SUMMARY CMI

DROPERIDOL

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Droperidol Medsurge?

Droperidol Medsurge contains the active ingredient droperidol. Droperidol Medsurge is used for the following:

ANAESTHESIA

Droperidol solution for injection is indicated to produce tranquillisation and to reduce the incidence of nausea and vomiting in surgical and diagnostic procedures; for premedication, induction, and as an adjunct in the maintenance of general and regional anaesthesia; in neuroleptanalgesia in which droperidol solution for injection is given concurrently with a narcotic analgesic, to aid in producing tranquillity and decreasing anxiety and pain.

PSYCHIATRY

The management of severe agitation, hyperactivity, or aggressiveness in psychotic disorders, including schizophrenic reaction and the manic type of manic depressive illness, or in disturbed states, such as some types of acute brain syndrome and in nonpsychotic acute excitation states

For more information, see Section 1. Why am I using Droperidol Medsurge? in the full CMI.

2. What should I know before I use Droperidol Medsurge?

Do not use if you have ever had an allergic reaction to droperidol or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Droperidol Medsurge? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Droperidol Medsurge and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Droperidol Medsurge?

• Your doctor will decide how much Droperidol solution for injection you will need. This will depend on your age, body weight, medical history and condition.
• Droperidol solution for injection will be injected into a muscle or slowly into a vein.

More instructions can be found in Section 4. How do I use Droperidol Medsurge? in the full CMI.

5. What should I know while using Droperidol Medsurge?

For more information, see Section 5. What should I know while using droperidol? in the full CMI.

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking medicine.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

DROPERIDOL

Active ingredient(s): Droperidol solution for injection

Consumer Medicine Information (CMI)

This leaflet provides important information about using Droperidol Medsurge. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Droperidol Medsurge.

Where to find information in this leaflet:

1. Why am I using Droperidol Medsurge?
2. What should I know before I use Droperidol Medsurge?
3. What if I am taking other medicines?
4. How do I use Droperidol Medsurge?
5. What should I know while using Droperidol Medsurge?
6. Are there any side effects?
7. Product details

1. Why am I using Droperidol Medsurge?

Droperidol Medsurge contains the active ingredient droperidol. Droperidol is a neuroleptic drug of the butyrophenone group that also includes haloperidol.

Droperidol Medsurge is used for the following:

ANAESTHESIA

Droperidol solution for injection is indicated to produce tranquillisation and to reduce the incidence of nausea and vomiting in surgical and diagnostic procedures; for premedication, induction, and as an adjunct in the maintenance of general and regional anaesthesia; in neuroleptanalgesia in which droperidol solution for injection is given concurrently with a narcotic analgesic, to aid in producing tranquillity and decreasing anxiety and pain.

PSYCHIATRY

The management of severe agitation, hyperactivity, or aggressiveness in psychotic disorders, including schizophrenic reaction and the manic type of manic depressive illness, or in disturbed states, such as some types of acute brain syndrome and in nonpsychotic acute excitation states

2. What should I know before I use Droperidol Medsurge?

Do not use Droperidol Medsurge if:

• you are allergic to droperidol or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.
• any other similar medicines such as haloperidol.
• you are intoxicated with alcohol

Droperidol solution for injection should not be given if you have:

• severe drowsiness and slowness as a result of brain disease or damage
• Parkinson's disease
• pheochromocytoma, a type of tumour, which causes high blood pressure
• a rare heart disorder known as QT prolongation. Sometimes this runs in families
• a slow heart beat
• low levels of salt in your blood.

Check with your doctor if you:

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

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

• heart disease
• a family history of sudden death kidney disease lung disease
• dementia, if you are over 65 years of age history of blood clots or strokes
• vomiting or diarrhoea
• epilepsy or convulsions
• sleep apnoea, temporarily stopping breathing while you sleep.

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

Do not use this medicine after the expiry date (EXP) printed on the pack.

• If you are given it after the expiry date has passed, it may not work very well.

Do not use this medicine if the packaging is torn or shows signs of tampering or if the injection shows any visible signs of deterioration.

