Zenpep 20,000 IU Capsules
It is used to help break down food when the pancreas is not working the right way.
Drug Class
Digestive enzymes
Pharmacologic Class
Pancreatic enzyme replacement therapy (PERT)
Pregnancy Category
Category C
FDA Approved
Jan 2009
DEA Schedule
Not Controlled
Overview
What is this medicine?
Zenpep is a medication that helps your body digest food, especially fats, proteins, and carbohydrates. It contains natural enzymes (lipase, protease, and amylase) that are normally made by your pancreas. People who have conditions like cystic fibrosis or chronic pancreatitis often don't make enough of these enzymes, leading to problems digesting food and absorbing nutrients. Zenpep helps replace these missing enzymes so you can properly digest your meals and get the nutrition you need.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor. Read all the information provided with your medication and follow the instructions carefully.
Take your medication with meals and snacks to help minimize potential side effects.
Swallow the medication whole. Do not chew, crush, or hold the medication in your mouth, as this can cause mouth irritation or affect how the medication works. If you have any concerns, discuss them with your doctor.
Take each dose with a full glass of water or other fluid to ensure you swallow all the contents.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Special Instructions for Taking Your Medication
If you have trouble swallowing the capsule, you can sprinkle the contents onto a small amount of applesauce. Do not chew the mixture. Swallow it immediately and follow with a glass of water or juice.
After mixing the medication with food, take the dose right away. Do not store the mixture for later use.
Some medications can be mixed with foods other than applesauce. Be sure to 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 determine if your medication can be administered through a feeding tube.
Instructions for Infants (Up to 12 Months Old)
Give your child this medication at every feeding.
Sprinkle the contents of the capsule into your child's mouth or onto a small amount of applesauce. Some products can also be mixed with other baby foods, such as bananas or pears. Check with your doctor or pharmacist to see what foods are safe to use.
Do not mix the medication with baby formula or breast milk.
Give the mixture to your child right away. Do not store it for later use.
After giving the medication, have your child drink baby formula or breast milk as usual.
Check your child'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 make up for the missed dose.
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor. Read all the information provided with your medication and follow the instructions carefully.
Take your medication with meals and snacks to help minimize potential side effects.
Swallow the medication whole. Do not chew, crush, or hold the medication in your mouth, as this can cause mouth irritation or affect how the medication works. If you have any concerns, discuss them with your doctor.
Take each dose with a full glass of water or other fluid to ensure you swallow all the contents.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Special Instructions for Taking Your Medication
If you have trouble swallowing the capsule, you can sprinkle the contents onto a small amount of applesauce. Do not chew the mixture. Swallow it immediately and follow with a glass of water or juice.
After mixing the medication with food, take the dose right away. Do not store the mixture for later use.
Some medications can be mixed with foods other than applesauce. Be sure to 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 determine if your medication can be administered through a feeding tube.
Instructions for Infants (Up to 12 Months Old)
Give your child this medication at every feeding.
Sprinkle the contents of the capsule into your child's mouth or onto a small amount of applesauce. Some products can also be mixed with other baby foods, such as bananas or pears. Check with your doctor or pharmacist to see what foods are safe to use.
Do not mix the medication with baby formula or breast milk.
Give the mixture to your child right away. Do not store it for later use.
After giving the medication, have your child drink baby formula or breast milk as usual.
Check your child'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 make up for the missed dose.
Lifestyle & Tips
- Always take Zenpep with every meal and snack. If you forget a dose, take it as soon as you remember with food, or skip it if it's almost time for your next meal.
- Swallow capsules whole. Do not chew or crush them. If you have trouble swallowing, you can open the capsule and sprinkle the contents on a small amount of soft, acidic food (like applesauce, pureed banana, or yogurt) and swallow immediately without chewing.
- Drink plenty of fluids throughout the day to help prevent constipation.
- Maintain a balanced diet as recommended by your doctor or dietitian. You may still need to take vitamin supplements, especially fat-soluble vitamins (A, D, E, K).
