Pancrease (Pancrelipase)

PANCREASE® PANCREASE® MT

Janssen-Ortho

Pancrelipase

Digestant

Action And Clinical Pharmacology: The enteric-coated microtablets resist gastric inactivation and deliver predictable, high levels of biologically active pancreatic enzymes (lipase, amylase, and protease) into the duodenum. The enzymes catalyze the hydrolysis of fats into glycerol and fatty acids, proteins into proteoses and derived substances, and starch into dextrins and sugars.

Pharmacokinetics: Absorption: The intestinal bioavailability of Pancrease MT 16 capsules was determined, in vitro, under simulated physiological conditions. The capsules were placed into a test tube containing an incubation medium consisting of 2 g NaCl, 9.2 g NaH2PO4 and distilled water ad 1 000 mL. Employing a disintegration tester, the contents of the test tube were shaken at a constant speed of 30 rpm at an incubation temperature of 37°C. The pH of the mixture was adjusted by adding 4N HCl or 4N NaOH.

To simulate the acidic conditions of the stomach during a meal, a pH of 4.0 was initially established and gradually reduced in increments of 0.5 at 30-minute intervals to a pH of 2.5. To simulate the relative alkalinity of the intestine, the preparation was then transferred to a buffer where a pH of 6.6 was maintained. While the preparation was exposed to the buffer, release of pancreatic lipase, the marker enzyme, was measured as a function of time. The lipase content of the incubation medium was determined every 15 minutes for 120 minutes. More than 90% of the enzyme activity of the Pancrease MT capsules was released at 15 minutes with peak levels (97%) occurring at 30 minutes. The results demonstrate that Pancrease MT capsules are nearly 100% bioavailable and rapidly release high levels of pancreatic enzymes.

Excretion: Unused enzymes in the capsules are excreted in the feces. Digested enzymes are absorbed and are subsequently excreted in the urine.

Indications And Clinical Uses: For patients with exocrine pancreatic enzyme deficiency as in, but not limited to, cystic fibrosis, chronic pancreatitis, post-pancreatectomy, post-gastrointestinal bypass surgery, and ductal obstruction from neoplasm (e.g., of the pancreas or common bile duct).

Contra-Indications: In patients known to be hypersensitive to pork protein and in patients with acute pancreatitis or with acute exacerbations of chronic pancreatic diseases.

Manufacturers’ Warnings In Clinical States: Should hypersensitivity occur, discontinue medication and treat the patient symptomatically.

Precautions: To protect the enteric coating, the microtablets should not be crushed or chewed. Where swallowing of capsules is difficult, they may be opened and the contents may be shaken onto a small quantity of a soft food which does not require chewing (e.g., applesauce, dessert gelatin, etc.), and swallowed immediately. Contact of the microtablets with foods having a pH greater than 6.0 (e.g., milk, custard, ice cream and many other dairy products) can dissolve the protective enteric coating.

Cases of fibrotic stricture formation in the ascending colon have been reported in cystic fibrosis patients with the use of high potency enzyme supplements in high doses (6 500 to 50 000 BP lipase units/kg/meal). If symptoms suggestive of gastrointestinal obstruction occur the possibility of bowel strictures should be considered.

Any change in pancreatic enzyme replacement therapy (e.g., dose or brand of medication) should be made cautiously and only under medical supervision.

Pregnancy: Animal reproduction studies have not been conducted with pancrelipase. It is also not known whether enteric coated pancrelipase can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. The capsules should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus.