3. What if I am taking other medicines?

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

• medicines that act on the heart, such as quinidine, disopyramide, procainamide, amiodarone, sotalol and bepridil
• medicines used to treat depression, such as maprotiline and amitriptyline
• medicines used to treat mental illness, such as phenothiazines, pimozide and sertindole
• medicines used to treat allergies or hay fever, such as astemizole and terfenadine
• alcohol or medicines that make you feel drowsy or slow to react, such as sleeping tablets, tranquillisers or strong pain killers
• medicines used to treat high blood pressure
• medicines used to treat epilepsy, such as phenobarbitone, carbamazepine or phenytoin
• medicines used to treat Parkinson's disease such, as levodopa, bromocriptine, lisuride
• cisapride, a medicine used to treat certain digestive problems
• halofantrine, a medicine used to treat malaria
• sparfloxacin, an antibiotic used to treat lung infections
• some medicines use to treat viral infections, fungal infections or bacterial infections such as ritonavir, itraconazole or ciprofloxacin.

These medicines may be affected by Droperidol solution for injection or may affect how well it works. You may need different amounts of this medicine, or you may need to take different medicines. Your doctor or pharmacist will advise you.

Some medicines may interfere with Droperidol Medsurge and affect how it works.

Concomitant use of droperidol solution for injection with CYP1A2 inhibitors and/or CYP3A4 inhibitors could decrease the rate of droperidol metabolism and prolong its pharmacological action.

Medicines that may increase the effect of Droperidol Medsurge include:

Droperidol may potentiate the action of sedative drugs (barbiturates, benzodiazepines, morphinomimetics). The same applies to antihypertensive agents, so that orthostatic hypotension may ensue.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Droperidol Medsurge.

4. How do I use Droperidol Medsurge?

How much to take / use

Your doctor will decide how much Droperidol solution for injection you will need. This will depend on your age, body weight, medical history and condition.

How it is given

Droperidol solution for injection will be injected into a muscle or slowly into a vein.

If you use too much Droperidol Medsurge

As Droperidol solution for injection is given to you under the supervision of your doctor; it is very unlikely that you will receive an overdose.

Symptoms would include:

• unusual movements, including trembling and shaking of the hands and fingers, twisting movements of the body, shuffling walk and stiffness of the arms and legs
• uncontrollable movements
• dizziness, light headedness
• extreme drowsiness
• shallow breathing
• fits
• irregular heart beat

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Droperidol Medsurge?

Things you should do

• Remind any doctor, dentist or pharmacist you visit that you are using droperidol.

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 up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Droperidol Medsurge affects you.

This medicine may cause dizziness and drowsiness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Drinking alcohol

Tell your doctor if you drink alcohol.

Be careful when drinking alcohol while you are being given this medicine.

If you drink alcohol, dizziness or drowsiness may be worse.

Looking after your medicine

Droperidol solution for injection will be stored in the pharmacy or on the ward.

Store below 25°C. Protect from light.

Product is for single use in one patient only. Discard any residue

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

If you are over 65 years of age you may have an increased chance of getting side effects.

Serious side effects

Very serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What Droperidol Medsurge contains

Do not take this medicine if you are allergic to any of these ingredients.

What Droperidol Medsurge looks like

Droperidol Medsurge 1.25 mg/1 mL solution for injection is a sterile, clear colourless solution in 1 mL amber glass ampoule containing 1.25 mg droperidol available in 5 x 1.25 mg/1 mL, 10 x 1.25 mg/1 mL. and 50 x 1.25 mg/1 mL packs.

Droperidol Medsurge 2.5 mg/1 mL solution for injection is a sterile, clear colourless solution in 1 mL amber glass ampoule containing 2.5 mg droperidol available in 5 x 2.5 mg/1 mL, 10 x 2.5 mg/1 mL and 50 x 2.5 mg/1 mL packs.

Not all presentations or pack sizes are marketed.

Droperidol Medsurge 1.25 mg/1 mL: AUST R 353873

Droperidol Medsurge 2.5 mg/1 mL: AUST R 353872

Who distributes Droperidol Medsurge

Medsurge Pharma Pty Ltd
Unit 1 & 2, 6-7 Gilda Court
Mulgrave, Victoria 3170

Marketed and Distributed by Medsurge Healthcare.

Telephone: 1300 788 261
Website: www.medsurgehc.com

This leaflet was prepared in April 2024.

Published by MIMS June 2024

Notes

Distributed by Medsurge Healthcare

1 Name of Medicine

Droperidol.

