Usage
Diastase + Pepsin + Simethicone is prescribed for digestive disorders, including dyspepsia (indigestion), flatulence (gas), bloating, infant colic, and abdominal distension. It is also used to improve digestion and nutrient absorption, especially in individuals with slow digestion or enzyme deficiencies. This combination medication falls under the pharmacological classifications of digestive aids and antiflatulents. It works by breaking down carbohydrates and proteins, reducing gas and bloating, and relieving stomach discomfort.
Alternate Names
This combination medication doesn’t have a universally recognized international nonproprietary name (INN). It is often referred to simply by its component ingredients. Some common brand names include Colicaid EZ, Digras, and others. Different manufacturers in various regions might market it under different trade names.
How It Works
Pharmacodynamics:
- Diastase: This amylase enzyme breaks down starch into simpler sugars (maltose and dextrins), aiding carbohydrate digestion.
- Pepsin: This proteolytic enzyme breaks down proteins into smaller peptides and amino acids, facilitating protein digestion.
- Simethicone: This anti-foaming agent reduces the surface tension of gas bubbles in the gastrointestinal tract, allowing them to coalesce and be expelled more easily, thereby relieving bloating and discomfort.
Pharmacokinetics:
- Absorption: Diastase and Pepsin are administered orally, with absorption occurring primarily in the small intestine.
- Metabolism: Minimal metabolism of the enzymes occurs as they work primarily within the gut lumen.
- Elimination: These enzymes are primarily eliminated through fecal excretion. Simethicone, being inert, is also eliminated unchanged in the feces.
Dosage
Standard Dosage
Adults:
The standard adult dosage varies depending on the formulation and manufacturer. A common recommendation for syrup formulations is 5-10 mL after meals, once or twice daily. Tablet formulations often recommend 2-4 tablets after meals, taken once or twice daily.
Children:
For infants below 1 year: 0.5 ml - 1 ml daily in single or divided doses. For children above 1 year: 1 ml daily in single or divided doses during or immediately after a meal. Dosing should be determined by a pediatrician based on the child’s age and weight.
Special Cases:
- Elderly Patients: Dose adjustments may be needed due to age-related changes in renal and hepatic function.
- Patients with Renal Impairment: Dose modifications may be necessary depending on the degree of impairment.
- Patients with Hepatic Dysfunction: Dosage adjustments are generally not necessary as the drug isn’t significantly metabolized by the liver. However, caution is still recommended.
- Patients with Comorbid Conditions: For patients with conditions like diabetes, pancreatitis or other gastrointestinal issues, dosing must be carefully considered and adapted by a physician.
Clinical Use Cases
Dosage in specific clinical settings is not explicitly defined for this drug combination. It is not generally utilized for the management of conditions that require intubation, surgical procedures, mechanical ventilation, or ICU management. Its use is primarily limited to symptomatic relief of dyspepsia and other related conditions.
Dosage Adjustments
Dose adjustments might be required based on factors such as age, coexisting medical conditions (especially renal and hepatic impairment), and individual response to the medication.
Side Effects
Common Side Effects
- Nausea
- Vomiting
- Constipation
- Diarrhea
- Abdominal discomfort
- Chills
- Dry mouth
Rare but Serious Side Effects
- Allergic reactions (rash, itching, swelling) - seek immediate medical attention.
Long-Term Effects
No specific long-term effects have been documented for this drug combination. However, it’s not recommended for prolonged use without medical supervision.
Adverse Drug Reactions (ADR)
Severe allergic reactions can be considered a significant ADR requiring immediate medical intervention.
Contraindications
- Hypersensitivity to any of the components (diastase, pepsin, simethicone)
- Acute pancreatitis
- Pork protein allergy (if pepsin is derived from porcine sources)
- Fructose intolerance
- Glucose-galactose malabsorption
- Pre-existing gastrointestinal bleeding
Drug Interactions
- Antacids (aluminum hydroxide, magnesium hydroxide): May reduce the effectiveness of the enzymes.
- H2 receptor antagonists (ranitidine): May impact the effectiveness of the enzymes.
- Proton pump inhibitors (omeprazole): May interfere with the enzymes’ activity.
- Anti-diabetic drugs (acarbose, miglitol): Diastase and pepsin may reduce the effectiveness of these medications.
- Alcohol: Can exacerbate heartburn and indigestion.
Pregnancy and Breastfeeding
The safety during pregnancy and breastfeeding has not been definitively established. Consult a physician before use. Caution is advised, and it is generally recommended to use only if clearly needed and under medical supervision.
Drug Profile Summary
- Mechanism of Action: Diastase breaks down carbohydrates, pepsin breaks down proteins, and simethicone reduces gas bubbles.
- Side Effects: Nausea, vomiting, constipation, diarrhea, abdominal discomfort, allergic reactions.
- Contraindications: Hypersensitivity, acute pancreatitis, pork protein allergy.
- Drug Interactions: Antacids, H2 blockers, PPIs, anti-diabetic drugs, alcohol.
- Pregnancy & Breastfeeding: Consult a physician before use.
- Dosage: Varies depending on the formulation and patient’s age; typically administered after meals.
- Monitoring Parameters: Resolution of digestive symptoms.
Popular Combinations
Diastase + Pepsin + Simethicone is sometimes combined with other enzymes (like papain) or vitamin B complex and Activated Charcoal to address vitamin deficiencies in the setting of digestive problems.
Precautions
- Assess for allergies and history of pancreatitis.
- Monitor renal and hepatic function, particularly in the elderly and those with impaired organ function.
- Patients with diabetes should use with caution.
- Avoid alcohol.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Diastase + Pepsin + Simethicone?
A: The dosage varies depending on the specific product and the individual’s age and condition. Consult the prescribing physician or the product packaging for specific instructions. General guidelines suggest 5-10 mL of syrup or 2-4 tablets for adults after meals, one or two times daily. Pediatric dosing should be determined by a doctor.
Q2: How does this combination medication work?
A: Diastase aids carbohydrate digestion, pepsin helps with protein digestion, and simethicone reduces gas formation.
Q3: What are the common side effects?
A: Common side effects include nausea, vomiting, constipation, diarrhea, and mild abdominal discomfort.
Q4: Who should not take this medication?
A: Individuals with hypersensitivity to any of the components, acute pancreatitis, or a pork protein allergy should avoid this medication.
Q5: Can pregnant or breastfeeding women take it?
A: Consult a doctor before using during pregnancy or breastfeeding, as safety has not been fully established.
Q6: Does it interact with other medications?
A: Yes, it can interact with antacids, H2 blockers, proton pump inhibitors, anti-diabetic medications, and alcohol. Inform your doctor about all other medications you are taking.
Q7: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember. If it’s close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose.
Q8: Can this be used for weight loss?
A: No, this combination is not intended for weight loss. It is a digestive aid, not a weight-loss supplement.
Q9: What are the long-term effects of taking this combination?
A: No significant long-term adverse effects have been reported with appropriate usage. However, prolonged use should be under medical supervision.
Q10: Are there any specific precautions for elderly patients?
A: Yes, dose adjustments may be necessary in the elderly due to age-related decline in kidney and liver function.
Q11: Can I drive or operate machinery after taking this medication?
A: Generally, this medication doesn’t impair driving or operating machinery. However, if you experience side effects like dizziness or headache, it is best to avoid these activities until the effects subside.
Q12: Are there any dietary restrictions while taking this medication?
A: No specific dietary restrictions are associated with this medication. However, maintaining a balanced diet and limiting foods that trigger indigestion or gas may be generally beneficial. It is also advisable to avoid excessive alcohol consumption, as it can exacerbate underlying digestive problems.