Adverse Reactions: The most frequently reported adverse reactions to pancrelipase-containing products are gastrointestinal in nature such as nausea and diarrhea. Less frequently, allergic-type reactions have also been observed. Extremely high doses of exogenous pancreatic enzymes have been associated with hyperuricemia and hyperuricosuria when the preparations given were pancrelipase in powdered or capsule form or pancreatin in tablet form.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: There have been no reports of accidental or purposeful overdosage with pancrelipase capsules. Pancrelipase microtablets are classified as nontoxic by the Poisindex Information System, and serious toxicity from overdose is unlikely. Should toxicity occur, treat symptomatically. tag_DosageDosage

Dosage And Administration: Dosage should be adjusted according to the severity of the exocrine pancreatic enzyme deficiency. The number of capsules or capsule strength given with meals and/or snacks should be estimated by assessing which dose minimizes steatorrhea and maintains good nutritional status. In some patients with pancreatic enzyme deficiency, satisfactory responses have been achieved with dosages (expressed in USP units of lipase) similar to the ones stated below. However, dosages should be adjusted according to the response of the patient.

Dose increases, if required, should be made slowly, with careful monitoring of response and symptomatology. It is important to ensure adequate hydration of patients at all times while administering pancrelipase.

Adults: 4 000 to 16 000 units (more if necessary) with each meal and with snacks.

Under 6 months Not established. The assessment of the end points in children is aided by charting growth curves.

SuppliedSupplied: Pancrease: Each hard gelatin capsule with a clear or natural cap and opaque, white body, imprinted McNEIL – PANCREASE in synthetic iron oxide with a ring of the same color located around the end of both cap and body and off-white beads visible through the clear end of the capsule contains: No less than lipase 4 000 USP units, capable of liberating a minimum of 4 mEq fatty acid/minute; amylase 20 000 USP units, capable of digesting a minimum of 20 g starch; and, protease 25 000 USP units, capable of digesting a minimum of 25 g protein. Nonmedicinal ingredients: cellulose acetate phthalate, cornstarch, diethyl phthalate, gelatin, povidone, sodium starch glycolate, sugar, talc and titanium dioxide. Energy: 5.887 kJ (1.4 kcal). Bottles of 100 and 250.

Pancrease MT 4: Each yellow opaque, clear hard gelatin capsule, imprinted “PANCREASE MT 4” on clear cap, and “McNEIL” on body, contains: lipase 4 000 USP units, amylase 12 000 USP units and protease 12 000 USP units. Capsules are filled with off-white microtablets. Nonmedicinal ingredients: cellulose, crospovidone, gelatin, iron oxide, magnesium stearate, methacrylic acid copolymer, polydimethylsiloxane, sodium lauryl sulfate, silicon dioxide, talc, titanium dioxide, triethylcitrate, wax and other trace ingredients. Bottles of 100.

Pancrease MT 10: Each pink opaque, clear hard gelatin capsule, imprinted “PANCREASE MT 10” on clear cap, and “McNEIL” on body, contains: lipase 10 000 USP units, amylase 30 000 USP units and protease 30 000 USP units. Capsules are filled with off-white microtablets. Nonmedicinal ingredients: cellulose, crospovidone, gelatin, iron oxide, magnesium stearate, methacrylic acid copolymer, polydimethylsiloxane, sodium lauryl sulfate, silicon dioxide, talc, titanium dioxide, triethylcitrate, wax and other trace ingredients. Bottles of 100.

Pancrease MT 16: Each salmon opaque, clear hard gelatin capsule, imprinted “PANCREASE MT 16” on clear cap, and “McNEIL” on body, contains: lipase 16 000 USP units, amylase 48 000 USP units and protease 48 000 USP units. Capsules are filled with off-white microtablets. Nonmedicinal ingredients: cellulose, crospovidone, gelatin, iron oxide, magnesium stearate, methacrylic acid copolymer, polydimethylsiloxane, sodium lauryl sulfate, silicon dioxide, talc, titanium dioxide, triethylcitrate, wax and other trace ingredients. Bottles of 100.

Keep bottles tightly closed. Store between 10 to 25°C in a dry place. Do not refrigerate. Dispense in tight container.

PANCREASE® PANCREASE® MT Janssen-Ortho Pancrelipase Digestant

Connected Diseases :

Cystic Fibrosis

General Illness Information Common Name: Cystic Fibrosis Medical Term: Cystic Fibrosis, CF Description: An inherited disease of the exocrine glands, primarily affecting the Gastro-intestinal and…