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Fentanyl Dosage

Medically reviewed by Drugs.com. Last updated on Oct 27, 2023.

Applies to the following strengths: 50 mcg/mL; 1200 mcg; 200 mcg; 400 mcg; 600 mcg; 800 mcg; 100 mcg; 300 mcg; 1600 mcg; 25 mcg/hr; 50 mcg/hr; 75 mcg/hr; 100 mcg/hr; 2 mcg/mL-0.9%; 5 mcg/mL-0.9%; 10 mcg/mL-0.9%; 20 mcg/mL-0.9%; 12 mcg/hr; 37.5 mcg/hr; 62.5 mcg/hr; 87.5 mcg/hr; 1.5 mg/mL; 2.5 mg/mL; 25 mcg/0.5 mL; 100 mcg/inh; 400 mcg/inh; 300 mcg/inh; 5 mcg/mL-D5%; 25 mcg/mL-0.9%; 4 mcg/mL-D5%; 10 mcg/mL-NaCl 0.9%; 1000 mcg/250 mL-NaCl 0.9%; 40 mcg/mL-NaCl 0.9%; 5 mcg/mL-NaCl 0.9%; 20 mcg/mL-NaCl 0.9%; 40 mcg/dose; 150 mcg/30 mL-D5%; 100 mcg/10 mL-D5%; 300 mcg/30 mL-D5%; 1250 mcg/50 mL-D5%; 2500 mcg/250 mL-D5%; 50 mcg/mL-NaCl 0.9% preservative-free; 10 mcg/mL-NaCl 0.9% preservative-free; 16 mcg/mL-NaCl 0.9% preservative-free; 10 mcg/mL-D5%

Usual Adult Dose for Chronic Pain

TRANSDERMAL PATCH:


Initial doses: The initial dose should be individualized taking into account the patient's prior treatment experience. This dose may be calculated based on the dose conversion guidelines in the product package insert, local protocol, or another reliable reference; when calculating, be aware there is substantial inter-patient variability in the relative potency of different opioid drugs and products and therefore it is preferable to underestimate a 24-hour fentanyl requirement and provide rescue medication than to overestimate which could result in adverse reactions.
Dose titration:
Maintenance dose: Adjust dose to obtain an appropriate balance between pain management and opioid-related adverse reactions. During chronic therapy, periodically reassess the continued need for opioid analgesics.

Comments:

Use: For the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Usual Adult Dose for Breakthrough Pain

TRANSMUCOSAL PRODUCTS


TRANSMUCOSAL LOZENGE (Actiq(R))
Initial dose: 200 mcg consumed over 15 minutes
Dose titration: If breakthrough pain is not relieved 15 minutes after completion of 1 unit (30 minutes after start), 1 additional unit of the same strength may be taken; Patients must wait at least 4 hours before re-treating. If breakthrough pain had not been relieved with 1 unit, the dose should be increased to the next highest strength with subsequent episodes of pain.
Maintenance dose: An effective dose is achieved when 1 unit is mostly sufficient to treat an episode of breakthrough pain; however, if there is inadequate analgesia a second dose of the same strength may be given 15 minutes after completion (30 minutes after start); no more than 2 doses should be used to treat any episode of breakthrough pain.
Maximum dose: 4 breakthrough episodes per day at intervals of at least 4 hours

Comments: The lozenge should be placed in mouth between cheek and lower gum and sucked; occasionally move from side to side using the handle; do not chew.

NASAL SPRAY (Lazanda(R))
Initial dose: 100 mcg sprayed in 1 nostril
Dose titration: If adequate analgesia is not achieved after 30 minutes, the dose should be escalated in a step-wise manner over consecutive episodes. Patients must wait at least 2 hours between doses. Patients should confirm the dose that works for them with a second episode of breakthrough pain.
Maintenance dose: Once an effective dose has been established, patients should use that dose for each subsequent breakthrough episode.
Maximum dose: 800 mcg per dose; 4 breakthrough episodes per day at intervals of at least 2 hours

SUBLINGUAL TABLETS (Abstral(R))
Initial dose: 100 mcg sublingually
Dose titration: If adequate analgesia is not obtained after 30 minutes, a second dose of the same strength may be taken. Patients must wait at least 2 hours before re-treating. Dose escalation should proceed in a stepwise manner (200 to 300 to 400 to 600 to 800 mcg) as needed. During titration, multiples of 100 mcg and/or 200 mcg tablets may be used for any single dose. Patients should not use more than 4 tablets at one time.
Maintenance dose: An effective dose is achieved when 1 dose is sufficient to treat most episodes of breakthrough pain; however, if there is inadequate analgesia a second dose of the same strength may be given after 30 minutes; no more than 2 doses should be used to treat any episode of breakthrough pain. Patients should limit treatment to 4 or fewer breakthrough episodes per day.
Maximum dose: 4 episodes per day; 800 mcg per dose at intervals of at least 2 hours

Comments: The sublingual tablet should be placed on the floor of the mouth and allowed to completely dissolve; do not eat or drink until the tablet is completely dissolved.

