Management of moderate to moderately severe pain. Efficacy established in patients with moderately severe acute or chronic pain, including postoperative, gynecologic, obstetric, and cancer pain.
Extended-release tablets are used for the management of moderate to moderately severe pain when continuous, around-the-clock analgesia is needed for an extended period of time. Efficacy established in patients with moderate to moderately severe chronic pain associated with osteoarthritis.
Used in fixed-combination with acetaminophen for short-term (≤5 days) management of acute pain.
Dosage and Administration
Administration
Oral Administration
Administer orally alone or in fixed combination with acetaminophen.
Administer tramadol conventional tablets without regard to meals.
Administer tramadol extended-release tablets once daily in a consistent manner relative to food intake.
Manufacturer makes no specific recommendation regarding administration of the fixed combination of tramadol-acetaminophen with food.
Initially, 25 mg daily in the morning; titrate dosage slowly to reduce risk of adverse effects. Increase dosage in 25-mg increments as separate doses every 3 days to a dosage of 100 mg daily (25 mg 4 times daily); then may increase total daily dosage by 50 mg every 3 days as tolerated, up to 200 mg daily (50 mg 4 times daily.) After titration, 50–100 mg can be given every 4–6 hours, up to 400 mg daily.
If more rapid onset of analgesia is required, may initiate therapy at 50–100 mg every 4–6 hours (up to 400 mg daily), but risk of adverse events may be increased.
Extended-release Tablets
Oral
Initially, 100 mg once daily; increase dosage in 100-mg increments every 5 days, as needed and tolerated, up to 300 mg daily.
Fixed Combination with Acetaminophen
Oral
75 mg of tramadol hydrochloride every 4–6 hours as needed (up to 300 mg daily).
Prescribing Limits
Adults
Pain
Conventional Tablets
Oral
Maximum 400 mg daily.
Extended-release Tablets
Oral
Maximum 300 mg daily.
Fixed Combination with Acetaminophen
Oral
Maximum 300 mg daily.
Special Populations
Hepatic Impairment
In patients with cirrhosis, 50 mg (as conventional tablets) every 12 hours. (See Special Populations under Pharmacokinetics.)
Extended-release tablets not recommended for use in patients with severe (Child-Pugh class C) hepatic impairment. Available tablet strengths do not provide sufficient dosing flexibility for safe use in these patients.
Tramadol in fixed combination with acetaminophen not recommended in patients with hepatic impairment.
Renal Impairment
Reduced dosage recommended in patients with severe renal impairment (Clcr <30 mL/minute). (See Special Populations under Pharmacokinetics.)
Severe Renal Impairment
Conventional tablets: 50–100 mg of tramadol every 12 hours (maximum 200 mg daily). In hemodialysis patients, administer the patient's regular dose on dialysis days (not substantially removed by dialysis).
Fixed combination with acetaminophen: Maximum of 75 mg of tramadol hydrochloride (in combination with acetaminophen) every 12 hours.
Extended-release tablets not recommended. Available tablet strengths do not provide sufficient dosing flexibility for safe use.
Geriatric Patients
Cautious dosage selection; initiate therapy at the lower end of the dosage range.
In patients >75 years of age, maximum 300 mg daily.
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