Consumer medicine information

Metaraminol GH Pharma Injection

Metaraminol

BRAND INFORMATION

Brand name

Metaraminol GH Pharma

Active ingredient

Metaraminol

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Metaraminol GH Pharma Injection.

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Metaraminol GH Pharma Injection. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risk of you being given Metaraminol GH Pharma Injection against the benefits it is expected to have for you.

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

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

WHAT METARAMINOL GH PHARMA INJECTION IS USED FOR

The name of your medicine is Metaraminol GH Pharma Injection. It contains the active ingredient Metaraminol tartrate.

Metaraminol GH Pharma 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.

Your doctor may have prescribed Metaraminol GH Pharma Injection for another reason.

Ask your doctor if you have any questions about why Metaraminol GH Pharma Injection was prescribed for you. Your doctor may have prescribed it for another reason.

How Metaraminol GH Pharma Injection works

Metaraminol GH Pharma 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 GH Pharma Injection is addictive.

BEFORE YOU TAKE METARAMINOL GH PHARMA INJECTION

When you must not take it

You should not be given Metaraminol GH Pharma Injection if:

  • You are allergic to the active ingredient or any of the inactive ingredients mentioned at the end of this leaflet under Product Description. Metaraminol GH Pharma Injection contains sodium metabisulfite. A sulfite may cause an allergic- type reaction or an asthmatic episode in certain susceptible people. Symptoms of an allergic reaction include rash, asthma attack or hay fever.
  • You are being given cyclopropane or halothane anaesthesia (unless clinical circumstances demand their use).
  • It is past its expiry date or the packaging appears to have been tampered with.

Metaraminol GH Pharma Injection is not recommended for children.

Before you are given Metaraminol GH Pharma Injection

Tell your doctor if you have allergies to:

  • Any other medicines, especially if they are in the same drug class as metaraminol
  • Sulfites
  • 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 GH Pharma Injection.

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

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

If you have not told your doctor about any of the above, tell them before you start taking Metaraminol GH Pharma Injection.

Taking other medicines

Tell your doctor if you are taking any other medicine, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

In particular, tell your doctor if you take any of the following:

  • 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 GH Pharma Injection, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.

HOW TO TAKE METARAMINOL GH PHARMA INJECTION

The dose of Metaraminol GH Pharma Injection you will receive depends on your medical condition and other factors such as your weight.

Metaraminol GH Pharma Injection is administered in a hospital as an injection into a vein or is diluted before use and given with fluids into a vein. This medicine must only be given by a doctor or nurse.

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.

If you are given too much

Metaraminol GH Pharma Injection is administered in a hospital, under the supervision of a doctor. Therefore it is unlikely that you will receive too much. However, you should tell your doctor or nurse immediately if you feel unwell at all whilst you are being given Metaraminol GH Pharma Injection. You may need urgent medical attention.

WHILE YOU ARE TAKING METARAMINOL GH PHARMA INJECTION

Things you must do

  • Always follow your doctor's instructions carefully.
  • Your doctor or nurse will monitor your blood pressure.

SIDE EFFECTS

All medicines can have unwanted effects. Sometimes they are serious, most of the time they are not. Do not be alarmed by this list of possible side effects. You may not experience any of them.

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Metaraminol GH Pharma Injection.

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

  • Fast or pounding heartbeat.

These may be serious side effects of Metaraminol GH Pharma Injection. You may need urgent medical attention.

If any of the following happen, tell your doctor immediately, or go to Accident and Emergency 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. All of these side effects are very rare.

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

AFTER TAKING METARAMINOL GH PHARMA INJECTION

Storage

Metaraminol GH Pharma 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 GH Pharma 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 Metaraminol GH Pharma Injection looks like

Metaraminol GH Pharma Injection is a clear, colourless sterile solution.

Metaraminol GH Pharma Injection is provided in three presentations as follows:

10 mg/1 mL presentation: 1 mL solution in a 1 ml clear glass ampoule. It is supplied in a carton containing 5 ampoules.

3 mg/6 mL presentation: 6 mL solution in a 6 ml clear glass vial. It is supplied in a carton containing 5 vials.

5 mg/10 mL presentation: 10 mL solution in a 10 mL glass vial. It is supplied in a carton containing 5 vials.

