Usage
- This combination medication is prescribed for the symptomatic relief of gastrointestinal discomfort related to acidity, heartburn, indigestion, gas, bloating, and stomach ulcers. It may also be used for gastroesophageal reflux disease (GERD) and dyspepsia. Some formulations may be indicated for period pain (dysmenorrhea).
- Pharmacological Classification: This is a combination drug containing an antacid (magaldrate), antiflatulent (simethicone), and a local anesthetic (oxetacaine). It can thus be classified as an antacid, anti-flatulent, and local anesthetic.
- Mechanism of Action: Magaldrate neutralizes excess stomach acid, raising gastric pH. Simethicone reduces the surface tension of gas bubbles, facilitating their expulsion. Oxetacaine provides local anesthetic action, numbing the stomach and esophagus lining to relieve pain associated with ulcers or acid irritation.
Alternate Names
- No widely recognized alternate names exist for this specific combination. It is frequently identified by its constituent drugs.
- Brand Names: This combination is marketed under various brand names, some examples include Amalcap-O, Rantac MPS LA Suspension, Siloxine Suspension (currently unavailable), and others, which may vary regionally. Many generic formulations also exist.
How It Works
- Pharmacodynamics: Magaldrate reacts with gastric acid to form aluminum and magnesium salts, thereby increasing gastric pH. Simethicone alters the surface tension of gas bubbles, leading to their coalescence and easier passage. Oxetacaine blocks nerve impulse transmission, producing local anesthetic action.
- Pharmacokinetics: Magaldrate is poorly absorbed systemically. Simethicone is not absorbed and is eliminated unchanged in the feces. Oxetacaine is minimally absorbed systemically when used orally.
- Mode of Action: Magaldrate acts chemically to neutralize HCl. Simethicone acts physicochemically by reducing surface tension. Oxetacaine binds to sodium channels, inhibiting nerve impulse transmission.
- Receptor binding, enzyme inhibition, or neurotransmitter modulation: Oxetacaine blocks voltage-gated sodium channels in neurons. Magaldrate and simethicone do not have specific receptor binding or enzyme inhibition properties relevant to their therapeutic actions.
- Elimination pathways: Magaldrate primarily eliminated through feces; small absorbed portion renally excreted. Simethicone eliminated unchanged in feces. Oxetacaine, minimally absorbed, excreted renally.
Dosage
Standard Dosage
Adults:
- 5-10 mL (or 1-2 tablespoons) of the suspension, taken 3-4 times a day, after meals and at bedtime, or as needed. Some sources suggest a single maximum dose of 5 mL three times daily.
- Maximum daily dose should not exceed 40 mL.
Children:
- This medication is generally not recommended for children under 12 years of age. Some sources suggest a maximum of 5 ml three times a day for children under 5 years old. Consult a pediatrician for guidance. Safety and efficacy in children have not been well established.
Special Cases:
- Elderly Patients: Use with caution. The usual adult dose may be appropriate, but careful monitoring is recommended, especially for renal function.
- Patients with Renal Impairment: Use with caution. Dose adjustments may be needed.
- Patients with Hepatic Dysfunction: Data on dose adjustments is not readily available. Consult a healthcare provider.
- Patients with Comorbid Conditions: Use with caution in patients with other medical conditions, especially those on a magnesium-restricted diet.
Clinical Use Cases
- Dosing in specific clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations should be guided by clinical judgment and the patient’s condition. This medication is primarily used for symptom management and does not have specific applications in these critical care scenarios.
Dosage Adjustments
- Adjustments based on renal/hepatic dysfunction, metabolic disorders, or genetic polymorphisms are not well defined. Individualized dosing based on patient assessment and clinical response is essential.
