Tapentadol Dosage

Medically reviewed by Drugs.com. Last updated on Jan 16, 2024.

Usual Adult Dose for Pain

IMMEDIATE-RELEASE (IR) TABLETS OR ORAL SOLUTION:
Initial Dose: 50 to 100 mg orally every 4 to 6 hours, as needed for pain

• On the first day of therapy, a second dose may be given as soon as 1 hour after the first dose, if needed.
• Subsequent doses should be titrated based on individual response to initial dose.

Maintenance Dose: 50, 75, or 100 mg orally every 4 to 6 hours, adjusted to maintain adequate analgesia with acceptable tolerability
Maximum Dose: 700 mg/day on the first day of therapy; 600 mg/day on subsequent days

CONVERSION FROM TAPENTADOL IR TABLETS/ORAL SOLUTION TO EXTENDED-RELEASE (ER) TABLETS:

• The total daily dose (mg/day) of tapentadol IR tablets or oral solution should be divided into 2 equal doses of tapentadol ER and administered orally twice a day about 12 hours apart.
• Conversion to the ER formulation may increase the risk of excessive sedation and respiratory depression.

Comments:

• Use the lowest effective dose for the shortest duration of time consistent with treatment goals.
• Titration of this drug should be reserved for when lower doses are ineffective and the benefits of higher opioid doses outweigh the risks.
• If pain increases after dose stabilization, identify pain source prior to titrating dose; if unacceptable opioid-related adverse effects occur after dose titration (including greater pain) consider a dose reduction.
• Dose selection should be conservative and cautiously titrated in older adults, reflecting the higher frequency of reduced clearance and increased rate of comorbidities in this population.
• Consider the overall clinical picture and individual patient factors when planning dose reduction or discontinue this drug.
• Ensure on-going care and/or a multimodal approach and/or specialist referral during treatment transitions.

Use: For the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate

Usual Adult Dose for Neuropathic Pain

EXTENDED-RELEASE TABLETS:
Initial Dose (in opioid-naive/not opioid tolerant patients): 50 mg orally twice a day, about every 12 hours
Maintenance Dose: Titrate to adequate analgesia by 50 mg no more than twice a day every 3 days to a recommended dosage range of 100 to 250 mg orally twice a day.
Maximum Dose: 500 mg/day

CONVERSION FROM TAPENTADOL IR TABLETS/ORAL SOLUTION TO ER TABLETS:

• The total daily dose (mg/day) of tapentadol IR tablets or oral solution should be divided into 2 equal doses of tapentadol ER and administered orally twice a day about 12 hours apart.
• Conversion to ER formulation may increase the risk of excessive sedation and respiratory depression.

CONVERSION FROM OTHER OPIOIDS (INCLUDING METHADONE) TO TAPENTADOL ER:

• Initiate dosing of tapentadol ER with 50 mg orally every 12 hours under close observation with frequent titration until stable.
• It is safest to initially underestimate the patient's 24-hour oral opioid requirement when converting from other opioids; there are no established conversion ratios that are defined by clinical trials.
• Methadone has a long half-life and may accumulate; therefore, the conversion ratio of methadone may vary widely as a function of previous exposure and patients may require additional monitoring.

Comments:

• When administering tapentadol ER tablets, discontinue use of all other tapentadol, tramadol, or opioid analgesics other than those used on an as needed basis for breakthrough pain.
• Utilize the lowest effective dose for the shortest duration of time consistent with treatment goals.
• Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.
• Titration of this drug should be reserved for when lower doses are ineffective and the benefits of higher opioid doses outweigh the risks.
• Ensure dose adjustments provide adequate analgesia with minimization of adverse effects.
• If pain level increases after dose stabilization, attempt to identify pain source before increasing dose.
• An immediate-release analgesic (rescue medication) may be needed for patients with breakthrough pain.
• Dose selection should be conservative and cautiously titrated in older adults, reflecting the higher frequency of reduced clearance and increased rate of comorbidities in this population.
• Periodically reassess the continued need for opioid analgesics during extended use of this drug.

Uses:

• For the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.
• For the management of severe and persistent neuropathic pain associated with diabetic peripheral neuropathy that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.

