Usage
This combination medication is prescribed for the symptomatic relief of various gastrointestinal discomforts, including:
- Irritable Bowel Syndrome (IBS): To alleviate abdominal pain, cramping, bloating, and discomfort.
- Dyspepsia (Indigestion): To manage symptoms such as heartburn, bloating, and nausea.
- Gastroesophageal Reflux Disease (GERD): To reduce heartburn and acid reflux.
- Peptic Ulcers: To provide pain relief and support healing (in conjunction with other medications).
- Flatulence: To reduce excessive gas and bloating.
Pharmacological Classification: This is a combination product encompassing several drug classes:
- Dicyclomine: Anticholinergic, antispasmodic
- Magaldrate: Antacid
- Oxetacaine: Local anesthetic
- Simethicone: Anti-foaming agent
Mechanism of Action: Each component contributes to the overall therapeutic effect:
- Dicyclomine: Relaxes the smooth muscles in the gastrointestinal tract by blocking acetylcholine at muscarinic receptors, reducing spasms and cramping.
- Magaldrate: Neutralizes excess stomach acid, providing relief from heartburn and acid indigestion.
- Oxetacaine: Numbs the lining of the stomach and esophagus, offering immediate pain relief from acid irritation or ulcers.
- Simethicone: Reduces the surface tension of gas bubbles trapped in the digestive system, allowing them to combine into larger bubbles for easier expulsion through belching or flatulence.
Alternate Names
This combination medication is available under various brand names such as Coligon O, Spascrom D, and others. There’s no widely recognized international non-proprietary name (INN) for this specific combination.
How It Works
Pharmacodynamics: The combined action of the four components targets different aspects of gastrointestinal distress. Dicyclomine’s antispasmodic action reduces smooth muscle contractions. Magaldrate neutralizes gastric acid, increasing the stomach’s pH. Oxetacaine provides local anesthetic action, numbing the affected area. Simethicone decreases the surface tension of gas bubbles, facilitating their removal.
Pharmacokinetics:
- Dicyclomine: Well-absorbed orally, metabolized in the liver, and primarily excreted renally.
- Magaldrate: Not systemically absorbed; acts locally in the GI tract. Aluminum and magnesium ions from magaldrate are minimally absorbed.
- Oxetacaine: Acts locally in the GI tract with minimal systemic absorption.
- Simethicone: Not absorbed; passes through the GI tract unchanged.
Mode of Action:
- Dicyclomine: Muscarinic receptor antagonist.
- Magaldrate: Chemical neutralization of gastric acid.
- Oxetacaine: Blocks voltage-gated sodium channels on nerve cells, inhibiting pain signal transmission.
- Simethicone: Reduces surface tension of gas bubbles.
Elimination:
- Dicyclomine: Primarily renal excretion.
- Magaldrate: Excreted in feces. Minimal amounts of aluminum and magnesium are excreted renally.
- Oxetacaine: Primarily excreted unchanged in feces.
- Simethicone: Excreted unchanged in feces.
Dosage
Standard Dosage
Adults: The typical dose is one to two tablespoons (15-30 ml) or one tablet, taken 15 minutes before meals and at bedtime, as needed. The exact dose and frequency should be determined by a physician.
Children: This medication is generally not recommended for children under 12 years of age unless specifically prescribed by a doctor. Pediatric dosages should be determined by a physician based on the child’s weight and age. Doses for children weighing less than 10.9 kg may be lower (e.g., 20mg after meals and at bedtime).
Special Cases:
- Elderly Patients: Dose adjustment may be necessary depending on renal function.
- Patients with Renal Impairment: Dose reduction is usually required due to dicyclomine’s renal excretion.
- Patients with Hepatic Dysfunction: Caution should be exercised. Dose adjustments might be needed.
- Patients with Comorbid Conditions: Careful evaluation and dose adjustment may be required based on specific comorbidities.
Clinical Use Cases
Dosage in clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations should be determined by a physician based on patient needs and specific guidelines. The combination is not typically used in these settings.
Dosage Adjustments
Dose modifications are based on patient-specific factors, including renal or hepatic dysfunction, age, and other medical conditions. Always consult with a physician for appropriate dosage adjustments.
