Zenpep 40,000 IU Capsules
It is used to help break down food when the pancreas is not working the right way.
Drug Class
Pancreatic enzyme replacement
Pharmacologic Class
Digestive enzymes
Pregnancy Category
Category B
FDA Approved
Jul 2009
DEA Schedule
Not Controlled
Overview
What is this medicine?
Zenpep is a medicine that helps your body digest food, especially fats, proteins, and starches. It's used when your pancreas doesn't make enough of its own digestive enzymes, which can happen with conditions like cystic fibrosis or chronic pancreatitis. Taking Zenpep with your meals helps your body absorb the nutrients from your food.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most out of your medication, follow these steps:
1. Follow Your Doctor's Orders: Take this medication exactly as directed by your doctor. Read all the information provided with your medication and follow the instructions carefully.
2. Take with Food and Fluids: Take this medication with meals and snacks to help prevent stomach upset. Swallow the capsule whole with plenty of fluids, such as water or juice, to ensure you swallow all the contents.
3. Do Not Chew or Crush: Do not chew, crush, or hold the capsule in your mouth, as this can cause mouth irritation or affect how the medication works. If you have any concerns, talk to your doctor.
4. Alternative Administration: If you have trouble swallowing the capsule, you can sprinkle the contents on applesauce. Do not chew the mixture; swallow it right away and follow with water or juice. Some products can be mixed with other foods, such as bananas or pears, but be sure to check with your doctor or pharmacist first.
5. Feeding Tube Administration: Some 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 administered this way.
Special Instructions for Infants (Up to 12 Months Old)
1. Give with Feedings: Give this medication to your infant every time you feed them.
2. Mix with Food: Sprinkle the contents of the capsule into your infant's mouth or mix with a small amount of applesauce, bananas, or pears. Do not mix with baby formula or breast milk.
3. Give Immediately: Give the mixture right away; do not store it for later use.
4. Check for Swallowing: After feeding, check your infant's mouth to ensure they have swallowed the medication.
5. Follow with Formula or Breast Milk: Have your infant drink baby formula or breast milk right after giving the medication.
Storing and Disposing of Your Medication
1. Store at Room Temperature: Store your medication at room temperature with the lid tightly closed.
2. Keep in Original Container: Store your medication in its original container. If the bottle has a desiccant packet, keep it in the bottle to keep the medication dry. 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 normal schedule. Do not take two doses at the same time or extra doses.
To ensure you get the most out of your medication, follow these steps:
1. Follow Your Doctor's Orders: Take this medication exactly as directed by your doctor. Read all the information provided with your medication and follow the instructions carefully.
2. Take with Food and Fluids: Take this medication with meals and snacks to help prevent stomach upset. Swallow the capsule whole with plenty of fluids, such as water or juice, to ensure you swallow all the contents.
3. Do Not Chew or Crush: Do not chew, crush, or hold the capsule in your mouth, as this can cause mouth irritation or affect how the medication works. If you have any concerns, talk to your doctor.
4. Alternative Administration: If you have trouble swallowing the capsule, you can sprinkle the contents on applesauce. Do not chew the mixture; swallow it right away and follow with water or juice. Some products can be mixed with other foods, such as bananas or pears, but be sure to check with your doctor or pharmacist first.
5. Feeding Tube Administration: Some 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 administered this way.
Special Instructions for Infants (Up to 12 Months Old)
1. Give with Feedings: Give this medication to your infant every time you feed them.
2. Mix with Food: Sprinkle the contents of the capsule into your infant's mouth or mix with a small amount of applesauce, bananas, or pears. Do not mix with baby formula or breast milk.
3. Give Immediately: Give the mixture right away; do not store it for later use.
4. Check for Swallowing: After feeding, check your infant's mouth to ensure they have swallowed the medication.
5. Follow with Formula or Breast Milk: Have your infant drink baby formula or breast milk right after giving the medication.
