Cotazym
Generic Name: Pancrelipase
Brand Name: Cotazym
Indications
Cotazym (pancrelipase) capsules are indicated for treatment of steatorrhea due to exocrine pancreatic enzyme deficiency.
Dosage and Administration
Cotazym (pancrelipase) are opaque green capsules supplied in bottles of 100 and bottles of 500.
Normal Dosage:
The dosage of Cotazym (pancrelipase) must be individualized according to the patient's remaining exocrine pancreatic function, pH of the gut lumen (if such measurements are routinely taken) and intake of fat and protein. Dosage should depend on nutritional intake as well as body weight, and varies with age. A high caloric diet with unrestricted fat appropriate to age and clinical status should be consumed. While the dose may need to be adjusted for control of steatorrhea, a total daily dose should not exceed 2500 lipase units/kg per meal without careful evaluation of the patient. A dose higher than 6000 lipase units/kg per meal should not be administered.
Overdose: Overdose symptoms may include diarrhea or stomach upset.
Drug Description
Cotazym (pancrelipase) contains pancrelipase obtained from the porcine pancreas. Pancrelipase is composed principally of lipase, amylase and protease and is used for oral digestive enzyme replacement. Each capsule contains not less than:
Lipase 8,000 USP Units
Protease 30,000 USP Units
Amylase 30,000 USP Units
At release, up to 25% more lipase may be present.
Each capsule also contains the inactive ingredients: cornstarch, precipitated calcium carbonate, gelatin, magnesium stearate, talc, titanium dioxide, FD&C Green #3 and D&C Yellow #10 as coloring.
Side Effects
Adverse reactions to Cotazym (pancrelipase) have been reported uncommonly. The most frequent adverse reactions reported during clinical use are diarrhea and stool abnormalities, such as green stools. Other reactions reported include pharyngitis, vomiting, abdominal pain, gastric burning, syncope, mouth irritation, mouth ulcers, mild anemia, abnormal smell and taste, stomach trouble and belching. Hyperuricosuria and/or hyperuricemia have been reported in patients taking high doses of Cotazym, pancreatic extracts have high purine content. Renal damage has not been reported. Hypersensitivity reactions, such as anaphylaxis, allergy, nasal irritation, coughing spells and episodes of bronchospasm, can occur in people exposed to the enzyme powder from opened capsules. High doses of the powder may cause mouth or perianal excoriation. In addition, pancreatic enzyme preparations may interfere with folic acid and iron absorption.
Precautions
- You should not take pancrelipase if you are allergic to pork proteins.
- Before taking pancrelipase, tell your doctor if you are allergic to any drugs, or if you have a sudden onset of pancreatitis, or worsening of chronic pancreatic disease.
- It is important to use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of the medicine completely.
- Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.
- Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.
- Do not change brands of pancrelipase without first talking to your doctor or pharmacist. Some brands of pancrelipase are interchangeable while others are not. Ask your pharmacist which brands or generic forms can be substituted for another.
- Skip the missed dose and wait until your next scheduled dose to take the medicine. Do not take extra medicine to make up the missed dose.
Drug Interactions
Antacids containing calcium carbonate and magnesium hydroxide should not be taken concurrently with pancrelipase. The combination of calcium carbonate and magnesium hydroxide with pancrelipase may precipitate glycine-conjugated bile acids and may form calcium and magnesium fatty acid soaps, causing a decrease in fat absorption and thus an increase in steatorrhea.