Alfentanil

Name: Alfentanil

What are some things I need to know or do while I take Alfentanil?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until the effects of alfentanil wear off and you feel fully awake.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • This medicine has an opioid drug in it. The use of opioid drugs along with a benzodiazepine drug or other drugs that may make you drowsy or slow your actions has led to very bad side effects. Side effects that have happened include slowed or trouble breathing and deaths. Benzodiazepine drugs include drugs like alprazolam, diazepam, and lorazepam. Benzodiazepine drugs are used to treat many health problems like anxiety, trouble sleeping, or seizures. Talk with the doctor.
  • Many drugs interact with this medicine and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use alfentanil with all of your drugs.
  • Do not take with alcohol or products that have alcohol. Unsafe and sometimes deadly effects may happen.
  • This medicine may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to your doctor to see if you have a greater chance of seizures while taking this medicine.
  • If you are 65 or older, use alfentanil with care. You could have more side effects.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.
  • Using alfentanil for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor.
  • Tell your doctor if you are breast-feeding or plan to breast-feed. This medicine passes into breast milk and may harm your baby.

What are some other side effects of Alfentanil?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Feeling sleepy.
  • Dizziness.
  • Upset stomach or throwing up.
  • Muscle stiffness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Indications and Usage for Alfentanil

Alfentanil injection is indicated:

  • as an analgesic adjunct given in incremental doses in the maintenance of anesthesia with barbiturate/nitrous oxide/oxygen.
  • as an analgesic administered by continuous infusion with nitrous oxide/oxygen in the maintenance of general anesthesia.
  • as a primary anesthetic agent for the induction of anesthesia in patients undergoing general surgery in which endotracheal intubation and mechanical ventilation are required.
  • as the analgesic component for monitored anesthesia care (MAC).

PRINCIPAL DISPLAY PANEL - 2 mL Ampule Label - IM-0831

2 mL UNI-AMP® ampul

Alfentanil Inj., USP
1000 mcg/2 mL
(500 mcg/mL)

CII

Rx only
Hospira

NDC 0409-2266-02
Hospira, Inc.
Lake Forest, IL 60045 USA

IM-0831 (10/04)

PRINCIPAL DISPLAY PANEL - 5 mL Ampule Label

RL-0834 (10/04)

NDC 0409-2266-05

5 mL Single-dose
Discard unused portion

CII

Alfentanil Inj., USP
2500 mcg/5 mL

(500 mcg/mL)

May be habit forming.
For I.V. use.
Store at 20 to 25°C (68 to 77°F). [See USP
Controlled Room Temperature.]
Protect from light.
Hospira, Inc.
Lake Forest, IL 60045 USA

Rx only

Hospira

Onset of Action

Rapid, within 5 minutes

Special Populations Elderly

Reduced plasma clearance and extended terminal elimination may develop.

Dosing Adult

Doses should be titrated to appropriate effects; wide range of doses is dependent upon desired degree of analgesia/anesthesia

Anesthesia: Base dose on actual body weight unless >20% above ideal body weight, then base dose on lean body weight. Administer induction doses slowly over 3 minutes; as induction dosing may produce loss of vascular tone and hypotension, consider fluid replacement prior to induction.

Alfentanil Dosage Range for Use During Anesthesia

Indication

Approx Duration of Anesthesia (min)

Induction Period (Initial Dose) (mcg/kg)

Maintenance Period (Increments/ Infusion)

Total Dose (mcg/kg)

Effects

Incremental injection

≤30

8 to 20

3 to 5 mcg/kg every 5 to 20 minutes or 0.5 to 1 mcg/kg/minute

8 to 40

Spontaneously breathing or assisted ventilation when required.

30 to 60

20 to 50

5 to 15 mcg/kg every 5 to 20 minutes

Up to 75

Assisted or controlled ventilation required. Attenuation of response to laryngoscopy and intubation.

Continuous infusion

>45

50 to 75

0.5 to 3 mcg/kg/minute; average infusion rate 1 to 1.5 mcg/kg/minute

Dependent on duration of procedure

Assisted or controlled ventilation required. Some attenuation of response to intubation and incision, with intraoperative stability.