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 for cystic fibrosis, or 7,200 to 40,000 lipase units per meal for other conditions.
Dose Range:
7200 - 90000 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, whichever is less.
otherEPI:
Initial: 7,200 to 40,000 lipase units per meal and half of the mealtime dose with snacks. Titrate based on clinical response.
Pediatric Dosing
Neonatal:
Not established (generally not indicated for neonates unless specific conditions like congenital pancreatic agenesis).
Infant:
Cystic Fibrosis (CF) <1 year: 2,000 to 4,000 lipase units per 120 mL of formula or per breast-feeding. Max: 2,500 lipase units/kg/meal or 10,000 lipase units/kg/day.
Child:
CF (1-4 years): Initial 1,000 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, whichever is less. Other EPI: Same as adult initial dosing, individualized.
Adolescent:
Same as adult dosing, individualized.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
No adjustment needed.
Dialysis:
No adjustment needed, as enzymes are not systemically absorbed.
Hepatic Impairment:
Mild:
No adjustment.
Moderate:
No adjustment.
Severe:
No adjustment.
Pharmacology
Mechanism of Action
Pancrelipase is a pancreatic enzyme product (PEP) containing lipase, protease, and amylase. It acts locally in the gastrointestinal tract to hydrolyze fats into glycerol and fatty acids, proteins into peptides and amino acids, and starches into dextrins and short-chain sugars. These enzymes are essential for the digestion and absorption of nutrients in patients with exocrine pancreatic insufficiency (EPI).
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (enzymes are not absorbed systemically)
Tmax:
Not applicable
FoodEffect:
Must be taken with food to mix with chyme and facilitate digestion.
Distribution:
Vd:
Not applicable (local action)
ProteinBinding:
Not applicable
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (local action)
Clearance:
Not applicable
ExcretionRoute:
Fecal (as digested protein fragments)
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Immediately upon mixing with food in the small intestine.
PeakEffect:
Coincides with food digestion.
DurationOfAction:
Duration of a meal (typically 1-2 hours).
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
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 attention immediately:
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 may be symptoms 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 experience no side effects or only minor side effects while taking this medication. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Dizziness or headache
Constipation, diarrhea, stomach pain, or upset stomach
Heartburn
Gas
Cough
Sore throat
Anal irritation
Reporting Side Effects
These are not all the possible side effects that may occur. 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 attention immediately:
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 may be symptoms 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 experience no side effects or only minor side effects while taking this medication. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Dizziness or headache
Constipation, diarrhea, stomach pain, or upset stomach
Heartburn
Gas
Cough
Sore throat
Anal irritation
Reporting Side Effects
These are not all the possible side effects that may occur. 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 abdominal pain or discomfort (especially if new or worsening)
- Bloody or black, tarry stools
- Severe diarrhea or constipation
- Allergic reactions (rash, itching, swelling, severe dizziness, trouble breathing)
- Unusual or severe joint pain (rare, but can be a sign of fibrosing colonopathy)
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 allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to ensure safe use and avoid potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions or drugs.
To guarantee your safety, it is vital to verify that this medication is compatible with all your medications and health conditions. 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 allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to ensure safe use and avoid potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions or drugs.
To guarantee your safety, it is vital to verify that this medication is compatible with all your medications and health conditions. 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 diet 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.
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.
Overdose Information
Overdose Symptoms:
- High doses of pancreatic enzymes have been associated with fibrosing colonopathy (a rare, serious condition affecting the large intestine), particularly in pediatric patients with cystic fibrosis.
- Other symptoms may include hyperuricemia (high uric acid levels) and hyperuricosuria (high uric acid in urine).
What to Do:
If you suspect an 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 if fibrosing colonopathy is suspected.
Drug Interactions
Moderate Interactions
- Antacids (e.g., calcium carbonate, magnesium hydroxide): May theoretically degrade the enteric coating of some pancrelipase products, leading to premature release of enzymes in the stomach and inactivation. However, Zenpep's enteric coating is designed to be acid-resistant.
- Iron supplements: High doses of pancreatic enzymes may theoretically decrease iron absorption, though clinical significance is generally low.
Monitoring
Baseline Monitoring
Nutritional status (weight, height, BMI, fat-soluble vitamin levels A, D, E, K)
Rationale: To assess the severity of EPI and establish baseline for treatment efficacy.
Timing: Prior to initiation of therapy.
Stool fat content (e.g., 72-hour fecal fat excretion)
Rationale: Objective measure of malabsorption and treatment efficacy.
Timing: Prior to initiation and periodically during dose titration.
Routine Monitoring
Clinical symptoms (abdominal pain, bloating, flatulence, stool frequency/consistency)
Frequency: Regularly (e.g., daily/weekly initially, then monthly/quarterly)
Target: Improvement or resolution of symptoms.
Action Threshold: Persistent or worsening symptoms indicate need for dose adjustment or re-evaluation.
Growth parameters (in pediatric patients)
Frequency: Monthly to quarterly
Target: Normal growth velocity for age.
Action Threshold: Failure to thrive or poor weight gain indicates inadequate enzyme replacement.
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 enzyme dose adjustment.
Symptom Monitoring
- Reduction in steatorrhea (oily, foul-smelling stools)
- Decrease in abdominal pain and bloating
- Improved stool consistency and frequency
- Weight gain and improved nutritional status
- Reduced flatulence
Special Patient Groups
Pregnancy
Use during pregnancy should be considered if clearly needed. Pancrelipase is not systemically absorbed, so maternal use is not expected to result in fetal exposure. However, adequate nutrition during pregnancy is crucial for fetal development.
Trimester-Specific Risks:
First Trimester:
No known specific risks, as systemic absorption is negligible.
Second Trimester:
No known specific risks.
Third Trimester:
No known specific risks.
Lactation
Pancrelipase is not systemically absorbed by the mother, so it is not expected to be present in breast milk. Therefore, it is considered compatible with breastfeeding. Adequate maternal nutrition is important for milk production.
Infant Risk:
Low risk; no expected exposure to the infant.
Pediatric Use
Dosing is weight-based and individualized. Close monitoring of growth, nutritional status, and symptoms is crucial. High doses (exceeding 2,500 lipase units/kg/meal or 10,000 lipase units/kg/day or 4,000 lipase units/gram of fat ingested per day) have been associated with fibrosing colonopathy, particularly in children with cystic fibrosis. Adherence to recommended maximum doses is important.
Geriatric Use
No specific dose adjustments are required for elderly patients. Dosing should be individualized based on clinical response and fat intake, similar to younger adults.
Clinical Information
Clinical Pearls
- Always take Zenpep with food (meals and snacks) to ensure proper mixing with chyme for digestion.
- Do not chew or crush capsules or their contents, as this can inactivate the enzymes and irritate the oral mucosa.
- For patients who cannot swallow capsules, the contents can be sprinkled on soft, acidic food and consumed immediately.
- Monitor for signs of inadequate dosing (e.g., continued steatorrhea, abdominal pain, weight loss) or excessive dosing (e.g., constipation, fibrosing colonopathy symptoms).
- Ensure adequate hydration to prevent constipation, a common side effect.
- Patients with cystic fibrosis should be particularly cautious about exceeding maximum recommended doses due to the risk of fibrosing colonopathy.
Alternative Therapies
- Creon (pancrelipase)
- Viokace (pancrelipase, requires co-administration with a proton pump inhibitor)
- Pancreaze (pancrelipase)
- Pertzye (pancrelipase)
Cost & Coverage
Average Cost:
$500 - $2000+ per 100-300 capsules (varies by strength)
Insurance Coverage:
Tier 3 or Specialty Tier (requires prior authorization for many plans)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.