This combination is indicated for the treatment of nausea and vomiting during pregnancy in women who do not respond adequately to conservative management.

Doxylamine Succinate is an antihistamine that blocks Histamine (H1) receptors. It crosses the blood-brain barrier and has a strong affinity for H1 receptors in the brain, helping to reduce nausea and vomiting. It also decreases histamine action by affecting the vestibular system and blocking muscarinic receptors, which helps reduce stimulation of the vomiting center. Its effect on the vestibular system and muscarinic receptor inhibition both contribute to its antiemetic action. Pyridoxine Hydrochloride is a vitamin B6 analog with antiemetic properties. It is commonly used to help prevent and control nausea and vomiting.

Initially, take one tablet orally at bedtime (Day 1). If this dose adequately controls symptoms the next day, continue taking one tablet daily at bedtime only. However, if symptoms persist on Day 2, increase the daily dose to one tablet in the morning and one tablet at bedtime. The maximum recommended dose is two tablets per day, one in the morning and one at bedtime. Take on an empty stomach with a glass of water. Swallow tablets whole. Do not crush, chew, or split this tablets. Take daily and not on an as needed basis.

The use of Doxylamine Succinate and Pyridoxine Hydrochloride is contraindicated in women taking monoamine oxidase inhibitors (MAOIs), as these drugs may prolong and intensify the central nervous system and anticholinergic effects of antihistamines. Concurrent use with alcohol or other CNS depressants such as sedatives, hypnotics, and tranquilizers is also not recommended.

Doxylamine Succinate and Pyridoxine Hydrochloride are contraindicated in women with any of the following conditions:

• Known hypersensitivity to Doxylamine Succinate, other ethanolamine derivative antihistamines, Pyridoxine Hydrochloride, or any inactive ingredient of the formulation
• Use of monoamine oxidase (MAO) inhibitors, as these may intensify and prolong the adverse central nervous system effects of this combination

Somnolence or drowsiness is the most common side effect. The risk increases when used together with other CNS depressants.

Pregnancy Category A. This combination is used for the treatment of nausea and vomiting during pregnancy when conservative management is not effective. Both doxylamine succinate and pyridoxine hydrochloride are excreted in breast milk; therefore, caution is advised during breastfeeding.

This combination may cause drowsiness due to the anticholinergic effect of doxylamine. Patients should avoid driving or operating heavy machinery while taking this medicine. It should not be used with alcohol or other CNS depressants. Use with caution in women with asthma, increased intraocular pressure, narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, or urinary bladder-neck obstruction.

As this is an extended-release formulation, overdose symptoms may not appear immediately. Symptoms may include restlessness, dry mouth, dilated pupils, drowsiness, dizziness, confusion, and tachycardia. Severe overdose may cause seizures, rhabdomyolysis, acute renal failure, and even death. Treatment includes gastric lavage, activated charcoal, bowel irrigation, and supportive care.

Anti-emetic drugs

Store below 30°C in a dry place, protected from light. Keep out of reach of children.