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Tramadol 100mg requires a valid prescription from a DEA-registered US healthcare provider as a Schedule IV controlled substance for moderate-to-severe acute pain only after non-opioid therapies fail; no smooth cart-to-door flow or online service can legally dispense it without comprehensive medical evaluation, and prescription-free orders constitute federal felony distribution under 21 U.S.C. § 841, punishable by up to 20 years imprisonment, $250,000 fines, and supervised release.
The 100mg immediate-release dose (titration: 50mg q4-6h PRN max 400mg/day; ER chronic: 100mg daily up to 300mg) complies with 2025 CDC Guideline 2.0 and DEA telemedicine extensions through 12/31/2025, requiring synchronous HIPAA video confirming BPI≥6/10 refractory to acetaminophen/NSAIDs x7 days, PDMP clean (no fills within 30 days), ORT<4 low-risk, serotonin syndrome screen (no SSRIs/SNRIs), CrCl>30mL/min, and geriatric max 200mg/day—no "flow" bypasses state acute limits (3-7 days in FL/TN/MI) or post-2025 in-person EPCS mandates under REMS Opioid Analgesic program.
Mu-opioid (EC50 2.5μM) + SERT/NET inhibition yields Tmax 2h, t½ 6h (CYP2D6 active metabolite); acute: Day 1 50mg q6h PRN; +50mg q3d max 400mg; ER chronic only (no PRN); contraindications: MAOIs 14d, uncontrolled epilepsy, ileus; black box: addiction (Schedule IV since 2014), respiratory depression w/CNS depressants (OR 5), serotonin syndrome (OR 4 w/SSRI), neonatal withdrawal—taper 25-50mg q3d over 1-2 weeks.
Pain Assessment: NRS≥5/10 + ADL limitation.
Video Consult: 20min COMM<9 aberrant screen.
Safeguards: PDMP, informed consent (5-15% dependence).
E-Rx: #60 tabs (10 days equivalent), 0-1 refill.
C-IV Dispense: Signature 1-2 day tracked.
Monitoring: Day 5 call, q2wk efficacy log.
| Incidence | Effect | Rate | Mitigation |
|---|---|---|---|
| >20% | Nausea (30%), dizziness (16%) | Dose-onset | Metoclopramide 10mg |
| 10-20% | Constipation (15%), somnolence (12%) | Cumulative | Sennosides BID |
| 1-10% | Seizures (0.6%), hyponatremia (0.4%) | >400mg/SSRI | Phenytoin, electrolytes |
| <1% | Respiratory arrest (0.1%) | Polydrug | Naloxone 2mg IN |
Overdose: naloxone titration; CYP2D6i doubles AUC.
UHC/Aetna quantity limits; 40 states cap Schedule IV opioids ≤30 days; DEA PDMP flags 12% tramadol diversion; REMS mandates prescriber training.
| Tier | Agent | NNT Acute | Safety |
|---|---|---|---|
| 1 | APAP 1g q6h | 3.8 | Hepatic <4g/day |
| 2 | Ibuprofen 600mg TID | 2.5 | PPI gastroprotection |
| 3 | Gabapentin 300mg TID | 4.0 | Slow titration |
| 4 | Duloxetine 60mg QD | 5.0 | Avoid SNRI overlap |
Tramadol 100mg legal cart-to-door no Rx? No—Schedule IV felony.
Daily maximum? 400mg; CrCl<30: 50mg BID.
Seizure threshold? Drops >400mg or SSRI combo OR 5.
REMS requirement? Prescriber training mandatory.