Usual Adult Dose for Chronic Pain

EXTENDED-RELEASE TABLETS:
Initial Dose (in opioid-naive/not opioid tolerant patients): 50 mg orally twice a day, about every 12 hours
Maintenance Dose: Titrate to adequate analgesia by 50 mg no more than twice a day every 3 days to a recommended dosage range of 100 to 250 mg orally twice a day.
Maximum Dose: 500 mg/day

CONVERSION FROM TAPENTADOL IR TABLETS/ORAL SOLUTION TO ER TABLETS:

• The total daily dose (mg/day) of tapentadol IR tablets or oral solution should be divided into 2 equal doses of tapentadol ER and administered orally twice a day about 12 hours apart.
• Conversion to ER formulation may increase the risk of excessive sedation and respiratory depression.

CONVERSION FROM OTHER OPIOIDS (INCLUDING METHADONE) TO TAPENTADOL ER:

• Initiate dosing of tapentadol ER with 50 mg orally every 12 hours under close observation with frequent titration until stable.
• It is safest to initially underestimate the patient's 24-hour oral opioid requirement when converting from other opioids; there are no established conversion ratios that are defined by clinical trials.
• Methadone has a long half-life and may accumulate; therefore, the conversion ratio of methadone may vary widely as a function of previous exposure and patients may require additional monitoring.

Comments:

• When administering tapentadol ER tablets, discontinue use of all other tapentadol, tramadol, or opioid analgesics other than those used on an as needed basis for breakthrough pain.
• Utilize the lowest effective dose for the shortest duration of time consistent with treatment goals.
• Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.
• Titration of this drug should be reserved for when lower doses are ineffective and the benefits of higher opioid doses outweigh the risks.
• Ensure dose adjustments provide adequate analgesia with minimization of adverse effects.
• If pain level increases after dose stabilization, attempt to identify pain source before increasing dose.
• An immediate-release analgesic (rescue medication) may be needed for patients with breakthrough pain.
• Dose selection should be conservative and cautiously titrated in older adults, reflecting the higher frequency of reduced clearance and increased rate of comorbidities in this population.
• Periodically reassess the continued need for opioid analgesics during extended use of this drug.

Uses:

• For the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.
• For the management of severe and persistent neuropathic pain associated with diabetic peripheral neuropathy that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.

Usual Pediatric Dose for Pain

6 years or older:
IMMEDIATE-RELEASE TABLETS:
Weight 40 to 59 kg:

• Recommended Dose: 50 mg orally every 4 hours
• Do not titrate to a 75 mg tablet if adequate analgesia is not achieved with initial dosing regimen; instead, consider tapentadol oral solution for greater dosing flexibility.
• Maximum Single Dose: 50 mg
• Maximum Daily Dose: 7.5 mg/kg/day (i.e., six 1.25 mg/kg doses over 24 hours)

Weight 60 to 79 kg:

• Initial Dose: 50 mg orally every 4 hours
• Maintenance Dose: May titrate up to 75 mg orally every 4 hours, if needed.
• Do not increase to a 100 mg tablet if adequate analgesia is not achieved after titration; instead, consider tapentadol oral solution for greater dosing flexibility.
• Maximum Single Dose: 75 mg
• Maximum Daily Dose: 7.5 mg/kg/day (i.e., six 1.25 mg/kg doses over 24 hours)

Weight 80 kg or greater:

• Initial Dose: 50 mg orally every 4 hours
• Maintenance Dose: May titrate stepwise to 75 mg or up to 100 mg orally every 4 hours, if needed, to maintain adequate analgesia with acceptable tolerability.
• Maximum Single Dose: 100 mg
• Maximum Daily Dose: 7.5 mg/kg/day (i.e., six 1.25 mg/kg doses over 24 hours), or max 600 mg/day

ORAL SOLUTION:
Weight 16 kg to less than 40 kg:

• Recommended Dose: 1.25 mg/kg orally every 4 hours
• Maximum Single Dose: 1.25 mg/kg
• Maximum Daily Dose: 7.5 mg/kg/day (i.e., six 1.25 mg/kg doses over 24 hours)

Weight 40 kg or greater:

• Initial Dose: 50 mg orally every 4 hours
• Maintenance Dose: May titrate up to 1.25 mg/kg orally every 4 hours, as needed, to maintain adequate analgesia with acceptable tolerability.
• Maximum Single Dose: 100 mg
• Maximum Daily Dose: 7.5 mg/kg/day (i.e., six 1.25 mg/kg doses over 24 hours), or max 600 mg/day

Comments:

• Duration of therapy should not exceed 3 days in pediatric patients.
• Use the lowest effective dose for the shortest duration of time consistent with treatment goals.
• Refer to the manufacturer product information for the oral solution for dose calculation examples.
• Dose adjustments should aim to provide adequate analgesia with acceptable tolerability; consider dose reductions over time as acute pain decreases.
• In pediatric patients with high body mass index (BMI), the maximum daily dose must not exceed the calculated maximum dose for a body weight at the 97th percentile for a given age.
• Tablets are for use in children at least 6 years old that weigh at least 40 kg, and who can swallow tablets.
• The oral solution is for use in children at least 6 years old that weigh at least 16 kg, and who cannot swallow tablets or require greater dosing flexibility.

