Names and pronunciation
(tram′a-dole) ConZip, Durela , Qdolo, Ralivia , Tridural , Ultram, Zytram XL
Source page 1319
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Individual generic drug information
Extracted information for traMADol only.
(tram′a-dole) ConZip, Durela , Qdolo, Ralivia , Tridural , Ultram, Zytram XL
Source page 1319
Func. class.: Analgesic—miscel- laneous Controlled Substance Schedule IV
Source page 1319
Do not confuse: traMADol/traZODone Ultram/lithium
Source page 1319
ACTION: Binds to μ-opioid receptors, inhibits reuptake of norepinephrine, serotonin
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USES: Management of moderate to severe pain, chronic pain
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Unlabeled uses: Restless legs syn- drome (RLS), premature ejaculation
Source page 1319
Extracted information for traMADol only.
CONTRAINDICATIONS: Hyper- sensitivity, acute intoxication with any CNS depressant, alcohol, asthma, children, adenoidectomy, GI obstruction ileus, MAOIs
Source page 1319
Black Box Warning: Respiratory de- pression Precautions: Pregnancy, breastfeeding, geriatric patients, seizure disorder, renal/ hepatic disease, head trauma, increased intracranial pressure, acute abdominal condition, drug abuse, depression, sui- cidal ideation, abrupt discontinuation, constipation Black Box Warning: Coadministration with other CNS depressants, neonatal opioid withdrawal syndrome Black Box Warning: Increase: CNS de- pression—alcohol, sedatives, hypnotics, opiates Increase: serotonin syndrome—SSRIs, SNRIs, serotonin-receptor agonists Increase: traMADol levels—CYP3A4 inhibitors (aprepitant, antiretroviral protease inhibitors, clarithromycin, danazol, delavirdine, diltiaZEM, eryth- romycin, fluconazole, FLUoxetine, flu- voxaMINE, imatinib, ketoconazole, mibefradil, nefazodone, telithromycin, voriconazole) Decrease: traMADol effects—CYP3A4 inducers (barbiturates, bosentan, carBA- Mazepine, efavirenz, phenytoins, nevira pine, rifabutin, rifAMPin) Decrease: levels of traMADol—carBAMazepine Drug/Herb • Avoid use with St. John’s wort Increase: CNS depression—chamomile, hops, kava, skullcap, valerian Drug/Lab Test Increase: creatinine, hepatic enzymes Decrease: HB Black Box Warning: Respiratory de- pression: withhold if respirations <12/ min; may be compounded by use of other CNS depressants Black Box Warning: Neonatal opi- oid withdrawal syndrome: prolonged use of opioids in the mother may cause withdrawal in the neonate; can be fatal; assess for irritability, hyperactivity, ab- normal sleep pattern, high-pitched cry, tremor, vomiting, diarrhea, failure to gain weight in the neonate • Fluid balance: I&O ratio: check for decreasing output; may indicate urinary retention • Need for product; dependency, tolera- tion, need for upward titration • Bowel pattern; for constipation; in- crease fluids, bulk in diet • CNS changes: dizziness, drowsiness, hallucinations, euphoria, LOC, pupil reac- tion; avoid use with other CNS depressants • Hypersensitivity: usually after begin ning treatment • Increased side effects in renal/hepatic disease • Serotonin syndrome, neuroleptic malignant syndrome: increased heart rate, shivering, sweating, dilated pupils, tremors, high B/P, hyperthermia, headache, confusion; if these occur, stop product, ad minister serotonin antagonist if needed • Safety: Assistance with ambulation; safety measures: side rails, nightlight, call bell within easy reach • Pregnancy/breastfeeding: use only if benefits outweigh fetal risk, no well-con trolled studies; do not use in labor/deliv ery; do not breastfeed • Beers: avoid in older adults; may lower seizure threshold; monitor for seizures frequently in those with a seizure disorder
Source pages 1319, 1320, 1321
SIDE EFFECTS CNS: Dizziness, CNS stimulation, somno- lence, headache, anxiety, confusion, euphoria, seizures, hallucinations, seda- tion, neuroleptic malignant syndrome– like reactions CV: Vasodilation, orthostatic hypotension, tachycardia, hypertension, abnormal ECG EENT: Visual disturbances GI: Nausea, constipation, vomiting, dry mouth, diarrhea, abdominal pain, anorexia, flatulence, GI bleeding GU: Urinary retention/frequency, meno- pausal symptoms, dysuria, menstrual disorder INTEG: Pruritus, rash, urticaria, vesicles, flushing SYST: Anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis, serotonin syndrome
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INTERACTIONS • Inhibition of norepinephrine and se- rotonin reuptake: MAOIs; use together with caution
Source page 1320
Extracted information for traMADol only.
