COTAZYM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for COTAZYM (COTAZYM).
Pancreatic enzyme replacement therapy; lipase, protease, and amylase hydrolyze fats, proteins, and carbohydrates, respectively, facilitating digestion and absorption.
| Metabolism | Enzymes are proteins that are degraded by proteolysis in the gastrointestinal tract; systemic absorption is negligible. |
| Excretion | Cotazym (pancrelipase) is a mixture of digestive enzymes (lipase, protease, amylase) that act locally in the gastrointestinal tract. The enzymes are not significantly absorbed systemically. Excretion occurs primarily via fecal elimination of unabsorbed enzymes and their degradation products. No significant renal or biliary excretion of intact enzymes. |
| Half-life | As a locally acting enzyme replacement, Cotazym does not have a meaningful systemic half-life. The enzymatic activity is inactivated in the stomach and upper small intestine by gastric acid and proteolysis. The effective half-life is approximately 30-60 minutes within the intestinal lumen, depending on pH and proteolytic activity. |
| Protein binding | Cotazym enzymes are not significantly bound to plasma proteins as they are intended to act locally in the gut. Systemic absorption is minimal (<1%), so protein binding data are not clinically relevant. |
| Volume of Distribution | Not applicable; Cotazym is not absorbed systemically to a significant extent. Therefore, volume of distribution is not a relevant parameter. The enzymes act locally within the gastrointestinal lumen. |
| Bioavailability | Oral bioavailability is negligible (<1%) as the enzymes are not absorbed intact. They act locally in the gastrointestinal tract to digest fats, proteins, and carbohydrates. |
| Onset of Action | Oral administration: Onset of action occurs within 30-60 minutes after ingestion, corresponding to the time for the enzyme capsules to dissolve and release enzymes into the duodenum. Maximal lipolytic activity in the duodenum is achieved within 1-2 hours. |
| Duration of Action | The duration of action is approximately 1-4 hours, corresponding to the transit time of enzymes through the small intestine and the time of digestion of a meal. Clinical effect is seen during and shortly after a meal. Dosing is typically with each meal or snack. |
1 to 3 capsules orally with each meal or snack, dose based on severity of pancreatic insufficiency; typical adult dose is 500 to 1000 lipase units per gram of dietary fat.
| Dosage form | CAPSULE |
| Renal impairment | No dose adjustment required for renal impairment. |
| Liver impairment | No specific adjustment for hepatic impairment per Child-Pugh; use standard dosing. |
| Pediatric use | Infants: 2,000-4,000 lipase units per 120 mL expressed breast milk or formula; Children: 500-4,000 lipase units per gram of dietary fat, typically 1,000-2,500 lipase units per kg per meal, not to exceed 10,000 lipase units/kg/day. |
| Geriatric use | No specific geriatric dose adjustment; use standard adult dosing. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for COTAZYM (COTAZYM).
| Breastfeeding | Excreted in milk in undefined amounts; M/P ratio unknown. Caution advised; consider risk-benefit. |
| Teratogenic Risk | No known teratogenic risk; FDA pregnancy category C. Limited human data; animal studies not conducted. Use only if clearly needed. |
| Fetal Monitoring | Monitor for allergic reactions and pancreatitis symptoms. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to porcine-derived products or any component of the formulation.","Acute pancreatitis or acute flare of chronic pancreatitis."]
| Precautions | ["Fibrosing colonopathy reported with high doses; avoid exceeding recommended lipase units.","Potential for allergic reactions (e.g., egg protein, porcine-derived products).","May cause mucosal irritation if powder is retained in mouth; ensure complete swallowing.","Monitor for hyperuricemia and hyperuricosuria with high doses."] |
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| Fertility Effects | No known effects on fertility. |