Use: For the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate

Renal Dose Adjustments

ADULTS:
Mild to moderate renal dysfunction (CrCl 30 to 90 mL/min): No adjustment recommended
Severe renal dysfunction (CrCl less than 30 mL/min): Not recommended

PEDIATRIC:
Renal dysfunction: Use is not recommended in this population; data not available.

Liver Dose Adjustments

ADULTS:
Mild Liver Dysfunction (Child-Pugh Score 5 to 6): No adjustment recommended

Moderate Liver Dysfunction (Child-Pugh Score 7 to 9):
IR Tablets/Oral Solution:

• Initiate treatment with 50 mg orally no more frequently than every 8 hours.
• Shorten or lengthen dosing interval to achieve maintenance of analgesia with acceptable tolerability, up to a maximum of 3 doses in 24 hours.

ER Tablets:

• Initiate treatment with 50 mg orally every 24 hours.
• Do not exceed 100 mg/day; monitor regularly for respiratory or CNS depression.

Severe Liver Dysfunction (Child-Pugh Score 10 to 15): Not recommended; data not available

PEDIATRIC:
Liver Dysfunction: Use is not recommended in this population; data not available.

Dose Adjustments

RECOMMENDATIONS FOR DOSE REDUCTION OR THERAPY DISCONTINUATION:

• There are no standard opioid tapering schedules suitable for all ages; a patient-specific plan is recommended.
• In physically opioid-dependent patients, taper dose incrementally (e.g., 10% to 25% of total daily dose) every 2 to 4 weeks; a more rapid taper may be tolerated in patients taking opioids for a shorter duration.
• If signs and symptoms of withdrawal occur, pause the taper or increase the dose to the previous level and then taper more slowly.
• Consult the manufacturer product information for additional recommendations on dose reduction or discontinuation.

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for all opioids intended for outpatient use. The new FDA Opioid Analgesic REMS is a designed to assist in communicating the serious risks of opioid pain medications to patients and health care professionals. It includes a medication guide and elements to assure safe use. For information on opioid analgesic REMS visit www.opioidanalgesicrems.com or call 1-800-503-0784. For additional information visit www.accessdata.fda.gov/scripts/cder/rems/index.cfm

US BOXED WARNINGS:

• ADDICTION, ABUSE, AND MISUSE: This drug exposes patients and others to the risks of opioid addiction, abuse, or misuse, which can lead to overdose and death. Assess each patient's risk before prescribing and monitor regularly for these behaviors or conditions.
• INTERACTION WITH ALCOHOL (taptentadol ER [extended-release]): Instruct patients not to consume alcoholic beverages or use products that contain alcohol while taking this drug. Ingestion with alcohol can result in fatal plasma tapentadol levels.
• LIFE-THREATENING RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur with use of this drug, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration are essential. Patients taking tapentadol ER should swallow tablets whole; crushing, chewing, or dissolving ER tablets can result in rapid release and potentially fatal dose absorption.
• ACCIDENTAL INGESTION: Accidental ingestion of even one dose of this drug can result in fatal overdose, especially in children, can be fatal.
• RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant use to cases when alternative treatment options are inadequate; limit dosage/duration to minimum required; monitor for signs/symptoms of respiratory depression and sedation.
• NEONATAL OPIOID WITHDRAWAL SYNDROME (NOWS): If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, which may be life-threatening if not recognized and treated. Ensure management by neonatology experts will be available at delivery.
• RISK EVALUATION AND MITIGATION STRATEGY (REMS): Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and/or their caregivers, with every prescription on safe use, serious risks, the importance of reading the Medication Guide with each prescription.
• RISK OF MEDICATION ERRORS (Oral Solution): Ensure accuracy when prescribing, dispensing, and administering the oral solution formulation of this drug. Dosing errors due to confusion between mg and mL and other tapentadol oral solutions can result in accidental overdose and death.

