Simethicone 180mg Capsules

Manufacturer RUGBY LABORATORIES Active Ingredient Simethicone Capsules and Tablets(sye METH i kone) Pronunciation sye METH i kone
It is used to ease too much gas in the GI (gastrointestinal) tract.
đŸˇī¸
Drug Class
Antiflatulent
đŸ§Ŧ
Pharmacologic Class
Surfactant; Defoaming agent
🤰
Pregnancy Category
Not available (minimal systemic absorption, generally considered safe)
✅
FDA Approved
Jan 1970
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Simethicone is an anti-gas medicine that helps relieve painful pressure, bloating, and fullness caused by excess gas. It works by breaking up gas bubbles in your stomach and intestines, making them easier to pass.
📋

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 this medication after meals and at bedtime, or as directed by your doctor.

Storing and Disposing of Your Medication

Store this 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 disposal, 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, 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 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).
  • Eat slowly and chew food thoroughly to reduce air swallowing.
  • Avoid chewing gum or sucking on hard candies.
  • Regular exercise may help with gas motility.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: 180 mg (1 capsule) to 250 mg (1-2 capsules/softgels) orally as needed after meals and at bedtime. Do not exceed 500 mg in 24 hours.
Dose Range: 180 - 500 mg

Condition-Specific Dosing:

gasRelief: 180 mg to 250 mg orally as needed, up to 4 times daily.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established for 180mg capsules. Simethicone drops (e.g., 20 mg/0.3 mL or 40 mg/0.6 mL) are typically used for infants: 20 mg (0.3 mL) to 40 mg (0.6 mL) up to 12 times daily, not exceeding 480 mg/day.
Infant: Not established for 180mg capsules. Simethicone drops (e.g., 20 mg/0.3 mL or 40 mg/0.6 mL) are typically used for infants: 20 mg (0.3 mL) to 40 mg (0.6 mL) up to 12 times daily, not exceeding 480 mg/day.
Child: For children 2-12 years: 40 mg to 125 mg orally as needed, up to 4 times daily. 180mg capsule may be too high a single dose for younger children. Consult pediatrician.
Adolescent: For children 12 years and older: Same as adult dosing (180 mg to 250 mg orally as needed, up to 4 times daily).
âš•ī¸

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

đŸ”Ŧ

Mechanism of Action

Simethicone is an antiflatulent that works by reducing the surface tension of gas bubbles in the gastrointestinal tract. This causes the bubbles to coalesce into larger bubbles, which are then more easily passed or absorbed. It acts as a defoaming agent, facilitating the elimination of gas by belching or passing flatus.
📊

Pharmacokinetics

Absorption:

Bioavailability: Negligible (less than 0.01%)
Tmax: Not applicable (minimal systemic absorption)
FoodEffect: Administered after meals for optimal effect on post-prandial gas.

Distribution:

Vd: Not applicable (not systemically distributed)
ProteinBinding: Not applicable (not systemically absorbed)
CnssPenetration: No

Elimination:

HalfLife: Not applicable (not systemically absorbed)
Clearance: Not applicable (not systemically absorbed)
ExcretionRoute: Feces (unchanged)
Unchanged: Nearly 100%
âąī¸

Pharmacodynamics

OnsetOfAction: Within 30 minutes
PeakEffect: Variable, as needed for symptom relief
DurationOfAction: Variable, depends on gas production and elimination

Safety & Warnings

âš ī¸

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. Although rare, some people may have severe and potentially life-threatening side effects when taking this medication. Be aware of the following signs of a severe allergic reaction:
- 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 side effects that bother you or do not go away, contact your doctor for advice. Not all possible side effects are listed here. If you have questions or concerns about side effects, discuss them with your doctor.

Reporting Side Effects
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.
🚨

Seek Immediate Medical Attention If You Experience:

  • Severe or persistent abdominal pain
  • Bloody stools
  • Unexplained weight loss
  • Fever
  • Symptoms that worsen or do not improve after several days of use
📋

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 assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
âš ī¸

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, you must discuss this with your doctor. This conversation will help you understand the benefits and risks of taking this drug, both for you and your baby, allowing you to make an informed decision.
🆘

Overdose Information

Overdose Symptoms:

  • Simethicone is generally considered non-toxic, even in large doses, due to its lack of systemic absorption. Overdose symptoms are unlikely but could include mild gastrointestinal upset (e.g., diarrhea, constipation) if very large quantities are ingested.

What to Do:

Due to its inert nature and lack of absorption, specific medical intervention for simethicone overdose is rarely needed. If concerns arise or large quantities are ingested, contact a poison control center (Call 1-800-222-1222) or seek medical attention.

Drug Interactions

Monitoring

đŸ‘ī¸

Symptom Monitoring

  • Reduction in bloating
  • Decrease in abdominal discomfort
  • Reduction in flatulence
  • Improvement in feeling of fullness

Special Patient Groups

🤰

Pregnancy

Generally considered safe for use during pregnancy due to minimal to no systemic absorption. Consult a healthcare provider before use.

Trimester-Specific Risks:

First Trimester: Low risk
Second Trimester: Low risk
Third Trimester: Low risk
🤱

Lactation

Considered safe for use during breastfeeding as it is not absorbed systemically by the mother and therefore not excreted in breast milk. L1 (Safest) rating.

Infant Risk: No known risk to the breastfed infant.
đŸ‘ļ

Pediatric Use

Safe for use in infants and children when dosed appropriately for age and weight, typically using liquid drops for younger children. Always follow product-specific dosing instructions or consult a pediatrician.

👴

Geriatric Use

No specific dose adjustment needed for elderly patients. Generally well-tolerated. Use adult dosing.

Clinical Information

💎

Clinical Pearls

  • Simethicone provides symptomatic relief and does not prevent gas formation.
  • It is often combined with antacids in various OTC products, but its mechanism of action is distinct.
  • Advise patients that while effective for gas, persistent or severe abdominal pain should be evaluated by a healthcare professional.
  • Chewable tablets should be chewed thoroughly before swallowing for best effect.
🔄

Alternative Therapies

  • Alpha-galactosidase (e.g., Beano) for gas from complex carbohydrates
  • Lactase enzyme (e.g., Lactaid) for lactose intolerance
  • Activated charcoal (less common for gas, can cause constipation)
  • Dietary modifications (avoiding gas-producing foods)
  • Probiotics (for some individuals with digestive issues)
💰

Cost & Coverage

Average Cost: $5 - $20 per 30-60 capsules/softgels
Generic Available: Yes
Insurance Coverage: Generally OTC, not typically covered by insurance unless prescribed or through FSA/HSA.
📚

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 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 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.