Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Aramine. 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 Aramine 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 in a safe place. You may need to read it again.

What Aramine is used for

The name of your medicine is Aramine. It contains the active ingredient metaraminol tartrate.

Aramine is used to increase your blood pressure which can drop during spinal anaesthesia or can drop as a reaction to medications or surgical complications.

How Aramine works

Aramine belongs to a group of medicines known as sympathomimetic amines.

It strengthens the contraction of the heart muscle and constricts blood vessels to help increase the blood pressure.

There is no evidence that Aramine is addictive.

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

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

Aramine is not recommended for use in children

Before you are given Aramine

When you must not be given it

You should not be given Aramine if:

• you are allergic to metaraminol or any of the ingredients listed at the end of this leaflet. Aramine contains sodium metabisulfite. A sulfite may cause an allergic-type reaction or an asthmatic episode in certain susceptible people.
• you are being given cyclopropane or halothane anaesthesia (unless clinical circumstances demand their use).

Aramine is not recommended for children.

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 Aramine if the solution is discoloured, cloudy, turbid, or a precipitate is present. The solution is normally a clear, colourless solution.

The doctor or nurse will check to ensure the medicine is not past its expiry date and has not been tampered with.

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, sulfites or any other substances including foods, preservatives or dyes.

Tell your doctor if you plan on becoming pregnant or will be breastfeeding while you are given Aramine.

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

• Liver disease
• Heart or thyroid disease
• High blood pressure
• Diabetes
• Malaria.

If you have not told your doctor about any of the above, tell him/her before you are given Aramine.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket, health food shop, naturopath or herbalist.

Some medicines and metaraminol may interfere with each other. These include:

• certain medicines used to treat depression, e.g. Monoamine Oxidase Inhibitors (MAOI’s) or Tricyclic antidepressants (TCA’s).
• digoxin, a medicine used to treat heart failure.

If you are unsure whether you are taking one of the above drugs, ask your doctor or pharmacist.

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

Your doctor has more information on medicines to be careful with or avoid while being given this medicine.

How Aramine is given

Aramine must only be given by a doctor or nurse.

How it is given

Aramine is administered in a hospital as an injection into a vein or diluted before use and given with fluids into a vein.

To reduce microbial hazard, use as soon as practicable after preparation. If storage is necessary, hold at 2-8°C for not more than 24 hours. The injection solution contains no antimicrobial preservative and is for single use in one patient only. Discard any residue.

How much is given

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

If you are given too much (overdose)

As Aramine is always given to you in a hospital under the supervision of a doctor, it is unlikely that you will receive an overdose.

However, you should tell your doctor or nurse immediately if you feel unwell at all whilst you are being given Aramine. You may need urgent medical attention.

If you notice any symptoms of an overdose immediately contact your doctor or go to the Emergency Department at the nearest hospital.

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

While you are being given Aramine

Things you must do

Always follow your doctor's instructions carefully.

Your doctor or nurse will monitor your blood pressure.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Aramine.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

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

Ask your doctor to answer any questions you may have.

If any of the following happen, tell your doctor immediately:

• Fast or pounding heartbeat

These may be serious side effects of Aramine. You may need urgent medical attention.

If any of the following happen, tell your doctor immediately or go to the Emergency Department at your nearest hospital:

• Swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing.
• Breathlessness or any difficulty breathing.

These are very serious side effects. You may need urgent medical attention or hospitalisation

Other side effects not listed above may also occur in some people. Tell your doctor if you notice any other effects.

After being given Aramine

Storage

Aramine should only be given to you in a hospital. It should be kept in the original packaging until it has been given to you.

Aramine must be stored below 25°C. Protect from light.

Disposal

Any unused or out of date medicine should be returned to your pharmacist.

Product description

What it looks like

Aramine is a clear, colourless to slightly yellow/pink solution in a clear glass vial sealed with a grey rubber stopper and aluminium seal with a plastic flip off cap.

Aramine is available as a 1 mL solution.

Ingredients

Each mL of Aramine contains 10 mg of metaraminol in water for injections.

It also contains:

• sodium chloride
• sodium metabisulfite
• tartaric acid
• sodium hydroxide.

This medicine contains sodium as sodium chloride and sodium metabisulfite. It does not contain lactose, sucrose, gluten, tartrazine, alcohol, dyes or preservatives.

Sponsor

Aramine is made in Australia by:

Phebra Pty Ltd
19 Orion Road, Lane Cove West,
NSW 2066, Australia.
Telephone: 1800 720 020

Aramine 10 mg/mL solution for injection vial.

AUST R 284785

Phebra product code- INJ188

Date of most recent amendment
19 Oct 2020

Aramine, Phebra and the Phi symbol are trademarks of Phebra Pty Ltd, 19 Orion Road, Lane Cove West, NSW 2066, Australia.

Published by MIMS December 2020

1 Name of Medicine

Metaraminol tartrate.

2 Qualitative and Quantitative Composition

Aramine injection contains 10 mg/mL metaraminol (as tartrate) as the active ingredient.
Each mL of Aramine injection contains metaraminol (as tartrate) 10 mg and sodium metabisulfite 2.0 mg as antioxidant.
Metaraminol tartrate is a white, crystalline powder, which is freely soluble in water, slightly soluble in alcohol, and practically insoluble in chloroform and in ether.

