Sufentanil Injection

Name: Sufentanil Injection

Before Using sufentanil

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 sufentanil, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to sufentanil 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 performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of sufentanil injection in children.

Geriatric

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

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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 sufentanil, 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 sufentanil 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.

  • Nalmefene
  • Naltrexone
  • Safinamide

Using sufentanil 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.

  • Acepromazine
  • Alfentanil
  • Almotriptan
  • Alprazolam
  • Amineptine
  • Amisulpride
  • Amitriptyline
  • Amitriptylinoxide
  • Amobarbital
  • Amoxapine
  • Amphetamine
  • Anileridine
  • Aripiprazole
  • Asenapine
  • Baclofen
  • Benperidol
  • Benzphetamine
  • Bromazepam
  • Bromopride
  • Brompheniramine
  • Buprenorphine
  • Buspirone
  • Butabarbital
  • Butorphanol
  • Carbamazepine
  • Carbinoxamine
  • Carisoprodol
  • Carphenazine
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorpheniramine
  • Chlorpromazine
  • Chlorzoxazone
  • Citalopram
  • Clobazam
  • Clomipramine
  • Clonazepam
  • Clorazepate
  • Clozapine
  • Cocaine
  • Codeine
  • Cyclobenzaprine
  • Desipramine
  • Desmopressin
  • Desvenlafaxine
  • Dexmedetomidine
  • Dextroamphetamine
  • Dextromethorphan
  • Dezocine
  • Diazepam
  • Dibenzepin
  • Dichloralphenazone
  • Difenoxin
  • Dihydrocodeine
  • Diphenhydramine
  • Diphenoxylate
  • Dolasetron
  • Donepezil
  • Doxepin
  • Doxylamine
  • Droperidol
  • Duloxetine
  • Eletriptan
  • Enflurane
  • Escitalopram
  • Estazolam
  • Eszopiclone
  • Ethopropazine
  • Ethylmorphine
  • Fentanyl
  • Flibanserin
  • Fluoxetine
  • Flurazepam
  • Fluspirilene
  • Fluvoxamine
  • Fospropofol
  • Frovatriptan
  • Furazolidone
  • Granisetron
  • Halazepam
  • Haloperidol
  • Halothane
  • Hexobarbital
  • Hydrocodone
  • Hydromorphone
  • Hydroxytryptophan
  • Hydroxyzine
  • Imipramine
  • Iproniazid
  • Isocarboxazid
  • Isoflurane
  • Ketamine
  • Ketazolam
  • Ketobemidone
  • Levomilnacipran
  • Levorphanol
  • Linezolid
  • Lisdexamfetamine
  • Lithium
  • Lofepramine
  • Lorazepam
  • Lorcaserin
  • Loxapine
  • Meclizine
  • Melitracen
  • Melperone
  • Meperidine
  • Mephobarbital
  • Meprobamate
  • Meptazinol
  • Mesoridazine
  • Metaxalone
  • Methadone
  • Methamphetamine
  • Methdilazine
  • Methocarbamol
  • Methohexital
  • Methotrimeprazine
  • Methylene Blue
  • Midazolam
  • Milnacipran
  • Mirtazapine
  • Moclobemide
  • Molindone
  • Moricizine
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Naratriptan
  • Nefazodone
  • Nialamide
  • Nicomorphine
  • Nitrazepam
  • Nitrous Oxide
  • Nortriptyline
  • Olanzapine
  • Ondansetron
  • Opipramol
  • Opium
  • Opium Alkaloids
  • Orphenadrine
  • Oxazepam
  • Oxycodone
  • Oxymorphone
  • Palonosetron
  • Papaveretum
  • Paregoric
  • Paroxetine
  • Pentazocine
  • Pentobarbital
  • Perampanel
  • Perazine
  • Periciazine
  • Perphenazine
  • Phenelzine
  • Phenobarbital
  • Pimozide
  • Piperacetazine
  • Piritramide
  • Prazepam
  • Primidone
  • Procarbazine
  • Prochlorperazine
  • Promazine
  • Promethazine
  • Propofol
  • Protriptyline
  • Quazepam
  • Quetiapine
  • Ramelteon
  • Rasagiline
  • Remifentanil
  • Remoxipride
  • Rizatriptan
  • Secobarbital
  • Selegiline
  • Sertindole
  • Sertraline
  • Sibutramine
  • Sodium Oxybate
  • St John's Wort
  • Sulpiride
  • Sumatriptan
  • Suvorexant
  • Tapentadol
  • Thiethylperazine
  • Thiopental
  • Thiopropazate
  • Thioridazine
  • Tianeptine
  • Tilidine
  • Tizanidine
  • Tolonium Chloride
  • Topiramate
  • Tramadol
  • Tranylcypromine
  • Trazodone
  • Triazolam
  • Trifluoperazine
  • Trifluperidol
  • Triflupromazine
  • Trimeprazine
  • Trimipramine
  • Tryptophan
  • Venlafaxine
  • Vilazodone
  • Vortioxetine
  • Zaleplon
  • Ziprasidone
  • Zolmitriptan
  • Zolpidem
  • Zopiclone
  • Zotepine

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

  • Alcohol abuse, or history of or
  • Brain tumor or
  • Breathing or lung problems (eg, COPD, cor pulmonale) or
  • Drug dependence, especially with narcotics, or history of or
  • Head injury, history of or
  • Weakened physical condition—May increase risk for more serious side effects.
  • Gallbladder problems or
  • Heart disease or
  • Hypotension (low blood pressure) or
  • Pancreatitis (inflammation of the pancreas) or
  • Seizures, history of or
  • Slow heartbeat—Use with caution. May make these conditions worse.

