Efficacy of a paracetamol and caffeine combination in the treatment of the key symptoms of primary dysmenorrhoea

Ali, Zeeshan; Burnett, I.; Eccles, Ronald; North, Michelle L.; Jawad, M. S. M.; Jawad, S. S. M.; Clarke, Geoff; Milsom, Ian

doi:10.1185/030079907x182239

Cited by 39 publications

(20 citation statements)

References 22 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Time effect curves for pain were presented in all four of the papers [43–46]. The dysmenorrhea study showed a statistically significant difference in favor of the combination at 30 minutes after dosing ( P < 0.05) and this difference was maintained for the duration of the study [43]. Similar results were observed in the combined analysis of two studies in headache patients [44] and in each of the four studies presented by Laska et al.…”

Section: Resultssupporting

confidence: 70%

“…All of the eight studies included in the meta‐analysis provided efficacy results as mean TOTPAR values over 0–4 hours [43–46]. In the four studies reported by Laska et al.…”

Section: Resultsmentioning

confidence: 99%

“…One study assessed pain relief for up to 6 hours post dosing [43]. The 6 hour results were treated in the same manner as above, enabling calculation of half pain relief achieved at 6 hours.…”

Section: Resultsmentioning

confidence: 99%

See 2 more Smart Citations

A Risk-Benefit Assessment of Paracetamol (Acetaminophen) Combined with Caffeine

Palmer¹,

Graham²,

Williams³

et al. 2010

Pain Med

View full text Add to dashboard Cite

show abstract

Section: Resultssupporting

confidence: 70%

“…All of the eight studies included in the meta‐analysis provided efficacy results as mean TOTPAR values over 0–4 hours [43–46]. In the four studies reported by Laska et al.…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

A Risk-Benefit Assessment of Paracetamol (Acetaminophen) Combined with Caffeine

Palmer¹,

Graham²,

Williams³

et al. 2010

Pain Med

View full text Add to dashboard Cite

show abstract

“…With specific relevance to paracetamol plus caffeine vs. paracetamol alone, the relative potency estimate was 1.37 [13]. More recent clinical studies on adjuvant actions of caffeine suggest that caffeine was useful for enhancing relief of headache pain [14][15][16] and menstrual pain [17].…”

Section: Discussionmentioning

confidence: 99%

Pharmacokinetic and Bioequivalence Study Evaluating a New Paracetamol/Caffeine Formulation in Healthy Human Volunteers

Liu¹,

Kotler²,

Sharples³

2011

JBB

View full text Add to dashboard Cite

Purpose: Aim of this study was to evaluate the bioequivalence and clinical pharmacokinetics of newly developed paracetamol 500 mg and caffeine 65 mg combination (PANADOL ® EXTRA ADVANCE product), compared with currently marketed conventional paracetamol/caffeine caplet (PANADOL EXTRA ® product) in fasted and semi-fed states.Methods: Thirty subjects were enrolled and all completed this 4-way crossover study. Serial blood samples were collected pre-dose until 10-hours post-dose for each period. Plasma samples were assayed for paracetamol and caffeine concentration using HPLC/MS methods. PK parameters were computed using non-compartmental model. Linear mixed-effect model was used to analyze logarithmically transformed AUC 0-∞ , AUC 0-t and C max as well as AUC 0-30min and AUC 0-60min values . T max was analyzed by signed rank test on within-subject differences. Time to reach minimum therapeutic concentration in plasma of 4 µg/ml (T 4 ) for paracetamol was evaluated. The AEs were also assessed. Ratios of AUC 0-∞ , AUC 0-t , and C max were compared for new formulation vs. PANADOL EXTRA ® in fasted and semi-fed states, and analyzed for bioequivalence as determined by 90% confidence intervals (CI90%). Results:Bioequivalence was established between these two formulations in both fasted and semi-fed states, as the ratios were within 0.8-1.25, except the C max of paracetamol in fasted state. In addition, the new formulation showed significantly greater early absorption (AUC 0-30min and AUC 0-60min ), as well as significantly shorter T max , for both paracetamol and caffeine compared to PANADOL EXTRA ® in fasted and semi-fed states. Based on T 4 , paracetamol absorption was twice as fast for the new formulation as compared to the corresponding conventional caplet in the fasted and fed states. The new formulation was safe and well tolerated. Conclusions:The new Panadol ® Extra Advance formulation is bioequivalent to the currently marketed conventional formulation. Both paracetamol and caffeine are absorbed significantly faster with the new formulation compared to Panadol ® Extra product.

show abstract

“…Since her menarche began, she had taken at least 2 caplets of pain relievers (each contains 500 mg of acetaminophen and 65 mg of caffeine) without exception to maintain her normal lifestyle during menstrual periods, which happened to be the dose recommended by a previous report (1 g of acetaminophen and 130 mg of caffeine). 24 The symptoms of dysmenorrhea usually accompanied the start of menstrual flow and lasted for about 3 days, with intensity peaking on the second day. Associated symptoms included diarrhea (once on the first day of each menstrual period), referred lower back pain, and fatigue.…”

Section: Case Reportmentioning

confidence: 99%