Usage
- This combination medication is primarily prescribed for the symptomatic relief of abdominal pain, cramping, bloating, and discomfort associated with conditions like irritable bowel syndrome (IBS), intestinal colic, biliary colic, renal colic, and spasmodic dysmenorrhea (painful menstruation). It is also used to relieve symptoms of trapped gas.
- Pharmacological Classifications: Antispasmodic, analgesic, antipyretic, antiflatulent.
- Mechanism of Action: This combination works through the synergistic actions of its components. Dicyclomine, an anticholinergic/antispasmodic, relaxes smooth muscles in the gastrointestinal tract by blocking acetylcholine’s action. Paracetamol acts as an analgesic and antipyretic by inhibiting prostaglandin synthesis. Simethicone, an anti-foaming agent, reduces gas by breaking down gas bubbles in the gut.
Alternate Names
- While there isn’t a universally recognized alternate name for this specific combination, each component has synonyms. Dicyclomine is also known as Dicycloverine. Paracetamol is also known as Acetaminophen. Simethicone may also be called Activated Dimethicone.
- Brand Names: Trispas, others (availability varies by region).
How It Works
- Pharmacodynamics: Dicyclomine acts peripherally to reduce spasms and cramping by inhibiting muscarinic receptors and decreasing smooth muscle motility in the GI tract. Paracetamol’s central action reduces pain and fever by inhibiting prostaglandin synthesis. Simethicone alters the surface tension of gas bubbles, allowing them to coalesce and be expelled more readily.
- Pharmacokinetics: Dicyclomine is well-absorbed orally. Paracetamol is rapidly absorbed from the GI tract, reaching peak plasma concentrations within 30-60 minutes. Simethicone is not absorbed and is eliminated unchanged in the feces.
- Mode of Action: Dicyclomine acts as an anticholinergic, competitively inhibiting the actions of acetylcholine at muscarinic receptors. Paracetamol’s precise mechanism of action is not fully understood but involves inhibiting cyclooxygenase (COX) enzymes in the central nervous system, reducing prostaglandin synthesis. Simethicone, being inert, does not have a pharmacological mode of action. It works physically by reducing the surface tension of gas bubbles.
- Elimination: Dicyclomine is primarily metabolized in the liver and excreted via renal and biliary pathways. Paracetamol is extensively metabolized in the liver, and metabolites are excreted in the urine. Simethicone is not absorbed and is excreted unchanged in the feces.
Dosage
Standard Dosage
Adults:
One tablet/capsule (containing Dicyclomine 10-20 mg, Paracetamol 500 mg, and Simethicone 40-80 mg) three to four times daily, taken orally 30-60 minutes before meals.
Children:
Dosing for children below 12 years old should be determined by a pediatrician and is based on the child’s age and weight. Safety and efficacy have not been established for children under 6 months.
Special Cases:
- Elderly Patients: Start with lower doses due to potential for increased sensitivity to anticholinergic effects. Close monitoring is recommended.
- Patients with Renal Impairment: Dose adjustment may be required based on the degree of impairment.
- Patients with Hepatic Dysfunction: Use with caution. Dose adjustment may be necessary.
- Patients with Comorbid Conditions: Exercise caution in patients with glaucoma, urinary retention, prostatic hypertrophy, myasthenia gravis, cardiovascular disease, hyperthyroidism, and obstructive gastrointestinal disorders.
Clinical Use Cases
The use of this combination in settings such as intubation, surgical procedures, mechanical ventilation, and the ICU is generally not indicated, as its primary benefit lies in relieving gastrointestinal symptoms like pain and bloating. In emergency situations, it does not have a role.
Dosage Adjustments
Dose adjustments are crucial in patients with renal or hepatic impairment, and those with comorbid conditions. Always consider patient-specific factors, including drug interactions and potential for adverse effects.
Side Effects
Common Side Effects:
Dry mouth, blurred vision, dizziness, drowsiness, constipation, nausea, urinary hesitancy.
Rare but Serious Side Effects:
Allergic reactions (rash, itching, swelling), difficulty breathing, confusion, hallucinations, rapid or irregular heartbeat, urinary retention.
Long-Term Effects:
Chronic use of paracetamol can lead to hepatotoxicity. Long-term use of dicyclomine can lead to tolerance.
Adverse Drug Reactions (ADR):
Severe allergic reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute angle-closure glaucoma, paralytic ileus.
Contraindications
- Hypersensitivity to any component of the medication.
- Glaucoma (especially angle-closure).
- Obstructive gastrointestinal disorders (e.g., pyloric stenosis, paralytic ileus).
- Myasthenia gravis.
- Severe ulcerative colitis.
- Toxic megacolon.
- Obstructive uropathy.
- Infants under 6 months of age.
Drug Interactions
- Anticholinergic agents (additive effects).
- Amantadine (additive effects).
- Tricyclic antidepressants (additive anticholinergic effects).