Proper Use of sufentanil

A nurse or other trained health professional will give you sufentanil in a hospital. sufentanil is given through a needle placed into a vein or into your back (spinal cord).

Precautions While Using sufentanil

Your doctor will check your progress closely while you or your child are receiving sufentanil. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

Symptoms of an overdose include extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor right away if you or your child notice these symptoms.

Check with your doctor before using sufentanil with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with sufentanil may worsen the side effects of sufentanil, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

sufentanil may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how sufentanil affects you. Sit or lie down if you feel dizzy. Stand up carefully.

Tell your doctor if you or your child have stiffness in the muscles of your neck, chest, hands, or legs after receiving sufentanil.

Check with your doctor right away if you or your child have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, 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.

sufentanil may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

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

Using sufentanil while you are pregnant may cause neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.

Using too much of sufentanil may cause infertility (unable to have children). Talk with your doctor before using sufentanil if you plan to have children.

Do not eat grapefruit or drink grapefruit juice while you are using sufentanil.

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

For the Consumer

Applies to sufentanil: injection solution

Along with its needed effects, sufentanil 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 while taking sufentanil:

Incidence not known
  • Agitation
  • blurred vision
  • confusion
  • cough
  • darkening of the skin
  • diarrhea
  • difficult or troubled breathing
  • difficulty with swallowing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • fast heartbeat
  • fever
  • hives, itching, or skin rash
  • irregular, fast or slow, or shallow breathing
  • loss of appetite
  • mental depression
  • muscle stiffness
  • nausea
  • overactive reflexes
  • pale or blue lips, fingernails, or skin
  • poor coordination
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • restlessness
  • shivering
  • sweating
  • talking or acting with excitement you cannot control
  • tightness in the chest
  • trembling or shaking
  • twitching
  • unusual tiredness or weakness
  • vomiting

For Healthcare Professionals

Applies to sufentanil: compounding powder, injectable solution

General

The most commonly reported adverse events have been apnea, rigidity, and bradycardia.[Ref]

Respiratory

Common (1% to 10%): Respiratory depression
Uncommon (0.1% to 1%): Apnea
Frequency not reported: Respiratory arrest[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity
Postmarketing reports: Anaphylaxis[Ref]

Cardiovascular

Common (1% to 10%): Increased heart rate, increased blood pressure, decreased blood pressure
Uncommon (0.1% to 1%): Decreased heart rate
Rare (0.01% to 0.1%): Bradycardia
Frequency not reported: Severe bradycardia, severe hypotension including orthostatic hypotension, syncope[Ref]

Musculoskeletal

Common (1% to 10%): Involuntary muscle spasms, muscle twitching
Frequency not reported: Muscle rigidity, muscle movement[Ref]

Gastrointestinal

Very common (10% or more): Nausea, vomiting
Common (1% to 10%): Constipation, dyspepsia
Uncommon (0.1% to 1%): Dry mouth

Opioids:
Frequency not reported: increase in serum amylase[Ref]

Psychiatric

Common (1% to 10%): Confusional state
Uncommon (0.1% to 1%): Apathy, nervousness
Frequency not reported: Addiction, abuse, misuse[Ref]

Nervous system

Cases of serotonin syndrome have been reported during concomitant use of opioids with serotonergic drugs.[Ref]

Common (1% to 10%): Dizziness, headache, sedation
Uncommon (0.1% to 1%): Somnolence, paresthesia, ataxia, dystonia, hyperreflexia
Frequency not reported: Seizures, coma

Opioids:
Postmarketing reports: Serotonin syndrome[Ref]

Dermatologic

Very common (10% or more): Pruritus (up to 25%)
Uncommon (0.1% to 1%): Hyperhidrosis, rash, dry skin
Frequency not reported: Erythema[Ref]

Genitourinary

Common (1% to 10%): Urinary retention[Ref]

Ocular

Uncommon (0.1% to 1%): Vision disturbances
Frequency not reported: Miosis[Ref]

Other

Very common (10% or more): Pyrexia
Uncommon (0.1% to 1%): Chills, asthenia
Frequency not reported: Drug withdrawal syndrome[Ref]

Endocrine

Cases of adrenal insufficiency have been reported with opioid use of greater than 1-month duration. Cases of androgen deficiency have occurred with chronic opioid use.[Ref]

Opioids:
Postmarketing reports: Adrenal insufficiency, androgen deficiency[Ref]

Some side effects of sufentanil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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