Consumer medicine information

Metaraminol Sandoz Solution for injection

Metaraminol

BRAND INFORMATION

Brand name

Metaraminol Sandoz Solution for injection

Active ingredient

Metaraminol

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Metaraminol Sandoz Solution for injection.

What is in this leaflet

This leaflet answers some common questions about Metaraminol Sandoz injection. 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 Metaraminol Sandoz injection 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 Metaraminol Sandoz injection is used for

The name of your medicine is Metaraminol Sandoz injection. It contains the active ingredient Metaraminol tartrate.

Metaraminol Sandoz injection 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 Metaraminol Sandoz injection works

Metaraminol Sandoz injection 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 Metaraminol Sandoz injection 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.

Metaraminol Sandoz injection is not recommended for use in children.

Before you are given Metaraminol Sandoz injection

When you must not be given it

You should not be given Metaraminol Sandoz injection if:

  • You are allergic to metaraminol or any of the ingredients listed at the end of this leaflet. Metaraminol Sandoz injection 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).

Metaraminol Sandoz injection 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 Metaraminol Sandoz injection 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 Metaraminol Sandoz injection.

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 Metaraminol Sandoz injection.

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 Metaraminol Sandoz injection is given

Metaraminol Sandoz injection must only be given by a doctor or nurse.

How it is given

Metaraminol Sandoz injection 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 Metaraminol Sandoz injection 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 Metaraminol Sandoz injection 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 Metaraminol Sandoz injection. 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 Metaraminol Sandoz injection

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 Metaraminol Sandoz injection.

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 Metaraminol Sandoz injection. 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 Metaraminol Sandoz injection

Storage

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

Metaraminol Sandoz injection 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

Metaraminol Sandoz injection is a clear, colourless solution in a clear glass vial sealed with a grey rubber stopper and aluminium seal with a plastic flip off cap.

Metaraminol Sandoz injection is available as a 6mL and 10mL solution.

Ingredients

Each mL of Metaraminol Sandoz injection contains 0.5 mg of metaraminol in water for injections.

It also contains:

  • Sodium chloride
  • Sodium metabisulfite

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

Supplier

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park NSW 2113
Australia
Tel: 1800 634 500

Metaraminol Sandoz injection 3 mg/6 mL (0.5 mg/mL) solution for injection vial.

AUST R 264254
Phebra product code - INJ176

Metaraminol Sandoz injection 5 mg/10 mL (0.5 mg/mL) solution for injection vial.

AUST R 264255
Phebra product code - INJ184

Date prepared: November 2016

BRAND INFORMATION

Brand name

Metaraminol Sandoz Solution for injection

Active ingredient

Metaraminol

Schedule

S4

 

Name of the medicine

Metaraminol tartrate.

Excipients.

Each mL of Metaraminol Sandoz solution for injection contains sodium chloride 9 mg, sodium metabisulfite 1.2 mg as antioxidant in water for injections to 1 mL.

Description

The molecular weight of the compound is 317.29 and the CAS registry number is 33402-03-8.
The molecular formula is C9H13NO2.C4H6O6.
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.
Each mL of Metaraminol Sandoz solution for injection contains metaraminol (as tartrate) 0.5 mg, sodium chloride 9 mg, sodium metabisulfite 1.2 mg as antioxidant in water for injections to 1 mL.

Pharmacology

Pharmacodynamics.

Metaraminol is a potent sympathomimetic amine that increases both systolic and diastolic blood pressure. The pressor effect begins one to two minutes after intravenous injection, about ten minutes after intramuscular injection, 5 to 20 minutes after subcutaneous injection, and lasts about 20 minutes to one hour. Metaraminol has a positive inotropic effect on the heart and has a peripheral vasoconstrictor action.
Renal, coronary, and cerebral blood flow are a function of perfusion pressure and regional resistance. In most instances of cardiogenic shock, the beneficial effect of sympathomimetic amines is attributable to their positive inotropic effect. In patients with insufficient or failing vasoconstriction, there is additional advantage to the peripheral action of metaraminol, but in most patients with shock, vasoconstriction is adequate and any further increase is unnecessary. Therefore, blood flow to vital organs may decrease with metaraminol if regional resistance increases excessively.
The pressor effect of metaraminol is decreased but not reversed by alpha-adrenergic blocking agents. A primary or secondary fall in blood pressure and a tachyphylactic response to repeated use are uncommon.

