Usage
- This combination medication is prescribed for indigestion (dyspepsia), flatulence, bloating, fullness after eating, heartburn, anorexia, pancreatic and hepatic insufficiency, post-operative digestive upset, and during convalescence. It is also indicated for conditions like exocrine pancreatic insufficiency due to cystic fibrosis or chronic pancreatitis.
- Pharmacological classification: Digestive enzyme supplement.
- Mechanism of action: Pancreatin provides digestive enzymes (amylase, lipase, and protease) to break down carbohydrates, fats, and proteins, respectively. Sodium tauroglycocholate, a bile salt, emulsifies fats, aiding lipase activity and promoting the absorption of fats and fat-soluble vitamins.
Alternate Names
- Pancreatin and Sodium Tauroglycocholate Combination
- Pancreatin/Sodium Tauroglycocholate
- Brand Names: Enzar Forte, Dizec (with simethicone)
How It Works
- Pharmacodynamics: Pancreatin supplements deficient pancreatic enzymes, improving digestion of carbohydrates, fats, and proteins. Sodium tauroglycocholate facilitates emulsification and absorption of fats and fat-soluble vitamins. This combined action reduces symptoms like bloating, steatorrhea, and abdominal discomfort.
- Pharmacokinetics:
- Absorption: Pancreatin enzymes are absorbed in the small intestine. Sodium tauroglycocholate is absorbed in the ileum.
- Metabolism: Pancreatin enzymes are metabolized in the gastrointestinal tract. Sodium tauroglycocholate undergoes enterohepatic circulation.
- Elimination: Metabolic byproducts are eliminated primarily through feces.
- Mode of action: Pancreatin replaces missing pancreatic enzymes. Amylase hydrolyzes starch to dextrins and sugars, lipase hydrolyzes triglycerides to fatty acids and glycerol, and protease hydrolyzes proteins to peptides and amino acids. Sodium tauroglycocholate emulsifies fats, increasing surface area for lipase action and facilitating micelle formation for absorption.
- Receptor binding, enzyme inhibition or neurotransmitter modulation: This medication doesn’t involve receptor binding, enzyme inhibition, or neurotransmitter modulation. Its action is based on enzyme supplementation and facilitation of physiological digestive processes.
- Elimination pathways: Primarily fecal elimination of metabolic byproducts.
Dosage
Standard Dosage
Adults:
- One tablet with each meal. The tablet should be sucked for a few seconds and then swallowed whole with water. Avoid chewing, which can irritate the oral mucosa. For pancreatic insufficiency, up to two tablets 2-3 times daily, adjusting based on pancreatic function and patient’s response.
Children:
- Dosage should be determined by a pediatrician based on the child’s age, weight, and specific condition. Generally, lower doses are recommended.
Special Cases:
- Elderly Patients: Start with a lower dose and increase gradually based on tolerance and effectiveness.
- Patients with Renal Impairment: Dosage adjustment may be required; consult a nephrologist.
- Patients with Hepatic Dysfunction: Use with caution and adjust dosage; monitor liver function tests.
- Patients with Comorbid Conditions: Dosage adjusted based on the overall health status and potential drug interactions.
Clinical Use Cases
- Intubation/Surgical Procedures/Mechanical Ventilation/ICU Use/Emergency Situations: This medication is not typically indicated for these acute clinical situations. Its use focuses on improving digestion in chronic conditions.
Dosage Adjustments
- Dose modifications may be needed for renal/hepatic dysfunction, metabolic disorders, or genetic polymorphisms. Consult specialists (nephrologist, hepatologist) as needed.
Side Effects
Common Side Effects
- Nausea, vomiting, diarrhea, abdominal pain/cramps, constipation, bloating
Rare but Serious Side Effects
- Allergic reactions (rash, itching, swelling, dizziness, difficulty breathing), hyperuricemia, hyperuricosuria, fibrosing colonopathy (in high doses, especially in cystic fibrosis)
Long-Term Effects
- Fibrosing colonopathy (rare, with high doses)
Adverse Drug Reactions (ADR)
- Severe allergic reactions, severe gastrointestinal issues
Contraindications
- Hypersensitivity to pancreatin, sodium tauroglycocholate, or pork protein
- Acute pancreatitis, acute exacerbations of chronic pancreatitis
- Bowel obstruction, meconium ileus, short bowel syndrome
- Gallbladder problems (if severe)
Drug Interactions
- Antacids (calcium carbonate, magnesium hydroxide), iron supplements can decrease the effectiveness of pancreatin.
- Certain antibiotics may alter the absorption of enzymes.
- Consult a healthcare professional regarding potential interactions with other medications, including OTC drugs and supplements.
- Food and lifestyle factors: No known significant interactions with food or alcohol.
Pregnancy and Breastfeeding
- Consult a doctor before use during pregnancy and breastfeeding. Safety data is limited.
Drug Profile Summary
- Mechanism of Action: Replaces pancreatic enzymes and facilitates fat absorption.
- Side Effects: Nausea, vomiting, diarrhea, abdominal pain, constipation, bloating.
- Contraindications: Hypersensitivity, acute pancreatitis, bowel obstruction.
- Drug Interactions: Antacids, iron supplements, certain antibiotics.
- Pregnancy & Breastfeeding: Consult a doctor before use.
- Dosage: 1 tablet with each meal; adjust for pancreatic insufficiency and special populations.
- Monitoring Parameters: Stool consistency, frequency; signs and symptoms of indigestion; uric acid levels (with high doses).
Popular Combinations
- Pancreatin + Simethicone + Sodium Tauroglycocholate: For indigestion with gas.
Precautions
- Monitor for allergic reactions, gastrointestinal side effects, and hyperuricemia.
- Exercise caution in patients with pre-existing gastrointestinal conditions, gout, renal impairment, and hyperuricemia.
- Children and pregnant/breastfeeding women should use under medical supervision.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Pancreatin + Sodium Tauroglycocholate?
A: Adults: 1 tablet with each meal. Adjust for pancreatic insufficiency. Children: Consult a pediatrician.
Q2: What are the common side effects?
A: Nausea, vomiting, diarrhea, abdominal pain, constipation, and bloating.
Q3: Who should not take this medication?
A: People with hypersensitivity to ingredients, acute pancreatitis, or bowel obstruction.
Q4: Can this be taken during pregnancy or breastfeeding?
A: Consult a physician before use. Safety data is limited.
Q5: How does this medication work?
A: Pancreatin supplements digestive enzymes, while sodium tauroglycocholate enhances fat absorption.
Q6: Are there any drug interactions I should be aware of?
A: Yes, antacids, iron supplements, and certain antibiotics may interact.
Q7: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember, unless it is almost time for your next dose. Do not double the dose.
Q8: Can I chew the tablet?
A: No, it’s recommended to suck the tablet for a few seconds and then swallow it whole to prevent oral mucosa irritation.
Q9: What should I monitor while taking this medication?
A: Monitor stool frequency/consistency, symptoms of indigestion, and for any signs of allergic reactions. With higher doses, monitor uric acid levels.
