Sublimaze

Generic Name: fentanyl (Injection route)

FEN-ta-nil

Commonly used brand name(s)

In the U.S.

  • Sublimaze

Available Dosage Forms:

  • Solution
  • Injectable

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For Sublimaze

Fentanyl injection is used to relieve severe pain during and after surgery. It is also used with other medicines just before or during an operation to help the anesthetic work better.

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

This medicine is to be administered only by or under the immediate supervision of your doctor.

Before Using Sublimaze

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of fentanyl injection in children younger than 2 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fentanyl injection in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving fentanyl injection.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Atazanavir
  • Boceprevir
  • Cobicistat
  • Lopinavir
  • Mifepristone
  • Naltrexone
  • Nelfinavir
  • Ritonavir
  • Saquinavir
  • Telaprevir
  • Tipranavir

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

  • Abiraterone Acetate
  • Alefacept
  • Alfentanil
  • Almotriptan
  • Alprazolam
  • Amiodarone
  • Amitriptyline
  • Amlodipine
  • Amobarbital
  • Amoxapine
  • Amphetamine
  • Amprenavir
  • Anileridine
  • Aprepitant
  • Atorvastatin
  • Baclofen
  • Bicalutamide
  • Bromazepam
  • Brompheniramine
  • Buprenorphine
  • Buspirone
  • Butabarbital
  • Butalbital
  • Butorphanol
  • Carbamazepine
  • Carbinoxamine
  • Carisoprodol
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorpheniramine
  • Chlorpromazine
  • Chlorzoxazone
  • Cilostazol
  • Cimetidine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clobazam
  • Clonazepam
  • Clorazepate
  • Clorgyline
  • Cocaine
  • Codeine
  • Conivaptan
  • Crizotinib
  • Cyclobenzaprine
  • Cyclosporine
  • Dabrafenib
  • Darunavir
  • Delavirdine
  • Desipramine
  • Desogestrel
  • Desvenlafaxine
  • Dexmedetomidine
  • Dextroamphetamine
  • Dextromethorphan
  • Diacetylmorphine
  • Diazepam
  • Dienogest
  • Difenoxin
  • Dihydrocodeine
  • Diltiazem
  • Diphenhydramine
  • Diphenoxylate
  • Doxepin
  • Doxylamine
  • Drospirenone
  • Duloxetine
  • Eletriptan
  • Enzalutamide
  • Erythromycin
  • Escitalopram
  • Eslicarbazepine Acetate
  • Estazolam
  • Estradiol
  • Eszopiclone
  • Ethchlorvynol
  • Ethinyl Estradiol
  • Ethylmorphine
  • Ethynodiol
  • Etonogestrel
  • Fluconazole
  • Flumazenil
  • Flunitrazepam
  • Fluoxetine
  • Flurazepam
  • Fluvoxamine
  • Fosamprenavir
  • Fosaprepitant
  • Fosphenytoin
  • Fospropofol
  • Frovatriptan
  • Furazolidone
  • Ginkgo Biloba
  • Goldenseal
  • Halazepam
  • Hydrocodone
  • Hydromorphone
  • Hydroxytryptophan
  • Hydroxyzine
  • Imatinib
  • Imipramine
  • Indinavir
  • Iproniazid
  • Isocarboxazid
  • Isoniazid
  • Itraconazole
  • Ketazolam
  • Ketobemidone
  • Ketoconazole
  • Levomilnacipran
  • Levonorgestrel
  • Levorphanol
  • Linezolid
  • Lithium
  • Lomitapide
  • Lorazepam
  • Lorcaserin
  • Meclizine
  • Meperidine
  • Mephobarbital
  • Meprobamate
  • Mestranol
  • Metaxalone
  • Methadone
  • Methocarbamol
  • Methohexital
  • Methotrimeprazine
  • Methylene Blue
  • Miconazole
  • Midazolam
  • Milnacipran
  • Mirtazapine
  • Mitotane
  • Moclobemide
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Naratriptan
  • Nefazodone
  • Nialamide
  • Nicardipine
  • Nicomorphine
  • Nifedipine
  • Nilotinib
  • Nitrazepam
  • Norelgestromin
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Nortriptyline
  • Opium
  • Opium Alkaloids
  • Orphenadrine
  • Ospemifene
  • Oxazepam
  • Oxycodone
  • Oxymorphone
  • Papaveretum
  • Paregoric
  • Pargyline
  • Paroxetine
  • Pazopanib
  • Pentazocine
  • Pentobarbital
  • Phenelzine
  • Phenobarbital
  • Phenytoin
  • Piperaquine
  • Piritramide
  • Posaconazole
  • Prazepam
  • Primidone
  • Procarbazine
  • Promethazine
  • Propofol
  • Propoxyphene
  • Quazepam
  • Ramelteon
  • Ranitidine
  • Ranolazine
  • Rasagiline
  • Regorafenib
  • Remifentanil
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Rizatriptan
  • Secobarbital
  • Selegiline
  • Sertraline
  • Sibutramine
  • Sodium Oxybate
  • St John's Wort
  • Sufentanil
  • Sumatriptan
  • Tapentadol
  • Telithromycin
  • Temazepam
  • Thiopental
  • Thioridazine
  • Ticagrelor
  • Tilidine
  • Tizanidine
  • Toloxatone
  • Topiramate
  • Tramadol
  • Tranylcypromine
  • Trazodone
  • Triazolam
  • Troleandomycin
  • Tryptophan
  • Valproic Acid
  • Venlafaxine
  • Verapamil
  • Voriconazole
  • Vortioxetine
  • Zaleplon
  • Zileuton
  • Zolmitriptan
  • Zolpidem
  • Zopiclone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Azithromycin
  • Clotrimazole
  • Dirithromycin
  • Econazole
  • Josamycin
  • Mepartricin
  • Miokamycin
  • Nevirapine
  • Perampanel
  • Rokitamycin
  • Roxithromycin
  • Spiramycin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol

