pancrelipase

Action and Spectrum

Actions and spectrum: 

pancrelipase is a medication that contains a combination of enzymes, including amylase, lipase, and protease. These enzymes are naturally produced by the pancreas and are involved in the digestion of carbohydrates, fats, and proteins. pancrelipase supplements the body’s own enzymes and helps improve digestion in individuals with pancreatic insufficiency. 

The spectrum of action of pancrelipase is primarily focused on the digestion of food. It aids in the breakdown of complex nutrients, such as starches, fats, and proteins, into smaller molecules that are absorbed and utilized by the body. By assisting in the digestion process, pancrelipase helps improve nutrient absorption and prevents malabsorption-related complications. 

Drug Interaction

Adverse Reaction

Frequency defined 

1-10% 

Cough (4-10%) 

Hyperglycemia (8%) 

Epistaxis (7%) 

Biliary tract stones (7%) 

Contusion (6%) 

Early satiety (6%) 

Dizziness (4%) 

Abnormal feces (4%) 

Nasopharyngitis (4%) 

Ascites (3%) 

Peripheral edema (3%) 

Viral infection (3%) 

Rash (3%) 

Dyspepsia (10%) 

Diarrhea (0-10%) 

Pharyngolaryngeal pain (7%) 

Anal pruritus (7%) 

Vomiting (6%) 

Weight loss (6%) 

Flatulence (5-6%) 

Hypoglycemia (4%) 

Frequent movements of bowel (4%) 

Anemia (3%) 

Flatulence (3%) 

Hydrocholecystis (3%) 

Renal cyst (3%)  

Post marketing Reports 

Skin disorders including rash, pruritus, and urticaria 

Gastrointestinal disorders:  abdominal pain, flatulence, nausea, Abdominal distension, diarrhea, and constipation; intestinal obstruction syndrome and fibrosing colonopathy rare reports 

Severe allergic reactions with asthma, anaphylaxis, and hives 

Asymptomatic liver enzymes elevations 

Endocrine:  May act on glycemic control in the susceptible patients 

Black Box Warning

Black Box Warning: 

There is no specific black box warning associated with the use of pancrelipase. 

Contraindication / Caution

Contraindication/Caution: 

Contraindication: 

pancrelipase is contraindicated in individuals who have a known hypersensitivity or allergic reaction to any component of the product. It is also contraindicated in acute pancreatitis or exacerbation of chronic pancreatitis, as well as those with acute exacerbation of chronic pancreatitis due to fibrosing colonopathy. Additionally, pancrelipase should not be used in known or suspected mechanical obstruction of the intestines. 

Caution: 

• Allergic reactions: pancrelipase may cause allergic reactions in some individuals. It is important to monitor signs of an allergic reaction, such as rash, itching, swelling, or difficulty breathing, and seek immediate medical attention if any symptoms occur. 
• Fibrosing colonopathy: pancrelipase has been associated with the development of fibrosing colonopathy, a rare condition characterized by the thickening of the intestinal wall. This condition can cause intestinal obstruction and may require surgical intervention. Patients should be closely monitored for symptoms such as abdominal pain, distention, constipation, or changes in bowel habits. 
• Gastrointestinal obstruction: pancrelipase should not be used with known or suspected mechanical obstruction of the intestines, as it may worsen the obstruction. Careful evaluation should be done in patients with a history of gastrointestinal obstruction or those at risk for it. 
• Diabetes mellitus: pancrelipase may affect blood glucose levels in patients with diabetes. monitoring of blood glucose levels is recommended in diabetic patients receiving pancrelipase. 
• Potential drug interactions: pancrelipase may interact with other medications, including antacids, H2 blockers, proton pump inhibitors, and certain anticoagulants. 

Comorbidities: 

• Cystic fibrosis: pancrelipase is commonly prescribed to individuals with cystic fibrosis, including the pancreas. Cystic fibrosis often leads to pancreatic insufficiency, necessitating the use of pancreatic enzyme replacement therapy. 
• Chronic pancreatitis: pancrelipase may be used in individuals with chronic pancreatitis, a condition characterized by long-term inflammation of the pancreas. Chronic pancreatitis can impair the secretion of digestive enzymes, leading to pancreatic insufficiency and the need for pancreatic enzyme replacement therapy. 
• Pancreatic cancer: Pancreatic cancer can cause damage to the pancreas and disrupt normal pancreatic function, resulting in pancreatic insufficiency. pancrelipase may be used as part of the supportive care for individuals with pancreatic cancer to aid in digestion and nutrient absorption. 
• Celiac disease: It is an autoimmune disorder characterized by an intolerance to gluten, barley, and rye. In some individuals with celiac disease, the inflammation and damage to the small intestine can lead to secondary pancreatic insufficiency. pancrelipase may be prescribed to help with the digestion of fats, proteins, and carbohydrates in individuals with celiac disease and pancreatic insufficiency. 

Pregnancy / Lactation

Pregnancy consideration: N/A 

Lactation: unknown  

Pregnancy category: 

• Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 
• Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 
• Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.   
• Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits. 
• Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women. 
• Category N: There is no data available for the drug under this category. 

