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At least 19 recordsLinked to original sources
PubMed1987

Trometamol-fosfomycin (Monuril) bioavailability and food-drug interaction.

A new water-soluble monobasic salt of fosfomycin with trometamol has recently been developed for oral administration. The objective of this study was to evaluate the pharmacokinetics of trometamol-fosfomycin (Monuril) in serum and in urine in 10 healthy volunteers after oral administration of one single dose (50 mg/kg). In the same volunteers the concentrations of fosfomycin were measured before and after food absorption, in serum and urine samples taken at t = 0, 2, 4, 6, 8 and 24 h after the dose (plus 0.5 and 1 h for serum samples). The measurement of fosfomycin levels was carried out by means of a microbiological procedure using Proteus mirabilis ATCC 21100 as test organism. The results indicated at 2 or 4 h serum peak levels ranging from 9 to 28 micrograms/ml, with mean values of about 17-21 micrograms/ml. The urine concentrations reached 2,000-2,500 micrograms/ml at 2 h, with high levels maintained till the 8th hour (1,200-2,750 micrograms/ml) and persistence of noticeable concentrations at 24 h (100-700 micrograms/ml). The influence of food absorption, even variable, decreased significantly the rate of absorption, with lower serum and urine levels, as measured in the same volunteers. Taking into account this factor influencing the bioavailability and the distribution of the drug, the results of the study confirm that a high proportion of the oral dose of trometamine salt of fosfomycin is absorbed; the extremely high urinary recovery of the drug even after food administration could certainly allow short-course therapy or even single-dose therapy in the treatment of uncomplicated urinary tract infection.

Administration, Oral↗
PubMed1987

[Fosfomycin-trometamol (monuril): pharmacokinetics and food-drug interactions].

A new water soluble monobasic salt of fosfomycin with trometamol has been recently developed for oral administration. The objective of this study was to evaluate the pharmacokinetics of trometamol-fosfomycin (monuril) in serum and urine in 10 healthy volunteers after oral administration of one single dose (50 mg/kg). In the volunteers, the concentrations of fosfomycin were measured before and after food absorption in serum and urine samples taken at t = 0, 2, 4, 6, 8, 24 h after the dose (plus 0.5 hand 1 h for serum samples). The measurement of fosfomycin levels was carried out by means of a microbiological procedure using Proteus mirabilis ATCC 21100 as test organism. The results indicated at 2 h after oral administration of the antibiotic, a mean serum peak level of 21.04 +/- 6.88 micrograms/ml. The urine concentrations reached 2,000 to 2,750 micrograms/ml at the 2nd hour, with high levels (mean: 1,876 +/- 709 micrograms/ml) till the 8th hour and persistence of noticeable concentrations at 24 h (334 +/- 210 micrograms/ml). The influence of food absorption, even variable, decreased significantly the rate of absorption with lower serum and urine levels. Taking into account this factor influencing the bioavailability and the distribution of the drug, the results of the study confirm that a high proportion of the oral dose of trometamine salt of fosfomycin is well absorbed; the extremely high urinary recovery of the drug could certainly allow short course therapy in the treatment of uncomplicated urinary tract infection.

Administration, Oral↗
PubMed1976

Food-drug interactions and interference.

Examples are given of interactions between foods and drugs, some of which may on occasion produce adverse effects. Such interactions are not as frequent and rarely as significant as interactions between drugs, which have become of increasing interest and importance.

Anti-Bacterial Agents↗
PubMed1989

[Influence of sucrose on aspirin ulcer].

