Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase (Zenpep)

Trade Name : Zenpep

Allergan, Inc.

CAPSULE, DELAYED RELEASE

Strength 100003200042000 [USP'U]/1[USP'U]/1[USP'U]/1

PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase (Zenpep) which is also known as Zenpep and Manufactured by Allergan, Inc.. It is available in strength of 10000; 32000; 42000 [USP'U]/1; [USP'U]/1; [USP'U]/1 per ml. Read more

Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase (Zenpep) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

No data

ZENPEP (pancrelipase)u00a0is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
ZENPEP is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, or other conditions ()

Dosage
ZENPEP is not interchangeable with any other pancrelipase product.u00a0
Children Older than 12 Months and Younger than 4 Years
Children 4 Years and Older and Adults
Limitations on Dosing

The active ingredient in ZENPEP evaluated in clinical trials is lipase. ZENPEP is dosed by lipase units.
ZENPEP is available in 7 color coded capsule strengths.
Other active ingredients include protease and amylase. Each ZENPEP capsule strength contains the specified amounts of lipase, protease, and amylase.
Capsules of all strengths are colored as follows:

Capsules: 3,000 USP units of lipase; 10,000 USP units of protease; 14,000 USP units of amylase. Capsules have a white opaque cap and body, printed with u201cAPTALIS 3u201du00a0()n
Capsules: 5,000 USP units of lipase; 17,000 USP units of protease; 24,000 USP units of amylase. Capsules have a white opaque cap and body, printed with u201cAPTALIS 5u201d ()n
Capsules: 10,000 USP units of lipase; 32,000 USP units of protease; 42,000 USP units of amylase. Capsules have a yellow opaque cap and white opaque body, printed with u201cAPTALIS 10u201d ()n
Capsules: 15,000 USP units of lipase; 47,000 USP units of protease; 63,000 USP units of amylase. Capsules have a red opaque cap and white opaque body, printed with u201cAPTALIS 15u201d ()n
Capsules: 20,000 USP units of lipase; 63,000 USP units of protease; 84,000 USP units of amylase. Capsules have a green opaque cap and white opaque body, printed with u201cAPTALIS 20u201du00a0()n
Capsules: 25,000 USP units of lipase; 79,000 USP units of protease; 105,000 USP units of amylase. Capsules have a blue opaque cap and white opaque body, printed with u201cAPTALIS 25u201du00a0()n
Capsules: 40,000 USP units of lipase; 126,000 USP units of protease; 168,000 USP units of amylase. Capsules have a orange opaque cap and white opaque body, printed with u201cAPTALIS 40u201du00a0()

None.
None ()

No data

Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement. Exercise caution when doses of ZENPEP exceed 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day). ()u00a0n
To avoid irritation of oral mucosa, do not chew ZENPEP or retain in the mouth. ()n
Exercise caution when prescribing ZENPEP to patients with gout, renal impairment, or hyperuricemia. ()n
There is theoretical risk of viral transmission with all pancreatic enzyme products including ZENPEP. ()n
Exercise caution when administering pancrelipase to a patient with a known allergy to proteins of porcine origin. ()

The most serious adverse reactions reported with different pancreatic enzyme products of the same active ingredient (pancrelipase) include fibrosing colonopathy, hyperuricemia and allergic reactions n n .

The most common adverse events (>6% of patients treated with ZENPEP) are abdominal pain, flatulence, headache, cough, decreased weight, early satiety, and contusion. ()

No drug interactions have been identified. No formal interaction studies have been conducted.

Pediatric Patients:

The safety and effectiveness of ZENPEP were assessed in pediatric patients, ages 1 to 17 years. ()n
The safety and efficacy of pancreatic enzyme products with different formulations of pancrelipase in pediatric patients have been described in the medical literature and through clinical experience. ()

In Study 1, a 10 year-old patient was administered a dose of 10,856 lipase units per kg body weight of ZENPEP for a period of one day. The patient did not experience any adverse events as a result of the dose increase, nor did this patient experience any adverse events during a 44-day follow-up period. No abnormalities from analyses of safety labs (chemistry, hematology, urinalysis or uric acid) were noted.
Chronic high doses of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures n n n n . High doses of pancreatic enzyme products have been associated with hyperuricosuria and hyperuricemia, and should be used with caution in patients with a history of hyperuricemia, gout, or renal impairment n n .

