Cystic Fibrosis Medication
Creon 10
 
Company Info
PANCREASEŽ (product information)  (Pancrelipase) Capsules
Enteric Coated Microspheres


PANCREASEŽ pancrelipase capsules are white, dye-free, orally administered capsules containing enteric coated microspheres of porcine pancreatic enzyme concentrate, predominately steapsin (pancreatic lipase), amylase and protease. Each capsule contains:

Lipase  4,500 U.S.P. Units
Amylase  20,000 U.S.P. Units
Protease  25,000 U.S.P. Units

Inactive ingredients include cellulose acetate phthalate, diethyl phthalate, gelatin, povidone, sodium starch glycollate, corn starch, sugar, talc and titanium dioxide.

CLINICAL PHARMACOLOGY
PANCREASEŽ pancrelipase capsules resist gastric inactivation and deliver predictable, high levels of biologically active enzymes into the duodenum. The enzymes catalyze the hydrolysis of fats into glycerol and fatty acids, protein into proteoses and derived substances, and starch into dextrins and sugars. PANCREASEŽ capsules are effective in controlling steatorrhea and its consequences at low daily dosage levels.

INDICATIONS AND USAGE
PANCREASEŽ pancrelipase capsules are indicated for persons with exocrine pancreatic enzyme deficiency as in but not limited to:
cystic fibrosis
chronic pancreatitis
post-pancreatectomy
post-gastrointestinal bypass surgery (e.g. Billroth II gastroenterostomy)
ductal obstruction from neoplasm (e.g. of the pancreas or common bile duct).
CONTRAINDICATIONS
PANCREASEŽ pancrelipase capsules are contraindicated in persons known to be hypersensitive to pork protein.


WARNINGS
Should hypersensitivity occur, discontinue medication and treat symptomatically.

PRECAUTIONS
TO PROTECT ENTERIC COATING, MICROSPHERES SHOULD NOT BE CRUSHED OR CHEWED. Where swallowing of capsules is difficult, they may be opened and the microspheres shaken onto a small quantity of a soft food (e.g. applesauce, gelatin, etc.), which does not require chewing, and swallowed immediately. Contact of the microspheres with foods having a pH greater than 5.5 can dissolve the protective enteric shell.

Pregnancy Category C. Diethyl phthalate, an enteric coating component of PANCREASEŽ pancrelipase capsules has been shown with high intraperitoneal dosing to be teratogenic in rats. However, when this coating was administered orally to rats up to 100 times the human dose, no teratogenic or embryocidal effects were observed. There were no adequate and well-controlled studies in pregnant women. PANCREASEŽ capsules should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Cases of fibrotic stricture in the ascending colon have been reported in cystic fibrosis persons with the use of enzyme supplements in high doses (approximately 6,500­50,000 U.S.P. lipase units/kg/meal).

If symptoms suggestive of gastrointestinal obstruction occur, the possibility of bowel strictures should be considered.

Any change in pancreatic enzyme replacement therapy (e.g., dose or brand of medication) should be made cautiously and only under medical supervision.

ADVERSE REACTIONS
The most frequently reported adverse reactions to PANCREASEŽ pancrelipase capsules are gastrointestinal in nature. Less frequently, allergic-type reactions have also been observed. Extremely high doses of exogenous pancreatic enzymes have been associated with hyperuricosuria and hyperuricemia.

DOSAGE AND ADMINISTRATION
Usual dosage: One or two capsules during each meal and one capsule with snacks. Occasionally a third capsule with meals may be required depending upon individual requirements for control of steatorrhea. Dose increases, if required, should be made slowly, with careful monitoring of response and symptomatology.

It is important to ensure adequate hydration of people at all times while dosing PANCREASEŽ.

HOW SUPPLIED
PANCREASEŽ pancrelipase capsules (white, dye-free, imprinted "McNEIL" and "PANCREASEŽ")
in bottles of:

100 NDC 0045-0095-60
250 NDC 0045-0095-69
Keep bottle tightly closed. Store below 25° C *(77° F) in a dry place. Do not refrigerate.

