Top3pe

Uses

Children:

• Reduced or absence of pancreatic exocrine secretion
• Cystic fbrosis

Adults:

In the conditions with defcient pancreatic exocrine function such as-

• Following pancreatectomy
• Following total gastrectomy
• Chronic pancreatitis
• Steatorrhea
• Somatostatinoma
• Celiac disease

Top3pe is also used to associated treatment for these conditions: Aerophagy, Deficiency Digestive enzymes, Diarrhoea, Dyspepsia, Exocrine Pancreatic Insufficiency, Flatulence, Gastrointestinal Discomfort, Pancreatic Insufficiency, Post Operative Gas, Pre-operative Gas, Fat malabsorption, Meteorism, Bile Duct Disorders, Carbohydrate Digestion, Digestive Aid, Fat Digestion, Liver Metabolism, Protein Digestion

How Top3pe works

Top3pe is used to replace the deficiency of pancreatic enzymes. As abovementioned, pancrelipase is formed by a mixture of lipase, protease, and amylase which are able to break down fat, protein, and starches, respectively, in the small intestine. For a more specific description of each mechanism of action, please visit Top3pe amylase, Top3pe protease and Top3pe lipase.

Dosage

Top3pe dosage

1-3 tablets daily with meal or as per direction of the physician.

Side Effects

Pancreatin may cause buccal and perianal soreness, particularly in infants. Hypersensitivity reactions have been reported; these may be sneezing, lacrimation or skin rashes.

Toxicity

The studies of the toxicology of pancrelipase are not needed as this drug has been used clinically for a long time. Clinical overdose studies proved no effect on lungs, pancreas, liver and kidneys but it can produce symptoms such as diarrhea or stomach upset. Carcinogenicity studies have not shown any increased incidence with the use of pancrelipase. As pancrelipase is not absorbed, the effect on fetal development or reproduction is not expected.

Precaution

A proper balance between fat, protein and starch intake must be maintained to avoid temporary indigestion.

Interaction

Alkaline media will rupture the enteric coating. As such to prevent bursting out of the content in the stomach Pancreatin should not be used concurrently with antacid.

Food Interaction

• Drink plenty of fluids.
• Take with fluids.
• Take with food. If swallowing the oral capsule is not tolerated, sprinkle on acidic soft foods with a pH of 4 or less.

Top3pe multivitamins interaction

[Moderate] Exogenous pancreatic enzymes may interfere with the gastrointestinal absorption of folic acid and iron.

The exact mechanism of interaction is unknown.

In one study, investigators compared oral iron absorption over a 3-hour period in the presence and absence of exogenous pancreatic enzymes in 13 stable young adults with cystic fibrosis and 9 age-matched controls.

There was no difference between patients and controls in iron absorption in the absence of exogenous pancreatic enzymes.

However, significant impairment of iron absorption was observed in both groups after administration of pancrelipase one hour prior to iron administration.

In the patient group, one hour after iron administration, there was a 188% increase in serum iron level above baseline in the absence of pancrelipase but only a 62% increase in the presence of pancrelipase.

In the controls, percentage increases as well as peak serum iron levels were significantly higher in the absence of pancrelipase during all 3 hours after iron administration.

Clinically, at least one-third of cystic fibrosis patients reportedly have iron deficiency.

In the study, mean serum iron concentration was significantly lower in patients than in controls (11.9 versus 18.9 micromoles
Patients receiving therapeutic iron or folate therapy should be monitored for potentially reduced hematologic response if pancreatic enzymes are administered concomitantly.

Separating the times of administration may be helpful.

Top3pe Drug Interaction

Unknown: zolpidem, aspirin, rosuvastatin, duloxetine, hydromorphone, levetiracetam, insulin glargine, atorvastatin, pregabalin, polyethylene glycol 3350, esomeprazole, insulin aspart, clopidogrel, pantoprazole, levothyroxine, acetaminophen, cyanocobalamin, ascorbic acid, cholecalciferol, ondansetron

Top3pe Disease Interaction

Moderate: hyperuricemia

Volume of Distribution

Top3pe acts locally in the GI tract and it is not absorbed in any significant amount thus, the volume of distribution is not relevant.

Elimination Route

Top3pe acts locally in the GI tract and it is not absorbed in any significant amount.

Half Life

Top3pe acts locally in the GI tract and it is not absorbed in any significant amount thus, the elimination half-life is not relevant.

Clearance

Top3pe acts locally in the GI tract and it is not absorbed in any significant amount thus, the clearance rate is not relevant.

Elimination Route

Top3pe is entirely eliminated in the feces.

Pregnancy & Breastfeeding use

Pregnancy category C. Not known whether Pancreatin is distributed into milk. Caution advised if Pancreatin is used.

Acute Overdose

Excessive dosage may produce a laxative efect. Systemic toxicity does not occur. Very high dosage may cause hyperuricemia and hyperuricos-uria.

Storage Condition

Store in a cool and dry place. Keep out of the reach of children.

Innovators Monograph

You find simplified version here Top3pe