Zenpep 3000 IU Capsules
It is used to help break down food when the pancreas is not working the right way.
Drug Class
Pancreatic enzyme replacement therapy (PERT)
Pharmacologic Class
Digestive enzymes
Pregnancy Category
Category C
FDA Approved
Jan 2009
DEA Schedule
Not Controlled
Overview
What is this medicine?
Zenpep is a medicine that replaces the natural enzymes your pancreas normally makes. These enzymes help your body digest fats, proteins, and carbohydrates in your food. Taking Zenpep with every meal and snack helps your body absorb nutrients and can reduce symptoms like bloating, gas, and oily stools.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
1. Follow Your Doctor's Instructions: Take your medication exactly as prescribed by your doctor. Read all the information provided with your medication and follow the instructions carefully.
2. Take with Food and Fluids: Take your medication with meals and snacks to help prevent stomach upset. Swallow the capsule whole with a full glass of water or other fluid. Do not chew, crush, or hold the capsule in your mouth, as this can cause mouth irritation or affect how the medication works.
3. Swallowing the Medication: Take each dose with plenty of fluids to ensure you swallow all the contents. If you have trouble swallowing, talk to your doctor.
4. Continuing Your Medication: Continue taking your medication as directed by your doctor, even if you start to feel better.
Special Instructions
If you have trouble swallowing the capsule, you can sprinkle the contents on applesauce. Do not chew the mixture; swallow it right away and follow with water or juice.
After mixing the medication with food, take the dose immediately. Do not store the mixture for later use.
Some products can be mixed with foods other than applesauce. Check with your doctor or pharmacist to see what foods are safe to use.
Certain brands of this medication can be given through a feeding tube, while others cannot. Check with your pharmacist to see if your brand can be given through a feeding tube.
Giving the Medication to Infants (up to 12 months old)
Give the medication to your infant at every feeding.
Sprinkle the contents of the capsule into your infant's mouth or mix with a small amount of applesauce or other baby food (such as bananas or pears). Do not mix with baby formula or breast milk.
Give the mixture immediately; do not store it for later use.
After giving the medication, have your infant drink baby formula or breast milk as usual.
Check your infant's mouth after feeding to ensure they have swallowed the medication.
Storing and Disposing of Your Medication
Store your medication at room temperature in the original container with the lid tightly closed.
If the bottle contains a desiccant packet to keep the medication dry, leave the packet in the bottle. Do not eat or swallow the desiccant.
What to Do If You Miss a Dose
If you miss a dose, skip it and take your next dose at the usual time.
* Do not take two doses at the same time or take extra doses.
To ensure you get the most benefit from your medication, follow these steps:
1. Follow Your Doctor's Instructions: Take your medication exactly as prescribed by your doctor. Read all the information provided with your medication and follow the instructions carefully.
2. Take with Food and Fluids: Take your medication with meals and snacks to help prevent stomach upset. Swallow the capsule whole with a full glass of water or other fluid. Do not chew, crush, or hold the capsule in your mouth, as this can cause mouth irritation or affect how the medication works.
3. Swallowing the Medication: Take each dose with plenty of fluids to ensure you swallow all the contents. If you have trouble swallowing, talk to your doctor.
4. Continuing Your Medication: Continue taking your medication as directed by your doctor, even if you start to feel better.
Special Instructions
If you have trouble swallowing the capsule, you can sprinkle the contents on applesauce. Do not chew the mixture; swallow it right away and follow with water or juice.
After mixing the medication with food, take the dose immediately. Do not store the mixture for later use.
Some products can be mixed with foods other than applesauce. Check with your doctor or pharmacist to see what foods are safe to use.
Certain brands of this medication can be given through a feeding tube, while others cannot. Check with your pharmacist to see if your brand can be given through a feeding tube.
Giving the Medication to Infants (up to 12 months old)
Give the medication to your infant at every feeding.
Sprinkle the contents of the capsule into your infant's mouth or mix with a small amount of applesauce or other baby food (such as bananas or pears). Do not mix with baby formula or breast milk.
Give the mixture immediately; do not store it for later use.
After giving the medication, have your infant drink baby formula or breast milk as usual.
Check your infant's mouth after feeding to ensure they have swallowed the medication.
