Adult Dosing

Exocrine pancreatic insufficiency

• Start with 500 lipase units/kg PO per meal
• Max: 2,500 lipase units/kg PO per meal (or 10,000 lipase units/kg/day), or < 4,000 lipase units/g fat ingested/day

Exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy

• Individualize dosage based on clinical symptoms, the degree of steatorrhea present and the fat content of the diet

• This drug is not interchangeable with any other pancrelipase product
• Avoid crushing, chewing of capsules and its contents
• Sprinkle the contents of capsules on soft acidic food with pH 4 or less, e.g. applesauce for infants or patients unable to swallow intact capsules
• Avoid exceeding the recommended maximum dosage set forth by the Cystic fibrosis foundation consensus conferences guidelines

Pediatric Dosing

• Safety and effectiveness of Viokace in pediatric patients have not been established

Exocrine pancreatic insufficiency

up to 12 mo

• 2000-4000 lipase units PO/ 120 mL of formula or breast feeding
• Note: Avoid mixing capsule contents directly into formula or breast milk prior to administration

1-4 yrs

• Start 1,000 lipase units/kg PO per meal
• Max: 2,500 lipase units/kg PO per meal (or =< 10,000 lipase units/kg/day), or < 4,000 lipase units/g fat ingested/day

4 yrs

• Start with 500 lipase units/kg PO per meal
• Max: 2,500 lipase units/kg PO per meal (or 10,000 lipase units/kg/day), or < 4,000 lipase units/g fat ingested/day

• This drug is not interchangeable with any other pancrelipase product
• Avoid crushing, chewing of capsules and its contents
• Sprinkle the contents of capsules on soft acidic food with pH 4 or less, e.g.applesauce for infants or patients unable to swallow intact capsules
• Avoid exceeding the recommended maximum dosage set forth by the Cystic fibrosis foundation consensus conferences guidelines

[Outline]

• Adult Dosing
• Pediatric Dosing

• Exocrine pancreatic insufficiency manifested by cystic fibrosis or other conditions
• In combination with a proton pump inhibitor, for treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy in adults (Viokace)

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to pork protein

• N/A

Renal Dose Adjustment

• Renal impairment: Use with caution; dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Higher dosages of pancreatic enzyme replacement for the treatment of cystic fibrosis can induce fibrosing colonopathy; pediatric patients with cystic fibrosis are more prone. Dosages >6,000 lipase units/kg of body weight per meal are associated with colonic stricture in children < 12 yrs of age; closely monitor patients with fibrosing colonopathy as some patients may be at risk of progressing to stricture formation. Cautiously use dosages of >2,500 lipase units/kg of body weight per meal (or >10,000 lipase units/kg of body weight per day); use only on evidence to be effective by 3-day fecal fat measures that indicate a significantly improved coefficient of fat absorption. Use cautious doses and enzymes <4,000 lipase units/g fat ingested per day only when clinically indicated. Examine patients receiving >6,000 lipase units/kg of body weight per meal and immediately decrease or titrate downward to a lower effective range
• Refrain from chewing, retaining of formulations in mouth and mixing in foods having a pH >4.5 as irritation to oral mucosa can occur
• Potential for risk of hyperuricemia exists
• Theoretical risk of viral transmission with all pancreatic enzyme products exists
• Rare severe allergic reactions including anaphylaxis, asthma, hives, and pruritus have occurred
• Assess benefit/risk in patients with severe allergy with the overall clinical needs of the patient

Cautions: Use cautiously in

• Renal impairment
• Hyperuricemia
• Gout
• Allergy to proteins of porcine origin
• History of short bowel syndrome
• History of recurrent GI obstruction
• History of meconium ileus
• History of Crohn disease
• Prior intestinal surgery

Supplemental Patient Information

• Advise patients that total daily dose should not be >10,000 lipase units/kg body weight/day unless clinically indicated; needs to be specially emphasized for patients eating multiple snacks and meals/day
• Inform patients that if a dose is missed, the next dose should be taken with the next meal or snack as directed. Avoid doubling of doses
• Advise patients and caregivers to contact their clinician immediately on occurrence of allergic reactions
• Instruct to notify physician if pregnant or plan to become pregnant during treatment
• Inform the physician about history of abnormal glucose levels before initiating treatment

Pregnancy Category:C

Breastfeeding: Safety unknown; Unknown whether this drug is excreted in human milk. Assess benefit/risk in the context of the need to provide adequate nutritional support to a nursing mother with exocrine pancreatic insufficiency. As many drugs are excreted in human milk, manufacturer advises caution.

