digestive enzymes (Rx, OTC)

Brand and Other Names:Arco Lase, Digepepsin, more...Gustase
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

delayed release capsules

  • Pertzye (bicarbonate buffered enteric buffered microspheres): Lipase (8,000 units), protease (28,750 units), amylase (30,250 units)
  • Pertzye (bicarbonate buffered enteric buffered microspheres): Lipase (16,000 units), protease (57,500 units), amylase (60,500 units)
  • Pancrelipase (enteric coated beads): Lipase (5,000 units), protease (17,000 units), amylase (27,000 units)
  • Zerpep (enteric coated beads): Lipase (3,000 units), protease (10,000 units), amylase (16,000 units)
  • Zerpep (enteric coated beads): Lipase (5,000 units), protease (17,000 units), amylase (27,000 units)
  • Zerpep (enteric coated beads): Lipase (10,000 units), protease (34,000 units), amylase (55,000 units)
  • Zerpep (enteric coated beads): Lipase (15,000 units), protease (51,000 units), amylase (82,000 units)
  • Zerpep (enteric coated beads): Lipase (20,000 units), protease (68,000 units), amylase (109,000 units)
  • Zerpep (enteric coated beads): Lipase (25,000 units), protease (85,000 units), amylase (136,000 units)
  • Creon (enteric coated microspheres): Lipase (3,000 units), protease (9,500 units), amylase (15,000 units)
  • Creon (enteric coated microspheres): Lipase (6,000 units), protease (19,000 units), amylase (30,000 units)
  • Creon (enteric coated microspheres): Lipase (12,000 units), protease (38,000 units), amylase (60,000 units)
  • Creon (enteric coated microspheres): Lipase (24,000 units), protease (76,000 units), amylase (120,000 units)

delayed release capsules, enteric coated microtablets

  • Pancreaze: Lipase (4,200 units), protease (10,000 units), amylase (17,500 units)
  • Pancreaze: Lipase (10,500 units), protease (25,000 units), amylase (43,750 units)
  • Pancreaze: Lipase (16,800 units), protease (40,000 units), amylase (70,000 units)
  • Pancreaze: Lipase (16,800 units), protease (40,000 units), amylase (70,000 units)
  • Pancreaze: Lipase (21,000 units), protease (37,000 units), amylase (61,000 units)
  • Ultresa: Lipase (13,800 units), protease (27,600 units), amylase (27,600 units)
  • Ultresa: Lipase (20,700 units), protease (41,400 units), amylase (41,400 units)
  • Ultresa: Lipase (23,000 units), protease (46,000 units), amylase (46,000 units)

tablet

  • Viokace: Lipase (10,440 units), protease (39,150 units), amylase (39,150 units)
  • Viokace: Lipase (20,880 units), protease (78,300 units), amylase (78,300 units)

Pancreatic Insufficiency

500 lipase units/kg per meal initially (up to the maximum dose); half the prescribed dose given for an individualized full meal often administered with each snack; total daily dose should reflect approximately 3 meals plus 2 or 3 snacks/day

Dose should not exceed 2,500 lipase units/kg per meal; 10,000 lipase units/kg/day; or 4,000 lipase units/g of fat ingested per day

Chronic Pancreatitis or Pancreatectomy

Creon: 72,000 lipase units per meal while consuming at least 100 g of fat per day

Dosage Forms & Strengths

delayed release capsules

  • Pertzye (bicarbonate buffered enteric buffered microspheres): Lipase (8,000 units), protease (28,750 units), amylase (30,250 units)
  • Pertzye (bicarbonate buffered enteric buffered microspheres): Lipase (16,000 units), protease (57,500 units), amylase (60,500 units)
  • Pancrelipase (enteric coated beads): Lipase (5,000 units), protease (17,000 units), amylase (27,000 units)
  • Zerpep (enteric coated beads): Lipase (3,000 units), protease (10,000 units), amylase (16,000 units)
  • Zerpep (enteric coated beads): Lipase (5,000 units), protease (17,000 units), amylase (27,000 units)
  • Zerpep (enteric coated beads): Lipase (10,000 units), protease (34,000 units), amylase (55,000 units)
  • Zerpep (enteric coated beads): Lipase (15,000 units), protease (51,000 units), amylase (82,000 units)
  • Zerpep (enteric coated beads): Lipase (20,000 units), protease (68,000 units), amylase (109,000 units)
  • Zerpep (enteric coated beads): Lipase (25,000 units), protease (85,000 units), amylase (136,000 units)
  • Creon (enteric coated microspheres): Lipase (3,000 units), protease (9,500 units), amylase (15,000 units)
  • Creon (enteric coated microspheres): Lipase (6,000 units), protease (19,000 units), amylase (30,000 units)
  • Creon (enteric coated microspheres): Lipase (12,000 units), protease (38,000 units), amylase (60,000 units)
  • Creon (enteric coated microspheres): Lipase (24,000 units), protease (76,000 units), amylase (120,000 units)

delayed release capsules, enteric coated microtablets

  • Pancreaze: Lipase (4,200 units), protease (10,000 units), amylase (17,500 units)
  • Pancreaze: Lipase (10,500 units), protease (25,000 units), amylase (43,750 units)
  • Pancreaze: Lipase (16,800 units), protease (40,000 units), amylase (70,000 units)
  • Pancreaze: Lipase (16,800 units), protease (40,000 units), amylase (70,000 units)
  • Pancreaze: Lipase (21,000 units), protease (37,000 units), amylase (61,000 units)
  • Ultresa: Lipase 13,800 units), protease (27,600 units), amylase (27,600 units)
  • Ultresa: Lipase 20,700 units), protease (41,400 units), amylase (41,400 units)
  • Ultresa: Lipase 23,000 units), protease (46,000 units), amylase (46,000 units)

tablet

  • Viokace: Lipase 10,440 units), protease (39,150 units), amylase (39,150 units)
  • Viokace: Lipase 20,880 units), protease (78,300 units), amylase (78,300 units)

