Between-lot and within-lot comparisons of bioavailability of macrocrystalline nitrofurantoin capsules.

Comparative bioavailability studies should be designed and the resulting data evaluated based on estimates of both intersubject and intrasubject variances in the kinetic parameters for the particular drug products(s) being studied. This report presents the results of two comparative bioavailability studies. In the first study, three production lots of macrocrystalline nitrofurantoin capsules (Macrodantin) were compared in 21 subjects, and in the second study, capsules from one production lot were administered to 21 different subjects on three occasions. Both model-independent kinetic parameters for urinary excretion and a one-compartment model with zero-order absorption were used to evaluate both the rate and the extent of bioavailability. Overall the results showed a very low variance between and within production lots and a relatively large intersubject variance in the rate and extent of absorption.

Furazolidone for treatment of diarrhoeal disease.

PIP: Furazolidone, a synthietic nitrofuran, is active against a broad spectrum of bacteria and Giardia lamblia. Since 1954, furazolidone has been used almost exclusively for the specific and symptomatic treatment of infectious diarrheal diseases. Diarrheal disease is the leading cause of death of children and a major contributing factor of malnutrition in the developing world. It can be avoided with proper water and waste treatment, personal hygiene, and food preparation. The most critical aspect of treating acute diarrhea is maintaining optimal hydration and electrolyte balance. Fluid and electrolyte replenishment must constitute the 1st line of therapy. Antimicrobial therapy, however, improves the outlook further. Effective antimicrobials reduce the average duration of illness and the likelihood of relapses, complications and death. The ideal antimicrobial for treating acute diarrhea is a single broad-spectrum antimicrobial agent of low toxicity that would be effective for empirical treatment of acute diarrheal disease. During 30 years of clinical use worldwide, the effectiveness of furazolidone has shown to be comparable or superior to that of other drugs used to treat these diseases. Because furazolidone has fairly low toxicity, it is a relatively safe drug. The most common reaction appears to be gastrointestinal distress, though dizziness, drowsiness, headaches, and general malaise have also been reported. A drug that acts specifically on its target is generally preferable to one with less specific activity. Furazolidone inhibits a variety of bacterial enzymes, an activity that minimizes the development of resistant organisms. Furazolidone is a single, broad-spectrum antimicrobial that is effective, relatively safe, specific, and is orally administered in tablet or suspension form.^ieng

The use of furoxone: a perspective.

Acute infectious diarrhoea is a widespread cause of morbidity and mortality. Some of the major diarrhoeal diseases are cholera, typhoid fever, shigellosis (bacillary dysentery), salmonellosis, "travellers' diarrhoea", and giardiasis These diseases can be avoided with proper education, sanitation, and hygiene. However, the majority of these diseases occur most frequently in areas of the world where political and social upheaval, poverty, overcrowding, and a lack of education prevail. Although vaccines are available for some of the diseases, they are not completely effective. Antimicrobial therapy is effective in decreasing the duration and severity of diarrhoea and in reducing the likelihood of relapses, complications, and death. An antimicrobial drug for the treatment of acute infectious diarrhoeal disease must be relatively specific, effective, and safe, and it should not promote the development of resistant bacteria. Furazolidone (Furoxone) has been used for 30 years for the specific and symptomatic treatment of bacterial or protozoal diarrhoea and enteritis caused by susceptible organisms. Its effectiveness has often been shown to be comparable or superior to that of other drugs. In addition, the toxicity of furazolidone is relatively low, and it minimizes the development of resistant organisms. These characteristics should contribute to the continued use of furazolidone as a rational choice in the treatment of acute infectious diarrhoeal diseases that occur worldwide.

Evaluation of bismuth subsalicylate in relieving symptoms of indigestion.

The efficacy of bismuth subsalicylate in relieving the symptoms of indigestion was evaluated in a randomized, placebo-controlled, double-blind, cross-over study in 48 adults. Each patient was treated for six episodes of indigestion, three episodes with bismuth subsalicylate and three with placebo. Volunteers took 30 ml when the symptoms first occurred and repeated the dose every half hour, as needed, for eight doses. The volunteers rated the severity of each symptom 15 and 30 minutes after each dose. Overall relief was achieved faster and in a higher proportion of cases in bismuth subsalicylate-treated episodes than in placebo-treated episodes. Bismuth subsalicylate provided greater and faster relief than placebo for nausea, sense of fullness, heartburn, feeling of abdominal distention, and flatulence, but not for upper abdominal pain.

Foetal safety of nitrofurantoin macrocrystals therapy during pregnancy: a retrospective analysis.

Urinary tract infection during pregnancy poses increased risk to mother and foetus and warrants prompt detection and treatment. Currently, there are no antibacterials approved for use in pregnant women. A retrospective analysis was undertaken to evaluate the safety to the human foetus of nitrofurantoin macrocrystals (Macrodantin) when administered during pregnancy. The records of ninety-one pregnancies in eighty-one obstetric patients who were treated with nitrofurantoin macrocrystals for urinary tract infection were reviewed. Safety was assessed according to incidence of foetal death, neonatal death, malformation, prematurity, low birth weight, low Apgar score and jaundice. The incidence of abnormal events in the pregnancies evaluated was not significantly different from that in the United States population. No abnormal event was considered to be drug-related. This study yielded no evidence that would implicate nitrofurantoin macrocrystals as toxic to the foetus or unsafe for treatment of maternal urinary tract infection during pregnancy.