From the Guidelines
Tramadol does not inherently contain acetaminophen, but it is available in combination products with acetaminophen, such as Ultracet, which typically contains 37.5 mg of tramadol and 325 mg of acetaminophen per tablet. Tramadol is an opioid pain medication that works on its own as a centrally-acting analgesic, affecting opioid receptors and serotonin and norepinephrine reuptake 1. However, combination products like Ultracet leverage the different pain-relieving mechanisms of both medications, with tramadol working on opioid receptors and acetaminophen reducing pain through different pathways, including inhibiting prostaglandin synthesis.
When prescribing or taking medication, it's essential to know exactly which formulation you have, as dosing recommendations and side effect profiles differ between tramadol alone and combination products 1. Always check the medication label or prescription information to confirm the exact components in your medication. The most recent guidelines, such as the 2023 ASCO guideline, emphasize the importance of careful opioid selection and dosing, considering the risks and benefits of different opioids, including tramadol and combination products 1.
Key points to consider:
- Tramadol is available in various formulations, including immediate-release and extended-release, with different dosing recommendations 1.
- Combination products like Ultracet contain both tramadol and acetaminophen, with specific dosing and side effect profiles 1.
- Careful selection and dosing of opioids, including tramadol and combination products, are crucial to minimize risks and maximize benefits 1.
- Patients should be aware of the exact components in their medication and follow dosing recommendations and guidelines to ensure safe and effective use.
From the FDA Drug Label
Tramadol hydrochloride has been studied in three long-term controlled trials involving a total of 820 patients, with 530 patients receiving tramadol hydrochloride Patients with a variety of chronic painful conditions were studied in double-blind trials of one to three months duration. Average daily doses of approximately 250 mg of tramadol hydrochloride in divided doses were generally comparable to five doses of acetaminophen 300 mg with codeine phosphate 30 mg (TYLENOL with Codeine #3) daily, five doses of aspirin 325 mg with codeine phosphate 30 mg daily, or two to three doses of acetaminophen 500 mg with oxycodone hydrochloride 5 mg (TYLOX® ) daily The FDA drug label does not answer the question.
From the Research
Tramadol and Acetaminophen Combination
- Tramadol hydrochloride/acetaminophen is a combination drug that contains tramadol hydrochloride and acetaminophen 2.
- The combination of tramadol and acetaminophen provides effective analgesia in patients with moderate to severe acute pain and those with chronic painful conditions 3.
- Tramadol/acetaminophen fixed-dose combination tablets combine tramadol, a centrally acting weak opioid analgesic, with low-dose acetaminophen 4.
Pharmacokinetics and Efficacy
- The pharmacokinetic profiles of extended-release and conventional tramadol/acetaminophen fixed-dose combination tablets have been compared in healthy volunteers 5.
- A fixed combination of tramadol and paracetamol (acetaminophen) has been shown to be effective in the treatment of pain in patients with advanced stage cancer 6.
- The combination of tramadol and acetaminophen has been found to provide faster onset and longer duration of action with fewer adverse events than either component separately 2, 3.
Dosage and Administration
- The initial dosage of tramadol and acetaminophen combination can be 3x1 tablet (112.5 mg tramadol and 975 mg acetaminophen) for pain intensity 4, up to 4x2 tablets (300 mg of tramadol and 2600 mg paracetamol) for pain intensity 7 and 8 6.
- The dose of the fixed combination tramadol and acetaminophen can be increased to a maximum of 8 tablets daily (300 mg of tramadol and 2600 mg paracetamol) if necessary 6.