Usage
This combination medication is prescribed to relieve spasmodic pain and discomfort associated with conditions like irritable bowel syndrome (IBS), biliary colic, intestinal colic, renal colic, and spasmodic dysmenorrhea. It combines the effects of an antispasmodic (dicyclomine), an antiemetic (domperidone), and an analgesic and antipyretic (paracetamol).
Alternate Names
While a fixed-dose combination of these three drugs may not have a universally recognized International Nonproprietary Name (INN), it is marketed under various brand names like Domspas, Pilspas, and Spasmopil, depending on the region and specific formulation.
How It Works
Pharmacodynamics:
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Dicyclomine: An anticholinergic agent that competitively blocks the action of acetylcholine at muscarinic receptors, particularly M1 and M3 receptors in the smooth muscle of the gastrointestinal (GI) tract. This inhibition reduces GI motility and spasms.
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Domperidone: A dopamine antagonist that blocks dopamine receptors at the chemoreceptor trigger zone (CTZ) in the brain, preventing nausea and vomiting. It also increases lower esophageal sphincter tone.
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Paracetamol: Acts primarily in the central nervous system (CNS) through inhibition of COX enzymes, leading to a reduction in prostaglandin synthesis. This mechanism contributes to its analgesic and antipyretic effects.
Pharmacokinetics:
- Dicyclomine: Well-absorbed orally, peak plasma concentrations achieved in 1 to 1.5 hours. Metabolized in the liver and excreted primarily in urine.
- Domperidone: Oral bioavailability is relatively low due to extensive first-pass metabolism. Peak plasma concentrations are reached in approximately 30 to 60 minutes. Primarily metabolized in the liver by CYP3A4 and excreted in urine and feces.
- Paracetamol: Rapidly absorbed from the GI tract. Peak plasma concentrations reached within 30 to 60 minutes. Metabolized primarily in the liver via glucuronidation and sulfation pathways. Excreted primarily in urine.
Dosage
Standard Dosage
Adults:
One tablet (containing the specified amounts of dicyclomine, domperidone, and paracetamol) three to four times a day, or as directed by the physician. It’s generally advised to take the medication 30 minutes to one hour before meals.
Children:
This combination is generally not recommended for children under 12 years of age. For older children, the dosage should be adjusted based on weight and medical condition, as determined by the physician. Doses for infants and children may use formulations containing only dicyclomine and paracetamol: Infants >6 months: 5 mg orally 3-4 times a day; Max: 20 mg/day orally. Children: 10 mg orally 3-4 times a day; Max: 40 mg/day orally.
Special Cases:
- Elderly Patients: Start with the lowest effective dose and increase cautiously, monitoring closely for adverse effects.
- Patients with Renal Impairment: Dosage adjustments may be necessary based on the degree of impairment.
- Patients with Hepatic Dysfunction: Caution should be exercised, and dosage adjustment may be needed.
- Patients with Comorbid Conditions: Caution should be used in patients with glaucoma, prostatic hypertrophy, urinary retention, or any other condition that could be exacerbated by anticholinergic effects.
Clinical Use Cases
The combination is generally not used in clinical settings like intubation, surgical procedures, mechanical ventilation, ICU, or emergency situations. Its primary indication is the management of spasmodic pain related to GI disorders.
Side Effects
Common Side Effects
Dry mouth, dizziness, blurred vision, nausea, drowsiness, constipation, weakness, nervousness.
Rare but Serious Side Effects
Allergic reactions (e.g., rash, hives, difficulty breathing), extrapyramidal symptoms (especially in children), cardiac arrhythmias (including QT prolongation), seizures.
Long-Term Effects
Chronic use of paracetamol, especially at high doses, can lead to liver damage. Long-term use of dicyclomine can potentially cause anticholinergic side effects, such as cognitive impairment.
Contraindications
Hypersensitivity to any component of the medication, paralytic ileus, gastrointestinal hemorrhage, mechanical obstruction of the GI tract, prolactin-releasing pituitary tumors, QT prolongation, uncontrolled arrhythmias.
Drug Interactions
Antacids may reduce the absorption of dicyclomine. Anticholinergic agents, CNS depressants, and other drugs metabolized by CYP3A4 (e.g., azole antifungals, macrolide antibiotics) may interact with components of this combination. Metoclopramide and other prokinetic agents may antagonize the effects of domperidone.
Pregnancy and Breastfeeding
Dicyclomine is generally avoided during pregnancy unless the benefits outweigh the risks. Domperidone is categorized as Pregnancy Category C; its use during pregnancy should be carefully considered. Paracetamol is generally considered safe for use during pregnancy when used at recommended doses. Dicyclomine and domperidone are excreted in breast milk and may have adverse effects on the nursing infant. Paracetamol is excreted in breast milk but is generally considered compatible with breastfeeding at usual therapeutic doses.
Drug Profile Summary
- Mechanism of Action: Dicyclomine: Anticholinergic/antispasmodic; Domperidone: Dopamine antagonist/antiemetic; Paracetamol: Analgesic/antipyretic.
- Side Effects: Dry mouth, dizziness, blurred vision, nausea, drowsiness, constipation.
- Contraindications: Hypersensitivity, GI obstruction, prolactin-releasing tumors, QT prolongation.
- Drug Interactions: Antacids, anticholinergics, CYP3A4 inhibitors/inducers, metoclopramide.
- Pregnancy & Breastfeeding: Use with caution; potential risks to the fetus and nursing infant.
- Dosage: Adults: One tablet three to four times daily before meals; Pediatric use not generally recommended.
- Monitoring Parameters: Liver function tests (with long-term paracetamol use), cardiac rhythm (especially with domperidone), symptoms of anticholinergic effects.
Popular Combinations
This particular combination is itself a popular formulation in some regions. However, separate combinations of dicyclomine + paracetamol or domperidone + paracetamol are more widely used.
Precautions
Caution in patients with glaucoma, prostatic hypertrophy, urinary retention, hepatic or renal impairment. Avoid alcohol. May cause dizziness or drowsiness; avoid activities requiring mental alertness.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Dicyclomine + Domperidone + Paracetamol?
A: Adults: One tablet three to four times a day, preferably before meals. Dosage adjustments may be necessary for elderly patients or those with hepatic or renal impairment.
Q2: What are the common side effects?
A: Common side effects include dry mouth, dizziness, blurred vision, nausea, drowsiness, constipation, weakness, and nervousness.
Q3: Is this combination safe during pregnancy?
A: Dicyclomine and domperidone should be used with caution during pregnancy, only if the potential benefits outweigh the risks. Paracetamol is generally considered safe during pregnancy at recommended doses. Consult with a specialist.
Q4: Can I breastfeed while taking this medication?
A: Dicyclomine and domperidone are excreted in breast milk and may pose risks to the infant. Consult with a specialist.
Q5: What are the contraindications to using this drug?
A: Contraindications include hypersensitivity, gastrointestinal obstruction, prolactin-releasing tumors, and QT prolongation.
Q6: Are there any drug interactions I should be aware of?
A: This combination may interact with antacids, anticholinergic drugs, CYP3A4 inhibitors/inducers, and metoclopramide, among others.
Q7: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember, unless it is almost time for the next dose. Do not double the dose to catch up.
Q8: Can I drive or operate machinery while taking this medication?
A: This medication can cause dizziness or drowsiness. It is advised to avoid activities requiring mental alertness until you know how the medication affects you.
Q9: How should this medication be stored?
A: Store in a cool, dry place away from direct sunlight and out of reach of children.
