Medine.co.uk

Out of date information, search another

Pyridoxine Tablets Bp 20mg

Out of date information, search another
Informations for option: Pyridoxine Tablets Bp 20mg, show other option

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