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Indications & Uses
Fentanyl Citrate is used to manage breakthrough pain in cancer patients who are already on opioid treatment for their ongoing cancer pain and who have become tolerant to it. A patient counts as opioid tolerant if, for a week or longer, they have been taking at least 60 mg of oral morphine a day, at least 25 mcg of transdermal Fentanyl Citrate an hour, at least 30 mg of oxycodone daily, or at least 8 mg of oral hydromorphone daily. An equianalgesic dose of another opioid also counts.
Pharmacology
Fentanyl is an opioid analgesic. It acts mainly on the opioid mu-receptor, though it also binds to kappa and delta-type opioid receptors. These mu-binding sites are spread in a discrete pattern through the human brain, the spinal cord and other tissues.
In clinical use, Fentanyl has its main effects on the central nervous system. The actions that matter most for treatment are analgesia and sedation. Fentanyl may raise a patient's tolerance for pain and lessen the perception of suffering, although the patient may still recognise that the pain is there. Besides pain relief, changes in mood, euphoria and dysphoria, and drowsiness commonly occur. Fentanyl also depresses the respiratory centers, depresses the cough reflex and constricts the pupils.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Oral
Starting dose: The initial dose of Fentanyl should be 100 mcg.
Re-dosing within a single episode: If one Fentanyl dose doesn't relieve the pain properly during an episode of breakthrough pain, the dose may be repeated once. This can be done 30 minutes after the start of administration, and the same dosage strength should be used.
Increasing the dose: Titration should start with multiples of the 100 mcg Fentanyl tablet. Patients who need to go above 100 mcg can be told to use two 100 mcg tablets, one on each side of the mouth in the buccal cavity. If that doesn't control the breakthrough pain episode, the patient may be told to place two 100 mcg tablets on each side of the mouth in the buccal cavity (four 100 mcg tablets in total). Above 400 mcg, titrate in 200 mcg increments. Using more than 4 tablets at the same time has not been studied, so bear that in mind. It is also important to keep the number of strengths available to patients to a minimum at any time, to prevent confusion and possible overdose. For the same reason, patients should have only one strength of Fentanyl tablet at hand at any one time during titration.
Dosage adjustment: Generally, the Fentanyl dose should be increased when a patient needs more than one dose per breakthrough pain episode for several consecutive episodes.
Injection
Fentanyl injection can be given intravenously, either as a bolus or by infusion, and also by the intramuscular route. The dose should be individualized according to age, body weight, physical status, underlying pathological condition, use of other drugs, and the type of surgery and anesthesia. Doses above 200mcg are for use in anesthesia only.
As a premedicant, 1 to 2 ml of fentanyl may be given intramuscularly 45 minutes before induction of anesthesia. After IV administration in unpremedicated adult patients, 2ml of fentanyl can be expected to give enough analgesia for 10 to 20 minutes in surgical procedures with low pain intensity. A bolus of 10 ml gives analgesia lasting about one hour, which is enough for moderately painful procedures. A dose of 50 mcg/kg gives intense analgesia for some four to six hours, for intensely stimulating surgery.
Fentanyl may also be given as an infusion. In ventilated patients, the loading dose may be given as a fast infusion of approximately 1 mcg/kg/min for the first 10 minutes, followed by an infusion of approximately 0.1 mcg/kg/min. The loading dose may alternatively be given as a bolus. Infusion rates should be titrated to the individual patient's response; lower infusion rates may be adequate. Unless post-operative ventilation is planned, stop the infusion about 40 minutes before the end of surgery. If spontaneous ventilation is to be maintained, lower infusion rates are necessary, e.g. 0.05 to 0.08 mcg/kg/min. Higher infusion rates (up to 3 mcg/kg/min) have been used in cardiac surgery.
Fentanyl is chemically incompatible with the induction agents thiopentone and methohexitone, because their pH is very different.
Use in elderly and debilitated patients: It is wise to reduce the dosage in elderly and debilitated patients. The effect of the initial dose should be taken into account when deciding on supplemental doses.
Transdermal
Intractable chronic pain, adult: The patches deliver fentanyl in doses ranging from 12 to 100 mcg/hr. Doses should be individually titrated based on previous use of opioids.
Opioid-naive patients: Start at ≤25 mcg/hr. It is recommended to titrate first with low doses of short-acting opioids before starting fentanyl patches.
Patients receiving a strong opioid analgesic: The initial dose should be based on the previous 24-hr opioid requirements. When transferring to fentanyl patches, the previous opioid treatment should be phased out gradually.
