Usage
- This drug combination is prescribed for the symptomatic relief of gastrointestinal disorders like irritable bowel syndrome (IBS), indigestion, gastroesophageal reflux disease (GERD), peptic ulcers, abdominal pain and cramping, bloating, and excess gas. It also helps with irregular bowel movements.
- Pharmacological Classification: This is a combination drug containing an antispasmodic (dicyclomine), an antacid (magaldrate), and a local anesthetic (oxetacaine). Some formulations also include simethicone, an anti-foaming agent.
- Mechanism of Action: Dicyclomine relaxes smooth muscles in the gastrointestinal tract by blocking acetylcholine, thus relieving spasms and cramps. Magaldrate neutralizes stomach acid, relieving heartburn and associated pain. Oxetacaine numbs the lining of the stomach and esophagus, providing relief from pain and discomfort related to acidity or ulcers. Simethicone, when present, reduces the surface tension of gas bubbles, allowing them to combine and be expelled more easily.
Alternate Names
- No specific alternate generic names exist for this combination. However, individual components have synonyms (e.g., dicycloverine for dicyclomine).
- Brand Names: Numerous brand names exist depending on the manufacturer and region, including Coligon O, Spascrom-MPS, Aulic, Speucid Forte, and others.
How It Works
- Pharmacodynamics: Dicyclomine acts as an anticholinergic agent, inhibiting the action of acetylcholine at muscarinic receptors in the GI tract, leading to smooth muscle relaxation. Magaldrate chemically neutralizes gastric acid. Oxetacaine blocks nerve conduction by inhibiting sodium channels, producing local anesthesia. Simethicone reduces surface tension of gas bubbles.
- Pharmacokinetics: Dicyclomine is well-absorbed orally. Magaldrate is not systemically absorbed but acts locally in the GI tract. Oxetacaine has low systemic absorption when used topically in the GI tract. Simethicone is not absorbed and is eliminated unchanged in the feces.
- Mode of Action: At the cellular level, dicyclomine inhibits smooth muscle contraction by blocking acetylcholine’s effect on muscarinic receptors. Magaldrate reacts with hydrochloric acid in the stomach to form aluminum and magnesium chloride and water, thus increasing the pH. Oxetacaine blocks voltage-gated sodium channels in nerve cells, preventing pain signal transmission. Simethicone alters the surface tension of gas bubbles.
- Elimination Pathways: Dicyclomine is primarily metabolized by the liver and excreted in urine. Magaldrate is eliminated in feces. Oxetacaine is minimally absorbed; what little is absorbed is metabolized and excreted. Simethicone is eliminated unchanged in feces.
Dosage
Standard Dosage
Adults:
- The typical dose is 1-2 tablets or 15-30 ml of suspension, taken orally after meals and at bedtime. Dosages may vary depending on the specific product formulation.
Children:
- This combination is generally not recommended for children under 12 years of age. Dosages for older children should be determined by a physician.
Special Cases:
- Elderly Patients: Use with caution; dosage adjustments may be needed due to age-related decline in organ function.
- Patients with Renal Impairment: Use cautiously as magaldrate can cause magnesium buildup.
- Patients with Hepatic Dysfunction: Use cautiously due to dicyclomine’s hepatic metabolism; dose adjustments may be required.
- Patients with Comorbid Conditions: Caution is advised in patients with glaucoma, myasthenia gravis, obstructive uropathy, GI obstruction, severe ulcerative colitis, and cardiovascular instability.
Clinical Use Cases
- This combination is not typically used in clinical settings like intubation, surgical procedures, mechanical ventilation, or the ICU. Its use is primarily limited to outpatient symptomatic relief of dyspepsia and related GI discomfort.
Dosage Adjustments
- Dosage adjustments should be made based on individual patient factors, including renal function, hepatic function, age, and other medical conditions.
Side Effects
Common Side Effects
- Dry mouth, dizziness, drowsiness, nausea, constipation, blurred vision.
Rare but Serious Side Effects
- Allergic reactions, difficulty breathing, rapid heart rate, confusion, hallucinations.
Long-Term Effects
- Long-term use of magaldrate can lead to electrolyte imbalances and bone problems.
Adverse Drug Reactions (ADR)
- Severe allergic reactions (anaphylaxis), paradoxical bronchospasm, cardiac arrhythmias.
Contraindications
- Hypersensitivity to any component, glaucoma, myasthenia gravis, obstructive uropathy, GI obstruction, unstable cardiovascular status, severe ulcerative colitis, toxic megacolon, reflux esophagitis with bleeding.
Drug Interactions
- Anticholinergics (atropine, scopolamine), other antispasmodics, CNS depressants (benzodiazepines), drugs affecting GI motility (metoclopramide), antibiotics (tetracyclines, quinolones), thyroid medications, medications for osteoporosis, antifungals (ketoconazole), and others. Alcohol can exacerbate drowsiness.
Pregnancy and Breastfeeding
- Pregnancy Safety Category: Not firmly established. Use only if clearly needed and under medical supervision.
- Breastfeeding: Not recommended as components may be excreted in breast milk.
Drug Profile Summary
- Mechanism of Action: Antispasmodic, antacid, and local anesthetic actions in the GI tract.
- Side Effects: Dry mouth, dizziness, drowsiness, nausea, constipation.
- Contraindications: Glaucoma, myasthenia gravis, GI obstruction, urinary obstruction.
- Drug Interactions: Anticholinergics, CNS depressants.
- Pregnancy & Breastfeeding: Use with caution during pregnancy; not recommended while breastfeeding.
- Dosage: Varies by formulation, generally 1-2 tablets or 15-30ml suspension after meals and at bedtime.
- Monitoring Parameters: Symptoms, electrolyte levels with prolonged antacid use.
Popular Combinations
- Sometimes combined with simethicone for added anti-gas effects.
Precautions
- Pre-existing medical conditions, especially renal or hepatic impairment, should be assessed before use. Caution in elderly patients. Avoid alcohol. May impair ability to drive or operate machinery.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Dicyclomine + Magaldrate + Oxetacaine?
A: The dosage varies depending on the specific formulation. Generally, 1-2 tablets or 15-30 ml of suspension after meals and at bedtime is recommended for adults.
Q2: What conditions does this combination treat?
A: IBS, indigestion, GERD, peptic ulcers, abdominal pain, cramping, bloating, excess gas.
Q3: Is it safe to use during pregnancy or breastfeeding?
A: Use with caution in pregnancy, only if clearly needed. Not recommended for breastfeeding mothers.
Q4: What are the common side effects?
A: Dry mouth, dizziness, drowsiness, nausea, constipation, blurred vision.
Q5: Are there any serious drug interactions?
A: Yes, with anticholinergics, CNS depressants, some antibiotics, and other medications.
Q6: Can it be used in children?
A: Generally not recommended for children under 12.
Q7: What precautions should be taken before prescribing?
A: Evaluate for glaucoma, myasthenia gravis, GI/urinary obstruction, renal/hepatic impairment.
Q8: What should patients be advised regarding lifestyle?
A: Avoid alcohol, and exercise caution when driving or operating machinery due to potential drowsiness.
Q9: 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.
Q10: What are the long-term effects of this medication?
A: Long-term use of the antacid component, magaldrate, can potentially lead to electrolyte imbalances (like low phosphate and high magnesium) and may contribute to bone problems. It is therefore important to monitor patients on prolonged therapy.
