Amlodipine besylate 209
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Amlodipine Besylate: Pharmacokinetics, Efficacy, and Safety
Pharmacokinetics and Bioequivalence of Amlodipine Besylate
Amlodipine besylate is a widely used medication for the treatment of hypertension and angina. A study aimed to evaluate the bioequivalence of two amlodipine besylate tablet formulations—generic and original—revealed no significant differences in their pharmacokinetic profiles. The study was conducted in both fasting and postprandial states, involving 28 subjects in each trial. The results showed that the 90% confidence intervals (CIs) for the peak concentration, area under the concentration-time curve (AUC) from time 0 to the last quantifiable concentration, and AUC from time 0 to infinity were within the accepted bioequivalence range of 80% to 125%. This indicates that both formulations are bioequivalent and that food intake does not significantly affect the drug's exposure.
Comparative Efficacy of Amlodipine Besylate and Amlodipine Adipate
A multicenter, randomized, double-blind study compared the antihypertensive effects and tolerability of amlodipine besylate with a new formulation, amlodipine adipate, in patients with mild to moderate hypertension. Over an 8-week period, both formulations significantly reduced diastolic blood pressure (DBP) and systolic blood pressure (SBP). The mean changes in DBP were -15.2 mm Hg for amlodipine adipate and -14.2 mm Hg for amlodipine besylate, demonstrating noninferiority of the adipate formulation. The response rates and incidence of adverse events were also comparable between the two groups. This suggests that amlodipine adipate is as effective and tolerable as amlodipine besylate for treating hypertension.
Combined Treatment with Amlodipine Besylate and Traditional Chinese Medicine
A study explored the effects of combining amlodipine besylate with acupoint application of traditional Chinese medicine (TCM) in treating renal failure and hypertension. The combination therapy significantly reduced systolic and diastolic blood pressures compared to amlodipine besylate alone. Additionally, the treatment improved various biochemical indices such as blood urea nitrogen (BUN), creatinine (CRE), and urine protein (UP). The study also found that the combination therapy modulated the PI3K/AKT signaling pathway, which is associated with improved renal function and reduced pathological changes in renal tissues. This indicates that integrating TCM with conventional amlodipine besylate treatment may offer enhanced therapeutic benefits for patients with renal failure and hypertension.
Pharmacokinetics and Tolerability of Amlodipine Besylate/Losartan Combination
A randomized, open-label study compared the pharmacokinetics and tolerability of fixed-dose combinations (FDCs) of amlodipine besylate/losartan and amlodipine camsylate/losartan in healthy subjects. The pharmacokinetic profiles of both combinations were similar, with the 90% CIs for the geometric mean ratios of maximum plasma concentration (Cmax) and AUC0–t falling within the accepted range. Both combinations were well tolerated, with no significant differences in the incidence of adverse events. This suggests that the amlodipine besylate/losartan combination is a viable option for patients requiring combination therapy for hypertension.
Conclusion
Amlodipine besylate is a well-studied medication with proven bioequivalence between generic and original formulations, unaffected by food intake. It is as effective and tolerable as newer formulations like amlodipine adipate. Combining amlodipine besylate with traditional Chinese medicine may offer additional benefits for patients with renal failure and hypertension. Furthermore, fixed-dose combinations of amlodipine besylate with losartan are pharmacokinetically comparable and well tolerated, providing effective options for combination therapy in hypertension management.
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