CONTRAINDICATIONS:

• Hypersensitivity to the active substance (e.g., anaphylaxis or angioedema) or any product ingredients
• Significant respiratory depression
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
• Known or suspected gastrointestinal obstruction, including suspected paralytic ileus
• Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days

IR Tablets: Safety and efficacy have not been established in patients younger than 6 years old weighing less than 40 kg
ER Tablets: Safety and efficacy have not been established in patients younger than 18 years
Oral Solution: Safety and efficacy have not been established in patients younger than 6 years old weighing less than 16 kg

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule II

Dialysis

Data not available

Other Comments

Administration advice:
All Formulations:

• Prior to starting treatment, individualize dosing regimen considering source and severity of pain, patient age, prior analgesic treatment experience/response, risk of respiratory depression, and risk factors for addiction, abuse, and misuse.
• Before initiation of therapy (and when renewing treatment), discuss and/or prescribe naloxone based on patient/household risk factors for opioid overdose.
• Do not abruptly discontinue administration of this drug in a physically-dependent patient.
• For oral use; administer with or without food.

Oral Solution:

• When prescribing or dispensing, include the total dose in both mg and mL to avoid errors.
• Use a graduated oral syringe with metric units to measure and administer dose.
• Only an adult should administer the oral solution to a pediatric patient.
• Pediatric doses 3 mL or less: Use 3 mL oral syringe to administer.
• Pediatric doses more than 3 mL: Use 5 mL oral syringe to administer.

ER Tablets:

• Do not cut, break, chew, dissolve, or crush tablets.
• Swallow 1 tablet at a time with plenty of water; do not pre-soak, lick, or wet tablet before administration.
• Tablets should be taken twice a day approximately 12 hours apart.

Storage requirements:

• Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
• Oral solution: Store upright after opening.
• Protect from moisture.
• Destroy tablets that are no longer needed by flushing down the toilet.
• Keep out of reach of children; pediatric patients should not have their own access to this drug.

General:

• Limitations of use: Due to the risks of addiction, abuse, or misuse with opioids, which may occur at any dose/duration, and because of the greater risks of overdose and death associated with ER/long-acting opioid formulations, reserve use of any formulations of this drug for when alternative treatment options are ineffective, not tolerated, or unable to provide adequate analgesia.
• Limitation of use: The extended release formulation of this drug is not indicated for use as an as-needed (PRN) analgesic.
• This drug should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids (including long-acting opioids) and how to mitigate associated risks.
• Many acute pain conditions (e.g., pain related to surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic; consult clinical guidelines when available.
• For patients receiving other opioid analgesics and then switching to this drug, it is safer to underestimate the 24-hour oral opioid requirement for a patient and provide rescue medication than overestimate and manage an adverse reaction; opioid conversion tables do not fully capture the substantial inter-patient variation in the relative potency of different opioid drugs.

Monitoring:

• Cardiovascular: For signs/symptoms of hypotension (during initiation and titration)
• General: For treatment necessity and level of pain control (regularly during therapy)
• Nervous system: For CNS depression (during initiation and titration)
• Psychiatric: For signs/symptoms of addiction, abuse/misuse, and withdrawal (during therapy and upon discontinuation)
• Renal: Kidney function, especially in patients aged 65 and older (regularly during treatment)
• Respiratory: For respiratory depression, especially in older adults (during initiation and titration)

Patient advice:

• Read the US FDA-approved Medication Guide and Instructions For Use (oral solution) each time this drug is dispensed.
• Understand the safe use, risks, and proper storage/disposal of this drug; store this drug safely out of the sight and reach of children, and protect it from theft or misuse.
• Recognize the signs and symptoms of an overdose and understand the use naloxone (if prescribed).
• This drug can result in addiction, abuse, and misuse; do not share this drug with others.
• Avoid abrupt discontinuation of this drug without a prior prescribed tapering plan.
• Understand the risk of life-threatening respiratory depression and when this risk is greatest.
• Recognize that this drug may cause drowsiness, dizziness, or impair thinking and avoid driving or operating heavy machinery until adverse effects are determined.
• Seek medical attention if any of the following symptoms are experienced: adrenal insufficiency, anaphylaxis, constipation, hyperalgesia.
• Inform your health care provider of all current medications to avoid contraindicated drug interactions.
• Oral solution:
• Patient and caregivers should not adjust the dose of this drug without consulting with a physician.
• This formulation may cause orthostatic hypotension.
• Pregnant women and/or women of childbearing potential should understand:
• The risk of fetal harm with use of this drug.
• The risk of neonatal opioid withdrawal syndrome with prolonged use of this drug during pregnancy.
• The potential for reduced fertility with extended use.
• Breastfeeding women: The ER formulation of this drug is not recommended during breastfeeding.

Further information

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

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