Zenpep 5,000 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
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 starches. It contains natural enzymes similar to those made by a healthy pancreas. People who have problems with their pancreas not making enough of these enzymes (like in cystic fibrosis or chronic pancreatitis) take Zenpep with every meal and snack to help them absorb nutrients and gain weight.
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 minimize potential side effects. Swallow the medication whole with plenty of fluids to ensure you swallow all of the contents.
3. Do Not Chew or Crush: Do not chew, crush, or hold the medication in your mouth, as this may 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 medication, you may sprinkle the contents of the capsule on applesauce. Do not chew the mixture; swallow it immediately and follow with water or juice.
5. Mixing with Food: Some products can be mixed with foods other than applesauce. Be sure to check with your doctor or pharmacist to see what foods are suitable for mixing with your medication.
6. Feeding Tube Administration: 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.
Special Instructions for Infants (Up to 12 Months Old)
1. Dosing Schedule: Give this medication to your infant every time you feed them.
2. Administration: Sprinkle the contents of the capsule into your infant's mouth or over a small amount of applesauce. Some products can also be mixed with other foods found in baby food jars, such as bananas or pears. Be sure to check with your doctor or pharmacist to see what foods are suitable for mixing with your medication.
3. Avoid Mixing with Formula or Breast Milk: Do not mix the medication with baby formula or breast milk.
4. Immediate Administration: Give the mixture to your infant immediately and do not store it for later use.
5. Follow-up: After giving the medication, have your infant drink baby formula or breast milk. Check inside your infant's mouth to ensure they have swallowed 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. Original Container: Keep your medication in its original container.
3. Desiccant Packet: If the bottle has 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 normal dosing 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 minimize potential side effects. Swallow the medication whole with plenty of fluids to ensure you swallow all of the contents.
3. Do Not Chew or Crush: Do not chew, crush, or hold the medication in your mouth, as this may 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 medication, you may sprinkle the contents of the capsule on applesauce. Do not chew the mixture; swallow it immediately and follow with water or juice.
5. Mixing with Food: Some products can be mixed with foods other than applesauce. Be sure to check with your doctor or pharmacist to see what foods are suitable for mixing with your medication.
6. Feeding Tube Administration: 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.
Special Instructions for Infants (Up to 12 Months Old)
1. Dosing Schedule: Give this medication to your infant every time you feed them.
2. Administration: Sprinkle the contents of the capsule into your infant's mouth or over a small amount of applesauce. Some products can also be mixed with other foods found in baby food jars, such as bananas or pears. Be sure to check with your doctor or pharmacist to see what foods are suitable for mixing with your medication.
3. Avoid Mixing with Formula or Breast Milk: Do not mix the medication with baby formula or breast milk.
4. Immediate Administration: Give the mixture to your infant immediately and do not store it for later use.
5. Follow-up: After giving the medication, have your infant drink baby formula or breast milk. Check inside your infant's mouth to ensure they have swallowed 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. Original Container: Keep your medication in its original container.
3. Desiccant Packet: If the bottle has 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 normal dosing schedule. Do not take two doses at the same time or extra doses.
Lifestyle & Tips
- Always take Zenpep with every meal and snack. Do not chew or crush the capsules or their contents.
- Swallow capsules whole. If you cannot swallow the capsule, open it and sprinkle the contents on a small amount of acidic food (e.g., applesauce, pureed banana) and swallow immediately without chewing.
- Drink plenty of liquids (water, juice) throughout the day to prevent constipation.
- Follow your doctor's dietary recommendations, which may include a high-calorie, high-fat diet.
- Do not hold the capsule contents in your mouth, as it can cause irritation.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose based on lipase units: 500 to 2,500 lipase units/kg/meal. Typically 500 to 2,500 lipase units/kg/meal or 4,000 to 50,000 lipase units per meal, adjusted based on clinical response and fat intake.
