Tramadol Indications and Dosage
- arthralgia †
- bone pain †
- dental pain †
- headache †
- moderate pain
- myalgia †
- neuropathic pain †
- osteoarthritis †
- postoperative shivering †
- restless legs syndrome (RLS) †
† non-FDA-approved indication
†Tramadol Indications and Dosage
For the treatment of moderate pain or moderately severe pain including arthralgia † , headache † , myalgia † , dental pain † following oral surgery such as extraction of impacted molars or chronic conditions such as low-back pain † , bone pain † and cancer-related pain † :
- for patients with moderate to moderately severe chronic pain not requiring rapid onset of analgesic effect:
Oral dosage:
Adults and adolescents >= 16 years: Initially, 25 mg PO once daily then titrated in 25 mg increments as separate doses every 3 days to reach a dose of 100 mg/day PO (i.e., 25 mg PO four times daily). Thereafter, the total daily dose may be increased by 50 mg as tolerated every 3 days to reach 200 mg/day PO (i.e., 50 mg PO four times daily). After titration, tramadol 50 - 100 mg PO every 4 - 6 hours as needed, not to exceed 400 mg/day PO. The tolerability of tramadol may be improved by initiating therapy with this dosage titration.
Elderly patients >= 75 years: Initially, 25 mg PO once daily and titrated in 25 mg increments as separate doses every 3 days to reach a dose of 100 mg/day PO (i.e., 25 mg PO four times daily). Thereafter the total daily dose may be increased by 50 mg as tolerated every 3 days to reach 200 mg/day PO (i.e., 50 mg PO four times daily). After titration, tramadol 50 - 100 mg PO every 4 - 6 hours as needed, not to exceed 300 mg/day PO. Available data suggest that a dosage adjustment is not necessary in elderly patients 65 - 75 years of age unless they also have renal or hepatic impairment.
- for the rapid relief of moderate pain to moderately severe pain in patients for whom the benefits outweight the risk of increased adverse reactions associated with higher initial doses:
Oral dosage:
Adults and adolescents >= 16 years: 50 - 100 mg PO every 4 - 6 hours as needed, not to exceed 400 mg/day PO.
Elderly patients >= 75 years: 50 - 100 mg PO every 4 - 6 hours as needed. Total doses should not exceed 300 mg/day PO. Available data suggest that a dosage adjustment is not necessary in elderly patients 65 - 75 years of age unless they also have renal or hepatic impairment.
Intravenous dosage (not available in US) † :
Adults: 50 - 100 mg IV every 4 - 6 hours as needed with total doses not exceeding 400 mg/day IV. The German recommended dosage is 0.7 mg/kg/dose IV with a maximum dose of 5.6 mg/kg/day IV. Tramadol 15 mg/hr IV as a continuous infusion has been shown to be effective for postoperative pain.
Intravenous dosage for patient controlled analgesia (PCA) (not available in US) † :
Adults: PCA loading doses of 100 mg IV and on-demand doses of 20 mg with a 5 minute lock-out and 500 mg limit within 4 hours has been used for 1 day postoperatively. Other regimens include tramadol 50 - 100 mg IV loading dose then 2.2 mg/hour IV infusion with a demand dose of 18.5 mg IV with a 1 minute lock-out (hourly maximum dose 193 mg) and tramadol 9.6 mg IV demand dose, with a 1 minute lockout, concurrent 1.15 mg/hour IV infusion and hour maximum dose of 100 mg.
Children > 12 years: The German recommended dosage is 0.7 mg/kg/dose IV with a maximum total daily dose of 5.6 mg/kg/day IV.
Intramuscular dosage (parenteral formulation not available in US) † :
Adults: 50 - 100 mg IM every 6 - 8 hours as needed. Maximum total daily dose of 400 mg/day IM. The German recommend dosage is 0.7 mg/kg/dose IM with a maximum total daily dose of 5.6 mg/kg/day IM.
Children > 12 years: The German recommended dosage is 0.7 mg/kg/dose IM with a maximum dose of 5.6 mg/kg/day IM.
