Zenpep 25,000 IU Capsules
It is used to help break down food when the pancreas is not working the right way.
Drug Class
Enzyme replacement therapy
Pharmacologic Class
Pancreatic enzymes
Pregnancy Category
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 if your pancreas isn't making enough of its own digestive enzymes. It contains enzymes (lipase, amylase, protease) that break down fats, carbohydrates, and proteins in your food so your body can absorb nutrients.
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 prescription 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, talk to your doctor.
Take each dose with a full glass of water or other fluid to ensure you swallow all of 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 medication, you can sprinkle the contents of the capsule 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 see if your medication can be given through a feeding tube.
Instructions for 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 onto a small amount of applesauce. Some medications can also be mixed with other foods found in baby food jars, 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 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 make sure they 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 packet.
What to Do If You Miss a Dose
If you miss a dose, skip it and go back to your regular schedule.
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:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription 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, talk to your doctor.
Take each dose with a full glass of water or other fluid to ensure you swallow all of 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 medication, you can sprinkle the contents of the capsule 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 see if your medication can be given through a feeding tube.
Instructions for 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 onto a small amount of applesauce. Some medications can also be mixed with other foods found in baby food jars, 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 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 make sure they 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 packet.
What to Do If You Miss a Dose
If you miss a dose, skip it and go back to your regular schedule.
Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Always take Zenpep with every meal and snack.
- Swallow capsules whole. Do not chew or crush them, as this can irritate your mouth or throat and make the medicine less effective.
- If you cannot swallow the capsule whole, open it and sprinkle the contents on a small amount of soft, acidic food (like applesauce) and swallow immediately without chewing. Do not store the mixture.
- Drink plenty of fluids while taking this medication.
- Follow your doctor's dietary recommendations, which may include a balanced diet with adequate fat intake.
- Do not exceed the prescribed dose without consulting your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose typically 500 lipase units/kg/meal, adjusted based on clinical response and fat intake. Zenpep 25,000 IU is a specific strength, usually taken with meals/snacks.
Dose Range:
500 - 2500 mg
Condition-Specific Dosing:
cysticFibrosis:
Initial: 500 lipase units/kg/meal. Max: 2500 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.
otherExocrinePancreaticInsufficiency:
Initial: 500 lipase units/kg/meal. Max: 2500 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.
Pediatric Dosing
Neonatal:
Not established (safety and efficacy not established in neonates).
Infant:
Initial: 2,000 lipase units per 120 mL of formula or breast milk. Max: 2,500 lipase units/kg/meal or 10,000 lipase units/kg/day or 4,000 lipase units/gram of fat ingested per day, whichever is less.
Child:
Initial: 500 lipase units/kg/meal. Max: 2500 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.
Adolescent:
Initial: 500 lipase units/kg/meal. Max: 2500 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.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended as pancreatic enzymes are not absorbed systemically.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended.
Dialysis:
No specific adjustment recommended.
Hepatic Impairment:
Mild:
No specific adjustment recommended as pancreatic enzymes are not absorbed systemically.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended.
Pharmacology
Mechanism of Action
Pancrelipase is an exogenous pancreatic enzyme preparation containing lipase, amylase, and protease. It acts locally 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. It replaces the deficient endogenous pancreatic enzymes in patients with exocrine pancreatic insufficiency.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible (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 food/meals 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:
Excreted in feces (as digested protein).
Unchanged:
Not applicable.
Pharmacodynamics
OnsetOfAction:
Immediately upon mixing with chyme in the duodenum.
PeakEffect:
During digestion of a meal.
DurationOfAction:
Duration of a meal (typically 1-2 hours).
Safety & Warnings
BLACK BOX WARNING
Fibrosing colonopathy is a rare, serious adverse reaction associated with high-dose pancreatic enzyme products. Patients with cystic fibrosis may be at increased risk. Doses exceeding 2,500 lipase units/kg/meal or 10,000 lipase units/kg/day should be used with caution and only if the benefits outweigh the risks.
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 mild side effects while taking this medication. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Dizziness or headache
Constipation, diarrhea, stomach pain, or upset stomach
Heartburn
Gas
Cough
Sore throat
Anal irritation
Reporting Side Effects
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 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 mild side effects while taking this medication. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Dizziness or headache
Constipation, diarrhea, stomach pain, or upset stomach
Heartburn
Gas
Cough
Sore throat
Anal irritation
Reporting Side Effects
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
- Bloody or black, tarry stools
- Severe constipation
- Unusual or severe rash
- Signs of allergic reaction (hives, difficulty breathing, swelling of face/lips/tongue/throat)
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, any of 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 and pharmacist identify potential interactions between this medication and other substances you are taking.
* Any health problems you have, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all of your current medications and health conditions. Never start, stop, or change the dose 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, any of 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 and pharmacist identify potential interactions between this medication and other substances you are taking.
