BENADON ® - Pyridoxine

BENADON ® is a pyridoxine based drug

THERAPEUTIC GROUP: Vitamin supplements: pyridoxine

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications BENADON ® - Pyridoxine

BENADON ® is used to restore normal concentrations of vitamin B6, during deficiencies associated with malnutrition or chronic alcoholism.

Sometimes BENADON ® can also be indicated as an adjunct to the treatment of hyperemesis gravidarum or neuritis.

Mechanism of action BENADON ® - Pyridoxine

Pyridoxine, also known as vitamin B6, is a water-soluble vitamin belonging to the B group vitamins, essential in maintaining the energy balance of the human body, being a cofactor in more than 100 different enzymatic reactions.

Its function is indispensable both in the regeneration of glucose (glycogenolysis and gluconeogens), and in the production of neurotransmitters such as serotonin, dopamine, noradrenaline and GABA, both in the synthesis of nucleic acids and niacin.

Fortunately, the lack of vitamin B6, rare as it is due to the excellent dietary availability and efficient intestinal absorption, is limited to particular categories of patients at risk such as chronic alcoholics exposed to particularly severe symptoms such as irritability, depression, mental confusion, inflammation of the mucous membrane of the oral cavity and tongue.

Studies carried out and clinical efficacy

1. VITAMIN B6 AND PREGNANCY HYPEREMESIS

Study that investigates the efficacy of vitamin B6 supplementation in the treatment of hyperemesis gravidarum. Although pregnant women with hyperemesis have lower pyridoxine blood concentrations than normal, supplementation with vitamin B6, while restoring the aforementioned levels, does not seem to produce a particularly appreciable symptomatic result.

2. VITAMIN B6 IN THE PREVENTION OF ISIONAZIDE POLINEUROPATHY

Work demonstrating the effectiveness of supplementation with pyridoxine in HIV positive patients with tuberculosis, in reducing the neurological complications associated with isionazide administration.

3. SUPPLEMENTATION WITH VITAMIN B6 IN CHILDREN WITH EPILEPSY

Supplementation with pyridoxine in pediatric patients on levetiracetam (anticonvulsant) therapy appears to significantly reduce the behavioral disorders associated with therapy.

Method of use and dosage

BENADON ®

Gastro-resistant tablets of 300 mg of pyridoxine hydrochloride;

Solution for injection for intramuscular use from 300mg of pyridoxine hydrochloride per 2 ml of solution:

the recommended dosage to cope with vitamin B6 deficiencies is 300 mg daily, taken orally or parenterally in case of intestinal malabsorption.

The aforementioned dosage could be modified by the doctor, based on the therapeutic needs of the patient.

Warnings BENADON ® - Pyridoxine

The use of BENADON ® in parkinsonian patients should be performed under medical supervision in order to monitor the therapeutic efficacy of L-dopa.

Clinical practice shows that injecting pyridoxine may be associated with a significant increase in allergic reactions, leading to severe respiratory difficulties, tachycardia and anaphylactic shock in the most serious cases.

PREGNANCY AND BREASTFEEDING

The use of BENADON ® as an adjuvant of hyperemesis gravidarum, should take place only in case of actual need and under strict medical indication, given the high dosage of vitamin B6 present.

Interactions

The concomitant assumption of antitubercular drugs such as the Eisionazide, L-dopa or penicillamine, could facilitate the formation of molecular complexes containing vitamin B6, thus causing a functional deficit of this vitamin.

At the same time, pyridoxine could decrease the therapeutic efficacy of anticonvulsants and L-dopa.

Contraindications BENADON ® - Pyridoxine

The use of BENADON ® is contraindicated in case of hypersensitivity to the active ingredient or to one of its excipients.

Undesirable effects - Side effects

The use of BENADON ®, when carried out according to medical indications, is free of clinically significant side effects, except for possible allergic reactions following parenteral administration of pyridoxine.

Prolonged use, at high doses, may instead be responsible for sensory neuropathy.