Trofentyl is an opioid medication. An opioid is sometimes called a narcotic. Trofentyl is used as part of anesthesia to help prevent pain after surgery or other medical procedure. Trofentyl may also be used for purposes not listed in Trofentyl guide.
How is Trofentyl given?
Trofentyl is injected into a muscle, or into a vein through an IV. A healthcare provider will give you this injection as part of the anesthesia given for your surgery or medical procedure. Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely while you are receiving Trofentyl. You may be given other pain medications to use after your Trofentyl treatment is discontinued.
What should I avoid after receiving Trofentyl?
Trofentyl can cause side effects that may impair your thinking or reactions. You should not plan on driving or doing anything that requires you to be awake and alert right after you are treated with Trofentyl. Dizziness or severe drowsiness can cause falls or other accidents. Follow your doctor's instructions about any other restrictions on food, beverages, or activity.
Trofentyl side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Your caregivers will watch for any side effects you have, which may clear up within minutes after stopping the Trofentyl infusion or decreasing the dose:
weak or shallow breathing;
fast or slow heart rate;
stiff muscles; or
severe weakness, feeling light-headed or fainting.
Common side effects may include:
slowed breathing;
slow heart rate;
muscle stiffness;
dizziness, vision problems;
nausea, vomiting;
itching, sweating; or
high blood pressure.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. See also: Side effects (in more detail)
Trofentyl dosing
Usual Adult Dose for Pain:
TRANSDERMAL PATCH: Initial dose: The initial dose should be calculated based on the dose conversion guidelines in the product package insert, local protocol, or another reliable reference. The initial calculated dose may be increased 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. Comments: -For patients already treated with strong opioids, the initial dose should be calculated based on the previous 24 hour opioid use. -It may take up to 6 days for drug levels to reach equilibrium on a new dose. Patients should be evaluated for further titration after no less than two 3-day applications before any further increase in dosage is made. -The dose should be titrated individually until a balance between analgesic efficacy and tolerability is achieved. -For delivery rates in excess of 100 mcg/hour, multiple systems may be used. -Once therapy is initiated, pain intensity and opioid adverse reactions should be assessed frequently, especially respiratory depression. Uses: 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. 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. -Most patients are adequately maintained with one patch applied every 72 hours. Some patients may not receive adequate analgesia using the 72 hour dosing interval and may require a 48 hour interval. An increase in the dose should be considered before changing dosing intervals in order to maintain patients on a 72 hour regimen. Dosing intervals less than every 72 hours are not recommended in children and adolescents. TRANSMUCOSAL LOZENGE: Initial dose: 200 mcg placed in mouth (in between cheek and gum) and consumed over 15 minutes no sooner than every 4 hours. Dose titration should occur based on individual requirements necessary to provide adequate pain relief using a single dosage unit per episode of breakthrough pain. Comments: -For management of breakthrough pain in patients already receiving maintenance opioid therapy for chronic cancer pain. -If signs of excessive opioid effects appear before the unit is consumed, the dosage unit should be removed from the patient's mouth immediately, disposed of properly, and subsequent doses should be decreased. -In cases where the breakthrough pain episode is not relieved 15 minutes after completion of the unit (30 minutes after the start of the unit), patients should only take one additional dose of the same strength for that episode. Patients should take a maximum of 2 doses for any breakthrough pain episode. -During titration, patients should be prescribed an initial titration supply of 6 units, thus limiting the number of units in the home during titration. Use: For the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. NASAL