DBL FENTANYL INJECTION 50 MCG/ML [SIN00754P]

Product Info

DBL FENTANYL INJECTION 50 MCG/ML

[SIN00754P]

4.1 Therapeutic Indications

DBL Fentanyl Injection is indicated for analgesic action of short duration during premedication, induction and maintenance of anaesthesia and in the immediate post-operative periods. It may be used as an opioid analgesic supplement in general and regional anaesthesia.

Fentanyl may be used in combination with neuroleptic agents such as droperidol as an anaesthetic premedication, for the induction of anaesthesia and as an adjunct in the maintenance of general and regional anaesthesia. The state of neurolept analgesia may be converted to neurolept anaesthesia by the concurrent administration of 65% nitrous oxide in oxygen.

4.2 Dose and Method of Administration

Dosage

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 medicines, type of anaesthesia to be used, and the surgical procedure involved.

Vital signs should be monitored routinely.

Reduced dosage is generally indicated for high-risk patients, including geriatric or debilitated patients, or those who have received other CNS depressant drugs. When used in conjunction with other CNS depressants as low as 25 to 33% of the usual dose is recommended.

Adult dosage

1. Premedication: (To be appropriately modified in the elderly, debilitated and those who have received other CNS depressant drugs). 50 to 100 micrograms (1 to 2 mL) fentanyl administered intramuscularly 30 to 60 minutes prior to surgery (modified for high-risk patients).

2. Adjunct to general anaesthesia:

   Induction: 50 to 100 micrograms (1 to 2 mL) administered intravenously and repeated at 2 to 3 minute intervals, until the desired effect is achieved. A reduced dose of 25 to 50 micrograms (0.5 to 1 mL) is recommended for elderly or high-risk patients.

   Maintenance: 25 to 50 micrograms (0.5 to 1 mL) should be administered intravenously or intramuscularly when movement and/or changes in vital signs indicate surgical stress or lightening of analgesia.

3. Adjunct to regional anaesthesia: 50 to 100 micrograms (1 to 2 mL) administered intramuscularly or by slow intravenous injection when analgesia is required.

4. Post-operatively (Recovery room): 50 to 100 micrograms (1 to 2 mL) administered intramuscularly repeated in 1 to 2 hours as needed.

Children’s dosage

Do not use DBL Fentanyl Injection in children less than 2 years of age. For children aged between 2 to 12 years, fentanyl may be used for induction and maintenance at a reduced level as low as 20 to 30 micrograms (0.4 to 0.6 mL) per 10 kg bodyweight (see section 4.4 Special Warnings and Precautions for Use – Paediatric Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use in elderly patients

Elderly patients may require lower doses of fentanyl and a varied dosage regimen as they may be more susceptible to adverse effects, such as respiratory depression and cardiovascular effects.

Dosage Adjustments

Renal/hepatic impairment

Fentanyl should be used with caution in patients with impaired renal or hepatic function.

Instructions for Use

Fentanyl should be given only in an environment where the airway can be controlled and by personnel who can control the airway (see section 4.4 Special Warnings and Precautions for Use – Respiratory Depression (Hypoventilation) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

DBL Fentanyl Injection is administered by intramuscular or intravenous injection only.

The dosage of fentanyl should be given in the smallest effective dose and as infrequently as possible to minimise the development of tolerance and physical dependence.

Contains no antimicrobial agent. Product is for single use in one patient only. Discard any residue.

Handling Instructions

Wear gloves while opening the ampoule.

Accidental dermal exposure should be treated by rinsing the affected area with water. Avoid usage of soap, alcohol, and other cleaning materials that may cause chemical or physical abrasions to the skin.

4.3 Contraindications

Fentanyl is contraindicated in patients with a known hypersensitivity or intolerance to fentanyl or other opioid analgesics.

It should not be administered to patients who fall into the following categories:

• Children less than 2 years old, because the safety of fentanyl in this age group has not been established (see section 4.4 Special Warnings and Precautions for Use – Paediatric Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Patients with severe respiratory disease, acute respiratory disease, respiratory depression, patients who may be particularly susceptible to respiratory depression such as comatose patients who may have head injury, brain tumour or increased intracranial pressure (see section 4.4 Special Warnings and Precautions for Use – Respiratory Depression (Hypoventilation) and Head Injuries and Increased Intracranial Pressure – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Patients suffering from bronchial asthma.

• Patients who have received monoamine oxidase (MAO) inhibitors within the previous 14 days (see section 4.5 Interactions with Other Medicines and Other Forms of Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Patients with myasthenia gravis: Fentanyl may cause thoracic muscle rigidity following intravenous administration. It should not be used in patients with a history of myasthenia gravis, as reversal of thoracic muscle rigidity with muscle relaxants is inappropriate in these patients.

• Use in chronic non-cancer pain.