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.

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. In particular, Metaraminol Sandoz injection is contraindicated in patients who are hypersensitive to sodium metabisulfite (see Precautions).

Precautions

Metaraminol Sandoz solution for 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 pregnancy.

(Category C)
There are no well controlled studies in pregnant women. Metaraminol Sandoz injection may cause fetal hypoxia by constricting the uterine vessels thereby limiting placental perfusion.
Metaraminol Sandoz injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use in lactation.

It is not known whether Metaraminol Sandoz injection is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised if Metaraminol Sandoz injection is given to a breastfeeding woman.

Paediatric use.

The effect of therapy with Metaraminol Sandoz injection in children has not been established.

Interactions

Metaraminol Sandoz 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.

Adverse Effects

Abscess formation, tissue necrosis or sloughing and anaphylactic reaction 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.

Dosage and Administration

Metaraminol Sandoz 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.

Direct intravenous injection.

In severe shock, when time is of great importance, it may be desirable to administer Metaraminol Sandoz injection by direct intravenous injection. The suggested dose is 0.5 to 5 mg (1 to 10 mL), followed by an infusion of 15 to 95 mg in a diluent made up to a total volume of 500 mL. Extreme care must be exercised to give the proper dose.

Intravenous infusion (for adjunctive treatment of hypotension).

The recommended dose is 15 to 100 mg (30 to 200 mL) in sodium chloride injection or glucose injection 5% to make up a total volume of 500 mL infusion, adjusting the rate of infusion to maintain the blood pressure at the desired level.
Higher concentrations of metaraminol tartrate (150 to 500 mg/500 mL of infusion fluid) have been used. However Metaraminol Sandoz is not suitable for use at these doses. A higher strength product should be used in these circumstances.
If the patient needs additional saline or glucose solution at a rate of flow that would provide an excessive dose of the vasopressor, the recommended volume (500 mL) of infusion fluid should be increased accordingly. Conversely, if a smaller volume of infusion fluid is desirable, the required dose of metaraminol tartrate may be added to less than 500 mL of diluent.

Compatibility.

In addition to sodium chloride injection and glucose injection 5%, Ringer’s injection and lactated Ringer’s injection were found physically and chemically compatible with Metaraminol Sandoz injection when 15 mg-100 mg of metaraminol (30 mL-200 mL Metaraminol Sandoz injection), when diluted to a total volume of 498 and 530 mL respectively. Compatibility with dextran 6% has not been tested.
When Metaraminol Sandoz injection is mixed with an infusion solution, sterile precautions should be observed. To reduce microbiological 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.

Overdosage

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.
The oral LD50 in the rat and mouse is 240 mg/kg and 99 mg/kg, respectively.
For information on the management of overdose, contact the Poisons Information Centre on 131 126 (Australia).

Presentation

A clear colourless sterile solution of metaraminol tartrate equivalent to 0.5 mg/mL metaraminol.
In addition to metaraminol, each 1 mL of injection also contains sodium chloride 9 mg, sodium metabisulfite 1.2 mg as antioxidant in water for injections to 1 mL.

3 mg/6 mL presentation.

6 mL solution in a 7 mL clear type I glass vial.
It is supplied in a carton containing 5 vials.
AUST R 264254
Phebra product code-INJ176

5 mg/10 mL presentation.

10 mL solution in a 10 mL clear type I glass vial.
It is supplied in a carton containing 5 vials.
AUST R 264255
Phebra product code-INJ184

Storage

Store below 25°C. Protect from light.

Poison Schedule

S4.