Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Arginine Hydrochloride Injection 60%. It does not contain all the available information. It does not take the place of talking to your doctor.

All medicines have risks and benefits.Your doctor has weighed the risks of you being given Arginine Hydrochloride Injection 60% against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your doctor.

Keep this leaflet. You may need to read it again.

What Arginine Hydrochloride Injection 60% is used for

Arginine Hydrochloride Injection 60% is used to treat:

• severe metabolic alkalosis where the pH of the blood is too high
• disorders in the urea cycle present at birth

Arginine Hydrochloride Injection 60% can also be used to stimulate the release of human growth hormone which can then be used as part of a test to evaluate growth disorders.

Ask your doctor if you have any questions about why Arginine has been prescribed for you. Your doctor may have prescribed it for another reason.

Before you are given Arginine Hydrochloride Injection

When you must not be given it

You must not be given Arginine Hydrochloride Injection 60% if you have an allergy to Arginine Hydrochloride.

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash itching or hives on the skin.

You should not be given this medicine if you have too much acid in your blood. This may be indicated by an increased rate of breathing.

You must not be given this medicine if you have low blood pressure.

You should not be given this medicine if you have problems metabolising Arginine. That is diseases related to nitric acid production.

You should not be given this medicine if the solution is discoloured, cloudy, turbid, or a precipitate is present. The solution is normally a clear, colourless liquid.

You should not be given this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If you are given this medicine after the expiry date has passed, it may not work as well.

If you are not sure whether you should be given this medicine, talk to your doctor.

Before you are given it

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

Tell your doctor if you have or have had any of the following medical conditions:

• severe liver disease
• kidney disease
• anuria (no production or passing of urine)
• unusual amount of salt in the body.

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor will discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you are given Arginine Hydrochloride Injection 60%.

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, health food shop, herbalist or naturopath.

Some medicines and Arginine Hydrochloride Injection 60% may interfere with each other. These include:

• Spironolactone, a diuretic used to treat heart disease or oedema.

This medicine may be affected by Arginine, or may affect how well it works.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while being given Arginine.

How Arginine Hydrochloride Injection 60% is given

Arginine Hydrochloride Injection 60% must only be given by a doctor or nurse. It is usually diluted and given as a slow infusion into a vein.

Your doctor will decide what dose of Arginine Hydrochloride Injection 60% you will receive and for how long you will receive it. This depends on your medical condition and other factors, such as your weight.

If you are given too much (overdose)

Arginine Hydrochloride Injection 60% must only be given by a doctor or nurse so an overdose is not likely to occur.

Symptoms of an overdose usually disappear after treatment with this medicine has finished.

Symptoms may include:

• rapid breathing
• faintness, dizziness or light-headedness
• numbness around the mouth, fingertips or toes
• cramping in the hands and fingers.

Immediately contact your doctor or nurse or go to Accident and Emergency at the nearest hospital if you notice symptoms of an overdose.

While you are being given Arginine Hydrochloride Injection 60%

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you have been given Arginine Hydrochloride Injection 60%.

Tell any other doctors, dentists, and pharmacists who treat you that you have been given this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you have been given this medicine. It may affect other medicines used during surgery.

Keep all of your doctor’s appointments so that your progress can be checked. Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Things to be careful of

Be careful driving or operating machinery until you know how Arginine affects you. This medicine may cause dizziness or light-headedness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else dangerous.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. Standing up slowly, especially when you get out of bed or chairs, will help your body get used to changes in position and blood pressure. If this problem continues or gets worse, talk to your doctor.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Arginine Hydrochloride Injection 60%. This medicine 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.

Do not be alarmed by the following list of side effects. You may not experience any of them.

Ask your doctor to answer any questions you may have.

Tell your doctor or nurse if you notice any of the following and they worry you:

• nausea or vomiting
• flushing
• headache
• numbness
• irritation at the site of the injection.

The above list includes the more common side effects of your medicine.

If any of the following happen, tell your doctor or nurse immediately, or go to accident or emergency at your local hospital:

• dizziness or light headedness
• rash, itching or hives on the skin
• swelling of face, lips, tongue or other parts of the body
• shortness of breath
• wheezing or troubled breathing
• changes in heart rate or chest pain.

The above list includes some very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Tell your doctor or nurse if you notice anything that is making you feel unwell. Some side effects not listed above may also occur in some people.

