Fentanyl (injection)

Fentanyl (injection)

Injection route (solution)

Fentanyl Citrate Injection is a Schedule II controlled substance with similar abuse susceptibility to other opioid analgesics. Assess risk before starting treatment and monitor for signs of misuse, misuse, and addiction during treatment. Severe, life-threatening or fatal respiratory depression may occur. Monitor for respiratory depression, particularly initially or after a dosage increase. Use with CYP3A4 inhibitors or inducers may alter fentanyl plasma levels and result in fatal overdose. Therefore, monitoring is recommended. Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may cause profound sedation, respiratory depression, coma, and death. Reserve concurrent prescribing for patients with inadequate alternative treatment options, limit dosage and duration to the minimum necessary, and monitor for respiratory depression and sedation.

Uses for Fentanyl

Fentanyl belongs to a group of medicines called narcotic analgesics (pain relievers). It acts in the central nervous system (CNS) or brain to relieve pain. Some of its side effects are also caused by CNS effects such as drowsiness or dizziness.

This medicine should only be administered by or under your doctor's direct supervision.

Before using fentanyl

When deciding whether to use a medicine, the risks of taking the medicine must be weighed against the benefits it produces. This is a decision that you and your doctor will make. The following should be noted with this medicine:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also tell your doctor if you have other allergies, such as to foods, dyes, preservatives or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatrics

No appropriate studies have been conducted on the relationship between age and the effects of fentanyl injection in children under 2 years of age. Safety and effectiveness have not been established.

geriatrics

Related studies conducted to date have not shown any geriatric-specific problems that would limit the benefit of fentanyl injection in the elderly. However, older patients are at higher risk of age-related lung, kidney, liver, or heart problems, which may require caution and dose adjustment in patients receiving fentanyl injection.

Breastfeeding

There are insufficient studies in women to determine the risk to infants when using this drug while breast-feeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug interactions

Although certain medicines should not be used together at all, in other cases two different medicines can be used together, although interactions may occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. If you are receiving this medicine, it is particularly important that your doctor knows whether you are taking any of the medicines listed below. The following interactions were selected for their potential significance and are not necessarily exhaustive.

The use of this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or to change some of the other medications you are taking.