- Monoamine Oxidase Inhibitors (MAOIs) (additive anticholinergic effects).
- Antihistamines (additive anticholinergic effects).
- Antipsychotics (additive anticholinergic effects).
- Benzodiazepines (increased sedation).
- Quinidine (additive anticholinergic effects).
- Antacids (reduced dicyclomine absorption).
- Alcohol (increased drowsiness).
- Metoclopramide (decreased efficacy of metoclopramide).
Pregnancy and Breastfeeding
- Pregnancy: Dicyclomine should be used with caution during pregnancy only if the potential benefit outweighs the risk. Paracetamol is generally considered safe. Simethicone is not systemically absorbed and is unlikely to pose a risk.
- Breastfeeding: Dicyclomine is contraindicated during breastfeeding as it may be excreted in breast milk. Paracetamol can be used while breastfeeding. Simethicone is unlikely to be present in breast milk.
Drug Profile Summary
- Mechanism of Action: Dicyclomine: Anticholinergic/antispasmodic, Paracetamol: Analgesic/antipyretic, Simethicone: Antiflatulent.
- Side Effects: Dry mouth, blurred vision, dizziness, drowsiness, constipation; rarely, allergic reactions, urinary retention.
- Contraindications: Glaucoma, myasthenia gravis, obstructive GI disorders, paralytic ileus, infants under 6 months.
- Drug Interactions: Other anticholinergics, amantadine, antidepressants, antihistamines, antipsychotics, benzodiazepines, quinidine, antacids, alcohol.
- Pregnancy & Breastfeeding: Dicyclomine should be avoided; paracetamol is generally safe; simethicone is unlikely to pose a risk.
- Dosage: See section above.
- Monitoring Parameters: Monitor for GI symptoms, vital signs, adverse effects. Monitor liver function with prolonged paracetamol use.
Popular Combinations
Dicyclomine is often combined with other medications for synergistic effects. For example, it is sometimes combined with mefenamic acid for period pain. The current combination, with paracetamol and simethicone, addresses both pain and gas.
Precautions
- General Precautions: Pre-screening for allergies, relevant medical history (glaucoma, urinary retention, prostatic hypertrophy, myasthenia gravis, cardiovascular disease, liver disease, kidney disease) is essential.
- Pregnant Women: Use dicyclomine only if clearly needed.
- Breastfeeding Mothers: Avoid dicyclomine.
- Children & Elderly: Dose adjustments are crucial for children and elderly patients.
- Lifestyle Considerations: Limit alcohol intake and avoid driving or operating machinery if drowsiness or blurred vision occurs.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Dicyclomine + Paracetamol + Simethicone?
A: The standard adult dose is one tablet/capsule three to four times a day. Pediatric dosages must be determined by a pediatrician, and elderly patients should start with lower doses. Dosing adjustments are required in patients with hepatic or renal impairment.
Q2: What are the common side effects of this combination?
A: Common side effects include dry mouth, blurred vision, dizziness, drowsiness, constipation, and nausea.
Q3: Can pregnant or breastfeeding women take this medicine?
A: Pregnant women should use dicyclomine with caution. Paracetamol is generally safe during pregnancy. Simethicone is not expected to pose a risk to the fetus. Breastfeeding women should avoid dicyclomine.
Q4: How does dicyclomine work to relieve abdominal pain?
A: Dicyclomine works by blocking acetylcholine’s action, which reduces muscle spasms in the gastrointestinal tract.
Q5: What are the contraindications for this medication?
A: Contraindications include hypersensitivity, glaucoma, obstructive GI disorders, myasthenia gravis, severe ulcerative colitis, toxic megacolon, obstructive uropathy, and infants under 6 months.
Q6: Are there any significant drug interactions I should be aware of?
A: Yes, several drugs interact with this combination. Noteworthy examples include other anticholinergics, amantadine, antidepressants, antihistamines, antipsychotics, benzodiazepines, quinidine, antacids, and alcohol. It can also reduce the efficacy of metoclopramide.
Q7: What should I do if a patient experiences an allergic reaction?
A: Discontinue the medication immediately and provide appropriate medical care, which may include antihistamines, corticosteroids, and epinephrine, depending on the severity of the reaction.
Q8: What is the role of simethicone in this combination?
A: Simethicone acts as an anti-foaming agent, relieving bloating and gas by breaking down gas bubbles in the gut.
Q9: Can this medicine be used long-term?
A: Long-term use, especially of paracetamol, should be monitored due to the potential for hepatotoxicity. Long-term use of dicyclomine can also lead to tolerance. Regular monitoring and evaluation are necessary.
Q10: How should I counsel patients about taking this medication?
A: Advise patients about potential side effects, drug interactions, and precautions, including avoiding alcohol and driving if drowsiness or blurred vision occur. Encourage them to report any unusual symptoms. Advise that it should be taken 30-60 minutes before meals.