SPRAY: Initial dose: 100 mcg in one nostril once. The dose should be individually titrated to a dose that provides adequate analgesia with tolerable side effects. Comments: -For the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. -Titrate through range of available strengths until adequate pain relief obtained. The same strength dosage form can be used again after 10 minutes at the earliest. Strength can be increased if more than one dose per breakthrough pain episode is required for consecutive episodes. Comments: -The dose should be titrated according to response. A maximum of 2 sprays should be used per breakthrough pain episode. A minimum 4 hour interval should be maintained between each dosage. Use: For the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. SUBLINGUAL TABLETS: Initial dose: 100 mcg sublingually once -If adequate analgesia is obtained within 30 minutes subsequent episodes of breakthrough pain should be treated with this dose. -If adequate analgesia is not obtained after 30 minutes, the patient may use a second dose (after 30 minutes) as directed by their health care provider. -No more than 2 doses should be used to treat an episode of breakthrough pain. -Patients should wait at least 2 hours before treating another episode of breakthrough pain. Titration: -If adequate analgesia was not obtained with the first 100 mcg dose, continue dose escalation in a stepwise manner over consecutive breakthrough episodes until adequate analgesia with tolerable side effects is achieved. -Increase the dose by 100 mcg multiples up to 400 mcg as needed. If adequate analgesia is not obtained with a 400 mcg dose, the next titration step is 600 mcg. -If adequate analgesia is not obtained with a 600 mcg dose, the next titration step is 800 mcg. -During titration, multiples of 100 mcg tablets and/or 200 mcg tablets may be used for any single dose. Patients should not use more than 4 tablets at one time. -Rescue medication as directed by the health care provider can be used if adequate analgesia is not achieved. -The efficacy and safety of doses higher than 800 mcg have not been evaluated in clinical studies in patients. Comments: -For the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. -Due to differences in the pharmacokinetic properties and individual variability, even patients switching from other Trofentyl containing products to the sublingual tablets should start with the 100 mcg dose. Use: For the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. SUBLINGUAL SPRAY: Initial dose: 100 mcg sublingually once -If adequate analgesia is obtained within 30 minutes subsequent episodes of breakthrough pain should be treated with this dose. -If adequate analgesia is not obtained after 30 minutes, the patient may use a second dose (after 30 minutes) as directed by their health care provider. -No more than 2 doses should be used to treat an episode of breakthrough pain. -Patients should wait at least 4 hours before treating another episode of breakthrough pain. -Once a maintenance dose is achieved, the patient should consume 4 or fewer does per day. Titration: -If adequate analgesia was not obtained with the first 100 mcg dose, change the dosage level until the patient reaches a dose that provides adequate analgesia using a single dose per breakthrough cancer pain episode with tolerable side effects. -For each breakthrough pain episode treated, if pain is not relieved after 30 minutes, patients should only take one additional dose of the same strength for that episode for a maximum of 2 doses for any breakthrough pain episode. -Patients should wait at least 4 hours before treating another episode of breakthrough pain. Comments: -This product is not bioequivalent with other Trofentyl products. Patients should not be converted on a mcg per mcg basis from other Trofentyl products. There are no conversion directions available for patients on any other Trofentyl products other than Trofentyl (R). (Note: This includes oral, transdermal, or parenteral formulations.) Uses: For the management of breakthrough pain in adult cancer patients who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. BUCCAL TABLETS: Initial dose: 100 mcg. From an initial dose, patients should be closely followed and the dosage strength changed until the patient reaches a dose that provides adequate analgesia with tolerable side effects. Titration: -Patients whose initial dose is 100 mcg and who need to titrate to a higher dose, should be instructed to use two 100 mcg tablets (one on each side of the mouth in the buccal cavity) with their next breakthrough pain episode. -If 2 tablets are not successful, the patient should be instructed to place two 100 mcg tablets on each side of the mouth in the buccal cavity (total of four 100 mcg tablets). -For doses above 400 mcg titrate using multiples 200 mcg (600 mcg and 800 mcg). Note: Should not use more than 4 tablets simultaneously. -In cases where the breakthrough pain episode is not relieved after 30 minutes, patients should only take one additional dose of the same strength for that episode. -Patients should take a maximum of 2 doses for any breakthrough pain episode. -During titration, one dose may include administration of 1 to 4 tablets of the same dosage strength (100 mcg or 200 mcg). -Patients should wait at least 4 hours before treating another episode of breakthrough pain. -To reduce the risk of overdosing during titration, patients should have only one strength available at any time. Comments: -For the treatment of breakthrough pain in patients with cancer who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Comments: -For patients being converted from Trofentyl (R) refer to the manufacturer product information or local protocol. -Patients should use all of their tablets of one strength prior to being prescribed the next strength. If this is not practical, unused Trofentyl buccal tablets should be disposed of safely. Use: For the management of breakthrough pain in cancer patients 18 years of age and older 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; wide range of doses exist, dependent 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 ---Continuous IV infusion: 0.5 to 2 mcg/kg/hour ---Sedation/analgesia: Slow IV push: 1 to 4 mcg/kg/dose; may repeat every 2 to 4 hours ---Continuous sedation/analgesia: Initial IV bolus: 1 to 2 mcg/kg, then 0.5 to 1 mcg/kg/hour; titrate upward ---Mean required dose: Neonates with gestational age less than 34 weeks: 0.64 mcg/kg/hour; neonates with gestational age greater than or equal to 34 weeks: 0.75 mcg/kg/hour ---Continuous sedation/analgesia during extracorporeal membrane oxygenation : Initial IV bolus: 5 to 10 mcg/kg slow IV push over 10 minutes, then 1 to 5 mcg/kg/hour; titrate upward; tolerance may develop; higher doses (up to 20 mcg/kg/hour) may be needed by day 6 of ECMO. Younger infants: ---Sedation/analgesia: Slow IV push: 1 to 4 mcg/kg/dose; may repeat every 2 to 4 hours ---Continuous sedation/analgesia: Initial IV bolus: 1 to 2 mcg/kg, then 0.5 to 1 mcg/kg/hour; titrate upward ---Continuous sedation/analgesia during extracorporeal membrane oxygenation ECMO: Initial IV bolus: 5 to 10 mcg/kg slow IV push over 10 minutes, then 1 to 5 mcg/kg/hour; titrate upward; tolerance may develop; higher doses (up to 20 mcg/kg/hour) may be needed by day 6 of ECMO. Older Infants and Children 1 to 12 years: ---Sedation for minor procedures/analgesia: IM or IV: 1 to 2 mcg/kg/dose; may repeat at 30 to 60 minute intervals. Note: Children 18 to 36 months of age may require 2 to 3 mcg/kg/dose. --- Intranasal: Children greater than or equal to 10 kg: 1.5 mcg/kg once (maximum: 100 mcg/dose); reported range: 1 to 2 mcg/kg; some studies allowed for additional incremental doses of 0.5 mcg/kg to be administered every 5 minutes, not to exceed a total dose of 3 mcg/kg depending on pain type and severity. ---Continuous sedation/analgesia: Initial IV bolus: 1 to 2 mcg/kg then 1 mcg/kg/hour; titrate upward; usual: 1 to 3 mcg/kg/hour; some require 5 mcg/kg/hour ---Moderate to severe chronic pain: Transdermal patch: Opioid-tolerant children greater than or equal to 2 years receiving at least 60 mg oral morphine equivalents per day: Initial: 25 mcg/hour system or higher, based on conversion to Trofentyl equivalents and administration of equianalgesic dosage ; use short-acting analgesics for first 24 hours with supplemental PRN doses thereafter (for breakthrough pain); dose may be increased after 3 days, based on the daily dose of supplementary PRN opioids required; use the ratio of 45 mg of oral morphine equivalents per day to a 12.5 mcg/hour increase in transdermal patch dosage; change patch every 72 hours; Note: Dosing intervals less than every 72 hours are not recommended for children and adolescents. Initiation of the transdermal patch in children taking less than 60 mg of oral morphine equivalents per day has not been studied in controlled clinical trials; in open-label trials, children 2 to 18 years of age who were receiving at least 45 mg of oral morphine equivalents per day were started with an initial transdermal dose of 25 mcg/hour (or higher, depending upon equianalgesic dose of opioid received). 