If a patient needs doses >100 mcg/hr, more than one patch may be used. Consider alternative or additional therapy if doses >300 mcg/hr are required. Replace the patch every 72 hr and put the new patch on a different site, and avoid using the same area of skin for a few days.
Elderly: Dose reduction may be needed.
Side Effects
Like other narcotic analgesics, Fentanyl Citrate most often causes these serious reactions: respiratory depression, apnoea, muscular rigidity, myoclonic movements and bradycardia. Respiratory depression is more likely when the intravenous dose is given too rapidly. With intramuscular administration it rarely occurs.
Cautions & Contraindications
Warnings & Precautions
Opioid analgesics can impair the mental and physical ability needed for potentially dangerous tasks, such as driving a car or operating machinery. Patients taking Fentanyl Citrate should be warned about these dangers and counselled accordingly. If the patient is also taking other drugs that act on the CNS, they need special care and observation. Chronic pulmonary disease: Fentanyl Citrate should be titrated with caution in patients with chronic obstructive pulmonary disease, or with existing medical conditions that make them more likely to develop respiratory depression. Head injuries and increased intracranial pressure: Opioids may obscure the clinical course of a patient with a head injury, so they should be used only if clinically warranted. Cardiac disease: Intravenous Fentanyl Citrate may produce bradycardia. For this reason, it should be used with caution in patients with bradyarrhythmias. Hepatic or renal disease: Fentanyl Citrate should be used with caution here, because it is metabolised in the liver and excreted by the kidneys.
Contraindications
Fentanyl should not be used to manage acute or postoperative pain. It must also not be given to patients who are not opioid tolerant. And it is contraindicated in anyone with a known intolerance or hypersensitivity to Fentanyl itself or to any of the components in the product.
Pregnancy & Breastfeeding
Fentanyl is a pregnancy category C medicine. No adequate and well-controlled studies have been done in pregnant women, so it should be used during pregnancy only if the possible benefit justifies the possible risk to the fetus.
Fentanyl passes into human milk. For this reason it should not be used in nursing women, because the infant may become sedated and/or have respiratory depression.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Overdose
In insufficient overdosage, Fentanyl Citrate would produce narcosis and marked skeletal muscle rigidity. Cardio-respiratory depression and cyanosis may also occur. If there is hypoventilation or apnoea, oxygen should be given and breathing should be assisted. A specific narcotic antagonist, such as naloxane, should be on hand and used as indicated to manage respiratory depression.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Fentanyl Citrate at 20 to 25°C, away from light.
Drug Interactions
Common questions about Fentanyl 100 mcg/2 ml
What is Fentanyl 100 mcg/2 ml Injection?
Fentanyl 100 mcg/2 ml Injection is a medicine that contains Fentanyl Citrate. It is made by Renata PLC. It belongs to the Opioid analgesics group of medicines.
What is Fentanyl used for?
Fentanyl Citrate is used to manage breakthrough pain in cancer patients who are already on opioid treatment for their ongoing cancer pain and who have become tolerant to it. A patient counts as opioid tolerant if, for a week or longer, they have been taking at least 60 mg of oral morphine a day, at least 25 mcg of transdermal Fentanyl Citrate an hour, at least 30 mg of oxycodone daily, or at least 8 mg of oral hydromorphone daily.
What are the side effects of Fentanyl?
Like other narcotic analgesics, Fentanyl Citrate most often causes these serious reactions: respiratory depression, apnoea, muscular rigidity, myoclonic movements and bradycardia. Respiratory depression is more likely when the intravenous dose is given too rapidly.
Can I take Fentanyl during pregnancy or while breastfeeding?
Fentanyl is a pregnancy category C medicine. No adequate and well-controlled studies have been done in pregnant women, so it should be used during pregnancy only if the possible benefit justifies the possible risk to the fetus. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Fentanyl?
In insufficient overdosage, Fentanyl Citrate would produce narcosis and marked skeletal muscle rigidity. Cardio-respiratory depression and cyanosis may also occur. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Fentanyl?
Keep Fentanyl Citrate at 20 to 25°C, away from light.
Can I take other medicines with Fentanyl?
Some medicines can interact with Fentanyl Citrate, for example: Erythromycin, Fluconazole, Verapamil Hydrochloride, Diltiazem Hydrochloride, Aprepitant, Clarithromycin. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Fentanyl?
Fentanyl is a prescription (Rx) medicine. Take it as your doctor advises.