Rectal dosage (not available in the US) † :
Adults: 100 mg PR every 6 - 8 hours. The German recommended dosage is 1.4 mg/kg/dose PR with a maximum total daily dose of 5.6 mg/kg/day PR.
For the adjuvant treatment of osteoarthritis † :
Oral dosage:
Adults: 50 - 100 mg PO every 4 - 6 hours as needed, not to exceed 400 mg/day PO. Dosage titration may improve tolerability. Tramadol has been shown to be effective in controlling breackthrough pain in patients receiving NSAIDs. A trial of tramadol versus diclofenac in patients with osteoarthritis of the hip and/or knee showed that the drugs were comparable. Tramadol may be an alternative to NSAIDs in patients who due not tolerate or have preexisting conditions that limit NSAID use or in patients with a limited inflammatory component to their osteoarthritis.
Elderly patients >= 75 years: 50 - 100 mg PO every 4 - 6 hours as needed with a maximum total daily dose not to exceed 300 mg PO.
For the treatment of neuropathic pain † including diabetic neuropathy † and postherpetic neuralgia † :
Oral dosage:
Adults: An average tramadol dose of 210 mg/day PO, in divided doses, provided significant relief of neuropathic pain in patients with diabetic neuropathy who participated in a placebo-controlled study. Patients receiving tramadol scored better in physical and social functioning ratings than placebo. In a study of patients with postherpetic neuralgia, tramadol 600 mg/day PO was compared to a control arm of clomipramine plus levomepromazine. Nine of 10 patients treated with tramadol and 6 of 11 control patients reported satisfactory results. A large number of randomized patients withdrew from both arms due to side effects.
For the treatment of restless legs syndrome (RLS) † :
Oral dosage:
Adults: In a small study, tramadol 50 - 150 mg/day PO for 15 - 24 months was effective in 10 of 12 patients. No major tolerance was seen and many patients were treated with single daily doses.
For the treatment of postoperative shivering † :
Intravenous dosage (not available in US) † :
Adults: 1 - 2 mg/kg IV stopped shivering within 5 minutes in post-anesthetic patients.
Maximum Dosage Limits:
- Adults: 100 mg/dose PO or 400 mg/day PO.
- Elderly >= 75 years: 100 mg/dose PO or 300 mg/day PO.
- Elderly 65 - 74 years: 100 mg/dose PO or 400 mg/day PO.
- Adolescents >= 16 years: 100 mg/dose PO or 400 mg/day PO.
- Adolescents 13 - 15 years: Maximum dosage has not been determined.
- Children: Maximum dosage has not been determined.
Patients with hepatic impairment:
A dose of 50 mg PO every 12 hours is recommended for patients with cirrhosis or severe hepatic impairment.
Patients with renal impairment:
CrCl <= 30 ml/min: increase dosage interval to 12 hours; maximum daily dose not to exceed 200 mg/day PO.
† non-FDA approved indication
[ Last revised: 9/12/2005 2:58:00 PM ]
References
898. Lehman KA. Tramadol for the management of acute pain. Drugs 1994;47 Suppl 1:19-32.
899. Katz WA. Pharmacology and clinical experience with tramadol in osteoarthritis. Drugs 1996;52 Suppl 3:39-47.
965. de Witte J, Deloof T, de Veylder J, et al. Tramadol in the treatment of postanesthetic shivering. Acta Anaesthesiol Scand 1997;41:506-10.
2540. Harati Y, Gooch C, Swenson M, et al. Double-blind randomized trial of tramadol for the treatment of the pain of diabetic neuropathy. Neurology 1998;50:1842-6.
2541. Gobel H, Stadler T. Treatment of pain due to postherpetic neuralgia with tramadol. Results of an open parallel pilot study versus clomipramine with or without levomepromazine. Clin Drug Invest 1995;10:208-14.
2542. Lauerma H, Markkula J. Treatment of restless legs syndrome with tramadol: an open study. J Clin Psychiatry 1999;60:241-4.
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