The Pyridoxine Hydrochloride + Doxylamine Succinate combination is indicated for the treatment of nausea and vomiting of pregnancy in women who do not achieve adequate relief with conservative management.
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Doxylamine Succinate is an ethanolamine-class antihistamine that acts by blocking histamine (H1) receptors. It readily crosses the blood–brain barrier and exhibits strong affinity for central H1 receptors. Its antiemetic effect is achieved through inhibition of the vestibular system and muscarinic receptors, thereby reducing stimulation of the vomiting center.
Pyridoxine Hydrochloride (Vitamin B6) is a vitamin B6 analog that possesses anti-nausea properties and plays a supportive role in reducing pregnancy-related nausea and vomiting.
Pregnancy Category A: Intended for the treatment of nausea and vomiting of pregnancy when conservative measures are ineffective.
Lactation: Both components are excreted into breast milk; therefore, caution is advised when administered to breastfeeding women.
Begin treatment with one tablet orally at bedtime (Day 1).
If symptoms are adequately controlled, continue with one tablet daily at bedtime.
If symptoms persist on Day 2, increase the dose to one tablet in the morning and one tablet at bedtime.
Maximum recommended dose: two tablets per day.
Tablets should be taken daily on an empty stomach with a glass of water. Swallow whole; do not crush, chew, or split. This medication should be taken regularly and not on an as-needed basis.
Concomitant use with monoamine oxidase inhibitors (MAOIs) is contraindicated, as MAOIs may intensify and prolong the central nervous system and anticholinergic effects of antihistamines.
Concurrent use with alcohol or other CNS depressants (e.g., sedatives, tranquilizers, hypnotics) is not recommended due to the increased risk of excessive sedation.
Somnolence
Increased risk of accidents when used with CNS depressants
Known hypersensitivity to Doxylamine Succinate, Pyridoxine Hydrochloride, other ethanolamine-derived antihistamines, or any formulation component
Concurrent use of monoamine oxidase (MAO) inhibitors
This medication may cause drowsiness due to the anticholinergic effects of doxylamine. Patients should avoid driving or operating heavy machinery while taking this medicine.
Use is not recommended in women who are consuming alcohol or other CNS depressants.
Due to anticholinergic activity, caution is required in patients with asthma, increased intraocular pressure, narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, or urinary bladder-neck obstruction.
Store in a cool, dry place below 30°C, protected from light and moisture. Keep out of reach of children.
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