ZENPEP is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine-derived lipases, proteases, and amylases.
Pancrelipase is a cream-colored powder. It is miscible in water and practically insoluble or insoluble in alcohol and ether.
Each capsule for oral administration contains enteric-coated beads (18-1.9mm for 3,000 and 5,000 USP units of lipase, 22-2.5mm for 10,000, 15,000, 20,000, 25,000, and 40,000 USP units of lipase).
The active ingredient evaluated in clinical trials is lipase. ZENPEP is dosed by lipase units.
Other active ingredients include protease and amylase.u00a0
Inactive ingredients in ZENPEP include colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc, and triethyl citrate and are contained in hypromellose capsules. The imprinting red ink on the 3,000 capsules strength contains, antifoam DC 1510, industrial methylated spirit, iron oxide red C.I. 77491-E172, n-butyl alcohol, shellac and soya lecithin.
3,000 USP units of lipase
The imprinting blue ink on the capsules strengths 5,000, 10,000, 15,000, 20,000, 25,000 and 40,000 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.u00a0
5,000 USP units of lipase
10,000 USP units of lipase
15,000 USP units of lipase
20,000 USP units of lipase
25,000 USP units of lipase
40,000 USP units of lipase;

No data

Carcinogenicity, genetic toxicology, and animal fertility studies have not been performed.

The short-term safety and efficacy of ZENPEP were evaluated in 2 studies conducted in 53 patients, ages 1 to 23 years, with exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF).
Study 1 was a randomized, double-blind, placebo-controlled, crossover study of 34 patients, ages 7 to 23 years, with EPI due to CF. The final analysis population was limited to 32 patients, who completed both double-blind treatment periods, and were included in the efficacy analysis population. Patients were randomized to receive ZENPEP or matching placebo for 6 to 7 days of treatment, followed by crossover to the alternate treatment for an additional 6 to 7 days. The mean dose during the controlled treatment periods ranged from a mean dose of 3,900 lipase units per kilogram per day to 5,700 lipase units per kilogram per day. All patients consumed a high-fat diet (greater than or equal to 100 grams of fat per day) during the treatment period.
The primary efficacy endpoint was the mean difference in the coefficient of fat absorption (CFA) between ZENPEP and placebo treatment. The CFA was determined by a 72-hour stool collection during both treatments, when both fat excretion and fat ingestion were measured. Each patientu2019s CFA during placebo treatment was used as their no-treatment CFA value.
Mean CFA was 88% with ZENPEP treatment compared to 63% with placebo treatment. The mean difference in CFA was 26 percentage points in favor of ZENPEP treatment with 95% Confidence Interval of (19, 32) and p0.001.
Subgroup analyses of the CFA results showed that mean change in CFA was greater in patients with lower no-treatment (placebo) CFA values than in patients with higher no-treatment (placebo) CFA values. There were similar responses to ZENPEP by age and gender.
Study 2, was an open-label, uncontrolled study of 19 patients, ages 1 to 6 years (mean age 4 years), with EPI due to CF. Approximately half of the patients were ages 1 to 3 years. Study 2 compared a measurement of fat malabsorption, spot fecal fat testing, before (while receiving therapy with another commercial PEP) and after oral administration of Zenpep capsules with each meal or snack.
All patients in Study 2 were transitioned to ZENPEP from their usual PEP treatment. After a 4-14 days screening period on the current PEP, patients in Study 2 received ZENPEP at individually titrated doses ranging between 2,300 and 10,000 lipase units per kg body weight per day, with a mean of approximately 5,000 lipase units per kg body weight per day (not to exceed 2,500 lipase units per kilogram per meal) for 14 days. There was no wash-out period. Overall, patients showed similar control of fat malabsorption by spot fecal fat testing when switched to ZENPEP treatment at similar doses.