Dose Range:
4000 - 90000 mg
Condition-Specific Dosing:
cysticFibrosis:
Initial: 500 lipase units/kg/meal. Max: 2,500 lipase units/kg/meal or 10,000 lipase units/kg/day, or 4,000 lipase units/gram of fat ingested per day.
chronicPancreatitis:
Initial: 4,000 to 50,000 lipase units per meal. Adjust based on clinical response and fat intake.
Pediatric Dosing
Neonatal:
Not established (safety and efficacy not established in neonates).
Infant:
Initial: 2,000 to 4,000 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: 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: 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 as pancrelipase is not absorbed systemically.
Moderate:
No specific adjustment needed as pancrelipase is not absorbed systemically.
Severe:
No specific adjustment needed as pancrelipase is not absorbed systemically.
Dialysis:
No specific adjustment needed as pancrelipase is not absorbed systemically.
Hepatic Impairment:
Mild:
No specific adjustment needed as pancrelipase is not absorbed systemically.
Moderate:
No specific adjustment needed as pancrelipase is not absorbed systemically.
Severe:
No specific adjustment needed as pancrelipase is not absorbed systemically.
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 enzymatic activity aids in the digestion and absorption of nutrients in patients with exocrine pancreatic insufficiency (EPI).
Pharmacokinetics
Absorption:
Bioavailability:
Minimal to none (intended for local action in GI tract)
Tmax:
Not applicable (not absorbed systemically)
FoodEffect:
Must be taken with meals or snacks to be effective
Distribution:
Vd:
Not applicable (not absorbed systemically)
ProteinBinding:
Not applicable (not absorbed systemically)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (not absorbed systemically)
Clearance:
Not applicable (not absorbed systemically)
ExcretionRoute:
Fecal (as degraded enzymes)
Unchanged:
Not applicable (degraded in GI tract)
Pharmacodynamics
OnsetOfAction:
Immediately upon mixing with food in the stomach/duodenum
PeakEffect:
During digestion of a meal
DurationOfAction:
Duration of meal digestion (typically 1-4 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 immediately or seek medical attention:
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 and they bother you or do not go away, contact your doctor:
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 immediately or seek medical attention:
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 and they bother you or do not go away, contact your doctor:
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 (could indicate fibrosing colonopathy, a rare but serious side effect, especially with very high doses)
- Rash, itching, hives, swelling of the face/lips/tongue (signs of allergic reaction)
- Difficulty breathing or swallowing (signs of severe allergic reaction)
- Worsening of gout symptoms (due to high uric acid levels, 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 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 assess 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 this medication can be taken with all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the 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 assess 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 this medication can be taken with all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood work and laboratory tests should be conducted as directed by your doctor to monitor your condition. Adhere to the 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 breast-feeding, inform your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
If you have diabetes (high blood sugar), it is crucial to closely monitor your blood sugar levels. Additionally, be aware of the potential for gout attacks and report any symptoms to your doctor promptly.
This medication is derived from pork (pig) pancreas tissue, which carries a minimal risk of transmitting 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 breast-feeding, inform your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Hyperuricemia (elevated uric acid in blood)
- Hyperuricosuria (elevated uric acid in urine)
- Fibrosing colonopathy (rare, but serious, with very high doses)
What to Do:
Discontinue the medication and seek medical attention. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Moderate Interactions
- Antacids (calcium carbonate, magnesium hydroxide): May decrease efficacy by degrading the enzyme coating or the enzymes themselves if the coating is compromised.
- Iron supplements: Pancrelipase may decrease iron absorption, though clinical significance is generally low.
Minor Interactions
- Acarbose, Miglitol: May theoretically reduce the effect of these alpha-glucosidase inhibitors, but clinical significance is low.
Monitoring
Baseline Monitoring
Nutritional status (weight, height, BMI)
Rationale: To assess baseline malabsorption and track treatment efficacy.
Timing: Prior to initiation of therapy
Stool frequency and consistency
Rationale: To assess baseline symptoms of malabsorption (e.g., steatorrhea).
