Pyridoxine: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Indonesia prescribing information.

Generic Medicine Info

Indications and Dosage

Intramuscular, Intravenous
Vitamin B6 deficiency

Adult: In cases where oral administration is not feasible: 10-20 mg daily for 3 weeks via IV or IM inj, then shift to daily oral treatment. Dosage recommendations may vary among individual products and between countries (refer to specific product guidelines).

Oral
Vitamin B6 deficiency

Adult: Up to 150 mg daily. Adjust dose based on patient's response. Dosage recommendations may vary among individual products and between countries (refer to specific product guidelines).

Oral
Homocystinuria, Primary hyperoxaluria, Sideroblastic anaemia

Adult: 100-400 mg daily. Alternatively, 200-600 mg daily. Adjust dose based on patient's response. Lifelong administration may be needed to prevent reoccurrence. Dosage recommendations may vary among individual products and between countries (refer to specific product guidelines).

Oral
Isoniazid-induced peripheral neuropathy

Adult: As prophylaxis: 10-50 mg daily. As treatment: 50 mg tid. Dosage recommendations may vary among individual products and between countries (refer to specific product guidelines).
Child: >12 years As prophylaxis: 10 mg daily. As treatment: 30-50 mg bid or tid. Dosage or treatment recommendations may vary among individual products and between countries (refer to specific product guidelines).

Administration

May be taken with or without food. Best taken w/ food & liqd. Consult product literature for specific instructions. ER tab: Swallow whole, do not break/crush/chew.

Special Precautions

Children. Pregnancy and lactation.

Adverse Reactions

Significant: Severe peripheral neuropathies, particularly during long-term use and/or use of high doses (risk may vary between individuals; there have been reported cases of peripheral neuropathy even with doses <50 mg/day); drug dependence and withdrawal (for doses ≥200 mg/day).
Gastrointestinal disorders: Nausea.
Immune system disorders: Hypersensitivity reaction.
Investigations: Increased serum AST, decreased serum folic acid levels.
Metabolism and nutrition disorders: Metabolic acidosis (particularly in patients with seizures following rapid infusion of high doses).
Nervous system disorders: Headache, paraesthesia, drowsiness; seizure (very high IV doses).

Pregnancy Category (US FDA)

IV/Parenteral/PO: A

Patient Counseling Information

If you develop tingling, burning, or numbness in the hands or feet during treatment, inform your doctor immediately.

Monitoring Parameters

Closely monitor for signs and symptoms of peripheral neuropathy. Consider performing nerve conduction velocity tests every 1-2 years in patients receiving long-term higher doses.

Drug Interactions

May reduce the serum levels of phenobarbital and phenytoin. May reduce the effect of levodopa (when concurrently used without a dopa-decarboxylase inhibitor) and altretamine. Oral contraceptives (e.g. estrogen), cycloserine, penicillamine, isoniazid and hydralazine may increase the requirements for pyridoxine.

Lab Interference

May produce false-positive results for urobilinogen in the spot test using Ehrlich's reagent.

Action

Description:
Mechanism of Action: Pyridoxine is a water-soluble vitamin that is involved in the metabolism of amino acids, carbohydrates, and fats. It is necessary for haeme formation and GABA synthesis in the CNS. It also helps release glycogen stored in the liver and muscle.
Synonym(s): Vitamin B₆.
Pharmacokinetics:
Absorption: Readily absorbed from the gastrointestinal tract.
Distribution: Mainly stored in the liver; low amounts in muscles and brain. Crosses the placenta and enters breast milk.
Metabolism: Converted into pyridoxal phosphate and pyridoxamine phosphate (active forms), which are stored and further metabolised in the liver via oxidation into 4-pyridoxic acid and other inactive metabolites.
Excretion: Via urine (as 4-pyridoxic acid and other inactive metabolites). Elimination half-life: 15-20 days.

Chemical Structure

Storage

Tab: Store between 15-30°C. Protect from excessive heat, moisture, and light. Solution for inj: Store between 20-25°C. Protect from light.

MIMS Class

Vitamin B-Complex / with C

ATC Classification

A11HA02 - pyridoxine (vit B6) ; Belongs to the class of other plain vitamin preparations. Used as dietary supplements.

References

Anon. Pyridoxine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 26/05/2023.

Anon. Pyridoxine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 26/05/2023.

B-6 Pyridoxine Hydrochloride Tablet (Marlex Pharmaceuticals Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 26/05/2023.

Buckingham R (ed). Isoniazid. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/06/2023.

Buckingham R (ed). Vitamin B6 Substances. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 26/05/2023.

Joint Formulary Committee. Pyridoxine Hydrochloride. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 26/05/2023.

Multichem NZ Ltd. Pyridoxine Multichem, 50 mg, Tablets data sheet 11 November 2021. Medsafe. http://www.medsafe.govt.nz. Accessed 26/05/2023.

Pyridoxine 10 mg Tablets (TOR Generics Ltd). MHRA. https://products.mhra.gov.uk. Accessed 26/05/2023.

Pyridoxine HCl Injection, Solution (HF Acquisition Co LLC, DBA HealthFirst). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 26/05/2023.

Pyridoxine Hydrochloride 50 mg Tablets (Strandhaven Limited t/a Somex Pharma). MHRA. https://products.mhra.gov.uk. Accessed 18/07/2023.

Pyridoxine, Vitamin B6. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 26/05/2023.

Rexom Vitamin B-6 Tablet 20 mg (KCK Pharmaceutical Industries Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 26/05/2023.

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