TAPENTADOL HYDROCHLORIDE

Opioid Analgesic

Brand names: TAPENTADOL

Oral

Mechanism of Action

12.1 Mechanism of Action Tapentadol is a centrally-acting synthetic analgesic. The exact mechanism of action is unknown. Although the clinical relevance is unclear, preclinical studies have shown that tapentadol is a mu-opioid receptor (MOR) agonist and a norepinephrine reuptake inhibitor (NRI). Analgesia in animal models is derived from both of these properties.

Indications

abuse

and misuse with opioids

which can occur at any dosage or duration

and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions (5.1) ]

reserve tapentadol extended-release tablets for use in patients for whom alternative treatment options (e.g.

non-opioid analgesics or immediate-release opioids) are ineffective

Contraindications

• including paralytic ileus Hypersensitivity (e.g.
• anaphylaxis

FDA Warnings

5 WARNINGS AND PRECAUTIONS Opioid-Induced Hyperalgesia and Allodynia: Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain
10 ) Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness : Monitor for sedation and respiratory depression
As an opioid, tapentadol extended-release tablets expose users to the risks of addiction, abuse, and misuse
Because extended-release products such as tapentadol extended-release tablets deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of tapentadol present [see Drug Abuse and Dependence (9) ]

Known Side Effects

6 documented side effects by frequency

Drug Not Working

0.1-1%

Nausea

0.1-1%

Fatigue

0.1-1%

Headache

0.1-1%

Dizziness

0.1-1%

Drowsiness

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral