This page contains brief details about the drug , it's indication, dosage & administaration, mechanism of action, related brands with strength, warnings and common side effects.
Background and Date of Approval
Doxylamine and pyridoxine is a well-established combination used primarily to treat nausea and vomiting during pregnancy (NVP), commonly known as morning sickness. Doxylamine is an antihistamine that helps reduce nausea through its antiemetic and sedative effects, while Pyridoxine (Vitamin B6) is a water-soluble vitamin that plays a crucial role in metabolic and neurological functions, with proven benefits in reducing pregnancy-related nausea.
This combination was first approved by the U.S. FDA under the brand name Diclegis® in 2013 for use in pregnant women. In India, Doxylamine, Pyridoxine is widely available and commonly prescribed by gynecologists and general practitioners as a first-line treatment for nausea and vomiting in early pregnancy. It is considered safe and effective when used as directed.
Mechanism of Action of undefined
The therapeutic effect of this combination comes from the complementary action of its two components:
- Doxylamine acts as a first-generation H1 antihistamine that blocks histamine receptors in the brain’s vomiting center, thereby reducing nausea and vomiting. It also has mild sedative properties, which can help pregnant women get restful sleep during early pregnancy.
- Pyridoxine (Vitamin B6) supports normal enzyme function and neurotransmitter balance. While its precise mechanism in reducing nausea is not fully understood, it is believed to normalize gastric activity and reduce the sensory input that triggers vomiting.
Uses of undefined
Doxylamine, Pyridoxine is used for:
- Managing nausea and vomiting during pregnancy (morning sickness)
- Offering non-hormonal relief for early pregnancy discomfort
- Supporting nutritional balance with added Vitamin B6
- Providing a safe antiemetic option when lifestyle changes are insufficient.
undefined Drug administaration and Dosage available
This combination is usually available in oral tablet form. The commonly recommended dosage is one tablet at bedtime on the first day. If symptoms persist, the dose may be increased under medical supervision to a maximum of one tablet in the morning, one in the afternoon, and two at bedtime.
Tablets should be swallowed whole and not crushed or chewed. It is advisable to take this medication on an empty stomach for best results. The dosage and duration should be strictly followed as per a doctor's advice.
Warnings, Precautions and Side Effects of undefined
Warnings
- Not to be used in individuals with hypersensitivity to Doxylamine, Pyridoxine, or other antihistamines.
- Avoid use with other central nervous system depressants (e.g., alcohol, sedatives) due to increased drowsiness.
- Use with caution in patients with asthma, glaucoma, or urinary retention.
- May cause drowsiness; avoid driving or operating heavy machinery.
- Not suitable for use in children unless specifically prescribed.
Precautions
Inform your doctor about any underlying liver disorders, epilepsy, or chronic medication use before starting this supplement. Pregnant women should use it strictly under medical guidance. Avoid combining it with other sources of Vitamin B6 or sedative medications unless advised.
Do not exceed the prescribed dose, as excess Pyridoxine may cause nerve-related side effects and excess Doxylamine may lead to increased sedation. Store in a cool, dry place away from children.
If you notice symptoms like confusion, dry mouth, blurred vision, or tingling sensations, consult your doctor. Routine monitoring is not usually required, but regular follow-up is recommended during pregnancy to ensure both maternal and fetal well-being.
Side Effects
Common Side Effects:
- Drowsiness
- Dry mouth
- Dizziness
- Headache
- Constipation
Serious Side Effects:
- Blurred vision
- Mood changes (e.g., confusion or irritability)
- Difficulty urinating
- Irregular heartbeat
- Allergic reactions like rash, itching, or swelling
Contact your doctor if any side effect worsens or doesn't go away.
Word Of Advice
Doxylamine, Pyridoxine is most effective when taken exactly as prescribed. Avoid making changes to your dose or timing without consulting your doctor. Do not take any additional sleep aids, allergy medications, or multivitamins containing B6 unless approved by a healthcare provider, as it may lead to vitamin overdose or increased drowsiness. Stay hydrated and avoid activities that require focus until you are aware of how the medication affects you.
Frequently Asked Question
References
Disclaimer
The content provided here is for informational purposes only and should not be considered a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of your physician or another qualified healthcare provider with any questions you may have regarding a medical condition.
