Digy

 

FERMASE TABLET

Composition

Each enteric-Sugar coated tablet contains:

Pancreatin   IP            192 mg
Amylase activity   -  15,000 USP units
Lipase activity       -   4,000 USP units
Protease activity    – 15,000 USP units
Bile constituents   – 25mg
(with sugar coating containing essential carminative oils)

INDICATIONS

Indigestion /Dyspepsia
Flatulence
Bloating
Fullness after eating
Heartburn
Anorexia
Hepatic and pancreatic insufficiency
Post operative digestive upsets and convalescence

Dosage and Administration

FERMASE TABLET is not interchangeable with any other pancreatic enzymes containing product.
FERMASE TAB  orally administered without chewing or breaking  . Therapy should be initiated at the lowest recommended dose and gradually increased. The dosage of FERMASE TABLET should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet (see Limitations on Dosing below).
Adults (including the elderly) and children:
Generally for children (below 6 years of age) usual initial starting dosage is up to one FERMASE TABLET  per meal or snack.
For adults and children (over 6 years of age) the usual initial starting dosage is one to two FERMASE TAB per meal or snack.
For cystic fibrosis patients, typical doses are 1,500–3,000 lipase units/kg/meal. Dosage should be adjusted according to the severity of the disease, control of steatorrhea and maintenance of good nutritional status.
FERMASE TABLET should be taken during meals or snacks, with sufficient fluid. Care should be taken to ensure that FERMASE TABLET is not crushed or chewed or retained in the mouth, to avoid irritation of the oral mucosa.
Adults with Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis or Pancreatectomy

Recommendations for pancreatic enzyme therapy in patients with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy are based on a clinical trial conducted in these populations.
The initial starting dose and increases in the dose per meal should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet.
In one clinical trial, patients received FERMASE TABLET at a dose of 72,000 lipase units per meal while consuming at least 100 g of fat per day. Lower starting doses recommended in the literature are consistent with the 500 lipase units/kg of body weight per meal lowest starting dose recommended for adults in the Cystic Fibrosis Foundation Consensus Conferences Guidelines. Usually, half of the prescribed FERMASE TABLET dose for an individualized full meal should be given with each snack.

Limitations on Dosing

Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines. If symptoms and signs of steatorrhea persist the dosage may be increased by the healthcare professional. Patients should be instructed not to increase the dosage on their own. There is great inter-individual variation in response to enzymes; thus, a range of doses is recommended. Changes in dosage may require an adjustment period of several days. If doses are to exceed 2,500 lipase units/kg of body weight per meal, further investigation is warranted. Doses greater than 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day) should be used with caution and only if they are documented to be effective by 3-day fecal fat measures that indicate a significantly improved coefficient of fat absorption. Doses greater than 6,000 lipase units/kg of body weight per meal have been associated with colonic stricture, indicative of fibrosing colonopathy, in children less than 12 years of age

Warnings and Precautions

Fibrosing colonopathy has been reported in patients with cystic fibrosis taking in excess of 10,000 units of lipase/kg/day. Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology. Patients currently receiving higher doses than 6,000 lipase units/kg of body weight per meal should be examined and the dosage either immediately decreased or titrated downward to a lower range.
When changing the strengths of pancreatic enzyme products, care should be taken to maintain equivalent lipase units for each divided dosage. It is important to ensure adequate hydration of patients at all times whilst dosing FERMASE TABLET

CONTRAINDICATIONS

FERMASE TABLET are contraindicated in the early stages of acute pancreatitis or in patients who are known to be hypersensitive to pancreatin of porcine origin or to any of the excipients.

Packaging Information

FERMASE TABLET  : Alu Alu  Strip of 10 Tablet.