BIOLOGICAL

What it is

Biological Therapies Sodium Ascorbate Solution Injection for Intravenous Infusion is available in strengths of 30 g in 100 mL, 15 g in 50 mL, 15 g in 100 mL, and 45 g in 500 mL. All formulations are hypertonic and single use. The injection is a clear and colourless to straw coloured solution with a pH range of 6.0 to 8.0. Presentation is in plastic bags or glass vials.

Approved indications

— Treatment of vitamin C deficiency when oral treatment is not feasible.

Dosing overview

The recommended dose in adults is 100–500 mg daily, and in children, 100–300 mg daily. Treatment may continue for up to three weeks. The dose may be given as a straight push or added to an infusion bag of sterile Water for Injections, saline or dextrose.

Key safety warnings

If the solution is injected too concentrated and/or too quickly into a small vein, there may be substantial pain in the vein; injection into a large vein is recommended, usually the cubital vein although the veins on the back of the hand have been used. Care should be exercised to avoid extravasation during the infusion; if this occurs with the hypertonic infusion it can cause quite severe pain. People with hyperoxaluria or who are prone to kidney stones should exercise caution in consuming or being injected with large amounts of Vitamin C, as ascorbate may cause acidification of the urine, occasionally leading to precipitation of urate, cystine or oxalate stones or drugs in the urinary tract. Care should be exercised in administering intravenous sodium ascorbate to those patients who either have hypernatraemia, congestive cardiac failure or may be unable to handle the increased sodium load as a result of renal insufficiency. Rarely, high doses of Vitamin C have been associated with sickle-cell crisis in patients with sickle-cell anaemia. There have been a few reports in the literature of high dose Vitamin C inducing haemolysis in G6PD deficient patients.

Contraindications

Biological Therapies Sodium Ascorbate Solution Injection for intravenous infusion is contraindicated in those persons who have shown hypersensitivity to any component of this preparation.

Regulatory history

Biological Therapies Sodium Ascorbate Solution Injections for Intravenous Infusion were first approved on 11 October 1999. Various sodium ascorbate formulations were first listed on the Australian Register of Therapeutic Goods on 8 October 1991, with additional strengths registered on 31 January 1994 and a vial formulation on 2 September 2019.