Consumer medicine information

1. Why am I being treated with DBL Fentanyl Injection?

DBL Fentanyl Injection contains the active ingredient fentanyl citrate. DBL Fentanyl Injection is a short-term pain reliever that belongs to a group of medicines called opioid analgesics. It is most commonly used to relieve severe pain. It may also be used just before, or during, an operation, to help the anaesthetic work better.
For more information, see Section 1. Why am I being treated with DBL Fentanyl Injection? in the full CMI.

2. What should I know before treatment with DBL Fentanyl Injection?

Do not use if you have ever had an allergic reaction to fentanyl 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 treatment with DBL Fentanyl Injection? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with DBL Fentanyl 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 is DBL Fentanyl Injection given?

Your doctor will decide what dose of fentanyl you will receive. This depends on your age, physical condition and other factors, such as your weight.
More instructions can be found in Section 4. How is DBL Fentanyl Injection given? in the full CMI.

5. What should I know during treatment with DBL Fentanyl Injection?

6. Are there any side effects?

Common side effects include sweating, dizziness, faintness, nausea or vomiting. Tell your doctor immediately if you notice slow or troubled breathing, muscle stiffness, slowed heart rate, blurred vision, spasm of the larynx (voice box) or itching. If you experience serious side effects such as allergic reactions, agitation, hallucinations, twitching or loss of coordination, severe dizziness and weakness, irregular heart rate, changes in blood pressure, skin turning blue or unconsciousness, you may need urgent medical attention or hospitalisation.
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.

Boxed Warnings

Limitations of use. Because of the risks associated with the use of opioids, fentanyl 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. Fentanyl 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 fentanyl. 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 CNS depressant medicines, such as other opioid analgesics, benzodiazepines, gabapentinoids, cannabis, sedatives, hypnotics, tricyclic antidepressants, antipsychotics, antihistamines, centrally-active anti-emetics, general anaesthetics, tranquilisers, 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 taking fentanyl (see Section 4.4 Special Warnings and Precautions for Use).

1 Name of Medicine

Fentanyl citrate.

2 Qualitative and Quantitative Composition

DBL Fentanyl Injection is a sterile solution of fentanyl citrate and sodium chloride in water for injections. It is presented in ampoules and containing 2 mL or 10 mL of a 50 microgram per mL solution of fentanyl present as fentanyl citrate. The solution does not contain any preservative. The pH of the solution is adjusted with sodium hydroxide or hydrochloric acid to 5.0 to 7.5, if necessary.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

DBL Fentanyl Injection is a clear, colourless solution for injection containing fentanyl citrate equivalent to fentanyl 50 microgram per mL.
Fentanyl citrate is a white or almost white powder, soluble in water, freely soluble in methanol, sparingly soluble in alcohol.

4 Clinical Particulars

4.9 Overdose

Signs and symptoms. The manifestations of DBL Fentanyl Injection overdosage are an extension of its pharmacological actions. In sufficient overdosage, fentanyl would produce narcosis, which may be preceded by marked skeletal muscle rigidity. Respiratory depression, which can vary in severity from bradypnoea to apnoea, may occur. This may be accompanied by cyanosis, followed by a fall in body temperature, circulatory collapse, coma and death. Toxic leucoencephalopathy has been observed with fentanyl overdose.
Treatment. Respiration may need to be assisted or controlled and an adequate airway be maintained. An opioid antagonist such as naloxone should be available to manage respiratory depression. However, it should be remembered that the duration of respiratory depression may be longer than the duration of action of the opioid antagonist, and other more immediate and supportive treatment should be initiated.
If respiratory depression is associated with muscle rigidity, it may be necessary to facilitate assisted or controlled respiration with the use of a neuromuscular blocking agent. If hypotension occurs and is possibly associated with hypovolaemia, appropriate fluid therapy should be used.
Bradycardia may be treated by administering atropine or a neuromuscular blocking agent with vagolytic activity such as pancuronium or gallamine.
Hypotension may be treated by administration of appropriate parenteral fluid therapy. Repositioning of the patient to improve venous return to the heart should be considered and, if necessary, a vasopressor and/or naloxone (postoperatively only) may be administered.
Other supportive measures should also be employed as needed.
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. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. The chemical formula of fentanyl citrate is C₂₂H₂₈N₂O.C₆H₈O₇ and its molecular weight is 528.6. The chemical structure of fentanyl citrate is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSFENTAC.gif CAS number. 990-73-8.

7 Medicine Schedule (Poisons Standard)

Schedule 8 (Controlled Drug).

Summary Table of Changes

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