Mag-Al Plus Liquid

Manufacturer PHARMACEUTICAL ASSOCIATES Active Ingredient Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone Suspension(a LOO mi num hye DROKS ide, mag NEE zhum hye DROKS ide, & sye METH i kone) Pronunciation AL-oo-MIN-um hye-DROK-side, mag-NEE-zhum hye-DROK-side, & sye-METH-i-kone
It is used to ease too much gas in the stomach.It is used to treat heartburn and upset stomach.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antacid, Antiflatulent
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Pharmacologic Class
Aluminum salt, Magnesium salt, Surfactant
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This medicine is a liquid antacid and anti-gas medication. It works by neutralizing stomach acid to relieve heartburn and indigestion, and by breaking up gas bubbles to relieve bloating and discomfort.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication after meals and at bedtime, or as directed by your doctor.

Before using the liquid form of this medication, shake the bottle well. To ensure accurate dosing, measure the liquid carefully using the measuring device provided with the medication. If a measuring device is not included, ask your pharmacist for one.

Storing and Disposing of Your Medication

Store your medication at room temperature, with the lid tightly closed. Avoid freezing the medication and keep it in a dry place. Do not store your medication in a bathroom. Keep all medications in a safe location, out of the reach of children and pets.

What to Do If You Miss a Dose

If you take your medication on a regular schedule and miss a dose, take it as soon as you remember. However, if it's almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Shake the bottle well before each use.
  • Do not take this medication within 2 hours of other medications, especially antibiotics (like tetracyclines or fluoroquinolones), iron supplements, or thyroid hormones, as it can interfere with their absorption.
  • Take between meals and at bedtime for best results.
  • Do not exceed the recommended dose.
  • If you are on a low-phosphate diet, consult your doctor before using this product.
  • Maintain adequate fluid intake to help prevent constipation (if experienced).
  • Avoid foods and drinks that trigger heartburn or gas (e.g., spicy foods, fatty foods, caffeine, carbonated beverages).
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 10-20 mL (2-4 teaspoonfuls) between meals, at bedtime, or as directed by a physician.
Dose Range: 10 - 20 mg

Condition-Specific Dosing:

heartburn: 10-20 mL as needed
indigestion: 10-20 mL as needed
gas: 10-20 mL as needed
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (consult physician)
Child: 6-12 years: 5-10 mL (1-2 teaspoonfuls) as needed, not exceeding 40 mL in 24 hours. Under 6 years: Consult physician.
Adolescent: 12 years and older: Same as adult dosing.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor for electrolyte imbalances (magnesium, aluminum, phosphate).
Moderate: Use with caution; reduced dose or avoid if possible. Monitor for hypermagnesemia and aluminum toxicity.
Severe: Contraindicated due to risk of hypermagnesemia and aluminum accumulation (encephalopathy, osteomalacia).
Dialysis: Contraindicated. Aluminum and magnesium are poorly dialyzable and can accumulate.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed.

Pharmacology

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Mechanism of Action

Aluminum Hydroxide and Magnesium Hydroxide act as antacids by neutralizing gastric acid, increasing gastric pH. Aluminum hydroxide also has a constipating effect, while magnesium hydroxide has a laxative effect, balancing the bowel effects in combination. Simethicone is an antiflatulent that reduces the surface tension of gas bubbles in the gastrointestinal tract, causing them to coalesce and be more easily expelled.
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Pharmacokinetics

Absorption:

Bioavailability: Aluminum Hydroxide: Minimally absorbed (approx. 15-30% of aluminum ions). Magnesium Hydroxide: Minimally absorbed (approx. 15-30% of magnesium ions). Simethicone: Not absorbed.
Tmax: Not applicable for simethicone. For antacid effect, onset is immediate.
FoodEffect: Taking with food may prolong the duration of acid neutralization.

