Nucynta (Tapentadol Hydrochloride)
Also sold as: Nucynta, Tapal, Tapsyn, Palexia, Tapenta
Pregnancy
Cat C
Lactation
Avoid
Schedule
X
Forms
Tablet IR 50mg, 75mg, 100mg +1
Indications
- Moderate to severe acute pain (IR)
- Chronic neuropathic pain — diabetic peripheral neuropathy (ER)
- Severe chronic pain requiring opioid analgesia (ER)
Adult Dosing
Acute pain (IR)
50-100 mg PO every 4-6 hours as needed
Max 600 mg/day on Day 1; subsequently max 500 mg/day
Chronic pain / Neuropathy (ER)
Start 50 mg PO BD; increase by 50 mg BD every 3 days to effective dose (max 500 mg/day ER)
ER twice daily at fixed intervals; do not crush/chew
Pediatric Dosing
AVOID in children and adolescents < 18 years
Renal Dose Adjustment
| CrCl / eGFR | Dose Adjustment |
|---|---|
| Mild-Moderate CKD | No adjustment needed |
| Severe CKD (CrCl < 30) | Not recommended — insufficient data |
Hepatic Adjustment
Mild: no adjustment. Moderate: max 100 mg (IR) / 50 mg BD (ER). Severe: AVOID
Pregnancy & Lactation
Pregnancy: Category C
Avoid — opioid neonatal withdrawal syndrome. If used near term, neonatal support for respiratory depression and withdrawal needed.
Lactation: Avoid
Excreted in breast milk; neonatal respiratory depression risk.
Top Drug Interactions
| Interacting Drug | Effect | Severity |
|---|---|---|
| MAO inhibitors | CONTRAINDICATED — serotonin syndrome, cardiovascular crisis; 14-day washout | Major |
| CNS depressants (benzodiazepines, alcohol, other opioids) | Additive CNS and respiratory depression — potentially fatal (Black Box) | Major |
| SSRIs / SNRIs / Tramadol / Triptans | Serotonin syndrome risk (NRI component) | Major |
| Anticholinergics | Additive anticholinergic effects, constipation, urinary retention | Moderate |
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Side Effects
Common
- Nausea (very common)
- Dizziness
- Somnolence
- Constipation
- Headache
- Vomiting
- Dry mouth
Serious / Discontinue If
- Respiratory depression (Black Box — especially with CNS depressants / alcohol)
- Serotonin syndrome (NRI mechanism)
- Addiction, abuse and misuse (schedule X)
- Seizures
- Adrenal insufficiency (prolonged use)
- Severe hypotension
Contraindications
- Concurrent MAO inhibitors
- Significant respiratory depression
- Acute or severe bronchial asthma
- Paralytic ileus
- Uncontrolled epilepsy (lowers seizure threshold — NRI component)
Available Indian Brands
| Brand | Manufacturer | Price (approx) |
|---|---|---|
| Tapal 50mg IR | Sun Pharma | 10 tab ₹285 |
| Tapsyn 50mg IR | Cipla | 10 tab ₹265 |
| Tapenta 100mg ER | Lupin | 10 tab ₹385 |
| Palexia 50mg | Grunenthal (imported) | 10 tab ₹450 |
Monitoring Required
- Pain scores (NRS)
- Respiratory rate and sedation level
- Signs of opioid misuse or diversion
- Bowel function (constipation)
- Serotonin syndrome symptoms
- Blood pressure
Patient Counseling Points
- Schedule X — controlled substance; cannot be prescribed more than 30 days at a time
- Do NOT combine with alcohol, sleeping pills, or other opioids — fatal respiratory depression
- Swallow ER tablets whole — crushing causes rapid drug release and overdose risk
- Physical dependence develops — do NOT stop suddenly after prolonged use
- Report: extreme drowsiness, slow/difficult breathing, agitation, confusion
- Safe storage essential — keep away from children, persons with substance use history
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EasyClinic auto-flags Nucynta interactions, renal cutoffs, and pregnancy warnings the moment you write the prescription. Built-in safety net for every Indian doctor.
Clinically reviewed by: Dr. Suresh Pillai, MS (Orthopaedics), Pain Specialist
Last reviewed: 2026-04-01
References
- BNF — Tapentadol
- FDA Tapentadol Black Box Warning
- ADA Diabetic Neuropathy Guidelines
- IASP Chronic Pain Guidelines