Usual Adult Dose for Pain
For mild to moderate severe chronic pain not requiring rapid onset of analgesic effect:
Initial dose: 25 mg every morning
Titration: increase in 25 mg increments as separate doses every 3 days to reach 100 mg per day taken as 25 mg 4 times per day. Then the total daily dose may be increased by 50 mg as tolerated every 3 days to reach 200 mg per day taken as 50 mg 4 times per day.
Maintenance: After titration, tramadol 50 mg to 100 mg can be administered as needed for pain relief every 4 to 6 hours not to exceed 400 mg per day.
For the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time:
Extended-Release Tablets:
Initial Dose: 100 mg once daily and titrated up as necessary by 100 mg increments every five days to relief of pain and depending upon tolerability.
Maximum Dose: Extended-release tablets should not be administered at a dose exceeding 300 mg per day.
For patients in whom rapid onset of analgesic effect is required and for whom the benefits outweigh the risk of discontinuation due to adverse events associated with higher initial dose:
Dose: 50 mg to 100 mg can be administered as needed for pain relief every 4 to 6 hours, not to exceed 400 mg per day.
Initial dose: 25 mg every morning
Titration: increase in 25 mg increments as separate doses every 3 days to reach 100 mg per day taken as 25 mg 4 times per day. Then the total daily dose may be increased by 50 mg as tolerated every 3 days to reach 200 mg per day taken as 50 mg 4 times per day.
Maintenance: After titration, tramadol 50 mg to 100 mg can be administered as needed for pain relief every 4 to 6 hours not to exceed 400 mg per day.
For the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time:
Extended-Release Tablets:
Initial Dose: 100 mg once daily and titrated up as necessary by 100 mg increments every five days to relief of pain and depending upon tolerability.
Maximum Dose: Extended-release tablets should not be administered at a dose exceeding 300 mg per day.
For patients in whom rapid onset of analgesic effect is required and for whom the benefits outweigh the risk of discontinuation due to adverse events associated with higher initial dose:
Dose: 50 mg to 100 mg can be administered as needed for pain relief every 4 to 6 hours, not to exceed 400 mg per day.
Usual Geriatric Dose for Pain
For patients over 65 years:
Dose selection should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.
For patients over 75 years:
Maximum dose of regular oral tablets: 300 mg per day in divided doses
Dose selection should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.
For patients over 75 years:
Maximum dose of regular oral tablets: 300 mg per day in divided doses
Usual Pediatric Dose for Pain
16 years old and up:
Brand name: Ryzolt
Initial: 100 mg once daily
Titrate by 100 mg increments every 2 to 3 days if needed for pain control
Maximum: 300 mg/day
Brand name: Ryzolt
Initial: 100 mg once daily
Titrate by 100 mg increments every 2 to 3 days if needed for pain control
Maximum: 300 mg/day
Renal Dose Adjustments
Regular-Release Tablets and Oral Disintegrating Tablets:
CrCl Less than 30 mL/min: Dosing interval increased to every 12 hours
Maximum dose: 200 mg per day in divided doses
Extended-Release Tablets:
CrCl Less than 30 mL/min: The limited availability of dose strengths of the extended-release tablets does not permit the dosing flexibility required for safe use in patients with severe renal impairment. Therefore, extended-release tablets should not be used in patients with severe renal impairment.
CrCl Less than 30 mL/min: Dosing interval increased to every 12 hours
Maximum dose: 200 mg per day in divided doses
Extended-Release Tablets:
CrCl Less than 30 mL/min: The limited availability of dose strengths of the extended-release tablets does not permit the dosing flexibility required for safe use in patients with severe renal impairment. Therefore, extended-release tablets should not be used in patients with severe renal impairment.
Liver Dose Adjustments
Regular-Release Tablets and Oral Disintegrating Tablets:
50 mg orally every 12 hours for patients with cirrhosis
Extended-Release Tablets:
Extended-release tablets should not be used in patients with severe hepatic impairment (Child-Pugh Class C).
Trade Name: Ryzolt
Do not use in patients with any degree of hepatic impairment.
50 mg orally every 12 hours for patients with cirrhosis
Extended-Release Tablets:
Extended-release tablets should not be used in patients with severe hepatic impairment (Child-Pugh Class C).
Trade Name: Ryzolt
Do not use in patients with any degree of hepatic impairment.
Precautions
Patients should be informed that the extended-release tablets are for oral use only and should be swallowed whole. The tablets should not be chewed, crushed, or split.
The oral disintegrating tablets (ODT) should be placed on the tongue until they completely disintegrate. This may take approximately one minute. After fully disintegrating, the tablet should be swallowed. The tablets should not be chewed, broken, or split. Orally disintegrating tablets may be taken with or without water.
Tramadol, like narcotic analgesics, may make clinical observation and assessment difficult and, therefore, should be administered with caution to patients with head injuries, increased intracranial pressure, acute undiagnosed abdominal pain, severe renal disease, severe liver disease, or respiratory depression (or risk factors for respiratory depression). Tramadol should not be for the treatment of patients with acute intoxication from alcohol, hypnotics, centrally acting analgesics, opioids, or psychotropic drugs since it could potentiate the effects of these agents. Tramadol should not be used in patients with a past or present history of narcotic dependence.
Tramadol may increase the risk of seizures in patients with a reduced seizure threshold due to certain medications, including: MAO inhibitors, tricyclic antidepressants, other tricyclic compounds (i.e. cyclobenzaprine, promethazine), neuroleptic drugs, selective serotonin reuptake inhibitors (SSRIs), and others.
Tramadol may increase the risk of seizures in patients with epilepsy, with a history of seizures, or with seizure risk (i.e. head trauma, metabolic disorders, alcohol and/or drug withdrawal, CNS infections, and so forth). Naloxone may increase the risk of seizures when it is used to reverse the effects of a tramadol overdose.
Safety and effectiveness of tramadol oral disintegrating tablets have not been established in pediatric patients under the age of 16 years.
The oral disintegrating tablets (ODT) should be placed on the tongue until they completely disintegrate. This may take approximately one minute. After fully disintegrating, the tablet should be swallowed. The tablets should not be chewed, broken, or split. Orally disintegrating tablets may be taken with or without water.
Tramadol, like narcotic analgesics, may make clinical observation and assessment difficult and, therefore, should be administered with caution to patients with head injuries, increased intracranial pressure, acute undiagnosed abdominal pain, severe renal disease, severe liver disease, or respiratory depression (or risk factors for respiratory depression). Tramadol should not be for the treatment of patients with acute intoxication from alcohol, hypnotics, centrally acting analgesics, opioids, or psychotropic drugs since it could potentiate the effects of these agents. Tramadol should not be used in patients with a past or present history of narcotic dependence.
Tramadol may increase the risk of seizures in patients with a reduced seizure threshold due to certain medications, including: MAO inhibitors, tricyclic antidepressants, other tricyclic compounds (i.e. cyclobenzaprine, promethazine), neuroleptic drugs, selective serotonin reuptake inhibitors (SSRIs), and others.
Tramadol may increase the risk of seizures in patients with epilepsy, with a history of seizures, or with seizure risk (i.e. head trauma, metabolic disorders, alcohol and/or drug withdrawal, CNS infections, and so forth). Naloxone may increase the risk of seizures when it is used to reverse the effects of a tramadol overdose.
Safety and effectiveness of tramadol oral disintegrating tablets have not been established in pediatric patients under the age of 16 years.
