Creon ARL-11 - History

Creon ARL-11 - History

Creon

In Greek mythology, the brother-in-law of Oedipus, also a legendary king of Corinth.

(ARL-11: dp. 2,125; 1. 328'; b. 50'; dr. 14'; s. 12 k.; cpl. 255; a. 1 3"; cl. Achelous)

Creon was launched 24 August 1944 by Boston Navy Yard; sponsored by Mrs. M. A. Pratt; placed in partial commission 16 September 1944, Lieutenant M. G. Pooley, USNR, in command; sailed to Baltimore, Md., and decommissioned 26 September 1944 for conversion; and commissioned in full 27 January 1945, Lieutenant M. Pooley, USNR, in command.

Clearing Norfolk 4 March 1945, Creon arrived at Biak, Shouten Islands, 4 May. Moving to Morotai the next day, she conducted amphibious training exercises, and on 1 July took part in the invasion of Balikpapan. She served off Borneo until arriving at Subic Bay I August to repair landing craft there until 18 December. After loading cargo at Guam, Creon arrived at Pearl Harbor for overhaul 22 January 1946.

Assigned to the service group for Operation "Cross. roads," the atomic weapons tests in the Marshalls, Creon arrived at Kwajalein 19 March 1946 and operated there and at the test site until 10 September when she departed for overhaul at San Pedro. She served as a repair ship for LSMs and LSM(R)s at San Diego from 15 December 1946 until 27 September 1948. Following an overhaul at Long Beach Naval Shipyard, Creon put out from San Diego 10 January 1949 for Kodiak, Alaska, to participate in a large-scale cold-weather exercise. Creon returned to San Diego 4 March and there was placed out of commission in reserve 8 June 1949.

Creon received one battle star for World WarII service.


Creon (pancrelipase) contains a combination of three enzymes (proteins): lipase, protease, and amylase. These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars.

Creon is used to replace these enzymes when the body does not have enough of its own. Certain medical conditions can cause this lack of enzymes, including cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts.

Creon may also be used following surgical removal of the pancreas.


"Mortal Law Verses Divine Law"-- In the play Antigone, there is a clear conflict between the written law made by the king, and the higher law, dictated by the religious beliefs of the time.

Laws were just as important to ancient societies as they are today, keeping an essential balance between interacting individuals. Without them, members of a society would be able to treat their fellow citizens in any way they wished, even if for purely personal gain. Some of these laws were made by the leader or leaders of the society. These were accepted as being for the common good. Other laws were developed within the society, things deemed "socially acceptable." Examples from today might be chewing with your mouth closed and dressing formally for a church service. There were also laws that were set by religious beliefs or moral codes and were highly respected. Breaking these laws would mean doing something like stealing, killing, or cheating. As cultures evolved, and beliefs changed, written, social, and ethical laws often conflicted with each other and created conflicts in society, as described by the play Antigone by Sophocles.

In this play, there is a clear conflict between the written law made by the king, and the higher law, dictated by the religious beliefs of the time.

When Creon, the king of Thebes, decrees that the body of Polyneices should be left unburied, he believes he is doing the right thing. He sees this law as good for the people because they will see him as a good, strong king who will not tolerate traitorous behavior from anyone, including his own nephew. When the body is discovered to have been covered with dust, the first person that Creon looks to for taking the blame is the unfortunate sentry who brings Creon the news. Creon tells the sentry that if he does not bring him the person who disobeyed his law that he is going to " string you up alive,

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Service history [ edit | edit source ]

Clearing Norfolk, Virginia 4 March 1945 Creon arrived at Biak, Shouten Islands 4 May. Moving to Morotai the next day, she conducted amphibious training exercises, and on 1 July took part in the invasion of Balikpapan. She served off Borneo until arriving at Subic Bay 1 August to repair landing craft there until 18 December. After loading cargo at Guam, Creon arrived at Pearl Harbor for overhaul 22 January 1946. Assigned to the service group for "Operation Crossroads," the atomic weapons tests in the Marshall Islands, Creon arrived at Kwajalein 19 March 1946 and operated there and at the test site until 10 September when she departed for overhaul at San Pedro, California. She served as a repair ship for LSMs and LSM(R)s at San Diego from 15 December 1946 until 27 September 1948. Following an overhaul at Long Beach Naval Shipyard, Creon put out from San Diego 10 January 1949 for Kodiak, Alaska to participate in a large-scale cold-weather exercise. Creon returned to San Diego 4 March and there was placed out of commission in reserve 8 June 1949. Struck from the Naval Vessel Register (date unknown), her final fate is unknown.


