INN monograph
Meclozine / pyridoxine [Vitamin B6]
Vitamin / mineral / nutritional supplement · POM
Verified · Updated 01 Aug 2026 · Source: Local active-ingredient clinical extract; Component monographs (multi-source pipeline); Professional class pharmacology (Vitamin / mineral / nutritional supplement)
Kenya market
Wholesale / list prices where loaded
Risk first
Contraindications
- [Meclozine] [From component Caffeine Citrate] CONTRAINDICATIONS Caffeine Citrate Injection is contraindicated in patients who have demonstrated hypersensitivity to any of its components.
Precautions
- [From component Pyridoxine] PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient.
- Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Point of care
Dosing
Adult
Dosing is indication-, age-, weight- and organ-function-specific for this INN. Do not use class averages for high-risk patients. Confirm the exact regimen in the current SmPC and Kenya Standard Treatment Guidelines. Typical professional workflow: (1) confirm indication, (2) check renal/hepatic function, (3) screen interactions/allergies, (4) select dose/route/duration, (5) define monitoring.
Paediatric
Paediatric dosing is weight- and age-based; use a paediatric formulary / SmPC. Do not extrapolate adult tablets without calculation.
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
- Prefer food-first then targeted replacement.
- Document laboratory indication for high-dose therapy.
- Public health: vitamin A, iron, folate programmes per MoH guidance.
Safety
Adverse effects
- [Meclozine] [From component Caffeine Citrate] ADVERSE REACTIONS Overall, the reported number of adverse events in the double-blind period of the controlled trial was similar for the caffeine citrate and placebo groups.
- The following table shows adverse events that occurred in the double-blind period of the controlled trial and that were more frequent in caffeine citrate-treated patients than placebo.
- ADVERSE EVENTS THAT OCCURRED MORE FREQUENTLY IN CAFFEINE CITRATE-TREATED PATIENTS THAN PLACEBO DURING DOUBLE-BLIND THERAPY Adverse Event (AE) Caffeine Citrate N=46 n (%) Placebo N=39 n (%) BODY AS A WHOLE Accidental Injury 1 (2.2) 0 (0.0) Feeding Intolerance 4 (8.7) 2 (5.1) Sepsis 2 (4.3) 0 (0.0) CARDIOVASCULAR SYSTEM Hemorrhage 1 (2.2) 0 (0.0) DIGESTIVE SYSTEM Necrotizing Enterocolitis 2 (4.3) 1 (2.6) Gastritis 1 (2.2) 0 (0.0) Gastrointestinal Hemorrhage 1 (2.2) 0 (0.0) HEMIC AND LYMPHATIC SYSTEM Disseminated Intravascular Coagulation 1 (2.2) 0 (0.0) METABOLIC AND NUTRITIVE DISORDERS Acidosis 1 (2.2) 0 (0.0) Healing Abnormal 1 (2.2) 0 (0.0) NERVOUS SYSTEM Cerebral Hemorrhage 1 (2.2) 0 (0.0) RESPIRATORY SYSTEM Dyspnea 1 (2.2) 0 (0.0) Lung Edema 1 (2.2) 0 (0.0) SKIN AND APPENDAGES Dry Skin 1 (2.2) 0 (0.0) Rash 4 (8.7) 3 (7.7) Skin Breakdown 1 (2.2) 0 (0.0) SPECIAL SENSES Retinopathy of Prematurity 1 (2.2) 0 (0.0) UROGENITAL SYSTEM Kidney Failure 1 (2.2) 0 (0.0) In addition to the cases above, three cases of necrotizing enterocolitis were diagnosed in patients receiving caffeine citrate during the open-label phase of the study.
- Three of the infants who developed necrotizing enterocolitis during the trial died.
- All had been exposed to caffeine.
- Two were randomized to caffeine, and one placebo patient was “rescued” with open-label caffeine for uncontrolled apnea.
- Adverse events described in the published literature include: central nervous system stimulation (i.e., irritability, restlessness, jitteriness), cardiovascular effects (i.e., tachycardia, increased left ventricular output, and increased stroke volume), gastrointestinal effects (i.e., increased gastric aspirate, gastrointestinal intolerance), alterations in serum glucose (i.e., hypoglycemia and hyperglycemia), and renal effects (i.e., increased urine flow rate, increased creatinine clearance, and increased sodium and calcium excretion).
- Published long-term follow-up studies have not shown caffeine to adversely affect neurological development or growth parameters.
- A published randomized, placebo-controlled, clinical trial in premature infants with birthweights of 500-1250 grams studied the safety of caffeine citrate in apnea of prematurity (NCT00182312).
- This trial randomized approximately 2000 premature infants with a mean gestational age of 27 weeks at birth.
- The median duration of caffeine therapy was 37 days.
- Prior to discharge home, death, ultrasonographic signs of brain injury, and necrotizing enterocolitis were not more common in the caffeine citrate group compared to the placebo.
- At follow up at both 18 months and 5 years corrected age, death was not more common in the caffeine citrate treated group compared to placebo, nor did caffeine citrate use adversely affect neurodevelopmental outcomes.
Use
Indications
- Therapeutic use is agent- and indication-specific within the class (Vitamin / mineral / nutritional supplement).
- Use according to culture results, national guidelines (Kenya STG/EML where applicable) and the current product SmPC.
- Nausea and vomiting
Pharmacology
Mode of action
Vitamins and minerals act as cofactors, antioxidants, structural elements or hormone precursors (e.
Full mechanism text
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 |
|---|---|---|---|
| No brands linked yet. | |||
Special populations
Pregnancy & lactation
Pregnancy
[Meclozine] [From component Caffeine Citrate] Pregnancy Pregnancy Category C Concern for the teratogenicity of caffeine is not relevant when administered to infants. In studies performed in adult animals, caffeine (as caffeine base) administered to pregnant mice as sustained release pellets at 50 mg/kg (less than the maximum recommended intravenous loading dose for infants on a mg/m 2 basis), during the period of organogenesis, caused a low incidence of cleft palate and exencephaly in the fetuses. There are no adequate and well-controlled studies in pregnant women.
Lactation
Maternal repletion often appropriate; avoid megadoses.
Diet
Food & alcohol
- Food
- Food
Trust
Sources & disclaimer
Source: Local active-ingredient clinical extract; 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.