Consumer medicine information

DBL Magnesium Chloride Concentrated Injection

Magnesium chloride hexahydrate

BRAND INFORMATION

Brand name

DBL Magnesium Chloride Concentrated Injection

Active ingredient

Magnesium chloride hexahydrate

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using DBL Magnesium Chloride Concentrated Injection.

What is in this leaflet

This leaflet answers some common questions about DBL™ Magnesium Chloride Concentrated Injection. It does not contain all the available information.

It does not take the place of talking to your doctor and pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given DBL™ Magnesium Chloride Concentrated Injection against the benefits this medicine is expected to have for you.

If you have any concerns about this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What DBL™ Magnesium Chloride Concentrated Injection is used for

Magnesium chloride hexahydrate is an electrolyte used to quickly increase the amount of magnesium in your body. It is also used to provide magnesium to your body if you are on total parenteral nutrition.

Magnesium chloride hexahydrate works by providing a source of magnesium for your body to use.

Your doctor may have prescribed Magnesium chloride hexahydrate for another reason. Ask your doctor if you have any questions about why Magnesium chloride hexahydrate has been prescribed for you.

This medicine is available only with a doctor’s prescription.

Magnesium chloride hexahydrate is not addictive.

Before you are given DBL™ Magnesium Chloride Concentrated Injection

When you must not be given it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have previously had a reaction to magnesium injections.

You should not be given DBL™ Magnesium Chloride Concentrated Injection if:

  • the packaging is torn or shows signs of tampering
  • the expiry date on the pack has passed
    If you are given this medicine after the expiry date has passed, it may not work as well.
  • you have any of the following medical conditions:
    - kidney failure
    - heart block

Before you are given it

Your doctor must know about all the following before you begin therapy with magnesium chloride.

  1. if you have or have ever had any other health problems/medical conditions, including:
  • kidney disease
  1. if you are pregnant or intend to become pregnant
Your doctor will discuss the risks and benefits of you being given Magnesium chloride hexahydrate during pregnancy.
  1. if you are breast-feeding or plan to breast-feed
Your doctor will discuss the risks and benefits of you being given Magnesium chloride hexahydrate when breast-feeding.

If you have not told your doctor about any of the above, tell them before you are given magnesium chloride.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines may interfere with magnesium chloride. These include:

  • Cardiac glycosides (such as digoxin)
  • Central nervous system depressants
  • Neuromuscular blocking agents
  • Treatments for blood pressure
  • Treatments for excess fluid.

These medicines may be affected by magnesium chloride, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while being given magnesium chloride.

How DBL™ Magnesium Chloride Concentrated Injection is given

Magnesium chloride hexahydrate is given as a slow injection into a vein.

Magnesium chloride hexahydrate must only be given by a doctor or nurse.

Your doctor will decide what dose of Magnesium chloride hexahydrate you will receive and how long you will receive it for. This depends on your medical condition and other factors, such as your weight.

Sometimes only a single dose of Magnesium chloride hexahydrate is required.

If you are given too much (overdose)

As DBL™ Magnesium Chloride Concentrated Injection is given to you under the supervision of your doctor, it is very unlikely that you will receive too much. However, if you experience any severe side effects after being given this medicine, tell your doctor or nurse immediately.

Symptoms of a Magnesium chloride hexahydrate overdose may include the side effects listed below in the ‘Side Effects’ section, but are usually of a more severe nature.

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26 in Australia, or call 0800 764 766 in New Zealand) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Magnesium Chloride. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given magnesium chloride.

Magnesium chloride hexahydrate helps most people with low levels of magnesium in their bodies, but it may have unwanted side-effects in a few people. All medicines can have side effects.

Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side-effects.

Ask your doctor or pharmacist to answer any questions you may have.

While being given it

Tell your doctor immediately if you notice any of the following:

  • flushing
  • nausea
  • vomiting
  • muscle weakness
  • blurred or double vision
  • loss of reflexes
  • breathing difficulties
  • irregular heartbeat

Some people may get other side effects while being given magnesium chloride.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After being given DBL™ Magnesium Chloride Concentrated Injection

Storage

DBL™ Magnesium Chloride Concentrated Injection will be stored in the pharmacy or on the ward. The injection is kept in a cool dry place where the temperature stays below 25°C.

Product description

What it looks like

DBL™ Magnesium Chloride Concentrated Injection is a clear, colourless solution.

Ingredients

DBL™ Magnesium Chloride Concentrated Injection contains:

  • Magnesium chloride hexahydrate as the active ingredient, and
  • water for injection.

DBL™ Magnesium Chloride Concentrated Injection does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Sponsor

DBL™ Magnesium Chloride Concentrated Injection is supplied by:

Australian Sponsor

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizer.com.au

DBL™ Magnesium Chloride Concentrated Injection is available in the following presentation:

  • 480 mg / 5 mL ampoules AUST R 16310

Date of leaflet update: April 2019

Published by MIMS July 2019

BRAND INFORMATION

Brand name

DBL Magnesium Chloride Concentrated Injection

Active ingredient

Magnesium chloride hexahydrate

Schedule

Unscheduled

 

1 Name of Medicine

Magnesium chloride hexahydrate.

