Vitamin B6 Hevert

For the treatment of vitamin B6-dependent disorders such as neuritis, hyperhomocysteinemia

Vitamin B6 is involved primarily in the metabolism of protein and the breakdown of homocysteine, together with vitamin B12 and folic acid. Vitamin B6 deficiency is usually coupled with a deficiency in other vitamins.

Typical signs of vitamin B6 deficiency are:

• nausea, loss of appetite, vomiting
• inflammatory, flaky skin conditions (dermatitis) especially around the nose and eyes
• inflammation in the mouth and on the lips
• insomnia, nervousness, irritability
• nerve disorders
• anemia that does not respond to iron

Changes in the blood due to vitamin B6 deficiency may include an increase in the CRP (C-reactive protein) value as an indication of an immune system disorder and an associated increase in the risk of cardiovascular disease, as well as an increase in the harmful amino acid homocysteine in the blood.

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Dosing instructions, method and duration of use

Adults: Treatment of peripheral neuropathy due to drug-induced vitamin B deficiency: The dose should be determined by the treating physician on an individual basis. Usually 50 mg to 300 mg pyridoxine hydrochloride (vitamin B6) per day are recommended. (1 tablet Vitamin B6-Hevert Tablets contains 100 mg pyridoxine hydrochloride.) – Treatment of pyridoxine-dependent disorders (primary hyperoxaluria type I, homocystinuria, cystathioninuria, xanthurenic aciduria, hypochromic microcytic anemia caused by vitamin B6 deficiency): The dose should be determined by the treating physician on an individual basis. The general recommendation is 10 mg to 250 mg, in individual cases also up to 600 mg and more pyridoxine hydrochloride (vitamin B6) per day. (1 tablet Vitamin B6-Hevert Tablets contains 100 mg pyridoxine hydrochloride.) − Treatment of pyridoxine-dependent disorders (sideroblastic anemia): The dose should be determined by the treating physician on an individual basis. Doses starting at 200 mg pyridoxine hydrochloride (vitamin B6) per day are usually recommended. (1 tablet Vitamin B6-Hevert Tablets contains 100 mg pyridoxine hydrochloride.) Children − Treatment of peripheral neuropathy due to drug-induced vitamin B deficiency: The dose should be determined by the treating physician on an individual basis. Usually 50 mg to 200 mg pyridoxine hydrochloride (vitamin B6) per day are recommended. (1 tablet Vitamin B6-Hevert Tablets contains 100 mg pyridoxine hydrochloride.) − Maintenance therapy following seizures caused by vitamin B6 deficiency in newborns and infants: The dose should be determined by the treating physician on an individual basis. Usually doses starting of 2 mg to 200 mg pyridoxine hydrochloride (vitamin B6) per day are recommended. The amount needed increases based on age and any comorbidities. (1 tablet Vitamin B6-Hevert Tablets contains 100 mg pyridoxine hydrochloride.) − Treatment of pyridoxine-dependent disorders in children over 1 year of age: The dose should be determined by the treating physician on an individual basis. Usually 10 mg to 250 mg (in babies up to 1 year old: 2 mg to 15 mg) pyridoxine hydrochloride (vitamin B6) per day are recommended. (1 tablet Vitamin B6-Hevert Tablets contains 100 mg pyridoxine hydrochloride.) Please note: For the treatment of simple vitamin B6 deficiency 25 mg pyridoxine hydrochloride (vitamin B6) per day is sufficient.

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Ingredients

1 tablet contains:
Pyridoxine hydrochloride (vitamin B6) 100 mg

Inactive ingredients:

Calcium hydrogenphosphate dihydrate, microcrystalline cellulose, magnesium stearate, corn starch, highly disperse silicon dioxide.

Dosage
Adults	Behandlung einer peripheren Neuropathie	50 mg bis 300 mg Pyridoxinhydrochlorid
	Behandlung von pyridoxinabhängigen Störungen	10 mg bis 250 mg, in Einzelfällen bis 600 mg und mehr Pyridoxinhydrochlorid
	Behandlung von pyridoxinabhängigen Störungen (Sideroblastische Anämie)	ab 200 mg Pyridoxinhydrochlorid pro Tag empfohlen
Children	Behandlung einer peripheren Neuropathie	50 mg bis 200 mg Pyridoxinhydrochlorid
	Behandlung von pyridoxinabhängigen Störungen	2 mg bis 200 mg
	Behandlung von pyridoxinabhängigen Störungen (Sideroblastische Anämie)	10 mg bis 250 mg Pyridoxinhydrochlorid pro Tag empfohlen

Indications

Adults: Treatment of peripheral neuropathy (neuritis) secondary to drug-induced vitamin B6 deficiency (e.g., caused by medications with active substances such as isoniazid, D-penicillamine, cycloserine).
− Treatment of pyridoxine-dependent disorders (rare metabolic disorders such as primary hyperoxaluria type I, homocystinuria, cystathioninuria, xanthurenic aciduria or rare blood formation disorders such as sideroblastic anemia, hypochromic microcytic anemia caused by vitamin B6 deficiency which can be treated in part with higher vitamin B6 doses).
Children: Treatment of peripheral neuropathy (neuritis) secondary to drug-induced vitamin B6 deficiency (e.g., caused by medications with active substances such as isoniazid, D-penicillamine, cycloserine).
− Maintenance therapy following seizures caused by vitamin B6 deficiency in newborns and infants.
− Treatment of pyridoxine-dependent disorders in children over 1 year of age (rare metabolic disorders such as primary hyperoxaluria type I, homocystinuria, cystathioninuria, xanthurenic aciduria or rare blood formation disorders such as sideroblastic anemia, hypochromic microcytic anemia caused by vitamin B6 deficiency which can be treated in part with higher vitamin B6 doses).

Contraindications

Do not take Vitamin B6-Hevert Tablets if you have an allergy to pyridoxine hydrochloride (vitamin B6) or any of other ingredients.

Adverse effects

In patients taking daily doses above 50 mg vitamin B6 as well as short-term use of doses in the one gram range peripheral sensory neuropathy has been observed (nerve disorder with tingling and a pins-and-needles sensation) (see also under Precautions for use). Photosensitivity (hypersensitivity to sunlight) has been described with very high daily doses. Gastrointestinal disturbances have been reported at higher doses.