Bendectin
| Combination of | |
|---|---|
| Pyridoxine | Vitamin |
| Doxylamine | Antihistamine |
| Clinical data | |
| Trade names | Diclegis, Bendectin, Debendox, Lenotan, Merbental, Diclectin |
| Pregnancy category |
|
| Routes of administration |
Oral |
| Legal status | |
| Legal status |
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| Identifiers | |
| CAS Number | |
| PubChem CID | |
| ChemSpider | |
Pyridoxine/doxylamine, sold under the brand name Diclectin among others, is a combination of pyridoxine hydrochloride (vitamin B6) and doxylamine succinate prescribed for the management of nausea and vomiting of pregnancy (morning sickness).
The combination of pyridoxine, more commonly referred to as vitamin B6 and doxylamine is effective for the management of nausea and vomiting of pregnancy.
Doxylamine and pyridoxine are currently referenced as pregnancy compatible drugs (Drugs in Pregnancy and Lactation 10th Edition), consistent with FDA’s safety assessment of the combination Product. They been categorized by the FDA as a category A drug (no evidence of risk to the fetus). This letter classification system for risk in pregnancy is no longer being utilized and is currently being phased out by the FDA.
The American Congress of Obstetricians and Gynecologists (ACOG) states that the recommendation of “taking Vitamin B6 or Vitamin B6 plus doxylamine is safe and effective and should be considered a first-line treatment” is based on consistent scientific evidence. This recommendation has been evaluated by the US Department of Health and Human Services’ Agency for Healthcare Research and Quality, who concur that the benefit of implementing the guideline recommendations would be a reduction on nausea and vomiting of pregnancy. The Society of Obstetricians and Gynaecologists of Canada (SOGC) published a Clinical Practice Guideline on the management of nausea and vomiting of pregnancy in which it states that the “doxylamine/pyridoxine combination should be the standard of care, since it has the greatest evidence to support its efficacy and safety”. The Motherisk Program, an internationally recognized teratogen information center located at the Hospital for Sick Children in Toronto, published a Current Practice Update for the treatment of nausea and vomiting of pregnancy. This updated algorithm recommends the combination of doxylamine and of pyridoxine as first-line therapy for the management of nausea and vomiting of pregnancy.
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