Simethicone 80mg Chewable Tablets
It is used to ease too much gas in the GI (gastrointestinal) tract.
Drug Class
Antiflatulent
Pharmacologic Class
Surfactant, Antifoaming Agent
Pregnancy Category
Category A
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Simethicone is an anti-gas medicine that works in your stomach and intestines to break up gas bubbles, making it easier for your body to get rid of them. It helps relieve bloating, pressure, and discomfort caused by too much gas. It is not absorbed into your body.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication after meals and at bedtime, or as directed by your doctor. Be sure to chew the medication thoroughly 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. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your normal 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.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication after meals and at bedtime, or as directed by your doctor. Be sure to chew the medication thoroughly 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. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your normal 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.
Lifestyle & Tips
- Avoid gas-producing foods (e.g., beans, broccoli, cabbage, carbonated drinks, fatty foods).
- Eat slowly and chew food thoroughly to reduce air swallowing.
- Avoid chewing gum and hard candy.
- Do not smoke, as it can cause air swallowing.
- Regular exercise may help with gas relief.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
80 mg to 125 mg after meals and at bedtime, or as needed. Do not exceed 500 mg in 24 hours.
Dose Range:
80 - 125 mg
Condition-Specific Dosing:
generalGasRelief:
80 mg to 125 mg as needed, up to 4 times daily.
Pediatric Dosing
Neonatal:
Consult physician. Some sources suggest 20 mg.
Infant:
Under 2 years (or under 24 lbs): 20 mg (0.3 mL of drops) 4 times daily, up to 12 doses/day. Do not exceed 240 mg in 24 hours.
Child:
2 to 12 years: 40 mg 4 times daily. Do not exceed 480 mg in 24 hours.
Adolescent:
Over 12 years: 80 mg to 125 mg after meals and at bedtime, or as needed. Do not exceed 500 mg in 24 hours.
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
Mechanism of Action
Simethicone is an antifoaming agent that reduces the surface tension of gas bubbles in the gastrointestinal tract. This causes the bubbles to coalesce into larger bubbles, which are then more easily eliminated by belching or passing flatus. It acts locally in the GI tract and is not absorbed into the bloodstream.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible (not absorbed)
Tmax:
Not applicable (not absorbed)
FoodEffect:
Taken after meals for best effect, but absorption is not affected as it is not absorbed.
Distribution:
Vd:
Not applicable (not absorbed)
ProteinBinding:
Not applicable (not absorbed)
CnssPenetration:
No (not absorbed)
Elimination:
HalfLife:
Not applicable (not absorbed)
Clearance:
Not applicable (not absorbed)
ExcretionRoute:
Feces (unchanged)
Unchanged:
100%
Pharmacodynamics
OnsetOfAction:
Minutes to hours
PeakEffect:
Not well-defined due to local action
DurationOfAction:
Variable, depends on gastrointestinal transit time
Safety & Warnings
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
+ 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 any side effects that bother you or do not go away, contact your doctor or seek medical help.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor. For medical advice about side effects, you can also call your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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
+ 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 any side effects that bother you or do not go away, contact your doctor or seek medical help.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor. For medical advice about side effects, you can also call your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Worsening or persistent abdominal pain
- Severe constipation
- Blood in stool
- Fever
- Unexplained weight loss
- Symptoms of appendicitis or other serious conditions (e.g., nausea, vomiting, severe pain)
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.
Potential interactions with other medications or health conditions. This drug may affect or be affected by other medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
All medications you are currently taking, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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.
Potential interactions with other medications or health conditions. This drug may affect or be affected by other medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
All medications you are currently taking, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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 to ensure the best possible outcome for both you and your baby.
Overdose Information
Overdose Symptoms:
- Generally considered non-toxic even in large doses due to lack of systemic absorption.
- May cause mild gastrointestinal upset (e.g., diarrhea, nausea) in very rare cases.
What to Do:
Due to minimal absorption, overdose is unlikely to cause serious effects. If a large amount is ingested, contact a poison control center (Call 1-800-222-1222) for advice. Supportive care is usually sufficient.
Drug Interactions
Monitoring
Baseline Monitoring
Not typically required
Rationale: Simethicone is an OTC medication with minimal systemic absorption and a high safety profile.
Timing: Not applicable
Routine Monitoring
Symptom relief (gas, bloating, discomfort)
Frequency: As needed
Target: Reduction or resolution of symptoms
Action Threshold: If symptoms persist or worsen after several days of use, consult a healthcare provider.
Symptom Monitoring
- Relief of gas
- Reduction in bloating
- Decrease in abdominal pressure
- Improvement in abdominal discomfort
Special Patient Groups
Pregnancy
Considered safe for use during pregnancy due to its lack of systemic absorption. It does not enter the bloodstream and therefore is not expected to reach the fetus.
Trimester-Specific Risks:
First Trimester:
Minimal to no risk.
Second Trimester:
Minimal to no risk.
Third Trimester:
Minimal to no risk.
Lactation
Considered safe for breastfeeding mothers and infants due to its lack of systemic absorption. It is not excreted in breast milk.
Infant Risk:
L1 (Safest) - No known risk to the breastfed infant.
Pediatric Use
Safe and commonly used in infants and children. Age-specific dosing instructions must be followed carefully. Always use the pediatric drops formulation for infants and young children.
Geriatric Use
No specific dose adjustment needed. Simethicone is safe for use in elderly patients as it is not systemically absorbed and does not interact with other medications or pre-existing conditions in a significant way.
Clinical Information
Clinical Pearls
- Simethicone acts locally in the gastrointestinal tract and is not absorbed into the bloodstream, making it a very safe option for gas relief.
- It is effective for symptoms of gas, bloating, and abdominal discomfort, but does not prevent gas formation.
- Chewable tablets should be chewed thoroughly before swallowing for optimal effect.
- Can be used before diagnostic procedures (e.g., endoscopy, ultrasound) to reduce gas shadows and improve visualization.
- Often combined with antacids in various OTC products for broader digestive relief.
Alternative Therapies
- Dietary modifications (e.g., avoiding gas-producing foods, lactose, gluten)
- Probiotics (for some causes of gas and bloating related to gut flora imbalance)
- Alpha-galactosidase enzyme (e.g., Beano, for gas caused by complex carbohydrates in beans and vegetables)
- Lactase enzyme (for gas caused by lactose intolerance)
- Activated charcoal (less common for chronic gas, can cause constipation)
- Peppermint oil (enteric-coated, for IBS-related gas and bloating)
Cost & Coverage
Average Cost:
Low cost (typically $5-$15) per 30 tablets
Generic Available:
Yes
Insurance Coverage:
OTC medication, generally not covered by insurance unless prescribed or purchased with a Flexible Spending Account (FSA) or Health Savings Account (HSA).
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.