Usage
This combination medication is primarily prescribed for the relief of abdominal pain and discomfort associated with conditions like irritable bowel syndrome (IBS) and other functional gastrointestinal disorders. It combines the antispasmodic action of dicyclomine, the anti-gas properties of dimethicone, and the analgesic and antipyretic effects of paracetamol.
Its pharmacological classifications include:
- Antispasmodic: Dicyclomine
- Anti-flatulent/Anti-foaming agent: Dimethicone
- Analgesic/Antipyretic: Paracetamol
The mechanism of action involves reducing intestinal smooth muscle spasms (dicyclomine), decreasing the surface tension of gas bubbles in the GI tract to relieve bloating (dimethicone), and inhibiting prostaglandin synthesis to reduce pain and fever (paracetamol).
Alternate Names
This specific combination doesn’t have a widely recognized international non-proprietary name (INN). However, the individual components are known by their respective INNs:
- Dicyclomine hydrochloride
- Dimethicone or simethicone (activated dimethicone)
- Paracetamol or acetaminophen (USAN)
Brand names vary depending on the region and manufacturer. Some examples include Spasomine Paediatric Drops (containing dicyclomine and dimethicone), and Spasmolar Tablet (containing dicyclomine, clidinium, dimethicone, and paracetamol). Many other brands exist combining these or similar ingredients.
How It Works
Pharmacodynamics:
- Dicyclomine: An anticholinergic that blocks the action of acetylcholine at muscarinic receptors in the GI tract, leading to smooth muscle relaxation and reduced spasms.
- Dimethicone: An anti-foaming agent that reduces the surface tension of gas bubbles, allowing them to coalesce and be expelled more readily, thereby relieving bloating and flatulence.
- Paracetamol: Thought to inhibit prostaglandin synthesis in the central nervous system, leading to analgesic and antipyretic effects. Its exact mechanism is still not fully understood.
Pharmacokinetics:
- Dicyclomine: Well-absorbed orally. Metabolized in the liver and excreted primarily in urine.
- Dimethicone: Not absorbed systemically. Passes through the GI tract unchanged and is eliminated in feces.
- Paracetamol: Rapidly absorbed orally. Metabolized in the liver (primarily by glucuronidation and sulfation) and excreted in urine. A small fraction is metabolized by CYP2E1 to a hepatotoxic metabolite (N-acetyl-p-benzoquinone imine or NAPQI), which is usually detoxified by glutathione.
Elimination Pathways:
- Dicyclomine: Primarily renal excretion.
- Dimethicone: Fecal excretion.
- Paracetamol: Renal excretion after hepatic metabolism.
Dosage
Dosage guidelines for this combination are not standardized and vary based on the specific product formulation. It is crucial to consult the product’s prescribing information. Since no single source provides pediatric dosage for the triple combination, the information below is for the individual drugs.
Standard Dosage
Adults:
Consult the specific product’s prescribing information. Dosage and frequency vary by product.
Children:
Consult the specific product’s prescribing information. Safety and efficacy have not been established for all age groups in all regions.
- Dicyclomine: Usage varies by age and is not recommended for children under 6 months. Pediatric dosing needs careful consideration and should be determined by a physician.
- Paracetamol: Dosing is weight-based (15 mg/kg/dose every 4-6 hours, not exceeding 4 doses in 24 hours). See the paracetamol calculator for dosage information.
- Dimethicone: Follow product label instructions for pediatric use.
Special Cases:
Dosage adjustments may be necessary based on:
- Elderly Patients: Lower starting doses are often recommended for dicyclomine and paracetamol due to age-related decline in renal and hepatic function.
- Patients with Renal Impairment: Dose adjustment may be necessary for dicyclomine and paracetamol.
- Patients with Hepatic Dysfunction: Dose adjustment is required for paracetamol and possibly dicyclomine.
- Patients with Comorbid Conditions: Consider drug interactions and disease-specific considerations.
Clinical Use Cases
The combination is not typically used in the clinical settings you listed (intubation, surgical procedures, mechanical ventilation, ICU, emergency situations). Individual components may be utilized separately in some of these scenarios.
Dosage Adjustments
Always adjust the dose based on individual patient factors, including renal/hepatic function, coexisting medical conditions, and concomitant medications.
Side Effects
Common Side Effects:
Dry mouth, dizziness, blurred vision, drowsiness, constipation, nausea, weakness, nervousness, urinary retention.
Rare but Serious Side Effects:
Allergic reactions (rash, itching, swelling), difficulty breathing, rapid heartbeat, confusion, hallucinations, liver damage (with paracetamol overdose).