• GI: Fibrosing colonopathy, intestinal obstruction, abdominal pain, flatulence, abnormal feces, frequent bowel movements, vomiting, anal pruritus, ascites
• CNS: Dizziness, headache
• HEMA: Anemia
• METABOLIC: Hyperglycemia, hypoglycemia
• EENT: Nasopharyngitis
• RESP: Cough
• HEPA: Biliary tract stones, hydrocholecystis
• GU: Renal cyst
• MISC: Hypersensitivity reaction, pruritus, urticaria, rashes, peripheral edema

• Digestive enzyme; acts like digestive enzymes physiologically secreted by the pancreas by catalyzing break down of fats, protein, and starches in the duodenum and proximal small intestine
• Not absorbed from the GI tract in appreciable amounts
• Metabolism: Unknown
• Excreted in feces
• Half life: Unknown

US Trade Name(s)

• Creon
• Pancreaze
• Pertzye
• Ultresa
• Viokace
• Zenpep

US Availability

pancrelipase (generic)

• ECAPS (lipase/protease/amylase): 5000/17000/27000 units

Creon

• Delayed Release CAPS (lipase/protease/amylase): 3000/9500/15000 units
• Delayed Release CAPS (lipase/protease/amylase): 6000/19000/30000 units
• Delayed Release CAPS (lipase/protease/amylase): 12000/38000/60000 units
• Delayed Release CAPS (lipase/protease/amylase): 24000/76000/120000 units
• Delayed Release CAPS (lipase/protease/amylase): 36000/114000/180000 units

Pancreaze

• Delayed Release CAPS (lipase/protease/amylase): 4200/10000/17500 units
• Delayed Release CAPS (lipase/protease/amylase): 10500/25000/43750 units
• Delayed Release CAPS (lipase/protease/amylase): 16800/40000/70000 units
• Delayed Release CAPS(lipase/protease/amylase): 21000/37000/61000 units

Pertzye

• Delayed Release CAPS (lipase/protease/amylase): 8,000/28,750/30,250 units
• Delayed Release CAPS (lipase/protease/amylase): 16,000/57,500/60,500 units

Ultresa

• Delayed Release CAPS(lipase/protease/amylase): 13,800/27,600/27,600 units
• Delayed Release CAPS (lipase/protease/amylase): 20,700/41,400/41,400 units
• Delayed Release CAPS (lipase/protease/amylase): 23,000/46,000/; 46,000 units

Viokace

• TABS (lipase/protease/amylase): 10,440/39,150/39,150 units
• TABS (lipase/protease/amylase): 20,880/78,300/78,300 units

Zenpep

• Delayed Release CAPS (lipase/protease/amylase): 3000/10000/16000 units
• Delayed Release CAPS (lipase/protease/amylase): 5000/17000/27000 units
• Delayed Release CAPS (lipase/protease/amylase): 10000/34000/55000 units
• Delayed Release CAPS (lipase/protease/amylase): 15000/51000/82000 units
• Delayed Release CAPS (lipase/protease/amylase): 20000/68000/109000 units
• Delayed Release CAPS (lipase/protease/amylase): 25000/85000/136000 units
• Delayed Release CAPS (lipase/protease/amylase): 40000/136000/218000 units

Canadian Trade Name(s)

• Bio-zyme
• Pancreatin

Canadian Availability

Bio-zyme

• OTC TABS: 50 mg

Pancreatin

• OTC TABS: 325 mg

UK Trade Name(s)

• Creon 10000
• Creon 25000
• Creon 40000
• Creon Micro
• Nutrizym 10
• Nutrizym 22
• Pancrease HL
• Pancrex
• Pancrex V capsules
• Pancrex V capsules 125 mg
• Pancrex V tablets
• Pancrex V forte tablets
• Pancrex V powder

