Fentanyl Martindale

Fentanyl.

Fentanyl 50 micrograms/ml Solution for Injection is a clear colourless solution.
Fentanyl 50 micrograms/ml Solution for Injection contains fentanyl citrate 78.5 micrograms equivalent to 50 micrograms fentanyl.
Excipients/Inactive Ingredients: sodium chloride, sodium hydroxide (for pH adjustment), water for injections.

Fentanyl belongs to a group of medicines called opioid analgesics, often used in anaesthesia or as a painkiller.

Fentanyl Injection can be used in the following situations: Provide pain relief during short surgical procedures (low doses); As anaesthetic and analgesic where breathing is assisted (higher doses); Provide pain relief; Treatment of severe pain.

This medicine is an injection and will be administered by the doctor. The dose will be determined based on the patient's age, body weight, general health and whether any other medicines are being taken.
Fentanyl Injection is administered into a vein either by injection or infusion (drip). It can be given undiluted intravenously. Under some circumstances, a dose higher than those stated as follows may be prescribed.
Adults and children aged 12 to 17 years old: During surgery if the patient is able to breathe on his/her own: The usual initial dose is between 50 and 200 micrograms, followed by a further dose of 50 micrograms if needed.
During surgery if the patient's breathing is assisted: The usual initial dose is between 300 and 3500 micrograms, followed by a further dose of 100-200 micrograms if needed.
By Infusion (drip): The usual initial dose is 1 microgram per kilogram every minute for the first 10 minutes, followed by a further dose of 0.1 microgram per kilogram every minute for the duration of the operation. The drip will normally be stopped 40 minutes before the end of the operation.
Elderly: If the patient is elderly, a reduced dose will be given.
Use in children aged 2 to 11 years old: During surgery if the child is able to breathe on his/her own: The usual initial dose is between 1 and 3 micrograms per kilogram of body weight, followed by a further dose of 1-1.25 micrograms per kilogram of body weight if needed.
During surgery if the child's breathing is assisted: The usual initial dose is between 1 and 3 micrograms per kilogram of body weight, followed by a further dose of between 1-1.25 micrograms per kilogram of body weight if needed.

As Fentanyl Injection will be administered in the hospital by a doctor, it is unlikely the patient will be given too much. However, the patient should be assessed if he/she thinks too much of this medicine has been given or he/she begins to experience breathing difficulties, dizziness or symptoms of low blood pressure or muscle stiffness.

Fentanyl Injection should not be given if the patient: is allergic (hypersensitive) to fentanyl or other opioid medicines or any of the other ingredients (listed in Description); suffers from asthma, shallow breathing or other breathing difficulties; is taking or has recently (within the last two weeks) taken Monoamine Oxidase Inhibitors (MAOIs) (see Interactions).

Exercise caution before administering Fentanyl 50 micrograms/ml Solution for Injection if the patient: is pregnant, planning to become pregnant or is breast-feeding; has an underactive thyroid gland; is suffering from lung disease; suffers from myasthenia gravis; is suffering from liver or kidney disease; is receiving opioid therapy or has a history of opioid abuse; suffers from alcoholism; is suffering from severe undiagnosed headaches or has recently suffered a head injury; is suffering from low blood volume; has pain in right upper side of the abdomen (bile duct); has been administered during labour (Fentanyl Injection may affect the baby's breathing).
Special Monitoring: Repeated use of fentanyl can result in tolerance and addiction.
Take special care when giving this medicine if the patient is elderly or weak due to ill health or if the patient is in labour.
Fentanyl Injection may make breathing slower than usual or can cause shortness of breath. This medicine will only be given where the patient can be carefully monitored until breathing returns to normal.
Blood pressure and heart rate may also be monitored.
Exercise caution in patients with history of abuse of or dependence to opioids, alcohol, prescription medicines, or illegal drugs.
Repeated use of the product may result in the drug being less effective or becoming dependent on it.
If treatment is stopped, withdrawal symptoms may occur. Monitor patients who may be experiencing withdrawal symptoms (see also Side Effects).
Fentanyl Injection contains sodium: If salt intake needs to be controlled (controlled sodium diet), be aware that: Fentanyl Injection contains 3.5 mg sodium in each ml of solution (equivalent to 0.18% of the recommended maximum daily dietary intake of sodium for an adult); The contents of the ampoule may be diluted in a salt solution before being administered to the patient (this salt solution also contains sodium).
Driving and using machines: The patient should not drive or use any tools or machines for at least 24 hours after having Fentanyl Injection. Alertness may be lessened than usual. This medicine can affect the ability to drive as it may cause sleepiness or dizziness.
The patient should not drive while taking this medicine until he/she knows how it affects him/her. It is an offence to drive if this medicine affects the ability to drive.
However, the patient would not be committing an offence if: The medicine has been prescribed to treat a medical or dental problem; The patient has taken it according to the instructions given by the prescriber or in the information provided with the medicine; It was not affecting the ability to drive safely.
The patient should be advised if he/she is unsure whether it is safe to drive while taking this medicine.

The patient should be advised before taking this medicine if she is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby.
Fentanyl Injection should not be used during childbirth as it can affect the baby's breathing.
Fentanyl is excreted into breast milk. The patient should not breastfeed or use breast milk that has been expressed for 24 hours after having Fentanyl Injection.

Like all medicines, Fentanyl Injection can cause side effects, although not everybody gets them.
If any of the following symptoms occur, the patient should inform the doctor or nurse immediately. These are symptoms of a serious allergic reaction: sudden wheeziness and tightness of chest; swelling of eyelids, face or lips; skin lumps or hives; skin rash (red spots), itchiness, fever; collapse.
Very common side effects (affect more than 1 in 10 people): muscle stiffness; nausea or vomiting.
Common side effects (affect less than 1 in 10 people): feeling agitated; jerky or uncoordinated movements; drowsiness; dizziness; blurred vision, blind spots or haloes around lights (visual disturbances); a slow or irregular heartbeat; unusually low or high blood pressure; pain along the veins; choking caused by cramping (spasm) of throat muscles; wheezing or difficulty breathing; stopping breathing for a short period of time (if necessary, breathing will be helped by a ventilator); an itchy rash or redness of the skin; confusion.
Uncommon side effects (affect less than 1 in 100 people): euphoria; headache; swelling and clotting along a vein; changes in blood pressure; breathing faster than usual; hiccups; decrease in body temperature or chills; breathing complications.
Other side effects (frequency not known): a serious allergic reaction (see symptoms as previously mentioned); convulsions (fits or seizures); loss of consciousness; muscle twitching; cardiac arrest; slow or shallow breathing; itching of the skin; symptoms of withdrawal syndrome (may manifest by the occurrence of the following side effects: nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating); delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, hallucinations, sleep disturbance, nightmares).
Other side effects can occur when Fentanyl Injection is used with neuroleptics. These include: chills or shivering; restlessness; hallucinations; unusual movements, including trembling and shaking of the hands and fingers, twisting movements of the body, shuffling walk and stiffness of the arms and legs.
Reporting of side effects: If the patient experiences any side effects, the doctor or pharmacist should be informed. This includes any possible side effects not previously listed.

Other medicines and Fentanyl 50 micrograms/ml Solution for Injection: Concomitant use of fentanyl and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However, if fentanyl is prescribed together with sedative medicines, the dose and duration of concomitant treatment should be limited. Take note of all sedative medicines being taken by the patient. Ensure that the patient follows dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms previously stated. Be aware when the patient is experiencing such symptoms. Exercise caution if the patient is using or has recently used or might use any other medicines, including medicines obtained without a prescription.
Fentanyl Injection must not be used with Monoamine Oxidase Inhibitors (MAOIs), such as phenelzine or moclobemide, or if their intake has been stopped within the last 2 weeks.
Exercise caution if the patient: is taking Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) for depression (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine); is taking any major tranquilizer (antipsychotic) drug.
Medicines which may interact with Fentanyl Injection include: CNS depressants, including sleeping pills, antihistamines that cause drowsiness, medicines used to treat certain mental disorders, other painkillers or a general anaesthetic such as etomidate; ritonavir and other protease inhibitors such as indinavir and saquinavir; droperidol; muscle relaxants; antifungal medicines such as fluconazole or voriconazole; midazolam.
The dose of etomidate and midazolam may need to be reduced if given together with Fentanyl Injection.
Fentanyl Injection may increase the effects of the previously mentioned drugs or prevent them from working properly if they are being concomitantly taken.
Using Fentanyl Injection with food, drink and alcohol: The patient should not drink alcohol during treatment with Fentanyl Injection.

This medicine should not be used if any discoloration is noticed or there are particles in it. If only part of the solution is used, the remainder should be discarded.
Fentanyl 50 mcg/ml Solution for Injection can be diluted with Sodium Chloride 0.9% w/v or Glucose 5% w/v infusion solutions to the final concentration of 5 mcg/ml and 25 mcg/ml.
The product is chemically incompatible with the induction agents thiopentone and methohexitone because of the wide differences in pH.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Do not store above 25°C and keep container in the outer carton to protect from light.
The diluent product can be stored under both ambient (15-25°C) and refrigerated (2-8°C) for up to 24 hours.

Analgesics (Opioid)

N01AH01 - fentanyl ; Belongs to the class of opioid anesthetics. Used as general anesthetics.

DD, P₁S₁