the colleges Sacrosidase Class: Enzymes ATC Class: A16AB06 VA Class: GA500 Chemical Name: Saccharomyces cerevisiae clone F14 protein moiety reduced CAS Number: 85897-35-4 Brands: Sucraid Overview Side Effects Professional Pregnancy Reviews More Support Group Q & A Introduction Synthetic form of sucrase; derived from Saccharomyces cerevisiae . 1 2 3 Slideshow Treatment of Opioid-Induced Constipation: The Hard Facts Uses for Sacrosidase Congenital Sucrase-Isomaltase Deficiency Oral replacement therapy for the genetic sucrase deficiency that is part of congenital sucrase-isomaltase deficiency (CSID) 1 2 3 (designated an orphan drug by FDA for this use). b May be used as a short (e.g., 1-week) therapeutic trial to assess response in patients suspected of having CSID when the diagnosis is in doubt. 1 2 Sacrosidase Dosage and Administration Administration Oral Administration Administer orally with each meal or snack. 1 2 3 4 Use measuring scoop or dropper dispensing tip provided by manufacturer for measurement of the dose. 1 2 3 4 Dose must be diluted with 60 120 mL of water, milk, or infant formula prior to administration. 1 2 4 Do not dilute or consume with fruit juice. 1 2 4 (See Compatibility under Stability.) Do not warm or heat diluents before or after addition of sacrosidase; decreased potency likely with heat. 1 2 4 Administer cold or at room temperature. 1 2 4 Administration with food and/or milk appears to diminish the degradation of the enzyme by intragastric pepsin. 2 (See Elimination under Pharmacokinetics.) Administer half of each dose at the beginning of each meal or snack, and the other half at the end of meal or snack. 1 2 3 4 Dosage Dosage expressed in international units (IU, units). 1 2 Each mL of sacrosidase contains 8500 units of the enzyme. 1 2 Pediatric Patients Congenital Sucrase-Isomaltase Deficiency Oral For patients weighing 15 kg: 8500 units (1 mL using the measuring scoop provided or 22 drops from the Sucraid container tip) with each meal or snack. 1 2 3 4 For patients weighing >15 kg: 17,000 units (2 mL using the measuring scoop provided or 44 drops from the Sucraid container tip) with each meal or snack. 1 2 3 4 Adults Congenital Sucrase-Isomaltase Deficiency Oral 17,000 units (2 mL using the measuring scoop provided or 44 drops from the Sucraid container tip) with each meal or snack. 1 2 3 4 Special Populations No special population dosage recommendations at this time. c Cautions for Sacrosidase Contraindications Known hypersensitivity to yeast, yeast products, or glycerin (glycerol). 1 2 Warnings/Precautions Sensitivity Reactions Hypersensitivity Reactions Serious hypersensitivity reactions (i.e., severe wheezing) reported 90 minutes after administration of a second dose. 1 2 3 Administer initial doses near a facility where adequate treatment for acute hypersensitivity reactions can be obtained. 1 2 4 Alternatively, perform skin testing to assess presence of hypersensitivity to sacrosidase. 1 3 If hypersensitivity reaction occurs, discontinue immediately and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway, oxygen). 1 3 General Precautions Dietary Restriction of Starch Sacrosidase does not provide replacement for isomaltase deficiency; restriction of dietary starch may be necessary to achieve greatest reduction in symptoms. 1 2 4 Evaluate each patient treated to determine need for restriction of dietary starch. 1 2 Acquired Disaccharidase Deficiencies Not evaluated in patients with secondary (acquired) disaccharidase deficiencies. 1 2 Diabetes Mellitus Sacrosidase allows absorption of glucose and fructose (products of sucrose hydrolysis); careful consideration recommended in dietary planning in patients with diabetes mellitus. 1 2 Specific Populations Pregnancy Category C. 1 2 Lactation Not distributed into milk; sacrosidase not absorbed intact into systemic circulation. 2 Pediatric Use Safety and efficacy established in pediatric patients; sacrosidase has been used in patients 5 months of age. 3 Common Adverse Effects Abdominal pain, vomiting, constipation, diarrhea, nausea, dehydration, headache, insomnia, nervousness. 