Usage
- This combination medication is primarily prescribed for the management of acute, moderate to severe pain, often associated with smooth muscle spasms or cramps. Conditions where it may be used include irritable bowel syndrome (IBS), biliary colic, renal colic, dysmenorrhea (painful menstruation), and other functional bowel disorders. It may also be used for post-surgical pain or other types of acute pain.
- Pharmacological Classification: Analgesic (Paracetamol and Tramadol), Antispasmodic (Dicyclomine), Opioid Analgesic (Tramadol).
- Mechanism of Action: This combination targets pain through multiple pathways. Paracetamol reduces pain and fever by inhibiting prostaglandin synthesis in the central nervous system. Tramadol acts as an opioid analgesic, binding to opioid receptors and modulating pain perception. Dicyclomine, an anticholinergic, relaxes smooth muscles in the gastrointestinal tract, reducing spasms and cramping.
Alternate Names
- While “Dicyclomine + Paracetamol + Tramadol” is the generic name, regional variations may exist.
- Brand Names: Spasmo Proxyvon, Ultraspas, and others.
How It Works
- Pharmacodynamics: Paracetamol inhibits prostaglandin synthesis, reducing pain and fever. Tramadol binds to mu-opioid receptors, inhibiting pain transmission. It also inhibits serotonin and norepinephrine reuptake, further contributing to analgesia. Dicyclomine acts as an anticholinergic agent, blocking acetylcholine at muscarinic receptors. This leads to smooth muscle relaxation in the GI tract.
- Pharmacokinetics: Paracetamol is rapidly absorbed after oral administration, reaching peak plasma concentrations within 30-60 minutes. It is metabolized in the liver and excreted primarily in the urine. Tramadol is also well-absorbed orally, with peak plasma levels occurring in about 2 hours. It undergoes hepatic metabolism, including via CYP2D6, and is excreted mainly in the urine. Dicyclomine is well-absorbed orally and is metabolized in the liver. The specific elimination pathway of Dicyclomine is not well-defined, though it’s presumed to be primarily hepatic.
- Mode of Action: Paracetamol’s precise mechanism isn’t fully understood but involves central COX inhibition and other pathways. Tramadol is a mu-opioid receptor agonist and also affects monoamine reuptake. Dicyclomine competitively inhibits acetylcholine at muscarinic receptors, decreasing smooth muscle tone and motility.
- Receptor Binding/Enzyme Inhibition/Neurotransmitter Modulation: Tramadol: Mu-opioid receptor agonist, serotonin and norepinephrine reuptake inhibitor. Paracetamol: COX inhibitor (centrally acting). Dicyclomine: Muscarinic receptor antagonist.
- Elimination Pathways: Paracetamol and Tramadol: Primarily renal excretion after hepatic metabolism. Dicyclomine: Primarily hepatic metabolism; excretion pathway not explicitly defined.
Dosage
Standard Dosage
Adults:
- One tablet of Dicyclomine 10 mg + Paracetamol 325 mg + Tramadol 50 mg every 6 hours as needed for pain. Maximum 8 tablets in 24 hour period.
- Alternative Formulation: Dicyclomine 20 mg + Paracetamol 500 mg + Tramadol 37.5 mg. Dosage may vary according to this formulation and as prescribed by the doctor.
Children:
- Not recommended for children under 12 years of age. For children aged 12-18 years of age, the dosage should be determined by a physician based on weight and clinical condition.
Special Cases:
- Elderly Patients: Start with a lower dose and titrate upwards as needed, monitoring closely for adverse effects. Consider renal/hepatic function.
- Patients with Renal Impairment: Dose adjustment may be required based on creatinine clearance.
- Patients with Hepatic Dysfunction: Reduce the dose or avoid use, especially in severe hepatic impairment.
- Patients with Comorbid Conditions: Exercise caution in patients with glaucoma, prostatic hypertrophy, urinary retention, asthma, respiratory depression, or substance abuse disorder.
Clinical Use Cases
- Intubation/Surgical Procedures/Mechanical Ventilation/ICU Use/Emergency Situations: The use of this specific combination in these settings isn’t explicitly established. Tramadol and Paracetamol, individually or in combination, might be used for post-operative pain management, but dicyclomine is not typically used in these situations. Dosage adjustments may be necessary. Consult with an anesthesiologist or critical care specialist for appropriate pain management strategies in these settings.