Anesthetic induction

>45

130 to 245

0.5 to 1.5 mcg/kg/minute or general anesthetic

Dependent on duration of procedure

Assisted or controlled ventilation required. Concentration of volatile inhalation anesthetics reduced by 30% to 50% for initial hour.

Monitored Anesthesia Care (MAC)

3 to 8

3 to 5 mcg/kg every 5 to 20 minutes or 0.25 to 1 mcg/kg/minute

3 to 40

Sedation, responsiveness, spontaneously breathing

Table has been converted to the following text.

Alfentanil Dosage Range for Use During Anesthesia

Incremental injection in anesthesia ≤30 minutes:

• Initial dose (induction period): 8 to 20 mcg/kg

• Maintenance period (increments/infusion): 3 to 5 mcg/kg every 5 to 20 minutes or 0.5 to 1 mcg/kg/minute

• Total dose: 8 to 40 mcg/kg

• Appropriate effects: Spontaneously breathing or assisted ventilation when required

Incremental injection in anesthesia of 30 to 60 minutes:

• Initial dose (induction period): 20 to 50 mcg/kg

• Maintenance period (increments/infusion): 5 to 15 mcg/kg every 5 to 20 minutes

• Total dose: Up to 75 mcg/kg

• Appropriate effects: Assisted or controlled ventilation required. Attenuation of response to laryngoscopy and intubation.

Continuous infusion >45 minutes:

• Initial dose (induction period): 50 to 75 mcg/kg

• Maintenance period (increments/infusion): 0.5 to 3mcg/kg/min; average infusion rate: 1 to 1.5 mcg/kg/minute

• Total dose: Dependent on duration of procedure

• Appropriate effects: Assisted or controlled ventilation required. Some attenuation of response to intubation and incision, with intraoperative stability.

Anesthetic induction >45 minutes:

• Initial dose (induction period): 130 to 245 mcg/kg

• Maintenance period (increments/infusion): 0.5 to 1.5 mcg/kg/minute or general anesthetic

• Total dose: Dependent on duration of procedure

• Appropriate effects: Assisted or controlled ventilation required. Concentration of volatile inhalation anesthetics reduced by 30% to 50% for initial hour.

Monitored Anesthesia Care (MAC):

• Initial dose (induction period): 3 to 8 mcg/kg

• Maintenance period (increments/infusion): 3 to 5 mcg/kg every 5 to 20 minutes or 0.25 to 1 mcg/kg/minute

• Total dose: 3 to 40 mcg/kg

• Appropriate effects: Sedation, responsiveness, spontaneously breathing

ALERT U.S. Boxed Warning

Addiction, abuse, and misuse

Alfentanil exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing alfentanil, and monitor all patients regularly for the development of these behaviors and conditions.

Pregnancy Considerations

Adverse events have been observed in some animal reproduction studies. Alfentanil is known to cross the placenta, which may result in severe respiratory depression in the newborn (Mattingly 2003). When used for pain relief during labor, opioids may temporarily affect the heart rate of the fetus (ACOG 2002). Use during labor and immediately prior to labor is not recommended by the manufacturer.

For the Consumer

Applies to alfentanil: intravenous solution

Along with its needed effects, alfentanil 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 alfentanil:

More common
  • Blurred vision
  • chest pain or discomfort
  • confusion
  • difficult or troubled breathing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • fast, slow, pounding, or irregular heartbeat or pulse
  • headache
  • irregular, fast or slow, or shallow breathing
  • lightheadedness, dizziness, or fainting
  • nervousness
  • not breathing
  • pale or blue lips, fingernails, or skin
  • pounding in the ears
  • sweating
  • trouble breathing
  • unusual tiredness or weakness
Rare
  • Cough
  • noisy breathing
  • rigid muscles of the neck, arms, and legs
  • tightness in the chest
Incidence not known
  • Agitation
  • cough
  • darkening of the skin
  • diarrhea
  • difficulty with swallowing
  • fainting
  • fever
  • hives, itching, or skin rash
  • loss of appetite
  • nausea
  • overactive reflexes
  • 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
  • trembling or shaking
  • twitching
  • vomiting

Some side effects of alfentanil 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:

More common
  • Drowsiness
  • sleepiness
Rare
  • False or unusual sense of well-being

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