Tapentadol Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Pain

IMMEDIATE RELEASE TABLETS AND SOLUTION:
Initial dose: 50, 75, or 100 mg orally every 4 to 6 hours depending on pain intensity
Maximum dose: 600 mg/day

Comments:
-Adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic experience, general condition, other medications, and risk factors for abuse.
-On the first day of dosing, the second dose may be administered as soon as one hour later if adequate pain relief is not attained.
-May be taken with or without food.
-Consider starting elderly patients at the lower end of the recommended dose range.
-When the patient no longer requires therapy with this drug, gradually taper to prevent withdrawal symptoms in the physically dependent patient.

Use: Moderate to severe acute pain in adults

EXTENDED RELEASE TABLETS:
Initial dose: 50 mg orally twice a day
Maximum dose: 500 mg/day

Comments:
-Adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic experience, general condition, other medications, and risk factors for abuse.
-Convert from immediate release to extended release using the equivalent total daily dose of the immediate release and divide it into 2 equal doses of the extended release separated by approximately 12 hour intervals.
-When converting from other opioids begin with half of the estimated daily tapentadol requirement as the initial dose and manage inadequate analgesia with immediate release rescue medication.
-Consider starting elderly patients at the lower end of the recommended dose range.
-Monitor for respiratory depression, especially within the first 24-72 hours of initiating therapy.
-Titrate with dose increases of 50 mg no more than twice a day every three days.
-Efficacy was demonstrated relative to placebo between 100 and 250 mg twice a day.
-Tablets must be swallowed whole. Cutting, crushing, chewing, or dissolving this drug will result in uncontrolled delivery and could result in death.
-Discontinue all other tapentadol, tramadol, and around-the-clock opioid products when taking this drug.
-When the patient no longer requires therapy with this drug, gradually taper to prevent withdrawal symptoms in the physically dependent patient.

-Uses: Pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate; neuropathic pain associated with diabetic peripheral neuropathy in adults severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Renal Dose Adjustments

Mild to moderate renal dysfunction: No adjustment recommended.
Severe renal dysfunction (CrCl 15 to less than 30 mL/min): Not recommended.

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh 5-6): No adjustment recommended.

Moderate liver dysfunction (Child-Pugh 7 to 9):
-Immediate release tablets and solution: Initial dose 50 mg orally no more than every 8 hours (maximum of 3 doses in 24 hours)
-Extended release tablets: Initial dose 50 mg orally once a day (maximum of 100 mg/day)

Severe liver dysfunction (Child-Pugh 10-15): Not recommended.

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting (ER/LA) opioid analgesics. It includes a medication guide, elements to assure safe use, and an implementation system. For additional information: www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

US BOXED WARNINGS (Extended release tablets):
-ADDICTION, ABUSE, AND MISUSE: Addiction to, abuse, or misuse of this drug can lead to overdose and death. Assess each patient's risk before prescribing and monitor regularly for these behaviors or conditions.
-LIFE-THREATENING RESPIRATORY DEPRESSION: Respiratory depression with fatal outcome can occur. Monitor closely upon initiation or following a dose increase. Instruct patients to swallow the tablets whole; crushing, chewing, or dissolving the tablets can cause rapid release and absorption of a potentially fatal dose.
-ACCIDENTAL INGESTION: Accidental ingestion, especially in children, can be fatal.
-NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use during pregnancy can result in this life-threatening syndrome if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk and ensure appropriate treatment will be available.
-INTERACTION WITH ALCOHOL: 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.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule II

Dialysis

Data not available

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