Dosage Adjustments
- Dose adjustments are based on patient factors like renal/hepatic function, age, and comorbidities. Consult current guidelines and resources for specific recommendations.
Side Effects
Common Side Effects:
- Nausea, vomiting, constipation, dry mouth, drowsiness, dizziness, blurred vision, weakness, headache.
Rare but Serious Side Effects:
- Allergic reactions (rash, itching, swelling, difficulty breathing), seizures, respiratory depression, serotonin syndrome (confusion, agitation, fever, sweating, tremor), hepatic injury.
Long-Term Effects:
- Tolerance to tramadol, dependence, constipation, and other gastrointestinal issues.
Adverse Drug Reactions (ADR):
- Anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis, hepatotoxicity.
Contraindications
- Hypersensitivity to any component, acute alcohol intoxication, concomitant use of MAOIs, severe hepatic impairment, uncontrolled epilepsy, respiratory depression, paralytic ileus, acute abdominal conditions requiring surgery, recent opioid use, children under 12.
Drug Interactions
- CYP450 Interactions: Tramadol is metabolized by CYP2D6. Inhibitors (e.g., fluoxetine, paroxetine) can increase tramadol levels. Inducers (e.g., rifampin) can decrease tramadol levels. Paracetamol metabolism can be affected by certain CYP enzymes.
- Other Interactions: Alcohol, opioids, benzodiazepines, sedatives, antidepressants (especially MAOIs and SSRIs), antihistamines, anticholinergics (e.g., atropine), warfarin, carbamazepine, other medications metabolized by CYP2D6.
Pregnancy and Breastfeeding
- Pregnancy Safety Category: Not established. Tramadol is generally avoided during pregnancy due to potential neonatal withdrawal symptoms. Dicyclomine use during pregnancy should be carefully evaluated.
- Breastfeeding: Tramadol and dicyclomine can be excreted in breast milk. The combination should generally be avoided during breastfeeding.
Drug Profile Summary
- Mechanism of Action: See “How It Works” above.
- Side Effects: See “Side Effects” above.
- Contraindications: See “Contraindications” above.
- Drug Interactions: See “Drug Interactions” above.
- Pregnancy & Breastfeeding: Avoid if possible.
- Dosage: See “Dosage” above.
- Monitoring Parameters: Liver function tests, respiratory rate, mental status, pain scores.
Popular Combinations
- This particular combination is itself a combined formulation. Individual components may be combined with other drugs depending on the clinical scenario. For example, paracetamol may be used in combination with NSAIDs for enhanced pain relief. Tramadol can be given with non-opioid pain killers like paracetamol.
Precautions
- Assess for allergies, hepatic and renal function, respiratory status, history of substance abuse, and concurrent medications. Avoid alcohol. Caution in elderly patients, those with underlying medical conditions, and during pregnancy/breastfeeding. Advise patients against driving or operating machinery if drowsiness or dizziness occurs.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Dicyclomine + Paracetamol + Tramadol?
A: See “Dosage” above.
Q2: Can this combination be used in children?
A: Not recommended for children under 12. Use with caution and dosage adjustment in children 12-18.
Q3: What are the serious side effects to watch out for?
A: Respiratory depression, serotonin syndrome, seizures, allergic reactions, hepatotoxicity.
Q4: Can a patient on this medication drink alcohol?
A: No. Alcohol can potentiate the CNS depressant effects of tramadol and dicyclomine.
Q5: What should be done in case of an overdose?
A: Seek immediate medical attention. Supportive care and naloxone (for tramadol overdose) may be required.
Q6: Is this combination safe during pregnancy?
A: Generally avoid during pregnancy due to the potential for fetal/neonatal risks.
Q7: What are the main drug interactions?
A: MAOIs, SSRIs, opioids, benzodiazepines, alcohol, anticholinergics.
Q8: What if a patient misses a dose?
A: Take the missed dose as soon as remembered, unless it is close to the next scheduled dose. Do not double the dose.
Q9: Can this drug be used long-term?
A: Long-term use requires careful monitoring for tolerance, dependence, and other adverse effects. Periodic reassessment of the need for continued use is essential.
