Effect of Silymarin on the Oral Bioavailability of Ranitidine in Healthy Human Volunteers

Rao, B Nageshwar; Maddi, Srinivas; Kumar, Y. Shravan; Rao, Yi

doi:10.1515/dmdi.2007.22.2-3.175

Cited by 17 publications

(11 citation statements)

References 8 publications

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“…In contrast, milk thistle did not alter the pharmacokinetics of nifedipine [179], digoxin [180], indinavir [181], rosuvastatin [182], debrisoquine [183], ranitidine [184], and midazolam [185] in humans. It appears milk thistle does not affect the activity of CYP3A4 and P-gp in vivo.…”

Section: Irinotecan + Milk Thistlementioning

confidence: 78%

Herbal Interactions with Anticancer Drugs: Mechanistic and Clinical Considerations

Yang

Liu

et al. 2010

CMC

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A large number of herbal remedies (e.g. garlic, mistletoe, Essiac, Lingzhi, and astragalus) are used by cancer patients for treating the cancer and/or reducing the toxicities of chemotherapeutic drugs. Some herbal medicines have shown potentially beneficial effects on cancer progression and may ameliorate chemotherapy-induced toxicities. However, there is no or weak scientific basis for the clinical use of these herbal medicines in cancer management and almost none of these plant medicines have been tested in rigorous clinical trials. There are increased reports on the interaction of herbal medicines and anticancer drugs that is becoming a safety concern. For example, a clinical study in cancer patients reported that treatment of St John's wort at 900 mg/day orally for 18 days decreased the plasma levels of the active metabolite of irinotecan, SN-38, by 42%. In healthy subjects, 2 weeks of treatment with St John's wort at 900 mg/day significantly decreased the systemic exposure of imatinib by 32%. In women with advanced breast cancer, coadministration of garlic supplement reduced the clearance of docetaxol by 23.1-35.1%, although the difference did not achieve statistical significance. Most anticancer drugs undergo Phase I and/or II metabolism and are substrates of P-glycoprotein, breast cancer resistance protein, multidrug resistance associated proteins, and/or other transporters. Induction and inhibition of these enzymes and transporters is considered an important mechanism for herb-anticancer drug interactions. Further studies are warranted to investigate potentially harmful herbal interactions with anticancer drugs in patients.

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Section: Irinotecan + Milk Thistlementioning

confidence: 78%

Herbal Interactions with Anticancer Drugs: Mechanistic and Clinical Considerations

Yang

Liu

et al. 2010

CMC

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“…In vitro studies have shown that silymarin, in higher concentrations, has a strong inhibitory effect on both P450 3A4 [56–58] and P‐gp [59–61]. The concentration tested in vitro exceeded physiologically attainable levels [56–58, 60, 61] and hence previous studies in vivo have shown no to mild inhibition effects when co‐administered with ranitidine [62], nifedipine [63], midazolam [64] and indinavir [65, 66] in healthy volunteers. Recently, Schrieber et al.…”

Section: Discussionmentioning

confidence: 91%

Population pharmacokinetics of sirolimus in de novo Chinese adult renal transplant patients

Jiao

Shi

et al. 2009

Brit J Clinical Pharma

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WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT?• Sirolimus is an immunosuppressive agent used for the prophylaxis of renal allograft rejection.• Several conventional pharmacokinetic and population pharmacokinetic studies have been conducted to assess the pharmacokinetic characteristics of sirolimus in White or African-American recipients. WHAT THIS STUDY ADDS?• The population pharmacokinetics of sirolimus in Chinese adult renal transplant recipients was characterized for the first time.• New drug-drug interactions between herbal medicines and sirolimus were identified as the covariates on sirolimus clearance. AIMSThis study was aimed at determining the population pharmacokinetics of sirolimus and identifying factors that explain pharmacokinetic variability in de novo Chinese adult renal transplant patients. METHODSData were retrospectively extracted from a formal multicentre clinical trial, which was originally designed to evaluate the safety and efficacy of ciclosporin dose reduction and ciclosporin elimination in patients receiving sirolimus. All patients received 12-month treatment, i.e. induction therapy with ciclosporin, sirolimus and corticosteroids during the first 3 months followed by either ciclosporin dose reduction or ciclosporin discontinuation thereafter. Eight-hundred and four sirolimus trough blood concentrations (C 0) from 112 patients were used to develop a population pharmacokinetic model using the NONMEM program. A one-compartment model with first-order absorption and elimination was selected as the base model. The influence of demographic characteristics, biochemical and haematological indices, ciclosporin daily dose, ciclosporin C0 as well as other commonly used co-medications were explored. RESULTSThe typical values with interindividual variability for apparent clearance (CL/F) and apparent volume of distribution (V/F) were 10.1 l h -1 (23.8%) and 3670 l (56.7%), respectively. The residual variability was 29.9%. CL/F decreased significantly with silymarin or glycyrrhizin co-therapy in hepatically impaired patients, and with increasing total cholesterol levels or ciclosporin C0. Moreover, CL/F increased nonlinearly with increasing sirolimus daily dose. The median parameter estimates from a nonparametric bootstrap procedure were comparable and within 5% of the estimates from NONMEM. CONCLUSIONSThese results provide important information for clinicians to optimize sirolimus regimens in Chinese renal transplant patients.

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“…Rao et al demonstrated the effect of silymarin pretreatment on the pharmacokinetics of ranitidine was investigated in healthy male human volunteers. There was no influence of silymarin on the C max and AUC, significant difference in area under the first moment curve (AUMC) and mean residence time of ranitidine (Rao et al, 2007).…”

Section: Ranitidinementioning

confidence: 91%

Drug–drug interactions of silymarin on the perspective of pharmacokinetics

Lin

Tsai

2009

Journal of Ethnopharmacology

165

116

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Effect of Silymarin on the Oral Bioavailability of Ranitidine in Healthy Human Volunteers

Cited by 17 publications

References 8 publications

Herbal Interactions with Anticancer Drugs: Mechanistic and Clinical Considerations

Herbal Interactions with Anticancer Drugs: Mechanistic and Clinical Considerations

Population pharmacokinetics of sirolimus in de novo Chinese adult renal transplant patients

Drug–drug interactions of silymarin on the perspective of pharmacokinetics

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