Drug information of Pancrelipase


Pancrelipase

Drug group:

Pancrelipase is a combination of three enzymes (proteins): lipase, protease, and amylase. These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars.
Pancrelipase is used to replace these enzymes when the body does not have enough of its own. Certain medical conditions can cause this lack of enzymes, including cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts.
Pancrelipase may also be used following surgical removal of the pancreas.
Pancrelipase may also be used for purposes not listed in this medication guide.

Mechanism of effect

Pancrelipase is a natural product harvested from the porcine pancreatic glands. It contains a combination of lipase, amylase, and protease. Products are formulated to dissolve in the more basic pH of the duodenum so that they may act locally to break down fats, protein, and starch.

Pharmacodynamic

Pancrelipase is a natural product harvested from the porcine pancreatic glands. It contains a combination of lipase, amylase, and protease. Products are formulated to dissolve in the more basic pH of the duodenum so that they may act locally to break down fats, protein, and starch.

Pharmacokinetics

Absorption
None; acts locally in GI tract
Excretion
Feces

Drug indications

Pancreatic insufficiency (exocrine): Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions
 

Dosage

Usual Adult Dose for Pancreatic Exocrine Dysfunction
Initial dose: 500 lipase units/kg orally per meal
Maintenance dose: Up to 2500 lipase units/kg orally per meal
Maximum dose: 10,000 lipase units/kg/day OR 4000 lipase units/gram fat
ingested per day

Usual Adult Dose for Cystic Fibrosis

Initial dose: 500 lipase units/kg orally per meal
Maintenance dose: Up to 2500 lipase units/kg orally per meal
Maximum dose: 10,000 lipase units/kg/day OR 4000 lipase units/gram fat ingested per day

sual Adult Dose for Chronic Pancreatitis

Initial dose: 500 lipase units/kg orally per meal
Maintenance dose: Up to 2500 lipase units/kg orally per meal
Maximum dose: 10,000 lipase units/kg/day OR 4000 lipase units/gram fat ingested per day

Usual Pediatric Dose for Pancreatic Exocrine Dysfunction

Up to 12 months: 2000 to 4000 lipase units per 120 mL of formula or breastfeeding

Older than 12 months to younger than 4 years:
-Initial dose: 1000 lipase units/kg orally per meal
-Maintenance dose: Up to 2500 lipase units/kg orally per meal
-Maximum dose: 10,000 lipase units/kg/day OR 4000 lipase units/gram fat ingested per day

4 years and older:
-Initial dose: 500 lipase units/kg orally per meal
-Maintenance dose: Up to 2500 lipase units/kg orally per meal
-Maximum dose: 10,000 lipase units/kg/day OR 4000 lipase units/gram fat ingested per day

Usual Pediatric Dose for Cystic Fibrosis

Up to 12 months: 2000 to 4000 lipase units per 120 mL of formula or breastfeeding

Older than 12 months to younger than 4 years:
-Initial dose: 1000 lipase units/kg orally per meal
-Maintenance dose: Up to 2500 lipase units/kg orally per meal
-Maximum dose: 10,000 lipase units/kg/day OR 4000 lipase units/gram fat ingested per day

4 years and older:
-Initial dose: 500 lipase units/kg orally per meal
-Maintenance dose: Up to 2500 lipase units/kg orally per meal
-Maximum dose: 10,000 lipase units/kg/day OR 4000 lipase units/gram fat ingested per day

Drug contraindications

No contraindications have been reported for this product.

Side effects

More common complications:
Blurred vision
Dry mouth
Wash skin, dry
The smell of fruity breath
Headache
Hunger has increased
Increased thirst
Increased urination
Sweating
Unexplained weight loss
Vomit
Less common complications:
Abnormal stools
Anxiety
Feeling bloated
لرز
Cold sweat
Confusion
Cool and pale skin
Depression
There is excess air or gas in the stomach or intestines
Feeling full
Fever
Frequent bowel movements
Loss of consciousness
Muscle aches
Nightmares
Gas passage
runny nose
Convulsions
To shake
Tongue tie
Sore throat
Rare side effects:
Skin rash or urticaria
Complications of high doses:
Ileus
Diarrhea
nausea
Stomach cramps or pain
Complications of very high doses:
Blood in the urine
joint's pain
Swelling of the legs or lower legs
Complications of powder form or powder from opened capsules:
- If a person suffers from nasal congestion while breathing, the chest feels tight
Side effects of holding the pill in the mouth:
Oral irritation
Side effects that are not known:
Cough
Difficulty swallowing
Vertigo
Fast heart rate
Itching
Noisy breathing
Swelling or swelling of the eyelids or around the eyes, face, lips and tongue
Redness of the skin
Severe stomach pain
Unusual fatigue or weakness

Interactions

There is no significant interference.

Alerts

• Fibrosing colonopathy: Fibrosing colonopathy, advancing to colonic strictures, has been reported (rarely). Risk may be increased with high doses, prolonged use, and in pediatric patients with cystic fibrosis; however, the mechanism is unknown. Doses of lipase >6,000 units/kg/meal have been associated with colonic stricture in children <12 years. Patients taking doses of lipase >6,000 units/kg/meal should be examined and the dose decreased. Doses of lipase >2,500 units/kg/meal, lipase >10,000 units/kg/day, or lipase >4,000 units/g fat daily should be used with caution and only with documentation of effectiveness by 3-day fecal fat measures indicating a significantly improved coefficient of fat absorption.

• Hypersensitivity: Severe, allergic reactions (eg anaphylaxis, asthma, hives, pruritus) have rarely been observed; use with caution in patients hypersensitive to pork proteins, taking into consideration the patient's overall clinical needs.

• Mucosal irritation: Crushing or chewing the contents of the capsules or tablets, or mixing the capsule contents with foods outside of product labeling, may cause early release of the enzymes, causing irritation of the oral mucosa and/or loss of enzyme activity. When mixing the contents of capsules with food, the mixture should be swallowed immediately and followed with water or juice to ensure complete ingestion. Pancrelipase should not be mixed in foods with pH >4.5.

• Pork: Products are derived from porcine pancreatic glands. Transmission of porcine viruses, and diseases caused by novel or unidentified viruses, is theoretically a risk; however, testing and/or inactivation or removal of certain viruses, reduces the risk. There have been no cases of transmission of an infectious illness reported.

Points of recommendation

Administer with meals or snacks and swallow whole with a generous amount of liquid. Do not crush or chew; retention in the mouth before swallowing may cause mucosal irritation

Pregnancy level

Safe - has not been found to be teratogenic

Systemic absorption of pancreatipase is limited.
Following its use by mothers, it is expected that the fetus will not be significantly exposed to the drug.
Pancreatalipaz is suitable for use during pregnancy.


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