Clinical beta

FMBM is currently in clinical beta. Content is for professional review/testing and must not replace local protocols, senior clinical judgment, or official prescribing references.

Drug Monograph

Tramadol

USE IF: Moderate pain, post-op pain, when NSAIDs contraindicated

AVOID IF: MAOI use, SSRI/SNRI high-risk combo, seizure disorder, children <12

Tramadol

Weak opioid (WHO Step II) + SNRI analgesic

OpioidSNRIDual-mechanismControlled drugSeizure risk

Indication

Moderate pain when paracetamol/NSAIDs are insufficient

At a glance

INDICATION -> Moderate pain (when paracetamol/NSAIDs are insufficient)

ADULT DOSE -> 50–100 mg q4–6h (IR)

MAX DOSE -> 400 mg/day (IR); 300 mg/day (ER)

CONTRA -> MAOI use, children <12, seizure disorder, high seizure risk

ANTIDOTE -> Naloxone (respiratory depression) + benzodiazepines for seizures

Quick facts

Onset

~1 hour (PO); 15–30 min (IV).

Duration

4–6 h

Routes

PO, IV, IM, PR

Pregnancy

Avoid

Renal

Adjust if CrCl <30

Hepatic

Reduce dose in hepatic impairment

Do not miss

Time to action: 1 h (PO), 15β€”30 min (IV)

Max dose

  • 400 mg/day (IR).
  • 300 mg/day (ER).

Black box risks

  • Respiratory depression (black box).
  • Seizure risk (dose-dependent; can occur at therapeutic doses).
  • Higher seizure risk with SSRIs/SNRIs, TCAs, epilepsy, and alcohol withdrawal.
  • Serotonin syndrome (dual mechanism).
  • Addiction/misuse potential.

Antidote

  • Naloxone for respiratory depression (may not reverse toxicity fully).
  • Naloxone does NOT treat seizures and may worsen them.
  • Benzodiazepines = first-line for seizures.

High-risk scenarios

  • Avoid SSRIs/SNRIs/TCAs/MAOIs with tramadol when possible.
  • If combined, monitor for serotonin syndrome (agitation, hyperreflexia, clonus).
  • Cirrhosis.
  • CKD.
  • Elderly.

Key interactions

  • MAOI.
  • SSRIs/SNRIs -> ↑ seizures + serotonin syndrome.
  • Benzodiazepines -> respiratory depression risk (additive CNS/respiratory depression).
  • CYP2D6 inhibitors -> ↓ analgesia + ↑ toxicity.
  • TCAs -> ↑ seizure risk.

Indications

Primary

  • Post-op pain
  • MSK pain
  • Dental pain
  • Moderate pain

Secondary

  • Fibromyalgia (selected)
  • Chronic pain (selected)
  • Renal colic adjunct (selected)

Other

  • Premature ejaculation (off-label)
  • RLS (off-label)

Dosing

Standard: 50β€”100 mg q4β€”6h (IR)

Max daily dose

  • IR max 400 mg/day.
  • ER max 300 mg/day.

Adult - PO

  • IR: 50–100 mg q4–6h PRN (max 400 mg/day).
  • ER: max 300 mg/day.

Adult - IV

  • IR/IV: 50–100 mg IV slow push or infusion q4–6h.

Pediatric

  • <12 contraindicated.
  • 12–17 specialist only.

Renal adjustment

  • CrCl <30: max 200 mg/day.
  • Increase dosing interval to q12h.
  • Avoid ER in severe renal impairment.

Hepatic adjustment

  • Reduce dose in hepatic impairment.
  • Avoid ER in severe hepatic disease.

Warnings

Clinical warnings

  • Respiratory depression (black box).
  • Serotonin syndrome (dual mechanism).
  • Seizures (dose-dependent).
  • SIADH / hyponatremia (especially elderly or with SSRIs).
  • Hypoglycemia (monitor especially in elderly/diabetics).
  • Addiction and misuse potential.
  • CNS depression risk with benzodiazepines.
  • Neonatal withdrawal.

Adverse effects

  • Common: nausea, dizziness, sedation.
  • Serious: seizures, serotonin syndrome, respiratory depression, dependence.

Contraindications / caution

Do not use

  • MAOI use within 14 days.
  • Children <12.
  • Post-tonsillectomy/adenoidectomy (respiratory risk).
  • Severe respiratory depression.