DOSAGE AND ROUTES Mild to moderate pain T • Adult: PO 25 mg daily, titrate by 25 mg ≥3 days to 100 mg/day (25 mg qid), then may increase by 50 mg ≥3 days to 200 mg (50 mg qid), then 50- 100 mg q4-6hr, max 400 mg/day, use caution in geriatric patients • Geriatric >75 years: PO <300 mg/day in divided doses Moderate to severe chronic pain • Adult: PO-ER (Ultram ER) 100 mg daily, titrate upward q5days in 100-mg increments, max 300 mg/day; (Ryzolt) 100 mg, titrate upward q2-3days in 100-mg increments, max 300 mg/day; products are not interchangeable Renal dose • Adult: PO CCr <30 mL/min, give regu lar dose q12hr, max 200 mg/day; do not use ext rel tab Hepatic dose • Adult: PO (Child-Pugh C) 50 mg q12hr; do not use ext rel tab Restless legs syndrome (RLS) (unlabeled) • Adult: PO 50-150 mg/day × 15-24 mo
Source pages 1319, 1320
Available forms: Tabs 50 mg; ext rel tab 100, 200, 300 mg
Source page 1320
Administer: • Some ext rel products (Ultram ER) are not interchangeable • Do not break, crush, or chew ext rel product • With antiemetic for nausea, vomiting • When pain is beginning to return; deter- mine dosage interval by patient response • With or without food; ER: always give with food, or always give on empty stomach • Store in cool environment; protected from sunlight
Source page 1320
Extracted information for traMADol only.
Assess: • Pain: location, type, character; give before pain becomes extreme
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Evaluate: • Therapeutic response: decrease in pain
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • Before taking, inform health care provider of any history of head injury; seizures; liver, kidney, thyroid problems; problems in urinating; pancreas or gall- bladder problems; abuse of street or prescription drugs; alcohol addiction; or mental health problems • Not to take other prescription medica- tions, OTC products, vitamins, or herbal supplements without approval from health care provider • To take exactly as prescribed by health care provider; not to take more than prescribed dose and not to take >8 tab- lets/day. If dose is missed, to take the next dose at usual time • To notify health care provider if the prescribed does not control pain • Not to stop product abruptly if taking regularly without talking to health care provider • Not to drive or operate heavy ma- chinery until effects of product are known; may cause dizziness or light- headedness • Not to drink alcohol or use a pre- scription or OTC product that contains alcohol • To notify health care provider of severe constipation, nausea, sleepiness, vomit- ing, tiredness, headache, dizziness, ab- dominal pain • To get emergency medical help for difficulty in breathing, shortness of breath, fast heartbeat, chest pain, swell- ing of face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agita- tion, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion • To notify health care provider if preg nancy is planned or suspected. Prolonged use during pregnancy can cause with drawal symptoms in neonate that could T be life threatening if not recognized and treated. Do not breastfeed HIGH ALERT
Source page 1321
Extracted information for traMADol only.
PHARMACOKINETICS Rapidly and almost completely absorbed, steady state 2 days, peak 1.5 hr, duration 6 hr, half-life 7.9-8.8 hr (PO), 8-10 hr (ext rel), may cross blood-brain barrier, exten- sively metabolized, 30% excreted in urine as unchanged product, protein binding 20%
Source page 1320
Filter the extracted dose blocks for this individual drug.
Mild to moderate pain T
• Adult: PO 25 mg daily, titrate by 25 mg ≥3 days to 100 mg/day (25 mg qid), then may increase by 50 mg ≥3 days to 200 mg (50 mg qid), then 50- 100 mg q4-6hr, max 400 mg/day, use caution in geriatric patients
Candidate age grouping · source pages 1319, 1320
Mild to moderate pain T
• Geriatric >75 years: PO <300 mg/day in divided doses Moderate to severe chronic pain
Candidate age grouping · source pages 1319, 1320
Mild to moderate pain T
• Adult: PO-ER (Ultram ER) 100 mg daily, titrate upward q5days in 100-mg increments, max 300 mg/day; (Ryzolt) 100 mg, titrate upward q2-3days in 100-mg increments, max 300 mg/day; products are not interchangeable Renal dose
Candidate age grouping · source pages 1319, 1320
Mild to moderate pain T
• Adult: PO CCr <30 mL/min, give regu lar dose q12hr, max 200 mg/day; do not use ext rel tab Hepatic dose
Candidate age grouping · source pages 1319, 1320
Mild to moderate pain T
• Adult: PO (Child-Pugh C) 50 mg q12hr; do not use ext rel tab Restless legs syndrome (RLS) (unlabeled)
Candidate age grouping · source pages 1319, 1320
Mild to moderate pain T
• Adult: PO 50-150 mg/day × 15-24 mo
Candidate age grouping · source pages 1319, 1320