Storing and Disposing of Your Medication
Store your medication at room temperature in the original container with the lid tightly closed.
If the bottle contains a desiccant packet to keep the medication dry, leave the packet in the bottle. Do not eat or swallow the desiccant.
What to Do If You Miss a Dose
If you miss a dose, skip it and take your next dose at the usual time.
* Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take Zenpep with every meal and snack.
- Swallow capsules whole. Do not crush or chew the capsules or their contents, as this can irritate your mouth or cause the medicine to not work properly.
- If you cannot swallow the capsule whole, open it and sprinkle the contents on a small amount of soft, acidic food (like applesauce, pureed banana, or yogurt) and swallow immediately without chewing. Do not store the mixture.
- Drink plenty of fluids throughout the day to help prevent constipation.
- Follow your doctor's dietary recommendations, which may include a balanced diet with adequate fat intake.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized based on clinical symptoms, steatorrhea, and fat intake. Initial dose typically 500 lipase units/kg/meal. Zenpep 3000 IU capsules are used to achieve the target lipase units per meal/snack.
Dose Range:
500 - 2500 mg
Condition-Specific Dosing:
cysticFibrosis:
Initial: 500 lipase units/kg/meal. Max: 2,500 lipase units/kg/meal or 10,000 lipase units/kg/day or 4,000 lipase units/gram of fat ingested per day.
otherPancreaticInsufficiency:
Initial: 500 lipase units/kg/meal. Max: 2,500 lipase units/kg/meal or 10,000 lipase units/kg/day or 4,000 lipase units/gram of fat ingested per day.
Pediatric Dosing
Neonatal:
Not established (generally not used in neonates unless specific indication and careful titration)
Infant:
2,000 to 4,000 lipase units per 120 mL of formula or breast milk. Administer immediately before or during feeding. Do not mix directly into formula/breast milk.
Child:
1-3 years: Initial 1,000 lipase units/kg/meal. 4 years and older: Initial 500 lipase units/kg/meal. Max: 2,500 lipase units/kg/meal or 10,000 lipase units/kg/day or 4,000 lipase units/gram of fat ingested per day.
Adolescent:
Same as adult dosing (initial 500 lipase units/kg/meal).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific considerations, as not systemically absorbed.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Pancrelipase is an exogenous pancreatic enzyme preparation containing lipase, amylase, and protease. It acts intraluminally in the gastrointestinal tract to hydrolyze fats into glycerol and fatty acids, starches into dextrins and sugars, and proteins into peptides and amino acids, thereby facilitating their absorption in patients with exocrine pancreatic insufficiency.
Pharmacokinetics
Absorption:
Bioavailability:
Effectively 0% (not absorbed systemically)
Tmax:
Not applicable (not absorbed systemically)
FoodEffect:
Must be taken with food (meals and snacks) to be effective, as it acts intraluminally to digest food.
Distribution:
Vd:
Not applicable (not absorbed systemically)
ProteinBinding:
Not applicable (not absorbed systemically)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (not absorbed systemically)
Clearance:
Not applicable (not absorbed systemically)
ExcretionRoute:
Fecal (as degraded enzymes)
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Immediately upon contact with food in the GI tract
PeakEffect:
During the digestive process of the meal/snack
DurationOfAction:
Duration of the digestive process (typically 1-4 hours post-meal)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of gallstones, including:
+ Sudden pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Yellow skin or eyes
+ Fever with chills
Joint pain, stiffness, redness, or swelling
Mouth or tongue irritation
Swollen gland
Abnormal or severe stomach pain, bloating, trouble passing stools, upset stomach, vomiting, or diarrhea, which could be signs of a rare bowel problem called fibrosing colonopathy
Signs of high or low blood sugar, such as:
+ Breath that smells like fruit
+ Dizziness
+ Fast breathing
+ Fast heartbeat
+ Feeling confused, sleepy, or weak
+ Flushing
+ Headache
+ Unusual thirst or hunger
+ Passing urine more often
+ Shaking or sweating
Other Possible Side Effects
Most people do not experience serious side effects, and many have no side effects or only minor ones. However, if you notice any of the following side effects and they bother you or do not go away, contact your doctor or seek medical help:
Dizziness or headache
Constipation, diarrhea, stomach pain, or upset stomach
Heartburn
Gas
Cough
Sore throat
Anal irritation
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of gallstones, including:
