Tramadol Dosage

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Usual Adult Dose for:

Usual Geriatric Dose for:

Usual Pediatric Dose for:

Additional dosage information:

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.

Tramadol Extended-Release (ER):
Patients not currently treated with tramadol immediate-release:
Initial dose: 100 mg once daily and titrated up as necessary by 100 mg increments every 5 days to relief of pain and individualized according to patient need and tolerability.
Maximum dose: 300 mg per day
Patients currently on tramadol IR:
Calculate the 24-hour tramadol IR dose:
Initial dose: Round down to the next lowest 100 mg increment. The dose may subsequently be individualized according to patient need and tolerability.
Maximum dose: 300 mg per day
Due to limitations in flexibility of dose selection with tramadol ER, some patients maintained
on tramadol IR products may not be able to convert.

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

Usual Pediatric Dose for Pain

4 to 16 years:
Immediate release formulations: 1 to 2 mg/kg/dose every 4 to 6 hours
Maximum single dose: 100 mg
Maximum total daily dose is the lesser of: 8 mg/kg/day or 400 mg/day

16 years and older:
Initial dose: 50 to 100 mg every 4 to 6 hours
Maximum dose: 400 mg/day
Alternatively, for patients not requiring a rapid onset of effect, side effects may be decreased by initiating dosage at 25 mg/day and increasing by 25 mg every 3 days up to 25 mg 4 times a day. Dosage may then be increased by 50 mg every 3 days as tolerated to 50 mg 4 times a day.

16 years and older:
Oral disintegrating tablet (ODT):
Initial: 50 to 100 mg every 4 to 6 hours
Maximum: 400 mg/day
Alternatively, for patients not requiring a rapid onset of effect, side effects may be decreased by initiating dosage at 50 mg/day and increasing by 50 mg every 3 days up to 50 mg 4 times a day.
Maximum: 400 mg/day

16 years and older:
Extended-release formulations:
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.

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.

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.

Dialysis

Since only 7% of an administered dose is removed by hemodialysis, dialysis patients can receive their regular dose on the day of dialysis.

Other Comments

Good pain management practices dictate that the dose be individualized according to patient need using the lowest beneficial dose. Studies with tramadol have reported that starting with the lowest possible dose and titrating upward will result in fewer discontinuations and increased tolerability.

Tramadol extended-release should be swallowed whole, not chewed, crushed or split.

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