Storing and Disposing of Your Medication
1. Store at Room Temperature: Store your medication at room temperature with the lid tightly closed.
2. Keep in Original Container: Store your medication in its original container. If the bottle has a desiccant packet, keep it in the bottle to keep the medication dry. 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 normal schedule. Do not take two doses at the same time or extra doses.
Lifestyle & Tips
- Always take Zenpep with every meal and snack.
- Swallow capsules whole. Do not crush or chew the capsules or their contents, as this can destroy the enteric coating and make the medicine ineffective.
- If you cannot swallow the capsule whole, you may open it and sprinkle the contents on a small amount of soft, acidic food (e.g., applesauce, pureed banana) and swallow immediately without chewing. Do not store the mixture.
- Drink plenty of fluids throughout the day to help prevent constipation.
- Follow your doctor's instructions regarding diet and fat intake.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized based on clinical symptoms, steatorrhea, and fat intake. Initial dose typically 500 lipase units/kg/meal for cystic fibrosis patients, or 4,000 to 50,000 lipase units per meal for other indications. Zenpep 40,000 IU refers to 40,000 lipase units per capsule.
Dose Range:
4000 - 90000 mg
Condition-Specific Dosing:
cysticFibrosis:
Initial dose 500 lipase units/kg/meal, not to exceed 2,500 lipase units/kg/meal or 10,000 lipase units/kg/day, or 4,000 lipase units/gram of fat ingested per day.
otherPancreaticInsufficiency:
Initial dose 4,000 to 50,000 lipase units per meal, with half the dose for snacks. Adjust based on clinical response.
Pediatric Dosing
Neonatal:
Not established (generally not recommended for infants < 12 months unless specifically indicated and monitored).
Infant:
For infants 12 months to < 4 years: Initial dose 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.
Child:
For children 4 years and older: 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:
Same as adult dosing guidelines, individualized based on weight and fat intake.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Dialysis:
No specific considerations as enzymes are not renally cleared.
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 sugars. This facilitates the absorption of nutrients in patients with exocrine pancreatic insufficiency (EPI) who have insufficient endogenous pancreatic enzyme secretion.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption; enzymes are proteins and are largely denatured and digested within the gastrointestinal tract.
Tmax:
Not applicable for systemic absorption. Enzymatic activity occurs throughout the small intestine.
FoodEffect:
Must be taken with food to ensure mixing with chyme and optimal enzymatic activity.
Distribution:
Vd:
Not applicable (minimal systemic absorption).
ProteinBinding:
Not applicable (minimal systemic absorption).
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (minimal systemic absorption).
Clearance:
Not applicable (minimal systemic absorption).
ExcretionRoute:
Excreted primarily in feces as digested protein and inactive enzyme components.
Unchanged:
Not applicable (minimal systemic absorption).
Pharmacodynamics
OnsetOfAction:
Immediate upon mixing with food in the stomach and release in the duodenum.
PeakEffect:
During digestion of a meal, typically within 1-2 hours post-ingestion.
DurationOfAction:
Duration of a meal's digestion (typically 2-4 hours).
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 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 help 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 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 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 help 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 or unusual abdominal pain (especially in children with cystic fibrosis, as this could indicate fibrosing colonopathy)
- Allergic reactions (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
- Worsening of existing symptoms of malabsorption despite taking the medication as directed
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 or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that this medication can be taken safely with all your current medications and health conditions. Never start, stop, or adjust 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 or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that this medication can be taken safely with all your current medications and health conditions. Never start, stop, or adjust 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 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 are breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to both you and your baby. This will enable your healthcare provider to make informed decisions about your treatment plan.
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 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 are breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to both you and your baby. This will enable your healthcare provider to make informed decisions about your treatment plan.
Overdose Information
Overdose Symptoms:
- Hyperuricemia (high uric acid in blood)
- Hyperuricosuria (high uric acid in urine)
- Diarrhea
- Abdominal discomfort
What to Do:
Discontinue medication and seek medical attention. Call a poison control center at 1-800-222-1222.
Drug Interactions
Moderate Interactions
- Antacids (e.g., calcium carbonate, magnesium hydroxide): May theoretically degrade the enteric coating of pancrelipase products, leading to premature release of enzymes in the stomach and inactivation by gastric acid. However, clinical significance is generally low with modern enteric-coated formulations.
- Iron supplements: Pancrelipase may theoretically impair the absorption of iron, though clinical evidence is limited.
Minor Interactions
- Acarbose, Miglitol: Pancrelipase may reduce the effectiveness of these alpha-glucosidase inhibitors by breaking down complex carbohydrates.
Monitoring
Baseline Monitoring
Nutritional status (weight, height, BMI)
Rationale: To assess baseline malabsorption and track improvement.
Timing: Prior to initiation of therapy.
Stool fat excretion (quantitative fecal fat analysis)
Rationale: To objectively measure the degree of malabsorption and guide initial dosing.
Timing: Prior to initiation of therapy (if feasible).
Fat-soluble vitamin levels (A, D, E, K)
Rationale: To assess for deficiencies due to malabsorption.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical symptoms (abdominal pain, bloating, steatorrhea, 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 further investigation.
Weight and growth (especially in pediatric patients)
Frequency: Monthly to quarterly, depending on patient stability.
Target: Appropriate weight gain and growth for age.
Action Threshold: Failure to thrive or weight loss indicates inadequate enzyme replacement.
Stool characteristics (frequency, consistency, odor, presence of oil)
Frequency: Daily patient self-monitoring, discussed at follow-up.
Target: Normal stool consistency and frequency, absence of steatorrhea.
Action Threshold: Persistent greasy, foul-smelling, or frequent stools suggest inadequate dosing.
Nutritional status and fat-soluble vitamin levels
Frequency: Annually or as clinically indicated.
Target: Normal vitamin levels.
Action Threshold: Deficiencies require dose adjustment or supplementation.
Symptom Monitoring
- Abdominal pain
- Bloating
- Gas/flatulence
- Steatorrhea (greasy, foul-smelling stools)
- Diarrhea
- Weight loss or poor weight gain
- Muscle wasting
- Symptoms of fat-soluble vitamin deficiencies (e.g., night blindness, bone pain, easy bruising)
Special Patient Groups
Pregnancy
Category B. Animal reproduction studies have not demonstrated a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women. Pancrelipase is generally considered safe and essential for maintaining nutritional status in pregnant women with EPI.
Trimester-Specific Risks:
First Trimester:
No known specific risks.
Second Trimester:
No known specific risks.
Third Trimester:
No known specific risks.
Lactation
L3. Pancrelipase is minimally absorbed systemically, and therefore, is not expected to be excreted in breast milk. It is generally considered compatible with breastfeeding, and maintaining maternal nutritional status is important for lactation.
Infant Risk:
Low risk to the breastfed 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 or inactivation.
Geriatric Use
No specific dose adjustments are required based on age alone. However, geriatric patients may have comorbidities or polypharmacy that warrant careful monitoring for potential drug interactions or adverse effects.
Clinical Information
Clinical Pearls
- Always take pancrelipase with every meal and snack to ensure proper digestion.
- The dose is highly individualized; adjust based on symptoms, stool characteristics, and fat intake, not just weight.
- Do not crush or chew the capsules or their contents, as this will inactivate the enzymes and cause oral irritation.
- For patients who cannot swallow capsules, the contents can be sprinkled on soft, acidic food and consumed immediately.
- Ensure adequate hydration to prevent constipation, a common side effect.
- Monitor for signs of fibrosing colonopathy, especially in pediatric cystic fibrosis patients on high doses (severe abdominal pain, distention, vomiting, constipation).
Alternative Therapies
- Dietary modifications (e.g., low-fat diet, medium-chain triglycerides)
- Nutritional supplementation (e.g., fat-soluble vitamins)
Cost & Coverage
Average Cost:
Varies widely, typically $500 - $2000+ per 100 capsules
Insurance Coverage:
Tier 3 or Tier 4 (Specialty Drug) on most insurance formularies, often requiring prior authorization.
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. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.