1 2 3 4 Sacrosidase Pharmacokinetics Absorption Bioavailability Not absorbed intact into systemic circulation. 2 Elimination Metabolism Undergoes degradation to simple amino acids by pepsin produced by the GI mucosa; resultant amino acids and peptides are absorbed into systemic circulation as nutrients. 1 2 Stability Storage Oral Solution Concentrate 2 8 C; protect from heat and light. 4 a Discard 4 weeks after opening. 1 2 Compatibility For information on systemic interactions resulting from concomitant use, see Interactions. Oral Solution Compatibility May be diluted with water, milk, or infant formula. 1 4 a Do not dilute or consume with fruit juice; acidity may reduce enzyme activity. 1 2 4 Actions Replaces the deficient endogenous enzyme (sucrase) in patients with CSID. 1 2 3 Hydrolyzes sucrose into glucose and fructose. 1 Advice to Patients Importance of notifying clinician immediately if swelling of the face, difficulty breathing, wheezing, or other manifestations of an allergic reaction are experienced. 1 2 4 Importance of storing sacrosidase oral solution in a refrigerator, protecting the bottle from heat and light, 4 and discarding 4 weeks after first opening the bottle. 1 2 Importance of taking sacrosidase as prescribed with each meal or snack. 1 2 3 4 Importance of rinsing the measuring cup with water after each use because of potential for bacterial growth. 1 2 Importance of not diluting or consuming sacrosidase oral solution with fruit juice because of possible reduction in enzyme activity caused by juice acidity. 1 2 4 Importance of not diluting sacrosidase oral solution in warm or hot beverages or heated infant formula because of possible heat-related reduction in enzyme activity. 1 2 4 Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. 1 Importance of patients informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses, especially diabetes mellitus. a Importance of informing patients of other important precautionary information. 1 (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Sacrosidase Routes Dosage Forms Strengths Brand Names Manufacturer Oral For solution, concentrate 8500 units/mL Sucraid QOL AHFS DI Essentials. Copyright 2017, Selected Revisions October 30, 2014. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. References 1. Orphan Medical, Inc. Sucraid (sacrosidase) oral solution prescribing information. Minnetonka, MN; 1998 Apr. 2. Orphan Medical, Inc. Product monograph on Sucraid (sacrosidase) oral solution. Minnetonka, MN; 1998. 3. Treem WR, McAdams L, Stanford L et al. Sacrosidase therapy for congenital sucrase-isomaltase deficiency. J Pediatr Gastroenterol Nutr . 1999; 28:137 42. (IDIS 422478) [PubMed 9932843] 4. Orphan Medical, Inc. Sucraid (sacrosidase) oral solution patient information. Minnetonka, MN; 1998 Apr. a. QOL Medical, LLC. Sucraid (sarcrosidase) oral solution product information. In: Package Insert. From the DailyMed website (). Last revised 2006 Jun. Accessed 2007 Sept 28. b. Food and Drug Administration. Cumulative list of orphan drugs designated and/or approved. Rockville, MD; 2007, Oct 3. From FDA web site (http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanProductDesignation/default.htm). c. AHFS drug information 2007. McEvoy GK, ed. Sacrosidase. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2741-2. Next Pregnancy Warnings Print this page Add to My Med List More about sacrosidase Side Effects During Pregnancy Support Group En Español 0 Reviews Add your own review/rating Drug class: digestive enzymes Consumer resources Sacrosidase Sacrosidase (Advanced Reading) Professional resources Other brands: Sucraid Related treatment guides Enzymopathy, Unspecified} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Digestive enzymes Related Drugs Enzymopathy, Unspecified n/a Sacrosidase Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } most useful
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