+ Sudden pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Yellow skin or eyes
+ Fever with chills
Joint pain, stiffness, redness, or swelling
Mouth or tongue irritation
Swollen gland
Abnormal or severe stomach pain, bloating, trouble passing stools, upset stomach, vomiting, or diarrhea, which could be signs of a rare bowel problem called fibrosing colonopathy
Signs of high or low blood sugar, such as:
+ Breath that smells like fruit
+ Dizziness
+ Fast breathing
+ Fast heartbeat
+ Feeling confused, sleepy, or weak
+ Flushing
+ Headache
+ Unusual thirst or hunger
+ Passing urine more often
+ Shaking or sweating
Other Possible Side Effects
Most people do not experience serious side effects, and many have no side effects or only minor ones. However, if you notice any of the following side effects and they bother you or do not go away, contact your doctor or seek medical help:
Dizziness or headache
Constipation, diarrhea, stomach pain, or upset stomach
Heartburn
Gas
Cough
Sore throat
Anal irritation
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe or unusual abdominal pain (could indicate fibrosing colonopathy, a rare but serious condition)
- Worsening of existing symptoms (e.g., increased steatorrhea, weight loss)
- Allergic reactions (rash, itching, swelling, severe dizziness, trouble breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products, such as herbal supplements
Vitamins
Any existing health problems
Carefully review your medications and health conditions with your doctor to confirm that it is safe to take this medication. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products, such as herbal supplements
Vitamins
Any existing health problems
Carefully review your medications and health conditions with your doctor to confirm that it is safe to take this medication. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood work and laboratory tests should be conducted as directed by your doctor to monitor your condition. Adhere to the dietary plan recommended by your doctor to ensure optimal management of your health.
If you have diabetes (high blood sugar), it is crucial to closely monitor your blood sugar levels. Additionally, be aware of the potential for gout attacks and report any symptoms to your doctor promptly.
This medication is derived from pork (pig) pancreas tissue, which carries a minimal risk of transmitting a viral disease. Although no cases have been reported, it is essential to discuss this risk with your doctor. If you experience persistent symptoms of pancreas problems, such as stomach pain, bloating, fatty stools, or weight loss, while taking this medication, contact your doctor immediately, as your dosage may need to be adjusted.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to both you and your baby. This will enable your healthcare provider to make an informed decision about your treatment.
If you have diabetes (high blood sugar), it is crucial to closely monitor your blood sugar levels. Additionally, be aware of the potential for gout attacks and report any symptoms to your doctor promptly.
This medication is derived from pork (pig) pancreas tissue, which carries a minimal risk of transmitting a viral disease. Although no cases have been reported, it is essential to discuss this risk with your doctor. If you experience persistent symptoms of pancreas problems, such as stomach pain, bloating, fatty stools, or weight loss, while taking this medication, contact your doctor immediately, as your dosage may need to be adjusted.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to both you and your baby. This will enable your healthcare provider to make an informed decision about your treatment.
Overdose Information
Overdose Symptoms:
- Hyperuricemia (high uric acid levels, potentially leading to gout)
- Hyperuricosuria (high uric acid in urine)
- Fibrosing colonopathy (rare, but serious, characterized by severe abdominal pain, vomiting, constipation, and abdominal distension, especially with very high doses)
What to Do:
In case of suspected overdose, seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic. Discontinuation of the drug may be necessary in severe cases of fibrosing colonopathy.
Drug Interactions
Moderate Interactions
- Antacids (may theoretically reduce efficacy by altering gastric pH, though enteric coating minimizes this)
- H2-receptor antagonists (may theoretically reduce efficacy by altering gastric pH)
- Proton pump inhibitors (may theoretically reduce efficacy by altering gastric pH)
- Iron supplements (may decrease iron absorption)
Minor Interactions
- Acarbose (may reduce efficacy of acarbose)
Monitoring
Baseline Monitoring
Nutritional status (weight, height, BMI)
Rationale: To assess baseline pancreatic insufficiency severity and monitor treatment efficacy.
