Finished product reference
Acetaminophen / Caffeine / Codeine Phosphate
Tablet · Oral · 300 mg/15 mg/15 mg
- List code
- 52159
- Pharmacologic class
- Compound opioid analgesic (paracetamol, codeine, caffeine)
What it is and how it works
Paracetamol acts centrally to relieve pain and fever; codeine is a weak opioid agonist whose analgesic effect depends largely on CYP2D6-mediated conversion to morphine; caffeine is an adjuvant that may enhance analgesia.
Indications
Short-term treatment of acute moderate pain not relieved by paracetamol or ibuprofen alone.
Dosage and administration (summary)
Oral, usually 1–2 tablets every 4–6 hours as required, not exceeding the maximum daily paracetamol (4 g) and codeine (240 mg) doses; treatment should be limited to about 3 days.
Contraindications
Children under 12 years; patients under 18 undergoing tonsillectomy or adenoidectomy; known CYP2D6 ultra-rapid metabolisers; breastfeeding; acute respiratory depression; severe hepatic impairment.
Warnings and precautions
Risk of respiratory depression, dependence, misuse and medication-overuse headache with prolonged use. Avoid other paracetamol-containing products; caution with CNS depressants, benzodiazepines and alcohol. Causes constipation and drowsiness.
Pregnancy
Avoid regular use, especially near term, because of the risk of neonatal respiratory depression and withdrawal.
Storage and supply
Store below 25 °C, protected from moisture.
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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