UK Availability

Creon 10000

• ECAPS (lipase/protease/amylase): 10000/600/8000 units

Creon 25000

• ECAPS (lipase/protease/amylase): 25000/1000/18000 units

Creon 40000

• ECAPS (lipase/protease/amylase): 40000/1600/25000 units

Creon Micro

• GRAN (lipase/protease/amylase): 5000/200/3600 units/ 100 g

Nutrizym 10

• CAPS (lipase/protease/amylase): 10000/500/9000 units

Nutrizym 22

• CAPS (lipase/protease/amylase): 22000/1100/19800

Pancrease HL

• CAPS (lipase/protease/amylase): 25000/1250/22500

Pancrex

• GRAN (lipase/protease/amylase): 5000/300/4000 units

Pancrex V capsules

• CAPS (lipase/protease/amylase): 8000/430/9000 units

Pancrex V capsules 125 mg

• CAPS (lipase/protease/amylase): 2950/160/3300 units

Pancrex V tablets

• TABS (lipase/protease/amylase): 1900/110/1700 units

Pancrex V forte tablets

• TABS (lipase/protease/amylase): 5600/330/5000 units

Pancrex V powder

• PWDR (lipase/protease/amylase): 25000/1400/30000 units/g

Australian Trade Name(s)

• Cotazym-S Forte
• Creon
• Panzytrat 25000

Australian Availability

Cotazym-S Forte

• CAPS (Lipase/protease/amylase): 10000/750/7700

Creon

• CAPS (Lipase/protease/amylase): 5000/300/4000 units
• CAPS (Lipase/protease/amylase): 10000/600/8000 units
• CAPS (Lipase/protease/amylase): 25000/1000/18000 units

Panzytrat 25000

• CAPS (Lipase/protease/amylase): 25000/1250/22500 units

[Outline]

Gastrointestinal

Digestive Agent

Pancreatic Enzymes

Gastrointestinal

Digestive Enzymes

Pricing data from www.DrugStore.com in U.S.A.

• Pancreaze 10500 Unit CPEP [Bottle] (JANSSEN)
  30 unit = $59.99
  90 unit = $157.5
• Pancreaze 4200 Unit CPEP [Bottle] (JANSSEN)
  30 unit = $30.99
  60 unit = $50.97
• Creon 24000 UNIT CPEP [Bottle] (ABBOTT)
  100 unit = $325
  300 unit = $955.97
• Creon 12000 UNIT CPEP [Bottle] (ABBOTT)
  30 unit = $61.99
  90 unit = $166.97
• Creon 6000 UNIT CPEP [Bottle] (ABBOTT)
  30 unit = $38.99
  90 unit = $92.97
• Pancreaze 16800 Unit CPEP [Bottle] (JANSSEN)
  30 unit = $87.99
  90 unit = $242.74
• Pancreaze 21000 Unit CPEP [Bottle] (JANSSEN)
  30 unit = $109.99
  90 unit = $310.97
• Pancrelipase (Lip-Prot-Amyl) 5000 UNIT CPEP [Bottle] (X-GEN PHARMACEUTICALS)
  INC unit = $30
  unit = $60
• Zenpep 15000 UNIT CPEP [Bottle] (AXCAN PHARMA US)
  30 unit = $80.99
  90 unit = $225.96

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

• Creon 12,000 (lipase) Enteric Coated Capsule (Physicians Total Care, Inc.)
• Creon 12,000 (lipase) Enteric Coated Capsule (Solvay Pharmaceuticals, Inc.)
• Creon 6000 (lipase) Enteric Coated Capsue (Solvay Pharmaceuticals, Inc.)
• Zenpep 10 Enteric Coated Capsule (Eurand Pharmaceuticals Inc.)
• Zenpep 15 Enteric Coated Capsule (Eurand Pharmaceuticals Inc.)
• Zenpep 20 Enteric Coated Capsule (Eurand Pharmaceuticals Inc.)
• Zenpep 5 Enteric Coated Capsule (Eurand Pharmaceuticals Inc.)