Usage
- This combination medication is prescribed for the symptomatic relief of indigestion, dyspepsia, and other related gastrointestinal issues. These issues may include abdominal discomfort, bloating, fullness, flatulence (gas), and fatty food intolerance. It is also used for patients with exocrine pancreatic insufficiency due to conditions like chronic pancreatitis or cystic fibrosis.
- Pharmacological Classification: Digestive aid and anti-foaming agent combination.
- Mechanism of Action: This drug combines three active ingredients that work synergistically to improve digestion and reduce gas:
- Pancreatin: A mixture of digestive enzymes (amylase, lipase, and protease) that break down carbohydrates, fats, and proteins, respectively.
- Simethicone: An anti-foaming agent that decreases the surface tension of gas bubbles in the GI tract, promoting their coalescence and expulsion.
- Sodium Tauroglycocholate: A bile salt that emulsifies fats, making them more accessible to pancreatic lipase for enhanced digestion and absorption.
Alternate Names
- Dizec (brand name in some regions)
- Pancreatin/Simethicone/Sodium Tauroglycocholate combination
How It Works
- Pharmacodynamics: Pancreatin facilitates the digestion of food, simethicone reduces gas, and sodium tauroglycocholate emulsifies fats to improve absorption.
- Pharmacokinetics:
- Absorption: Each component is absorbed orally and exerts its action within the gastrointestinal tract.
- Metabolism: Pancreatin enzymes are broken down in the GI tract. Simethicone is not absorbed and is eliminated unchanged in the feces. Sodium tauroglycocholate undergoes enterohepatic circulation.
- Elimination: Primarily via feces (simethicone and unabsorbed components); sodium tauroglycocholate after enterohepatic circulation.
- Mode of Action: Pancreatin enzymes catalyze the hydrolysis of fats, proteins, and carbohydrates. Simethicone reduces the surface tension of gas bubbles. Sodium tauroglycocholate emulsifies fats.
- Receptor Binding, Enzyme Inhibition, or Neurotransmitter Modulation: Not applicable to this combination.
- Elimination Pathways: Primarily fecal elimination for all components.
Dosage
Standard Dosage
Adults:
- One tablet orally with meals, three times a day.
Children:
- Dosage should be determined by a physician based on age and weight. Generally, lower doses are recommended.
Special Cases:
- Elderly Patients: Dose adjustment may be required. Start with a lower dose and increase as needed.
- Patients with Renal Impairment: Careful monitoring and possible dose adjustments are necessary.
- Patients with Hepatic Dysfunction: Use with caution and monitor closely. Dose adjustments might be needed.
- Patients with Comorbid Conditions: Individualized dosing based on the specific comorbidity.
Clinical Use Cases
- This medication is not typically used in clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. Its main purpose is to provide symptomatic relief of indigestion and related conditions.
Dosage Adjustments
- Dose modifications may be needed based on individual patient factors, such as renal and hepatic function, other medications, and response to therapy.
Side Effects
Common Side Effects
- Nausea
- Diarrhea
- Stomach pain
- Bloating
- Constipation
Rare but Serious Side Effects
- Severe abdominal discomfort
- Frequent/painful urination
- Joint pain
- Allergic reactions (rash, itching/swelling, severe dizziness, trouble breathing)
Long-Term Effects
- Data on long-term adverse effects are limited.
Adverse Drug Reactions (ADR)
- Similar to the rare but serious side effects. Seek immediate medical attention if any severe reactions occur.
Contraindications
- Hypersensitivity to any component (including pork protein allergy for pancreatin)
- Acute pancreatitis
- Worsening of chronic pancreatitis
- Biliary duct obstruction
Drug Interactions
- Antacids may interfere with the action of pancreatin.
- Iron supplements may reduce pancreatin’s effectiveness.
- Medications for diabetes (acarbose, miglitol) may interact with pancreatin.
Pregnancy and Breastfeeding
- Pregnancy: Consult a physician before use. Use only if clearly needed. Safety not fully established.
- Breastfeeding: Consult a physician before use. Safety not fully established.
Drug Profile Summary
- Mechanism of Action: Combines digestive enzymes, anti-foaming agent, and bile salt to improve digestion and reduce gas.
- Side Effects: Nausea, diarrhea, stomach pain, bloating, constipation (common); severe abdominal discomfort, allergic reactions (rare).
- Contraindications: Hypersensitivity, acute pancreatitis, worsening of chronic pancreatitis, biliary duct obstruction.
- Drug Interactions: Antacids, iron supplements, acarbose, miglitol.
- Pregnancy & Breastfeeding: Consult a physician before use.
- Dosage: One tablet orally with meals, three times daily for adults. Pediatric and special population dosing should be individualized.
- Monitoring Parameters: Monitor for symptom relief, digestive function, and any adverse effects.
Popular Combinations
- This combination itself is frequently used. Sometimes, antacids might be prescribed separately for added relief from heartburn if needed.
Precautions
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General Precautions: Evaluate for allergies (especially pork protein), history of pancreatitis, or biliary tract disease.
-
Specific Populations:
- Pregnant Women: Use cautiously and only if clearly needed.
- Breastfeeding Mothers: Use cautiously and under physician guidance.
- Children & Elderly: Dosage adjustment may be required.
-
Lifestyle Considerations: No specific restrictions on alcohol or smoking are noted, but moderation is always advisable.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Pancreatin + Simethicone + Sodium Tauroglycocholate?
A: The standard adult dose is one tablet with meals, three times a day. Pediatric and special population dosages should be individualized.
Q2: What are the common side effects?
A: Common side effects include nausea, diarrhea, stomach pain, bloating, and constipation.
Q3: Are there any contraindications?
A: Yes, contraindications include hypersensitivity, acute pancreatitis, worsening of chronic pancreatitis, and biliary duct obstruction.
Q4: What should I do if I miss a dose?
A: Take the next dose with your next meal or snack. Don’t double the dose.
Q5: Can this medication be taken during pregnancy or breastfeeding?
A: Consult a physician before using during pregnancy or breastfeeding. Safety isn’t fully established.
Q6: How does this medication interact with other drugs?
A: It may interact with antacids, iron supplements, and some diabetes medications.
Q7: How should this medication be stored?
A: Store at room temperature away from light and moisture.
Q8: Is this combination used in hospital settings?
A: No, it’s primarily for outpatient symptomatic relief of indigestion.
Q9: Does this medication contain pork products?
A: Pancreatin is typically sourced from pigs, so those with pork allergies should avoid it.
Q10: Can I crush or chew the tablets?
A: Swallow the tablets whole with water. Chewable forms should be chewed thoroughly before swallowing. If swallowing capsules is difficult, they can be opened and mixed with food or liquid. Avoid holding the tablet in the mouth, as it can irritate the gums and cheeks.