Description

Overview

HYDROXO-B12 INJECTION is a specialized pharmaceutical preparation containing hydroxocobalamin, designed for the effective management of vitamin B12 deficiency and related conditions. This formulation is presented as a 1 mg/mL solution, characterized by its clear, dark red appearance, and is provided in glass ampoules typically containing 1 mL each.

Indications

This injection is primarily indicated for:

• The prevention and treatment of anaemias associated with vitamin B12 deficiency, including pernicious anaemia.
• Treatment of specific optic neuropathies such as tobacco amblyopia and Leber’s optic atrophy.
• Serving as an antidote for acute cyanide poisoning.
• Managing nitrous oxide neurotoxicity.

Mechanism of Action

Hydroxocobalamin acts as a precursor to the active forms of vitamin B12, playing a crucial role in DNA synthesis, nerve function, and haemopoiesis. It also serves as a cyanide antagonist, binding cyanide to form cyanocobalamin, thus mitigating cyanide toxicity.

Administration

Administration is conducted parenterally, with intramuscular injection being standard. In cases of cyanide poisoning, intravenous use is employed. This injection should only be administered by healthcare professionals, with dosage and frequency tailored by a physician based on individual clinical needs.

Contraindications and Precautions

Contraindications include known hypersensitivity to hydroxocobalamin, cobalt, or any injection components. It is not recommended for use in megaloblastic anaemia of pregnancy. Precautions involve monitoring vitamin B12 levels and potential hypokalaemia, as well as possible interference with laboratory tests. Use during pregnancy or breastfeeding should be carefully considered.

Adverse Effects

Common side effects may include injection site reactions, nausea, headache, and changes in urine or stool color. Less common effects involve hypersensitivity reactions and cardiovascular symptoms. Proper coordination with healthcare providers is essential to manage these potential outcomes.

Storage and Handling

HYDROXO-B12 INJECTION should be stored below 25°C, protected from light, and kept in its original packaging. It is intended for single use only and should be kept out of reach of children.

Regulatory Information

This product holds the Australian Registration Number AUST R 161606 and is classified as a General Sale Medicine in New Zealand. It is unscheduled in the Poisons Standard in Australia, highlighting its specialized yet accessible nature for appropriate medical use.