Pedigas

Approved Indications:

• Gastrointestinal Gas Relief:
• Treatment of symptoms associated with excessive gas, including bloating, flatulence, abdominal pressure, and discomfort caused by trapped gas in the stomach or intestines.
• Diagnostic Use:
• Adjunct in abdominal imaging (e.g., X-ray, ultrasound, endoscopy) to reduce gas bubbles and improve visualization.
• Pediatric Use:
• Relief of infant colic and gastrointestinal gas symptoms in neonates and infants.

Off-label or Clinically Accepted Uses:

• Irritable Bowel Syndrome (IBS): Adjunctive therapy for gas-related symptoms such as bloating.
• Functional Dyspepsia: Used in combination regimens for upper gastrointestinal discomfort associated with gas.
• Post-laparoscopic Surgery: Alleviation of postoperative pain due to residual insufflation gas.

Route of Administration: Oral

Formulations Available in Bangladesh (Medex Verified):

• Oral drops: 40 mg/mL
• Oral emulsion: 40 mg/0.6 mL
• Chewable tablets: 40 mg, 80 mg, 125 mg
• Softgel capsules: 125 mg, 180 mg

Adults and Adolescents (≥12 years):

• 40–125 mg orally, 4 times daily after meals and at bedtime.
• Maximum daily dose: Generally not to exceed 500 mg.

Children (2 to 12 years):

• 40–50 mg orally, 3 to 4 times daily after meals and at bedtime.
• Use chewable tablets or oral suspension.

Infants (<2 years):

• Oral drops: 20–40 mg (0.3–0.6 mL) per dose, up to 4 times daily.
• Can be given directly or mixed with formula or water.

Elderly:

• No specific dose adjustment necessary.

Renal/Hepatic Impairment:

• Dose adjustment not required as Simethicone is not systemically absorbed.

Administration Instructions:

• Chewable tablets must be chewed thoroughly before swallowing.
• Liquid preparations should be shaken well before use.
• Best taken after meals and before bedtime.

Simethicone is an inert, surface-active agent that acts as an anti-foaming agent. It reduces the surface tension of gas bubbles in the gastrointestinal tract, causing them to merge into larger bubbles that can be more easily passed via belching or flatus. This mechanical action facilitates gas dispersion without altering gastric secretions, motility, or pH. Simethicone does not undergo systemic absorption or pharmacologic activity and is purely a physical agent acting locally in the gut.

• Absorption: Not absorbed from the gastrointestinal tract.
• Distribution: No systemic distribution; remains localized within the gut.
• Metabolism: Not metabolized.
• Excretion: Excreted unchanged in feces.
• Onset of Action: Typically within 15 to 30 minutes of oral administration.
• Bioavailability: 0% (non-systemic).
• Half-life: Not applicable.
• Elimination Route: Fecal.

Pregnancy:

• FDA Category C (old classification); however, clinical use and non-absorption support safety in pregnancy.
• Considered safe during pregnancy due to absence of systemic exposure.

Lactation:

• Not excreted in human breast milk.
• No adverse effects reported in breastfed infants.
• Safe for use during breastfeeding.

Note: No known reproductive toxicity or teratogenicity. Use considered acceptable in both pregnancy and lactation.

• Primary Class: Antiflatulent
• Subclass: Gastrointestinal gas-relieving agent
• Nature: Non-systemic, surface-active silicone compound

• Known hypersensitivity to Simethicone or any of its inactive ingredients.
• Suspected intestinal obstruction or gastrointestinal perforation, where masking of symptoms may delay diagnosis.

• Persistent symptoms: Prolonged bloating or abdominal discomfort should be evaluated to rule out underlying disorders.
• Allergic components: Some formulations contain dyes, flavorings, or sweeteners (e.g., sorbitol, aspartame) that may cause hypersensitivity or adverse reactions.
• Pediatric Use: Ensure accurate dosing in infants; do not exceed recommended limits.
• Diagnostic clarity: Avoid masking symptoms of serious gastrointestinal disease.
• Surgical Use: Caution in post-abdominal surgery unless obstruction is excluded.

Common (but mild):

• Gastrointestinal:
• Soft stools
• Mild diarrhea or constipation (rare)

Rare but Serious:

• Hypersensitivity:
• Rash
• Itching or swelling (face/lips/throat)
• Anaphylaxis (extremely rare; often due to excipients, not Simethicone itself)

Systemic Side Effects: None reported due to non-absorption.

Timing:

• Typically mild and transient
• No dose-dependent toxicity

• Drug–Drug Interactions:
• No significant pharmacokinetic interactions.
• May interfere with antacid absorption if co-administered—prefer staggered timing.
• Drug–Food Interactions: None known.
• Drug–Alcohol Interactions: None reported.
• Enzyme System Involvement: Not applicable (non-systemic).

• No major changes by FDA, EMA, or WHO in recent years.
• Continues to be listed as a first-line treatment for infant gas and adult bloating.
• Pediatric guidelines still support use for symptomatic gas relief in colicky infants.
• No newly added safety warnings, labeling changes, or contraindications.

• Temperature: Store at 20°C to 25°C (68°F to 77°F).
• Excursion Limits: Allowable between 15°C and 30°C.
• Protection:
• Protect from excessive heat, light, and moisture.
• Do not freeze liquid preparations.
• Handling:
• Shake suspensions well before each use.
• Ensure tight closure of bottles after opening.
• Shelf Life: Usually 1 to 2 years from the date of manufacture; check packaging.