Mintox Max Susp 355ml

Manufacturer MAJOR PHARMACEUTICALS 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 MIN-tox MAX suh-SPEN-shun (a-LOO-mi-num 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
Antacids (Aluminum Hydroxide, Magnesium Hydroxide), Defoaming Agent (Simethicone)
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Pregnancy Category
Not assigned (OTC product, generally considered Category B/C for individual components for occasional use)
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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?

Mintox Max is an over-the-counter liquid medicine used to relieve heartburn, indigestion, and gas. It works by neutralizing stomach acid and breaking up gas bubbles in your digestive system.
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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 medication and follow the instructions closely. Take your medication after meals and at bedtime, or as directed by your doctor. Before using, shake the medication well to ensure it is properly mixed.

When taking the liquid form of this medication, measure your dose carefully using the measuring device provided with the medication. If a measuring device is not included, ask your pharmacist for one to ensure accurate dosing.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it 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, take the missed dose as soon as you remember. However, if it is close to the 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 your medication as needed, do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Avoid foods and drinks that trigger your symptoms (e.g., spicy foods, fatty foods, caffeine, alcohol, carbonated beverages).
  • Eat smaller, more frequent meals.
  • Do not lie down immediately after eating; wait at least 2-3 hours.
  • Elevate the head of your bed if heartburn is worse at night.
  • Maintain a healthy weight.
  • Avoid smoking.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 10-20 mL (equivalent to 400-800 mg Aluminum Hydroxide, 400-800 mg Magnesium Hydroxide, 40-80 mg Simethicone) orally, four times daily, 20 minutes to 1 hour after meals and 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 orally, four times daily, or as directed by a physician. 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 hypermagnesemia and aluminum accumulation with chronic use.
Moderate: Avoid chronic use; monitor for hypermagnesemia and aluminum accumulation. Consider alternative agents.
Severe: Contraindicated due to risk of hypermagnesemia and aluminum toxicity.
Dialysis: Contraindicated due to risk of hypermagnesemia and aluminum toxicity.

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 are inorganic salts that act as antacids by neutralizing gastric acid, increasing gastric pH. Aluminum hydroxide tends to cause constipation, while magnesium hydroxide tends to cause diarrhea; their combination helps to balance these effects. Simethicone is a defoaming agent 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 and Magnesium are minimally absorbed (1-5% for Al, 15-30% for Mg); Simethicone is not absorbed.
Tmax: Not applicable for antacid action (immediate local effect); for absorbed ions, variable (hours).
FoodEffect: Taking after meals prolongs the neutralizing effect.

Distribution:

Vd: Not applicable for primary action; absorbed ions distribute throughout extracellular fluid.
ProteinBinding: Minimal for absorbed ions; Simethicone is not protein bound.
CnssPenetration: Limited for absorbed ions; Simethicone does not penetrate CNS.

Elimination:

HalfLife: Not applicable for primary action; absorbed ions are renally excreted (Al, Mg).
Clearance: Not applicable for primary action; absorbed ions cleared renally.
ExcretionRoute: Unabsorbed drug excreted in feces; absorbed ions (Al, Mg) excreted renally.
Unchanged: Nearly 100% for Simethicone; majority for Aluminum and Magnesium Hydroxides.
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Pharmacodynamics

OnsetOfAction: Within minutes (antacid effect); within 30 minutes (simethicone effect).
PeakEffect: Within 30-60 minutes (antacid effect).
DurationOfAction: 1-3 hours (on an empty stomach); up to 3-4 hours (if taken after meals).
Confidence: Medium

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, difficulty 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, although not everyone will experience them. Many people have either no side effects or only mild ones. If you encounter any of the following side effects, or if any other side effects bother you or do not go away, contact your doctor for advice:
- Diarrhea
- Constipation

Important Note: This list does not include all possible side effects. If you have concerns about side effects, consult your doctor. For medical advice regarding 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 experience severe abdominal pain.
  • You have difficulty swallowing.
  • You vomit blood or have black, tarry stools.
  • You experience unexplained weight loss.
  • Signs of too much magnesium (e.g., feeling very tired, weak muscles, slow heartbeat, low blood pressure).
  • Signs of too little phosphate (e.g., muscle weakness, bone pain, fatigue).
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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 allergic reaction you experienced, including any symptoms that occurred.
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 health conditions and medications with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or concerns

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication with all your other drugs and health conditions.
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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 take other medications by mouth, your doctor may recommend taking them at a different time than this drug to minimize interactions. Be sure to discuss this with your doctor.

