Zenpep 60,000 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 that people with certain conditions, like cystic fibrosis or chronic pancreatitis, don't make enough of. Taking Zenpep with every meal and snack helps your body absorb nutrients, reducing symptoms like greasy stools, stomach pain, 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 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 it 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.
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 products 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.
Giving 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 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 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.
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 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 it 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.
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 products 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.
Giving 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 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 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.
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. The dose depends on the amount of fat in your food.
- Swallow capsules whole. Do not chew or crush them, as this can irritate your mouth and inactivate the enzymes.
- If you cannot swallow the capsule whole, open it and sprinkle the contents on a small amount of acidic food (e.g., applesauce, pureed banana) and swallow immediately without chewing. Do not store the mixture.
- Drink plenty of fluids while taking this medication to prevent constipation.
- Maintain a balanced diet as recommended by your doctor or dietitian.
- Store at room temperature, away from moisture and heat.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose typically 500 lipase units/kg/meal. Doses should be individualized based on clinical symptoms, steatorrhea, and fat intake. Zenpep 60,000 IU capsules are for higher enzyme needs.
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, whichever is less.
otherExocrinePancreaticInsufficiency:
Initial: 500 lipase units/kg/meal. Max: Doses exceeding 2,500 lipase units/kg/meal or 10,000 lipase units/kg/day should be used with caution and only if clearly documented to be effective, as higher doses have been associated with fibrosing colonopathy.
Pediatric Dosing
Neonatal:
Not established (typically not used in neonates unless specific conditions like CF are diagnosed and require it, then individualized dosing based on weight and fat intake).
Infant:
Initial: 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:
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.
Adolescent:
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.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed as enzymes are not systemically absorbed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Dialysis:
No specific adjustment needed.
Hepatic Impairment:
Mild:
No specific adjustment needed as enzymes are not systemically absorbed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Pharmacology
Mechanism of Action
Pancrelipase is a pancreatic enzyme product (PEP) 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. These enzymes are essential for the digestion and absorption of nutrients in patients with exocrine pancreatic insufficiency (EPI) due to conditions such as cystic fibrosis, chronic pancreatitis, pancreatectomy, or other pancreatic diseases.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (enzymes act locally in GI tract, not absorbed systemically)
Tmax:
Not applicable
FoodEffect:
Must be taken with food to ensure mixing with chyme and optimal digestive activity.
Distribution:
Vd:
Not applicable
ProteinBinding:
Not applicable
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (enzymes are inactivated/digested in GI tract)
Clearance:
Not applicable
ExcretionRoute:
Fecal (as inactivated/digested protein)
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Immediately upon mixing with food in the stomach and release in the duodenum.
PeakEffect:
Corresponds to the time of maximal digestion, typically within 1-2 hours post-meal.
DurationOfAction:
Duration of a meal's digestion (typically 2-4 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 (could indicate fibrosing colonopathy, especially with very high doses)
- Unusual rash or allergic reaction
- Worsening of digestive symptoms despite taking medication
- Signs of gout (joint pain, swelling) due to high purine content (rare)
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 information will help your doctor and pharmacist identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, 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 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, 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 information will help your doctor and pharmacist identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, 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 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 (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, as it is necessary 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, as it is necessary to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Hyperuricemia (elevated uric acid levels)
- Hyperuricosuria (elevated uric acid in urine)
- Gout (rare)
- Fibrosing colonopathy (with chronic, very high doses)
What to Do:
Discontinue medication, seek medical attention. Symptomatic and supportive care. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Moderate Interactions
- Antacids (calcium carbonate, magnesium hydroxide): May degrade the enteric coating of pancrelipase, leading to premature release of enzymes in the stomach and inactivation by gastric acid. Separate administration times or use acid-suppressing agents if needed.
- Iron supplements: Theoretical interaction where pancreatic enzymes may reduce iron absorption, though clinical significance is generally low.
Monitoring
Baseline Monitoring
Nutritional status (weight, height, BMI)
Rationale: To assess baseline malabsorption and guide initial dosing.
Timing: Prior to initiation of therapy.
Stool elastase-1 or fecal fat quantification
Rationale: To confirm diagnosis of exocrine pancreatic insufficiency and severity.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical symptoms (steatorrhea, abdominal pain, bloating, flatulence)
Frequency: Regularly, at each follow-up visit (e.g., monthly initially, then every 3-6 months).
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)
Frequency: Every 3-6 months or as clinically indicated.
Target: Maintenance of healthy weight, appropriate growth curve for children.
Action Threshold: Weight loss, poor growth, or signs of malnutrition require dose adjustment or further investigation.
Fat-soluble vitamin levels (A, D, E, K)
Frequency: Annually or as clinically indicated, especially if malabsorption persists.
Target: Within normal limits.
Action Threshold: Deficiencies require supplementation and/or enzyme dose adjustment.
Symptom Monitoring
- Reduction in frequency and volume of greasy, foul-smelling stools (steatorrhea)
- Decrease in abdominal pain and bloating
- Improved weight gain or maintenance
- Reduced flatulence
- Improved appetite
Special Patient Groups
Pregnancy
Pancrelipase is generally considered safe during pregnancy as it is not absorbed systemically. However, it is classified as Pregnancy Category C because animal reproduction studies have not been conducted. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
No specific risks identified due to lack of systemic absorption.
Second Trimester:
No specific risks identified due to lack of systemic absorption.
Third Trimester:
No specific risks identified due to lack of systemic absorption.
Lactation
Pancrelipase is generally considered safe during breastfeeding as it is not absorbed systemically by the mother and therefore not expected to be present in breast milk. The benefits of breastfeeding should be weighed against the mother's need for the drug.
Infant Risk:
Low risk to breastfed infant.
Pediatric Use
Dosing is weight-based and individualized. Close monitoring of growth, nutritional status, and symptoms is crucial. Caution is advised with very high doses due to the rare risk of fibrosing colonopathy, especially in children with cystic fibrosis.
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
- Pancrelipase dosing is highly individualized; there is no 'one-size-fits-all' dose. It must be titrated based on clinical response (reduction in steatorrhea, improved weight gain) and dietary fat intake.
- Always take with meals and snacks. If a meal is missed, do not take a double dose for the next meal.
- Ensure patients understand the importance of not crushing or chewing the capsules/microspheres to preserve the enteric coating and prevent oral irritation/inactivation.
- Patients should be educated on signs of malabsorption (e.g., persistent greasy stools, weight loss) that indicate a need for dose adjustment.
- High doses (exceeding 2,500 lipase units/kg/meal or 10,000 lipase units/kg/day) should be approached with caution due to the rare risk of fibrosing colonopathy, particularly in CF patients.
Alternative Therapies
- Creon (pancrelipase)
- Viokace (pancrelipase, non-enteric coated)
- Pancreaze (pancrelipase)
- Pertzye (pancrelipase)
- Ultresa (pancrelipase)
Cost & Coverage
Average Cost:
Varies widely by strength and quantity, typically several hundred to over a thousand USD per 100 capsules
Insurance Coverage:
Tier 3 or 4 (Specialty/Non-preferred Brand)
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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.