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  • 1
    Electronic Resource
    Electronic Resource
    Placental transfer of pethidine and norpethidine and their pharmacokinetics in the newborn (1980)
    Springer
    European journal of clinical pharmacology 18 (1980), S. 25-30 
    Details
    ISSN: 1432-1041
    Keywords: pethidine ; norpethidine ; placental transfer ; pharmacokinetics ; newborns
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The literature data available on pethidine and norpethidine kinetics in women in labour and in their newborns is reviewed and compared with recent personal observations. In pregnant women the apparent blood half-life of pethidine is not different from that in healthy controls, however, apparent volume of distribution and total body clearance are reduced. Norpethidine blood levels are measurable after 10–20 min and tend to increase with time. The amount of drug transferred to the foetus is clearly linked to the dose administered to the mother, the dosing-delivery interval and to the metabolic capability of the mother. An equilibrium between maternal and umbilical venous blood is reached 2–3 h after dosing for pethidine and later for norpethidine. In the neonate, the apparent pethidine half-life is 2 to 7 times longer than in adults with values ranging from 7 to 32 h. Norpethidine is actively formed in the newborn with peak blood levels at 12–36 h and an apparent blood half-life of 20–36 h. At the doses usually recommended blood concentrations at birth are frequently higher than those required for analgesia and close to or within toxic ranges. An effort toward a more individualized dosage as well as toward a better understanding of the possible role of norpethidine with regard to adverse effects is needed.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00561475
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  • 2
    Electronic Resource
    Electronic Resource
    Effectiveness and pharmacokinetics of indomethacin in premature newborns with patent ductus arteriosus (1980)
    Springer
    European journal of clinical pharmacology 18 (1980), S. 83-88 
    Details
    ISSN: 1432-1041
    Keywords: patent ductus arteriosus ; indomethacin ; premature newborns ; pharmacokinetics ; side effects
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary A review of the published data on pharmacological closure of PDA in premature newborns shows that doses of 0.2 mg/kg indomethacin are less successful when given enterally (18 to 85% closure) than when given intravenously (88 to 90% closure). The elimination half-life is markedly prolonged in premature newborns compared to adults but there are wide differences between the patients and some discrepancies between mean values reported by various authors. The present study compares clinical and pharmacological results obtained in two groups of low birth weight infants with symptomatic PDA and treated with 0.2 mg/kg indomethacin: 7 patients treated enterally (group A) and 11 patients treated intravenously (group B). Permanent closure of the ductus was observed in 4 cases in group A and in 9 cases in group B. Transient closure was observed twice in each group. Of a total of 18 infants, 15 were saved (83%). One baby treated with indomethacin in spite of preexisting oliguria died from persistent anuria. Indomethacin plasma levels were measured by gas chromatography. The mean elimination half-life of the drug in group A (40.3±12.2 h) did not differ from that in group B (33.9±11.7 h). The apparent plasma half-life appears to be inversely correlated with gestational age (r=0.66,p〈0.05). No relationship between peak plasma levels and ductal closure was established, but a significant difference was found for area under the curve (0 to 24 h) between patients in whom a permanent closure was obtained and those in whom the closure was either transient or absent.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00561483
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  • 3
    Electronic Resource
    Electronic Resource
    To nurse when receiving acebutolol: Is it dangerous for the neonate? (1986)
    Springer
    European journal of clinical pharmacology 30 (1986), S. 737-739 
    Details
    ISSN: 1432-1041
    Keywords: acebutolol ; neonates ; beta-blocking agents ; perinatal pharmacology ; excretion in milk ; transplacental passage ; diacetolol ; neonatal beta-blockade
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The concentrations of acebutolol and of its main active metabolite diacetolol in milk and plasma were studied in 7 hypertensive mothers treated with acebutolol, a cardioselective β-adrenoceptor blocking agent. Clinical monitoring on their newborn babies was also done, as well as measurement of plasma level of the drug in them. The ratio between milk and plasma concentrations ranged from 1.9 to 9.2 for acebutolol and from 2.3 to 24.7 for diacetolol, and in any given milk sample, the diacetolol concentration was always higher than that of acebutolol. In a newborn infant, plasma concentrations of the two transplacentally acquired substances was raised when breast feeding started and remained high. Clinical signs of pharmacological β-blockade were observed. Evaluation of the iatrogenic risk shows that pharmacologically active amounts of acebutolol might be received by a neonate if the daily maternal dosage exceeds 400 mg/day and/or renal function in the mother is impaired.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00608227
