Fentanyl Citrate Injection

Fentanyl Citrate Injection

1. Qualitative and quantitative composition

Fentanyl citrate 78.5 micrograms equivalent to 50 micrograms per ml fentanyl.

Each:

2ml ampoule contains 100 micrograms of fentanyl as fentanyl citrate.

10ml ampoule contains 500 micrograms of fentanyl as fentanyl citrate.

50ml vial contains 2500 micrograms of fentanyl as fentanyl citrate.

Excipient with known effect:

Moreover; this medicine contains 7.1 mg (or 0.31 mmol) sodium per 2 ml ampoule, that is to say essentially ‘sodium-free’. and 35.4 mg (or 1.54 mmol) sodium) per 10 ml ampoule, equivalent to 2% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

• 177 mg (or 7.70 mmol) sodium per 50 ml vial, equivalent to 9% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Solution for injection

Clear, colourless solution

4. Clinical particulars
4.1 Therapeutic indications
Fentanyl is an opioid analgesic used in:

– low doses to provide analgesia during short surgical procedures

– high doses as an analgesic/respiratory depressant in patients requiring assisted ventilation

– combination with a neuroleptic drug as part of the technique of neuroleptanalgesia

– the treatment of severe pain, such as the pain of myocardial infarction

4.2 Posology and method of administration
Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with fentanyl in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4).

Route of administration

Intravenous administration either as a bolus or by infusion.

Intramuscular administration.

Fentanyl should be given only in an environment where the airway can be controlled and by personnel who can control the airway.

Also check our Fentanyl tablet, Fentanyl lozenges, Hydrocodone Tablet and fentanyl transdermal system.