SUBLINGUAL SPRAY:
Initial dose: 100 mcg sprayed sublingually
Dose titration: If adequate analgesia is not obtained after 30 minutes, a second dose of the same strength may be used. Patients must wait at least 4 hours before re-treating. If breakthrough pain is not relieved with the 100 mcg dose, dose escalation should proceed in a stepwise manner (200 to 400 to 600 to 800 to 1200 to 1600 mcg) for subsequent episodes of pain.
Maintenance dose: An effective dose is achieved when 1 dose is sufficient to treat most episodes of breakthrough pain; however, if there is inadequate analgesia a second dose of the same strength may be given after 30 minutes; no more than 2 doses should be used to treat any episode of breakthrough pain. Patients should limit treatment to 4 or fewer breakthrough episodes per day.
Maximum dose: 4 episodes per day at intervals of at least 4 hours

Comments: Spray into mouth underneath the tongue.

BUCCAL TABLETS (Fentora(R))
Initial dose: 100 mcg buccally
Dose titration: If adequate analgesia is not obtained after 30 minutes, a second dose of the same strength may be taken. Patients must wait at least 4 hours before re-treating. If breakthrough pain is not relieved with 100 mcg, the next dose should be two 100 mcg tablets (one on each side of the mouth in the buccal cavity). The patient may be further titrated in a stepwise manner. During titration, multiples of 100 mcg or 200 mcg tablets may be used for any single dose. Patients should not use more than 4 tablets at one time.
Maintenance dose: An effective dose is achieved when 1 dose is sufficient to treat most episodes of breakthrough pain; however, if there is inadequate analgesia a second dose of the same strength may be given after 30 minutes; no more than 2 doses should be used to treat any episode of breakthrough pain. Patients should limit treatment to 4 or fewer breakthrough episodes per day.
Maximum dose: 4 episodes per day; at intervals of at least 4 hours

Comments: Tablet should be placed in the buccal cavity (above the rear molar, between the upper cheek and gum); alternatively, may be placed under the tongue.

Use: For the management of breakthrough pain in patients who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.

Usual Adult Dose for Anesthesia

Premedication for Anesthesia:
50 to 100 mcg IM, 30 to 60 minutes prior to surgery.
Lozenge: 5 mcg/kg (400 mcg is the maximum dose).
Lower doses should be used for vulnerable patients.

General Anesthesia:
Total Low dose: 2 mcg/kg (minor procedures).
Maintenance low dose: Infrequently needed.
Total Moderate dose: 2 to 20 mcg/kg.
Maintenance moderate dose: 25 to 100 mcg IV/IM.
Total high dose: 20 to 50 mcg/kg (prolonged surgeries).
Maintenance high dose: 25 mcg to half of the initial dose.

Adjunct to Regional Anesthesia:
50 to 100 mcg IM or slow IV over 3 to 5 minutes as required.

Postoperative :
50 to 100 mcg IM. May repeat dose in 1 to 2 hours as needed.

Usual Pediatric Dose for Anesthesia

Doses should be titrated to appropriate effects; a wide range of doses is possible depending upon desired degree of analgesia/anesthesia, clinical environment, patient's status, and presence of opioid tolerance.

Neonates: Analgesia: International Evidence-Based Group for Neonatal Pain recommendations:
Intermittent doses: Slow IV push: 0.5 to 3 mcg/kg/dose


Younger infants:

Older Infants and Children 1 to 12 years:

Children greater than or equal to 5 years and less than 50 kg:
Patient-controlled analgesia (PCA): IV: Opioid-naive: Note: PCA has been used in children as young as 5 years of age; however, clinicians need to assess children 5 to 8 years of age to determine if they are able to use the PCA device correctly. All patients should receive an initial loading dose of an analgesic (to attain adequate control of pain) before starting PCA for maintenance. Adjust doses, lockouts, and limits based on required loading dose, age, state of health, and presence of opioid tolerance. Use lower end of dosing range for opioid-naive. Assess patient and pain control at regular intervals and adjust settings if needed.

