What are the side effects and type of Dicletin (pyridoxine and doxylamine) medication?

From the Guidelines

Dicletin, a combination of pyridoxine and doxylamine, is a safe and effective medication for treating nausea and vomiting during pregnancy, with common side effects including drowsiness, dry mouth, and dizziness, as supported by the American College of Obstetricians and Gynecologists (ACOG) recommendations 1. The medication is classified as an antihistamine-vitamin combination, with doxylamine acting as an antihistamine to reduce nausea and pyridoxine (vitamin B6) helping to address pregnancy-related vitamin deficiencies that may contribute to morning sickness. Some key points to consider when taking Dicletin include:

• Taking the medication as directed by a healthcare provider, often on a schedule rather than as needed, to maintain consistent blood levels for better symptom control 1.
• Taking the medication with a full glass of water and potentially with food if stomach upset occurs.
• Avoiding activities requiring alertness due to the sedative effects of the medication until you know how it affects you.
• Being aware of severe but rare side effects, such as confusion, irregular heartbeat, or allergic reactions, and reporting them to a healthcare provider immediately. The use of Dicletin is supported by guidelines that recommend its use for persistent nausea and vomiting of pregnancy (NVP) refractory to non-pharmacologic therapy, highlighting its role in managing symptoms that can significantly impact quality of life 1.

From the Research

Dicletin Side Effects and Medication Type

• Dicletin is a combination of doxylamine and pyridoxine, used to treat nausea and vomiting of pregnancy (NVP) 2, 3, 4, 5.
• The medication is available in a delayed-release formulation, which has been shown to be effective and well-tolerated in treating NVP 3, 5.
• The side effects of Dicletin are not extensively discussed in the provided studies, but it is mentioned that the combination of doxylamine and pyridoxine has been demonstrated to be safe for use during pregnancy, with no increased fetal risk for congenital malformations and other adverse pregnancy outcomes 2, 5.

Medication Type and Formulation

• Dicletin is a delayed-release combination pill, containing 10 mg of doxylamine succinate and 10 mg of pyridoxine hydrochloride 2, 3, 5.
• The pharmacokinetics of the ingredients in Dicletin have been studied, and it has been found that there is large variability in the onset and duration of action among women 6.
• The relative bioavailability of pyridoxine in Dicletin has been calculated to be 100%, and interindividual differences in metabolism may be an important source of variability in the medication's effectiveness 6.

Efficacy and Safety

• The efficacy of Dicletin in treating NVP has been demonstrated in several clinical trials, and it is recommended as a first-line treatment for NVP by several leading healthcare and professional organizations 2, 3, 5.
• The safety of Dicletin has been established through studies on over 200,000 women exposed to doxylamine and pyridoxine in the first trimester of pregnancy, which have shown no increased fetal risk for congenital malformations and other adverse pregnancy outcomes 2, 5.