Other Medical Problems

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

  • Bradycardia (slow heart rhythm) or
  • Breathing problems or difficult breathing or
  • Chronic obstructive pulmonary disease (COPD) or
  • Heart rhythm problems (eg, QT prolongation) or
  • Hypertension (high blood pressure)—Use with caution. May make these conditions worse.
  • Brain tumor, history of or
  • Head injury, history of or
  • Heart disease or
  • Hypokalemia (eg, low potassium in the blood) or
  • Hypomagnesemia (eg, low magnesium in the blood)—May cause side effects to become worse.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Sublimaze

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

Precautions While Using Sublimaze

It is very important that your doctor check you closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

Check with your doctor right away if you or your child have bluish lips or skin; chest pain; difficulty with breathing; a fast, pounding, or irregular heartbeat or pulse; shortness of breath; or muscle stiffness after receiving this medicine.

Dizziness, lightheadedness, or fainting may occur with this medicine, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help, but if the problem continues or gets worse, check with your doctor.

This medicine will add to the effects of other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds; sedatives, tranquilizers, or sleeping pills; prescription pain medicine or narcotics; barbiturates or medicine for seizures; muscle relaxants, or other anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you or your child are receiving this medicine.

Sublimaze Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

More common
  • Chest pain or discomfort
  • difficult or troubled breathing
  • irregular, fast or slow, or shallow breathing
  • lightheadedness, dizziness, or fainting
  • pale or blue lips, fingernails, or skin
  • severe muscle stiffness
  • shortness of breath
  • slow or irregular heartbeat
  • unusual tiredness
Incidence not known
  • Blurred vision
  • change in consciousness
  • chills
  • confusion
  • cough
  • difficulty with swallowing
  • fast heartbeat
  • feeling cold
  • headache
  • hives
  • inability to move the eyes
  • inability to sit still
  • increased blinking or spasms of the eyelid
  • itching
  • low blood pressure or pulse
  • nervousness
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • restlessness
  • seeing, hearing, or feeling things that are not there
  • skin rash
  • sticking out the tongue when not meaning to
  • sweating
  • tightness in the chest
  • uncontrolled twisting movements of the neck, trunk, arms, or legs
  • unusual facial expressions

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known
  • Increased sweating
  • redness of the skin
  • vomiting
  • welts

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Side effects (in more detail)

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