Some of the side effects (for example high levels of potassium in the blood) can only be found when your doctor does tests from time to time to check your progress.

After being given Arginine Hydrochloride Injection 60%

Storage

Arginine Hydrochloride Injection 60% will be stored in the surgery, pharmacy or ward of a hospital. The injection is kept in a cool dry place where the temperature stays below 30°C.

Arginine Hydrochloride Injection 60% will be opened for use on you. It will be used only once and then it will be discarded. It will never be stored after it is opened or used for more than one person.

Product description

What it looks like

Arginine Hydrochloride Injection 60% is a clear, colourless solution in a clear glass vial sealed with a grey rubber stopper and aluminium seal with a white plastic flip off cap in packs of 10.

25mL of the product is supplied in 50mL vials.

Ingredients

Arginine Hydrochloride Injection 60% contains 0.6g/mL of Arginine Hydrochloride in Water for Injections.

This medicine does not contain lactose, sucrose, gluten, tartrazine, dyes or any preservatives.

Manufacturer

Arginine Hydrochloride Injection 60% is made in Australia by
Phebra Pty Ltd
19 Orion Road
Lane Cove West, NSW 2066
Australia

AUST R 22934

Phebra Product Code: INJ162

This leaflet was amended December 2013.

Published by MIMS July 2014

1 Name of Medicine

Arginine hydrochloride.

2 Qualitative and Quantitative Composition

Arginine Hydrochloride 60% Concentrated Injection 15 g in 25 mL contains arginine hydrochloride 600 mg/mL in water for injections to 25 mL.

3 Pharmaceutical Form

Arginine Hydrochloride 60% 15 g in 25 mL concentrated injection for infusion is a clear colourless solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Arginine stimulates the release of growth hormone by the pituitary gland and may be used instead of, or in addition to, other tests such as insulin induced hypoglycaemia, for the evaluation of growth disorders; false positive and false negative results are relatively common and evaluation therefore should not be made on the basis of a single arginine test.
Arginine is used as an acidifying agent in severe metabolic alkalosis.
Arginine is used in some conditions accompanied by hyperammonaemia stemming from inborn errors of the urea cycle, particularly where there is a severe deficiency of ornithine carbamoyl transferase or carbamoyl phosphate synthetase, where respiratory alkalosis is present.

4.2 Dose and Method of Administration

Arginine Hydrochloride 60% Concentrated Injection is compatible for dilution with either sodium chloride 0.9% or glucose 5%. It should be diluted before use to make a concentration of arginine hydrochloride 10%. The resulting infusion solution should be given over 30 minutes.
The usual dose is:

Adults.

Children.

4.3 Contraindications

Arginine Hydrochloride 60% Concentrated Injection is contraindicated in:
patients who are highly allergic;
patients hypersensitive to arginine or who have severe acidosis;
patients with hypotension or any defects or diseases related to nitric oxide production.

4.4 Special Warnings and Precautions for Use

Antihistamine medication should be available during treatment, in the event of an allergic reaction.
Patient blood pressure should be monitored during use and for 24 hours following cessation of intravenous administration due to the possibility of hypotension.

Use with caution.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Arginine has been known to interact with spironolactone.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

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)

Nausea, vomiting, flushing, headache, numbness and local venous irritation may occur if arginine solutions are infused too rapidly.

Rare adverse reactions.

Reporting suspected adverse reactions.

4.9 Overdose

An overdosage may cause a transient metabolic acidosis with hyperventilation. The acidosis can generally be compensated and the base deficit will return to normal following completion of the infusion. If the condition persists, the deficit should be determined and corrected by a calculated dose of an alkalosing agent. Hypotension may develop due to stimulation of nitric oxide production.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Arginine is considered to be a normal metabolite in animals and man.

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

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)¹. The expiry date can be found on the packaging.
¹AUST R 22934.

6.4 Special Precautions for Storage

Store below 30°C. Do not freeze.

6.5 Nature and Contents of Container

Arginine Hydrochloride 60% Concentrated Injection is presented as 25 mL of solution in a 50 mL glass vial in a pack of 10 vials.
Phebra product code - INJ162.
The vial stopper is not made with natural rubber latex.

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

Arginine hydrochloride is a white or almost white crystalline powder or colourless crystals, that is freely soluble in water, very slightly soluble in alcohol, and practically insoluble in ether.
The molecular weight of the compound is 210.7. The molecular formula is C₆H₁₄N₄O₂.HCl.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes