Simethicone 125mg Chewable Tablets

Manufacturer RELIABLE 1 LABS Active Ingredient Simethicone Chewable Tablets(sye METH i kone) Pronunciation sye METH i kone
It is used to ease too much gas in the GI (gastrointestinal) tract.
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Drug Class
Antiflatulent
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Pharmacologic Class
Surfactant; Antifoaming Agent
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Pregnancy Category
Not assigned (minimal systemic absorption)
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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?

Simethicone is an anti-gas medicine that helps break up gas bubbles in your stomach and intestines, making it easier for your body to get rid of them. It helps relieve bloating, pressure, and discomfort caused by excess gas.
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How to Use This Medicine

Taking Your Medication

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. Be sure to chew the medication well before swallowing.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or participate in a local drug take-back program if available.

Missing a Dose

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

  • Chew tablets thoroughly before swallowing for best results.
  • Take after meals and at bedtime, or as directed by a doctor.
  • Avoid gas-producing foods (e.g., beans, broccoli, carbonated drinks) if they worsen symptoms.
  • Stay hydrated and engage in light physical activity to help with gas passage.

Dosing & Administration

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Adult Dosing

Standard Dose: 125 mg to 250 mg after meals and at bedtime, as needed. Do not exceed 500 mg in 24 hours.
Dose Range: 125 - 250 mg

Condition-Specific Dosing:

general: Take as needed for gas, bloating, or discomfort.
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Pediatric Dosing

Neonatal: Not established (consult pediatrician for infants, liquid drops are typically used for younger ages)
Infant: Not established for chewable tablets (liquid drops are typically used for infants, e.g., 20-40 mg up to 4 times daily)
Child: Not established for 125mg chewable tablets for children under 12 years (for children 2-12 years, 80 mg chewable or liquid is common, consult pediatrician)
Adolescent: 125 mg to 250 mg after meals and at bedtime, as needed. Do not exceed 500 mg in 24 hours (same as adult).
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No adjustment needed; not systemically absorbed

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

Pharmacology

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Mechanism of Action

Simethicone is an antifoaming agent that works by reducing the surface tension of gas bubbles in the gastrointestinal tract. This causes the small gas bubbles to coalesce into larger bubbles, which can then be more easily passed or absorbed.
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Pharmacokinetics

Absorption:

Bioavailability: Negligible (not absorbed systemically)
Tmax: Not applicable (no systemic absorption)
FoodEffect: Taken after meals to address gas produced during digestion.

Distribution:

Vd: Not applicable
ProteinBinding: Not applicable
CnssPenetration: No

Elimination:

HalfLife: Not applicable
Clearance: Not applicable
ExcretionRoute: Feces (unchanged)
Unchanged: 100%
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes to hours)
PeakEffect: Not well-defined due to local action in the GI tract
DurationOfAction: Varies depending on gas production and expulsion

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- 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. However, many people do not experience any side effects or only have mild ones. If you have side effects that bother you or do not go away, contact your doctor for advice.

Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, discuss them with 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 last longer than 2 weeks
  • Severe abdominal pain
  • Blood in stool or black, tarry stools
  • Unexplained weight loss
  • Fever
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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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.

To ensure your safety, it is crucial to verify that this medication can be taken in conjunction with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are pregnant, planning to become pregnant, or are breast-feeding, be sure to discuss this with your doctor. You and your doctor will need to carefully weigh the benefits and risks of using this medication during this time to ensure the best possible outcome for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Simethicone is considered very safe due to its lack of systemic absorption. Overdose is unlikely to cause serious harm.
  • Mild gastrointestinal upset (e.g., diarrhea) might occur with extremely high doses, but is rare.

What to Do:

Due to minimal toxicity, management is generally supportive. If concerned, call a poison control center (1-800-222-1222) or seek medical attention.

Drug Interactions

Monitoring

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Symptom Monitoring

  • Relief of gas, bloating, and abdominal discomfort
  • Absence of new or worsening abdominal pain
  • Absence of signs of gastrointestinal bleeding (e.g., black, tarry stools)

Special Patient Groups

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Pregnancy

Simethicone is generally considered safe for use during pregnancy due to its lack of systemic absorption. Consult a healthcare provider before use.

Trimester-Specific Risks:

First Trimester: Low risk
Second Trimester: Low risk
Third Trimester: Low risk
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Lactation

Simethicone is considered safe for use during breastfeeding as it is not absorbed systemically by the mother and therefore cannot pass into breast milk.

Infant Risk: L1 (Safest)
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Pediatric Use

For children under 12 years, consult a pediatrician. Liquid simethicone drops are typically used for infants and younger children, with specific dosing based on age/weight. 125mg chewable tablets are generally for adolescents (12 years and older) and adults.

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Geriatric Use

No specific dose adjustment or special precautions are generally needed for geriatric patients, as simethicone is not systemically absorbed. Use as directed for adults.

Clinical Information

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Clinical Pearls

  • Simethicone works locally in the gut and is not absorbed into the bloodstream, making it a very safe option for gas relief.
  • Chewable tablets must be chewed thoroughly to release the active ingredient effectively.
  • It does not prevent gas formation but helps break down existing gas bubbles.
  • Often combined with antacids in combination products, but simethicone itself is not an antacid.
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Alternative Therapies

  • Alpha-galactosidase (e.g., Beano) for gas from certain foods
  • Activated charcoal (less common for routine gas, can cause constipation)
  • Dietary modifications (e.g., avoiding gas-producing foods, lactose avoidance)
  • Probiotics (for overall gut health, may indirectly help with gas for some individuals)
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Cost & Coverage

Average Cost: $5 - $15 per 30 tablets
Generic Available: Yes
Insurance Coverage: Not typically covered by insurance (Over-The-Counter)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure 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.