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  • 4
    Electronic Resource
    Electronic Resource
    Placental transfer and perinatal pharmacokinetics of betaxolol (1990)
    Springer
    European journal of clinical pharmacology 38 (1990), S. 477-483 
    Details
    ISSN: 1432-1041
    Keywords: Betaxolol ; Milk ; Neonates ; Placental Transfer ; Pharmacokinetics
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Betaxolol levels in blood were monitored in the perinatal period in 28 pregnant hypertensive women and in their babies. In the mothers betaxolol concentrations at delivery ranged from 〈1 to 115 ng · ml−1 after doses of 10 to 40 mg · day−1. The apparent blood half-life was 15.6 to 22.1 h mean (19 h). Umbilical cord levels indicated a rapid equilibrium between fetal and maternal units (ratio 0.93) within few hours after dosing. Milk betaxolol concentrations, measured in few cases, exceeded those in blood by a factor of 3. Amniotic fluid concentrations were similar to those observed in maternal venous blood and umbilical cord blood. In neonates, the blood betaxolol half-life ranged from 14.8 to 38.5 h, with a definite trend towards a negative correlation with gestational age. A 11–61% rise in the betaxolol concentration was observed in 64% of the neonates during the first 12 h of extrauterine life. The data indicate that betaxolol kinetics is not altered in pregnant women and they stress the need for careful and prolonged (72–96 h) intensive monitoring of neonates born to hypertensive mothers treated with β-blocking agents.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF02336687
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  • 5
    Electronic Resource
    Electronic Resource
    Betaxolol: a pilot study of its pharmacological and therapeutic properties in pregnancy (1990)
    Springer
    European journal of clinical pharmacology 38 (1990), S. 535-539 
    Details
    ISSN: 1432-1041
    Keywords: betablockers ; betaxolol ; hypertensive pregnancy ; foetus ; newborn
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Twenty two pregnant women with mild to moderate hypertension were treated with betaxolol (10–40 mg/day), a cardioselective beta adrenoceptor blocking agent. The analysis of the changes from the baseline confirmed the antihypertensive effect of the drug with a mean decrease in SBP of 11.8 mm Hg and in DBP of 8.3 mm Hg. A diastolic BP 〈 90 mm Hg was obtained in 20 patients after the first day of therapy. Fetal safety, assessed by ultrasonography and cardiotocographic recording was excellent. The 22 mothers gave birth to 23 live born babies (one twin pregnancy). Mean Apgar scores were 8.3 and 9.1 at 1 and 5 min. Only 1 newborn had an Apgar score 〈 7. Three newborns suffered from fetal distress and 1 from threat for causes not related to therapy. At 9 months follow-up, all 23 babies were in good health. These data suggest that betaxolol is effective in reducing maternal blood pressure without any deleterious effect on the foetus and the newborn.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00278577
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  • 6
    Electronic Resource
    Electronic Resource
    Population approaches in drug development (1994)
    Springer
    European journal of clinical pharmacology 46 (1994), S. 389-391 
    Details
    ISSN: 1432-1041
    Keywords: Population approach ; Drug development ; software ; pharmacokinetics ; pharmacodynamics
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract An expert meeting to discuss population pharmacokinetic/pharmacodynamic software was held in Brussels in November 1993 under the auspices of the European Co-operation in Science and Technology (COST), Medicine (B1) programme. Recently developed statistical methods offer the possibility of gaining integrated information on pharmacokinetics and response from relatively sparse observational data obtained directly in patients who are being treated with the drug under development. These methods can minimize the need to exclude patient groups and also allow analysis of a variety of unbalanced designs that frequently arise in the evaluation of the relationships between dose or concentration on the one hand and efficacy or safety on the other relationships that do not readily lend themselves to other forms of statistical analysis. The purpose of the Brussels meeting was to evaluate the state of both existing software and software under development, and to specify the needs and wishes of potential users of such software. It was apparent from the meeting that software development for population data analysis is currently a very active area of investigation and that several very good packages are already available, with more in development. The general consensus of the meeting was that well validated, easy to use software was essential to the implementation of the population approach to drug development.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00191898
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  • 7
    Electronic Resource
    Electronic Resource
    Pharmacokinetics of furosemide in neonates (1982)
    Springer
    European journal of clinical pharmacology 22 (1982), S. 39-45 