If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor. You and your doctor will need to weigh the benefits and risks of this medication to both you and your baby to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Severe constipation or diarrhea
  • Nausea, vomiting
  • Abdominal pain
  • Signs of hypermagnesemia (e.g., lethargy, muscle weakness, hypotension, bradycardia, respiratory depression, coma)
  • Signs of hypophosphatemia (with chronic aluminum hydroxide overdose: muscle weakness, bone pain, fatigue, confusion)

What to Do:

Discontinue use. For severe symptoms or suspected overdose, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222 in the US).

Drug Interactions

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Major Interactions

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

  • Digoxin: Decreased absorption.
  • Iron salts: Decreased absorption.
  • Ketoconazole, Itraconazole: Decreased absorption due to increased gastric pH.
  • Mycophenolate mofetil: Decreased absorption.
  • Gabapentin: Decreased absorption.
  • H2-receptor antagonists (e.g., ranitidine, famotidine): Reduced efficacy if taken concurrently due to pH alteration.
  • Sodium polystyrene sulfonate (Kayexalate): Risk of metabolic alkalosis and intestinal necrosis (with aluminum hydroxide).
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Minor Interactions

  • Salicylates: Increased urinary excretion of salicylates.
  • Sulfonylureas: Potentially altered absorption.

Monitoring

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Routine Monitoring

Symptom relief (heartburn, indigestion, gas)

Frequency: Daily, as needed

Target: Resolution or significant reduction of symptoms

Action Threshold: Persistent or worsening symptoms after 2 weeks of use; consult physician.

Bowel habits (constipation/diarrhea)

Frequency: Daily, as needed

Target: Normal bowel function

Action Threshold: Severe constipation or diarrhea; consult physician.

Serum Magnesium (for chronic high-dose use or renal impairment)

Frequency: Periodically, as clinically indicated

Target: 1.5-2.5 mg/dL

Action Threshold: >2.5 mg/dL (hypermagnesemia); discontinue or reduce dose.

Serum Phosphate (for chronic high-dose aluminum hydroxide use)

Frequency: Periodically, as clinically indicated

Target: 2.5-4.5 mg/dL

Action Threshold: <2.5 mg/dL (hypophosphatemia); discontinue or reduce dose, consider phosphate supplementation.

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Symptom Monitoring

  • Persistent heartburn or indigestion
  • Severe abdominal pain
  • Difficulty swallowing
  • Vomiting blood or black, tarry stools
  • Unexplained weight loss
  • Signs of hypermagnesemia (e.g., muscle weakness, lethargy, hypotension, bradycardia)
  • Signs of hypophosphatemia (e.g., muscle weakness, bone pain, fatigue)

Special Patient Groups

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Pregnancy

Generally considered safe for occasional use during pregnancy, but consult a healthcare provider before use. Avoid chronic or high-dose use due to potential for electrolyte imbalances (e.g., hypophosphatemia with aluminum, hypermagnesemia).

Trimester-Specific Risks:

First Trimester: Low risk with occasional use.
Second Trimester: Low risk with occasional use.
Third Trimester: Low risk with occasional use; however, avoid excessive magnesium intake near term as it may affect uterine contractions.
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Lactation

Generally considered safe for use during breastfeeding. Minimal absorption of active ingredients means negligible transfer into breast milk.

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 physician. Dosing must be carefully adjusted by age and weight. Avoid in very young infants unless specifically directed by a doctor. Risk of aluminum accumulation in premature infants or those with renal impairment.

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Geriatric Use

Use with caution, especially in patients with impaired renal function, due to increased risk of hypermagnesemia and aluminum accumulation. Start with lower doses and monitor for adverse effects and drug interactions.

Clinical Information

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Clinical Pearls

  • Shake the suspension well before each use.
  • Take this medication 20 minutes to 1 hour after meals and at bedtime for best results.
  • Separate administration of this antacid from other medications by at least 2 hours (before or after) to minimize drug interactions, especially with antibiotics (tetracyclines, fluoroquinolones), thyroid hormones, and bisphosphonates.
  • Aluminum hydroxide can cause constipation, and magnesium hydroxide can cause diarrhea. The combination aims to balance these effects, but individual responses vary.
  • Simethicone is not absorbed and works by physically breaking down gas bubbles, providing relief from bloating and flatulence.
  • Not intended for long-term daily use without medical supervision. If symptoms persist for more than 2 weeks, consult a healthcare provider.
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Alternative Therapies

  • H2-receptor antagonists (e.g., famotidine, ranitidine) for longer-lasting acid reduction.
  • Proton pump inhibitors (e.g., omeprazole, lansoprazole) for more potent and prolonged acid suppression.
  • Other antacids (e.g., calcium carbonate, sodium bicarbonate).
  • Dietary and lifestyle modifications.
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Cost & Coverage

Average Cost: $5 - $15 per 355 mL bottle
Generic Available: Yes
Insurance Coverage: Not typically covered by prescription insurance as it is an OTC product; 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 your 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 medication taken, the amount, and the time it happened.