No data

ZENPEPn- Arrayn- (pancrelipase) Delayed-Release Capsules
3,000 USP units of lipase; 10,000 USP units of protease; 14,000 units of amylase.
Each ZENPEP capsule is available as a two piece hypromellose capsule with white opaque cap and white body with a red radial print and printed with u201cAPTALIS 3u201d, 1.8-1.9mm enteric-coated beads.Capsules are supplied in bottles of:
ZENPEPn- Arrayn- (pancrelipase) Delayed-Release Capsules
5,000 USP units of lipase; 17,000 USP units of protease; 24,000 units of amylase.
Each ZENPEP capsule is available as a two piece hypromellose capsule with white opaque cap and white body with a blue radial print and printed with u201cAPTALIS 5u201d, 1.8-1.9mm enteric-coated beads.Capsules are supplied in bottles of:
ZENPEPn- Arrayn- (pancrelipase) Delayed-Release Capsules
10,000 USP units of lipase; 32,000 units of protease; 42,000 units of amylase.
Each ZENPEP capsule is available as a two piece hypromellose capsule with yellow opaque cap and white body with a blue radial print and printed with u201cAPTALIS 10u201d, that contains 2.2-2.5mm enteric-coated beads. Capsules are supplied in bottles of:
ZENPEPn- Arrayn- (pancrelipase) Delayed-Release Capsules
15,000 USP units of lipase; 47,000 units of protease; 63,000 units of amylase.
Each ZENPEP capsule is available as a two piece hypromellose capsule with red opaque cap and white body with a blue radial print and printed with u201cAPTALIS 15u201d, that contains 2.2-2.5mm enteric-coated beads. Capsules are supplied in bottles of:
ZENPEPn- Arrayn- (pancrelipase) Delayed-Release Capsulesn- u00a0
20,000 USP units of lipase; 63,000 units of protease; 84,000 units of amylase.
Each ZENPEP capsule is available as a two piece hypromellose capsule with green opaque cap and white body with a blue radial print and printed with u201cAPTALIS 20u201d, that contains 2.2-2.5mm enteric-coated beads. Capsules are supplied in bottles of:
ZENPEPn- Arrayn- (pancrelipase) Delayed-Release Capsulesn- u00a0
25,000 USP units of lipase; 79,000 units of protease; 105,000 units of amylase.
Each ZENPEP capsule is available as a two piece hypromellose capsule with blue opaque cap and white body with a blue radial print and printed with u201cAPTALIS 25u201d, that contains 2.2-2.5mm enteric-coated beads. Capsules are supplied in bottles of:u00a0
ZENPEPn- Arrayn- (pancrelipase) Delayed-Release Capsules
40,000 USP units of lipase; 126,000 units of protease; 168,000 units of amylase.
Each ZENPEP capsule is available as a two piece hypromellose capsule with orange opaque cap and white body with a blue radial print and printed with u201cAPTALIS 40u201d, that contains 2.2-2.5mm enteric-coated beads. Capsules are supplied in bottles of:
Storage and Handling
Original n- u00a0n- container:
Avoid excessive heat. Store at room temperature (68-77u00b0F; 20-25u00b0C), brief excursions permitted to 15-40u00b0C (59-104u00b0F). Protect from moisture. AFTER OPENING, KEEP BOTTLE TIGHTLY CLOSED between uses to PROTECT FROM MOISTURE.
Repackaged HDPE container:
Avoid excessive heat. Store at up to 30u00b0C (86u00b0F) for up to 6 months. Brief excursions permitted to 15-40u00b0C (59-104u00b0F) for up to 30 days. Protect from moisture. AFTER OPENING, KEEP BOTTLE TIGHTLY CLOSED between uses to PROTECT FROM MOISTURE.
Dispense in tight container (USP).
Keep out of reach of children.
DO NOT CRUSH ZENPEP delayed-release capsules.

See FDA-approved patient labeling ()

