Consumer medicine information

Sodium Bicarbonate Injection MIN-I-JET

Sodium bicarbonate

BRAND INFORMATION

Brand name

Min-I-Jet Sodium Bicarbonate

Active ingredient

Sodium bicarbonate

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Sodium Bicarbonate Injection MIN-I-JET.

WHAT IS IN THIS LEAFLET?

This leaflet contains information about Sodium Bicarbonate Injection MIN-I-JET. Please read it carefully and keep it for future reference. The information in this leaflet is only a summary and is not intended to replace advice from your doctor.

Please consult your doctor or pharmacist if you have any comments or questions.

WHAT IS Sodium Bicarbonate Injection?

Sodium bicarbonate is a simple chemical which is used in medicine to counteract situations when the blood contains too much acid.

WHEN IS Sodium Bicarbonate Injection USED?

If the heart stops beating after a heart attack, no oxygen will be carried round the body as the blood stops circulating. When this happens, acid tends to accumulate throughout the body and if the patient is given first aid and the heart starts pumping again, the acid may poison the body. Sodium bicarbonate is injected directly into the blood to correct this acidity.

As sodium bicarbonate is only used in medical emergencies, the injection may be given by paramedical personnel such as ambulance or nursing staff.

WHO SHOULD NOT HAVE Sodium Bicarbonate Injections?

Sodium bicarbonate should not be given to people:

  • with high blood pressure
  • with severe kidney disease
  • with heart failure
  • with kidney stones
  • with some special chemical abnormalities in their blood

As Sodium Bicarbonate Injection is an emergency life-saving product it should not be withheld from anyone who needs it.

BEFORE YOU HAVE A Sodium Bicarbonate Injection

If you require a Sodium Bicarbonate Injection you will almost certainly be unconscious. You will therefore not be able to help your doctor by telling him details of your illness.

SIDE EFFECTS OF SODIUM BICARBONATE

As with any medicine, some side effects may occur.

Patients who need sodium bicarbonate in this way are extremely ill and likely to die. The most unpleasant effects are more likely to be due to the condition rather than the treatment. Side effects from Sodium Bicarbonate Injections are very uncommon unless an overdose is given (see OVERDOSE). Occasionally the area around the vein where the injection is given may become inflamed and an ulcer may form.

Always tell your doctor if you have any unpleasant effects after receiving Sodium Bicarbonate Injection MIN-I-JET.

THE DOSE OF SODIUM BICARBONATE

The dose of sodium bicarbonate will vary depending on the acidity of the blood. Enough is injected to correct this acidity.

OVERDOSE

Overdosage with sodium bicarbonate can cause overbreathing, shortness of breath, brain damage, mood changes, irritability, tiredness, muscle weakness, irregular heartbeat, muscle stiffness or twitches and fits. The treatment is to stop the injection of sodium bicarbonate and inject other products which will counter the effects which have been produced.

Contact the Poisons Information Centre on 13 11 26 for further advice on overdose management.

WHAT DOES Sodium Bicarbonate Injection MIN-I-JET CONTAIN?

Sodium Bicarbonate Injection MIN-I-JET contains sodium bicarbonate at a concentration of 4.2 g sodium bicarbonate in 50 mL of water. Australian Registration number is AUST R 29057. There are no additives.

HOW TO STORE Sodium Bicarbonate Injection MIN-I-JET?

Sodium Bicarbonate Injection MIN-I-JET should be protected from light and stored below 25°C (room temperature). It should not be used after the expiry date on the package.

WHERE CAN I GET MORE INFORMATION?

You can get more information from your doctor or pharmacist.

Sodium Bicarbonate Injection MIN-I-JET is manufactured by:

International Medication Systems Ltd

1886 Santa Anita Avenue,
South El Monte 91733,
California USA

and distributed by:

CSL Limited,
ABN. 99 051 588 348
45 Poplar Road,
Parkville 3052,
Victoria Australia

Date of Information: April 1996

Date of Amendment: June 2006

Published by MIMS November 2006

BRAND INFORMATION

Brand name

Min-I-Jet Sodium Bicarbonate

Active ingredient

Sodium bicarbonate

Schedule

Unscheduled

 

Name of the medicine

Sodium bicarbonate.

Description

Molecular formula: NaHCO3. CAS: 144-55-8. Sodium bicarbonate is a white, odourless crystalline powder. The pH of the solution is approximately 7.8.

Pharmacology

Bicarbonate in the body acts as a buffer. Excess hydrogen ions react with bicarbonate resulting in the formation of carbon dioxide and water. The former is excreted from the lungs and the latter from the kidneys.
Sodium bicarbonate therapy therefore, by increasing plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH and reverses clinical manifestations of metabolic acidosis. It is excreted mainly in the urine which it makes alkaline.

Indications

For the correction of documented metabolic acidosis caused by cardiac arrest after standard resuscitation measures have been instituted. Adequate ventilation must be maintained.