Pancreatic Insufficiency

>4 years

  • 500 lipase units/kg per meal initially (up to the maximum dose); half the prescribed dose given for an individualized full meal often administered with each snack; total daily dose should reflect approximately 3 meals plus 2 or 3 snacks/day
  • Dose should not exceed 2,500 lipase units/kg per meal; 10,000 lipase units/kg/day; or 4,000 lipase units/g of fat ingested per day

>12 months to < 4 years

  • 1,000 lipase units/kg per meal initially (up to the maximum dose); half the prescribed dose given for an individualized full meal often administered with each snack; total daily dose should reflect approximately 3 meals plus 2 or 3 snacks/day
  • Dose should not exceed 2,500 lipase units/kg per meal; 10,000 lipase units/kg/day; or 4,000 lipase units/g of fat ingested per day
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Interactions

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                    Adverse Effects

                    Frequency Not Defined

                    Nausea

                    Diarrhea

                    Abdominal cramping

                    Headache

                    Neck pain

                    Nasal congestion

                    Peripheral edema

                    Rash

                    Dizziness

                    Hypoglycemia

                    Hyperglycemia

                    Diabetes mellitus exacerbation

                    Flatulence

                    Dyspepsia

                    Biliary tract stones

                    Abnormal feces

                    Hydrocholecystis

                    Renal cyst

                    Viral infection

                    Asthma

                    Gastritis

                    Muscle spasm

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                    Warnings

                    Contraindications

                    Hypersensitivity to any component

                    Acute pancreatitis, acute exacerbation of chronic pancreatitis

                    Cautions

                    Dosage depends on condition being treated and digestive requirements of patients

                    Fibrosing colonopathy advancing to colonic strictures reported

                    Administering the contents of the capsules alone or mixing in food may irritation of the oral mucosa and or loss of enzyme activity

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                    Pregnancy & Lactation

                    Pregnancy Category: C

                    Lactation: Unknown; use caution

                    Pregnancy Categories

                    A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                    B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                    C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                    D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                    X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                    NA: Information not available.

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                    Pharmacology

                    Mechanism of Action

                    Enzymes break down dietary

                    • Carbohydrates: amylase, cellulase, pancreatin
                    • Fats: bile salts, lipase, pancreatin
                    • Proteins: pancreatin, pepsin, protease

                    Pharmacokinetics

                    Absorption: not absorbed, acts locally in GI tract

                    Excretion: feces

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                    Images

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                    Patient Handout

                    Patient Education
                    digestive enzymes oral

                    DIGESTIVE ENZYMES - ORAL

                    USES: This medication contains digestive enzymes, which are natural substances needed by the body to help break down and digest food. It is used when the pancreas cannot make or does not release enough digestive enzymes into the gut to digest the food. Depending on the amount of enzymes in your product, it may be used for indigestion, as a supplement, or as replacement therapy (e.g., in chronic pancreatitis, cystic fibrosis, cancer of the pancreas, after surgery on the pancreas or gut).Some supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details about the brand you use.The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.

                    HOW TO USE: Take this medication by mouth with meals and snacks as directed by your doctor.The dosage is based on your medical condition, diet, and response to treatment.If you are using the tablet form of the medication, make sure not to keep it in the mouth because doing so can cause irritation to the gums and cheeks. Swallow the medication with water. For the chewable tablets, chew thoroughly before swallowing.If you are using the capsule form of the medication and swallowing is difficult, the capsule may be opened and the powder mixed with food or liquid.Be careful not to inhale any of the powder because doing so can irritate the inside of the nose or cause an asthma attack.Use this medication regularly to get the most benefit from it.If your doctor has recommended that you follow a special diet, it is very important to follow the diet to get the most benefit from this medication.Do not change brands or dosage forms of this product without consulting your doctor or pharmacist. Different products may contain different amounts of the digestive enzymes.Tell your doctor if your condition persists or worsens.

                    SIDE EFFECTS: Diarrhea, abdominal pain/cramps, or nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: severe abdominal discomfort, frequent/painful urination, joint pain.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                    PRECAUTIONS: Before taking this digestive enzyme, tell your doctor or pharmacist if you are allergic to it; or to pork protein; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: sudden/severe swelling of the pancreas (acute pancreatitis), sudden worsening of long-term disease of the pancreas.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

                    DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: acarbose, miglitol.

                    OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                    NOTES: Do not share this product with others.

                    MISSED DOSE: If you miss a dose, take the next dose with your next meal or snack as directed. Do not double the dose to catch up.

                    STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

                    Information last revised July 2016. Copyright(c) 2021 First Databank, Inc.

                    IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                    Formulary

                    FormularyPatient Discounts

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                    The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                    Tier Description
                    1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                    2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                    3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                    4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    NC NOT COVERED – Drugs that are not covered by the plan.
                    Code Definition
                    PA Prior Authorization
                    Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                    QL Quantity Limits
                    Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                    ST Step Therapy
                    Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                    OR Other Restrictions
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                    Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.