Usage
Magaldrate + Oxetacaine is prescribed for the symptomatic relief of gastrointestinal discomfort related to hyperacidity, such as:
- Dyspepsia
- Heartburn
- Gastritis
- Peptic ulcers
- Gas and bloating
- Gastroesophageal reflux disease (GERD)
- Abdominal pain and cramping associated with these conditions
Pharmacological Classification: This is a combination drug with the following classifications:
- Magaldrate: Antacid
- Oxetacaine: Local anesthetic
It is often combined with Simethicone, an antiflatulent.
Mechanism of Action: Magaldrate neutralizes excess stomach acid, increasing gastric pH. Oxetacaine provides topical anesthetic action on the gastric mucosa, relieving pain associated with ulcers or acid irritation. Simethicone (when present) reduces surface tension of gas bubbles, facilitating their expulsion and relieving bloating.
Alternate Names
Magaldrate + Oxetacaine + Simethicone; Several brand names exist depending on the manufacturer (e.g., Ulgel A, Macbate, Amalcap-O, Tekcid O, Rantac MPS LA, Allercid Plus, Steris Antacid MSO, Sterichyme Forte, Z-CID O, Maalox Plus, Gee-Cid, Tekcid O Sugar Free, Macbate Mint Sugar Free).
How It Works
Pharmacodynamics: Magaldrate increases the pH of the stomach contents by neutralizing gastric acid. Oxetacaine exerts a local anesthetic effect, numbing the gastric mucosa. Simethicone (when present) decreases the surface tension of gas bubbles in the GI tract, promoting their coalescence and easier passage.
Pharmacokinetics:
- Absorption: Magaldrate is minimally absorbed systemically. Oxetacaine is absorbed locally, with limited systemic distribution. Simethicone is not absorbed and passes through the GI tract unchanged.
- Metabolism: Magaldrate is not metabolized. Limited information on oxetacaine metabolism is available. Simethicone is not metabolized.
- Elimination: Magaldrate is excreted primarily in the feces. Oxetacaine’s systemic elimination pathways are not well characterized. Simethicone is eliminated unchanged in the feces.
Mode of Action:
- Magaldrate chemically neutralizes hydrochloric acid in the stomach.
- Oxetacaine blocks voltage-gated sodium channels in nerve endings in the gastric mucosa, inhibiting pain signal transmission.
- Simethicone alters the surface properties of gas bubbles, allowing them to combine.
Receptor binding, enzyme inhibition, or neurotransmitter modulation: Oxetacaine blocks voltage-gated sodium channels. No receptor binding, enzyme inhibition, or neurotransmitter modulation has been described for Magaldrate and Simethicone.
Dosage
Dosage guidelines vary depending on the product formulation. Consult the manufacturer’s prescribing information and a healthcare professional for personalized recommendations.
Standard Dosage
Adults:
5-10 mL (1-2 teaspoons or 1-2 tablespoons) of oral suspension, taken 20 minutes to 1 hour after meals and at bedtime, or as needed. Some formulations recommend 15-30 mL three times daily. Maximum dose: 80 mL/24 hours.
Children:
Generally not recommended for children under 12 years. For children over 12, consult a physician for appropriate dosage adjustments according to age, weight, and condition. Some sources contraindicate its use in children, as safety and efficacy have not been established.
Special Cases:
- Elderly Patients: Use with caution. The standard adult dose may be appropriate, but close monitoring is advised. Dose adjustments may be based on renal function and health status.
- Patients with Renal Impairment: Use with caution. Dosage reduction may be required due to potential aluminum and magnesium accumulation.
- Patients with Hepatic Dysfunction: Use with caution as specific recommendations for dose adjustment may be needed.
Clinical Use Cases
Dosage for specific clinical use cases like intubation, surgical procedures, mechanical ventilation, ICU use, and emergencies has not been specifically defined in the provided literature. General dosage recommendations should be considered, with caution in patients with renal or hepatic impairment. Consult a healthcare professional for specific guidance.
Dosage Adjustments
Adjustments may be needed based on individual patient factors, including renal/hepatic function, other medical conditions, and concomitant medications. Always consult a doctor for personalized advice.