2 Qualitative and Quantitative Composition

Droperidol solution for injection contains the active ingredient droperidol.
Droperidol comes in two strengths and contains either 1.25 mg/1 mL or 2.5 mg/1 mL of droperidol.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Injection, solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Anaesthesia.

Psychiatry.

4.2 Dose and Method of Administration

Dosage should be individualised. Some of the factors to be considered in determining the dose are age, bodyweight, physical status, underlying pathological condition, use of other drugs, type of anaesthesia to be used and the surgical procedure involved.
Vital signs should be monitored routinely. To minimise the risk of ventricular arrhythmia, an electrocardiograph (ECG) should be performed and examined for evidence of QT prolongation before any operation commences. ECG monitoring should continue during the surgical procedure and subsequently for a period of time consistent with best medical judgment. This should be at least 7 hours after the end of the procedure (see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use).
Product is for single use in one patient only. Discard any residue.

Anaesthesia.

1. Premedication.

2. Adjunct to general anaesthesia.

3. Use without a general anaesthetic in diagnostic and minor surgical procedures.

Note.

4. Adjunct to regional anaesthesia.

Psychiatry.

4.3 Contraindications

Droperidol solution for injection is contraindicated in:
Known hypersensitivity to this drug or its metabolites;
Severe central nervous system depression;
Comatose states from any cause;
Parkinson's disease;
Phaeochromocytoma;
Breast feeding.
Droperidol solution for injection should not be used in female patients with a QTc of greater than 450 msec or male patients with a QTc of greater than 440 msec (see Section 4.4 Special Warnings and Precautions for Use).
Droperidol solution for injection is contraindicated in patients with acquired long QT interval, such as that associated with concomitant use of drugs known to prolong the QT interval, known hypokalaemia, or hypomagnesaemia, or clinically significant bradycardia (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Droperidol solution for injection is also contraindicated in patients with known congenital long QT interval or family history of congenital long QT syndrome.
Relative contraindication: acute alcohol intoxication.

4.4 Special Warnings and Precautions for Use

Fluids and other counter measures to manage hypotension should be readily available.
The benefits of using droperidol solution for injection should be weighed against the potential risk.
Droperidol solution for injection should only be used under appropriate medical supervision.
Patients with, or suspected of having, the following risk factors for cardiac arrhythmia should be carefully evaluated prior to the administration of droperidol solution for injection:
A history of significant cardiac disease, including serious ventricular arrhythmia, second or third degree atrioventricular block, sinus node dysfunction, congestive heart failure or ischaemic heart disease and left ventricular hypertrophy.
A family history of sudden death.
Renal failure (particularly with chronic dialysis).
Significant chronic obstructive pulmonary disease and respiratory failure.
Risk factors for electrolyte disturbances as seen in patients taking laxatives, glucocorticoids, potassium-wasting diuretics, in association with the administration of insulin in acute settings or in patients with persistent vomiting and/or diarrhoea. In these patients, an ECG and an assessment of serum electrolytes (potassium and magnesium) and renal function should be performed as part of this evaluation and the presence of QT prolongation excluded prior to administration of droperidol. Continuous pulse oximetry should be performed in patients with identified or suspected risk of ventricular arrhythmia and should continue for 30 minutes following single i.v. administration. In a hospital setting, ECG monitoring should be started, when possible, before the administration of droperidol solution for injection for anaesthesia (see Section 4.3 Contraindications). For patients with acute mania or agitation, it is recognised that performing an ECG prior to the initial dose(s) may be difficult. However, an ECG should be performed as soon as the patient's acute symptoms have subsided. Although the possibility of developing QT prolongation and torsade de pointes with the use of droperidol solution for injection is low, ECG monitoring and full cardiac resuscitation facilities should be available.
Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with droperidol solution for injection and preventive measures undertaken.
Outside the hospital setting, droperidol solution for injection should only be used for the management of the psychiatric crisis e.g. acute mania or severe agitation. A single injection should be administered intramuscularly (not greater than 5 mg) and the patient should then be transferred immediately to a hospital facility by an ambulance equipped for cardiac resuscitation.
As with other CNS depressant drugs, patients who have received droperidol solution for injection should have appropriate surveillance.
Patients with a history of alcohol abuse, or recent high intakes, are at the risk of increased arrhythmia.
If droperidol solution for injection is administered with a narcotic analgesic, the user should familiarise himself with the special properties of each drug, particularly with the widely differing durations of action. In addition, when such a combination is used, resuscitative equipment and a narcotic antagonist should be readily available to manage apnoea.
Narcotic analgesics may cause muscle rigidity, particularly involving the muscles of respiration. This effect is related to the speed of injection. Its incidence can be reduced by the use of slow intravenous injection. Once the effect occurs, it is managed by the use of assisted or controlled respiration and by a neuromuscular blocking drug if necessary.
The respiratory depressant effect of narcotics persists longer than their measured analgesic effect. When used with droperidol solution for injection, the total dose of all narcotic analgesics administered should be considered by the practitioner before ordering narcotic analgesics during recovery from anaesthesia. It is recommended that narcotics, when required, be used initially in reduced doses as low as 1/4 to 1/3 of those usually recommended.
Caution is advised if droperidol solution for injection is given concomitantly with strong CYP1A2 and CYP3A4 inhibitors.