UNLABELLED: At the present stage of drug interactions, little has been studied on food-drug interactions. Excess intake of sucrose is well known to cause arteriosclerosis, obesity, diabetes mellitus, toxicity to blood cells, dental caries, and accumulations of metabolic products in blood. Under the such conditions, it is possible that the ulcerogenic drugs, such as synthetic anti-inflammatory drugs, may cause severe gastric lesions by oral administration. The present investigation was undertaken to study the influences of sucrose on the gastric lesions induced by aspirin (aspirin ulcer) in rats maintained with 10% sucrose solution. Thus, the effect of sucrose on aggressive and protective factors, proposed by Shay and Sun, was studied. METHOD: Sixty rats were maintained with 10% sucrose solution ad libitum as drinking solution for 4 weeks (10% sucrose group). As control, purified water was given ad libitum to 60 rats (control group). Rats were starved for 24 hours, but allowed free access of water before the experiment, and then were subjected to the following experiments: (1) Twenty rats from each group were treated to prepare pylorus-ligated rats. Aspirin in 1% CMC (100mg/kg body-weight) was given in 10 rats from each group immediately after the ligation. Gastric juice excreted during 6 hours was collected and its supernatant (1,500 x g) was used for determinations of pH, acidity, acid output, pepsin activity, and pepsin output. Aspirin and salicylic acid contents in gastric juice were also determined by HPLC. (2) The mucosa of the stomach of (1) were subjected to the analysis of hexosamine. Twenty rats from each group without pylorus-ligation were also used for the analysis. Among them, 10 rats from each group were given aspirin in 1% CMC with the dose of 300 mg/kg body-weight. (3) Ten rats from each group were given aspirin with the dose of 300 mg/kg body-weight and the stomach (n = 10 for each group) was extracted 30 minutes after the aspirin administration for histochemical study to obtain covering mucus index, epitherial mucus index, total mucus index, and rate of mucous injury. (4) Aspirin in 1% CMC was given to 10 rats of each group with the dose of 300 mg/kg body-weight. Rats were sacrificed 6 hours after the administration of aspirin, and then stomachs were extracted and treated with 10% neutral formalin. The length of lesions was measured under a microscope (x 10), and then Ulcer Index was obtained.(ABSTRACT TRUNCATED AT 400 WORDS)

Animals↗
PubMed1985

Therapeutic effects of drug-nutrient interactions in the elderly.

The elderly are the major drug users both because they need specific prescription drugs for control of chronic diseases and because they make excessive use of over-the-counter (OTC) drugs. Therapeutic drugs that are required may be discontinued because the individuals suffer side effects or because the drug is ineffective. Adverse drug reactions in the elderly may result from drug overuse or misuse, slowed drug metabolism or elimination secondary to aging or to age-related chronic disease, intake of alcohol, food-drug incompatibilities, or nutrient-drug interactions. The timing of drug intake in relation to food intake is an important determinant of therapeutic efficacy in the elderly. Food-drug interactions in the gastrointestinal tract may reduce drug absorption. Enteral formula feeding may also interfere with drug absorption. Conversely, absorption of certain drugs (e.g., thiazides) may be promoted by meal-induced slowing of gastric emptying time. Therapeutic diet prescription can influence drug responses in the elderly because the protein composition of the diet influences the rate of drug metabolism. Nutrient depletion secondary to the effect of drugs may be recognized as an important and often avoidable type of adverse drug reaction.

Aged↗
PubMed1982

Food and drug interactions.

A significant contribution could be made to patient care if nutritional biochemists, basic and clinical toxicologists, and pharmacologists in the various fields were to mount the studies needed to understand the nature of food-drug interactions. If only a small fraction of the 120 billion dollars per year spent for food or the 10 billion dollars expended for drugs were allocated for research in this area, advances might be made for the health of the nation. Changes in man's diet produce marked effects on drug metabolism. We know that changing a customary diet to one high in protein and low in carbohydrate increases the rates of metabolism of antipyrine and theophylline, and shifting to an isocaloric diet of low protein-high carbohydrate slows the rates of metabolism of these drugs. Presumably, high-protein-low carbohydrate diets in man resemble the animal studies with high protein diets that show enhanced hepatic drug metabolism. However, numerous studies emphasize the considerable individual variability to changes in human diets; some people have dramatic changes, whereas others exhibit little or no response. Similar individuality has been found in the response to enzyme induction by smoking. Numerous foods and food ingredients affect drug metabolism in human beings and apparently follow the same patterns as found in experimental animal studies with changes in the levels of cytochrome P-450 dependent monooxygenases in the liver and intestine. These changes presumably exert some protective action against environmental carcinogens, cocarcinogens, or promoters. Dietary modifications are brought about by use of weight-reducing diets, vegetarian diets, hospitalization, or post-operative regimens. These diets are often continued for long periods of time and it is likely they result in changes in the metabolism by the body of subsequently administered drugs or exposure to environmental chemicals. Methods are needed to measure inter-individual and inter-group differences in metabolism of foreign compounds in order to accurately assess dietary influences on drug metabolism and vice versa. Epidemiologic studies of rigorously selected human populations, coupled with the newer sensitive chemical analytical methods, will provide the necessary data base for these investigations.