Side Effects
Common Side Effects
- Constipation
- Diarrhea
- Intestinal pain (stomach cramps)
- Nausea
- Vomiting
- Chalky taste
- Temporary changes in bowel habits
- Allergic reactions
Rare but Serious Side Effects
Serious side effects are uncommon but may include:
- Electrolyte imbalances (with prolonged use or renal impairment)
- Neurological effects (in patients with renal impairment, e.g., encephalopathy, dementia)
- Osteomalacia (with prolonged use or low-phosphate diets)
Long-Term Effects
Chronic complications are rare but may include:
- Phosphate depletion (with prolonged high doses or low-phosphate diets)
- Aluminum toxicity (in patients with impaired renal function)
Adverse Drug Reactions (ADR)
ADRs requiring urgent attention are rare but can occur:
- Severe allergic reactions (e.g., anaphylaxis)
- Signs of electrolyte imbalances
- Neurological symptoms (e.g., confusion, seizures)
Contraindications
- Hypersensitivity to any of the components
- Severe renal impairment
- Hypophosphatemia
- Gastrointestinal obstruction
- Severe ulcerative colitis
- Toxic megacolon
- Obstructive uropathy
- Unstable cardiovascular status
- Severe myasthenia gravis
- Glaucoma (especially angle-closure glaucoma)
- Active bleeding from reflux esophagitis or gastric ulcers
- Phenylketonuria (some formulations contain phenylalanine)
Drug Interactions
- Antibiotics (e.g., tetracyclines, quinolones, cephalosporins)
- Thyroid medications (e.g., levothyroxine)
- Osteoporosis medications (e.g., bisphosphonates)
- Antifungals (e.g., ketoconazole)
- Antihypertensives (e.g., ramipril)
- Anticonvulsants (e.g., phenytoin)
- Antacids containing aluminum or magnesium
- Antiretrovirals (e.g., raltegravir)
- Alcohol (increases acidity)
Pregnancy and Breastfeeding
Safety during pregnancy and breastfeeding has not been fully established. Consult a healthcare provider to assess the potential risks and benefits. Some sources advise caution or consider it generally safe, but data are limited.
Drug Profile Summary
- Mechanism of Action: Magaldrate neutralizes gastric acid; Oxetacaine provides local anesthesia; Simethicone (if present) reduces gas.
- Side Effects: Constipation, diarrhea, nausea, chalky taste, allergic reactions. Rare: electrolyte imbalances, neurological effects (in renal impairment), osteomalacia.
- Contraindications: Hypersensitivity, severe renal impairment, hypophosphatemia, GI obstruction, certain other conditions (see Contraindications section).
- Drug Interactions: Various drugs, including certain antibiotics, antifungals, and antacids.
- Pregnancy & Breastfeeding: Consult a healthcare provider. Safety not fully established.
- Dosage: Adults: 5-10 mL oral suspension after meals and at bedtime or as needed. Adjustments may be needed. Consult product information.
- Monitoring Parameters: Monitor for electrolyte imbalances, especially in long-term use or renal impairment.
Popular Combinations
Often combined with simethicone for enhanced relief of bloating and gas.
Precautions
- General Precautions: Allergy screening, assess renal function, monitor electrolyte levels in long-term use.
- Specific Populations: Consult a healthcare professional regarding use during pregnancy and breastfeeding. Use with caution in elderly patients and those with renal impairment. Not recommended for children under 12.
- Lifestyle Considerations: Limit alcohol and foods that worsen gastrointestinal symptoms.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Magaldrate + Oxetacaine?
A: The standard adult dose is 5-10 mL of oral suspension, 1-2 tablespoons, taken 20 minutes to 1 hour after meals and at bedtime or as needed. Some sources recommend up to 15-30 mL, one to two tablespoons three times a day. The maximum dose is 80 mL per day. Consult a healthcare professional or the specific product literature for guidance. Not generally recommended for children under 12.
Q2: What are the primary uses of this medication?
A: It is used to relieve symptoms of hyperacidity, such as heartburn, indigestion, gastritis, peptic ulcers, gas, bloating, and GERD.
Q3: How does Magaldrate + Oxetacaine work?
A: Magaldrate neutralizes stomach acid, while oxetacaine numbs the stomach lining, providing relief from pain and discomfort.
Q4: Are there any serious side effects?
A: Serious side effects are rare but may include electrolyte imbalances (with prolonged use or renal impairment), neurological effects (in patients with renal impairment), and osteomalacia (with prolonged use or low-phosphate diets).
Q5: Can pregnant or breastfeeding women take this medicine?
A: The safety during pregnancy and breastfeeding isn’t fully established. Consult a healthcare professional to assess risks and benefits.
Q6: What are the contraindications for Magaldrate + Oxetacaine?
A: Contraindications include hypersensitivity to the ingredients, severe renal impairment, hypophosphatemia, and certain gastrointestinal conditions like obstruction or severe ulcerative colitis.
Q7: Does this medication interact with other drugs?
A: Yes, it can interact with several medications, including some antibiotics, antifungals, thyroid medications, osteoporosis treatments, and other antacids. Consult a physician about potential interactions.
Q8: What precautions should patients take while using this medication?
A: Patients should inform their doctor about allergies, kidney problems, or if they are on a magnesium-restricted diet. Avoid alcohol and large amounts of citrus fruits, which can worsen gastrointestinal symptoms. Monitor for signs of electrolyte imbalances, especially with long-term use.
Q9: Is it safe to use this medication long-term?
A: Long-term use should be monitored by a healthcare professional. Potential risks with long-term use, especially at high doses, include phosphate depletion and aluminum toxicity (in patients with impaired renal function).
