Pyridoxine/ Thiamine/ Cyanocobalamin

Registered South African indications:

• Deficiency of vitamin B1, B6 or B12

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

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Should not be used in patients on levodopa therapy
• Children below the age of 14 years (due to the high doses of the active ingredients) (inj)

Cautions

Caution in the following patient groups

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly

Vitamin B12 deficiency

• Pyridoxine/ thiamine/ cyanocobalamin should not be given for vitamin B12 deficiency before a diagnosis has been fully established to avoid masking symptoms of subacute degeneration of the spinal cord

Optic neuropathies

• Pyridoxine/ thiamine/ cyanocobalamin are not suitable for treating optic neuropathies associated with raised plasma concentrations of vitamin B12

Prolonged use (inj)

• Neuropathies have been reported following long-term intake of more than 50mg mean daily dose of vitamin B6 for 6 to 12 months
• Regular monitoring is recommended if used over longer periods of time

Effects on ability to drive and use machines (inj)

• No effects of the product on the ability to drive or use machines are known

Forms avail. in SA and covered in this monograph: tab, inj 

Pyridoxine deficiency 
Thiamine deficiency 
Cyanocobalamin deficiency 

Pyridoxine/ Thiamine/ Cyanocobalamin
200/100/0.2 (mg)

• Oral (tab): 1 tab, daily 

Pyridoxine/ Thiamine/ Cyanocobalamin
100/100/1 (mg/3ml)

- Mild deficiency
- Follow up therapy following severe deficiency 

• IM: 6-9ml, weekly

- Severe deficiency

• IM: 3ml, daily; Treatment duration: until acute symptoms subside 

Preferably administered as deep intragluteal intramuscular injection

Not established for use in children below the age of 14 years (inj) (see contraindications) 
No information available (tab)

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

Pregnancy

• Caution
• The safety of this preparation in pregnancy has not been established

Breastfeeding

• Caution; not recommended (inj)
• Caution (tab)
• The safety of this preparation in lactation has not been established
• Vitamins B1, B6 and B12 are secreted into human breast milk, but risks of overdose for the infant are not known. High doses of vitamin B6, i.e. > 600mg daily, may inhibit the production of breast milk. Mothers on pyridoxine/ thiamine/ cyanocobalamin should not breastfeed their infants

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution, no information available

Elderly

• Caution; no information available

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

•  Permitted - No warnings

Pyridoxine 
Central Nervous System Disorders

• Severe peripheral neuritis 

Thiamine
Gastrointestinal Disorders

• Nausea and vomiting 
• Diarrhoea 
• Abdominal pain  

Immune, Blood and Lymphatic System Disorders

• Allergic reactions
• Anaphylactic reactions 

Cyanocobalamin
Central Nervous System Disorders

• Abnormal gait
• Anxiety
• Ataxia
• Dizziness
• Headache
• Hypoaesthesia
• Pain
• Paraesthesia

Cardiovascular Disorders

• Congestive cardiac failure
• Peripheral vascular disease
• Thrombosis

Respiratory Disorders

• Dyspnoea
• Pulmonary oedema
• Rhinitis

Gastrointestinal Disorders

• Diarrhoea
• Dyspepsia
• Glossitis
• Nausea and vomiting
• Pharyngitis

Musculoskeletal Disorders

• Arthritis
• Back pain
• Myalgia 
• Weakness

Immune, Blood and Lymphatic System Disorders

• Allergic reactions
• Polycythemia vera

Pyridoxine

• Isoniazid 
• Penicillamine 
• Oral contraceptives 
• Levodopa 

Thiamine

• Thiosemicarbazone
• 5-Fluorouracil

Cyanocobalamin

• Chloramphenicol
• Colchicine
• Alcohol 
• Oral contraceptives
• Folate

• Full blood count

Pyridoxine 
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.

Thiamine
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.

Cyanocobalamin
Vitamin B12 is used in the body in two forms, namely methylcobalamin and 5-deoxyadenosyl cobalamin. Both these substances are cofactors needed in enzymatic processes. Methylcobalamin is essential for eventual DNA methylation, while 5-deoxyadenosyl cobalamin is needed in the extraction of energy from proteins and fats and for the production of haemoglobin.

COMBINATION PREPARATIONS

Pyridoxine (Vit B6)/ Thiamine (Vit B1)/ Cyanocobalamin (Vit B12)

Tablet 200mg/100mg/200μg

• Neurobion (Merck) originator

Injection (per 3ml) 100mg/100mg/1mg

• Neurobion (Merck) originator