Lipase: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: July 18, 2025🚩 Report this page

Lipase

Active ingredient

Sold as COTAZYM · VIOKACE · COTAZYM ECS 8 · PANCREASE MT 4 · COTAZYM ECS 20

CA Health CanadaGB MHRA

Drug class: -
Availability: See label
Routes: Oral
Markets covered: 2
Products on record: 16

Overview

Lipase is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
CA Canada	Health Canada	15	June 5, 2025
GB United Kingdom	MHRA	1	July 18, 2025

CACanada· Health Canada

15 products

Uses

CAOfficial regulatory label· revised March 22, 2025[1]

PANCREASE MT (pancrelipase) capsules are indicated for: • the treatment of pancreatic insufficiency attributed to cystic fibrosis, chronic pancreatitis, or any other medically defined pancreatic disease that might require pancreatic enzyme therapy.
1 Pediatrics Pancrease MT is approved for use in pediatrics for the treatment of pancreatic insufficiency attributed to cystic fibrosis, chronic pancreatitis, or any other medically defined pancreatic disease that might require pancreatic enzyme therapy (see 4 DOSAGE AND ADMINISTRATION).
2 Geriatrics It is recommended that enzyme doses, expressed as lipase units/kg/meal, be decreased in older patients since they weigh more but tend to ingest less fat per kilogram (see 4 DOSAGE AND ADMINISTRATION)

GBUnited Kingdom· MHRA

1 product

Uses

GBOfficial regulatory label· revised July 18, 2025[2]

Pancrex V is used to compensate for reduced intestinal enzyme activity in pancreatic deficiency states. It is indicated for the treatment of fibrocystic disease of the pancreas (cystic fibrosis), chronic pancreatitis and pancreatic steatorrhoea following pancreatectomy.
It may also be indicated following gastrectomy as an aid to digestion.

How to take

Sources & citations

[1]Health Canada (DPD) · 00789429 · revised March 22, 2025
[2]MHRA (UK) · PL410940005 · revised July 18, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[1]

1 Adverse Reaction Overview The most common adverse reactions are abdominal discomfort, constipation and dermatitis. Other gastrointestinal reactions are less common and include abnormal stool and diarrhea. Nausea and vomiting have been reported, but these are not common.
With high doses, perianal irritation and inflammation have been reported (see 7 WARNINGS AND PRECAUTIONS). At extremely high doses, hyperuricosuria and hyperuricemia have been reported. Allergic or hypersensitivity reactions of the skin have been reported (see 7 WARNINGS AND PRECAUTIONS, General).
5 Post-Market Adverse Reactions The following adverse reactions have been reported during post-marketing experience (Table ).
The frequencies are provided according to the following convention:
Very common  1/10 Common  1/100 and < 1/10 Uncommon  1/1,000 and < 1/100 Rare  1/10,000 and < 1/1000 Very rare < 1/10,000 Table 2: Adverse Drug Reactions Identified During Post-Marketing Experience with Pancrease MT by Frequency Category Estimated from Spontaneous Reporting Rates Gastrointestinal Disorders Very rare Abdominal distention, abdominal pain, diarrhea, intestinal obstruction*, nausea, vomiting Skin and Subcutaneous Tissue Disorders Very rare Rash * Mainly cases of fibrosing colonopathy in pediatric subjects with cystic fibrosis (see 7 WARNINGS AND PRECAUTIONS).

CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[1]

). Usually, half the mealtime dose is given with a snack. The total daily dose should reflect approximately three meals and two snacks per day. Instruct the patient to take the medication immediately and not store it to be taken later.
2 Recommended Dose and Dosage Adjustment If doses greater than 2,500 lipase units/kg/meal (4,000 lipase units/g fat/day) are required to control malabsorption, further investigation is warranted to rule out other causes of malabsorption.
Doses greater than 2,500 units/kg/meal should be used with caution and only if they are documented to be effective by 3-day fecal fat studies. Doses greater than 6,000 lipase units/kg/meal have been associated with colonic strictures, particularly in children with cystic fibrosis less than 12 years of age.
Patients currently on higher doses than 6,000 lipase units/kg/meal should be re-evaluated and the dosage either immediately decreased or titrated downward to the lowest effective clinical dose as assessed by 3-day fecal fat excretion (see 7 WARNINGS AND PRECAUTIONS, Gastrointestinal).
Pancrease MT (pancrelipase) Page 6 of 18 Infants (up to 12 months):
Fat Consumption Scheme • 2,000-4,000 USP lipase units per 120 mL of formula or per breast-feeding. 5 grams of fat per 120 mL standard cow’s milk-based formula). Higher doses are used in infants because, on average, infants ingest 5 grams of fat per kilogram of body weight per day, whereas adults tend to ingest about 2 grams of fat per kilogram per day.
Contents of the capsule should not be mixed directly into formula or breast milk as this may diminish efficacy.
Children (over 12 months) and Adults:
Weight-based Scheme • Less than 4 years: Begin with 1,000 USP lipase units/kg/meal to a maximum of 2,500 lipase units/kg/meal. • Over 4 years and Adults: Begin with 500 USP lipase units/kg/meal to a maximum of 2,500 lipase units/kg/meal.
Geriatrics (≥ 65 years of age): • Enzyme doses, expressed as lipase units/kg/meal, should be decreased in older patients, since they weigh more but tend to ingest less fat per kilogram. 4 Administration The capsules should not be chewed or crushed because the coating (that is formulated to deliver the enzymes to the correct place in the intestines) will be destroyed.
, milk, custard, ice cream, other dairy products) because the enteric coating will dissolve prematurely and limit absorption (see 4 DOSAGE AND ADMINISTRATION). 5 Missed Dose If the patient misses a dose, instruct him/her to wait until their next meal and take their usual number of capsules at their usual time.
Inform patients not to make up for missed doses. 5 OVERDOSAGE Chronic high doses of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures (see 7 WARNINGS AND PRECAUTIONS, Gastrointestinal).

This is not medical advice. Consult a qualified healthcare professional.