Long-Term Effects:
Chronic complications are unlikely with proper use. Long-term use of paracetamol at high doses can increase the risk of liver damage.
Adverse Drug Reactions (ADR):
Severe allergic reactions, liver failure (paracetamol overdose), paradoxical excitation (especially in children with dicyclomine).
Contraindications
- Hypersensitivity to any component.
- Glaucoma.
- Myasthenia gravis.
- Obstructive uropathy or GI obstruction.
- Severe ulcerative colitis.
- Reflux esophagitis.
- Infants under 6 months (dicyclomine).
Drug Interactions
- Anticholinergic drugs (additive effects).
- Antidepressants (tricyclic antidepressants).
- Antihistamines (additive anticholinergic effects).
- Opioid analgesics (additive CNS depression with dextropropoxyphene if present).
- Alcohol (increased drowsiness).
- Medications metabolized by CYP2E1 (e.g., isoniazid) may increase the risk of paracetamol toxicity.
Pregnancy and Breastfeeding
- Pregnancy: Dicyclomine is generally avoided during pregnancy. Paracetamol is generally considered safe for short-term use. Dimethicone is not systemically absorbed and is likely low risk. Consult a doctor before using this combination during pregnancy.
- Breastfeeding: Dicyclomine may decrease milk production. Paracetamol is considered compatible with breastfeeding. Dimethicone is not systemically absorbed. Consult a doctor before using this combination while breastfeeding.
Drug Profile Summary
- Mechanism of Action: Dicyclomine: Anticholinergic/antispasmodic; Dimethicone: Anti-flatulent; Paracetamol: Analgesic/antipyretic.
- Side Effects: Dry mouth, dizziness, blurred vision, drowsiness, constipation.
- Contraindications: Glaucoma, myasthenia gravis, GI obstruction, urinary retention.
- Drug Interactions: Other anticholinergics, antidepressants, alcohol.
- Pregnancy & Breastfeeding: Consult a physician before use.
- Dosage: Consult the specific product’s prescribing information.
- Monitoring Parameters: Liver function tests (with long-term paracetamol use), monitor for anticholinergic side effects.
Popular Combinations
This particular triple combination isn’t a standard or “popular” combination in most regions. More commonly, dicyclomine is combined with paracetamol, or dicyclomine is combined with dimethicone. Sometimes, tramadol is added to dicyclomine and paracetamol for enhanced pain relief.
Precautions
- General Precautions: Evaluate renal and hepatic function, especially in elderly patients.
- Specific Populations: Use with caution in elderly, pregnant/breastfeeding women, and patients with hepatic/renal impairment. Dicyclomine not recommended for infants under 6 months.
- Lifestyle Considerations: Avoid alcohol, driving may be impaired due to drowsiness and blurred vision.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Dicyclomine + Dimethicone + Paracetamol?
A: The dosage for this combination is not standardized and varies depending on the specific product formulation. Consult the product’s prescribing information or a healthcare professional.
Q2: Can this combination be used in children?
A: Dicyclomine is not generally recommended for children under 6 months of age. Consult product labeling and/or a pediatrician for specific age guidelines and dosing instructions. Paracetamol dosing is weight based for children.
Q3: What are the main side effects to watch out for?
A: Common side effects include dry mouth, blurred vision, dizziness, constipation, and drowsiness.
Q4: Are there any serious drug interactions?
A: Yes, this combination can interact with other anticholinergic medications, antidepressants, and alcohol, potentiating their effects.
Q5: Can I take this medication if I’m pregnant or breastfeeding?
A: Consult a doctor before use during pregnancy or while breastfeeding. Dicyclomine is generally avoided during pregnancy and breastfeeding.
Q6: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember, unless it is close to the time for your next dose. Do not double the dose to catch up.
Q7: How should this medication be stored?
A: Store at room temperature away from excessive heat, moisture, and direct sunlight. Keep out of reach of children.
Q8: What conditions is this combination specifically contraindicated in?
A: This combination should not be used in patients with glaucoma, myasthenia gravis, obstructive uropathy, GI obstruction, or severe ulcerative colitis. Dicyclomine is contraindicated in infants under 6 months.
Q9: Can I drink alcohol while taking this medication?
A: Alcohol should be avoided as it can increase the risk of side effects such as drowsiness and dizziness.
Q10: How does this combination relieve abdominal pain?
A: Dicyclomine relieves spasms, dimethicone reduces bloating and gas, and paracetamol provides additional pain relief.
