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Tramadol Dosage

Applies to the following strength(s): 50 mg ; 100 mg/24 hours ; 200 mg/24 hours ; 300 mg/24 hours ; 150 mg/24 hours

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Geriatric Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Pain

Immediate-release: 50 to 100 mg orally every 4 to 6 hours as needed for pain
Maximum dose: 400 mg per day

Comments:
-Dose should be individualized; for patients not requiring rapid onset of analgesic effect, the tolerability may be increased by initiating at the lowest possible dose and titrating upward.

Use: For the management of moderate to moderately severe pain.

Usual Adult Dose for Chronic Pain

For patients with moderate to moderately severe chronic pain not requiring rapid onset of analgesic effect, tolerability can be improved by initiating slowly

Immediate-Release (IR):
-Initial dose: 25 mg orally once a day; titrate in 25 mg increments every 3 days to reach a dose of 25 mg four times a day; thereafter increase by 50 mg as tolerated every 3 days to reach a dose of 50 mg four times a day
-Maintenance dose: After titration, 50 to 100 mg orally as needed for pain every 4 to 6 hours
-Maximum dose: 400 mg per day

Extended-Release (ER):
-Initial dose (tramadol-naive): 100 mg orally once a day
-Individually titrate in 100 mg increments every 5 days to an effective dose that minimizes adverse reactions
-Maximum Dose: 300 mg orally per day

Initial Dose for patients CURRENTLY receiving IR tramadol: Calculate 24-hour IR requirement and initiate with a total daily ER dose rounded down to the next lowest 100 mg increment orally once a day
Initial Dose for those on Other Opioids: Discontinue all other around the clock opioid drugs; initiate with ER 100 mg orally once a day
-Individually titrate in 100 mg increments every 5 days to an effective dose that minimizes adverse reactions
-Maximum Dose: 300 mg per day

Comments:
-Due to limitations of dose selection with ER formulations, some patients may not be able to convert from the IR to ER.
-The ER products should not be used with other tramadol products and should not be taken more often than once a day.
-Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of therapy and following doe increases.

Use: 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.

Usual Geriatric Dose for Pain

Age: 75 years or older: Maximum dose: 300 mg per day

Comments:
-Respiratory depression is the chief risk for elderly patients treated with opioids; titrate dose slowly and monitor closely for signs of central nervous system and respiratory depression.

Usual Geriatric Dose for Chronic Pain

Age: 75 years or older: Maximum dose: 300 mg per day

Comments:
-Respiratory depression is the chief risk for elderly patients treated with opioids; titrate dose slowly and monitor closely for signs of central nervous system and respiratory depression.

Usual Pediatric Dose for Pain

17 years or older:
Immediate-release: 50 to 100 mg orally every 4 to 6 hours as needed for pain
Maximum dose: 400 mg per day

For patients with moderate to moderately severe chronic pain not requiring rapid onset of analgesic effect, tolerability can be improved by initiating slowly:
Immediate-Release:
-Initial dose: 25 mg orally once daily; titrate in 25 mg increments every 3 days to reach a dose of 25 mg four times a day; thereafter increase by 50 mg as tolerated every 3 days to reach a dose of 50 mg four times a day
-Maintenance dose: After titration, 50 to 100 mg orally as needed for pain every 4 to 6 hours
-Maximum dose: 400 mg per day

Comments:
-Dose should be individualized; starting at the lowest possible dose and titrating upward may result in increased tolerability and fewer drug discontinuations.

Use: For the management of moderate to moderately severe pain.

Renal Dose Adjustments

Immediate-release:
-CrCl less than 30 mL/min: Dosing interval should be increased to every 12 hours; maximum dose should not exceed 200 mg per day

Extended-release:
-CrCl less than 30 mL/min: Use is not recommended.

Liver Dose Adjustments

Immediate-release:
-Patients with cirrhosis: 50 mg orally every 12 hours

Extended-release:
-Severe hepatic impairment (Child-Pugh Class C): Use is not recommended

Trade Name: Ryzolt
Do not use in patients with any degree of hepatic impairment.

Dose Adjustments

Concomitant use of Drugs affecting CYP450 Isoenzymes:
-CYP450 3A4 inhibitors or inducers:

Upon discontinuation:
-Gradually decrease by 25% to 50% every 2 to 4 days
-If patient develops signs or symptoms of withdrawal, raise the dose to the previous level and taper more slowly by either increasing the interval between decreases, decreasing the amount of change in dose, or both.
-Do not abruptly discontinue therapy.

Precautions

US BOXED WARNINGS: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYP450 ISOENZYMES; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS:
-Addiction, Abuse, and Misuse which can lead to overdose and death is a risk for patients and other users. Assess each patient's risk prior to prescribing and monitor all patients regularly for the development of these behaviors or conditions.
-Life-Threatening Respiratory Depression including life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation or following a dose increase. Instruct patients using extended-release formulations to swallow product whole and not to split, break, chew, crush, or dissolve the contents as this may lead to a potentially fatal drug dose.
-Accidental Ingestion of/exposure to even one dose, especially by children, can result in a fatal overdose.
-Neonatal Opioid Withdrawal Syndrome, a potentially life-threatening condition if not recognized and treated, may result from prolonged maternal opioid use of this drug during pregnancy; it requires management according to protocols developed by neonatology experts. If use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure appropriate treatment be available.
-Concomitant use or discontinuation of CYP450 isoenzymes including CYP450 3A4 inducers, CYP450 3A4 inhibitors, or CYP450 2D6 inhibitors are complex; concomitant use requires careful consideration of the effects on the parent drug, tramadol, and the active metabolite, M1.
-Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

Immediate-release: Safety and efficacy have not been established in patients younger than 17 years.
Extended-release: Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule IV

Dialysis

Hemodialysis patients can receive their regular dose on dialysis days since only 7% of dose is removed.
Peritoneal dialysis: No data available

Other Comments

OTHER COMMENTS:
Administration advice:
-May be taken with or without food
Extended release capsules and tablets:
-Swallow whole; do not crush, chew, split, or dissolve

General:
-Seizures and/serotonin syndrome may occur when used concomitantly with serotonergic agents (SSRIs, SNRIs, and triptans) or with drugs that significantly reduce the metabolic clearance of tramadol.
-Taking this drug in excessive doses, either alone or in combination with other CNS depressants, including alcohol, is a major cause of drug-related deaths.
-This drug should not be used for longer than therapeutically necessary; evaluate continued use at regular intervals.

Monitoring:
-Monitor regularly for the development of addiction, abuse, and misuse.

Patient advice:
-Patients should understand the risks of life-threatening respiratory depression, and be informed as to when this risk is greatest.
-This drug may cause drowsiness, dizziness, or impair thinking or motor skills; patients should avoid driving or operating machinery until adverse effects are determined.
-Patients should be instructed not to exceed the recommended dose, take with alcohol, or take with other products that may cause CNS depression without first speaking with their healthcare provider.
-Advise patient to speak to physician or health care professional if pregnant, intend to become pregnant, or are breastfeeding.
-Women of child bearing potential should understand that prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome and that prompt recognition and treatment will be necessary.

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