Side Effects
Common Side Effects
- Constipation
- Diarrhea
- Chalky taste
- Nausea
- Vomiting
- Stomach cramps
- Allergic reactions
- Intestinal pain
- Temporary changes in bowel habits
Rare but Serious Side Effects
- Aluminum toxicity (with prolonged or excessive use)
- Hypermagnesemia (in patients with renal impairment)
- Hypophosphatemia (with long-term use or in low-phosphate diets)
- Osteomalacia (with prolonged use)
- Intestinal obstruction (in high-risk patients)
Long-Term Effects
- Phosphate depletion
- Bone softening (osteomalacia)
Adverse Drug Reactions (ADR)
- Allergic reactions (rare): Skin rash, itching, swelling, difficulty breathing, severe dizziness
Contraindications
- Hypersensitivity to any of the components
- Severe kidney disease
- Gastrointestinal obstruction
- Toxic megacolon
- Severe ulcerative colitis
Drug Interactions
- Antibiotics (tetracyclines, quinolones, cephalosporins)
- Antifungals (ketoconazole)
- Thyroid medications (levothyroxine)
- Iron supplements
- Other antacids (especially aluminum- or magnesium-containing antacids)
- Antihypertensives (ramipril)
- Anticonvulsants (phenytoin)
- Alcohol (increases stomach acid production)
Pregnancy and Breastfeeding
- Pregnancy Safety Category: Not classified by FDA (Category N). Some sources list pregnancy as a contraindication. Consult a physician before use during pregnancy.
- Fetal risks and teratogenicity are not well established.
- Excretion in breast milk and potential effects on neonates are unknown. Consult a physician before use during breastfeeding.
Drug Profile Summary
- Mechanism of Action: Neutralizes stomach acid (Magaldrate), provides local anesthetic action (Oxetacaine), reduces gas bubble surface tension (Simethicone).
- Side Effects: Constipation, diarrhea, chalky taste, nausea, vomiting, stomach cramps, allergic reactions, intestinal pain.
- Contraindications: Severe kidney disease, hypersensitivity, gastrointestinal obstruction. Pregnancy and breastfeeding are contraindicated in some sources.
- Drug Interactions: Antibiotics, antifungals, thyroid medications, iron supplements, other antacids, alcohol, antihypertensives, anticonvulsants.
- Pregnancy & Breastfeeding: Consult a physician before use. Safety not established.
- Dosage: Adults: 5-10 mL or 1-2 tablespoons 3-4 times daily after meals and at bedtime. Pediatric use not recommended. Adjustments based on renal function are needed.
- Monitoring Parameters: Renal function, magnesium levels, phosphate levels (with prolonged use).
Popular Combinations
- This combination of magaldrate, oxetacaine, and simethicone is itself a commonly used formulation. It may sometimes be combined with dicyclomine for added antispasmodic effect in some regions, but this combination may have increased risk of side effects.
Precautions
- General Precautions: Pre-screening for allergies, kidney function, and gastrointestinal disorders.
- Pregnant Women: Consult a physician; some sources contraindicate use.
- Breastfeeding Mothers: Consult a physician; some sources contraindicate use.
- Children & Elderly: Not recommended for children under 12. Use with caution in the elderly.
- Menstruating Individuals: May be helpful for period pain in certain formulations, consult a physician for advice.
- Lifestyle Considerations: Avoid alcohol and smoking. Maintain a balanced diet with adequate fiber and fluids. Driving may be impaired if drowsiness or dizziness occurs.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Magaldrate + Oxetacaine + Simethicone?
A: The typical adult dose is 5-10 mL (1-2 tablespoons) taken 3-4 times daily after meals and at bedtime. Pediatric use is generally not recommended.
Q2: Can this medicine be used during pregnancy or breastfeeding?
A: Safety during pregnancy and breastfeeding hasn’t been definitively established. Some sources contraindicate its use. Consult a physician before use.
Q3: What are the common side effects?
A: Common side effects include constipation, diarrhea, chalky taste, nausea, vomiting, stomach cramps.
Q4: Are there any serious side effects I should be aware of?
A: While rare, serious side effects include aluminum toxicity, hypermagnesemia, hypophosphatemia, and intestinal obstruction, especially with prolonged or excessive use.
Q5: Does this medication interact with other drugs?
A: It can interact with certain antibiotics, antifungals, thyroid medications, iron supplements, and other antacids. It is important to inform your doctor about all medications you are currently taking.
Q6: Can I consume alcohol while taking this medicine?
A: Alcohol is known to increase stomach acid production and may exacerbate symptoms. It’s best avoided.
Q7: How should this medicine be stored?
A: Store at room temperature away from direct sunlight and moisture. Keep out of reach of children.
Q8: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember, unless it is almost time for the next dose. Do not double the dose.
Q9: Is this medication safe for long-term use?
A: Long-term use may carry risks like phosphate depletion and bone softening. Consult your doctor about the duration of treatment.
Q10: Can this medication be used for children?
A: Its use in children under 12 is generally not recommended as its safety and efficacy have not been well established. Consult a pediatrician.