• Levoketoconazol
• Mifepriston
• Nalmefen
• Naltrexon
• Safinamid
• Samidorphan

Using this medicine with any of the following medicines is not usually recommended but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Abametapir
• Acepromazin
• Adagrasib
• Alefacept
• Alfentanil
• Almotriptan
• Alprazolam
• Amifampridin
• Amineptin
• Amiodaron
• Amitriptylin
• Amitriptylinoxid
• Amobarbital
• Amoxapin
• Amphetamin
• Amprenavir
• Anileridin
• Aprepitant
• Aripiprazol
• Armodafinil
• Asciminib
• Asenapin
• Atazanavir
• Avacopan
• Baclofen
• Belzutifan
• Benperidol
• Benzhydrocodon
• Benzphetamin
• Berotralstat
• Boceprevir
• Bosentan
• Bromazepam
• Bromoprid
• Brompheniramin
• Buprenorphin
• Bupropion
• Buspiron
• Butabarbital
• Butorphanol
• Calciumoxybat
• Cannabidiol
• Cannabis
• Carbamazepin
• Carbinoxamin
• Cariprazin
• Carisoprodol
• Carphenazin
• Ceritinib
• Cetirizin
• Chloralhydrat
• Chlordiazepoxid
• Chlorpheniramin
• Chlorpromazin
• Chlorzoxazon
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clomipramin
• Clonazepam
• Clopidogrel
• Clorazepat
• Clozapin
• Cobicistat
• Kokain
• Kodein
• Conivaptan
• Crizotinib
• Cyclobenzaprin
• Cyclosporin
• Dabrafenib
• Daridorexant
• Darunavir
• Delavirdin
• Desipramin
• Desmopressin
• Desvenlafaxin
• Dexamethason
• Dexmedetomidin
• Dextroamphetamin
• Dextromethorphan
• Dezocine
• Diazepam
• Dibenzepin
• Dichloralphenazon
• Difenoxin
• Dihydrocodein
• Diltiazem
• Diphenhydramin
• Diphenoxylat
• Dolasetron
• Donepezil
• Doxepin
• Dronedaron
• Droperidol
• Duloxetin
• Efavirenz
• Eletriptan
• Eluxadolin
• Enfluran
• Enzalutamid
• Erdafitinib
• Erythromycin
• Escitalopram
• Esketamin
• Eslicarbazepinacetat
• Estazolam
• Eszopiclon
• Ethchlorvinyl
• Ethopropazin
• Ethylmorphin
• Etravirin
• Fedratinib
• Fenfluramin
• Fexinidazol
• Flibanserin
• Fluconazol
• Fluoxetin
• Fluphenazin
• Flurazepam
• Fluspirilene
• Fluvoxamin
• Fosamprenavir
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Fospropofol
• Frovatriptan
• Furazolidon
• Gabapentin
• Gabapentin Enacarbil
• Gepiron
• Granisetron
• Halazepam
• Haloperidol
• Halothan
• Hexobarbital
• Hydrocodon
• Hydromorphon
• Hydroxyamphetamin
• Hydroxytryptophan
• Hydroxyzin
• Idelalisib
• Imatinib
• Imipramin
• Indinavir
• Iproniazid
• Isocarboxazid
• Isofluran
• Itraconazol
• Ivacaftor
• Ketamin
• Ketobemidon
• Ketoconazol
• Lacosamid
• Lanreotid
• Lasmiditan
• Lefamulin
• Lemborexant
• Lenacapavir
• Levocetirizin
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamin
• Lithium
• Lofepramin
• Lofexidin
• Lomitapid
• Lopinavir
• Lorazepam
• Lorcaserin
• Lorlatinib
• Loxapin
• Lumacaftor
• Magnesiumoxybat
• Mavacamten
• Meclizin
• Melitracen
• Melperon
• Meperidin
• Mephobarbital
• Meprobamat
• Meptazinol
• Mesoridazin
• Metaxalone
• Methadon
• Methamphetamin
• Methdilazin
• Methocarbamol
• Methohexital
• Methotrimeprazin
• Methylenblau
• Metoclopramid
• Mibefradil
• Midazolam
• Milnacipran
• Mirtazapin
• Mitotan
• Mobocertinib
• Moclobemid
• Modafinil
• Molindon
• Moricizin
• Morphium
• Morphinsulfat-Liposom
• Nafcillin
• Nalbuphin
• Naratriptan
• Nefazodon
• Nelfinavir
• Netupitant
• Nevirapin
• Nialamid
• Nicardipin
• Nicomorphin
• Nifedipin
• Nilotinib
• Nirmatrelvir
• Nitrazepam
• Lachgas
• Nortriptylin
• Octreotid
• Olanzapin
• Omaveloxolon
• Ondansetron
• Opipramol
• Opium
• Opiumalkaloide
• Orphenadrin
• Oxazepam
• Oxcarbazepin
• Oxycodon
• Oxymorphon
• Ozanimod
• Palbociclib
• Palonosetron
• Papaveretum
• Paregorisch
• Paroxetin
• Pazopanib
• Pentazocin
• Pentobarbital
• Perampanel
• Perazin
• Periciazin
• Perphenazin
• Phenelzin
• Phenobarbital
• Phenytoin
• Pimozid
• Piperacetazin
• Pipotiazin
• Piritramid
• Pirtobrutinib
• Posaconazol
• Kaliumoxybat
• Prazepam
• Prednison
• Pregabalin
• Primidon
• Procarbazin
• Prochlorperazin
• Promazin
• Promethazin
• Propofol
• Protriptylin
• Quazepam
• Quetiapin
• Ramelteon
• Ranitidin
• Ranolazin
• Rasagilin
• Remifentanil
• Remimazolam
• Remoxiprid
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentin
• Ritlecitinib
• Ritonavir
• Rizatriptan
• Ropeginterferon Alfa-2b-njft
• Saquinavir
• Scopolamin
• Secobarbital
• Selegilin
• Selpercatinib
• Sertindol
• Sertralin
• Sibutramin
• Natriumoxybat
• Sotorasib
• Johanniskraut
• Sufentanil
• Sulpirid
• Sumatriptan
• Suvorexant
• Tacrolimus
• Tapentadol
• Taurursodiol
• Telaprevir
• Telithromycin
• Temazepam
• Thiethylperazin
• Thiopental
• Thiopropazat
• Thioridazin
• Tianeptin
• Tilidin
• Tizanidin
• Tocilizumab
• Toloniumchlorid
• Topiramat
• Tramadol
• Tranylcypromin
• Trazodon
• Triazolam
• Trifluoperazin
• Trifluperidol
• Triflupromazin
• Trimeprazin
• Trimipramin
• Trofinetid
• Tryptophan
• Tucatinib
• Venlafaxin
• Verapamil
• Vilazodon
• Voriconazol
• Vortioxetin
• Voxelotor
• Zaleplon
• Ziprasidon
• Zolmitriptan
• Zolpidem
• Zopiclon
• Zotepin
• Zuranolon

