Usage
Oxetacaine + Simethicone is prescribed for the symptomatic relief of gastrointestinal discomfort associated with conditions like gastritis, peptic ulcers, esophageal reflux, heartburn, acidity, gas, bloating, and dyspepsia. It is also used to alleviate menstrual cramps.
Pharmacological Classification: This combination product falls under the following classifications:
- Antacid: (Magaldrate/Aluminum Hydroxide/Magnesium Hydroxide)
- Antiflatulent: (Simethicone)
- Local Anesthetic: (Oxetacaine)
Mechanism of Action: This combination works through the synergistic action of its components:
- Magaldrate/Aluminum Hydroxide/Magnesium Hydroxide: Neutralizes excess stomach acid, thereby increasing the pH level of the stomach contents. This offers protection to the stomach lining and promotes ulcer healing.
- Simethicone: Reduces the surface tension of gas bubbles in the digestive tract, facilitating their coalescence into larger bubbles. These larger bubbles are easier to expel through belching or flatulence, easing bloating and discomfort.
- Oxetacaine: Acts as a local anesthetic, numbing the lining of the stomach and esophagus to provide relief from pain associated with ulcers or acid irritation.
Alternate Names
No widely recognized alternate names exist for the combination itself. However, it is marketed under various brand names like Amalcap-O, Rantac MPS LA Suspension, Ulgel-A, Sterichyme Forte, and Z-Cid O, among others. The individual components may be referred to by their chemical names or other synonyms.
How It Works
Pharmacodynamics: The combined effect of the three components addresses multiple aspects of gastrointestinal distress. The antacids neutralize gastric acid, simethicone reduces gas, and oxetacaine provides local pain relief.
Pharmacokinetics:
- Absorption: Magaldrate is poorly absorbed systemically. Simethicone is not absorbed at all and is eliminated unchanged in the feces. Oxetacaine is moderately absorbed after oral administration but acts primarily locally.
- Metabolism: Limited information is available regarding the metabolism of oxetacaine.
- Elimination: Magaldrate is mainly eliminated in the feces. Simethicone is eliminated unchanged in the feces. Oxetacaine is likely metabolized, though specific elimination pathways are not well documented.
Mode of Action:
- Magaldrate/Aluminum Hydroxide/Magnesium Hydroxide: Chemically neutralizes hydrochloric acid in the stomach.
- Simethicone: Physically disrupts the surface tension of gas bubbles.
- Oxetacaine: Blocks voltage-gated sodium channels in nerve cells, preventing pain signal transmission.
Dosage
Standard Dosage
Adults: The usual dose is 10-30 ml of the suspension, taken 1-2 hours after meals and at bedtime, or as directed by a physician. The dose may be given up to four times daily as needed. However, dosages should not exceed 500mg of Simethicone daily if self-medicating.
Children: The combination is generally not recommended for children under 12 years of age. For children above 12, the dosage needs to be determined by a physician based on individual needs. Dosing for simethicone alone in children is as follows:
- Infants < 2 years: 20 mg four times daily, as needed, after meals and at bedtime. Maximum dose: 240 mg/day.
- Children ≥ 2 years: 40 mg four times daily, as needed, after meals and at bedtime. Maximum dose: 480 mg/day.
Special Cases:
- Elderly Patients: Use with caution; dosage adjustments may be necessary due to potential age-related decline in renal function.
- Patients with Renal Impairment: Use cautiously to avoid potential complications such as hypermagnesemia, with close monitoring of renal function and electrolyte levels. Dosage adjustments are necessary.
- Patients with Hepatic Dysfunction: No specific adjustments are typically mentioned, but caution is advised.
- Patients with Comorbid Conditions: Consult a doctor before using this medication if patients have kidney problems, high blood pressure, or history of GI bleeding.
Clinical Use Cases
The combination is not typically used in settings like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. Its use is primarily limited to outpatient management of dyspepsia, gas, and related gastrointestinal discomfort.
Dosage Adjustments
Dose adjustments are needed for renal impairment and should be considered for the elderly. Always consult a doctor for appropriate adjustments.
