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Biomedical subjects

P J Roylance

Publications and source records attributed to P J Roylance.

13 recordsLinked to original sources

Review of the efficacy of oral norfloxacin in pyelonephritis and nosocomial urinary tract infection.

One hundred thirty-eight patients with pyelonephritis were treated with norfloxacin, 400 mg twice daily. Women accounted for 74% of cases, and Escherichia coli was the predominant pathogen, accounting for 51% of organisms. Tests for antibody-coated bacteria (ACB) were performed in 48% of patients, and 72% (48 of 67) were positive. Forty percent of the patients had temperatures greater than 37.6 degrees C at the time of study entry. Patients who had both fevers and positive ACB tests had cure rates similar to those of afebrile, ACB-negative patients. Norfloxacin was also highly effective in the treatment of multiply resistant, nosocomial urinary tract infections (UTIs), in which Pseudomonas aeruginosa and E. coli predominated. It is concluded that, when used appropriately, i.e., in nonbacteremic patients who are able to absorb oral drugs, norfloxacin is a highly effective alternative modality in the therapy of certain UTIs that historically have been treated with parenteral antibiotics.

Administration, Oral↗

Clinical profile of angioedema associated with angiotensin converting-enzyme inhibition.

Based on data from three studies with complete recording of adverse events in about 12,000 patients each, we determined that angioedema in association with the angiotensin converting-enzyme inhibitor enalapril maleate occurred during the first week of therapy at the rate of one case per 3000 patients per week. Thereafter, the incidence was 14-fold lower, without evidence of a temporal trend in incidence beyond the first week of therapy. The cumulative incidence was one case per 1000 patients treated (0.1%). An additional 138 case reports consistent with the diagnosis of angioedema were obtained from our overall controlled and marketed experience using enalapril in more than 1.2 million patients. These reports were examined to further characterize the reaction. The cases generally were mild, and they resolved on discontinuation of drug therapy. Seven patients experienced angioedema or urticaria in association with both enalapril and captopril, a structurally different angiotensin converting-enzyme inhibitor. This further suggested that the side effect is mechanism based. If angioedema is suspected, therapy with any angiotensin converting-enzyme inhibitor should be interrupted promptly, respiratory distress should be treated appropriately, and subsequent therapy should be initiated with an agent from an alternative class of medication.

Angioedema↗

International prescription drug labeling.

Yesterday's therapeutic compounds were meticulously prepared, elegantly presented, and relatively innocuous (Dunlop). Today's powerful and complex drugs are manufactured with sophisticated technology and require clear, concise, and comprehensive information for the physicians throughout the world in order to provide maximum benefit for the patient. Our company, Merck & Co, Inc, has adhered for many years to strict requirements for full and balanced disclosure in all information disseminated to professionals about our products, including circulars, labeling, and advertising. Our practice is to provide complete information to physicians, pharmacists, and regulatory authorities, both on the recommended uses for our products and on their potential adverse effects. The cornerstone of our international disclosure system, the International Physicians Circular (IPC), is provided for each product and comprises part of the initial submission to each national health authority in connection with application for marketing approval. Each IPC sets forth the company's best scientific judgment with respect to both the positive and negative aspects of our drugs, defining actions, indications, and dosage, as well as all contraindications, precautions, and side effects. These circulars are updated in the process of continuous medical review.

Drug Industry↗

The effect of indomethacin upon experimental fractures in the rat.

The effect of Indomethacin upon the process of fracture repair and osteogenesis in bone isografts has been studied in the rat. It was found that the drug had no significant effect upon new bone formation in heterotopic bone grafts. It had no effect upon the osteogenesis in repairing drill holes in 2 month old rats. A significant impairment of osteogenesis was detected, however, in older (6--9 months) animals given continuous treatment with Indomethacin from the week before fracture. This effect was not apparent if treatment was terminated on the day after induction of the lesion. There is histological evidence of increased fibrogenesis and decreased osteogenesis and remodelling in fractures in old rats given high dosages of Indomethacin.

Age Factors↗

A controlled study of diflunisal in sprains and strains.

A preliminary double-blind, randomized trial was carried out in general practice to compare the efficacy of treatment with diflunisal (500 mg) twice daily and a combination of dextropropoxyphene (65 mg) plus paracetemol (650 mg) 3-times daily for 3 days in relieving pain associated with strains and sprains. Analysis of the results from 51 patients showed that both treatments were equally effective in releiving spontaneous pain and pain on movement after 1 and 3 days, and there were no differences between the two groups in patients' overall evaluation of treatment or physicians' assessment of therapeutic response. Both treatments were well tolerated during the short-term period of the trial.

Acetaminophen↗