Tramazac Sr 100 / 150 / 200 mg FC tablets

Tramazac Sr 100 / 150 / 200 mg FC tablets

S5
PDF Leaflet Revision Date: 07 June 2024

API: Tramadol | Company: Zydus Healthcare Sa

Clinical Summary

Quick overview from the medicine insert

Indication

Management of moderate to severe pain.

Dosage (summary)

Initial dose: 100 mg twice daily; max: 400 mg/day.

Onset of Action / Duration

Onset: 1 hour, Duration: 6 hours

Special Populations

  • Elderly patients
  • Renal impairment
  • Hepatic impairment

Pregnancy & Breastfeeding

Contraindicated in pregnancy and breastfeeding.

Key Drug Interactions

  • MAO inhibitors
  • CNS depressants
  • Serotonergic medicines
  • Seizure threshold-lowering medicines

Contraindications

  • Hypersensitivity to tramadol
  • Acute intoxication with CNS depressants
  • Respiratory depression
  • Increased intracranial pressure
  • Epilepsy

Common side effects

  • Nausea
  • Dizziness
  • Sedation
  • Constipation

Counselling Points

  • Avoid alcohol and CNS depressants.
  • Monitor for signs of misuse or dependence.
  • Do not use in children under 12 years.

Serious warnings

  • Risk of seizures
  • Risk of dependence and withdrawal
  • Serotonin syndrome
  • CNS depression
Important Disclaimer

The Tramazac Sr 100 / 150 / 200 mg FC tablets professional information leaflet below is the property of Zydus Healthcare Sa and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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