MEDICATION GUIDE
ZENPEPn- Arrayn- (ZEN-pep)
(pancrelipase)
dn- elayed-n- rn- elease n- cn- apsules
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?
Take ZENPEP exactly as prescribed. Do not take more or less ZENPEP than directed by your doctor.
What is ZENPEP?
ZENPEP is a prescription medicine for people who cannot digest food normally because their pancreas does not make enough enzymes. ZENPEP may help your body use fats, proteins and sugars from food.
ZENPEP contains a mixture of digestive enzymes including lipases, proteases, and amylases from pig pancreas.
ZENPEP is safe and effective in children.
What should I tell my doctor before taking ZENPEP?
Before taking ZENPEP, tell your doctor about all your medical conditions, including if youn- :
Tell your doctor about n- alln- the medicines you take
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.
How should I take ZENPEP?
Giving ZENPEP to children and adults
Giving ZENPEP to infants
1. Give ZENPEP right before each feeding of formula or breast milk.
2. Do not mix ZENPEP capsule contents directly into formula or breast milk.
3. Open the capsule and sprinkle the contents on a small amount of applesauce, pureed bananas or pears. These foods should be the kind found in baby food jars that you buy at the store, or other food recommended by your doctor. You may also sprinkle the contents directly into your childu2019s mouth.
4. If you sprinkle the ZENPEP on food, give the ZENPEP and food mixture to your child right away.
5. Give your child enough liquid to completely swallow the ZENPEP contents or the ZENPEP and food mixture.
6. Look in your childu2019s mouth to make sure that allu00a0of the medicine has been swallowed.
What are possible side effects of ZENPEP?
ZENPEP may cause serious side effects, including:
See n
Call your doctor right away if you have any of these symptoms.
The most common side effects of ZENPEP include
Other Possible Side Effects
ZENPEP and other pancreatic enzyme products are made from the pancreas of pigs, the same pigs people eat as pork. These pigs may carry viruses. Although it has never been reported, it may be possible for a person to get a viral infection from taking pancreatic enzyme products that come from pigs.
Tell your doctor if you have any side effect that bothers you or does not go away.
These are not all the possible side effects of ZENPEP. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Allergan at 1-800-678-1605.
How do I store ZENPEP?
Keep ZENPEP and all medicines out of the reach of children.
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:
Inactive ingredients:
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,u00a020,000, 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:
3,000 USP units and 5,000 USP units of lipase contain carnauba wax or talc,
carrageenan, hypromellose, potassium chloride, titanium oxide, and water.
10,000 USP units of lipase contain carnauba wax or talc, carrageenan, hypromellose,
potassium chloride, titanium oxide, water and yellow ferric oxide.
15,000 USP units of lipase contain carnauba wax or talc, carrageenan, hypromellose,
potassium chloride, red ferric oxide, titanium oxide, and water.
20,000 USP units of lipase contain carnauba wax or talc, carrageenan, FD&C Blue #2,
hypromellose, potassium chloride, titanium oxide, water, and yellow ferric oxide.
25,000 USP units of lipase contain carnauba wax or talc, carrageenan, FD&C Blue #2,
hypromellose, potassium chloride, titanium oxide, and water.
40,000 USP units of lipase contain FD&C Yellow #6,
hypromellose, titanium oxide and water.
This Medication Guide has been approved by the n- Food and Drug Administration.
nttu00a0u00a0u00a0u00a0u00a0nt
Distributed by:
Allergan USA, Inc.
Irvine, CA 92612
For further information, please call Allergan at 1-800-678-1605.
u00a92017 Allergan. All rights reserved.
Revised March 2017
u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
73313US10

NDC 0023-6113-01ZENPEPu00a0(Pancrelipase) Delayed-Release CapsulesLipase 3,000 USP unitsProtease 10,000 USP unitsAmylase 14,000 USP units100 Delayed-Release CapsulesRx Only

NDC 0023-6115-01ZENPEPu00a0(Pancrelipase)Delayed-Release CapsulesLipase 5,000 USP unitsProtease 17,000 USP unitsAmylase 24,000 USP units100 Delayed-Release CapsulesRx Only

NDC 0023-6110-01ZENPEPu00a0(Pancrelipase)Delayed-Release CapsulesLipase 10,000 USP unitsProtease 32,000 USP unitsAmylase 42,000 USP units100 Delayed-Release CapsulesRx Only

NDC 0023-6111-01ZENPEPu00a0(Pancrelipase)Delayed-Release CapsulesLipase 15,000 USP unitsProtease 47,000 USP unitsAmylase 63,000 USP units100 Delayed-Release CapsulesRx Only

NDC 0023-6112-01ZENPEPu00a0(Pancrelipase)Delayed-Release CapsulesLipase 20,000 USP unitsProtease 63,000 USP unitsAmylase 84,000 USP units100 Delayed-Release CapsulesRx Only

NDC 0023-6116-01ZENPEPu00a0(Pancrelipase)Delayed-Release CapsulesLipase 25,000 USP unitsProtease 79,000 USP unitsAmylase 105,000 USP units100 Delayed-Release CapsulesRx Only

NDC 0023-6114-01ZENPEPu00a0(Pancrelipase)Delayed-Release CapsulesLipase 40,000 USP unitsProtease 126,000 USP unitsAmylase 168,000 USP units100 Delayed-Release CapsulesRx Only

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Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase (Zenpep)

Trade Name : Zenpep

CAPSULE, DELAYED RELEASE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase (Zenpep)

Trade Name : Zenpep

CAPSULE, DELAYED RELEASE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

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Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

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US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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