Usage
This medication is prescribed for pancreatic enzyme deficiency or pancreatic insufficiency. These conditions occur when the pancreas doesn’t produce enough enzymes needed for digestion in the small intestine. This leads to indigestion, stomach pain, bloating, and a feeling of fullness. This drug belongs to the pharmacological classifications of digestive enzymes and antifoaming agents. It works by providing the missing enzymes (pancreatin and bile constituents) to aid digestion and by reducing gas bubbles (simethicone) to relieve bloating and discomfort.
Alternate Names
While the generic name is Bile constituents + Pancreatin + Simethicone, several brand names exist (e.g., Dyzerax, Nichzyme, Xylase, Enzoset PB, Evanzyme, Ntzyme, Pankreoflat HD, Enzygut Forte).
How It Works
Pharmacodynamics: Pancreatin supplements the deficient pancreatic enzymes (lipase, protease, amylase) enabling the digestion of fats, proteins, and carbohydrates. Bile constituents enhance fat emulsification and absorption. Simethicone, an antifoaming agent, reduces the surface tension of gas bubbles, leading to their coalescence and easier passage.
Pharmacokinetics: Pancreatin acts locally in the digestive tract with limited systemic absorption. Bile constituents are partially reabsorbed via enterohepatic circulation. Simethicone is not absorbed systemically and is eliminated in the feces.
Dosage
Standard Dosage
Adults: One to two tablets or capsules with each meal. Dosage should be individualized based on the patient’s condition and response.
Children: Dosage for children should be determined by a pediatrician based on weight, age, and specific condition. Close monitoring is essential. For simethicone dosing in children:
- Under 10.9 kg: 20 mg orally after meals and at bedtime as needed. Maximum dose: 240 mg/day.
- Over 10.9 kg: 40 mg orally after meals and at bedtime as needed. Maximum dose: 480 mg/day.
Special Cases:
- Elderly Patients: Dosage may need adjustment based on individual needs and digestive function.
- Patients with Renal Impairment: Caution is advised. Dose adjustment might be necessary.
- Patients with Hepatic Dysfunction: Caution is advised. Dose adjustment might be necessary.
- Patients with Comorbid Conditions: Conditions like gout, Crohn’s disease, and hyperuricemia require careful monitoring and potential dose adjustments.
Clinical Use Cases
Dosage recommendations for specific clinical situations (Intubation, Surgical Procedures, Mechanical Ventilation, Intensive Care Unit (ICU) Use, Emergency Situations) should be determined by the treating physician based on individual patient needs. There are no standardized dosage adjustments specific to these situations. Please note that this might change with future research.
Dosage Adjustments
Dosage adjustments should be based on individual patient factors like renal or hepatic dysfunction, other medical conditions, and response to therapy. Regular monitoring of symptoms and digestive function is important.
Side Effects
Common Side Effects
Nausea, abdominal pain or cramps, diarrhea, constipation, headache, vomiting, bloating, and gas.
Rare but Serious Side Effects
Severe abdominal discomfort, frequent/painful urination, joint pain, allergic reactions (rash, itching, swelling), fibrosing colonopathy (with high doses in children).
Long-Term Effects
Long-term use, especially at high doses, can potentially increase the risk of fibrosing colonopathy, especially in children with cystic fibrosis.
Adverse Drug Reactions (ADR)
Severe allergic reactions require immediate medical attention. Report any unusual or severe side effects to the physician immediately.
Contraindications
Hypersensitivity to pork protein or any component of the formulation; acute pancreatitis; worsening of chronic pancreatitis; complete blockage of the pancreatic or biliary ducts; gout; stomach or intestinal obstruction; Crohn’s disease.
Drug Interactions
Acarbose; miglitol; iron supplements; oral contraceptives; anticoagulants (e.g., warfarin); some medications for type 2 diabetes; hormonal medications (e.g., levothyroxine). It may also impair the oral absorption of folic acid. Avoid alcohol consumption.
Pregnancy and Breastfeeding
Consult a physician before using this medication during pregnancy or breastfeeding. Safety during these periods has not been fully established. The potential benefits should be weighed against the potential risks.
Drug Profile Summary
- Mechanism of Action: Combines pancreatic enzyme supplementation, bile salt action, and antiflatulent properties to improve digestion and reduce gas.
- Side Effects: Nausea, abdominal pain, diarrhea, constipation, headache, vomiting. Rarely: allergic reactions, fibrosing colonopathy.
- Contraindications: Hypersensitivity to pork proteins, acute pancreatitis, bowel obstruction.
- Drug Interactions: Iron supplements, acarbose, miglitol, hormonal medications, some diabetes medications, folic acid, alcohol.
- Pregnancy & Breastfeeding: Consult a physician before use.
- Dosage: One to two tablets/capsules with meals. Adjust based on individual needs.
- Monitoring Parameters: Stool characteristics (frequency, consistency, fat content), weight, nutritional status.
Popular Combinations
This medication is often used alone. Combining it with other digestive aids may be considered in some cases, but under the guidance of a physician.
Precautions
- General Precautions: Assess for allergies, pre-existing gastrointestinal conditions, and concomitant medications.
- Specific Populations: Use cautiously in pregnant/breastfeeding women, children, and elderly patients.
- Lifestyle Considerations: Limit alcohol consumption. Modify diet as needed to manage symptoms.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Bile constituents + Pancreatin + Simethicone?
A: The standard dosage is one to two tablets or capsules with each meal. However, the dosage should be individualized based on the patient’s specific condition and response to therapy. Pediatric doses are weight-based and should be determined by a pediatrician.
Q2: What are the common side effects?
A: Common side effects include nausea, abdominal pain, diarrhea, constipation, headache, vomiting, bloating, and gas.
Q3: What are the contraindications?
A: Contraindications include hypersensitivity to any components (especially pork protein), acute pancreatitis, bowel obstruction, gout, and Crohn’s disease.
Q4: Can this medication be used during pregnancy or breastfeeding?
A: Consult a physician before use during pregnancy or breastfeeding, as safety has not been fully established.
Q5: How does this medication interact with other drugs?
A: It can interact with iron supplements, acarbose, miglitol, some diabetes medications, hormonal medications, and folic acid. Alcohol should be avoided.
Q6: What should I do if I miss a dose?
A: If you miss a dose, take it as soon as you remember. However, if it’s near the time for your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose.
Q7: Are there any long-term effects I should be aware of?
A: Long-term use, especially at high doses, might increase the risk of fibrosing colonopathy, particularly in children with cystic fibrosis.
Q8: What if I have renal or hepatic impairment?
A: Caution is advised, and dosage adjustments might be necessary. Consult your physician.
Q9: How should this medicine be stored?
A: Store below 30°C in a cool, dry place away from direct sunlight and moisture. Keep out of the reach of children.
Q10: Can I crush or chew the tablets/capsules?
A: Swallow the tablets or capsules whole with water. Do not crush, chew, or break them. This preserves the enteric coating that protects the enzymes from stomach acid.