    Details
    ISSN: 1432-1041
    Keywords: furosemide ; neonates ; kinetics ; placental transfer ; intravenous therapy
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The pharmacokinetics of furosemide was evaluated in 12 newborns who received the drug transplacentally, and in 21 neonates who received it directly for therapeutic reasons. In the first group, the apparent plasma half-lives ranged from 96 to 6.8 h with a significant inverse relationship (p〈0.01) between the gestational age and the elimination rate. In two cases a clear effect on diuresis was also observed. In the neonates receiving the drug i.v. for therapeutic reasons, the elimination kinetics appeared to follow a two-compartment open model, with a significant difference in the therminal plasma half-life between premature (26.8±12.2 h) and full-term newborns (13.4±8.6 h). In this group no relationship was observed between elimination rate and either gestational or conceptional age. In the case of repeated administration, an increase in plasma clearance and reduction in t1/2 β was noticed.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00606423
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  • 8
    Electronic Resource
    Electronic Resource
    Pharmacokinetics of diltiazem after intravenous and oral administration (1983)
    Springer
    European journal of clinical pharmacology 24 (1983), S. 349-352 
    Details
    ISSN: 1432-1041
    Keywords: diltiazem ; pharmacokinetics ; intravenous dose ; oral dose
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The kinetic profile of diltiazem, a novel calcium antagonist, was studied in 12 volunteers following oral (60 mg) and intravenous (15 mg) administration. After i.v. administration biphasic elimination was observed, with a distribution half-life of 0.3±0.2 h and an elimination half-life of 3.1±1.0 h; the apparent volume of distribution was 5.3±1.71/kg and the total clearance was 1.28±0.48 l/kg/h. After the oral dose the elimination phase had a half-life of 3.2±1.3 h. The absolute bioavailability of diltiazem ranged from 24 to 74% (mean 42±18%). The interindividual variation may be explained by a variable first pass effect.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00610053
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  • 9
    Electronic Resource
    Electronic Resource
    Treatment of persistent fetal circulation syndrome of the newborn. Comparison of different doses of tolazoline (1987)
    Springer
    European journal of clinical pharmacology 31 (1987), S. 569-573 
    Details
    ISSN: 1432-1041
    Keywords: tolazoline ; neonates ; persistent fetal circulation ; pharmacodynamic effects ; pharmacokinetics ; pulmonary circulation
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The effects of two doses of tolazoline have been compared in 2 groups of newborns suffering from the persistent fetal circulation syndrome. The effects on PaO2 and AaDO2 were similar in the 2 groups who received either a bolus of 1 or 0.5 mg·kg−1 tolazoline, followed by a continuous infusion of 1 or 0.5 mg·kg−1·h−1. The observed changes did not differ significantly from those previously observed in babies treated with 2 mg·kg−1. A rise in PaO2 and a reduction in AaDO2 were usually observed shortly after the bolus injection and at plasma levels between 1.5 and 4 µg·ml·−1. A progressive rise in plasma level over time occurred after 1 mg·kg−1 (and in the previous study of 2 mg) but not with 0.5g/kg tolazoline. The elimination half-life of tolazoline in 6 patients was 5 to 13 h. The data suggest that continuous infusion of tolazoline is not necessarily required and that the dose of 0.5 mg/kg is more appropriate and safer than the higher doses usually proposed.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00606632
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  • 10
    Electronic Resource
    Electronic Resource
    Plasma protein binding of alpidem in healthy volunteers, in neonates and in liver or renal insufficiency (1989)
    Springer
    European journal of clinical pharmacology 37 (1989), S. 29-32 
    Details
    ISSN: 1432-1041
    Keywords: alpidem ; cirrhotics ; anxiolytics ; placental serum ; renal failure ; plasma protein binding ; neonates
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The binding of alpidem, a new anxiolytic drug, has been studied in plasma from 6 healthy subjects, 12 patients with renal failure, 12 patients with liver cirrhosis and 12 chronic uraemics maintained on haemodialysis, as well as in 12 serum samples from the placental cord, to represent the situation in the newborn. The unbound fraction was 0.61% (healthy volunteers), 1.31% (newborns), 0.86% (cirrhotic patients), 0.72 (patients with renal failure), 0.70% (before haemodialysis) and 0.79% (after haemodialysis). Binding in the volunteers was significantly different from that in neonates and cirrhotics only. Alpidem became bound to isolated albumin (45 g·l−1) and alpha1-acid glycoprotein (0.75 g·l−1) to 97.2% and 97.1%, respectively. The bound fraction of the drug in a mixture of two proteins was 99.1%. For alpidem, it appears that alpha1-acid glycoprotein may balance the effect of any decrease in the albumin concentration.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00609419
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