Animals↗
PubMed1978

The role of biogenic amines in foods.

Biologically active amines are normal constituents of many foods for example cheese, plant foods and wines. These low molecular weight organic based do not represent any hazard to individuals, unless large quantities are ingested or natural mechanism of their catabolism are inhibited. Investigations were performed concerning the histamine and tyramine content of the Hungarian made cheese, domestic vegetables, fruits and some other foods. In this paper we should like to draw the attention to the problems of amines from the point of view of food hygiene and food-drug interactions.

Biogenic Amines↗
PubMed1990

Moclobemide (Ro 11-1163) safety in depressed patients.

Safety aspects were compared in 2203 patients given moclobemide and 1214 who received other antidepressants or placebo. A total of 2294 adverse events were reported by patients on moclobemide, mainly subjective symptoms (28.6%). Adverse events such as dry mouth, tremor, sweating, dizziness and constipation occurred much more frequently among 681 patients treated with various tricyclic antidepressants than in the 694 moclobemide patients with whom they were compared. Among 271 placebo-treated patients there were 287 adverse events, compared with 386 events in the 285 moclobemide patients in the same studies. Hypertensive episodes or food-drug interactions were reported by 19 patients on moclobemide and 5 on other antidepressants, but in only 2 of the former was ingestion of cheese a possible cause of headache. The assessment of tolerance on moclobemide was essentially the same as for placebo. Of the 1401 moclobemide patients in the electronic database, only 3.2% stopped treatment prematurely because of poor tolerance; the rates were higher for tranylcypromine, nomifensine, desipramine, clomipramine, amitriptyline and imipramine. During treatment, 6 patients attempted suicide with moclobemide alone (950-2000 mg) or together with imipramine (300 mg and 1200 mg). None of the intoxications was life-threatening.

Antidepressive Agents↗
PubMed1987

The influence of food on the bioavailability of a slow release theophylline preparation.

Food-induced changes in the absorption of Theostat 300, a controlled release formulation of theophylline, have been studied in healthy volunteers. This open, randomised, 3-way, single-dose study involved 12 volunteers who received the drug either while fasting, or with a standardised low-fat (10g), or high-fat (60g) breakfast. Each subject was studied over a 3-week period, with 3 separate days of oral treatment and a 7-day washout period between treatments. The results showed no differences in AUC0-24 and tmax values between the 3 kinds of diet. The only differences observed concerned absorption. Food intake increased Cmax values by 20%. The steady-state peak concentration obtained by means of simulated plasma levels was not influenced by food intake. This slight food-drug interaction of Theostat 300 seemed to be of no clinical significance.

Adult↗
PubMed1995

Isolation of syncytial microvillous membrane vesicles from human term placenta and their application in drug-nutrient interaction studies.

The initial step in placental uptake of nutrients occurs across the syncytial microvillous membrane of the trophoblast. This study was designed to isolate syncytial microvillous membrane vesicles (SMMV) of human term placenta, to validate their purity and viability, and to investigate the interaction of several commonly used drugs with the transport of two essential nutrients: alanine and choline. SMMV were isolated according to an established procedure, but instead of homogenization the initial preparation step was replaced by mincing of placental tissue followed by gently stirring to loosen the microvilli. These modifications doubled the protein recovery and increased the enrichment in alkaline phosphatase, whereas no substantial contamination with basal membranes nor interfering subcellular organelles was found. The functional viability of the vesicles was evaluated through the transport of alanine. In accordance with literature, uptake was sodium-dependent, inhibitable by structural analogues, and saturable. A number of cationic drugs were were able to able to inhibit choline uptake, whereas no effect on alanine transport was observed. Anionic drugs, drugs of abuse, and catecholamines did not interfere with alanine transport either. In conclusion, our isolated SMMV provide a suitable tool for screening drug-nutrient interactions at the level of membrane transport. In view of the very low susceptibility of the alanine transporter to drug inhibition and the relatively high drug concentrations necessary to inhibit choline transport, it seems unlikely that clinically important drug interactions may occur with these nutrients.