Interactions with food/tobacco/alcohol

Certain medicines should not be taken during or near food or consumption of certain foods because interactions may occur. Consuming alcohol or tobacco with certain medications can also lead to interactions. The following interactions were selected for their potential significance and are not necessarily exhaustive.

The use of this medicine for any of the following conditions is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or frequency of use of this medication, or give you special instructions about food, alcohol, or tobacco consumption.

• Ethanol
• Grapefruitsaft

Other medical problems

The presence of other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Nebennierenprobleme bzw
• Hirntumor, Vorgeschichte von oder
• Atem- oder Lungenprobleme (z. B. COPD, Atemdepression, Schlafapnoe) oder
• Cor pulmonale (schwere Herzerkrankung) oder
• Drogenabhängigkeit, insbesondere von Betäubungsmitteln, oder Vorgeschichte von oder
• Kopfverletzung, Vorgeschichte von oder
• Herzkrankheit bzw
• Hypokaliämie (niedriger Kaliumspiegel im Blut) oder
• Hypomagnesiämie (niedriger Magnesiumspiegel im Blut) – Mit Vorsicht anwenden. Kann das Risiko schwerwiegenderer Nebenwirkungen erhöhen.

• Bradykardie (langsamer Herzrhythmus) oder
• Gallenblasenprobleme bzw
• Herzrhythmusstörungen (z. B. QT-Verlängerung) oder
• Hypertonie (Bluthochdruck) bzw
• Hypotonie (niedriger Blutdruck) oder
• Pankreatitis (Entzündung oder Schwellung der Bauchspeicheldrüse) oder
• Anfälle, Anamnese: Mit Vorsicht verwenden. Kann diese Bedingungen verschlimmern.

• Nierenerkrankung bzw
• Lebererkrankung – Mit Vorsicht anwenden. Die Wirkung kann durch die langsamere Entfernung des Arzneimittels aus dem Körper verstärkt werden.

Proper use of fentanyl

A doctor or other trained health professional will give you or your child this medicine in a hospital. This medicine is given as an injection into a muscle or vein.

Precautions when using fentanyl

It is very important that your doctor checks you closely while you or your child is receiving this medicine. This will help your doctor determine whether the medicine is working properly and decide whether you should continue to receive it.

This medicine can cause a serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor immediately if you or your child experience rash, itching, hoarseness, difficulty breathing, difficulty swallowing, or swelling of the hands, face, or mouth while using this medication.

Do not take too much of this medicine or use it more often than your doctor has prescribed. This can be life-threatening. Symptoms of overdose include: extreme dizziness or weakness, slow heartbeat or breathing, seizures, difficulty breathing, and cold, clammy skin. Call your doctor immediately if you notice these symptoms.

You may experience dizziness, lightheadedness, or fainting while taking this medicine, especially when you suddenly get up from a lying or sitting position. Getting up slowly can help alleviate this problem. Lying down for a long time can also relieve the feeling of dizziness or lightheadedness.

This medicine increases the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants include antihistamines or medications for hay fever, allergies, or colds, sedatives, sedatives, or sleeping pills, prescription pain relievers or narcotics, barbiturates or anti-seizure medications, muscle relaxants, or anesthetics (numbing medications), including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Consult your doctor or dentist before taking any of the above medicines while you or your child are receiving this medicine.

This medicine may cause sleep-related breathing problems (e.g., sleep apnea, sleep-related hypoxemia). Your doctor may reduce your dose if you have sleep apnea (short pauses in breathing during sleep) while using this medicine.