* Any health problems you have, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all of your current medications and health conditions. Never start, stop, or change the dose 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, it is crucial to closely monitor your blood sugar levels, as this medication may affect them. 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 viral diseases. 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 breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
If you have diabetes, it is crucial to closely monitor your blood sugar levels, as this medication may affect them. 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 viral diseases. 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 breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Diarrhea
- Abdominal discomfort
- Hyperuricemia (high uric acid levels)
- Hyperuricosuria (high uric acid in urine)
- Rarely, fibrosing colonopathy (severe abdominal pain, vomiting, bloating, constipation, bloody stools)
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.
Drug Interactions
Moderate Interactions
- Antacids (calcium carbonate, magnesium hydroxide): May decrease efficacy of pancrelipase by degrading the enteric coating or inactivating the enzymes. Separate administration by 1-2 hours if possible.
- Iron supplements: High doses of pancreatic enzymes may theoretically impair iron absorption, though clinical significance is generally low.
Minor Interactions
- Folic acid: High doses of pancreatic enzymes may theoretically impair folic acid absorption.
Monitoring
Baseline Monitoring
Nutritional status (weight, height, BMI)
Rationale: To assess baseline pancreatic insufficiency and guide initial dosing.
Timing: Prior to initiation of therapy.
Stool fat excretion (quantitative fecal fat analysis)
Rationale: To objectively assess malabsorption and guide enzyme dose titration.
Timing: Prior to initiation, if feasible.
Routine Monitoring
Clinical symptoms (steatorrhea, abdominal pain, bloating, flatulence)
Frequency: Regularly, at each follow-up visit.
Target: Resolution or significant improvement of symptoms.
Action Threshold: Persistent or worsening symptoms indicate need for dose adjustment or re-evaluation.
Nutritional status (weight, growth in children, vitamin levels - A, D, E, K)
Frequency: Every 3-6 months or as clinically indicated.
Target: Maintenance of healthy weight, appropriate growth, normal vitamin levels.
Action Threshold: Weight loss, poor growth, or vitamin deficiencies indicate inadequate enzyme replacement.
Stool consistency and frequency
Frequency: Daily patient self-monitoring.
Target: Normal stool consistency and frequency.
Action Threshold: Persistent greasy, bulky, foul-smelling stools or increased frequency.
Symptom Monitoring
- Steatorrhea (greasy, bulky, foul-smelling stools)
- Abdominal pain
- Bloating
- Flatulence
- Weight loss or failure to thrive (in children)
- Diarrhea
- Constipation
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Pancrelipase is minimally absorbed systemically, so systemic exposure to the fetus is unlikely. However, adequate nutritional status is crucial during pregnancy, and enzyme replacement can help maintain it.
Trimester-Specific Risks:
First Trimester:
No specific risks identified due to minimal systemic absorption. Focus on maintaining maternal nutritional status.
Second Trimester:
No specific risks identified. Continued focus on maternal nutritional status.
Third Trimester:
No specific risks identified. Continued focus on maternal nutritional status.
Lactation
Pancrelipase is minimally absorbed systemically, so it is unlikely to be excreted in breast milk or cause harm to a breastfed infant. It is generally considered compatible with breastfeeding. Monitor the infant for any gastrointestinal symptoms.
Infant Risk:
Low risk (L3 - Moderately safe, but caution advised due to limited data).
Pediatric Use
Dosing is weight-based and individualized. Close monitoring of growth, nutritional status, and symptoms is essential. The risk of fibrosing colonopathy is higher in children with cystic fibrosis receiving very high doses.
Geriatric Use
No specific dose adjustments are required based on age alone. Dosing should be individualized based on clinical response and fat intake, similar to younger adults. Elderly patients may have other comorbidities that require careful consideration.
Clinical Information
Clinical Pearls
- Always take pancrelipase with meals and snacks to ensure proper digestion.
- Do not crush or chew the capsules/microspheres; this can inactivate the enzymes and cause oral irritation.
- If a dose is missed, take it as soon as possible with food, but do not double dose.
- Monitor for signs of inadequate dosing (persistent steatorrhea, weight loss) or excessive dosing (abdominal pain, constipation, potential fibrosing colonopathy).
- Patients with cystic fibrosis are at higher risk for fibrosing colonopathy with very high doses; adhere strictly to recommended maximum doses.
- Ensure adequate hydration to prevent constipation, a common side effect.
Alternative Therapies
- Dietary modifications (e.g., low-fat diet, although this is often counterproductive for patients needing enzyme replacement)
- Nutritional supplements (e.g., medium-chain triglycerides, fat-soluble vitamins)
Cost & Coverage
Average Cost:
Varies widely by strength and quantity (e.g., $500-$2000+) per 100 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires 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, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.