Distribution:

Vd: Not applicable for simethicone. For absorbed Al/Mg, distributed throughout extracellular fluid.
ProteinBinding: Not applicable for simethicone. For absorbed Al/Mg, minimal protein binding.
CnssPenetration: Limited for Al/Mg in healthy individuals; can penetrate in renal failure leading to toxicity. Simethicone: No.

Elimination:

HalfLife: Not applicable for simethicone. For absorbed Al/Mg, renally excreted. Unabsorbed portions are eliminated in feces.
Clearance: Not applicable for simethicone. For absorbed Al/Mg, primarily renal clearance.
ExcretionRoute: Fecal (unabsorbed Al/Mg, all simethicone); Renal (absorbed Al/Mg).
Unchanged: Simethicone: 100% unchanged. Al/Mg: Unabsorbed portion excreted unchanged in feces.
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Pharmacodynamics

OnsetOfAction: Immediate (within minutes for antacid effect).
PeakEffect: Within 30 minutes for antacid effect.
DurationOfAction: 1-3 hours (dependent on gastric emptying rate).

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.

Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor if you experience any of the following side effects or if they persist or bother you:
- Diarrhea
- Constipation

Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Symptoms worsen or do not improve after 2 weeks of use.
  • You develop black, tarry stools or vomit that looks like coffee grounds (signs of bleeding).
  • You experience severe stomach pain.
  • You experience unusual weakness, muscle cramps, or dizziness (signs of electrolyte imbalance).
  • You have kidney disease and experience any new or worsening symptoms.
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you have kidney problems, as this may affect the safety and efficacy of the medication.

This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other medications and health conditions.

Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are following a low-magnesium diet, consult with your doctor to discuss any potential interactions. Do not exceed the prescribed duration of treatment with this drug, as directed by your doctor.

This medication may interfere with the absorption of other oral medications, reducing their effectiveness. If you are taking other drugs by mouth, your doctor may recommend taking them at a different time than this medication to minimize potential interactions.

If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe diarrhea (magnesium overdose)
  • Constipation (aluminum overdose)
  • Nausea, vomiting
  • Muscle weakness, fatigue
  • Dizziness, lightheadedness
  • Slowed heart rate
  • Low blood pressure
  • Confusion, altered mental status (especially in kidney disease)
  • Bone pain (chronic aluminum toxicity)

What to Do:

Discontinue use. Seek immediate medical attention. Call 1-800-222-1222 (Poison Control Center) or go to the nearest emergency room.

Drug Interactions

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Major Interactions

  • Tetracyclines (e.g., doxycycline, minocycline): Reduced absorption due to chelation.
  • Fluoroquinolones (e.g., ciprofloxacin, levofloxacin): Reduced absorption due to chelation.
  • Bisphosphonates (e.g., alendronate): Reduced absorption.
  • Thyroid hormones (e.g., levothyroxine): Reduced absorption.
  • Digoxin: Reduced absorption.
  • Iron salts: Reduced absorption.
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Moderate Interactions

  • Azithromycin: Reduced absorption.
  • Captopril: Reduced absorption.
  • Corticosteroids (e.g., prednisone): May reduce absorption of corticosteroids.
  • Gabapentin: Reduced absorption.
  • Ketoconazole/Itraconazole: Reduced absorption due to increased gastric pH.
  • Mycophenolate mofetil: Reduced absorption.
  • Phenytoin: Reduced absorption.
  • Quinidine: Increased serum levels due to reduced excretion (alkaline urine).
  • Salicylates (e.g., aspirin): Increased excretion due to alkaline urine.
  • Sodium Polystyrene Sulfonate (Kayexalate): Risk of metabolic alkalosis and intestinal obstruction (especially with aluminum hydroxide).
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Minor Interactions

  • Benzodiazepines (e.g., diazepam): May delay absorption.
  • Non-steroidal anti-inflammatory drugs (NSAIDs): May reduce absorption.

Monitoring

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Baseline Monitoring

Renal function (BUN, Creatinine)

Rationale: To assess risk of aluminum and magnesium accumulation, especially in elderly or those with known renal issues.

