Tapentadol

What it is used for

Tapentadol hydrochloride oral solution is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults.

Limitations of Use

Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy,, reserve opioid analgesics, including tapentadol hydrochloride oral solution for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Pediatric use information is approved for Collegium Pharmaceutical, Inc.’s NUCYNTA oral solution. However, due to Collegium Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

Side effects, and when to stop

The following adverse reactions are discussed, or described in greater detail in other sections:

• Addiction, Abuse, and Misuse
• Life-Threatening Respiratory Depression
• Interactions with CNS Benzodiazepine or Other Depressants
• Neonatal Opioid Withdrawal Syndrome
• Opioid-Induced Hyperalgesia and Allodynia
• Serotonin Syndrome
• Adrenal Insufficiency
• Severe Hypotension
• Gastrointestinal Adverse Reactions
• Seizures
• Withdrawal

Who should not take it

Tapentadol hydrochloride oral solution is contraindicated in patients with:

• 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
• Hypersensitivity to tapentadol (e.g. anaphylaxis, angioedema) or to any other ingredients of the product
• Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days.

Other medicines and interactions

Table 2 includes clinically significant drug interactions with tapentadol hydrochloride oral solution.

Table 2 Clinically Significant Drug Interactions with tapentadol hydrochloride oral solution