This medicine may cause dizziness, sleepiness, confusion, or disorientation. Make sure you know how you react to this medicine before driving, operating machinery, or doing anything else that could be dangerous if you are dizzy or inattentive.

This medicine can be habit forming. If you feel that the medicine is not working as well, do not take more than the prescribed dose. Call your doctor for instructions.

Taking narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink plenty of fluids, or increase the amount of fiber in your diet. Be sure to follow the instructions carefully as persistent constipation can lead to more serious problems.

If you have been using this medicine regularly for several weeks or longer, do not change your dose or stop using it suddenly without consulting your doctor first. Your doctor may want you to gradually reduce the amount you take before stopping it completely. This can help prevent your condition from worsening and reduce the possibility of withdrawal symptoms such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or difficulty sleeping.

This medicine may increase the risk of muscle stiffness and movement. Tell your doctor if you or your child have stiff or stiff muscles after using this medicine.

Contact your doctor immediately if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle cramps, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using this medication during pregnancy may cause neonatal withdrawal syndrome in your newborns. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shaking or shaking, weight loss or vomiting, or failure to gain weight.

Taking too much of this medicine may cause reduced infertility (inability to have children). If you plan to have children, talk to your doctor before using this medicine.

Do not eat grapefruit or drink grapefruit juice while using this medicine.

Do not take any other medicines unless you have discussed this with your doctor. This includes both prescription and nonprescription (over-the-counter [OTC]) medications and herbal or vitamin supplements.

Side effects of fentanyl

In addition to the necessary effects, a medicine may also have some undesirable effects. Although not all of these side effects may occur, medical attention may be required if they occur.

Contact your doctor or nurse immediately if any of the following side effects occur:

More common

• Schmerzen oder Unwohlsein in der Brust
• schwieriges oder gestörtes Atmen
• unregelmäßige, schnelle oder langsame oder flache Atmung
• Benommenheit, Schwindel oder Ohnmacht
• blasse oder blaue Lippen, Fingernägel oder Haut
• starke Muskelsteifheit
• langsamer oder unregelmäßiger Herzschlag
• ungewöhnliche Müdigkeit

Incident not known

• Verschwommene Sicht
• Veränderung im Bewusstsein
• Schüttelfrost
• Verwirrung
• Husten
• Schwierigkeiten beim Schlucken
• schneller Herzschlag
• frieren
• Kopfschmerzen
• Nesselsucht, Juckreiz oder Hautausschlag
• Unfähigkeit, die Augen zu bewegen
• Unfähigkeit, still zu sitzen
• vermehrtes Blinzeln oder Krämpfe des Augenlids
• Nervosität
• in den Ohren hämmern
• Schwellungen oder Schwellungen der Augenlider oder um die Augen, das Gesicht, die Lippen oder die Zunge
• Unruhe
• Dinge sehen, hören oder fühlen, die nicht da sind
• die Zunge rausstrecken, wenn man es nicht will
• Schwitzen
• Engegefühl in der Brust
• unkontrollierte Drehbewegungen des Halses, Rumpfes, der Arme oder Beine
• ungewöhnliche Gesichtsausdrücke

Some side effects may occur that usually do not require medical attention. These side effects may disappear during treatment as your body gets used to the medicine. Your doctor may also be able to give you ways to prevent or reduce some of these side effects. If any of the following side effects persist or are bothersome, or if you have any questions, contact your doctor:

Incident not known

• Blutungen, Blasenbildung, Brennen, Kälte, Verfärbung der Haut, Druckgefühl, Nesselsucht, Infektion, Entzündung, Juckreiz, Knoten, Taubheitsgefühl, Schmerzen, Hautausschlag, Rötung, Narbenbildung, Schmerzen, Stechen, Schwellung, Druckempfindlichkeit, Kribbeln, Geschwürbildung usw Wärme an der Injektionsstelle
• vermehrtes Schwitzen
• Rötung der Haut
• Erbrechen
• Striemen

Some patients may also experience other side effects not listed. If you notice other side effects, contact your doctor.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Commonly used brand names

In the USA

• Sublimieren

Available dosage forms:

• Lösung

Therapeutic class: Analgesic

Chemical Class: Opioid

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