Contraindications

The administration of sodium bicarbonate is contraindicated in patients with renal failure, metabolic or respiratory alkalosis, hypertension, oedema, congestive cardiac failure, hypoventilation, chloride depletion, hypernatraemia, hypocalcaemia, coexistent potassium depletion or a history of urinary calculi.

Precautions

For intravenous administration only.
Whenever sodium bicarbonate is used intravenously, arterial blood gas analyses, in particular arterial/ venous blood pH and carbon dioxide levels should be performed before and during the course of treatment to minimize the possibility of overdosage and resultant alkalosis.
Whenever respiratory acidosis is concomitant with metabolic acidosis, both pulmonary ventilation and perfusion must be adequately supported to get rid of excess carbon dioxide.
Rapid injection (10 mL/minute) of sodium bicarbonate solutions in children up to 2 years of age may produce hypernatraemia, decreased CSF pressure and possible intracranial haemorrhage. In emergency situations, such as cardiac arrest, the risk of rapid infusion of the drug must be weighed against the potential for death from acidosis. Also, administration of this drug to children undergoing cardiopulmonary resuscitation may worsen respiratory acidosis.
To minimise the risks of pre-existing hypokalaemia and/or hypocalcaemia, these electrolyte disturbances should be corrected prior to initiation of, or concomitantly with, sodium bicarbonate therapy.
Accidental extravascular injection of hypertonic solutions may cause vascular irritation or sloughing. The use of scalp veins should be avoided.
The sodium bicarbonate is in a single use Minijet prefilled syringe. Once the unit is assembled and used, any remaining portion of the solution must be discarded with the entire unit.

Use in pregnancy.

Safe use in pregnancy has not been established. The benefits of using the product should be weighed against possible risks to the foetus.

Use in lactation.

Safe use in breastfeeding has not been established.

Interactions

Caution should be used when administering sodium ions to patients receiving corticosteroids or corticotrophin.
Urinary alkalisation will increase the renal clearance of tetracyclines, especially doxycycline, but it will increase the half-life and duration of action of basic drugs such as quinidine, amphetamines, ephedrine and pseudoephedrine.
Hypochloraemic alkalosis may occur if sodium bicarbonate is used in conjunction with potassium depleting diuretics such as bumetanide, ethacrynic acid, frusemide and thiazides. Concurrent use in patients taking potassium supplements may reduce serum potassium concentration by promoting an intracellular ion shift.
The addition of sodium bicarbonate to parenteral solutions containing calcium should be avoided except where compatibility has been previously established; precipitation or haze may result. Should this occur, the solution should be immediately discarded.

Effects on laboratory tests.

The high urinary alkalinity sometimes produced by sodium bicarbonate may cause a false positive Labstix test for urinary protein.

Adverse Effects

Alkalosis and/or hypokalaemia may ensue as a result of prolonged use or overcorrection of the bicarbonate deficit. Hyperirritability or tetany may occur, caused by rapid shifts of free ionised calcium or due to serum protein alterations arising from the pH changes.
Accidental extravasation of hypertonic sodium bicarbonate solutions has been reported to cause chemical cellulitis and ulceration.

Dosage and Administration

The dose of sodium bicarbonate to be used for the treatment of metabolic acidosis depends on the requirements of the individual patient as determined by blood gas analyses and pH testing both before and during treatment.

Adults.

The usual dose is 1 mmol/kg (1 mL/kg) followed by 0.5 mmol/kg (0.5 mL/kg) given at 10 minute intervals.

Children.

The usual dose is 1 mmol/kg (1 mL/kg) given by slow intravenous injection. Up to 2 years of age, the solution should be diluted with an equal amount of 5% dextrose and it is recommended that the rate of IV administration does not exceed 8 mL/kg/day.

Elderly.

As for adults.

Overdosage

Excessive administration of bicarbonate may lead to hypokalaemia and metabolic alkalosis, especially in patients with impaired renal function. Symptoms include mood changes (hyperirritability), tiredness, shortness of breath, muscle weakness and irregular heartbeat. Muscle hypertonicity, twitching and tetany may develop, especially in hypocalcaemic patients.
Overdosage may also be accompanied by compensatory hyperventilation and paradoxical acidosis of the cerebrospinal fluid.

Management.

Should alkalosis result, the bicarbonate should be stopped and the patient managed according to the degree of alkalosis present. Rebreathing expired air may help but, if more severe, calcium gluconate may be necessary, particularly if tetany is present. In severe alkalosis, an infusion of 2.14% ammonium chloride is recommended except in patients with pre-existing hepatic disease. If hypokalaemia is present, administer potassium chloride.
Contact the Poisons Information Centre on 131 126 for further advice on overdose management.

Presentation

Solution for injection (sterile, aqueous), 1 mmol/mL (8.4% w/v): 50 mL (single use, prefilled Minijet syringe).

Storage

Store below 25°C. Protect from light.

Poison Schedule

Unscheduled.