Finished product reference
Tilidine / Naloxone
Tablet, Extended Release · Oral · 100 mg/8 mg
- List code
- 53280
- Pharmacologic class
- Opioid analgesic combined with an opioid antagonist
What it is and how it works
Tilidine is a prodrug converted in the liver to nortilidine, a mu-opioid receptor agonist. Naloxone is largely inactivated by first-pass metabolism after oral use but antagonises opioid effects if the product is injected or taken in excessive doses, reducing abuse potential.
Indications
Moderate to severe acute and chronic pain.
Dosage and administration (summary)
Oral: immediate-release forms typically 50–100 mg tilidine up to four times daily; prolonged-release tablets usually twice daily; maximum generally 600 mg tilidine daily.
Contraindications
Opioid dependence (risk of precipitated withdrawal), acute respiratory depression, porphyria and severe hepatic impairment.
Warnings and precautions
In severe hepatic impairment naloxone is not adequately metabolised, so analgesic efficacy may be lost. Respiratory depression and sedation are increased by alcohol, benzodiazepines and other CNS depressants. Dependence and withdrawal can occur with prolonged use.
Pregnancy
Not recommended in pregnancy; prolonged use may cause neonatal withdrawal.
Storage and supply
Store below 25 °C; controlled drug requirements apply.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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