Adverse Reactions

The most serious adverse reactions reported with different pancreatic enzyme products of the same active ingredient (pancrelipase) that are described elsewhere in the label include fibrosing colonopathy, hyperuricemia and allergic reactions [see Warnings and Precautions (5)] .

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The short-term safety of Creon was assessed in clinical trials conducted in 121 patients with exocrine pancreatic insufficiency (EPI): 67 patients with EPI due to cystic fibrosis (CF) and 25 patients with EPI due to chronic pancreatitis or pancreatectomy were treated with Creon.

Studies 1 and 2 were randomized, double-blind, placebo-controlled, crossover studies of 49 patients, ages 7 to 43 years, with EPI due to CF. Study 1 included 32 patients ages 12 to 43 years and Study 2 included 17 patients ages 7 to 11 years. In these studies, patients were randomized to receive Creon at a dose of 4,000 lipase units/g fat ingested per day or matching placebo for 5 to 6 days of treatment, followed by crossover to the alternate treatment for an additional 5 to 6 days. The mean exposure to Creon during these studies was 5 days.

In Study 1, one patient experienced duodenitis and gastritis of moderate severity 16 days after completing treatment with Creon. Transient neutropenia without clinical sequelae was observed as an abnormal laboratory finding in one patient receiving Creon and a macrolide antibiotic.

In Study 2, adverse reactions that occurred in at least 2 patients (greater than or equal to 12%) treated with Creon were vomiting and headache. Vomiting occurred in 2 patients treated with Creon and did not occur in patients treated with placebo headache occurred in 2 patients treated with Creon and did not occur in patients treated with placebo.

The most common adverse reactions (greater than or equal to 4%) in Studies 1 and 2 were vomiting, dizziness, and cough. Table 1 enumerates adverse reactions that occurred in at least 2 patients (greater than or equal to 4%) treated with Creon at a higher rate than with placebo in Studies 1 and 2.

Table 1: Adverse Reactions Occurring in at Least 2 Patients (greater than or equal to 4%) in Cystic Fibrosis (Studies 1 and 2)
Adverse Reaction Creon Capsules
n = 49 (%)
Placebo
n = 47 (%)
Vomiting 3 (6) 1 (2)
Dizziness 2 (4) 1 (2)
Cough 2 (4) 0

An additional open-label, single-arm study assessed the short-term safety and tolerability of Creon in 18 infants and children, ages 4 months to 6 years, with EPI due to cystic fibrosis. Patients received their usual pancreatic enzyme replacement therapy (mean dose of 7,000 lipase units/kg/day for a mean duration of 18.2 days) followed by Creon (mean dose of 7,500 lipase units/kg/day for a mean duration of 12.6 days). There were no serious adverse reactions. Adverse reactions that occurred in patients during treatment with Creon were vomiting, irritability, and decreased appetite, each occurring in 6% of patients.

Chronic Pancreatitis or Pancreatectomy

A randomized, double-blind, placebo-controlled, parallel group study was conducted in 54 adult patients, ages 32 to 75 years, with EPI due to chronic pancreatitis or pancreatectomy. Patients received single-blind placebo treatment during a 5-day run-in period followed by an intervening period of up to 16 days of investigator-directed treatment with no restrictions on pancreatic enzyme replacement therapy. Patients were then randomized to receive Creon or matching placebo for 7 days. The Creon dose was 72,000 lipase units per main meal (3 main meals) and 36,000 lipase units per snack (2 snacks). The mean exposure to Creon during this study was 6.8 days in the 25 patients that received Creon.

The most common adverse reactions reported during the study were related to glycemic control and were reported more commonly during Creon treatment than during placebo treatment.

Table 2 enumerates adverse reactions that occurred in at least 1 patient (greater than or equal to 4%) treated with Creon at a higher rate than with placebo.

Table 2: Adverse Reactions in at Least 1 Patient (greater than or equal to 4%) in the Chronic Pancreatitis or Pancreatectomy Trial
Adverse Reaction Creon Capsules
n = 25 (%)
Placebo
n = 29 (%)
Hyperglycemia 2 (8) 2 (7)
Hypoglycemia 1 (4) 1 (3)
Abdominal Pain 1 (4) 1 (3)
Abnormal Feces 1 (4) 0
Flatulence 1 (4) 0
Frequent Bowel Movements 1 (4) 0
Nasopharyngitis 1 (4) 0

Postmarketing Experience

Postmarketing data from this formulation of Creon have been available since 2009. The following adverse reactions have been identified during post approval use of this formulation of Creon. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal disorders (including abdominal pain, diarrhea,

flatulence, constipation and nausea), skin disorders (including pruritus,

urticaria and rash), blurred vision, myalgia, muscle spasm, and asymptomatic elevations of liver

enzymes have been reported with this formulation of Creon.

Delayed- and immediate-release pancreatic enzyme products with different formulations of the same active ingredient (pancrelipase) have been used for the treatment of patients with exocrine pancreatic insufficiency due to cystic fibrosis and other conditions, such as chronic pancreatitis. The long-term safety profile of these products has been described in the medical literature. The most serious adverse reactions included fibrosing colonopathy, distal intestinal obstruction syndrome (DIOS), recurrence of pre-existing carcinoma, and severe allergic reactions including anaphylaxis, asthma, hives, and pruritus.


Creon (pancrelipase)

Creon is a brand-name prescription medication. It’s FDA-approved to treat exocrine pancreatic insufficiency (EPI) that’s caused by:

  • Cystic fibrosis(CF).CF is a genetic condition that causes thick, sticky mucus in your lungs, pancreas, and other body parts.
  • Chronic pancreatitis. With chronic pancreatitis, you have long-lasting inflammation in your pancreas that can cause damage.
  • Pancreatectomy. Pancreatectomy is surgery that’s done to remove all or part of your pancreas. It may be needed because of cancer or other health conditions.
  • Certain other conditions. Other conditions, such as type 2 diabetes, can affect the health of your pancreas and lead to EPI.

With EPI, your body doesn’t have pancreatic enzymes available like usual to help digest foods. (Pancreatic enzymes are substances made by your pancreas to help break down fats, proteins and carbohydrates from your diet.) For more information about EPI and its possible causes, see the “Creon uses” section below.

Creon is approved for use in infants, children, and adults of all ages. But the recommended dosage and how the drug is given may vary depending on age. For more information, see the “Creon dosage” section below.

Drug details

Creon comes as capsules that are taken by mouth with every meal and snack. These capsules have a delayed-release formulation with enteric-coated spheres inside. (Enteric-coating stops your stomach acid from breaking down Creon’s active ingredients until they reach your small intestine.)

Creon’s active ingredients are a mixture of enzymes called pancrelipase. The pancrelipase that’s found in Creon comes from the pancreas of pigs. Creon’s enzyme mixture includes:

  • lipases, which help digest fats
  • proteases, which help digest proteins
  • amylases, which help digest carbohydrates

Creon comes in many strengths that vary by amounts of these enzymes contained in them. For information on available strengths, see the “Creon dosage” section below.

Effectiveness

For information about the effectiveness of Creon, see the “Creon uses” section below.

Creon contains a mixture of enzymes called pancrelipase. It’s available only as a brand-name medication. It’s not currently available in generic form. (A generic drug is an exact copy of the active drug in a brand-name medication.)

Everyone’s Creon dosage is different. The Creon dosage your doctor prescribes will depend on several factors that are discussed below.

Typically, your doctor will start you on the lowest dosage. Then they’ll adjust it over time to reach the amount that’s right for you. So your Creon dosage may change as your body, health, or diet changes. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Creon comes as capsules that are taken by mouth. These capsules have a delayed-release formulation with enteric-coated spheres inside. (Enteric-coating stops your stomach acid from breaking down Creon’s active ingredients until they reach your small intestine.)

Creon capsules come in many strengths that vary by the amounts of pancreatic enzymes they contain. These specific enzymes include lipases, proteases, and amylases. Your doctor will prescribe Creon by the number of lipase units. (Lipase is the enzyme that breaks down fats in your food.)

Your doctor may write out the lipase units per dose as a whole number. For example, 12,000 lipase units. Or your doctor may shorten the lipase units, as 12k lipase units, for instance.

Creon capsules come in the following strengths:

Abbreviated strengthLipase unitsProtease unitsAmylase unitsCapsule imprint
Creon 3,0003k3,0009,50015,000CREON 1203
Creon 6,0006k6,00019,00030,000CREON 1206
Creon 12,00012k12,00038,00060,000CREON 1212
Creon 24,00024k24,00076,000120,000CREON 1224
Creon 36,00036k36,000114,000180,000CREON 1236

Dosage for exocrine pancreatic insufficiency

Creon dosages for exocrine pancreatic insufficiency (EPI)* are started at a low dose and slowly increased by a small amount. Starting dosages and typical recommended daily dosages are based on:

  • your age
  • your weight
  • your daily fat intake
  • the condition your EPI is due to
  • symptoms of EPI you may be having
  • your risk for certain serious side effects, such as fibrosing colonopathy (scarring or narrowing in your colon)

Creon must be taken with every meal or snack. But you shouldn’t take more Creon than the total daily dose prescribed by your doctor. So you’ll need to plan your day’s meals and snacks according to how much Creon you can take each day.

For example, your doctor may prescribe your maximum daily Creon dose based on 3 meals and 2 snacks. Don’t add in extra mealtimes or Creon doses without your doctor’s instruction. And if you skip a meal, skip that Creon dose. Don’t take this medication without food.

Typical dosages of Creon for EPI due to certain conditions are described below.

* For more information about EPI and its possible causes, see the “Creon uses” section below.

Dosage for EPI caused by cystic fibrosis

For EPI that’s due to cystic fibrosis, your doctor may base your Creon dosage on your body weight or your daily fat intake. General dosage guidelines for this use are listed below. They’re recommended by the Cystic Fibrosis Foundation.

Recommended Creon dosages for meals in adults are as follows:

  • 500 lipase units per kilogram (kg)* of body weight for each full meal
  • this dose can be increased by your doctor if needed, but no more than 2,500 lipase units per kg of body weight should be taken with each meal

Recommended Creon dosages for snacks in adults are typically half of the Creon dosage prescribed for meals. Typical total daily dosages of Creon allow for 2 or 3 snacks each day. Ask your doctor how many snacks are included in your total daily dosage.

For this use, the total daily dosage of Creon shouldn’t exceed 10,000 lipase units per kg of body weight. Or the dosage shouldn’t be more than 4,000 lipase units per gram of fat eaten each day.

* One kg is equal to about 2.2 pounds (lb).

Dosage for EPI caused by chronic pancreatitis, pancreatectomy, or other conditions

For EPI that’s due to chronic pancreatitis*, pancreatectomy†, or other conditions, your doctor may base your Creon dosage on your body weight or your daily fat intake. And your doctor may change your dosage based on your overall health, diet, or symptoms of fatty stools.

A recommended Creon dosage for this use in adults is as follows:

But this recommendation is for people with a daily fat intake of 100 grams. If your daily fat intake is higher than 100 grams, ask your doctor what your recommended Creon dosage should be.

For this purpose, another recommendation is to use the suggested dosage for adults with EPI due to cystic fibrosis. (For information, see the “Dosage for EPI caused by cystic fibrosis” section above.)

If you have EPI that’s due to chronic pancreatitis, pancreatectomy, or other conditions, talk with your doctor about the dosage of Creon that’s best for you.

* Chronic pancreatitis is long-lasting inflammation in your pancreas.
† A pancreatectomy is a partial or full removal of the pancreas.

Children’s dosage

Recommended dosages of Creon for children are based on age as described below. If you have questions about the dosage of Creon that’s best for a child, talk with your doctor.

Dosage for infants

The recommended Creon dosage for newborns and infants ages 12 months and younger is 3,000 lipase units for every 120 mL (about 4 ounces) of formula consumed or for each episode of breastfeeding.

The Cystic Fibrosis Foundation recommends a range of 2,000 to 4,000 lipase units per feeding. But the lowest strength of Creon available contains 3,000 lipase units. So, infants should be given the contents of one Creon capsule (containing 3,000 units of lipase) per feeding.

Dosage for children older than 12 months and younger than 4 years

The recommended Creon dosage for children who are older than 12 months but younger than 4 years of age is as follows:

  • 1,000 lipase units per kilogram (kg)* of body weight each meal
  • this dose can be increased by a doctor if needed, but no more than 2,500 lipase units per kg of body weight should be given per meal

In this age group, total daily dosage of Creon shouldn’t exceed 10,000 lipase units per kg of body weight. Or the dosage shouldn’t be more than 4,000 lipase units per each gram of fat eaten each day.

* One kg is equal to about 2.2 pounds (lb).

Dosage for children age 4 years and older

The Creon dosage for children ages 4 years and older is the same as it is for adults taking the drug for EPI that’s due to cystic fibrosis. For details, see the “Dosage for EPI caused by cystic fibrosis” section above.

Dosage questions

Below are answers to some questions you may have about taking Creon.

What if I miss a dose?

For the best results, you should take Creon at the start of every meal and snack. If you skip a meal or snack, skip that Creon dose, too. This medication only works when there’s food to digest inside your body.

If you forget to take Creon with a meal or snack, just skip that dose of Creon. Wait and take your usual dose with your next meal or snack. Don’t take extra capsules or double your next dose.

If you’re concerned or have questions about missed doses, call your doctor or pharmacist.

How can I remember to take Creon?

It can be hard to remember your Creon doses when you’re on the go. Plan ahead by keeping Creon with you at all times. Store it in your desk at work or school. Or tuck it in your bag or purse. Just make sure to keep Creon capsules cool and dry.

Will I need to use this drug long term?

Creon is meant to be used as a long-term treatment. If you and your doctor determine that Creon is safe and effective for you, you’ll likely take it long term. But this depends on your overall health and other factors.

Creon can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Creon. These lists do not include all possible side effects.

For more information about the possible side effects of Creon, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Creon, you can do so through MedWatch.

Mild side effects

Mild side effects* of Creon can include:

  • abnormal stools, such as having stools with a strange color, consistency, form, or smell
  • dizziness
  • frequent bowel movements
  • gas
  • high or low blood sugar levels
  • sore throat, cough, or other cold symptoms
  • abdominal (belly) pain
  • vomiting

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Creon. To learn about other mild side effects, talk with your doctor or pharmacist, or visit Creon’s Medication Guide.

Serious side effects

Serious side effects from Creon aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • Mouth irritation. Symptoms can include:
    • sores or ulcers in your mouth or on your tongue
    • burning or stinging in your mouth
    • swollen or painful joints
    • swelling, pain, or redness in your big toe

    * For more information about this side effect, see the “Side effect details” section below.

    Side effects in children

    One 2010 clinical trial looked at the safety of using Creon in children ages 7 to 11 years. In this study, side effects were seen in:

    • 29.4% of children taking Creon
    • 56.3% of children taking a placebo (treatment with no active drug)

    None of the children quit the study due to side effects. And none of the side effects reported in the children were serious.

    Another study checked the short-term safety of Creon in infants and children with exocrine pancreatic insufficiency (EPI)* caused by cystic fibrosis. Their ages ranged from 4 months to 6 years. In this study, during Creon treatment:

    • 0% of the infants and children had serious side effects
    • 6% of the infants and children had:
      • vomiting
      • irritability
      • lowered appetite

      * For more information about EPI and its possible causes, see the “Creon uses” section below.

      Side effect details

      You may wonder how often certain side effects occur with this drug.Below is some detail on certain side effects this drug may cause. The side effects described below were seen in clinical studies involving both adults and children taking Creon.

      Allergic reaction

      As with most drugs, some people can have an allergic reaction after taking Creon.

      Call your doctor right away if you have an allergic reaction to Creon, as the reaction could become severe. But call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

      Mild allergic reactions

      Allergic reactions weren’t reported during clinical trials of Creon. But some symptoms of mild allergic reaction, such as rash and itching, have been reported since Creon was released onto the market.

      However, because these side effects weren’t seen during clinical studies, it’s hard to know how often they occur. It’s also difficult to know if Creon actually causes them. For more information about possible skin side effects with Creon, see the “Skin conditions” section below.

      Symptoms of a mild allergic reaction can include:

      Severe allergic reactions

      A more severe allergic reaction is rare but possible.

      For example, pancrelipase, which Creon contains, comes from the pancreas of pigs. So if you have an allergy to pork, you may be allergic to pancrelipase medications, including Creon. Severe allergies with other products made with pig pancrelipase have occurred.

      Severe allergies, including pork allergies, weren’t reported during clinical trials of Creon. But possible symptoms of severe allergies, such as certain skin problems, have been reported since Creon was released onto the market.

      However, because these side effects weren’t seen during clinical studies, it’s hard to know how often they occur. It’s also difficult to know if Creon actually causes them. (For more information about possible skin side effects with Creon, see the “Skin conditions” section below.)

      Symptoms of a severe allergic reaction can include:

        (severe, life threatening allergy), which may cause:
        • swelling under your skin, typically in your eyelids, lips, hands, or feet
        • swelling of your tongue, mouth, or throat
        • trouble breathing

        Tell your doctor if you have a pork allergy before starting Creon. They can help you weigh the risks and benefits of using this medication.

        Viral infections

        Pancrelipase medications, such as Creon, are made using the pancreas of pigs. So it’s possible that by taking pancrelipase you may become infected with a virus found in pigs. But this type of infection hasn’t been reported in anyone taking Creon.

        General symptoms of viral infections can include:

        • fever
        • fatigue (lack of energy)
        • body aches
        • malaise (generally not feeling well)

        If you have symptoms of infection and you’re concerned it’s a viral infection from Creon, talk with your doctor. They can check to see if you have an infection. And they’ll recommend how to treat your symptoms.

        Fibrosing colonopathy

        Creon could increase your risk for fibrosing colonopathy. This condition is rare, but it’s also very serious. With fibrosing colonopathy, your colon becomes narrowed inside because of scarring or strictures.

        Initial clinical trials of Creon didn’t report fibrosing colonopathy in anyone taking the drug. But it has been reported with other pancreatic enzyme replacement products similar to Creon.

        Fibrosing colonopathy is a serious condition. Call your doctor right away if you have any of its symptoms. These can include any new or worsening:

        • bloating
        • bloody diarrhea
        • constipation
        • nausea, vomiting, or diarrhea
        • abdominal (belly) pain

        You may be able to lower your risk for fibrosing colonopathy by sticking to your Creon treatment plan as prescribed by your doctor.

        If you develop the condition, you may need surgery to treat it. Or your doctor may lower your Creon dosage to try and keep the condition from getting worse. It’s unclear whether or not fibrosing colonopathy can be reversed once it’s occurred.

        Call your doctor right away if you have any of the symptoms listed above. But don’t stop taking Creon or change your Creon dosage without first talking with your doctor.