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PANCREASEŽ MT (product information)  (Pancrelipase) Capsules Enteric Coated Microspheres

PANCREASEŽ MT
pancrelipase capsules are orally administered capsules containing enteric coated microtablets of porcine pancreatic enzyme concentrate, predominately steapsin (pancreatic lipase), amylase and protease.

Each PANCREASEŽ MT 4 capsule contains:

Lipase  4,000 U.S.P. Units
Amylase  12,000 U.S.P. Units
Protease  12,000 U.S.P. Units

Inactive ingredients: cellulose, crospovidone, gelatin, iron oxide, magnesium stearate, methacrylic acid copolymer, polydimethylsiloxane, sodium lauryl sulfate, silicon dioxide, talc, titanium dioxide, triethylcitrate, wax and other trace ingredients.

CLINICAL PHARMACOLOGY
PANCREASEŽ MT pancrelipase capsules resist gastric inactivation and deliver predictable, high levels of biologically active enzymes into the duodenum. The enzymes catalyze the hydrolysis of fats into glycerol and fatty acids, protein into proteoses and derived substances, and starch into dextrins and sugars. PANCREASEŽ MT capsules are effective in controlling steatorrhea and its consequences.

INDICATIONS AND USAGE
PANCREASEŽ MT pancrelipase capsules are indicated for persons with exocrine pancreatic enzyme deficiency such as:

cystic fibrosis
chronic pancreatitis
post-pancreatectomy
post-gastrointestinal bypass surgery (e.g. Billroth II gastroenterostomy)
ductal obstruction from neoplasm (e.g. of the pancreas or common bile duct).
CONTRAINDICATIONS
PANCREASEŽ MT pancrelipase capsules are contraindicated in people known to be hypersensitive to pork protein.

PANCREASEŽ MT capsules are contraindicated in people with acute pancreatitis or with acute exacerbations of chronic pancreatic diseases.

WARNINGS
Should hypersensitivity occur, discontinue medication and treat symptomatically.

PRECAUTIONS
General
TO PROTECT ENTERIC COATING, MICROTABLETS SHOULD NOT BE CRUSHED OR CHEWED. Where swallowing of capsules is difficult, they may be opened and the microtablets shaken onto a small quantity of a soft food (e.g. applesauce, gelatin, etc.), which does not require chewing, and swallowed immediately. Contact of the microtablets with foods having a pH greater than 6.0 can dissolve the protective enteric shell.

Pregnancy Category C. Animal reproduction studies have not been conducted with PANCREASEŽ MT pancrelipase capsules. It is also not known whether PANCREASEŽ MT can cause fetal harm when administered to a pregnant woman or can effect reproduction capacity. PANCREASEŽ MT should be given to a pregnant woman only if clearly needed.

Cases of fibrotic stricture formation in the ascending colon have been reported in cystic fibrosis people with the use of enzyme supplements in high doses (approximately 6,500­50,000 U.S.P. lipase units/kg/meal). If symptoms suggestive of gastrointestinal obstruction occur, the possibility of bowel strictures should be considered.
Any change in pancreatic enzyme replacement therapy (e.g., dose or brand of medication) should be made cautiously and only under medical supervision.

ADVERSE REACTIONS
The most frequently reported adverse reactions to pancrelipase-containing products are gastrointestinal in nature. Less frequently, allergic-type reactions have also been observed. Extremely high doses of exogenous pancreatic enzymes have been associated with hyperuricosuria and hyperuricemia when the preparations given were pancrelipase in powdered or capsule form, or pancreatin in tablet form.

DOSAGE AND ADMINISTRATION
Dosage should be adjusted according to the severity of the exocrine pancreatic enzyme deficiency. The number of capsules or capsule strength given with meals and/or snacks should be estimated by assessing which dose minimizes steatorrhea and maintains good nutritional status. Dose increases, if required, should be made slowly, with careful monitoring of response and symptomatology.

It is important to ensure adequate hydration of a person at all times while dosing PANCREASEŽ MT.

In some CF people with pancreatic enzyme deficiency, satisfactory responses have been achieved with dosages (expressed in U.S.P. units of lipase) similar to the ones stated below. However, dosages should be adjusted according to the response of the person.

Children 7 to 12 years: 4,000 to 12,000 units (more if necessary) with each meal and with snacks.