Timing: Prior to initiation of therapy
Stool frequency and consistency
Rationale: To assess baseline symptoms of malabsorption (e.g., steatorrhea).
Timing: Prior to initiation of therapy
Fat-soluble vitamin levels (A, D, E, K)
Rationale: To identify baseline deficiencies due to malabsorption.
Timing: Prior to initiation of therapy
Albumin/Prealbumin
Rationale: To assess overall nutritional status.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical symptoms (abdominal pain, bloating, steatorrhea)
Frequency: Regularly, at each follow-up visit
Target: Resolution or significant improvement of symptoms
Action Threshold: Persistent or worsening symptoms may indicate need for dose adjustment or re-evaluation.
Weight and growth (pediatric patients)
Frequency: Regularly, at each follow-up visit
Target: Appropriate weight gain and growth for age
Action Threshold: Failure to thrive or weight loss may indicate inadequate dosing or other issues.
Stool fat analysis (e.g., 72-hour fecal fat excretion)
Frequency: Periodically, if clinical response is suboptimal or to confirm diagnosis/efficacy
Target: Reduction in fecal fat excretion
Action Threshold: Persistently high fecal fat indicates inadequate digestion.
Fat-soluble vitamin levels (A, D, E, K)
Frequency: Annually or as clinically indicated
Target: Within normal limits
Action Threshold: Deficiencies require supplementation and/or dose adjustment of pancrelipase.
Symptom Monitoring
- Abdominal pain
- Bloating
- Gas
- Diarrhea
- Steatorrhea (oily, foul-smelling stools)
- Weight loss or failure to gain weight (especially in children)
- Signs of malnutrition (e.g., fatigue, muscle wasting)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies of pancrelipase in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Pancreatic enzymes are essential for maternal nutrition, which is critical for fetal development.
Trimester-Specific Risks:
First Trimester:
Limited data, theoretical risk is low due to lack of systemic absorption.
Second Trimester:
Limited data, theoretical risk is low due to lack of systemic absorption.
Third Trimester:
Limited data, theoretical risk is low due to lack of systemic absorption.
Lactation
It is not known whether pancrelipase is excreted in human milk. However, because pancrelipase is not absorbed systemically, it is generally considered safe for use during breastfeeding. The benefits of breastfeeding should be weighed against any potential risks.
Infant Risk:
Low risk to the infant due to lack of systemic absorption of the drug by the mother.
Pediatric Use
Essential for children with exocrine pancreatic insufficiency, particularly those with cystic fibrosis. Dosing is weight-based and highly individualized. Careful monitoring of growth, nutritional status, and symptoms is crucial. Fibrosing colonopathy has been reported in children with cystic fibrosis receiving high doses of pancreatic enzyme products.
Geriatric Use
No specific dose adjustments are necessary for geriatric patients. However, geriatric patients may have concomitant medical conditions or be on multiple medications, requiring careful monitoring for potential interactions or adverse effects.
Clinical Information
Clinical Pearls
- Dosing of pancrelipase is highly individualized and should be titrated based on clinical symptoms (e.g., reduction in steatorrhea, improved weight gain) and fat intake.
- Always take pancrelipase with every meal and snack to ensure proper digestion.
- Emphasize the importance of not crushing or chewing the capsules or their contents to preserve the enteric coating and prevent oral irritation.
- Monitor for signs of fibrosing colonopathy, especially in cystic fibrosis patients on high doses, which presents as severe abdominal pain, vomiting, and constipation.
- Ensure adequate hydration, as this can help prevent constipation, a common side effect.
- Patients should be educated on the signs of malabsorption (e.g., persistent steatorrhea, weight loss) and when to contact their healthcare provider for dose adjustments.
Alternative Therapies
- Creon (pancrelipase)
- Viokace (pancrelipase)
- Pertzye (pancrelipase)
- Ultresa (pancrelipase)
- Pancreaze (pancrelipase)
Cost & Coverage
Average Cost:
Highly variable, typically $300-$1000+ per 100-200 capsules
Insurance Coverage:
Tier 2 or Tier 3 (Specialty drug, may require prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Please read it carefully and review it again whenever you refill your prescription. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the quantity, and the time it occurred.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Please read it carefully and review it again whenever you refill your prescription. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the quantity, and the time it occurred.