List of excipients with known effect.

3 Pharmaceutical Form

Aramine injection is a clear colourless to slightly yellow/pink sterile solution of metaraminol tartrate equivalent to 10 mg/mL metaraminol.

4 Clinical Particulars

4.1 Therapeutic Indications

Prevention and treatment of the acute hypotensive state occurring with spinal anaesthesia; adjunctive treatment of hypotension due to haemorrhage, reactions to medications, surgical complications, and shock associated with brain damage due to tumour or trauma.
It may also be useful as an adjunct in the treatment of hypotension due to cardiogenic shock or septicaemia.

4.2 Dose and Method of Administration

Aramine injection is for intravenous administration only (injection or infusion) and should be used in one patient on one occasion only. It contains no antimicrobial preservative. Unused solution should be discarded.
Because the maximum effect is not immediately apparent, at least ten minutes should elapse before increasing the dosage. As the effect tapers off when the vasopressor is discontinued, the patient should be carefully observed so that therapy can be reinitiated promptly if the blood pressure falls too rapidly. Patients with coexistent shock and acidosis may show a poor response to vasopressors. Established methods of shock management, such as blood or fluid replacement when indicated, and other measures directed to the specific cause of the shock also should be used.

Intravenous infusion (for adjunctive treatment of hypotension).

Direct intravenous injection.

4.3 Contraindications

Use with cyclopropane or halothane anaesthesia should be avoided, unless clinical circumstances demand such use.
Hypersensitivity to any component of this product including sulfites.

4.4 Special Warnings and Precautions for Use

Aramine injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
Caution should be exercised to avoid an excessive blood pressure response. Rapidly induced hypertensive responses have been reported to cause acute pulmonary oedema, cardiac arrhythmias and arrest. Patients with cirrhosis should be treated with caution, with adequate restoration of electrolytes if diuresis ensues. A fatal ventricular arrhythmia has been reported in a patient with Laennec's cirrhosis while receiving metaraminol tartrate. In several instances, ventricular extrasystoles that appeared during infusion subsided promptly when the rate of flow was reduced.
With the prolonged action of this drug, a cumulative effect is possible, and with an excessive vasopressor response there may be a prolonged elevation of blood pressure even when therapy with metaraminol tartrate is discontinued.
Because of its vasoconstrictor effect, metaraminol tartrate should be given with caution in the presence of heart or thyroid disease, hypertension, or diabetes. Sympathomimetic amines may provoke a relapse in patients with a history of malaria.
When vasopressor amines are used for long periods, the resulting vasoconstriction may prevent adequate expansion of the circulating volume and may cause perpetuation of the shock state. There is evidence that plasma volume may be reduced in all types of shock, and that the measurement of central venous pressure is useful in assessing the adequacy of the circulating blood volume. Therefore, blood or plasma volume expanders should be employed when the principal reason for hypotension or shock is decreased circulating volume.
In choosing the site of injection, it is important to avoid those areas recognised as unsuitable for the use of any pressor agent, and to discontinue the infusion immediately if infiltration or thrombosis occurs. Although the urgent nature of the patient's condition may force the choice of an unsuitable injection site, the preferred areas of injection should be used when possible. The larger veins of the antecubital fossa or thigh are preferred to the veins in the ankle or the dorsum of the hand, particularly in patients with peripheral vascular disease, diabetes mellitus, Buerger's disease, or conditions with coexistent hypercoagulability.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Aramine injection should be used with caution in digitalised patients, since the combination of digitalis and sympathomimetic amines is capable of causing ectopic arrhythmic activity.
MAOIs and tricyclic antidepressants have been reported to potentiate the action of sympathomimetic amines.

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)

Abscess formation, tissue necrosis or sloughing rarely follow the use of metaraminol tartrate.
Sympathomimetic amines, including metaraminol tartrate, may cause sinus or ventricular tachycardia or other arrhythmias, especially in patients with myocardial infarction.

Reporting suspected adverse effects.

4.9 Overdose

Overdosage may result in severe hypertension accompanied by headache, constricting sensation in the chest, nausea, vomiting, euphoria, diaphoresis, pulmonary oedema, tachycardia, bradycardia, sinus arrhythmia, atrial or ventricular arrhythmias, myocardial infarction, cardiac arrest or convulsions.
Should an excessive elevation of blood pressure occur, it may be immediately relieved by a sympatholytic agent, e.g. phentolamine. An appropriate antiarrhythmic agent may also be required.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).
The oral LD50 in the rat and mouse is 240 mg/kg and 99 mg/kg, respectively.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each mL of Aramine injection contains sodium chloride 8.5 mg, sodium metabisulfite 2.0 mg as antioxidant in water for injections to 1 mL. Tartaric acid and/or sodium hydroxide are added for pH adjustment.

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 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

Aramine injection is presented as 1 mL clear, colourless to slight yellow/pink solution in a 2 mL clear type I glass vial.
It is supplied in a carton containing 5 vials.
Phebra product code: INJ188.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

The molecular weight of the compound is 317.29. The molecular formula is C₉H₁₃NO₂.C₄H₆O₆.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes