Consumer medicine information

Medsurge Hydromorphone HP 10 mg/mL High-potency solution for injection

Hydromorphone hydrochloride

BRAND INFORMATION

Brand name

Medsurge Hydromorphone, HP

Active ingredient

Hydromorphone hydrochloride

Schedule

S8

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Medsurge Hydromorphone HP 10 mg/mL High-potency solution for injection.

1. Why am I using Medsurge Hydromorphone Injection?


Medsurge Hydromorphone Injection contains the active ingredient hydromorphone hydrochloride. Medsurge Hydromorphone Injection is used for the short-term relief of severe pain for which other treatment options have failed or otherwise unsuitable to provide sufficient management of pain.
For more information, see Section 1. Why am I using Medsurge Hydromorphone Injection? in the full CMI.

2. What should I know before I use Medsurge Hydromorphone Injection?


Do not use if you have ever had an allergic reaction to hydromorphone 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 Medsurge Hydromorphone Injection? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with Medsurge Hydromorphone Injection 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 Medsurge Hydromorphone Injection?

  • Your doctor will tell you exactly how much to take.
  • Follow the instructions given to you by your doctor or pharmacist exactly.
  • You must only take Medsurge Hydromorphone Injection.

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

5. What should I know while using Medsurge Hydromorphone Injection?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Medsurge Hydromorphone Injection.
  • Tell your doctor or pharmacist if you are taking any other medicines that you use to help you relax, anything that contains alcohol (like cough syrup) or other medicines that treat pain.
Things you should not do
  • Do not stop using this medicine suddenly.
  • Do not take more than your doctor tells you to
Driving or using machines
  • Medsurge Hydromorphone Injection may cause drowsiness, if affected do not drive a vehicle or operate machinery
Drinking alcohol
  • Avoid alcohol
  • Alcohol may make you feel more sleepy, and could increase the risk of serious side effects, such as shallow breathing with the risk of stopping breathing and loss of consciousness.
Looking after your medicine
  • Store below 30°C. Protect from light
  • Keep it where young children cannot reach it.

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

6. Are there any side effects?


Medsurge Hydromorphone Injection may cause constipation, nausea, dizziness, drowsiness and be habit forming if taken frequently or over long periods.
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.

BRAND INFORMATION

Brand name

Medsurge Hydromorphone, HP

Active ingredient

Hydromorphone hydrochloride

Schedule

S8

 

Notes

Distributed by Medsurge Healthcare Pty Ltd

Boxed Warnings

Limitations of use. Because of the risks associated with the use of opioids, Hydromorphone/Hydromorphone HP/Hydromorphone XHP injections should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain (see Section 4.4 Special Warnings and Precautions for Use).
Hazardous and harmful use. Hydromorphone/Hydromorphone HP/Hydromorphone XHP injections poses risks of hazardous and harmful use which can lead to overdose and death. Assess the patient's risk of hazardous and harmful use before prescribing and monitor the patient regularly during treatment (see Section 4.4 Special Warnings and Precautions for Use).
Life-threatening respiratory depression. Serious, life-threatening or fatal respiratory depression may occur with the use of Hydromorphone/Hydromorphone HP/Hydromorphone XHP injections. Be aware of situations which increase the risk of respiratory depression, modify dosing in patients at risk and monitor patients closely, especially on initiation or following a dose increase (see Section 4.4 Special Warnings and Precautions for Use).
Concomitant use of benzodiazepines and other central nervous system (CNS) depressants, including alcohol. Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Limit dosages and durations to the minimum required; and monitor patients for signs and symptoms of respiratory depression and sedation. Caution patients not to drink alcohol while using Hydromorphone/Hydromorphone HP/Hydromorphone XHP injections.

1 Name of Medicine

Hydromorphone hydrochloride.