Timing: Prior to initiating chronic or high-dose therapy.

Serum Electrolytes (Magnesium, Phosphate, Calcium)

Rationale: To establish baseline levels before chronic use, particularly in patients at risk for electrolyte imbalances (e.g., renal impairment, malnutrition).

Timing: Prior to initiating chronic or high-dose therapy.

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Routine Monitoring

Symptom relief (heartburn, indigestion, gas)

Frequency: Daily, as needed

Target: Resolution or significant reduction of symptoms

Action Threshold: If symptoms persist for more than 2 weeks or worsen, consult a physician.

Bowel habits

Frequency: Daily

Target: Normal bowel movements

Action Threshold: Significant constipation or diarrhea; adjust dose or consult physician.

Serum Magnesium, Phosphate, Calcium

Frequency: Periodically (e.g., monthly to quarterly) for chronic or high-dose use, especially in patients with renal impairment.

Target: Within normal limits

Action Threshold: Abnormal levels (e.g., hypermagnesemia, hypophosphatemia); discontinue or reduce dose, consult physician.

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Symptom Monitoring

  • Persistent or worsening heartburn
  • Persistent or worsening indigestion
  • Persistent or worsening gas/bloating
  • Constipation
  • Diarrhea
  • Muscle weakness
  • Dizziness
  • Confusion (signs of aluminum toxicity)
  • Slowed heart rate (signs of hypermagnesemia)

Special Patient Groups

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Pregnancy

Generally considered safe for occasional use at recommended doses during pregnancy, but prolonged or high-dose use should be avoided due to potential for electrolyte imbalances (e.g., hypermagnesemia, hypophosphatemia). Consult a healthcare provider before use.

Trimester-Specific Risks:

First Trimester: Low risk with occasional use.
Second Trimester: Low risk with occasional use.
Third Trimester: Low risk with occasional use, but high doses of magnesium near term could theoretically affect fetal heart rate or cause neonatal hypotonia (though rare with antacid doses). Aluminum accumulation is a theoretical concern with prolonged high doses.
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Lactation

Considered safe for use during lactation. Minimal absorption of active ingredients means negligible amounts are excreted into breast milk. Simethicone is not absorbed.

Infant Risk: Low risk to infant.
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Pediatric Use

Use in children under 12 years should be under the guidance of a healthcare professional. Dosing for children 6-12 years is reduced. Not recommended for infants or children under 6 years without medical advice.

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Geriatric Use

Use with caution in elderly patients, especially those with impaired renal function, due to increased risk of aluminum and magnesium accumulation and associated toxicities (e.g., hypermagnesemia, aluminum-induced encephalopathy or osteomalacia). Monitor renal function and electrolytes if used chronically.

Clinical Information

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Clinical Pearls

  • Always shake the suspension well before measuring each dose to ensure uniform distribution of active ingredients.
  • Advise patients to separate administration of this antacid from other medications by at least 2 hours to minimize drug interactions.
  • Warn patients with kidney disease about the serious risks of aluminum and magnesium accumulation; this product is generally contraindicated in severe renal impairment.
  • Educate patients that while this product provides symptomatic relief, it does not treat the underlying cause of heartburn or indigestion. If symptoms persist, further medical evaluation is needed.
  • The combination of aluminum (constipating) and magnesium (laxative) hydroxides aims to balance the bowel effects, but individual responses may vary.
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Alternative Therapies

  • H2-receptor antagonists (e.g., famotidine, ranitidine)
  • Proton pump inhibitors (e.g., omeprazole, lansoprazole)
  • Alginic acid-containing products (e.g., Gaviscon Advance)
  • Bismuth subsalicylate (for indigestion/diarrhea, not primary antacid)
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Cost & Coverage

Average Cost: $5 - $20 per 355 mL (12 fl oz) bottle
Generic Available: Yes
Insurance Coverage: OTC (Over-The-Counter) - generally not covered by prescription insurance, but may be eligible for FSA/HSA.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.