Septrin dose in paediatric patients with moderate to severe atopic dermatitis, a dose of 0.5 mg/kg twice weekly in divided doses for 15 weeks was associated with a significant reduction in the number of patients with a severe response to treatment and/or grade 3 (moderate to severe) adverse reactions (0.2% compared with 0.5% in placebo group at week 15) and a reduction in PSA levels the 0.3- to 0.4-μg/ml range. In the placebo group, there was a significant increase in PSA at week 15 and the end of study. However, PSA levels in the 0.3- and 0.4-μg/ml range were not significantly increased (P>0.5 for both comparisons). The 0.5- and 1.0-mg/kg doses were also associated with significantly greater reductions in PSA levels compared with placebo.
Pregnancy and lactation
Pregnancy Category C. No drug-related adverse events were experienced among pregnant women taking EGCG. No adverse events were reported in lactating or peri-menopausal women.
Interactions
None well documented.
Adverse Reactions
Common (1% to 10%):
Clinical Trials Experience
Because clinical trials are conducted under widely varying circumstances, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
For safety information on EGCG, please visit US Pharmacopeia website.
Please visit www.Pharmacopeia.com/drugstore for a compendium of information on over-the-counter medications.
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