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Digestive enzyme replacement therapy: pancreatic enzymes and lactase.

Maldigestion occurs when digestive enzymes are lacking to help break complex food components into absorbable nutrients within the gastrointestinal tract. Education is needed to help patients manage the intricacies of digestive enzyme replacement therapies and ensure their effectiveness in reducing symptoms of maldigestion.

Digestive enzymes are a necessary part of the chemical process of digestion. These enzymes break food components (e.g., proteins, fats, polysaccharides) into products that can be absorbed (e.g., amino acids, fatty acids, monosaccharides) in the gastrointestinal tract. Digestive enzymes are excreted from exocrine glands (e.g., salivary gland, pancreas, gallbladder, liver) or cells and glands in the gastrointestinal mucosa. Some digestive enzymes are found on the surface of epithelial cells within the intestinal tract (Mills & Stappenbeck, 2014).

When interference occurs in the chemical digestion process, maldigestion results. Maldigestion often is caused by the body's inability to produce digestive enzymes (Huether, 2016). This article focuses on pharmacologic therapies used to manage two of the most common maldigestion problems: exocrine pancreatic insufficiency and lactose intolerance.

Exocrine Pancreatic Insufficiency

The pancreas is an essential organ that produces necessary enzymes to metabolize food and control blood glucose (Pancreatic Cancer Action Network [PCAN], 2015). The pancreatic endocrine cells secrete insulin to help control blood glucose, while the exocrine cells produce enzymes to aid with food digestion (Sonnenday, 2014). Enzymes produced by the exocrine cells pass into the duodenum to help break complex food components into absorbable nutrients (PCAN, 2015).

Pancreatic enzymes include amylase (aids in digestion of carbohydrates), lipase (fats), and protease (proteins) (Sonnenday, 2014). A normally functioning pancreas secretes approximately 1,500 ml of pancreatic juice every day (PCAN, 2015; Sonnenday, 2014).

Exocrine pancreatic insufficiency (EPI) occurs when the pancreas has been damaged, causing blockage to the biliary duct (Sonnenday, 2014). The biliary duct is a small tube that carries pancreatic juices into the duodenum. When the biliary duct is blocked, pancreatic juices cannot reach the duodenum to aid in chemical digestion. Common causes of EPI include chronic pancreatitis, pancreatic cancer, and pancreatic resection (Huether, 2016). Cystic fibrosis (CF), a genetic disorder, also can cause EPI. Patients with CF often report respiratory problems due to buildup of thick mucus (Sharma, 2015). However, they also secrete thick, sticky mucus that can block the biliary duct and contribute to EPI (Wilschanski & Novak, 2013).

A patient diagnosed with EPI will need changes in lifestyle (e.g., cessation of alcohol and smoking) and diet (e.g., low-fat diet, vitamin and mineral supplementation). Pharmacologic therapy also may be indicated to improve clinical symptoms. A review of evidence by Nakajima, Oshida, Muneyuki, and Kakei (2012) indicated pancreatic enzyme replacement therapy (PERT) improves clinical symptoms of maldigestion syndromes in patients with EPI, and allows patients to discontinue the low-fat diet regimen. Patients may need PERT for as few as 6 months or may need it for the rest of their lives, depending on the severity of the pancreatic damage and EPI (WebMD, 2015).


Pancrelipase is the generic name of all six PERT medications approved by the U.S. Food and Drug Administration (WebMD, 2015). All medications (Creon[R], Pancreaze[R], Pertzye[R], Ultresa[R], Viokase[R], and Zenpep[R]) contain the digestive enzymes amylase, protease, and lipase in differing amounts (Al-Kaade, 2014). Digestive enzymes in these medications come from a porcine source (Nakajima et al., 2012). Creon, Pancreaze, Pertzye, Ultresa, and Zenpep have been approved for the treatment of EPI due to CF and other conditions. Viokase (combined with a proton pump inhibitor) is indicated for treatment of EPI due to chronic pancreatitis and pancreatectomy. Creon also can be given to patients with EPI due to chronic pancreatitis and pancreatectomy (Kizior, Hodgson, Hodgson, & Witmer, 2016). PERT dosage is expressed in lipase units/kg. Healthcare providers individualize dosage requirements for each patient depending on severity of clinical symptoms, body weight, degree of steatorrhea, and amount of fat in diet (Al-Kaade, 2015; Kizior et al., 2016).