Use caution / avoid high doses

  • SSRIs/SNRIs.
  • Seizure disorder.
  • CKD, cirrhosis.
  • Elderly.
  • OSA.

Drug interactions

  • MAOI -> fatal serotonin syndrome (contraindicated).
  • SSRIs/SNRIs -> ↑ seizures + serotonin syndrome.
  • Benzodiazepines -> respiratory depression.
  • CYP2D6 inhibitors -> ↓ analgesia + ↑ toxicity.
  • TCAs -> ↑ seizure risk.

Special populations

Pediatrics

<12 contraindicated; 12–17 specialist only.

Pregnancy

Avoid (NOWS risk).

Breastfeeding

Avoid (infant toxicity risk).

Elderly

Max 300 mg/day; if >75 mg -> consider 200 mg/day; reduce dose and monitor closely.

Liver disease

Cirrhosis: 50 mg q12h only.

Renal impairment

CrCl <30: reduce dose; avoid ER in severe impairment.

Administration

  • PO preferred.
  • IV/IM widely used in Gulf.
  • Give antiemetic before IV.
  • Avoid rapid IV bolus.

Infusion / dilution

  • IV: 100 mg diluted over 15–30 min.

Monitoring

  • Renal function.
  • LFTs.
  • Sodium (SIADH).
  • Respiratory rate.
  • Pain score.
  • Seizure signs.
  • Serotonin syndrome signs.

Overdose / toxicity

IF SUSPECTED TRAMADOL OVERDOSE: ABC first.

Recognition

  • Dual toxidrome: opioid -> respiratory depression; serotonergic -> agitation, clonus, seizures.
  • Mixed opioid + serotonergic toxicity (dual mechanism).
  • Toxic dose: >500 mg -> seizures possible.

Immediate actions

  • Naloxone for respiratory depression (may not reverse toxicity fully).
  • Naloxone does NOT treat seizures and may worsen them.
  • Benzodiazepines for seizures (first-line).
  • Activated charcoal <=2 h when appropriate.

Antidote

  • Naloxone for respiratory depression (partial effect only).
  • Naloxone does NOT treat seizures and may worsen them.
  • Benzodiazepines = first-line for seizures.

Decontamination

  • Activated charcoal <=2 h if indicated and airway protected.

Escalation

  • ICU for severe toxicity.

Clinical pearls

Common mistakes, resistance logic, and bedside traps

Dual toxidrome

  • Dual toxidrome is the key exam concept.
  • Naloxone alone is NOT enough.

Dual mechanism

  • Dual mechanism -> unpredictable toxicity vs classic opioids.

Not just weak opioid

  • Not a 'weak opioid' β€” unique risks (seizures, serotonin syndrome).

CYP2D6 variability

  • CYP2D6 variability is critical (↑ in Gulf).
  • Leading cause of opioid toxicity in MENA.

MAOI danger

  • MAOI interaction is most dangerous.
  • Always check antidepressants before prescribing.

Not for severe pain

  • Not for severe pain (use morphine instead).

IV requirement

  • IV tramadol: give antiemetic pre-treatment.

Pharmacokinetics

  • Bioavailability ~70%.
  • Protein binding ~20%.
  • CYP2D6 -> active M1 metabolite.
  • Renal elimination.
  • Half-life ~6–7 h.

Mechanism of action

  • Weak mu-opioid agonist via M1 metabolite.
  • SNRI effect (serotonin + norepinephrine reuptake inhibition).
  • Dual mechanism -> dual toxicity in overdose.

Common brand names

Saudi Arabia

Tramal Β· Contramal Β· Nobligan Β· Zaldiar

Global

Ultram Β· Ultram ER Β· Conzip Β· Qdolo

Common trade names are curated examples only β€” formulations and availability vary. Verify the exact product name with your local pharmacy and national regulator before prescribing or dispensing.

Country practice notes

  • Widely used across Gulf (Tramal, Contramal, Nobligan, Zaldiar).
  • Controlled drug in Saudi Arabia (SFDA CDS clearance required for travel).
  • High CYP2D6 ultra-rapid metabolizer prevalence -> ↑ toxicity risk.
  • Common cause of overdose and misuse in MENA region.
  • IV tramadol widely used in Gulf hospitals.

Saudi Arabia β€” confirm with local formulary.