Thiamine/ Nicotinamide/ Phenobarbitone/ Pyridoxine/ Riboflavin

Registered South African indications:

• Nervous insomnia
• Epilepsy
• Anxiety

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Thiamine
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product  

Cautions

• Pregnancy (if doses > recommended daily allowance)
• Breastfeeding

Nicotinamide
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product

Cautions

• Pregnancy
• Breastfeeding 
• Hepatic impairment
• Diabetes mellitus
• Gout
• History of peptic ulcer disease

Phenobarbitone
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Pregnancy
• Severe renal impairment
• Severe hepatic impairment
• Acute intermittent porphyria
• Severe respiratory depression

Cautions

• Breastfeeding
• Mild to moderate renal impairment
• Mild to moderate hepatic impairment
• Elderly
• Respiratory depression
• Young patients
• Debilitated patients
• Senile patients
• Abrupt withdrawal
• Acute on chronic pain
• Prolonged use
• History of drug abuse
• Alcoholism
• May impair ability to drive and operate machinery

Pyridoxine
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product

Cautions

• Pregnancy (if doses > recommended daily allowance)
• Prolonged therapy
• High doses

Riboflavin
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product

Cautions

• Vitamin deficiency

Additional contraindications for this combination product

• Hyperkinetic children

Forms avail. in SA and covered in this monograph: syr

Nervous insomnia
Epilepsy
- Especially for grand mal seizures or psychomotor attacks
Anxiety

Thiamine/ Nicotinamide/ Phenobarbitone/ Pyridoxine/ Riboflavin
3/10/16/0.25/1 (mg/5ml)

• Oral (syr): 10ml, 8-12hrly with water

Paed. forms avail. in SA and covered in this monograph: syr

Nervous insomnia
Epilepsy
- Especially for grand mal seizures or psychomotor attacks
Anxiety

Thiamine/ Nicotinamide/ Phenobarbitone/ Pyridoxine/ Riboflavin
3/10/16/0.25/1 (mg/5ml)

• Infants: 2.5-5ml, 8-12hrly with water
• Children: 5-10ml, 8-12hrly with water

Recommendations for this combination product as per highest risk category when comparing individual active ingredients

Pregnancy

• FDA Pregnancy Category D (Phenobarbitone) 

Breastfeeding

• Caution; not recommended (Phenobarbitone)

Renal Impairment

• Mild to moderate: Caution; no dose adjustment recommended (Phenobarbitone)
• Severe: Contraindicated (Phenobarbitone)

Hepatic Impairment

• Mild to moderate: Caution; no dose adjustment recommended (Phenobarbitone) 
• Severe: Contraindicated (Phenobarbitone)

Elderly

• Caution; dose adjustment recommended (Phenobarbitone)

Drugs in Sport

• Permitted - No warning

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Thiamine
Gastrointestinal Disorders 

• Nausea and vomiting
• Diarrhoea
• Abdominal pain  

Immune Disorders

• Allergic reactions
• Anaphylactic reactions

Nicotinamide
Central Nervous System Disorders

• Fainting
• Headache
• Dizziness

Cardiovascular Disorders

• Flushing

Gastrointestinal Disorders

• Abdominal pain
• Diarrhoea
• Nausea and vomiting

Hepatobiliary Disorders

• Jaundice
• Increased hepatic enzymes
• Hepatotoxicity

Endocrine and Metabolic Disorders

• Hyperglycaemia

Skin and Subcutaneous Tissue Disorders

• Rash

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions

Sensory Disorders

• Blurred vision

Phenobarbitone
Central Nervous System Disorders

• Hyperactivity
• Behavioural disturbances in children
• Ataxia
• Nystagmus
• Paradoxical reactions
• Hallucinations
• Restlessness 
• Confusion in the elderly
• Mental depression
• Memory and cognitive impairment
• Drowsiness
• Lethargy

Cardiovascular Disorders

• Hypotension

Respiratory Disorders

• Respiratory depression

Hepatobiliary Disorders

• Hepatitis
• Cholestasis

Musculoskeletal Disorders

• Osteomalacia
• Rickets
• Decreased bone mineral density
• Osteopenia
• Osteoporosis
• Fractures

Skin and Subcutaneous Tissue Disorders

• Allergic skin reactions 
• Exfoliative dermatitis
• Erythema multiforme
• Stevens-Johnson syndrome 
• Toxic epidermal necrolysis

Immune, Blood and Lymphatic System Disorders

• Megaloblastic anaemia 
• Agranulocytosis
• Thrombocytopenia
• Hypersensitivity syndrome

Pyridoxine
Central Nervous System Disorders

• Severe peripheral neuritis

Riboflavin
Gastrointestinal Disorders

• Urine discolouration

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Thiamine

• Thiosemicarbazone
• 5-Fluorouracil  

Nicotinamide

• HMG-CoA reductase inhibitors
• Antidiabetic agents
• Primidone
• Carbamazepine

Phenobarbitone

• Central nervous system depressants 
• Antidepressants 
• Antiepileptics
• Antipsychotics
• Folic acid
• Memantine 
• Methylphenidate
• St John's wort 
• Anti-arrhythmics
• Antibacterials
• Anticoagulants
• Antifungals
• Antivirals 
• Anxiolytics
• Hypnotics
• Aprepitant
• Beta blockers
• Calcium channel blockers 
• Cardiac glycosides
• Ciclosporin 
• Tacrolimus
• Corticosteroids
• Cytotoxics
• Diuretics 
• Hormone antagonists
• Methadone
• Montelukast
• Oestrogens
• Progestogens
• Sodium oxybate
• Theophylline
• Thyroid hormones
• Tibolone
• Tropisetron
• Vitamins 

Pyridoxine

• Isoniazid
• Penicillamine
• Oral contraceptives
• Levodopa

Riboflavin 

• No information available

• Renal function
• Hepatic function
• Full blood count

Specific cases may require

• Phenobarbitone serum concentrations

Thiamine (Vit B1)
Thiamine pyrophosphate (TPP), the coenzymatic form of thiamine, is involved in decarboxylation of alpha-ketoacids and transketolation. Therefore, the main physiological role of thiamine is as a coenzyme in carbohydrate metabolism, where TPP is required for several stages in the breakdown of glucose to provide energy. Thiamine also plays a role in neurotransmitter function and in nerve conduction. In high doses, thiamine suppresses the transmission of neural stimuli and thus can have an analgesic effect. 

Nicotinamide
Nicotinamide is a water-soluble component of the vitamin B complex group. It functions as a component of the coenzyme nicotinamide adenine dinucleotide and nicotinamide adenine dinucleotide phosphate. It is involved in proper utilisation of fats, healthy skin, nerves, digestive system, blood vessels and cholesterol control. It is also essential for the synthesis of sex hormones. 

Phenobarbitone
Phenobarbitone is a long acting barbituate acting by depression of the central nervous system.

Pyridoxine (Vit B6)
Pyridoxine is converted to pyridoxal 5-phosphate in the body. Pyridoxal 5-phosphate is a coenzyme for the synthesis of amino acids, neurotransmitters (serotonin, norepinephrine), sphingolipids and aminolevulinic acid. 

Riboflavin (Vit B2)
Component of flavoprotein enzymes that work together, which are necessary for normal tissue respiration; also needed for activation of pyridoxine and conversion of tryptophan to niacin

COMBINATION PREPARATIONS

Thiamine/ Nicotinamide/ Phenobarbitpne/ Pyridoxine/ Riboflavin

Syrup (per 5ml) 3mg/10mg/16mg/0.25mg/1mg

• Adco-Phenobarbitone Vitalet (Adcock)