INGREDIENTS

Each mL of Metaraminol GH Pharma Injection contains 10 mg (ampoule) or 0.5 mg (vial) 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

Metaraminol GH Pharma Injection is supplied in Australia by:

Global Harvest Pharmaceuticals Pty Ltd
Level 7, 151 Clarence Street,, Sydney, NSW 2000

For Medical Enquiries telephone: 1800 114 717

This leaflet was revised in May 2019

AUSTRALIAN REGISTER NUMBER

Metaraminol GH Pharma Injection 10mg/1ml: AUST R 99402

Metaraminol GH Pharma Injection 3 mg/6mL – AUST R 300197

Metaraminol GH Pharma Injection 5 mg/ 10 mL – AUST R 304084

Published by MIMS November 2019

BRAND INFORMATION

Brand name

Metaraminol GH Pharma

Active ingredient

Metaraminol

Schedule

S4

 

1 Name of Medicine

Metaraminol tartrate.

6.7 Physicochemical Properties

Chemical name: (1R,2S)-2-amino-1-(3-hydroxyphenyl) propan-1-ol hydrogen (2R,3R) tartrate.
Molecular formula: C9H13NO2.C4H6O6.
Molecular weight: 317.29.

Chemical structure.


CAS number.

33402-03-8.

2 Qualitative and Quantitative Composition

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.

Active ingredient.

Metaraminol tartrate.

Excipients.

For full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Metaraminol GH Pharma Injection is a clear colourless sterile solution.
Metaraminol GH Pharma Injection is available as solution for injection containing metaraminol tartrate 10 mg/mL in clear glass ampoules and 3 mg/6 mL and 5 mg/10 mL in clear glass vials.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Metaraminol is a potent sympathomimetic amine that increases both systolic and diastolic blood pressure. 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.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

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.
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.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

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.

4.3 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 (see Section 4.4 Special Warnings and Precautions for Use).

4.4 Special Warnings and Precautions for Use

Metaraminol GH Pharma 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 nonasthmatic 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.

Paediatric use.

The effect of therapy with Metaraminol GH Pharma Injection in children has not been established.

Use in the elderly.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Metaraminol GH Pharma 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

Effect on fertility.

No data available.
(Category C)
There are no well controlled studies in pregnant women. Metaraminol may cause fetal hypoxia by constricting the uterine vessels thereby limiting placental perfusion. Metaraminol GH Pharma Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether Metaraminol GH Pharma Injection is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised if Metaraminol GH Pharma Injection is given to a breastfeeding woman.

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.

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.

4.2 Dose and Method of Administration

Metaraminol GH Pharma Injection is administered intravenously only (injection or infusion). The injection solution contains no antimicrobial preservative and is for single use in one patient only. Discard any residue.
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).

Metaraminol GH Pharma 10 mg/mL Solution for Injection (1 mL ampoule) should be used to prepare the intravenous infusion.
The recommended dose is 15 to 100 mg in 500 mL of sodium chloride injection or glucose injection 5%, adjusting the rate of infusion to maintain the blood pressure at the desired level. See Table 1.
Higher concentrations of metaraminol tartrate (150 to 500 mg/500 mL of infusion fluid) have been used.
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%, the following infusion solutions were found physically and chemically compatible with metaraminol when 5 mL of metaraminol injection, 10 mg/mL (metaraminol equivalent), was added to 500 mL of infusion solution: Ringer's injection, lactated Ringer's injection, Dextran 6% in saline and Normosol-M in D5-W.
When metaraminol 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.

Direct intravenous injection.

In severe shock, when time is of great importance, it may be desirable to administer metaraminol by direct intravenous injection. The suggested dose is 0.5 to 5 mg, followed by an infusion of 15 to 100 mg in 500 mL of diluent. See Table 1.
Direct intravenous injection of undiluted solution should be employed only in instances of grave emergency when prompt action is imperative to save life. Extreme care must be exercised to give the proper dose.

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.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
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.

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Table 2.

6.2 Incompatibilities

See Section 4.2 for Compatibility information.
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). 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

Container type/pack sizes.

Metaraminol GH Pharma Injection is provided in three presentations as follows.
10 mg/1 mL presentation: 1 mL solution in a 1 mL clear glass ampoule. It is supplied in a carton containing 5 ampoules. AUST R 99402.
3 mg/6 mL presentation: 6 mL solution in a 6 mL clear glass vial. It is supplied in a carton containing 5 vials. AUST R 300197.
5 mg/10 mL presentation: 10 mL solution in a 10 mL glass vial. It is supplied in a carton containing 5 vials. AUST R 304084.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed in accordance with appropriate disposal procedures within theatre.

Summary Table of Changes