Pyridoxine Tablets Bp 20mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pyridoxine Tablets BP 20mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pyridoxine Hydrochloride Ph.Eur. 20mg For excipients see section 6.1
3 PHARMACEUTICAL FORM
Tablets
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Pyridoxine is indicated in the treatment of isoniazid-induced peripheral neuritis, idiopathic sideroblastic anaemia and pyridoxine deficiency states.
4.2 Posology and method of administration
Adults and Children over 12
Deficiency states: 20-50mg up to three times daily
Isoniazid neuropathy: Prophylaxis 10mg daily Therapeutic 50mg three times
daily
Idiopathic sideroblastic anaemia: 100mg-400mg daily in divided doses
Elderly
As for adults. No information to suggest that reduced dosage requirements are necessary.
Children under 12 years
Little information is available on the use of pyridoxine in children. Doses of 4mg/Kg have been used to treat children with familial pyridoxine resistance.
Route of administration
Oral.
4.3 Contraindications
None known.
4.4 Special warnings and precautions for use
With reference to the presence of lactose in the formulation, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine
4.5 Interaction with other medicinal products and other forms of interaction
Pyridoxine antagonises the therapeutic effect of levodopa when it is used without a dopa-decarboxylase inhibitor.
Larger doses of pyridoxine can cause a reduction in serum phenytoin and phenobarbitone levels in some patients.
Pyridoxine requirements have been reported to be increased by oral contraceptives, hydralazine, isoniazid and penicillamine.
4.6 Fertility, Pregnancy and lactation Pregnancy
Vitamin B complex preparations containing pyridoxine in addition to thiamine, riboflavin and nicotinamide have been used widely during pregnancy and animal studies have shown no hazard. As with all drugs the use of pyridoxine should be avoided if possible during the first trimester of pregnancy.
Lactation
Pyridoxine has been found in breast milk but no definite information is available on its use during lactation.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
None at recommended dosages. Large daily doses taken over a prolonged period can cause the development of severe peripheral neuropathy.
4.9 Overdose
Ingestion of 2-3g may cause headache. No treatment necessary.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pyridoxine is one of three similar compounds that may be referred to as Vitamin B6. The other two compounds are pyridoxal and pyridoxamine. Pyridoxine, converted to pyridoxal phosphate, is a co-enzyme for transamination and is involved in many metabolic processes.
5.2 Pharmacokinetic properties
Pyridoxine is readily absorbed from the gastrointestinal tract following oral administration and is converted to the active forms of pyridoxal phosphate and pyridoxamine phosphate, which are stored in the liver. The principal excretory product is 4-pyridoxic acid, which is formed by the action of hepatic aldehyde oxidase on free pyridoxal. Pyridoxine crosses the placenta and also appears in breast milk.
Preclinical safety data
5.3
None available.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose Maize Starch
Microcrystalline Cellulose (Avicel PH 101)
Talc
Magnesium Stearate
6.2 Incompatibilities
None.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Store below 30°C. Protect from light.
6.5 Nature and contents of container
Opaque polypropylene containers having snap-on polythene lids, with integral tear-off security seals e.g. Jaycare “Securitainer” or Wragby “Snap-Secure” container in pack sizes of 250 and 500 tablets.
In case any supply difficulties should arise the alternative is amber glass bottles with screw caps and steran faced liner.
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
Teva UK Limited Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG
8 MARKETING AUTHORISATION NUMBER(S)
PL 00289/1807
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
26th April 1994 / 18th February 1999
10 DATE OF REVISION OF THE TEXT
11/02/2013