Nursing considerations. Pancrelipase is contraindicated in patients who have known allergies to porcine products (Vallerand, Sanoski, & Deglin, 2015). The drug may cause an increase in serum uric acid so it should be used cautiously in patients who also have been diagnosed with gout, hyperuricemia, and renal impairment (Kizior et al., 2016; Vallerand et al., 2015). Safety of use during pregnancy and lactation has not been established; medications thus should be used cautiously by pregnant and lactating women (Vallerand et al., 2015). Side effects with PERT therapy are rare. Adverse effects are related to allergic reaction to porcine content. Patients may experience mouth irritation, shortness of breath, or wheezing if having an allergic reaction to the medication, and will require emergency care (Kizior et al., 2016). Patients who take more than 6,000 lipase units/kg of body weight per meal (or 10,000 lipase units/kg of body weight/day) are at risk for developing fibrosing colonopathy, a type of stricture of the colon (Medscape, 2016; Vallerand et al., 2015). Symptoms include abdominal pain and distention, vomiting, and constipation (Vallerand et al., 2015). The patient and/or family member should notify the healthcare provider immediately if the patient experiences any symptom of fibros ing colonopathy (Medscape, 2016).

Adequate patient and family education is needed to help patients adhere to the intricacies of PERT administration. Medication should not be broken, crushed, chewed, dissolved, or divided. The medication should be given whole to the patient with a generous amount of fluids just before a meal or snack (Kizior et al., 2016; WebMD, 2015). For patients with difficulty swallowing, contents may be sprinkled onto soft acidic food, such as applesauce, mashed fruit, or rice cereal, then followed with a glass of water or juice (Kizior et al., 2016). Viokase lacks an enteric coating, so it should be taken with a proton pump inhibitor such as omeprazole (Al-Kaade, 2014; Vallerand et al., 2015).

Patients also should be informed PERT medications are not interchangeable due to differences in digestive enzyme content (Vallerand et al., 2015). Patients should not change brands of PERT medications without consulting their healthcare providers. If patients have concerns about the efficacy of the current PERT medication, they also should consult their healthcare providers (Vallerand et al., 2015).

PERT is considered effective if a patient with EPI shows improved nutrition (Kizior et al., 2016). Signs of improved nutrition include increased body weight. Another sign of PERT effectiveness is the improvement of clinical symptoms of EPI, such as steatorrhea and abdominal pain due to maldigestion (Nakajima et al., 2012).

Lactose Intolerance

Lactose is the main source of sugar in dairy products (Misselwitz et al., 2013). To help digest lactose, the body produces an enzyme called lactase through the protein lactasephlorizin hydrolase. This protein is expressed on the small intestine brush border, with the most expression found in the mid-jejunum (Di Rienzo et al., 2013; Usai-Satta, Scarpa, Oppia, & Cabras, 2012).

Most people are born with the ability to digest lactose. However, approximately 75% of the world's population loses this ability at some point as they mature, especially when their intake of dairy products lessen (Mattar, de Campos Mazo, & Carrilho, 2012). Primary lactase deficiency, which may occur when a person reaches adulthood, is common among Blacks, Latinos, and Native Americans (Huether, 2016). A decline in the production of lactase causes an individual to have symptoms of bloating, gas, and abdominal discomfort when consuming dairy products (Usai-Satta et al, 2012). Secondary (acquired) lactase deficiency may occur as a complication of intestinal diseases, such as enteritis, gluten-sensitive enteropathy, or intestinal bacterial overgrowth (Huether, 2016). Symptoms for secondary lactase deficiency will be similar to those for the primary disorder (Usai-Satta et al., 2012).

A lactase deficiency does not allow lactose to be broken into absorbable nutrients within the intestinal tract. The nonabsorbed lactose will retain water in the lumen to maintain the osmolality of the undigested chyme (Mills & Stappenbeck, 2014). Fluid retention causes patients to experience abdominal pain (cramps), nausea, bloating, gas, and diarrhea (National Institute of Diabetes and Digestive and Kidney Diseases [NIDDK], 2014). Bacterial fermentation of the undigested lactose in the small intestine and colon further exacerbates the symptoms (Mills & Stappenbeck, 2014).

Lactose intolerance (LI) usually is managed by a change in diet. Some people may need only to limit their intake of dairy products, while others may need to eliminate dairy products from their diets altogether (NIDDK, 2014). Enzyme replacement therapy also may prevent LI (Usai-Satta et al., 2012). Some people will need to take a lactase enzyme supplement to manage symptoms of LI (NIDDK, 2014).


Lactase enzyme supplements (LacDose[R], LactAid Fast Act[R], LactAid Ultra[R], LactAid[R], lactase enzyme, lactase fast acting, SureLac[R]) are readily available over-the-counter (OTC) (, 2016). Lactase supplements contain various amounts of (3galactosidase made from nonhuman sources, specifically Aspergillus oryzae and Kluyveromyces lactis. This helps with hydrolization of lactose, which comprises galactose and glucose linked by a (3-galactoside bond (Di Rienzo et al., 2013; Savaiano, 2014). Lactase supplementation is available in capsule, tablet, or liquid form (, 2016). Dosages are expressed in FCC lactase units, and may be available in regular or extrastrength/fast-acting forms. Regularstrength lactase is available OTC, with each capsule/tablet having 3,000 to 4,500 FCC lactase units. Fast-acting lactase (also available OTC) has 9,000 FCC lactase units in each capsule/ tablet (, 2016).

