Alginic Acid + Magaldrate + Simethicone

Usage

This combination medication is prescribed for the symptomatic relief of gastrointestinal discomfort associated with excess stomach acid and gas. This includes heartburn, acid indigestion, sour stomach, upset stomach, bloating, gas pains, pressure/discomfort in the stomach/gut, gastroesophageal reflux disease (GERD), and as an adjunct therapy for peptic ulcers, gastritis, and esophagitis.

• Pharmacological Classification: This is a combination product containing a raft-forming agent (alginic acid), an antacid (magaldrate), and an antiflatulent (simethicone).

• Mechanism of Action: Alginic acid forms a viscous gel “raft” that floats on the stomach contents, creating a physical barrier against acid reflux. Magaldrate neutralizes excess stomach acid, increasing gastric pH. Simethicone reduces the surface tension of gas bubbles, allowing them to combine and be expelled more readily.

Alternate Names

This combination medication is available under various brand names such as Acigol-XT, Betacid, Dayflux, Gastril MPS, and Titer. There’s no widely recognized international non-proprietary name, and it is sometimes referred to as a “raft-forming antacid”.

How It Works

• Pharmacodynamics: Alginic acid creates a physical barrier against acid reflux. Magaldrate chemically neutralizes gastric acid, raising gastric pH and relieving associated symptoms. Simethicone physically reduces surface tension of gas bubbles, promoting their coalescence and expulsion.

• Pharmacokinetics: Alginic acid is not absorbed systemically. Some magnesium and aluminum from magaldrate may be absorbed, primarily excreted renally. Simethicone is not absorbed and is eliminated unchanged in the feces.

• Mode of Action/Receptor Binding/Enzyme Inhibition/Neurotransmitter Modulation: This combination acts through physical and chemical mechanisms rather than receptor binding, enzyme inhibition, or neurotransmitter modulation. Alginic acid’s raft formation is a physical process. Magaldrate’s acid neutralization is a chemical reaction. Simethicone’s effect on gas bubbles is physical. Elimination is described above.

Dosage

Standard Dosage

Adults: 5-10 mL (or 1-2 teaspoonfuls, equivalent to 540-1080 mg of magaldrate) four times daily, after meals and 30 minutes before bedtime. The maximum daily dose is 80 mL (16 teaspoonfuls).

Children: Consult a physician for pediatric dosing as safety and efficacy haven’t been fully established. Dosing is usually adjusted based on weight and age.

Special Cases:

• Elderly Patients: Use with caution; dose adjustment may be needed based on renal function. Monitor renal function and magnesium levels.
• Patients with Renal Impairment: Use with caution; dose reduction is often required. Closely monitor for hypermagnesemia. Contraindicated in severe renal impairment.
• Patients with Hepatic Dysfunction: While hepatic metabolism is not the primary route of elimination, caution is still recommended. Monitor patient’s condition.
• Patients with Comorbid Conditions: Consult a physician for patients with conditions such as diabetes, cardiovascular disease, or other relevant conditions.

Clinical Use Cases

This combination is not typically used in clinical settings like intubation, surgical procedures, mechanical ventilation, ICU, or emergency situations.

Dosage Adjustments

Dose modifications may be necessary based on renal function, concurrent medications, and patient tolerance.

Side Effects

Common Side Effects: Constipation, diarrhea, nausea, vomiting, stomach cramps, chalky taste in the mouth, loss of appetite.

Rare but Serious Side Effects: Allergic reactions (rash, itching, swelling, difficulty breathing); hypermagnesemia (high blood magnesium) in patients with renal impairment; aluminum toxicity (rare, usually with prolonged high doses).

Long-Term Effects: Potential for electrolyte imbalances with long-term use; possible bone problems (osteomalacia) with prolonged high doses of aluminum-containing antacids.

Adverse Drug Reactions (ADR): Any sign of an allergic reaction requires immediate medical attention. Hypermagnesemia symptoms should prompt immediate evaluation, especially in patients with impaired renal function.

Contraindications

Known hypersensitivity to any component; severe renal impairment; hypophosphatemia; hypermagnesemia.

Drug Interactions

May interact with tetracycline antibiotics, quinolone antibiotics, iron supplements, levothyroxine, bisphosphonates, digoxin, some antacids, and other medications. Separate administration by at least 2 hours. Consult a physician or pharmacist for a complete list. Interactions with OTC drugs, supplements, alcohol, smoking, or grapefruit juice haven’t been definitively established for this specific combination.

Pregnancy and Breastfeeding

Consult a physician before use. Generally considered safe for occasional use during pregnancy, but prolonged use should be avoided. Consult a physician before use during breastfeeding. Small amounts of aluminum and magnesium that may be absorbed are unlikely to pose a significant risk to the infant.

Drug Profile Summary

As above.

Popular Combinations

This combination itself is a popular formulation. It may be combined with other antacids or antiflatulents.

Precautions

As mentioned above in special cases. Additional precautions include informing the doctor about all health conditions and medications, avoiding prolonged use without consulting a physician, and monitoring for any adverse events. Specific considerations regarding menstruating individuals are not typically relevant with this medication. Lifestyle considerations such as alcohol and smoking are usually not contraindicated, however, it is essential to discuss any alcohol abuse and/or smoking habits with the physician before starting this medication. There are no specified driving restrictions after taking this medication, however, dizziness or sleepiness may occur after taking this medicine. It is recommended to avoid driving or operating machinery in such cases.

FAQs (Frequently Asked Questions)

Q1: What is the recommended dosage for Alginic Acid + Magaldrate + Simethicone?

A: Adults: Typically 5-10 mL (or 1-2 teaspoonfuls) four times a day, after meals and 30 minutes before bedtime. Consult a physician for pediatric dosing.

Q2: How does this combination work to relieve heartburn?

A: Alginic acid forms a protective raft over stomach contents, preventing acid reflux. Magaldrate neutralizes stomach acid, reducing irritation.

Q3: Can this medication be taken during pregnancy or while breastfeeding?

A: Consult a physician before use during pregnancy or breastfeeding. Occasional use is generally considered safe during pregnancy.

Q4: What are the common side effects?

A: Common side effects include constipation, diarrhea, nausea, vomiting, stomach cramps, chalky taste, and loss of appetite.

Q5: Are there any serious side effects I should be aware of?

A: Rare but serious side effects can include allergic reactions and hypermagnesemia (primarily in patients with renal impairment).

Q6: What should I do if I miss a dose?

A: If you miss a dose, take it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and continue your regular schedule. Do not double the dose.

Q7: Does this medication interact with other medications?

A: Yes, it can interact with various medications, including some antibiotics, iron supplements, and thyroid medications. Consult with your physician or pharmacist about potential interactions.

Q8: How should this medication be stored?

A: Store at room temperature away from moisture and heat. Keep out of reach of children. Refer to specific product labeling for detailed storage instructions.

Q9: Can I use this medication for long periods?

A: Consult a physician before using this medication for prolonged periods, as long-term use can potentially lead to electrolyte imbalances or other complications.