Timing: Prior to initiation of therapy
Symptoms of malabsorption (abdominal pain, bloating, flatulence)
Rationale: To assess baseline symptom burden.
Timing: Prior to initiation of therapy
Routine Monitoring
Weight and growth (especially in pediatric patients)
Frequency: Regularly (e.g., every 3-6 months or as clinically indicated)
Target: Appropriate for age/sex
Action Threshold: Failure to gain weight, weight loss, or poor growth
Stool characteristics (frequency, consistency, presence of oil/fat)
Frequency: Regularly (e.g., at each clinic visit)
Target: Normal stool output, absence of steatorrhea
Action Threshold: Persistent steatorrhea, increased stool frequency, or oily stools
Symptoms of malabsorption (abdominal pain, bloating, flatulence)
Frequency: Regularly (e.g., at each clinic visit)
Target: Resolution or significant improvement of symptoms
Action Threshold: Persistent or worsening symptoms
Fat-soluble vitamin levels (A, D, E, K)
Frequency: Periodically (e.g., annually or as clinically indicated)
Target: Within normal limits
Action Threshold: Deficiency requiring supplementation
Symptom Monitoring
- Abdominal pain
- Bloating
- Flatulence
- Diarrhea
- Steatorrhea (oily, foul-smelling stools)
- Weight loss
- Poor growth (in children)
Special Patient Groups
Pregnancy
Use with caution during pregnancy. Pancrelipase is minimally absorbed systemically, so maternal systemic exposure and fetal exposure are expected to be low. However, adequate nutrition is critical during pregnancy, and treatment of maternal malabsorption is important for fetal development. Consult with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption; focus on maintaining maternal nutritional status.
Second Trimester:
Low risk due to minimal systemic absorption; focus on maintaining maternal nutritional status.
Third Trimester:
Low risk due to minimal systemic absorption; focus on maintaining maternal nutritional status.
Lactation
Considered compatible with breastfeeding. Pancrelipase is minimally absorbed systemically, so it is unlikely to be excreted in breast milk or cause systemic effects in the breastfed infant. The benefits of breastfeeding should be weighed against the mother's need for the drug.
Infant Risk:
Low risk
Pediatric Use
Dosing is weight-based and adjusted according to age and severity of exocrine pancreatic insufficiency. Close monitoring of growth, weight gain, and stool characteristics is essential. Fibrosing colonopathy has been reported in pediatric patients with cystic fibrosis receiving very high doses of pancreatic enzyme products.
Geriatric Use
No specific dose adjustments are typically required for elderly patients. However, elderly patients may have other comorbidities or be on multiple medications, so careful monitoring for efficacy and adverse effects is prudent.
Clinical Information
Clinical Pearls
- Always take pancrelipase with every meal and snack. The dose should be individualized based on clinical symptoms, stool fat content, and dietary fat intake.
- Do not chew or crush the capsules or their contents, as this can inactivate the enzymes and cause oral irritation.
- For patients who cannot swallow capsules, the contents can be sprinkled on soft, acidic food (e.g., applesauce) and swallowed immediately without chewing.
- Ensure adequate hydration to prevent constipation, a common side effect.
- Monitor for signs of fibrosing colonopathy (severe abdominal pain, distention, vomiting, constipation), especially in cystic fibrosis patients on high doses, though this is rare with current formulations.
- Patients should be educated on proper administration technique to maximize efficacy and minimize side effects.
Alternative Therapies
- Dietary modifications (e.g., reduced fat intake, medium-chain triglycerides)
- Nutritional supplementation (e.g., fat-soluble vitamins)
Cost & Coverage
Average Cost:
Varies widely by strength and quantity, typically $300-$1000+ per 100 capsules
Insurance Coverage:
Tier 2 or 3 (Specialty drug, may require 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. When reporting the overdose, be prepared to provide details about the medication taken, the quantity, and the time it occurred.