2 Qualitative and Quantitative Composition

The molecular formula of magnesium chloride hexahydrate is MgCl2.6H2O. It has a molecular weight of 203.3.
Each 5 mL solution contains magnesium chloride hexahydrate equivalent to 480 milligrams of magnesium chloride anhydrous and water for injection. Each mL of injection contains 1 mmol (2 mEq) of magnesium ions and 2 mmol (2 mEq) of chloride ions.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Magnesium chloride hexahydrate exists as colourless, odourless, deliquescent or hygroscopic crystals or flakes. It is very soluble in water and freely soluble in alcohol.
DBL Magnesium Chloride Concentrated Injection is a clear, colourless, sterile solution. The product contains no preservative. The pH of the solution ranges between 5.0 and 8.0.

4 Clinical Particulars

4.1 Therapeutic Indications

Parenteral administration of magnesium is indicated in the treatment of acute hypomagnesaemia.
Magnesium salts are also indicated to prevent hypomagnesaemia in patients receiving total parenteral nutrition.

4.2 Dose and Method of Administration

Dosage.

Acute hypomagnesaemia.

Adults.

It is suggested that a dose of 3.3 to 7.2 gram of magnesium chloride anhydrous (70 to 150 mEq of magnesium) be given by slow intravenous infusion on the first day, followed by 2.4 gram of magnesium chloride anhydrous (50 mEq of magnesium) daily until hypomagnesaemia is corrected. A total of 15.3 gram of magnesium chloride anhydrous (320 mEq of magnesium) may be required.
Total parenteral nutrition.

Adults.

A dose of 0.2 to 1.2 gram magnesium chloride anhydrous (4 to 24 mEq of magnesium) daily may be administered.

Infants.

A dose of 0.1 to 0.5 gram magnesium chloride anhydrous (2 to 10 mEq of magnesium) daily may be administered.

Method of administration.

DBL Magnesium Chloride Concentrated Injection is administered intravenously, usually by slow intravenous infusion. Intravenous doses should be diluted in glucose 5%.

Maximum dose.

1.9 gram of magnesium chloride anhydrous (40 mEq of magnesium) may be diluted with 250 mL of 5% glucose and infused at a rate not to exceed 3 mL per minute (0.5 mEq/min).
The dose of magnesium should be adjusted according to the patient's individual requirements and response. The total adult daily dose should not exceed 18.7 gram of magnesium chloride anhydrous per day.

Compatibilities.

Magnesium salts are reported to be chemically stable and compatible with either sodium chloride 0.9%, glucose 5% in water or glucose 5% in sodium chloride 0.9%. Solutions diluted for infusion should be prepared and used immediately as they are not preserved.

4.3 Contraindications

Magnesium may form precipitates if mixed with other electrolyte solutions (see Section 6.2 Incompatibilities).
Magnesium is contraindicated in patients with heart block, since magnesium may exacerbate this condition.
Magnesium is also contraindicated in patients with renal failure (creatinine clearance < 20 mL/min), since there is an increased risk of hypermagnesaemia in these patients.
Magnesium chloride should not be given to a pregnant woman within two hours preceding delivery as there is a risk of respiratory depression due to hypermagnesaemia in the neonate.

4.4 Special Warnings and Precautions for Use

Magnesium may precipitate an acute myasthenic crisis. Sensitivity to parenteral magnesium has been reported. An intravenous preparation of a calcium salt (e.g. calcium gluconate) should be readily available when magnesium chloride is given.
The patellar reflex should be tested prior to administering repeat doses of magnesium chloride. Suppression of the reflex is an indication of magnesium intoxication. Respiration rate should be determined and should be at least 16 per minute prior to each dose of magnesium as respiratory depression is the most critical side effect of the medication. Urine output should be monitored and should be at least 100 mL during the four hours preceding dosing to ensure adequate excretion of magnesium.

Use in renal impairment.

Magnesium should be administered with caution in patients with impaired renal function, since the risk of hypermagnesaemia is increased in these patients.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

Monitoring of serum magnesium levels is advised at periodic intervals during therapy to ensure that normal serum magnesium levels are not exceeded.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Cardiac glycosides/ digitalis.

Magnesium salts should be administered with caution in patients treated with cardiac glycosides, since heart block may occur if calcium salts are required to treat magnesium toxicity (see Section 4.9 Overdose).

CNS depressants.

Concurrent use of magnesium salts and CNS depressant drugs may result in an enhanced CNS depressant effect.

Magnesium containing preparations (including antacids, laxatives).

Concurrent use of magnesium salts with other magnesium containing preparations may cause magnesium toxicity especially in patients with renal insufficiency.

Neuromuscular blocking agents.