Children 1 to 6 years: 4,000 to 8,000 units with each meal and 4,000 units with snacks.

Children under 1 year: Dosage for children under 6 months of age has not been established. Children 6 months to 1 year have responded to 2,000 units of lipase per meal.

The assessment of the end points in children is aided by charting growth curves.

Adults: 4,000 to 20,000 units (more if necessary) with each meal and with snacks.

HOW SUPPLIED
PANCREASEŽ MT 4 pancrelipase capsules (yellow and clear, printed "McNeil" and "PANCREASEŽ MT 4") in bottles of 100­NDC 0045-0341-60.
Keep bottle tightly closed. Store below 25°C (77°F) in a dry place. Do not refrigerate. For human consumption only.
Dispense in tight container as defined in the official compendium.

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Creon 10 Capsules
1. Trade Name of the Medicinal Product:Creon Capsules

2. Qualitative and Quantitative Composition
Each capsule contains pancreatin equivalent to:
Lipase 8000 B.P. units
Amylase 9000 B.P. units
Protease 210 B.P. units

3. Pharmaceutical Form
Brown/yellow hard gelatin capsules containing buff coloured enteric coated granules.
Clinical Particulars

4.1. Therapeutic Indications
For the treatment of pancreatic exocrine insufficiency.

4.2. Posology and Method of Administration
Adults (including the elderly) and children:
Initially one to two capsules with meals. Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology.
It is important to ensure adequate hydration of patients at all times whilst dosing Creon.

The capsules can be swallowed whole, or for ease of administration they may be opened and the granules taken with fluid or soft food. If the granules are mixed with food, it is important that they are taken immediately, otherwise dissolution of the enteric coating may result. In order to protect the enteric coating, it is important that the granules are not crushed or chewed.

Colonic damage has been reported in patients with cystic fibrosis taking in excess of 10,000 units of lipase/kg/day (see Undesirable Effects).

4.3. Contra-indications
Substitution with pancreatic enzymes is contraindicated in the early stages of acute pancreatitis.
Patients with known hypersensitivity to porcine proteins.

4.4. Special Warnings and Precautions for Use
The product is of porcine origin.

4.5. Interactions with other Medicaments and other forms of Interaction
None known.

4.6. Pregnancy and Lactation
Pregnancy: There is inadequate evidence of safety in use during pregnancy.
Lactation: There is inadequate evidence of safety in use during lactation. However, as enzymes are not absorbed, it is unlikely that there would be any effect on the nursing infant.

4.7. Effects on Ability to Drive and Use Machines
None known.
4.8. Undesirable Effects
Rarely cases of hyper-uricosuria and hyper-uricaemia have been reported with very high doses of pancreatin. Perianal irritation, and rarely, inflammation, could occur when large doses are used.

Stricture of the ileo-caecum and large bowel and colitis has been reported in children with cystic fibrosis taking high doses of pancreatic enzyme supplements. To date, Creon has not been implicated in the development of colonic damage. However, unusual abdominal symptoms or changes in abdominal symptoms should be reviewed to exclude the possibility of colonic damage - especially if the patient is taking in excess of 10,000 units of lipase/kg/day.

4.9. Overdose
Most cases respond to supportive measures including stopping enzyme therapy, ensuring adequate rehydration.

Pharmacological Properties
5.1. Pharmacodynamic Properties
Replacement therapy in pancreatic enzyme deficiency states. The enzymes have hydrolytic activity on fat, carbohydrates and proteins.
5.2. Pharmacokinetic Properties
Pharmacokinetic data are not available as the enzymes act locally in the gastro-intestinal tract. After exerting their action, the enzymes are digested themselves in the intestine.

Pharmaceutical Particulars
6.1. List of Excipients
Granules: Polyethylene glycol 4000, liquid paraffin, methylhydroxypropyl cellulose phthalate (HP-55), dibutyl phthalate, dimethicone 1000.
Capsules: Gelatin, red, yellow and black iron oxides (E172), titanium dioxide (E171).
6.2. Incompatibilities
None known.
6.3. Shelf Life
Two years.
6.4. Special Precautions for Storage
Store at room temperature.
6.5. Nature and Contents of Container
Polypropylene tablet container containing 100 or 250 capsules

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