Side Effects
Common Side Effects:
Drowsiness, dizziness, dry mouth, blurred vision, nausea, constipation, weakness, nervousness, chalky taste, diarrhea, stomach pain.
Rare but Serious Side Effects:
Allergic reactions, difficulty breathing, rapid or uneven heart rate, confusion, hallucinations, decreased urination.
Long-Term Effects:
With prolonged magaldrate use, monitor electrolyte levels.
Adverse Drug Reactions (ADR):
Severe allergic reactions, paralytic ileus, worsening of glaucoma, cardiac arrhythmias.
Contraindications
- Gastrointestinal obstruction
- Severe ulcerative colitis
- Toxic megacolon
- Obstructive uropathy
- Unstable cardiovascular status
- Severe myasthenia gravis
- Glaucoma (especially angle-closure glaucoma)
- Reflux esophagitis or gastric ulcers with active bleeding
- Hypersensitivity to any of the components.
Drug Interactions
- Anticholinergics (atropine, scopolamine): Additive anticholinergic effects.
- Other antispasmodics (hyoscyamine): Additive antispasmodic effects.
- CNS depressants (benzodiazepines): Increased sedation.
- Drugs affecting gastrointestinal motility (metoclopramide): Antagonistic effects.
- Antibiotics (quinolones, tetracyclines, cephalosporins): Reduced antibiotic absorption.
- Thyroid medications (levothyroxine): Reduced thyroid medication absorption.
- Osteoporosis medications (alendronate): Reduced absorption.
- Antifungals (ketoconazole): Reduced absorption.
- Alcohol: Increased drowsiness and dizziness.
Pregnancy and Breastfeeding
The safety of this combination during pregnancy and breastfeeding has not been fully established. Consult a doctor before use.
Drug Profile Summary
- Mechanism of Action: See above.
- Side Effects: See above.
- Contraindications: See above.
- Drug Interactions: See above.
- Pregnancy & Breastfeeding: Consult a physician before use.
- Dosage: See above.
- Monitoring Parameters: Vital signs, electrolyte levels (with prolonged antacid use), renal function.
Popular Combinations
Data on specific combinations with this quartet is limited. However, combinations of antispasmodics, antacids, and/or simethicone are common for GI symptom relief.
Precautions
- Pre-existing conditions: Renal impairment, glaucoma, myasthenia gravis, etc.
- Avoid driving if experiencing drowsiness or dizziness.
- Avoid alcohol.
- Heat stroke risk due to decreased sweating (dicyclomine).
- Consult a physician before using during pregnancy or breastfeeding.
- Not recommended for infants under 6 months.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Dicyclomine + Magaldrate + Oxetacaine + Simethicone?
A: See dosage section above. Dosage needs to be individualized based on the patient’s condition and other factors. Always consult with a physician.
Q2: What are the common side effects?
A: Common side effects include drowsiness, dizziness, dry mouth, blurred vision, nausea, constipation.
Q3: Is this combination safe during pregnancy?
A: Safety during pregnancy and breastfeeding hasn’t been fully established. Consult a doctor before use.
Q4: Can I take this medication with alcohol?
A: Alcohol should be avoided, as it can exacerbate side effects like drowsiness and dizziness.
Q5: What conditions is this combination contraindicated in?
A: Contraindications include gastrointestinal obstruction, glaucoma, myasthenia gravis, and certain other conditions. See the contraindications section above.
Q6: How does dicyclomine work in this combination?
A: Dicyclomine acts as an antispasmodic, relaxing the smooth muscles of the GI tract.
Q7: What is the role of magaldrate?
A: Magaldrate is an antacid that neutralizes stomach acid.
Q8: How does simethicone relieve gas?
A: Simethicone reduces the surface tension of gas bubbles, making them easier to expel.
Q9: Are there any drug interactions I should be aware of?
A: Yes, this combination can interact with several medications, including anticholinergics, CNS depressants, and certain antibiotics. See the drug interactions section above.
Q10: What should I do if I miss a dose?
A: If you miss a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose and continue with your regular schedule. Do not double the dose. Consult a physician if you have questions.