Concurrent use of magnesium salts with neuromuscular blocking agents may result in an excessive neuromuscular blockade.

Antihypertensive agents.

Concurrent use of magnesium and nifedipine or other antihypertensive agents may result in an exaggerated hypotensive response.
Also see Section 6.2 Incompatibilities.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
Magnesium readily crosses the placenta. Foetal serum concentrations approximate those of the mother. Magnesium chloride should not be given to a pregnant woman within two hours preceding delivery as there is a risk of respiratory depression due to hypermagnesaemia in the neonate.
Bony abnormalities and congenital rickets have been reported in neonates born to mothers treated with parenteral magnesium for prolonged periods of time (4 to 13 weeks duration).
 After intravenous administration, magnesium is distributed into breast milk, and the concentration of magnesium in the breast milk is approximately twice that in the maternal serum. Magnesium chloride is therefore not recommended in lactating patients.

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)

Excessive administration of magnesium chloride may result in hypermagnesaemia. The signs of hypermagnesaemia may include nausea, vomiting, flushing, hypotension, muscle weakness, muscle paralysis, blurred or double vision, CNS depression and loss of reflexes. More severe hypermagnesaemia may result in respiratory depression, respiratory paralysis, renal failure, coma, cardiac arrhythmias and cardiac arrest. Hypocalcaemia with tetany, secondary to hypermagnesaemia, has been reported.

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

Clinical features.

Hypermagnesaemia may occur when large doses of magnesium are given, especially in patients with renal failure. Signs of hypermagnesaemia include nausea, vomiting, flushing, hypotension, muscle weakness, muscle paralysis, blurred or double vision, CNS depression and loss of reflexes. More severe hypermagnesaemia may result in respiratory depression, respiratory paralysis, renal failure, coma, cardiac arrhythmias and cardiac arrest.

Treatment.

In the treatment of hypermagnesaemia, the following measures may be required:
blood pressure and respiratory support;
intravenous administration of 2.5 to 5.0 mmol calcium salts (such as calcium gluconate) reverses the effects of magnesium toxicity;
dialysis may be required, particularly if renal function is impaired;
if renal function is normal, adequate fluids should be given so that urine output is at least 60 mL/hour to assist removal of magnesium from the body;
physostigmine (0.5 to 1.0 milligram subcutaneously) may be helpful, but routine use is not recommended due to the potential toxicity.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia). In New Zealand call 0800 764 766.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Magnesium is the second most abundant cation of intracellular fluid. It is an essential cation in over 300 enzymatic processes, and is necessary for several steps in glycolysis, the Krebs cycle and in protein and nucleic acid synthesis. It is thus vital for normal energy storage and transfer. Magnesium plays an important role in neurochemical transmission and is essential for proper neurochemical functioning.
Magnesium has an anticonvulsant effect. It possibly has antiarrhythmic effects and a role in calcium homeostasis and bone mineralisation. There is conflicting evidence that the routine use of intravenous magnesium in the setting of acute myocardial infarction is beneficial.
Deficiency of magnesium is closely associated with other electrolyte disturbances, particularly hypocalcaemia and hypokalaemia. The specific symptoms of hypomagnesaemia are therefore difficult to determine, but may include nausea, vomiting, muscle weakness, neuromuscular dysfunction such as paraesthesia, tremor and cramp, tachycardia and cardiac arrhythmias.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

The 95% confidence intervals for magnesium levels in healthy Australian subjects are: neonate 0.6 to 0.9 mmol/L and adult 0.8 to 1.0 mmol/L.
Approximately 50% of magnesium in the body is found in bone, with the majority of the remainder stored in muscle and soft tissue. 1% or less is contained in the extracellular compartment, of which approximately 33% is protein bound, with a further 12% bound to anions.
After intravenous infusion the duration of action of magnesium is approximately 30 minutes. Magnesium is primarily excreted in the urine, with small amounts excreted in faeces, saliva and breast milk. Over 90% of magnesium filtered by the kidneys is reabsorbed, mainly in the ascending limb of the Loop of Henle, with significant amounts also absorbed in the proximal and distal tubules. The clearance is proportional to the plasma magnesium concentration and the glomerular filtration rate.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Water for injections.

6.2 Incompatibilities

As mixtures of the following products with DBL Magnesium Chloride Concentrated Injection may cause precipitates to form, products containing these anions should not be mixed or co-administered with DBL Magnesium Chloride Concentrated Injection.
Magnesium salts have been reported to be incompatible with alkali carbonates, bicarbonates and soluble phosphates. Magnesium salts may also react with arsenates, phosphates and tartrates.

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. Protect from light.

6.5 Nature and Contents of Container

DBL Magnesium Chloride Concentrated Injection is supplied in glass ampoules.

Strength.

Magnesium chloride (anhydrous) 480 milligrams in 5 mL.

Pack.

10 x 5 mL ampoules.

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

Chemical structure.

No data available.

CAS number.

The CAS registry number is 7791-18-6.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes