Zenpep 10,000 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
C
FDA Approved
Jan 2009
DEA Schedule
Not Controlled
Overview
What is this medicine?
Zenpep is a medicine that helps your body digest food, especially fats, proteins, and carbohydrates. It contains natural enzymes similar to those your pancreas makes. People who have problems with their pancreas, like those with cystic fibrosis or chronic pancreatitis, need this medicine to help them absorb nutrients from their food and prevent symptoms like greasy stools and weight loss.
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 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.
Continuing Your Medication
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. Check with your doctor or pharmacist to see if this is an option for your medication.
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 infant this medication at every feeding.
Sprinkle the contents of the capsule into your infant's mouth or onto a small amount of applesauce. Some products can also be mixed with other baby foods, such as bananas or pears. Be sure to check with your doctor or pharmacist to see what foods are safe to mix with the medication.
Do not mix the medication with baby formula or breast milk.
Give the mixture to your infant right away. 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, with the lid tightly closed.
Keep the medication in its original container. 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 packet.
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 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.
Continuing Your Medication
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. Check with your doctor or pharmacist to see if this is an option for your medication.
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 infant this medication at every feeding.
Sprinkle the contents of the capsule into your infant's mouth or onto a small amount of applesauce. Some products can also be mixed with other baby foods, such as bananas or pears. Be sure to check with your doctor or pharmacist to see what foods are safe to mix with the medication.
Do not mix the medication with baby formula or breast milk.
Give the mixture to your infant right away. 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, with the lid tightly closed.
Keep the medication in its original container. 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 packet.
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
- Take Zenpep with every meal and snack. The dose depends on the amount of fat in your food.
- Swallow capsules whole. If you cannot swallow the capsule, open it and sprinkle the contents on a small amount of soft, acidic food (like applesauce, pureed banana, or yogurt). Do NOT crush or chew the beads inside the capsule, as this can destroy the enteric coating and make the medicine ineffective.
- Drink plenty of liquids while taking this medication.
- Do not hold the medicine in your mouth, as it can irritate the mouth.
- Store at room temperature, away from moisture and heat.
- Continue to follow any dietary recommendations from your doctor or dietitian.
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 10,000 IU is 10,000 lipase units per capsule.
Dose Range:
500 - 2500 mg
Condition-Specific Dosing:
cysticFibrosis:
Initial dose 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.
otherEPI:
Initial dose 500 lipase units/kg/meal. Adjust based on clinical response. 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 conditions like congenital pancreatic agenesis).
Infant:
Initial dose 2,000 to 5,000 lipase units per 120 mL of formula or breast milk. Max 2,500 lipase units/kg/meal or 10,000 lipase units/kg/day.
Child:
Initial dose 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:
Initial dose 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.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Dialysis:
No specific adjustment needed as systemic absorption is minimal.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
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 facilitate the digestion and absorption of nutrients in patients with exocrine pancreatic insufficiency (EPI) who have insufficient endogenous pancreatic enzyme secretion.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal to none (enzymes act locally in GI tract and are not absorbed systemically in active form).
Tmax:
Not applicable (no systemic absorption).
FoodEffect:
Must be taken with meals and snacks to be effective.
Distribution:
Vd:
Not applicable (no systemic distribution).
ProteinBinding:
Not applicable.
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (no systemic half-life).
Clearance:
Not applicable.
ExcretionRoute:
Fecal (as inactivated enzymes or their breakdown products).
Unchanged:
Not applicable.
Pharmacodynamics
OnsetOfAction:
Immediately upon mixing with food in the stomach and release in the small intestine.
PeakEffect:
Coincides with digestion of food.
DurationOfAction:
Duration of a meal or snack.
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 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 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 or any other unusual symptoms, 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 an exhaustive list of 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 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 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 or any other unusual symptoms, 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 an exhaustive list of 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 abdominal pain (especially if new or worsening)
- Bloody or black, tarry stools
- Severe constipation
- Unusual rash or itching
- Swelling of the face, lips, tongue, or throat (signs of allergic reaction)
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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. Your doctor may need to adjust the dosage of this medication to ensure effective management of your condition.
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 doctor to provide personalized guidance and care.
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. Your doctor may need to adjust the dosage of this medication to ensure effective management of your condition.
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 doctor to provide personalized guidance and care.
Overdose Information
Overdose Symptoms:
- Hyperuricemia (high uric acid levels)
- Hyperuricosuria (high uric acid in urine)
- Fibrosing colonopathy (rare, severe abdominal pain, vomiting, bloating, constipation, especially in children with CF on very high doses)
What to Do:
Contact your doctor or poison control center immediately (Call 1-800-222-1222). Treatment is supportive. Discontinue medication if fibrosing colonopathy is suspected.
Drug Interactions
Moderate Interactions
- Antacids (calcium carbonate, magnesium hydroxide): May theoretically degrade the enteric coating of pancrelipase, leading to premature release and inactivation of enzymes. Clinical significance is generally low with modern enteric-coated products like Zenpep.
- Iron supplements: Theoretical interaction due to enzyme binding, but not clinically significant for most patients.
Monitoring
Baseline Monitoring
Clinical symptoms of malabsorption (e.g., steatorrhea, abdominal pain, bloating)
Rationale: To establish baseline severity of exocrine pancreatic insufficiency.
Timing: Prior to initiation of therapy.
Nutritional status (weight, height, BMI, fat-soluble vitamin levels - A, D, E, K)
Rationale: To assess baseline nutritional deficiencies due to malabsorption.
Timing: Prior to initiation of therapy.
Stool fat analysis (e.g., 72-hour fecal fat excretion)
Rationale: To objectively quantify fat malabsorption and guide initial dosing.
Timing: Prior to initiation of therapy (if feasible).
Routine Monitoring
Clinical symptoms of malabsorption
Frequency: Regularly (e.g., at each clinic visit, or as needed based on patient report)
Target: Resolution or significant improvement of symptoms (e.g., reduced steatorrhea, less abdominal pain, improved stool consistency)
Action Threshold: Persistent or worsening symptoms may indicate need for dose adjustment or re-evaluation of therapy.
Nutritional status (weight, height, BMI, fat-soluble vitamin levels)
Frequency: Periodically (e.g., every 6-12 months, or as clinically indicated)
Target: Maintenance of healthy weight, age-appropriate growth in children, normal vitamin levels.
Action Threshold: Weight loss, growth failure, or vitamin deficiencies may indicate inadequate dosing or other issues.
Stool characteristics (frequency, consistency, odor, presence of oil)
Frequency: Daily by patient/caregiver report
Target: Normal stool frequency and consistency, absence of steatorrhea.
Action Threshold: Persistent greasy, foul-smelling, or frequent stools may indicate need for dose adjustment.
Symptom Monitoring
- Abdominal pain
- Bloating
- Flatulence
- Steatorrhea (greasy, foul-smelling stools)
- Diarrhea
- Weight loss
- Nutritional deficiencies (e.g., fatigue, vision problems, bone pain)
Special Patient Groups
Pregnancy
Pancrelipase is generally considered safe during pregnancy as it is not absorbed systemically. However, adequate nutrition is critical during pregnancy, and treatment of EPI is important for maternal and fetal health. Use only if clearly needed.
Trimester-Specific Risks:
First Trimester:
No known specific risks.
Second Trimester:
No known specific risks.
Third Trimester:
No known specific risks.
Lactation
Pancrelipase is not absorbed systemically, so it is not expected to be excreted in breast milk. It is considered compatible with breastfeeding.
Infant Risk:
Low risk to infant.
Pediatric Use
Dosing is weight-based and individualized. Close monitoring for fibrosing colonopathy is crucial, especially in children with cystic fibrosis receiving high doses. Ensure proper administration (swallowing whole or sprinkling on appropriate food) to prevent oral irritation.
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 pancrelipase with meals and snacks. The enzymes need to be present when food is in the digestive tract.
- Do not crush or chew the enteric-coated beads inside the capsule. This will inactivate the enzymes.
- If opening capsules, mix beads with soft, acidic food (pH < 4.5) like applesauce, and consume immediately. Do not store the mixture.
- Dosing is highly individualized; adjust based on symptoms (e.g., steatorrhea, abdominal pain) and nutritional status.
- High doses, particularly in cystic fibrosis patients, have been associated with fibrosing colonopathy. Monitor for new or worsening abdominal symptoms.
- Ensure adequate hydration to prevent constipation.
Alternative Therapies
- Other pancreatic enzyme products (PEPs) such as Creon, Pancreaze, Viokace, Pertzye.
- Dietary modifications (e.g., low-fat diet, though PERT aims to allow a more normal diet).
Cost & Coverage
Average Cost:
$300 - $1000+ per 100 capsules (Zenpep 10,000 IU)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Specialty/Non-preferred Brand) for brand, Tier 1 for generic if available and covered.
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. 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.