Use in psychiatry.

Use in anaesthesia.

Uses in patients with the following states.

Sleep apnoea.

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

Drugs known to prolong the QT interval are contraindicated with droperidol solution for injection. Examples include certain antiarrhythmics, such as those of Class IA (such as quinidine, disopyramide and procainamide) and Class III (such as amiodarone and sotalol); tricyclic antidepressants (such as amitriptyline); certain tetracyclic antidepressants (such as maprotiline); certain antipsychotic medications (such as phenothiazines, pimozide and sertindole); certain antihistamines (such as astemizole and terfenadine); cisapride, bepridil, halofantrine and sparfloxacin.
Droperidol may potentiate the action of sedative drugs (barbiturates, benzodiazepines, morphinomimetics). The same applies to antihypertensive agents, so that orthostatic hypotension may ensue.
Like other sedative drugs, droperidol may potentiate respiratory depression caused by opioids. Since droperidol blocks dopamine receptors, it may inhibit the action of dopamine agonists, such as bromocriptine, lisuride, and L-dopa.
Theoretically, certain agents (e.g. phenobarbitone, carbamazepine, phenytoin), as well as smoking and alcohol consumption, which stimulate metabolising enzymes in the liver, may enhance the metabolic breakdown of neuroleptics, possibly necessitating adjustment of the dose.
Concomitant use of droperidol solution for injection with CYP1A2 inhibitors and/or CYP3A4 inhibitors could decrease the rate of droperidol metabolism and prolong its pharmacological action.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Droperidol solution for injection may impair mental and/or physical abilities for operating machinery or driving a motor vehicle. Patients should only drive or operate a machine if sufficient time has elapsed after the administration of droperidol, i.e. about 10 hours after a dose of up to 5 mg and 24 hours after higher doses.

4.8 Adverse Effects (Undesirable Effects)

Central nervous system.

Extrapyramidal reactions.

Tardive dyskinesia.

Neuroleptic malignant syndrome.

Other central nervous system effects.

Cardiovascular.

General.

Haematological.

Hepatic.

Skin and appendages.

Respiratory.

Endocrine.

Gastrointestinal.

Autonomic nervous system.

Reporting suspected adverse effects.

4.9 Overdose

Acute toxicity - The toxic dose in man is not known.

Symptoms of overdosage.

Treatment of overdosage.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Pharmacology in animals.

Pharmacology in humans.

Clinical trials.

5.2 Pharmacokinetic Properties

The absorption, metabolism and excretion of tritiated droperidol following intramuscular and intravenous administration have been studied in humans.
Total radioactivity levels were measured in plasma, urine, and faeces.

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Mannitol, tartaric acid, sodium hydroxide, water for injections.

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). 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

Droperidol Medsurge 1.25 mg/1 mL solution for injection is a sterile, clear colourless solution in 1 mL amber glass ampoule containing 1.25 mg droperidol available in 5 x 1.25 mg/1 mL, 10 x 1.25 mg/1 mL and 50 x 1.25 mg/1 mL packs (AUST R 353873).
Droperidol Medsurge 2.5 mg/1 mL solution for injection is a sterile, clear colourless solution in 1 mL amber glass ampoule containing 2.5 mg droperidol available in 5 x 2.5 mg/1 mL, 10 x 2.5 mg/1 mL and 50 x 2.5 mg/1 mL packs (AUST R 353872).
Not all presentations or pack sizes are marketed.

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.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes