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Doxylamine + Pyridoxine


Generic Medicine Info
Indications and Dosage
Oral
Pregnancy-associated nausea and vomiting
Adult: In patients not responsive to conservative management:
Doxylamine 10 mg and pyridoxine 10 mg delayed-release tab
Initially, 2 tabs at bedtime on Day 1. If symptoms improve the next day, continue with 2 tabs at bedtime. If symptoms persist into the afternoon of Day 2, continue the usual dose of 2 tabs at bedtime that night, then increase to 3 tabs (1 tab in the morning and 2 tabs at bedtime) on Day 3. If this dose adequately controls symptoms, continue with 3 tabs daily on Day 4. If symptoms are not adequately controlled on Day 3, may increase to 4 tabs (1 tab in the morning, 1 tab in the mid-afternoon, and 2 tabs at bedtime) starting on Day 4. Max dose: 4 tabs daily.

Doxylamine 20 mg and pyridoxine 20 mg extended-release tab
Initially, 1 tab at bedtime on Day 1, continue with the same dose if symptoms are adequately controlled. If symptoms are not adequately controlled on Day 2, dose may be increased to 2 tabs daily (1 tab in the morning and 1 tab at bedtime). Max dose: 2 tabs daily. Reassess the need for continued treatment as the pregnancy progresses.
What are the brands available for Doxylamine + Pyridoxine in Philippines?
Administration
Doxylamine + Pyridoxine Should be taken on an empty stomach. Swallow whole & do not chew/crush/split.
Contraindications
Concomitant use with MAOIs.
Special Precautions
Patient with asthma, increased intraocular pressure, narrow angle glaucoma, pyloroduodenal obstruction, stenosing peptic ulcer, bladder neck obstruction, hyperemesis gravidarum. Lactation.
Adverse Reactions
Significant: CNS depression.
Cardiac disorders: Tachycardia, palpitations.
Eye disorders: Blurred vision, visual disturbance.
Gastrointestinal disorders: Dry mouth, constipation, diarrhoea, abdominal distention, abdominal pain.
General disorders and administration site conditions: Fatigue, chest discomfort, malaise.
Nervous system disorders: Somnolence, dizziness, headache.
Psychiatric disorders: Insomnia, irritability.
Renal and urinary disorders: Dysuria, urinary retention.
Respiratory, thoracic and mediastinal disorders: Dyspnoea.
Skin and subcutaneous tissue disorders: Pruritus, rash, hyperhidrosis.
Patient Counseling Information
This drug may cause somnolence and dizziness, if affected, do not drive or operate machinery.
Monitoring Parameters
Monitor daily episodes of vomiting, heaves, and length of nausea.
Overdosage
Symptoms: Dry mouth, dilated pupils, vertigo, sleepiness, restlessness, mental confusion, tachycardia. Doxylamine: Rhabdomyolysis, seizures, acute renal failure, death. Management: Symptomatic treatment. May perform whole bowel irrigation, gastric lavage, or administer activated charcoal.
Drug Interactions
Prolonged and intensified anticholinergic effects with MAOIs. May enhance the CNS depressant effect with other CNS depressants (e.g. sedative hypnotics, tranquillisers), which may result in severe drowsiness.
Food Interaction
Decreased absorption and delayed onset of action with food. May enhance the CNS depressant effect of alcohol, which may result in severe drowsiness.
Lab Interference
May result in false-positive urine screening test for methadone, opiates and phencyclidine phosphate.
Action
Description:
Mechanism of Action: The exact mechanism of doxylamine and pyridoxine in pregnancy-associated nausea and vomiting has not been established.
Doxylamine, an ethanolamine derivative 1st generation antihistamine, selectively binds to H1 receptors in the brain. It inhibits the chemoreceptor trigger zone, reduces vestibular stimulation, and decreases labyrinthine function by exerting its central anticholinergic effects.
Pyridoxine, a water-soluble vitamin and precursor of pyridoxal, is involved in protein, carbohydrate, and fat metabolism. Pyridoxal also helps release glycogen stored in the liver and muscles, and in the synthesis of GABA in the CNS and haeme.
Synonym(s): Pyridoxine: Vitamin B6.
Pharmacokinetics:
Absorption: Food decreases the rate of absorption.
Doxylamine: Absorbed from the gastrointestinal tract, mainly in the jejunum. Time to peak plasma concentration: 2-4 hours.
Pyridoxine: Readily absorbed in the gastrointestinal tract.
Distribution: Enters breast milk.
Pyridoxine: Mainly stored in the liver; lesser amounts in muscle and brain. Crosses the placenta.
Metabolism: Doxylamine: Metabolised in the liver via N-dealkylation to N-desmethyldoxylamine and N,N-didesmethyldoxylamine.
Pyridoxine: Metabolised in the liver into pyridoxal phosphate and pyridoxamine phosphate (active forms).
Excretion: Doxylamine: Via urine (mainly as metabolites). Elimination half-life: 10-12 hours.
Pyridoxine: Via urine (as metabolites).
Chemical Structure

Chemical Structure Image
Doxylamine

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 3162, Doxylamine. https://pubchem.ncbi.nlm.nih.gov/compound/Doxylamine. Accessed Apr. 29, 2025.


Chemical Structure Image
Pyridoxine

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 1054, Pyridoxine. https://pubchem.ncbi.nlm.nih.gov/compound/Pyridoxine. Accessed Apr. 29, 2025.

Storage
Store between 15-30°C. Protect from moisture.
MIMS Class
Antiemetics
ATC Classification
R06AA59 - doxylamine, combinations ; Belongs to the class of aminoalkyl ethers used as systemic antihistamines.
References
Anon. Doxylamine Succinate. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 03/02/2025.

Anon. Pyridoxine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 03/02/2025.

Bonjesta Tablet, Extended Release (Duchesnay USA, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 03/02/2025.

Brayfield A, Cadart C (eds). Doxylamine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/02/2025.

Brayfield A, Cadart C (eds). Vitamin B6 Substances. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/02/2025.

Diclegis (Exeltis International Philippines, Inc). MIMS Philippines. http://www.mims.com/philippines. Accessed 03/02/2025.

Diclegis Tablet, Delayed Release (Duchesnay USA, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 03/02/2025.

Doxylamine and Pyridoxine. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 03/02/2025.

Doxylamine. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 03/02/2025.

Joint Formulary Committee. Doxylamine with Pyridoxine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/02/2025.

Pyridoxine. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 03/02/2025.

Xonvea 10 mg/10 mg Gastro-resistant Tablets (Exeltis Healthcare S.L.). MHRA. https://products.mhra.gov.uk. Accessed 03/02/2025.

Xonvea PR 20 mg/20 mg Prolonged-release Tablets (Exeltis Healthcare S.L.). MHRA. https://products.mhra.gov.uk. Accessed 03/02/2025.

Disclaimer: This information is independently developed by MIMS based on Doxylamine + Pyridoxine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2025 MIMS. All rights reserved. Powered by MIMS.com
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