Usual concentration: Determined by weight; some clinicians use the following:

Children greater than 12 years to adult:

Continuous sedation/analgesia:

Patient-controlled analgesia (PCA): IV: Children greater than 50 kg, Adolescents greater than 50 kg, and Adults: Note: All patients should receive an initial loading dose of an analgesic (to attain adequate control of pain) before starting PCA for maintenance. Adjust doses, lockouts, and limits based on required loading dose, age, state of health, and presence of opioid tolerance. Use lower end of dosing range for opioid-naive. Assess patient and pain control at regular intervals and adjust settings if needed:


Preoperative sedation, adjunct to regional anesthesia, postoperative pain: IM, IV: 25 to 100 mcg/dose

Adjunct to general anesthesia: Slow IV:

General anesthesia without additional anesthetic agents: IV: 50 to 100 mcg/kg with oxygen and skeletal muscle relaxant

Usual Pediatric Dose for Pain

Doses should be titrated to appropriate effects; a wide range of doses is possible depending upon desired degree of analgesia/anesthesia, clinical environment, patient's status, and presence of opioid tolerance.

Neonates: Analgesia: International Evidence-Based Group for Neonatal Pain recommendations:
Intermittent doses: Slow IV push: 0.5 to 3 mcg/kg/dose


Younger infants:

Older Infants and Children 1 to 12 years:

Children greater than or equal to 5 years and less than 50 kg:
Patient-controlled analgesia (PCA): IV: Opioid-naive: Note: PCA has been used in children as young as 5 years of age; however, clinicians need to assess children 5 to 8 years of age to determine if they are able to use the PCA device correctly. All patients should receive an initial loading dose of an analgesic (to attain adequate control of pain) before starting PCA for maintenance. Adjust doses, lockouts, and limits based on required loading dose, age, state of health, and presence of opioid tolerance. Use lower end of dosing range for opioid-naive. Assess patient and pain control at regular intervals and adjust settings if needed.

Usual concentration: Determined by weight; some clinicians use the following:

Children greater than 12 years to adult:

Continuous sedation/analgesia:

Patient-controlled analgesia (PCA): IV: Children greater than 50 kg, Adolescents greater than 50 kg, and Adults: Note: All patients should receive an initial loading dose of an analgesic (to attain adequate control of pain) before starting PCA for maintenance. Adjust doses, lockouts, and limits based on required loading dose, age, state of health, and presence of opioid tolerance. Use lower end of dosing range for opioid-naive. Assess patient and pain control at regular intervals and adjust settings if needed:


Preoperative sedation, adjunct to regional anesthesia, postoperative pain: IM, IV: 25 to 100 mcg/dose

Adjunct to general anesthesia: Slow IV:

General anesthesia without additional anesthetic agents: IV: 50 to 100 mcg/kg with oxygen and skeletal muscle relaxant

Usual Pediatric Dose for Sedation

Doses should be titrated to appropriate effects; a wide range of doses is possible depending upon desired degree of analgesia/anesthesia, clinical environment, patient's status, and presence of opioid tolerance.

Neonates: Analgesia: International Evidence-Based Group for Neonatal Pain recommendations:
Intermittent doses: Slow IV push: 0.5 to 3 mcg/kg/dose


Younger infants:

Older Infants and Children 1 to 12 years:

Children greater than or equal to 5 years and less than 50 kg:
Patient-controlled analgesia (PCA): IV: Opioid-naive: Note: PCA has been used in children as young as 5 years of age; however, clinicians need to assess children 5 to 8 years of age to determine if they are able to use the PCA device correctly. All patients should receive an initial loading dose of an analgesic (to attain adequate control of pain) before starting PCA for maintenance. Adjust doses, lockouts, and limits based on required loading dose, age, state of health, and presence of opioid tolerance. Use lower end of dosing range for opioid-naive. Assess patient and pain control at regular intervals and adjust settings if needed.

