drug that results in residues above established tolerances or safe levels.

Animals↗
PubMed1987

Metabolic oxidation of the pyrrole ring: structure and origin of some urinary metabolites of the anti-hypertensive pyrrolylpyridazinamine, mopidralazine. III: Studies with the 13C-labelled drug.

The metabolism of the anti-hypertensive drug, mopidralazine, N-(2',5'-dimethyl-1H-pyrrol-1-yl)-6-(4"-morpholinyl)-3-pyridazinamine, was reinvestigated in rats using the [2'(5')-13CH3]-labelled drug to determine the significance of the pharmacologically active intermediate 3-hydrazino-6-(4-morpholinyl)pyridazine. The previously proposed mesonic structure of the major metabolite I, i.e., 5'-hydroxy-3',6'-dimethyl-1'-[6-(4"-morpholinyl)-3-pyridazinyl]pyrida zinium hydroxide inner salt, was confirmed by chemical synthesis, X-ray diffraction analysis and 1H n.m.r. of the [3',6'-13CH3]-labelled metabolite I. Metabolite II, 3-methyl-6-(4-morpholinyl)-triazolo [4,3-6 b]pyridazine and metabolite VII, 3-methyl-7-(4-morpholinyl)-3H-pyridazino[1,6-c]pyridazine, were shown to retain the 13CH3 labelling of mopidralazine, whereas metabolite X, 3-acetyl-hydrazino-6-(4-morpholinyl)-pyridazine, loses the labelling, indicating that their formation involves two different pathways. It is hypothesized that the oxidation of the pyrrole leads to ring opening followed by a chemical rearrangement giving rise directly to metabolites II and VII or, with the intermediacy of the pharmacologically active 3-hydrazino-6-(4-morpholinyl) derivative and an enzymic acetylation or conjugation with pyruvic acid, to metabolites X, II and VII.

Animals↗
PubMed1994

Drug labelling.

Explore the source record for details and available documents.

Anesthetics↗
PubMed1989

Quality of instructions on prescription drug labels: effects on memory and comprehension in young and old adults.

We examined both comprehension of and memory for information on prescription labels as a function of age, memory load, and study time across three experiments with young and old adults. We found that older adults consistently manifested poorer recall of prescription information than young adults; age effects occurred even when participants received unlimited study time; and both young and old adults had substantial difficulty comprehending drug information as it is presented from a pharmacy.

Adolescent↗
PubMed2002

Unlicensed and off-label drug use: issues and recommendations.

Most adult patients would expect to receive only medicines which have been shown to be well tolerated, effective, and of a high quality. The licensing process to which most drugs are subjected gives the best assurance available that these criteria are met. However, every day, children are required to take medicines which are either not licensed, or are being used outside the terms of their license. Consequently, we cannot be sure that they meet the high standards we require for adult patients. This situation exists wherever children are treated across the world, and when they are in hospital or treated at home. The drugs involved are not obscure; they are routinely used drugs, and many are the mainstay of pediatric therapeutics. The terms 'unlicensed' and 'off-label' should not be taken to imply disapproval, nor incorrect or improper use of drugs, as such prescribing is a vital part of everyday pediatric drug therapy. It is essential because the gold-standard randomized clinical trials supporting adult medicine are often unavailable for children's treatments. Adequate information is not available to ensure that children have timely access to well tolerated and effective medicines with accurate, scientifically justified prescribing information. Many problems arise from this situation, including the lack of availability of appropriate pediatric drug formulations, poor prescribing information, and increased risk of medication errors and unanticipated adverse drug reactions. This situation is unacceptable. The US has taken the lead to change this situation by providing legislation and incentives to the pharmaceutical industry to perform pediatric clinical trials. Funding has been provided to set up research facilities where trials can be conducted by experienced pediatric investigators using imaginative, innovative, and noninvasive testing methods. The rest of the world should learn from these experiences and follow this lead to ensure that children have the same rights as adults to well tolerated and effective medicines.

Australia↗
PubMed2006

Adding pharmacogenetics information to drug labels: lessons learned.

The US Food and Drug Administration approved a revised package insert for two cancer drugs to include information about the increased risk of severe adverse events owing to enzyme deficiencies caused by genetic variants. The label revisions stopped short of recommending or requiring pharmacogenetic testing prior to or following an adverse event. Despite (or because of) the lack of specific recommendations, we believe the actions taken by US Food and Drug Administration will have implications for pharmacogenetics research, clinical integration, and other policy considerations. We review the reasons behind the cautious label changes and discuss some of the lessons that can be learned from these experiences.

Antineoplastic Agents↗
PubMed1979

The effect of crystal size on the bioavailability of benoxaprofen: studies utilizing deuterium labeled drug.

A study of the effect of crystal size on the bioavailability of benoxaprofen, 2-[4-chlorophenyl]-alpha-methyl-5-benzoxazoleacetic acid, in man is reported. The technique utilized comparison of either the plasma concentrations or urine levels, resulting from administration of deuterium labeled (2H7) drug in solution coadministered with a test capsule formulation. Drug concentrations were determined by gas chromatography, and the ratio of labeled to unlabeled drug was obtained by gas chromatography mass spectrometry. Measurements following coadministration of labeled and unlabeled drug in solution established the absence of an isotope effect due to the presence of deuterium. The dry formulations consisted of either a 3.17--100 micron fraction (mean = 18.5 microns) or a 32--1000 micron fraction (mean = 610 microns) formulated with starch powder. The results in three subjects indicate an almost complete availability (0.95--0.98) of the small crystals as measured by comparison of either area under the plasma level curves or urine excretion (0.94--0.97) of labeled versus unlabeled drug measured to 168 hours. The larger crystals exhibited a lower availability as shown by plasma levels (0.41--0.46) or urine recovery (0.39--0.43). A higher dose of the large crystal formulation resulted in decreased relative availability with a fourfold dose dropping availability to 0.22 in a single subject.

Adult↗