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#32 Quezada, Ester Florentina W. #40 Tan, Alexis Vianca T.

2DPH

Dicletin (doxylamine/pyrdoxine delayed-release combination) is used to alleviate the
symptoms of nausea and vomiting in pregnant women. It is widely used in Canada, but its
pharmacokinetics during pregnancy has never been discussed. This study was about the
pharmacokinetics of Dicletin. Its objective was to compare the pharmacokinetics of the 2
components of Dicletin in nonpregnant women of reproductive age who volunteered to
participate in a 4-week steady state PK study of Dicletin and women experiencing NVP in
the first trimester who participated in a randomized, placebo-controlled trial of Dicletin.
The apparent clearances (CL) of doxylamine and pyridoxal 5'-phospate (PLP) in pregnant
women were compared with those of healthy, adult, nonpregnant women.

It was recently characterized that the pharmacokinetics of Dicletin in nonpregnant
women of reproductive age had delayed-release characteristics. Thus, allowing the
women to take the medication before sleeping in order to obtain the best result in the
morning when symptoms are maximal. However, there are still no studies regarding the
effects of nausea and vomiting to the pharmacokinetics of any drug during pregnancy.
This is an important concept the authors mentioned. The definitions of these concepts
were clear because it didnt cause any misunderstanding and it also piqued the curiosity
of the readers.

An experiment was conducted by the authors in order to collect data. For
nonpregnant women, an open-label study was conducted to characterize steady-state
trough concentrations of the drug combination of doxylamine succinate and pyridoxine
hydrochloride administered in different doses. On the other hand, the pregnant women
underwent physical examination, laboratory tests, and were confirmed to have in utero
singleton pregnancies through ultrasound. Afterwards, a double-blind, randomized,
multicenter, placebo-controlled study was conducted using the same combination of
drugs mentioned earlier.

The data collected was hard to interpret because it was not tabulated. For the
characteristics of women included in the study, there was a table provided to help the
readers differentiate the age, weight, height of the women. However, it was hard to
compare and contrast the differences in considerations for nonpregnant and pregnant
women. Especially for pregnant women, a lot of factors were considered in taking the
drug and different tests were made for every factor. This caused some confusion and
misunderstanding for us.

It was found in the study that there is no difference in the apparent CL of doxylamine in
their first trimester of pregnancy when compared with nonpregnant women on days 4, 8,
and 15. There is no difference in the apparent CL of PLP on day 15 as well. Therefore,
there is no pregnancy-induced effect in the apparent CL of either doxylamine or PLP in
women during the first trimester of pregnancy despite the existence of morning sickness.

The ideas in the article were well presented and the authors provided the complete
information about their argument. The results were discussed and tabulated accordingly
and the whole article itself was clear and understood easily.

The authors concluded that the trough steady-state concentrations in women suffering
from mild and moderate forms of NVP are the same from those achieved among
nonpregnant controls. They also concluded that for most women suffering mild to
moderate forms of nausea and vomiting, effectiveness is confirmed by the
pharmacokinetics of the drug.

The data given in the results supports the conclusion of the author. Tables were
provided for the results thus it was made easier to understand and compare the results.
The results were thoughts provoking as well because it showed the difference between
the P value when using total body weight and lean body weight. It piques the curiosity of
the reader as to why different P values were obtained. The conclusion was straight to the
point and was not long and misleading. One way for this study to be improved is for the
authors to continue researching on the pharmacokinetics of Dicletin most especially in
pregnant women. We also recommend comparing the pharmacokinetics of Dicletin and
other drugs that can be a substitute to it.

We have learned that the pharmacokinetics of a drug is very important in determining its
safety and effectiveness, especially for patients who have special medical conditions. We
also learned that there is no pregnancy-induced effect in the apparent CL of Dicletin in
pregnant women which means that it is safe to take the drug during the first trimester of
pregnancy. Lastly, we have acquired additional knowledge about the pharmacokinetics of
drugs in the body.

Reference:
Matok, I., Clark, S., Caritis, S., Miodovnik, M., Umans, J., Hankins, G., Koren, G. (2013).
Comparing the Pharmacokinetics of Doxylamine/Pyridoxine Delayed-Release
Combination in Nonpregnant Women of Reproductive Age and Women in the First
Trimester of Pregnancy. The Journal of Clinical Pharmacology, 53(3), 334-338. doi:
10.1177/0091270012445207