QDOLO
Clinical safety rating: caution
Comprehensive clinical and safety monograph for QDOLO (QDOLO).
Tramadol is a centrally acting synthetic opioid analgesic. It binds to μ-opioid receptors and inhibits norepinephrine and serotonin reuptake.
| Metabolism | Primarily metabolized by CYP2D6 and CYP3A4 to active metabolite M1 (O-desmethyltramadol) and other metabolites. |
| Excretion | Renal 90% (60% unchanged, 30% as glucuronide conjugate), fecal 10% |
| Half-life | Terminal elimination half-life approximately 2-4 hours in adults; prolonged to 4-6 hours in elderly and up to 12-16 hours in severe renal impairment (CrCl <30 mL/min) |
| Protein binding | Approximately 20% bound to plasma proteins, primarily albumin |
| Volume of Distribution | Steady-state volume of distribution (Vdss) approximately 3-4 L/kg, indicating extensive tissue distribution |
| Bioavailability | Oral (immediate-release): 70-90% (first-pass metabolism reduces bioavailability); Extended-release: approximately 85% relative to immediate-release; Intravenous: 100% |
| Onset of Action | Oral (immediate-release): 30-60 minutes; Oral (extended-release): 1-2 hours; Intravenous: 5-10 minutes; Intramuscular: 10-15 minutes |
| Duration of Action | Oral (immediate-release): 4-6 hours; Oral (extended-release): 12-24 hours; Intravenous: 2-4 hours; Intramuscular: 3-4 hours. Duration is dose-dependent and prolonged in hepatic impairment |
Oral: 50-100 mg every 4-6 hours as needed for pain; maximum 400 mg per day. Immediate-release tablets only. Extended-release formulations require different dosing and are not interchangeable.
| Dosage form | SOLUTION |
| Renal impairment | GFR 30-49 mL/min: Administer every 8 hours. GFR 10-29 mL/min: Administer every 12 hours. GFR <10 mL/min: Administer every 12 hours; maximum 100 mg/day. Hemodialysis: Not dialyzable; dose as for GFR <10 mL/min. |
| Liver impairment | Child-Pugh Class A: No adjustment. Child-Pugh Class B: Reduce dose by 50% or increase dosing interval to 12 hours. Child-Pugh Class C: Not recommended; consider alternative therapy. |
| Pediatric use | Children ≥12 years: Same as adult. Age 7-11 years: 3-5 mg/kg/day divided into 4-6 doses; maximum 200 mg/day. Age 2-6 years: 3-5 mg/kg/day divided into 4-6 doses; maximum 150 mg/day. Do not use in children <2 years. |
| Geriatric use | Adults ≥65 years: Start at 25 mg every 6 hours as needed; maximum 300 mg/day. Titrate cautiously due to risk of falls, delirium, and QT prolongation. Avoid extended-release formulations. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for QDOLO (QDOLO).
| Breastfeeding | Tramadol and its active metabolite (M1) are excreted in breast milk. The M/P ratio for tramadol is approximately 1.2:1. Breastfeeding is not recommended due to potential for infant sedation, respiratory depression, and withdrawal. Consider risks versus benefits; alternate analgesics preferred. |
| Teratogenic Risk | Tramadol, the active ingredient in QDOLO, is classified as FDA Pregnancy Category C. First trimester: Data are limited, but animal studies have shown increased risk of skeletal variants and decreased fetal weight at doses 1.2-1.4 times the maximum human dose. Second and third trimesters: Chronic use may lead to neonatal opioid withdrawal syndrome (NOWS) and respiratory depression at birth. Use near term may cause neonatal respiratory depression. Avoid in late pregnancy unless clearly needed. |
■ FDA Black Box Warning
Serious and life-threatening respiratory depression; accidental ingestion; risks from concomitant use with benzodiazepines or other CNS depressants; opioid addiction, abuse, and misuse; neonatal opioid withdrawal syndrome; life-threatening respiratory depression in children; ultra-rapid metabolism of tramadol and other risk factors for life-threatening respiratory depression in children.
| Serious Effects |
Significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment; known or suspected gastrointestinal obstruction, including paralytic ileus; hypersensitivity to tramadol or any component of the product; concurrent use of MAOIs or within 14 days of such use; use in children younger than 12 years of age; use in children younger than 18 years of age after tonsillectomy and/or adenoidectomy.
| Precautions | Respiratory depression; risk of medication errors; addiction, abuse, and misuse; risks with CNS depressants; serotonin syndrome; adrenal insufficiency; severe hypotension; seizures; risks of use in patients with gastrointestinal obstruction; increased intracranial pressure; impaired mental or physical abilities; withdrawal; risks of driving and operating machinery; life-threatening respiratory depression in patients with chronic pulmonary disease; risks in patients with head injury, shock, or debilitation; risks in patients with hepatic or renal impairment; risks in elderly, cachectic, or debilitated patients; pregnancy; breastfeeding; drug dependence. |
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| Fetal Monitoring | Monitor for maternal respiratory depression, sedation, constipation, and opioid withdrawal. Fetal: For prolonged use, monitor for intrauterine growth restriction (IUGR) and NOWS after birth. Neonatal: Observe for respiratory depression, feeding difficulties, and withdrawal signs. Consider fetal non-stress tests if chronic use. |
| Fertility Effects | Tramadol may impair male fertility by altering sperm morphology and motility in animal studies. Human data limited; may cause hormonal imbalances (e.g., decreased testosterone). Reversible upon discontinuation. No established effects on female fertility. |