Pharmacokinetics, pharmacodynamics and toxicity of a combination of metoprolol succinate and telmisartan in Wistar albino rats: Safety profiling

Regulatory Toxicology and Pharmacology - Tập 65 - Trang 68-78 - 2013
Utpal Nandi1, Sanmoy Karmakar1, Anjan Kumar Das2, Balaram Ghosh3, Aswathi Padman1, Nilendra Chatterjee1, Tapan Kumar Pal1
1Department of Pharmaceutical Technology, Jadavpur University, Kolkata, 700032, India
2Department of Pathology, Calcutta National Medical College, Kolkata 700014, India
3Department of Pharmacology, Medical College, Kolkata 700073, India

Tài liệu tham khảo

Bahgata, 2008, Solanum indicum ssp. distichum extract is effective against l-NAME-induced hypertension in rats, Fundam. Clin. Pharm., 22, 693, 10.1111/j.1472-8206.2008.00627.x Chobanian, 2003, The seventh report of the joint national committee on prevention, detection, evaluation, and treatment of high blood pressure, J. Am. Med. Assoc., 289, 2560, 10.1001/jama.289.19.2560 Cook, 1995, Implications of small reductions in diastolic blood pressure for primary prevention, Arch. Intern. Med., 155, 701, 10.1001/archinte.1995.00430070053006 Deore, 2005, Toxicity studies of metoprolol succinate after repeated oral exposure in albino rats, Toxicol. Int., 12, 101 European Society of Hypertension-European Society of Cardiology Guidelines Committee, 2003, European Society of Hypertension-European Society of Cardiology guidelines for the management of arterial hypertension, J. Hypertens., 21, 1011, 10.1097/00004872-200306000-00001 Hansson, 1998, Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the hypertension optimal treatment (HOT) randomized trial, Lancet, 351, 1755, 10.1016/S0140-6736(98)04311-6 Hao, 2007, Pharmacokinetic–pharmacodynamic modeling of telmisartan using an indirect response model in spontaneously hypertensive rats, Acta Pharmacol. Sin., 28, 738, 10.1111/j.1745-7254.2007.00556.x Höcht, 2004, Pharmacokinetic–pharmacodynamic properties of metoprolol in chronic aortic coarctated rats, Naunyn Schmiedebergs Arch. Pharmacol., 370, 1, 10.1007/s00210-004-0945-2 Israili, 2000, Clinical pharmacokinetics of angiotensin II (AT1) receptor blockers in hypertension, J. Hum. Hypertens., 14, S73, 10.1038/sj.jhh.1000991 JNC Report, 2003, Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, Hypertension, 42, 1206, 10.1161/01.HYP.0000107251.49515.c2 Johnson, 2009, Pharmacogenomics of antihypertensive drugs: rationale and design of the pharmacogenomic evaluation of antihypertensive responses (PEAR) study, Am. Heart J., 157, 442, 10.1016/j.ahj.2008.11.018 Johnson, 1992, Sustained hypertension in the rat induced by chronic blockade of nitric oxide production, Am. J. Hypertens., 5, 919, 10.1093/ajh/5.12.919 Kalra, 2010, Combination therapy in hypertension: an update, Diabetol. Metab. Syndr., 2, 44, 10.1186/1758-5996-2-44 Kang, 1995, Reference values of hematology and serum chemistry in Ktc: Sprague–Dawley rats, Korean J. Lab. Anim. Sci., 11, 141 Lewington, 2002, Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies, Lancet, 360, 1903, 10.1016/S0140-6736(02)11911-8 McClellan, 1998, Telmisartan, Drugs, 55, 1039, 10.2165/00003495-199856060-00007 Mostafavi, 2000, Pharmacokinetics of metoprolol enantiomers following single and multiple administration of racemate in rat, Int. J. Pharm., 202, 97, 10.1016/S0378-5173(00)00430-0 Ofili, 2006, Dispelling the myth of “aggressive” antihypertensive therapy, J. Clin. Hypertens., 8, 4, 10.1111/j.1524-6175.2005.05293.x Ong, 2007, Prevalence, awareness, treatment, and control of hypertension among United States adults 1999–2004, Hypertension, 49, 69, 10.1161/01.HYP.0000252676.46043.18 Organization for Economic Co-operation and Development (OECD), 1995. Guideline for the testing of chemicals. Guideline 407: repeated dose 28-day oral toxicity study in rodents. Panda, 2006, Evaluation of the rationality of some FDC’s: focus on antihypertensive drugs, Indian J. Pharm. Sci., 68, 649, 10.4103/0250-474X.29639 Schmid, J., 1997. In vivo and in vitro biotransformation of telmisartan. Ist International Symposium on Angiotensin II Antagonism, London. Schwartz, 2004, Pharmacogenetics of antihypertensive drug responses, Am. J. Pharmacogenomics, 4, 151, 10.2165/00129785-200404030-00002 Shannon, 2007, Dose translation from animal to human studies revisited, FASEB J., 22, 659, 10.1096/fj.07-9574LSF Shimasaki, 1999, Pharmacokinetics of 14C-telmisartan: absorption, distribution and protein binding of 14C-telmisartan after a single oral administration to rats, Xenobiotic Metab. Dispos., 14, 425 Stanton, 2002, Fixed dose combination therapy in the treatment of hypertension, J. Hum. Hypertens., 16, 75, 10.1038/sj.jhh.1001312 Swaisland, 2005, Pharmacokinetic drug interactions of gefitinib with rifampicin, itraconazole and metoprolol, Clin. Pharmacokinet., 44, 1067, 10.2165/00003088-200544100-00005 Turner, S.T., Chapman, A.B., 2002. Antihypertensive pharmacogenetics. Euro Conference: Pharmacogenomics: The Promise and Reality of Individualized Treatment, France. US Food and Drug Administration, 1978. Good Laboratory Practice Regulations (Part 58 of 21 Code of Federal Regulations (CFR)). Federal Register 22 December 1979 and subsequent amendments. Vermeulen, 1993, Aging and the pharmacokinetics and metabolism of metoprolol enantiomers in the rat, J. Gerontol., 48, B108, 10.1093/geronj/48.3.B108 WHO, 2007. Model list of essential medicines 15th list, March, 2007. <http://www.who.int/medicines/publications/08_English_indexFinal_EML15.pdf>. Wienen, 2000, A review on telmisartan: a novel, long-acting angiotensin ii-receptor antagonist, Cardiovasc. Drug Rev., 18, 127, 10.1111/j.1527-3466.2000.tb00039.x Wolford, 1986, Reference range data base for serum chemistry and hematology values in laboratory animals, J. Toxicol. Environ. Health, 18, 161, 10.1080/15287398609530859