DBL™ Zinc Chloride Injection

MIMS Revision Date: 01 May 2019

1 Name of Medicine

Zinc chloride.

2 Qualitative and Quantitative Composition

DBL Zinc Chloride Injection is equivalent to zinc 5.1 mg in 2 mL, and is a clear, colourless solution containing 10.6 mg of zinc chloride and water for injection in each 2 mL ampoule. The zinc component of each ampoule is 0.078 mmol (5.1 mg) and the chloride component of each ampoule is 0.156 mmol (5.5 mg). The pH of the solution ranges between 4.0 and 5.5.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Zinc chloride injection is a colourless solution, concentrated injection.

4 Clinical Particulars

4.1 Therapeutic Indications

DBL Zinc Chloride Injection is intended for use as an additive to compatible intravenous fluids or total parenteral nutrition solutions. It is indicated for the prevention and treatment of zinc deficiency, which may be characterised by growth deterioration, skin lesions, alopecia, impaired reproductive development and function, and delayed or inhibited wound healing.

4.2 Dose and Method of Administration

Dosage. Adults. The suggested IV dosage is 2.5 to 4 mg zinc per day. An additional 2 mg zinc/day is suggested for acute catabolic states. If there is fluid loss from the small intestines, an additional 12.2 mg of zinc per litre of small intestinal fluid lost, or an additional 17.1 mg of zinc per kg of stool or ileostomy output is suggested. Blood levels of zinc should be frequently monitored to ensure proper dosage.
DBL Zinc Chloride Injection should be given via intravenous infusion by diluting each 2 mL ampoule in 1 litre of infusion solution (glucose 5% injection or sodium chloride 0.9% injection) and administering over 8 to 24 hours.
Children. For premature infants (up to 3 kg in bodyweight) 300 microgram of zinc/kg/day is suggested.
For full term infants and children up to 5 years of age, 100 microgram of zinc/kg/day is recommended.
For children over 5 years of age, the dose is the same as that recommended for adults; up to a maximum of 4 mg/day.
Note. DBL Zinc Chloride Injection should be filtered through asbestos or sintered glass, since they dissolve paper and cotton wool. DBL Zinc Chloride Injection should be diluted before use. It contains no preservative, therefore, any unused portions should be discarded.
Compatibilities. DBL Zinc Chloride Injection is reported to be compatible with glucose 5% injection or sodium chloride 0.9% injection.

4.3 Contraindications

Direct intramuscular (IM) or intravenous (IV) injection is contraindicated as the acidic pH of the injection may cause considerable tissue irritation. It is contraindicated in individuals hypersensitive to any of the ingredients in the preparation.

4.4 Special Warnings and Precautions for Use

Do not use unless solution is clear and seal is intact.
Zinc should be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment. The injection contains no preservatives, therefore any unused portion should be discarded.
The injection should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential for increased excretory loss of zinc from a bolus injection. Administration of zinc in the absence of copper may cause a decrease in serum copper levels. Periodic determinations of serum copper as well as zinc are suggested as a guideline for subsequent zinc administration.
Avoid contact of DBL Zinc Chloride Injection with the eyes and skin. Wash with copious amount of water if contamination of the skin and eyes occurs. Zinc chloride is a caustic agent and therefore should not be given orally.
Copper uptake, liver biopsy and clinical observations are all useful procedures to check the dose and compliance.
Use in renal impairment. There is a possible risk of zinc accumulation in patients with renal failure.
Use in the elderly. No data available.
Paediatric use. No data available.
Effects on laboratory tests. No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility. No data available.
Use in pregnancy. Animal reproduction studies have not been conducted with zinc chloride. It is not known whether zinc can cause fetal harm when administered to a pregnant woman, or whether it can affect reproductive capacity. Therefore, DBL Zinc Chloride Injection should be administered to pregnant women only if clearly indicated.
Use in lactation. Zinc is excreted in breast milk. The baby may be at risk of zinc induced copper deficiency. However, the amount of zinc in the milk may not be sufficient to induce copper deficiency in infants. Therefore, the potential hazards of zinc to the infant must be weighed against the potential benefits to the mother before zinc is administered to mothers who are breastfeeding.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Direct IM or IV injection may cause considerable tissue irritation and is therefore not recommended.
Chronic zinc toxicity in man has not been identified with certainty. Prolonged use of zinc may lead to copper deficiency and anaemia which has responded to withdrawal of zinc and symptomatic therapy.
Increased serum levels of amylase, lipase and alkaline phosphatase, which may indicate pancreatic damage, are commonly reported during zinc therapy. However, insufficient evidence was found for pancreatic damage in either humans or rat studies.
Reporting suspected adverse effects. Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Symptoms. Symptoms of zinc poisoning include hypotension, pulmonary oedema, diarrhoea, vomiting, jaundice and oliguria.
Treatment. Symptomatic and supportive measures should be given as required in the event of overdosage. Administration of sodium calcium edetate by mouth and intravenously has been suggested. To relieve pain, analgesics may be given. Electrolyte imbalance should be corrected.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia), 0800 764 766 (New Zealand).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action. Zinc is an essential trace element in nutrition. It is a constituent of many enzymatic systems, including alkaline phosphatase, carbonic anhydrase, carboxypeptidase and alcohol dehydrogenase. It is also present with insulin in the pancreas. Zinc is involved in DNA and protein synthesis and facilitates wound healing, helping to maintain normal growth rates. It is essential for immune function and development of the reproductive organs and normal functioning of the prostate gland. It is also involved in certain enzymatic reactions necessary for the normal functioning of the skin's oil glands. Zinc is required for the mobilisation of vitamin A from the liver into plasma. It also helps to maintain the senses of taste and smell.
Clinical trials. No data available.

5.2 Pharmacokinetic Properties

Zinc is distributed widely throughout the body and is excreted in the faeces. Only traces appear in the urine since the kidneys play only a minor role in regulating the content of zinc within the body. Approximately 70% of zinc is loosely bound to albumin and other proteins.
The normal concentration of zinc in plasma and serum ranges from 0.7 to 1.5 mg/L.

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Hydrochloric acid, sodium hydroxide, water for injections.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Strength. 10.6 mg zinc chloride equivalent to 5.1 mg zinc in 2 mL.
Pack. 5 x 2 mL ampoules.
ARTG. AUST R 16383.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

CAS number. 7646-85-7.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Date of First Approval

05 February 2008

Date of Revision

27 February 2019

Summary Table of Changes