2 Qualitative and Quantitative Composition

Hydromorphone hydrochloride 2 mg/1 mL.
Hydromorphone hydrochloride 10 mg/1 mL.
Hydromorphone hydrochloride 100 mg/10 mL.
Hydromorphone hydrochloride 20 mg/1 mL.
Hydromorphone hydrochloride 50 mg/1 mL.
Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid analgesic.
Hydromorphone hydrochloride is a fine, white or practically white, odourless, crystalline powder. It is freely soluble in water, sparingly soluble in ethanol and practically insoluble in ether.
For the full list of excipients, (see Section 6.1 List of Excipients).

3 Pharmaceutical Form

Solution for injection or concentrated solution for injection.
Medsurge Hydromorphone injection, Medsurge Hydromorphone HP injection and Medsurge Hydromorphone XHP concentrated injection are presented as a clear colourless to yellowish solution.
The solution does not contain any antioxidant or preservative.

4 Clinical Particulars

4.9 Overdose

Symptoms. Serious overdosage with hydromorphone is characterised by respiratory depression (reduced respiratory rate and/or tidal volume, cyanosis), extreme somnolence, progressing to stupor, coma or pneumonia aspiration, skeletal muscle flaccidity, cold and/or clammy skin, pupillary constriction, and possibly bradycardia, hypotension and death. Severe overdose may result in apnoea, pulmonary oedema, circulatory collapse and death.
Toxic leukoencephalopathy has been observed with hydromorphone overdose.
Treatment. The primary concern in the treatment of opioid overdose is immediate supportive therapy with the establishment of adequate respiratory exchanges through the provision of, and maintenance of, adequate ventilation - patients may need ventilatory support up to and including endotracheal intubation and controlled ventilation. Adequate body temperature and fluid balance should be maintained. Oxygen, intravenous fluids, vasopressors and other supportive measures should be used as indicated.
Tolerance to the respiratory and CNS-depressant effects of opioids develops concomitantly with tolerance to the analgesic effects, therefore making respiratory depression unlikely in an opioid-tolerant patient taking the usual therapeutic doses of hydromorphone. Activated charcoal may reduce absorption of the drug if given within one to two hours after ingestion. A potentially serious recent oral ingestion of hydromorphone, if suspected, may be treated with activated charcoal in a patient who is fully conscious with an intact gag reflex or a secured airway. Initial dose of charcoal is 30 to 100 g in adults and 1 - 2 g/kg in children and is given as a slurry via nasogastric tube. In patients who are not fully conscious or have an impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected.
If there are signs of clinically significant respiratory or cardiovascular depression, the use of an opioid antagonist such as naloxone should be considered (please refer to naloxone product information for further information).
Caution should always be observed when using an opioid antagonist for the treatment of suspected hydromorphone overdose as the duration of action of hydromorphone may exceed that of the antagonist. Continuing surveillance is mandatory to prevent recurrence of respiratory depression and supportive care - including ventilatory and circulatory resuscitation/support when indicated - should always be provided. Additional doses of antagonist may be given as indicated by the clinical situation.
Opioid antagonists such as naloxone may precipitate withdrawal in opioid-dependent patients and should be carefully titrated to the desired degree of reversal. The severity of the withdrawal precipitated by administration of an opioid antagonist is contingent upon the degree of dependence and the dose of antagonist given. Too rapid or complete reversal may induce nausea, vomiting, sweating and circulatory stress and may reverse the desirable therapeutic effects (analgesia) as well.
Toxicity. Toxicity may result from overdosage but because of the great interindividual variation in sensitivity to opioids it is difficult to determine an exact dose of any opioid that is toxic or lethal. The toxic effects and signs of overdosage may be less pronounced than expected, when pain and/or tolerance are manifest.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Hydromorphone was non-genotoxic in the Ames test and the in vivo mouse micronucleus assay but positive in mouse lymphoma assay with metabolic activation. Similar findings have been reported with other opioid analgesics such as codeine and oxycodone.
Carcinogenicity. Long term carcinogenicity studies have not been performed.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. The structural formula of hydromorphone hydrochloride is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSHYDHYD.gif CAS number. 71-68-1.

7 Medicine Schedule (Poisons Standard)

Schedule 8 - Controlled Drug.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/MEDHYDST.gif