See FDA-approved patient labeling (Medication Guide)
- Instruct patients and caregivers that ZENPEP should only be taken as directed by their healthcare professional. Patients should be advised that the total daily dose should not exceed 10,000 lipase units/kg body weight per day unless clinically indicated. This needs to be especially emphasized for patients eating multiple snacks and meals per day. Patients should be informed that if a dose is missed, the next dose should be taken with the next meal or snack as directed. Doses should not be doubled [see Dosage and Administration ( 2)].
- Instruct patients and caregivers that ZENPEP should always be taken with food. Patients should be advised that ZENPEP delayed-release capsules must not be crushed or chewed as doing so could cause early release of enzymes and/or loss of enzymatic activity. Patients should swallow the intact capsules with adequate amounts of liquid at mealtimes. If necessary, the capsules contents can also be sprinkled on soft acidic foods [see Dosage and Administration ( 2)].
- Instruct patients to notify their healthcare professional if they are pregnant or are thinking of becoming pregnant during treatment with ZENPEP [see Use in Specific Populations ( 8.1)] .
- Instruct patients and caregivers to notify the healthcare professional if the patient has a history of abnormal glucose levels before initiating treatment with ZENPEP [see Postmarketing Experience ( 6.2) ].
Advise patients and caregivers to follow dosing instructions carefully, as doses of pancreatic enzyme products exceeding 6,000 lipase units/kg of body weight per meal (10,000 lipase units/kg body weight/day) have been associated with colonic strictures in children below the age of 12 years [see Dosage and Administration ( 2)].
Advise patients and caregivers to contact their healthcare professional immediately if allergic reactions to ZENPEP develop [see Warnings and Precautions ( 5.5)].
Allergan USA, Inc.Madison, NJ 07940
For further information, please call Allergan at 1-800-678-1605.
ZENPEP® is a registered trademark of Allergan Therapeutics LLC.
Patented. See www.allergan.com/patents.
©2020 Allergan. All rights reserved.
|MEDICATION GUIDE ZENPEP ® (ZEN-pep) (pancrelipase) delayed-release capsules|
|Read this Medication Guide before you start taking ZENPEP and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.|
|What is the most important information I should know about ZENPEP? ZENPEP may increase your chance of having a rare bowel disorder called fibrosing colonopathy. This condition is serious and may require surgery. The risk of having this condition may be reduced by following the dosing instructions that your doctor gave you. Call your doctor ri ght away if you have any unusual or severe: |
| What is ZENPEP? |
|What should I tell my doctor before taking ZENPEP? Before taking ZENPEP, tell your doctor about all your medical conditions, including if you: |
|How should I take ZENPEP? |
|What are possible side effects of ZENPEP? ZENPEP may cause serious side effects, including: |
| How do I store ZENPEP? |
|General information about ZENPEP Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ZENPEP for a condition for which it was not prescribed. Do not give ZENPEP to other people, even if they have the same symptoms you have. It may harm them.This Medication Guide summarizes the most important information about ZENPEP. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about ZENPEP that is written for health professionals. For more information, go to www.ZENPEP.com or call 1-800-678-1605.|
|What are the ingredients in ZENPEP? Active ingredient: lipase, protease, amylaseInactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc, and triethyl citrate in hypromellose capsules.The red radial imprinting on the 3,000 capsule strength contains, antifoam DC 1510, industrial methylated spirit, iron oxide red C.I. 77491-E172, n-butyl alcohol, shellac and soya lecithin.The blue radial imprinting on the 5,000, 10,000, 15,000, 20,000, 25,000, and 40,000 capsule strengths contains dehydrated alcohol, FD&C Blue #2 aluminum lake C.I. 73015-E132, isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac and strong ammonia solution.Capsule shell ingredients: |
|Distributed by:Allergan USA, Inc. Madison, NJ 07940For further information, please call Allergan at 1-800-678-1605. ©2020 Allergan. All rights reserved|
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised 03/2020
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.