1. Clinical Overview
A fixed-dose combination (FDC) analgesic and antispasmodic medication. Dicyclomine is an anticholinergic/antispasmodic agent that relieves smooth muscle spasms, particularly in the gastrointestinal tract. Paracetamol (Acetaminophen) is a centrally-acting analgesic and antipyretic. Tramadol is a centrally-acting synthetic opioid analgesic with weak mu-opioid receptor agonist activity and inhibition of norepinephrine and serotonin reuptake. This combination is primarily used for the management of moderate to severe pain associated with smooth muscle spasm, such as in renal colic, biliary colic, and dysmenorrhea.
| Onset | Duration | Bioavailability |
|---|---|---|
| Oral: Tramadol - ~1 hour; Paracetamol - ~30-60 minutes; Dicyclomine - ~1-2 hours. | Tramadol: 4-6 hours; Paracetamol: 4-6 hours; Dicyclomine: 4-6 hours. | Tramadol: ~70-75%; Paracetamol: ~85-98%; Dicyclomine: ~67-72%. |
2. Mechanism of Action
This combination provides a multi-modal approach to pain relief. Dicyclomine acts as a competitive muscarinic acetylcholine receptor antagonist, reducing smooth muscle tone and motility in the GI and biliary tracts, thereby relieving spasm. Paracetamol's exact mechanism is not fully understood but is believed to involve inhibition of cyclooxygenase (COX) isoforms, particularly COX-2, in the central nervous system, reducing prostaglandin synthesis and elevating the pain threshold. Tramadol is a centrally-acting synthetic opioid that binds weakly to μ-opioid receptors and also inhibits the reuptake of norepinephrine and serotonin in the descending inhibitory pain pathways, providing dual analgesic action.
3. Indications & Uses
- Moderate to severe pain associated with smooth muscle spasm
- Renal colic (pain due to kidney stones)
- Biliary colic (pain due to gallstones)
- Severe dysmenorrhea (menstrual cramps)
4. Dosage & Administration
Adult Dosage: One tablet every 4-6 hours as needed for pain. The maximum recommended dose is 4 tablets in 24 hours (not exceeding Tramadol 150mg, Paracetamol 2000mg, Dicyclomine 80mg). Should be used at the lowest effective dose for the shortest duration.
Administration: Take with or after food to minimize gastrointestinal upset (nausea, dizziness). Swallow whole with a full glass of water. Do not crush, chew, or break the tablet. Should be used for acute, short-term pain management only.
5. Side Effects
Common side effects may include:
- Nausea
- Vomiting
- Dizziness
- Drowsiness/sedation
- Dry mouth
- Constipation
- Sweating
- Headache
- Blurred vision
6. Drug Interactions
| Drug | Effect | Severity |
|---|---|---|
| Other Opioids (Morphine, Codeine) | Additive CNS depression, respiratory depression, and constipation. | Major |
| Benzodiazepines (Alprazolam, Diazepam) | Profound sedation, respiratory depression, coma, death. | Major |
| Alcohol | Increased CNS depression and risk of hepatotoxicity. | Major |
| MAO Inhibitors (Phenelzine, Selegiline) | Risk of serotonin syndrome, hyperpyrexia, seizures. | Contraindicated |
| SSRIs/SNRIs (Fluoxetine, Sertraline, Venlafaxine) | Increased risk of serotonin syndrome. | Major |
| CNS Depressants (Antipsychotics, Antihistamines) | Additive sedation and impaired motor skills. | Moderate |
| Anticholinergics (Atropine, Trihexyphenidyl) | Enhanced anticholinergic side effects (dry mouth, urinary retention, constipation). | Moderate |
| Warfarin | Paracetamol may potentiate anticoagulant effect with long-term, high-dose use. | Moderate |
| CYP2D6 Inhibitors (Quinidine, Fluoxetine, Paroxetine) | Reduced conversion of Tramadol to active M1 metabolite, decreasing analgesia. | Moderate |
| CYP3A4 Inducers (Rifampicin, Carbamazepine) | Increased metabolism of Tramadol, reducing its effect. | Moderate |
7. Patient Counselling
- DO take exactly as prescribed by your doctor.
- DO take with food if you experience stomach upset.
- DO inform all your doctors and dentists you are taking this medicine.
- DO keep the medicine out of reach of children and pets.
- DONT consume alcohol while on this medication.
- DONT drive or operate heavy machinery until you know how it affects you.
- DONT take with other painkillers or sedatives without consulting your doctor.
- DONT stop taking suddenly if used for more than a few weeks; consult your doctor for tapering.
- DONT crush, chew, or break the tablet.
8. Toxicology & Storage
Overdose: Tramadol: CNS depression (somnolence to coma), respiratory depression, seizures, cardiac arrest. Paracetamol: Stage 1 (0-24h): Nausea, vomiting, malaise. Stage 2 (24-72h): Right upper quadrant pain, elevated LFTs. Stage 3 (72-96h): Peak hepatotoxicity, jaundice, coagulopathy. Stage 4 (4d-2wks): Recovery or fatal hepatic necrosis. Dicyclomine: Anticholinergic toxidrome: dry mouth, blurred vision, hyperthermia, tachycardia, urinary retention, delirium, seizures.
Storage: Store below 30°C, in a cool, dry place, protected from light and moisture. Keep in the original blister pack or container. Do not store in the bathroom. Keep it locked away and out of sight and reach of children, visitors, and others for whom it is not prescribed.