Usual concentration: Determined by weight; some clinicians use the following:

Children greater than 12 years to adult:

Continuous sedation/analgesia:

Patient-controlled analgesia (PCA): IV: Children greater than 50 kg, Adolescents greater than 50 kg, and Adults: Note: All patients should receive an initial loading dose of an analgesic (to attain adequate control of pain) before starting PCA for maintenance. Adjust doses, lockouts, and limits based on required loading dose, age, state of health, and presence of opioid tolerance. Use lower end of dosing range for opioid-naive. Assess patient and pain control at regular intervals and adjust settings if needed:


Preoperative sedation, adjunct to regional anesthesia, postoperative pain: IM, IV: 25 to 100 mcg/dose

Adjunct to general anesthesia: Slow IV:

General anesthesia without additional anesthetic agents: IV: 50 to 100 mcg/kg with oxygen and skeletal muscle relaxant

Usual Pediatric Dose for Breakthrough Pain

TRANSMUCOSAL LOZENGE (Actiq[R])
Age 16 years or older:


Initial dose: 200 mcg consumed over 15 minutes
Dose titration: If breakthrough pain is not relieved 15 minutes after completion of 1 unit (30 minutes after start), 1 additional unit of the same strength may be taken; Patients must wait at least 4 hours before re-treating. If breakthrough pain had not been relieved with 1 unit, the dose should be increased to the next highest strength with subsequent episodes of pain.
Maintenance dose: An effective dose is achieved when 1 unit is mostly sufficient to treat an episode of breakthrough pain; however, if there is inadequate analgesia a second dose of the same strength may be given 15 minutes after completion (30 minutes after start); no more than 2 doses should be used to treat any episode of breakthrough pain.
Maximum dose: 4 breakthrough episodes per day at intervals of at least 4 hours

Comments: The lozenge should be placed in mouth between cheek and lower gum and sucked; occasionally move from side to side using the handle; do not chew.

Use: For the management of breakthrough pain in adolescents 16 years or older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.

Usual Pediatric Dose for Chronic Pain

Do not initiate the transdermal patch as the first opioid; do not initiate in opioid nontolerant patients


2 years or older: 1 patch applied transdermally every 72 hours

DOSE TITRATION: May increase dose after 3 days based on the daily dose of supplemental opioid analgesics required by the patient on the second or third day of the initial application.
MAINTENANCE dose: Adjust dose to obtain an appropriate balance between pain management and opioid-related adverse reactions. During chronic therapy, periodically reassess the continued need for opioid analgesics.

Comments:

Use: For the management of pain in opioid-tolerant patients, severe enough to require daily, around the clock, long term opioid treatment and for which alternative treatment options are inadequate.

Renal Dose Adjustments

Transdermal patches:
Mild to moderate renal impairment: Start with one half of the usual dosage
Severe renal impairment: Avoid use

No specific dose adjustment guidelines for other dose forms have been suggested; however, caution is advised along with observation and dose reduction if indicated.

Liver Dose Adjustments

Transdermal patches:
Mild to moderate hepatic impairment: Start with one half of the usual dosage
Severe hepatic impairment: Avoid use

No specific dose adjustment guidelines for other dose forms have been suggested; however, caution is advised along with observation and dose reduction if indicated.

Dose Adjustments


CYP450 3A4 Inhibitors and Inducers: Increased fentanyl plasma concentrations may result from concomitant use with CYP450 3A4 inhibitors or discontinuation of concomitantly used CYP450 3A4 inducers; monitor patients concomitantly receiving any CYP450 3A4 inducers or inhibitors and make dose adjustments as appropriate.

Concomitant use with other CNS depressants, including other opioids, sedative or hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, sedating antihistamines, and alcoholic beverages may produce increased depressant effects; monitor patients receiving concomitant CNS depressants and consider adjusting fentanyl dose.

Initial Dose Recommendations for Patients on Transmucosal Lozenges (Actiq(R)):

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for:

For additional information: www.accessdata.fda.gov/scripts/cder/rems/index.cfm.

US BOXED WARNINGS:
RISK EVALUATION AND MITIGATION STRATEGY (REMS): To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, a REMS is required for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to complete a REMS-compliant education program; counsel patients and/or their caregivers, with every prescription on safe use, serious risks, storage, and disposal of these products; emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.

Additional Warnings for Transdermal Systems:

Additional Warnings for Transmucosal Immediate-Release Fentanyl (TIRF) Products (sublingual and buccal tablets, transmucosal lozenges, nasal and sublingual spray):

Iontophoretic transdermal system: This drug has been voluntarily withdrawn from the market by the manufacturer; all unused product should have been returned by 9/1/17.


Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule II

Dialysis

Data not available

Other Comments

Administration Advice:
Parenteral administration:


Transdermal patch:

Transmucosal lozenge:

Sublingual tablets:

Sublingual spray:

Nasal spray:

Buccal tablets:

Storage requirements: KEEP OUT OF THE REACH OF CHILDREN

Preparation and Disposal:

IV compatibility:

General:

Monitoring:

Patient advice:

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.