Finished product reference
Opium
Tincture · Oral · 10 mg/1mL · 60 mL
- List code
- 53348
- Pharmacologic class
- Opioid (natural opium alkaloids); antidiarrhoeal and opioid substitution agent
What it is and how it works
Opium tincture contains the natural alkaloids of opium, chiefly morphine, which act on mu-opioid receptors in the gut to reduce propulsive motility and secretion, and centrally to produce analgesia, sedation and suppression of opioid withdrawal.
Indications
Severe diarrhoea when other antidiarrhoeal treatments have not been effective (EU indication for standardised morphine-equivalent tincture); in some countries, including Iran, opioid substitution (maintenance) treatment within authorised programmes.
Dosage and administration (summary)
Oral, diluted in water; the dose depends on the morphine content of the preparation and the indication and must be individualised and titrated by the prescriber or treatment programme.
Contraindications
Respiratory depression, severe hepatic impairment, paralytic ileus, acute abdomen, raised intracranial pressure, diarrhoea due to infection with invasive organisms or pseudomembranous colitis, and children.
Warnings and precautions
Risk of fatal respiratory depression, particularly with alcohol, benzodiazepines or other CNS depressants and in opioid-naive patients. Do not confuse with camphorated opium tincture (paregoric), which is about 25 times weaker; doses must be measured accurately with the supplied dropper or measure. Dependence, tolerance and diversion risks require controlled supply.
Pregnancy
Use only if clearly needed; prolonged use may cause neonatal opioid withdrawal syndrome.
Storage and supply
Store below 25 °C, protected from light, in a tightly closed container; 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.
Other presentations of the same active ingredient
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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