INN monograph
Doxylamine / pyridoxine
Vitamin / mineral / nutritional supplement · POM
Verified · Updated 01 Aug 2026 · Source: Local active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Component monographs (multi-source pipeline); Professional class pharmacology (Vitamin / mineral / nutritional supplement)
Kenya market
Wholesale / list prices where loaded
Risk first
Contraindications
- [Doxylamine] Hypervitaminosis risk states (hypercalcaemia for vitamin D/A).
- Iron: avoid in iron overload.
- Potassium: severe hyperkalaemia / untreated Addison's. [pyridoxine] Hypervitaminosis risk states (hypercalcaemia for vitamin D/A).
- Iron: avoid in iron overload.
- Potassium: severe hyperkalaemia / untreated Addison's.
Precautions
- Warnings Do not use in children under 12 years of age with any other product containing doxylamine unless you have time for a full night’s sleep Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or any other sleep-aid tranquilizers any other antihistamines any other drugs When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery take only at bedtime Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks.
- Insomnia may be a symptom of serious underlying medical illness.
- If pregnant or breast-feeding, ask a health professional before use.
- Keep out of reach of children.
- In case of overdose, get medical help or contact a Poison Control Center right away.
Point of care
Dosing
Adult
Directions adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor children under 12 years of age: do not use
Paediatric
See label paediatric section if present; otherwise use paediatric formulary — do not extrapolate adult doses.
Renal
Fat-soluble vitamins and potassium need care in advanced CKD.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Hepatic
Vitamin A toxicity hepatic; niacin hepatotoxicity at high dose.
Safety
Drug interactions
- Pregnancy: Safety in pregnancy and lactation has not been established.
- Fixed-dose/multi-ingredient product.
- Clinical details partially inherited from component monographs: Doxylamine / pyridoxine, Pyridoxine.
- Confirm combination SmPC for exact dosing.
Safety
Adverse effects
- [Doxylamine] GI upset (iron, high-dose vitamin C).
- Hypercalcaemia (vitamin D excess).
- Neuropathy with B6 megadoses.
- Flushing (niacin). [pyridoxine] GI upset (iron, high-dose vitamin C).
- Hypercalcaemia (vitamin D excess).
- Neuropathy with B6 megadoses.
- Flushing (niacin).
Use
Indications
- Prevention or minimization of nausea and vomiting associated with pregnancy.
- Clinical selection for Doxylamine / pyridoxine should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC.
- Class context: Vitamin / mineral / nutritional supplement.
- Confirm site-specific dose, duration and monitoring before prescribing.
Pharmacology
Mode of action
It is a selective calcium antagonist.
Full mechanism text
It is a selective calcium antagonist. It prevents cellular calcium overload by reducing excessive transmembrane calcium influxes. Vitamins and minerals act as cofactors, antioxidants, structural elements or hormone precursors (e.g. vitamin D endocrine axis). Pharmacological high-dose effects differ from nutritional repletion.
ADME
Pharmacokinetics & PD
| Onset | Days–weeks for repletion |
|---|---|
| Duration | Depends on stores and ongoing intake |
| Route | ORAL / IM / IV (selected) |
| Absorption | depends on GI integrity, food matrix and binders (e.g. calcium/iron interactions). Fat-soluble vitamins (A,D,E,K) accumulate; water-soluble generally renally cleared. |
Kenya
Brands & prices
| Brand | Company | Pack | KES |
|---|---|---|---|
| Domi-6 | Lincoln Pharmaceuticals Ltd. | Standard Commercial Pack | — |
| Morniz | Aristo Pharmaceuticals Ltd. | Standard Commercial Pack | — |
| Nosic | Indoco Remedies Ltd. | Standard Commercial Pack | — |
| Preg Smile | Synergy Pharma | Standard Commercial Pack | — |
Special populations
Pregnancy & lactation
Pregnancy
[Doxylamine] Folic acid preconception/first trimester critical. Iron/folate common in ANC. Avoid excess vitamin A. [pyridoxine] Folic acid preconception/first trimester critical. Iron/folate common in ANC. Avoid excess vitamin A.
Lactation
Maternal repletion often appropriate; avoid megadoses.
Diet
Food & alcohol
- Food
- Food
Trust
Sources & disclaimer
Source: Local active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Component monographs (multi-source pipeline); Professional class pharmacology (Vitamin / mineral / nutritional supplement)
Last reviewed: 01 Aug 2026
Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.