Nifedipine gastrointestinal therapeutic system (GITS) as an alternative to slow-release for tocolysis—Tolerance and pharmacokinetic profile

Juon, A M; Kühn‐Velten, W. Nikolaus; Burkhardt, Tilo; Krähenmann, Franziska; Zimmermann, Roland; Mandach, Ursula von

doi:10.1016/j.ejogrb.2008.02.003

Cited by 11 publications

(4 citation statements)

References 11 publications

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“…References for each column: intra-partum (5–23), late ante-partum (24–30), ARVs (31–46), other ID (47–57), vitamins/minerals (58–60), other medications (61–85) .…”

Section: Resultsmentioning

confidence: 99%

Obstetric Pharmacokinetic Dosing Studies are Urgently Needed

McCormack

Best

2014

Front. Pediatr.

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Use of pharmacotherapy during pregnancy is common and increasing. Physiologic changes during pregnancy may significantly alter the overall systemic drug exposure, necessitating dose changes. A search of PubMed for pharmacokinetic clinical trials showed 494 publications during pregnancy out of 35,921 total pharmacokinetic published studies (1.29%), from the late 1960s through August 31, 2013. Closer examination of pharmacokinetic studies in pregnant women published since 2008 (81 studies) revealed that about a third of the trials were for treatment of acute labor and delivery issues, a third included studies of infectious disease treatment during pregnancy, and the remaining third were for varied ante-partum indications. Approximately, two-thirds of these recent studies were primarily funded by government agencies worldwide, one-quarter were supported by private non-profit foundations or combinations of government and private funding, and slightly <10% were supported by pharmaceutical industry. As highlighted in this review, vast gaps exist in pharmacology information and evidence for appropriate dosing of medications in pregnant women. This lack of knowledge and understanding of drug disposition throughout pregnancy place both the mother and the fetus at risk for avoidable therapeutic misadventures – suboptimal efficacy or excess toxicity – with medication use in pregnancy. Increased efforts to perform and support obstetric dosing and pharmacokinetic studies are greatly needed.

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“…References for each column: intra-partum (5–23), late ante-partum (24–30), ARVs (31–46), other ID (47–57), vitamins/minerals (58–60), other medications (61–85) .…”

Section: Resultsmentioning

confidence: 99%

Obstetric Pharmacokinetic Dosing Studies are Urgently Needed

McCormack

Best

2014

Front. Pediatr.

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“…Recently, gastrointestinal therapeutic system (GITS) tablets have been compared with the classically used extended-release tablets in the context of PTL. 74 GITS 90-mg tablets were found to have a similar pharmacokinetic profile and a good tolerance. If these findings are reproduced in larger studies, GITS tablets might qualify as a better alternative to the slowrelease tablets considering the significantly less common occurrence of headaches in the GITS group, one of the most commonly described side effects with nifedipine use.…”

Section: Protocol For Dosing and Administration Of Nifedipine For Acumentioning

confidence: 94%

Calcium Channel Blockers for the Management of Preterm Birth: A Review

Nassar

Aoun²,

Usta³

2010

Amer J Perinatol

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Preterm birth continues to be the leading cause of perinatal morbidity and mortality. A wide range of tocolytics have been utilized for the management of preterm labor. Calcium channel blockers, namely nifedipine, gained popularity as tocolytics due to the oral route of administration, availability of immediate- and slow-release preparations, the low incidence of maternal adverse effects associated with their use, and the fact that they are inexpensive. This article reviews the available literature on the clinical utility of calcium channel blockers for acute and maintenance tocolysis with special emphasis on potential adverse effects, the most appropriate dose/regimen, and contemporary practice patterns among obstetricians. There are no randomized, placebo-controlled studies demonstrating the benefit of nifedipine in preterm labor. A suggested tocolytic protocol would be to start with the lowest dose of oral immediate-release nifedipine. For the first 48 hours thereafter, all attempts should be made not to exceed 60-mg daily doses.

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“…An alternative regimen consists of nifedipin 10 mg to chew, combined with 20 mg nifedipin slow release (Adalat CR Ò ) for a rapid saturation; after 60 min a maintenance dose of 60 mg nifedipin low release is given and 30 mg nifedipin slow release kept in reserve [34]. A maintenance dose of 90 mg nifedipin slow release (alternating 30 mg and 60 mg every 12 h) also was well tolerated [35,36]. Nifedipin can be combined with high dose magnesium sulfate (i.e., with preeclampsia) [37].…”

Section: Calcium Antagonistsmentioning

confidence: 99%

Tocolysis for preterm labor: Expert opinion

Hösli

Sperschneider

Drack

et al. 2014

Arch Gynecol Obstet

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Tocolysis is an important treatment in the improvement of outcome in preterm labor and preterm birth, provided that its use follows clear evidence-based recommendations. In this expert opinion, the most recent evidence about efficacy and side effects of different tocolytics is being reviewed and evidence-based recommendation about diagnosis and treatment of preterm labor is given. Further aspects such as progesterone administration or antibiotic treatment for the prevention of preterm birth are included. Our review demonstrates that an individualized choice of different tocolytics and additional treatments is necessary to improve short- and long-term neonatal outcome in preterm labor and preterm birth.

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Nifedipine gastrointestinal therapeutic system (GITS) as an alternative to slow-release for tocolysis—Tolerance and pharmacokinetic profile

Cited by 11 publications

References 11 publications

Obstetric Pharmacokinetic Dosing Studies are Urgently Needed

Obstetric Pharmacokinetic Dosing Studies are Urgently Needed

Calcium Channel Blockers for the Management of Preterm Birth: A Review

Tocolysis for preterm labor: Expert opinion

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