Alanine↗
PubMed2026

Effect of Food on Balcinrenone/Dapagliflozin Pharmacokinetics and the Pharmacokinetics of Balcinrenone When Dosed with a P-gp Inhibitor.

Balcinrenone (AZD9977) is a novel selective non-steroidal mineralocorticoid receptor antagonist with a distinct mode of action being developed as a fixed-dose combination with the sodium-glucose cotransporter-2 inhibitor dapagliflozin for the treatment of heart failure with impaired kidney function, and chronic kidney disease. In this Phase 1 randomized open-label three-way crossover study we investigated the effect of food on balcinrenone/dapagliflozin pharmacokinetics, and the pharmacokinetics of balcinrenone when dosed with a P-glycoprotein (P-gp) inhibitor. Fourteen healthy participants were administered an oral capsule of balcinrenone/dapagliflozin 40 mg/10 mg in three dosing periods: fasted (reference), fed (high-fat, high-calorie meal) and with a P-gp inhibitor (quinidine 300 mg &#xd7; 2). Balcinrenone exposure was comparable in the fed and fasted states (geometric mean ratios [GMRs] [90% CI]: maximum plasma concentration [Cmax] 1.05 [0.88, 1.25]; area under the plasma concentration-time curve from time 0 to infinity [AUCinf] 1.12 [1.06, 1.19]). In the fed state, dapagliflozin AUCinf was comparable to the fasted state (GMR [90% CI] 1.05 [1.01, 1.09]), whereas Cmax was decreased (GMR [90% CI] 0.59 [0.51, 0.69]), in line with previous dapagliflozin food interaction studies. Co-administration with quinidine increased balcinrenone exposure: GMRs (90% CI) 1.48 (1.24, 1.76) and 1.24 (1.17, 1.31) for Cmax and AUCinf, respectively, but AUC fold increase was <2, the level used for classification of sensitive P-gp substrates. All interventions were well tolerated. In conclusion, this study supports dosing of balcinrenone/dapagliflozin without regard to food. Balcinrenone is not considered a sensitive P-gp substrate. No P-gp based dosing precautions are warranted based on this study.

Adult↗
PubMed2026

Safety, tolerability, pharmacokinetics, and pharmacodynamics of oral JMKX003002 in Chinese healthy participants: a randomized, double-blind, placebo-controlled, single- and multiple-ascending dose, and food-effect phase I clinical trial.

OBJECTIVE: To evaluate the safety, tolerability, pharmacokinetics (PK), and pharma-codynamics (PD) of the sodium-hydrogen exchanger 3 (NHE3) inhibitor JMKX003002 in Chinese healthy participants. PATIENTS AND METHODS: This phase I, randomized, double-blind, placebo-controlled study included a single-ascending dose (SAD) study with seven cohorts (1&#x2009;mg [n&#x2009;=&#x2009;4] and 5, 20, 50, 75, 100, or 125&#x2009;mg [n&#x2009;=&#x2009;8]), a food-effect (FE) study with six sequence groups (25&#x2009;mg twice daily, n&#x2009;=&#x2009;4), and a multiple-ascending dose (MAD) study with two cohorts (10&#x2009;mg or 20&#x2009;mg twice daily, n&#x2009;=&#x2009;10). RESULTS: JMKX003002 was well-tolerated, with mostly mild treatment-related adverse events. One Grade 3 diarrhoea occurred in each of the 50&#x2009;mg and 125&#x2009;mg groups. No serious adverse events were reported, and no participants discontinued or withdrew due to treatment-emergent adverse events. Most plasma samples were below the limit of quantification (0.2&#x2009;ng/mL), with only transient detection of low concentrations, indicating low systemic exposure. JMKX003002 was primarily excreted in&#xa0;stool (79.9% recovered) and was undetectable in urine. The PD results consistently showed decreased urinary sodium and phosphorus, along with increased stool sodium and phosphorus, compared to baseline across all three studies. One day after discontinuation, stool sodium and phosphorus remained elevated relative to baseline in the MAD study. Mixed-effects model analysis in the FE study demonstrated significant food effect on stool sodium and phosphorus excretion. CONCLUSION: JMKX003002 exhibited favorable safety and tolerability with minimal systemic exposure. It effectively increased sodium and phosphorus excretion in stool. These promising findings warrant further investigation of JMKX003002 to evaluate its clinical benefits. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2300070473). Registered on April 13, 2023; prospectively registered.