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 less than 12 kg: 10 mcg/mL ---Children 12 to 30 kg: 25 mcg/mL ---Children greater than 30 kg: 50 mcg/mL ---Demand dose: Usual initial: 0.5 to 1 mcg/kg/dose; usual range: 0.5 to 1 mcg/kg/dose ---Lockout: Usual initial: 5 doses/hour ---Lockout interval: Range: 6 to 8 minutes ---Usual basal rate: 0 to 0.5 mcg/kg/hour Children greater than 12 years to adult: Sedation for minor procedures/analgesia: IV: 0.5 to 1 mcg/kg/dose; may repeat after 30 to 60 minutes; or 25 to 50 mcg, repeat full dose in 5 minutes if needed, may repeat 4 to 5 times with 25 mcg at 5 minute intervals if needed. Note: Higher doses are used for major procedures. Continuous sedation/analgesia: ---Less than 50 kg: Initial IV bolus: 1 to 2 mcg/kg; continuous infusion rate: 1 to 2 mcg/kg/hour ---Greater than 50 kg: Initial IV bolus: 1 to 2 mcg/kg or 25 to 100 mcg/dose; continuous infusion rate: 1 to 2 mcg/kg/hour or 25 to 200 mcg/hour 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: ---Usual concentration: 50 mcg/mL ---Demand dose: Usual initial: 20 mcg; usual range: 10 to 50 mcg ---Lockout interval: Usual initial: 6 minutes; usual range: 5 to 8 minutes ---Usual basal rate: less than or equal to 50 mcg/hour Preoperative sedation, adjunct to regional anesthesia, postoperative pain: IM, IV: 25 to 100 mcg/dose Adjunct to general anesthesia: Slow IV: ---Low dose: 0.5 to 2 mcg/kg/dose depending on the indication ---Moderate dose: Initial: 2 to 20 mcg/kg/dose; Maintenance (bolus or infusion): 1 to 2 mcg/kg/hour. Discontinuing Trofentyl infusion 30 to 60 minutes prior to the end of surgery will usually allow adequate ventilation upon emergence from anesthesia. For "fast-tracking" and early extubation following major surgery, total Trofentyl doses are limited to 10 to 15 mcg/kg. ---High dose: 20 to 50 mcg/kg/dose; Note: High dose Trofentyl as an adjunct to general anesthesia is rarely used, but is still described in the manufacturer label. General anesthesia without additional anesthetic agents: IV: 50 to 100 mcg/kg with oxygen and skeletal muscle relaxant Moderate to severe chronic pain: Transdermal patch: Opioid tolerant patients receiving at least 60 mg oral morphine equivalents per day: Initial: 25 mcg/hour system or higher, based on conversion to Trofentyl equivalents and administration of equianalgesic dosage ; use short-acting analgesics for first 24 hours with supplemental PRN doses thereafter (for breakthrough pain); dose may be increased after 3 days based on the daily dose of supplementary PRN opioids required; use the ratio of 45 mg of oral morphine equivalents per day to a 12.5 mcg/hour increase in transdermal patch dosage; transdermal patch is usually administered every 72 hours but select adult patients may require every 48-hour administration; dosage increase administered every 72 hours should be tried before 48-hour schedule is used. Adolescents greater than or equal to 16 years to adult: Breakthrough cancer pain: Transmucosal lozenge: Opioid-tolerant patients: Titrate dose to provide adequate analgesia: Initial: 200 mcg; may repeat dose only once, 15 minutes after completion of first dose if needed. Do not exceed a maximum of 2 doses per each breakthrough cancer pain episode; patient must wait at least 4 hours before treating another episode. Titrate dose up to next higher strength if treatment of several consecutive breakthrough episodes requires more than 1 lozenge per episode; evaluate each new dose over several breakthrough cancer pain episodes (generally 1 to 2 days) to determine proper dose of analgesia with acceptable side effects. Once the dose has been determined, consumption should be limited to less than or equal to 4 units/day. Reevaluate maintenance (around-the-clock) opioid dose if patient requires more than 4 units/day. If signs of excessive opioid effects occur before a dose is complete, the unit should be removed from the mouth immediately, and subsequent doses decreased.