Nursing considerations. Lactase supplementation is not recommended for children below age 4, as safety and effectiveness of the medication have not been confirmed with this age group (, 2016). Side effects have not been reported with lactase supplement (WebMD, n.d.). It is contraindicated in patients who have allergies to lactase. If a patient is experiencing a severe allergic reaction to lactase supplements (e.g., hives, difficulty breathing, chest tightness), emergency medical care is needed (, 2016). Not enough is known regarding effects of lactase supplements during pregnancy or breastfeeding. Thus, pregnant and breastfeeding women should discuss with their healthcare providers the benefits and risks of taking this medication (, 2016).

Patients should be taught to take lactase according to the directions of their healthcare providers. However, as this is also an OTC medication, patients may follow the dosage directions on the purchased box of the lactase supplement (, 2016). Patients need to be informed that each preparation may result in different levels of LI symptom relief, despite having the same amount of FCC lactase units (Misselwitz et al., 2013). Patients should be taught to take the lactase supplement with their first bite or drink of dairy products. After 20 to

45 minutes of consuming dairy products, the patient will need to take another tablet/capsule of lactase supplement (, 2016).

Other Medications Used for Management of Lactose Intolerance

Other pharmacologic approaches to LI management include use of probiotics. Probiotics are nonpathogenic live microorganisms that contain p-galactosidase or lactase within their cells (Usai-Satta et al., 2012). Probiotics usually are added to food products (e.g., milk, yogurt), or can be taken as a supplement (Usai-Satta et al., 2016). Microbial lactase found in lactic acid bacteria (e.g., Lactobacillus, Bifidobacterium, Saccharomyces) can break down lactase through the process of fermentation. Through hydrolysis, microbial lactase will break unabsorbed lactose into monosaccharides, glucose, and galactose, which could be absorbed in the gastrointestinal tract (Di Rienzo et al., 2013). However, recent research shows p-galactosidase activity greatly varies among commercially available probiotic supplements (Johnson, Aljaloud, Gyawali, & Ibrahim, 2015). Researchers con cluded not all commercially available probiotic supplements have the same health benefits.

A major concern for patients with LI is the deficiency of calcium and vitamin D. Vitamin D helps the body absorb and use calcium (NIDDK, 2014). The Institute of Medicine (IOM, 2011) revised calcium and vitamin D recommendations based on an extensive review of over 1,000 studies, as well as testimonies from scientists and stakeholders (see Table 1). Patients with LI should be encouraged to increase intake of calcium and vitamin D through supplements and nondairy sources (Misselwitz et al., 2013). Nondairy food products that contain calcium include kale, spinach, soy-based products, tuna, and salmon (NIDDK, 2014).


Maldigestion occurs when digestive enzymes are lacking to help break complex food components into absorbable nutrients within the gastrointestinal tract. The two most common maldigestion syndromes are exocrine pancreas insufficiency and lactose intolerance.

Digestive Enzyme Replacement Therapy: Pancreatic Enzymes and Lactase

Deadline for Submission: June 30, 2018 MSN J1609

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Learning Outcome

After completing this learning activity, the learner will be able to discuss pharmacologic therapies used to manage two common maldigestion problems.

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Pharmacologic therapies are needed to manage symptoms of maldigestion. Education is needed to help patients manage the intricacies of digestive enzyme replacement therapies and ensure their effectiveness in reducing symptoms of maldigestion. Medical-surgical nurses should be familiar with EPI and LI therapies to assist patients who need these medications.


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Nakajima, K., Oshida, H., Muneyuki, T., & Kakei, M. (2012). Pancrelipase: An evidence-based review of its use for treating pancreatic exocrine insufficiency. Core Evidence, 7, 77-91.

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Rhea Faye D. Felicilda-Reynaldo, EdD, RN, is Associate Professor, Department of Nursing, Missouri State University, Springfield, MO; and MEDSURG Nursing Editorial Board Member. For comments and to suggest topics for the "Nursing Pharmacology" feature, contact

Maria Kenneally, DNP, FNP-BC, is Family Nurse Practitioner, Gilbert Center for Family Medicine, Gilbert, AZ.
Recommended Daily Allowance (RDA) for Calcium and Vitamin D

                                 Calcium RDA   Vitamin D RDA
             Age                   mg/day         IU/day

Infant 0-6 months
Infant 6-12 months
1-3 years                            700            600
4-8 years                           1,000           600
9-13 years                          1,300           600
14-18 years                         1,300           600
19-30 years                         1,000           600
31-50 years                         1,000           600
51-70 years male                    1,000           600
51-70 years female                  1,200           600
>70 years                           1,200           800
14-18 years pregnant/lactating      1,300           600
19-50 years pregnant/lactating      1,000           600

Source: Adapted from IOM, 2011.
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Title Annotation:Nursing Pharmacology
Author:Felicilda-Reynaldo, Rhea Faye D.; Kenneally, Maria
Publication:MedSurg Nursing
Article Type:Report
Date:May 1, 2016
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