Apo-pyridoxine

Overdose

a) Symptoms - None reported

b) Treatment - no treatment necessary.

Contraindications

Hypersensitivity to any of the ingredients.

Incompatibilities

None known

Undesirable effects

Long term administration of large doses of Apo-Pyridoxine is associated with the development of severe peripheral neuritis.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

Preclinical safety data

There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the Summary of Product Characteristics.

Therapeutic indications

Apo-Pyridoxine Hydrochloride is used for isoniazid-induced peripheral neuritis, idiopathic sideroblastic anaemia and Vitamin B6 deficiency states.

Pharmacodynamic properties

Apo-Pyridoxine hydrochloride is Vitamin B6. It is converted to pyridoxal phosphate which is the co-enzyme for a variety of metabolic transformations. It is essential for human nutrition.

Pharmacokinetic properties

Apo-Pyridoxine hydrochloride is absorbed from the gastrointestinal tract and is converted to the active forms pyridoxal phosphate and pyridoxamine phosphate. It crosses the placental barrier and appears in breast milk. It is excreted in the urine as 4-pyridoxic acid.

Name of the medicinal product

Apo-Pyridoxine

Qualitative and quantitative composition

Pyridoxine Hydrochloride

Special warnings and precautions for use

If symptoms persist or worsen, seek medical advice. Do not exceed the stated dose.

Effects on ability to drive and use machines

None known.

Dosage (Posology) and method of administration

For isoniazid-induced peripheral neuritis

Adults:

Treatment - 50mg three times daily

Prophylaxis - Not suitable with this dosage form

Children:

This presentation is not recommended

For idiopathic sideroblastic anaemia

Adults:

100 to 400mg daily in divided doses

Children:

This presentation is not recommended

For deficiency states

Adults:

50 to 150mg daily in divided doses

Children:

This presentation is not recommended

Elderly:

Dosage requirements appear to be similar to those for young adults

Special precautions for disposal and other handling

Not applicable.