Usual Pediatric Dose for Pain:
Doses should be titrated to appropriate effects; wide range of doses exist, dependent 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 ---Continuous IV infusion: 0.5 to 2 mcg/kg/hour ---Sedation/analgesia: Slow IV push: 1 to 4 mcg/kg/dose; may repeat every 2 to 4 hours ---Continuous sedation/analgesia: Initial IV bolus: 1 to 2 mcg/kg, then 0.5 to 1 mcg/kg/hour; titrate upward ---Mean required dose: Neonates with gestational age less than 34 weeks: 0.64 mcg/kg/hour; neonates with gestational age greater than or equal to 34 weeks: 0.75 mcg/kg/hour ---Continuous sedation/analgesia during extracorporeal membrane oxygenation (ECMO): Initial IV bolus: 5 to 10 mcg/kg slow IV push over 10 minutes, then 1 to 5 mcg/kg/hour; titrate upward; tolerance may develop; higher doses (up to 20 mcg/kg/hour) may be needed by day 6 of ECMO. Younger infants: ---Sedation/analgesia: Slow IV push: 1 to 4 mcg/kg/dose; may repeat every 2 to 4 hours ---Continuous sedation/analgesia: Initial IV bolus: 1 to 2 mcg/kg, then 0.5 to 1 mcg/kg/hour; titrate upward ---Continuous sedation/analgesia during extracorporeal membrane oxygenation ECMO: Initial IV bolus: 5 to 10 mcg/kg slow IV push over 10 minutes, then 1 to 5 mcg/kg/hour; titrate upward; tolerance may develop; higher doses (up to 20 mcg/kg/hour) may be needed by day 6 of ECMO. Older Infants and Children 1 to 12 years: ---Sedation for minor procedures/analgesia: IM or IV: 1 to 2 mcg/kg/dose; may repeat at 30 to 60 minute intervals. Note: Children 18 to 36 months of age may require 2 to 3 mcg/kg/dose. --- Intranasal: Children greater than or equal to 10 kg: 1.5 mcg/kg once (maximum: 100 mcg/dose); reported range: 1 to 2 mcg/kg; some studies allowed for additional incremental doses of 0.5 mcg/kg to be administered every 5 minutes, not to exceed a total dose of 3 mcg/kg depending on pain type and severity. ---Continuous sedation/analgesia: Initial IV bolus: 1 to 2 mcg/kg then 1 mcg/kg/hour; titrate upward; usual: 1 to 3 mcg/kg/hour; some require 5 mcg/kg/hour ---Moderate to severe chronic pain: Transdermal patch: Opioid-tolerant children greater than or equal to 2 years receiving at least 60 mg oral morphine equivalents per day: Initial: 25 mcg/hour system or higher, based on conversion to Trofentyl equivalents and administration of equianalgesic dosage ; use short-acting analgesics for first 24 hours with supplemental PRN doses thereafter (for breakthrough pain); dose may be increased after 3 days, based on the daily dose of supplementary PRN opioids required; use the ratio of 45 mg of oral morphine equivalents per day to a 12.5 mcg/hour increase in transdermal patch dosage; change patch every 72 hours; Note: Dosing intervals less than every 72 hours are not recommended for children and adolescents. Initiation of the transdermal patch in children taking less than 60 mg of oral morphine equivalents per day has not been studied in controlled clinical trials; in open-label trials, children 2 to 18 years of age who were receiving at least 45 mg of oral morphine equivalents per day were started with an initial transdermal dose of 25 mcg/hour (or higher, depending upon equianalgesic dose of opioid received). 