Side Effects
Common Side Effects:
- Constipation
- Diarrhea
- Nausea
- Vomiting
- Stomach upset
- Chalky taste
- Changes in bowel habits
- Allergic reactions (rare)
Rare but Serious Side Effects:
- Muscle weakness
- Loss of appetite
- Weight loss
Long-Term Effects: No specific long-term effects have been identified with this combination when used as directed.
Contraindications
- Hypersensitivity to any component
- Severe kidney disease
- Bowel obstruction
- Gastrointestinal bleeding or blockage
- Myasthenia Gravis
- Glaucoma
- Pyloric stenosis
- Prostatic hyperplasia
Drug Interactions
This combination can interact with various medications including:
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Antibiotics: Tetracyclines, quinolones, cephalosporins
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Antifungals: Ketoconazole
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Hormones: Levothyroxine
-
Antihypertensives: Ramipril, metoprolol
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Antacids: Aluminum or magnesium-containing antacids
-
OTC drugs and supplements: Consult a physician or pharmacist
-
Food and lifestyle factors: Alcohol can exacerbate acidity and should be avoided.
Pregnancy and Breastfeeding
Consult with a doctor before using this medication during pregnancy or while breastfeeding. Safety during pregnancy and breastfeeding has not been fully established. While simethicone is considered safe, the other components may pose potential risks.
Drug Profile Summary
- Mechanism of Action: Antacid neutralizes gastric acid; antiflatulent reduces gas bubbles; local anesthetic relieves pain.
- Side Effects: Constipation, diarrhea, nausea, chalky taste.
- Contraindications: Hypersensitivity, severe kidney disease, bowel obstruction.
- Drug Interactions: Various medications, including antibiotics, antifungals, and hormones.
- Pregnancy & Breastfeeding: Consult a doctor before use.
- Dosage: 10-30 ml 1-2 hours after meals and at bedtime, up to four times daily. Adjust for special populations.
- Monitoring Parameters: Renal function, electrolyte levels (especially in renal impairment).
Popular Combinations
No regularly prescribed specific drug combinations containing Oxetacaine + Simethicone are listed in provided sources.
Precautions
- General Precautions: Pre-existing conditions like kidney disease, magnesium-restricted diets should be evaluated before use. Avoid alcohol and foods that can cause indigestion.
- Specific Populations: See above section on Special Cases
- Lifestyle Considerations: Avoid alcohol, maintain a healthy diet and drink plenty of water. Driving may be affected if dizziness or drowsiness occurs.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Oxetacaine + Simethicone?
A: The standard dosage for adults is 10-30 ml of suspension, 1-2 hours after meals and at bedtime, or as directed by a physician. Pediatric dosing for simethicone is mentioned above, but the combination should be cautiously used in children older than 12. Adjustments needed for renal impairment and elderly patients.
Q2: What are the primary uses of this medication?
A: It is used to relieve symptoms associated with gastritis, peptic ulcers, acid reflux, heartburn, gas, bloating, and indigestion, and can help with menstrual cramps.
Q3: How does this combination work?
A: Magaldrate/Aluminum Hydroxide/Magnesium Hydroxide neutralizes stomach acid, simethicone breaks down gas bubbles, and oxetacaine numbs the stomach lining for pain relief.
Q4: What are the potential side effects?
A: Common side effects include constipation, diarrhea, nausea, chalky taste, and changes in bowel habits.
Q5: Who should not take this medicine?
A: Patients with hypersensitivity, severe kidney disease, bowel obstruction or those with other specific contraindicated conditions (listed above) should not use this medicine.
Q6: Are there any drug interactions I should be aware of?
A: Yes, it can interact with certain antibiotics, antifungals, hormones, antihypertensives, and other antacids. Consult a physician about specific interactions.
Q7: Can I take this medicine while pregnant or breastfeeding?
A: Consult a doctor before using this medication during pregnancy or breastfeeding, as the safety is not fully established.
Q8: What precautions should I take while on this medicine?
A: Avoid alcohol and irritating foods, inform your doctor about any pre-existing conditions, and monitor for side effects.
Q9: Are there any over-the-counter alternatives available?
A: Individual components of the combination, like antacids and simethicone, are available over-the-counter. However, the specific combination needs a prescription.
Q10: What should I do if I miss a dose?
A: If you miss a dose, take it as soon as you remember, unless it is close to the time for the next dose. Do not double the dose to catch up.
