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Paracetamol + Tramadol Hydrochloride | MedexInfo

Paracetamol + Tramadol Hydrochloride: Uses, Dosage, Side Effects & Brands | MedexInfo

Paracetamol + Tramadol Hydrochloride

Rx Only
Generic NameParacetamol + Tramadol HCl
Therapeutic ClassAnalgesic Combination (Opioid + Non-Opioid)
Common Dose1 tablet every 6–8 hours
Max / 24h8 tablets (depending on strength)
PregnancyCategory C
Indications ▼
Moderate to severe acute pain (postoperative, musculoskeletal, trauma)
Chronic pain requiring combination therapy
Pain not adequately controlled with paracetamol alone
Mechanism & Pharmacokinetics ▼
Mechanism: Paracetamol inhibits central prostaglandin synthesis producing analgesic effect. Tramadol is a weak μ-opioid receptor agonist and inhibits norepinephrine and serotonin reuptake, enhancing analgesia.
Pharmacokinetics: Both drugs rapidly absorbed orally. Tramadol metabolized in liver via CYP2D6 to active metabolite; excreted mainly via urine. Paracetamol metabolized via glucuronidation and sulfation. Half-life: Paracetamol 2–3 h, Tramadol 6–7 h.
Dosage & Administration ▼
Patient CategoryRecommended DoseMax / 24h
Adults1 tablet every 6–8 hours8 tablets/day (depends on strength)
ElderlyStart with 1 tablet every 8 hours; adjust for renal/hepatic impairment≤6 tablets/day
ChildrenNot recommended for <12 years (risk of opioid toxicity)N/A
Hepatic/Renal ImpairmentReduce dose and monitor closelyAs per physician guidance
Note: Take with water. Avoid concomitant use with other CNS depressants. Do not exceed recommended dose. Use lowest effective dose for shortest duration.
Side Effects ▼
Common: Nausea, dizziness, constipation, headache
Occasional: Somnolence, sweating, dry mouth
Rare: Seizures, severe allergic reactions, respiratory depression (especially in overdose)
Contraindications ▼
Hypersensitivity to paracetamol or tramadol
Respiratory depression or severe asthma
Paralytic ileus
Concurrent MAO inhibitors (within 14 days)
Drug Interaction ▼
CNS depressants: additive sedation (alcohol, benzodiazepines)
SSRIs/SNRIs: risk of serotonin syndrome with tramadol
Other opioids: increased risk of respiratory depression
Warfarin: monitor INR
Pregnancy & Lactation ▼
Category C; use only if benefit outweighs risk
Excreted in breast milk; avoid in nursing infants if possible
Clinical / Research Summary ▼
Combination therapy provides superior analgesia compared to paracetamol alone.
Effective for moderate to severe acute pain; reduces need for additional opioids.
Monitor for signs of opioid dependence or misuse during prolonged therapy.
Patient Counseling Points ▼
Take exactly as prescribed; do not exceed recommended dose.
Avoid alcohol or other CNS depressants.
Report dizziness, breathing difficulty, or severe constipation immediately.
Store safely out of reach of children.
Storage & Handling ▼
Store at room temperature, away from moisture and light
Keep tablets in original container
Keep out of reach of children
Medical Disclaimer: For educational purposes only. Not a substitute for professional medical advice.

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