Adult↗
PubMed1995

Influence of food on the bioavailability of oral methotrexate in children.

OBJECTIVE: To determine the bioavailability of oral methotrexate (MTX) in patients with juvenile rheumatoid arthritis in the fasting and fed states. METHODS: Each patient randomly received their usual weekly MTX dose either orally (po) after an overnight fast, po immediately after a breakfast of their choice, or intravenously (iv) on 3 consecutive weeks. Blood samples were taken at 0, 0.5, 1, 1.5, 2, 3, 4, and 6 h after po and 0, 0.08, 0.25, 0.5, 1, 1.5, 2, 3, 4, and 6 h after iv administration. RESULTS: Fourteen patients (10 female) aged 2.8 to 15.1 yrs completed the study; the results of 13 patients were evaluable. The mean elimination rate constant was 0.27 +/- 0.065, 0.26 +/- 0.067, and 0.25 +/- 0.11 h-1 after po fasting, po fed, and iv administration, respectively. The total area under the serum concentration vs time curve was 1.87 +/- 0.83, 1.50 +/- 0.51, and 1.85 +/- 0.80 mumol/l.h after po fasting, po fed, and iv administration, respectively. The maximum serum MTX concentration (Cmax) was 0.65 +/- 0.33 and 0.39 +/- 0.18 mumol/l after po fasting and po fed administration, respectively (p = 0.0022). The time to Cmax was 0.94 +/- 0.40 and 1.32 +/- 0.68 h after po fasting and po fed administration, respectively (p = 0.1464). The bioavailability of oral MTX while fasting was 1.1 +/- 0.51, while that after a meal was 0.88 +/- 0.35 (p = 0.0211). CONCLUSION: These data indicate greater oral bioavailability of MTX in the fasting state. We recommend that children receive MTX on an empty stomach.

Administration, Oral↗
PubMed1995

Interaction between propranolol and amino acids in the single-pass isolated, perfused rat liver.

Propranolol (PL) bioavailability has been shown to increase substantially when it is administered with a protein-rich meal. A change in metabolic capacity or tissue uptake, induced by amino acids (AAs) released as a result of digestion of dietary protein, is a possible contributing mechanism to the food effect. This hypothesis was tested in isolated, perfused rat livers in the single-pass mode. Rac-PL (20 micrograms/ml) was infused to steady-state at 3 ml/min/g liver for 150 min. A balanced mixture of I-AA was coinfused from 70 to 110 min. The AA reversibly increased the steady-state concentration of PL by 18% and reduced steady-state concentrations of 4-hydroxypropranolol, N-deisopropylpranolol, PL glycol, naphthoxylactic acid, and naphthoxyacetic acid by an average of 41% and propanolol conjugates by almost 100%, indicating metabolic inhibition. In a second experiment, PL was coinfused with AAs from the beginning of the experiment, and tissue binding was compared with control livers. There was no significant effect of AAs on PL tissue binding. In a third study, the effect of four different concentrations of AAs coinfused from 70 to 110 min was assessed. The percentage change in PL and phase I metabolite levels was linearly correlated to the influent AA concentration. The large magnitude, reversibility, lack of pathway specificity, and concentration dependence of the AA interaction in the perfused liver are also features of food interaction in humans. These similarities constitute evidence that metabolic inhibition by AAs originating from dietary protein could contribute to the PL-food interaction.

Adrenergic beta-Antagonists↗