Pharmacology

Pharmacology: 

pancrelipase is a medication that contains a combination of enzymes derived from the pancreas, including lipase, amylase, and protease. 

• Lipase: Lipase breakdown dietary fats into fatty acids and glycerol. pancrelipase provides supplemental lipase to individuals with pancreatic insufficiency, helping them digest and absorb fats more effectively. 
• Amylase: Amylase is an enzyme that aids in the digestion of carbohydrates, specifically breaking down complex carbohydrates (such as starch) into simpler sugars. pancrelipase contains amylase to assist individuals with pancreatic insufficiency in carbohydrate digestion. 
• Protease: Protease helps to break down proteins into smaller peptides and amino acids. pancrelipase includes protease to facilitate protein digestion for individuals with pancreatic insufficiency. 

Pharmacodynamics: 

The pharmacodynamics of pancrelipase primarily involve the enzymatic activity of its components, namely lipase, amylase, and protease. These enzymes act in the gastrointestinal tract to facilitate the digestion and absorption of fats, carbohydrates, and proteins. 

• Lipase: Lipase is responsible for the hydrolysis of triglycerides into monoglycerides and free fatty acids. By enhancing lipolysis, pancrelipase aids in the breakdown of dietary fats, which are then absorbed in the small intestine. 
• Amylase: Amylase acts on complex carbohydrates, such as starch and glycogen, and breaks them down into simpler sugars like glucose, maltose, and maltotriose. This enzymatic action supports the digestion of carbohydrates and facilitates their absorption in the intestine. 
• Protease: Protease enzymes in pancrelipase aid in the hydrolysis of dietary proteins into peptides and amino acids. By breaking down proteins into smaller components, pancrelipase enables efficient absorption of amino acids in the small intestine. 

The supplementation of these crucial digestive enzymes to compensate for inadequate pancreatic secretion in individuals with pancreatic insufficiency. This supplementation helps improve the digestion and absorption of nutrients, preventing malabsorption-related complications and supporting proper nutrition.  

Pharmacokinetics: 

Absorption 

pancrelipase is taken orally and is primarily intended to act in the gastrointestinal tract. The enzymes in pancrelipase are resistant to degradation by stomach acid and are designed to be released in the small intestine. The absorption of the enzymes from the intestinal lumen into the bloodstream is minimal, it is primarily localized to the gastrointestinal tract. 

Distribution 

After oral administration, pancrelipase remains primarily within the gastrointestinal tract and acts locally to facilitate digestion. Systemic distribution of the enzymes is limited. 

Metabolism 

The enzymes in pancrelipase are derived from porcine (pig) or bovine (cow) pancreas. These enzymes are proteins and are subject to enzymatic degradation by proteolytic enzymes in the gastrointestinal tract. pancrelipase does not undergo significant metabolic transformations within the body. 

Elimination and excretion 

pancrelipase is excreted primarily in the feces. The unabsorbed enzymes, along with the by-products of digestion, are eliminated through the normal process of bowel movements. 

Adminstartion

Administration: 

pancrelipase is typically administered orally in the form of capsules or tablets. 

• Take pancrelipase with meals or snacks. The enzymes in pancrelipase help in the digestion of fats, proteins, and carbohydrates, so it is usually taken with food to maximize its effectiveness. 
• Swallow the capsules or tablets whole, without chewing or crushing them. This allows the enzymes to be released in the appropriate parts of the gastrointestinal tract. 
• If there is difficulty swallowing the capsules or tablets, talk to your healthcare provider. They may suggest alternative methods of administration, such as opening the capsule and sprinkling the contents on a soft food or mixing them with a liquid. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: pancrelipase 

Pronounced: (Pan-cre-lip-ase)  

Why do we use pancrelipase? 

pancrelipase is primarily used in the management of pancreatic enzyme deficiency, which can occur in conditions such as cystic fibrosis, chronic pancreatitis, pancreatic cancer, and other pancreatic disorders. The main therapeutic use of pancrelipase is the absorption and digestion of fats, proteins, and carbohydrates in individuals with insufficient pancreatic enzyme production. 

• Pancreatic Insufficiency: pancrelipase is used to supplement the deficient pancreatic enzymes in individuals with pancreatic insufficiency from various conditions such as cystic fibrosis, chronic pancreatitis, and pancreatic surgery. 
• Cystic Fibrosis: pancrelipase is commonly prescribed for individuals with cystic fibrosis to help improve digestion and absorption of nutrients, particularly fat-soluble vitamins, in order to maintain proper nutrition. 
• Chronic Pancreatitis: pancrelipase may be used in the management of chronic pancreatitis, a condition characterized by inflammation and damage to the pancreas, leading to impaired enzyme production. pancrelipase helps compensate for the insufficient enzyme production and aids in digestion. 
• Pancreatic Cancer: pancrelipase can be used in individuals with pancreatic cancer, especially when the tumor or treatment affects the exocrine function of the pancreas, leading to enzyme deficiency.