Tramadol

What it is used for

Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:

• Have not been tolerated or are not expected to be tolerated.
• Have not provided adequate analgesia or are not expected to provide adequate analgesia.

Tramadol Hydrochloride Tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

Side effects, and when to stop

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

• Addiction, Abuse, and Misuse
• Life-Threatening Respiratory Depression
• Interactions with Benzodiazepines or Other CNS Depressants
• Neonatal Opioid Withdrawal Syndrome
• Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-threatening Respiratory Depression in Children
• Opioid-Induced Hyperalgesia and Allodynia
• Serotonin Syndrome
• Seizures
• Suicide
• Adrenal Insufficiency
• Severe Hypotension
• Gastrointestinal Adverse Reactions
• Hypersensitivity Reactions
• Withdrawal

Who should not take it

Tramadol hydrochloride tablets are contraindicated for:

• all children younger than 12 years of age.
• postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy.

Tramadol hydrochloride tablets are also 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 paralytic ileus.
• Hypersensitivity to tramadol, any other component of this product or opioids.
• Concurrent use of monoamine oxidase inhibitors (MAOIs) or use within the last 14 days.

Other medicines and interactions

Table 2: Clinically Significant Drug Interactions with Tramadol hydrochloride tablets