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Randomized two-way cross-over bioequivalence study of two amoxicillin formulations and inter-ethnicity pharmacokinetic variation in healthy Malay volunteers

Liew KB, Loh GO, Tan YT, Peh KK

Biomed Chromatogr, 2014 Sep;28(9):1246-53.
PMID: 24585432 DOI: 10.1002/bmc.3153

The objectives of this study were to develop a new deproteinization method to extract amoxicillin from human plasma and evaluate the inter-ethnic variation of amoxicillin pharmacokinetics in healthy Malay volunteers. A single-dose, randomized, fasting, two-period, two-treatment, two-sequence crossover, open-label bioequivalence study was conducted in 18 healthy Malay adult male volunteers, with one week washout period. The drug concentration in the sample was analyzed using high-performance liquid chromatography (UV-vis HPLC). The mean (standard deviation) pharmacokinetic parameter results of Moxilen® were: peak concentration (Cmax ), 6.72 (1.56) µg/mL; area under the concentration-time graph (AUC0-8 ), 17.79 (4.29) µg/mL h; AUC0-∞ , 18.84 (4.62) µg/mL h. Those of YSP Amoxicillin® capsule were: Cmax , 6.69 (1.44) µg/mL; AUC0-8 , 18.69 (3.78) µg/mL h; AUC00-∞ , 19.95 (3.81) µg/mL h. The 90% confidence intervals for the logarithmic transformed Cmax , AUC0-8 and AUC0-∞ of Moxilen® vs YSP Amoxicillin® capsule was between 0.80 and 1.25. Both Cmax and AUC met the predetermined criteria for assuming bioequivalence. Both formulations were well tolerated. The results showed significant inter-ethnicity variation in pharmacokinetics of amoxicillin. The Cmax and AUC of amoxicillin in Malay population were slightly lower compared with other populations.

Matched MeSH terms: Amoxicillin/adverse effects*
Omeprazole 40 mg o.m. combined with amoxycillin alone or with amoxycillin and metronidazole in the eradication of Helicobacter pylori

Goh KL, Peh SC, Parasakthi N, Wong NW, Tan KK, Lo YL

Am J Gastroenterol, 1994 Oct;89(10):1789-92.
PMID: 7942668

OBJECTIVES: Our objectives were to determine the effect of dual therapy with omeprazole and amoxicillin and of triple therapy with omeprazole, amoxicillin, and metronidazole in the eradication of Helicobacter pylori (HP) and to study the long-term results of eradication in these patients.
METHODS: A prospective, randomized, controlled trial was performed. Patients who were recruited had unequivocal evidence of HP infection based on culture, histology, rapid urease test, and Gram's stain of a tissue smear. Eradication was defined as the absence of bacteria in all tests performed on both corpus and antral biopsies.
RESULTS: The infection was eradicated in 15 of 19 (78.9%) patients randomized to receive dual therapy and in 19 of 22 (86.4%) patients who received triple therapy. We followed the course of 30 patients in whom HP had been eradicated for a prolonged term (up to 12 months). All remained clear of HP. Twenty-five of 28 patients (89.3%) with duodenal ulcers in whom HP was successfully eradicated remained healed at 12 months. Fewer side effects were reported among patients who received the dual therapy.
CONCLUSIONS: Combination therapy with omeprazole and amoxicillin with or without metronidazole is effective in the eradication of HP. In particular, the dual therapy regimen with amoxicillin is not only effective but is also well tolerated by patients.

Matched MeSH terms: Amoxicillin/adverse effects
Combination amoxycillin and metronidazole with famotidine in the eradication of Helicobacter pylori--a randomized, double-blind comparison of a three times daily and twice daily regimen

Goh KL, Parasakthi N, Chuah SY, Toetsch M

Eur J Gastroenterol Hepatol, 1997 Nov;9(11):1091-5.
PMID: 9431900

OBJECTIVES: To determine the efficacy of a three times daily (t.i.d.) versus a twice daily (b.i.d.) regimen of combination amoxycillin and metronidazole and famotidine in the eradication of Helicobacter pylori and the influence of metronidazole resistance on the outcome of treatment.
PATIENTS: Patients selected had unequivocal evidence of H. pylori infection based on the urease test, culture and histology and had either peptic ulcer disease or non-ulcer dyspepsia.
DESIGN: The study was a comparative and double-blind study and patients were randomized to receive either amoxycillin 750 mg t.i.d. and metronidazole 500 mg t.i.d. for 12 days or amoxycillin 1000 mg b.i.d. and metronidazole 500 mg b.i.d. for 12 days. Both groups also received famotidine 40 mg for 6 weeks.
MAIN OUTCOME MEASURE: Patients were assessed for successful eradication, defined as absence of bacteria in all tests, at least 4 weeks after completion of antibiotic therapy by repeat gastroscopy.
RESULTS: One hundred and twenty-nine patients were recruited for the study. Two patients defaulted follow-up, two patients were withdrawn from the study and six patients were found to be non-compliant with medications. The eradication rates of the t.i.d. regimen was higher than the b.i.d. regimen (per protocol (PP) analysis: 83.3% (50/60) vs. 76.3% (45/59), P=0.337; intention-to-treat (ITT) analysis: 78.5% (51/65) vs. 75.0% (48/64), P=0.642). Seventy-five patients had pre-treatment cultures checked for metronidazole resistance, 33 (44.0%) were found to be resistant. Acquired resistance occurred in 3/40 (7.5%) patients. Eradication rates of metronidazole-sensitive and metronidazole-resistant patients: t.i.d. regimen - 100% (17/17) and 88.2% (15/17), b.i.d. regimen - 19/21 (90.5%) and 11/15 (73.3%). Side effects were reported in up to 70% of patients but were mild and tolerable in the majority. Two patients were withdrawn from the study because of a fixed drug eruption in one and generalized macular rash in the other.
CONCLUSION: Combination amoxycillin and metronidazole is effective in eradicating H. pylori. There was a tendency for the t.i.d. regimen to be better than the b.i.d. regimen and for metronidazole-resistant infections to be associated with a lower eradication rate but these differences did not reach statistical significance.

Matched MeSH terms: Amoxicillin/adverse effects
Efficacy of 1-week proton pump inhibitor triple therapy as first-line Helicobacter pylori eradication regime in Asian patients: is it still effective 10 years on?

Qua CS, Manikam J, Goh KL

J Dig Dis, 2010 Aug;11(4):244-8.
PMID: 20649738 DOI: 10.1111/j.1751-2980.2010.00445.x

OBJECTIVE:
To re-examine the efficacy and tolerability of 1-week proton pump inhibitor triple therapy as a first-line Helicobacter pylori (H. pylori) eradication therapy.

METHODS:
Consecutive participants with a positive rapid urease test during an outpatient upper endoscopy were included. All participants were given pantoprazole 40 mg b.i.d., amoxycillin 1 g b.i.d. and clarithromycin 500 mg b.i.d. for 1 week. They were asked to return after 1 week to report any side effects related to the medications and to check for compliance. Successful eradication was defined by negative (13)C-urea breath test at least 4 weeks after the completion of therapy.

RESULTS:
A total of 191 patients were recruited into the study, of whom 81 were male (42.4%) and 110 female (57.6%), with a mean age of 55.6 (range 21-88) years. Overall 26 patients (13.6%) defaulted follow up and five patients were not compliant (taking less than 85%) with the medications. Per-protocol and intention-to-treat eradication rates were 84.4% (95% CI: 78.6-89.9%) and 71.2% (95% CI: 64.5-77.6%), respectively. Overall 68 participants (42.5%) reported no side effects, followed by 58 (36.3%) with a taste disturbance, 16 (10.0%) with epigastric pain, 15 (9.4%) with diarrhea, 13 (8.1%) with nausea or vomiting, 12 (7.5%) with loss of appetite, nine (5.6%) with dizziness and two (1.3%) with an allergic skin rash, none of which was severe.

CONCLUSION:
The current regime using pantoprazole, amoxycillin and clarithromycin is highly tolerable and effective and should continue to be recommended as a first-line therapy for H. pylori eradication in our setting.

Matched MeSH terms: Amoxicillin/adverse effects
Fulltext Long-term impact of oral surgery with or without amoxicillin on the oral microbiome-A prospective cohort study

Menon RK, Gomez A, Brandt BW, Leung YY, Gopinath D, Watt RM, et al.

Sci Rep, 2019 12 10;9(1):18761.
PMID: 31822712 DOI: 10.1038/s41598-019-55056-3

Routine postoperative antibiotic prophylaxis is not recommended for third molar extractions. However, amoxicillin still continues to be used customarily in several clinical practices worldwide to prevent infections. A prospective cohort study was conducted in cohorts who underwent third molar extractions with (group EA, n = 20) or without (group E, n = 20) amoxicillin (250 mg three times daily for 5 days). Further, a control group without amoxicillin and extractions (group C, n = 17) was included. Salivary samples were collected at baseline, 1-, 2-, 3-, 4-weeks and 3 months to assess the bacterial shift and antibiotic resistance gene changes employing 16S rRNA gene sequencing (Illumina-Miseq) and quantitative polymerase chain reaction. A further 6-month follow-up was performed for groups E and EA. Seven operational taxonomic units reported a significant change from baseline to 3 months for group EA (adjusted p 0.05). In conclusion, the salivary microbiome is resilient to an antibiotic challenge by a low-dose regimen of amoxicillin. Further studies evaluating the effect of routinely used higher dose regimens of amoxicillin on gram-negative bacteria and antibiotic resistance genes are warranted.

Matched MeSH terms: Amoxicillin/adverse effects*