Pyridoxine Hydrochloride Injection

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Pyridoxine Hydrochloride injection (Vitamin B6) is a sterile, clear solution used for the treatment of vitamin deficiencies, drug-induced deficiency (such as from Isoniazid), and specific metabolic disorders.

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Description

Pyridoxine Hydrochloride Injection (Vitamin B6)

Healthy Inc is a specialized global supplier and exporter of essential vitamins and critical antidotes. We provide high-purity Pyridoxine Hydrochloride Injection (100 mg / ml), manufactured in WHO–GMP certified sterile facilities. This “Neurological Coenzyme” is a mandatory export to tuberculosis (TB) treatment centers, neurology clinics, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the definitive prophylaxis against Isoniazid-induced neuropathy and a life-saving intervention for acute Isoniazid toxicity and pyridoxine-dependent neonatal seizures.


Product Overview

This formulation contains Pyridoxine Hydrochloride, a water-soluble B-complex vitamin that acts as a critical precursor in human metabolism.

The “Neuro-Metabolic” Specialist:

  • Mechanism (The Coenzyme Activator): Once injected, Pyridoxine is converted in the erythrocytes to its active forms: Pyridoxal 5′-phosphate (PLP) and pyridoxamine phosphate. PLP acts as a vital coenzyme for over 100 metabolic enzymes, primarily those involved in amino acid metabolism, the biosynthesis of heme, and the synthesis of crucial neurotransmitters (including GABA, dopamine, and serotonin).
  • The Tuberculosis (TB) Adjunct: Isoniazid (INH), a primary drug for TB, depletes Vitamin B6 by forming a hydrazone complex with pyridoxal, leading to severe peripheral neuropathy. Co-administration of Pyridoxine is the global standard of care to prevent this debilitating side effect.
  • Acute INH Poisoning Antidote: In massive Isoniazid overdoses (which cause refractory status epilepticus and metabolic acidosis), high-dose IV Pyridoxine is the specific, life-saving antidote, replenishing GABA levels in the brain to stop seizures.

Product Composition & Strength

We supply this product as a Sterile, Clear, Colorless to Pale Yellow Solution in glass ampoules or vials.

Active IngredientConcentrationTotal Content & Format
Pyridoxine Hydrochloride USP/BP100 mg / ml200 mg in 2 ml Glass Ampoule
Pyridoxine Hydrochloride USP/BP100 mg / ml1000 mg (1 g) in 10 ml Multi-Dose Vial (Antidote Protocol)
ExcipientsWater for InjectionPreservative-Free (Ampoules) / Chlorobutanol (Vials)

*Pack Sizes: Tray of 10 Ampoules or Box of 100 Ampoules.


Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Distributors.

HS Code3004.50.90 (Medicaments containing vitamins)
CAS Number58-56-0
Dosage FormInjection (Liquid Solution)
PackagingAmber Type I Glass Ampoule (Highly Light Sensitive).
StorageStore below 25°C. Protect from Light. (Prolonged exposure to sunlight gradually degrades the active ingredient).
CertificatesWHO-GMP, COPP, Free Sale Certificate

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

  • Photosensitivity Control: Pyridoxine solutions deteriorate rapidly upon exposure to light. Our manufacturing process utilizes strict UV-blocking lighting during compounding and filling, sealing the solution in amber glass to guarantee 100% potency throughout the product’s shelf life.
  • pH Optimization: Formulated at an optimal acidic pH (2.0 to 3.8) to maintain molecular stability and prevent precipitation, ensuring a safe, clear solution for deep intramuscular or intravenous administration.

Therapeutic Indications (Human Use)

Indicated for the treatment of severe vitamin deficiencies and specific toxicities:

  • Isoniazid (INH) Neuropathy: Prophylaxis and treatment of peripheral neuritis caused by INH therapy for Tuberculosis.
  • Acute INH Toxicity: Reversal of seizures and coma caused by Isoniazid overdose.
  • Pyridoxine-Dependent Seizures: A rare, genetic neonatal condition causing refractory seizures that respond instantly to IV Vitamin B6.
  • Severe Vitamin B6 Deficiency: Resulting from inadequate nutrition, malabsorption syndromes, or alcoholism.
  • Cycloserine & Hydrazine Toxicity: Used as a targeted antidote to prevent neurotoxicity.

Dosage & Administration

Recommended Dosage (Strictly as per Physician):

  • Route: Intramuscular (IM), Intravenous (IV), or Subcutaneous (SC).
  • Treatment of INH Neuropathy: 100 mg to 300 mg daily (IM or IV) until symptoms resolve, followed by oral maintenance.
  • Acute Isoniazid Toxicity (Antidote): Administer a dose of Pyridoxine equal to the amount of INH ingested (gram for gram). Generally, an initial 1 g to 4 g is given IV, followed by 1 g IM every 30 minutes until the total dose is reached or seizures stop.
  • Pyridoxine-Dependent Seizures (Neonates): 10 mg to 100 mg IV or IM as a diagnostic/therapeutic initial dose.

Safety Warnings (CRITICAL):

  • Sensory Neuropathy (Overdose): Paradoxically, while used to treat neuropathy, massive chronic overdoses of Pyridoxine (e.g., > 200 mg/day for several months) can cause severe, irreversible peripheral sensory neuropathy.
  • Levodopa Interaction: Pyridoxine accelerates the peripheral metabolism of Levodopa, reducing its efficacy in Parkinson’s disease (unless Levodopa is combined with a peripheral decarboxylase inhibitor like Carbidopa).
  • Injection Site Pain: IM injections may cause localized burning or pain. Deep IM injection is recommended.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Vitamin Injectables, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.

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