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 less than 12 kg: 10 mcg/mL ---Children 12 to 30 kg: 25 mcg/mL ---Children greater than 30 kg: 50 mcg/mL ---Demand dose: Usual initial: 0.5 to 1 mcg/kg/dose; usual range: 0.5 to 1 mcg/kg/dose ---Lockout: Usual initial: 5 doses/hour ---Lockout interval: Range: 6 to 8 minutes ---Usual basal rate: 0 to 0.5 mcg/kg/hour Children greater than 12 years to adult: Sedation for minor procedures/analgesia: IV: 0.5 to 1 mcg/kg/dose; may repeat after 30 to 60 minutes; or 25 to 50 mcg, repeat full dose in 5 minutes if needed, may repeat 4 to 5 times with 25 mcg at 5 minute intervals if needed. Note: Higher doses are used for major procedures. Continuous sedation/analgesia: ---Less than 50 kg: Initial IV bolus: 1 to 2 mcg/kg; continuous infusion rate: 1 to 2 mcg/kg/hour ---Greater than 50 kg: Initial IV bolus: 1 to 2 mcg/kg or 25 to 100 mcg/dose; continuous infusion rate: 1 to 2 mcg/kg/hour or 25 to 200 mcg/hour 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: ---Usual concentration: 50 mcg/mL ---Demand dose: Usual initial: 20 mcg; usual range: 10 to 50 mcg ---Lockout interval: Usual initial: 6 minutes; usual range: 5 to 8 minutes ---Usual basal rate: less than or equal to 50 mcg/hour Preoperative sedation, adjunct to regional anesthesia, postoperative pain: IM, IV: 25 to 100 mcg/dose Adjunct to general anesthesia: Slow IV: ---Low dose: 0.5 to 2 mcg/kg/dose depending on the indication ---Moderate dose: Initial: 2 to 20 mcg/kg/dose; Maintenance (bolus or infusion): 1 to 2 mcg/kg/hour. Discontinuing Trofentyl infusion 30 to 60 minutes prior to the end of surgery will usually allow adequate ventilation upon emergence from anesthesia. For "fast-tracking" and early extubation following major surgery, total Trofentyl doses are limited to 10 to 15 mcg/kg. ---High dose: 20 to 50 mcg/kg/dose; Note: High dose Trofentyl as an adjunct to general anesthesia is rarely used, but is still described in the manufacturer label. General anesthesia without additional anesthetic agents: IV: 50 to 100 mcg/kg with oxygen and skeletal muscle relaxant Moderate to severe chronic pain: Transdermal patch: Opioid tolerant patients receiving at least 60 mg oral morphine equivalents per day: Initial: 25 mcg/hour system or higher, based on conversion to Trofentyl equivalents and administration of equianalgesic dosage ; use short-acting analgesics for first 24 hours with supplemental PRN doses thereafter (for breakthrough pain); dose may be increased after 3 days based on the daily dose of supplementary PRN opioids required; use the ratio of 45 mg of oral morphine equivalents per day to a 12.5 mcg/hour increase in transdermal patch dosage; transdermal patch is usually administered every 72 hours but select adult patients may require every 48-hour administration; dosage increase administered every 72 hours should be tried before 48-hour schedule is used. Adolescents greater than or equal to 16 years to adult: Breakthrough cancer pain: Transmucosal lozenge: Opioid-tolerant patients: Titrate dose to provide adequate analgesia: Initial: 200 mcg; may repeat dose only once, 15 minutes after completion of first dose if needed. Do not exceed a maximum of 2 doses per each breakthrough cancer pain episode; patient must wait at least 4 hours before treating another episode. Titrate dose up to next higher strength if treatment of several consecutive breakthrough episodes requires more than 1 lozenge per episode; evaluate each new dose over several breakthrough cancer pain episodes (generally 1 to 2 days) to determine proper dose of analgesia with acceptable side effects. Once the dose has been determined, consumption should be limited to less than or equal to 4 units/day. Reevaluate maintenance (around-the-clock) opioid dose if patient requires more than 4 units/day. If signs of excessive opioid effects occur before a dose is complete, the unit should be removed from the mouth immediately, and subsequent doses decreased.
Usual Pediatric Dose for Sedation:
Doses should be titrated to appropriate effects; wide range of doses exist, dependent 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 ---Continuous IV infusion: 0.5 to 2 mcg/kg/hour ---Sedation/analgesia: Slow IV push: 1 to 4 mcg/kg/dose; may repeat every 2 to 4 hours ---Continuous sedation/analgesia: Initial IV bolus: 1 to 2 mcg/kg, then 0.5 to 1 mcg/kg/hour; titrate upward ---Mean required dose: Neonates with gestational age less than 34 weeks: 0.64 mcg/kg/hour; neonates with gestational age greater than or equal to 34 weeks: 0.75 mcg/kg/hour ---Continuous sedation/analgesia during extracorporeal membrane oxygenation : Initial IV bolus: 5 to 10 mcg/kg slow IV push over 10 minutes, then 1 to 5 mcg/kg/hour; titrate upward; tolerance may develop; higher doses (up to 20 mcg/kg/hour) may be needed by day 6 of ECMO. Younger infants: ---Sedation/analgesia: Slow IV push: 1 to 4 mcg/kg/dose; may repeat every 2 to 4 hours ---Continuous sedation/analgesia: Initial IV bolus: 1 to 2 mcg/kg, then 0.5 to 1 mcg/kg/hour; titrate upward ---Continuous sedation/analgesia during extracorporeal membrane oxygenation ECMO: Initial IV bolus: 5 to 10 mcg/kg slow IV push over 10 minutes, then 1 to 5 mcg/kg/hour; titrate upward; tolerance may develop; higher doses (up to 20 mcg/kg/hour) may be needed by day 6 of ECMO. Older Infants and Children 1 to 12 years: ---Sedation for minor procedures/analgesia: IM or IV: 1 to 2 mcg/kg/dose; may repeat at 30 to 60 minute intervals. Note: Children 18 to 36 months of age may require 2 to 3 mcg/kg/dose. --- Intranasal: Children greater than or equal to 10 kg: 1.5 mcg/kg once (maximum: 100 mcg/dose); reported range: 1 to 2 mcg/kg; some studies allowed for additional incremental doses of 0.5 mcg/kg to be administered every 5 minutes, not to exceed a total dose of 3 mcg/kg depending on pain type and severity. ---Continuous sedation/analgesia: Initial IV bolus: 1 to 2 mcg/kg then 1 mcg/kg/hour; titrate upward; usual: 1 to 3 mcg/kg/hour; some require 5 mcg/kg/hour ---Moderate to severe chronic pain: Transdermal patch: Opioid-tolerant children greater than or equal to 2 years receiving at least 60 mg oral morphine equivalents per day: Initial: 25 mcg/hour system or higher, based on conversion to Trofentyl equivalents and administration of equianalgesic dosage ; use short-acting analgesics for first 24 hours with supplemental PRN doses thereafter (for breakthrough pain); dose may be increased after 3 days, based on the daily dose of supplementary PRN opioids required; use the ratio of 45 mg of oral morphine equivalents per day to a 12.5 mcg/hour increase in transdermal patch dosage; change patch every 72 hours; Note: Dosing intervals less than every 72 hours are not recommended for children and adolescents. Initiation of the transdermal patch in children taking less than 60 mg of oral morphine equivalents per day has not been studied in controlled clinical trials; in open-label trials, children 2 to 18 years of age who were receiving at least 45 mg of oral morphine equivalents per day were started with an initial transdermal dose of 25 mcg/hour (or higher, depending upon equianalgesic dose of opioid received). 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 less than 12 kg: 10 mcg/mL ---Children 12 to 30 kg: 25 mcg/mL ---Children greater than 30 kg: 50 mcg/mL ---Demand dose: Usual initial: 0.5 to 1 mcg/kg/dose; usual range: 0.5 to 1 mcg/kg/dose ---Lockout: Usual initial: 5 doses/hour ---Lockout interval: Range: 6 to 8 minutes ---Usual basal rate: 0 to 0.5 mcg/kg/hour Children greater than 12 years to adult: Sedation for minor procedures/analgesia: IV: 0.5 to 1 mcg/kg/dose; may repeat after 30 to 60 minutes; or 25 to 50 mcg, repeat full dose in 5 minutes if needed, may repeat 4 to 5 times with 25 mcg at 5 minute intervals if needed. Note: Higher doses are used for major procedures. Continuous sedation/analgesia: ---Less than 50 kg: Initial IV bolus: 1 to 2 mcg/kg; continuous infusion rate: 1 to 2 mcg/kg/hour ---Greater than 50 kg: Initial IV bolus: 1 to 2 mcg/kg or 25 to 100 mcg/dose; continuous infusion rate: 1 to 2 mcg/kg/hour or 25 to 200 mcg/hour 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: ---Usual concentration: 50 mcg/mL ---Demand dose: Usual initial: 20 mcg; usual range: 10 to 50 mcg ---Lockout interval: Usual initial: 6 minutes; usual range: 5 to 8 minutes ---Usual basal rate: less than or equal to 50 mcg/hour Preoperative sedation, adjunct to regional anesthesia, postoperative pain: IM, IV: 25 to 100 mcg/dose Adjunct to general anesthesia: Slow IV: ---Low dose: 0.5 to 2 mcg/kg/dose depending on the indication ---Moderate dose: Initial: 2 to 20 mcg/kg/dose; Maintenance (bolus or infusion): 1 to 2 mcg/kg/hour. Discontinuing Trofentyl infusion 30 to 60 minutes prior to the end of surgery will usually allow adequate ventilation upon emergence from anesthesia. For "fast-tracking" and early extubation following major surgery, total Trofentyl doses are limited to 10 to 15 mcg/kg. ---High dose: 20 to 50 mcg/kg/dose; Note: High dose Trofentyl as an adjunct to general anesthesia is rarely used, but is still described in the manufacturer label. General anesthesia without additional anesthetic agents: IV: 50 to 100 mcg/kg with oxygen and skeletal muscle relaxant Moderate to severe chronic pain: Transdermal patch: Opioid tolerant patients receiving at least 60 mg oral morphine equivalents per day: Initial: 25 mcg/hour system or higher, based on conversion to Trofentyl equivalents and administration of equianalgesic dosage ; use short-acting analgesics for first 24 hours with supplemental PRN doses thereafter (for breakthrough pain); dose may be increased after 3 days based on the daily dose of supplementary PRN opioids required; use the ratio of 45 mg of oral morphine equivalents per day to a 12.5 mcg/hour increase in transdermal patch dosage; transdermal patch is usually administered every 72 hours but select adult patients may require every 48-hour administration; dosage increase administered every 72 hours should be tried before 48-hour schedule is used. Adolescents greater than or equal to 16 years to adult: Breakthrough cancer pain: Transmucosal lozenge: Opioid-tolerant patients: Titrate dose to provide adequate analgesia: Initial: 200 mcg; may repeat dose only once, 15 minutes after completion of first dose if needed. Do not exceed a maximum of 2 doses per each breakthrough cancer pain episode; patient must wait at least 4 hours before treating another episode. Titrate dose up to next higher strength if treatment of several consecutive breakthrough episodes requires more than 1 lozenge per episode; evaluate each new dose over several breakthrough cancer pain episodes (generally 1 to 2 days) to determine proper dose of analgesia with acceptable side effects. Once the dose has been determined, consumption should be limited to less than or equal to 4 units/day. Reevaluate maintenance (around-the-clock) opioid dose if patient requires more than 4 units/day. If signs of excessive opioid effects occur before a dose is complete, the unit should be removed from the mouth immediately, and subsequent doses decreased.
Dailymed."Fentanyl: dailymed provides trustworthy information about marketed drugs in the united states. dailymed is the official provider of fda label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
Can Trofentyl be stopped immediately or do I have to stop the consumption gradually to ween off?
In some cases, it always advisable to stop the intake of some medicines gradually because of the rebound effect of the medicine.
It's wise to get in touch with your doctor as a professional advice is needed in this case regarding your health, medications and further recommendation to give you a stable health condition.
Who should not take Trofentyl?
You should not receive this medicine if you are allergic to Trofentyl or other narcotic pain medicines.
To make sure Trofentyl is safe for you, tell your doctor if you have:
any type of breathing problem or lung disease;
history of head injury or brain tumor;
liver or kidney disease;
slow heartbeats; or
if you have used an MAO inhibitor in the past 14 days.
FDA pregnancy category C. It is not known whether Trofentyl will harm an unborn baby. Tell your doctor if you are pregnant.
It is not known whether Trofentyl passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
How should I take Trofentyl?
You should not receive this medicine if you are allergic to Trofentyl or other narcotic pain medicines.
What other drugs will affect Trofentyl?
For a short time after you receive Trofentyl, using other medicines that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.
Other drugs may interact with Trofentyl, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Can Trofentyl be taken or consumed while pregnant?
Please visit your doctor for a recommendation as such case requires special attention.
Can Trofentyl be taken for nursing mothers or during breastfeeding?
Kindly explain your state and condition to your doctor and seek medical advice from an expert.
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