        Digestive problems, such as constipation

        Digestive side effects have been seen with Creon. For example, two clinical trials studied Creon in people with exocrine pancreatic insufficiency (EPI)* due to cystic fibrosis. In these studies, vomiting occurred in:

        Another study looked at using Creon for EPI due to either chronic pancreatitis† or pancreatectomy‡. In this study, the following digestive system problems were reported:

        In people taking CreonIn people taking placebo
        Abdominal (belly) pain4%3%
        Abnormal stools (strange color, consistency, form, or smell)4%0%
        Flatulence (gas)4%0%
        Frequent bowel movements4%0%

        Diarrhea, nausea, and constipation have also been seen in people taking Creon. But these side effects weren’t seen in initial clinical trials of the drug.

        Instead, people reported having diarrhea, nausea, and constipation after Creon was released onto the market. Because these side effects weren’t seen during clinical studies, it’s unclear how often they’ve happened or if Creon actually causes them.

        * For more information about EPI and its possible causes, see the “Creon uses” section below.
        † With chronic pancreatitis, you have long-lasting inflammation in your pancreas.
        ‡ Pancreatectomy is a partial or full removal of the pancreas.

        What to do for digestive problems

        While you’re taking Creon, keep track of any digestive problems you’re having. Write down what you eat, your Creon doses, and any symptoms or side effects you’re having. Then share this information with your doctor.

        Digestive problems could be a side effect of Creon. But they could also be a sign that Creon therapy isn’t helping your body properly break down food. For example, having oily, smelly, or bulky stools could mean that your body isn’t absorbing fat from foods.

        Digestive symptoms could also be caused by your diet or a health condition you may have. Or they could be due to the condition you’re managing with Creon.

        Keep in mind that certain digestive symptoms may indicate a more serious side effect of Creon called fibrosing colonopathy. (For more information about this, see the “Fibrosing colonopathy” section above.) These symptoms include gas, abdominal (belly) pain, and constipation.

        So, don’t ignore new or worsening digestive system symptoms. Instead, tell your doctor right away. And don’t stop or change your Creon without your doctor’s instruction.

        Skin conditions

        Some people using Creon have had various skin conditions. But these skin side effects weren’t seen in initial clinical trials of Creon.

        Instead, people reported having skin conditions after Creon was released onto the market. Because the side effects weren’t seen during clinical studies, it’s hard to know how often they’ve occurred or if Creon actually caused them.

        Skin conditions reported by people using Creon include:

        Call your doctor right away if you have a severe rash, itching, or hives while using Creon. In some cases, these symptoms could indicate a serious allergic reaction to the drug. (For more information about this, see the “Allergic reaction” section above.)

        Also, tell your doctor if you have any mild skin issues that bother you or that don’t go away.

        Blurry vision

        Blurred vision has been reported in some people using Creon. But this side effect wasn’t seen in clinical trials of Creon.

        Instead, people reported having blurred vision after Creon was released onto the market. Because this wasn’t seen during clinical studies, it’s hard to know how often it has occurred or if Creon actually caused it.

        Keep in mind that blurry vision could also be a symptom of either high or low blood sugar levels. And either can happen in people with certain conditions that Creon is used to manage. In addition, having abnormal blood sugar levels is a possible side effect of Creon.

        So don’t ignore blurry vision that doesn’t clear up. Instead, tell your doctor about any vision problems you have with Creon treatment. You doctor can check to see if you have any conditions that could affect your blood sugar level or cause blurry vision.

        Muscle spasms or pain

        Some people have had myalgia (muscle pain) and muscle spasms while taking Creon. But these side effects weren’t seen in clinical trials of the drug. Instead, some people reported having myalgia and muscle spasms after Creon was released onto the market.

        Because muscle pain or spasms weren’t seen during clinical studies, it’s hard to know how often they’ve occurred or if Creon actually caused them. For example, pain can be caused by chronic pancreatitis*. And Creon is used in people with chronic pancreatitis.

        If you have new or worsening pain, especially abdominal (belly) or back pain, talk with your doctor. Don’t self-treat the pain or change your Creon dosage without your doctor’s instruction.

        * With chronic pancreatitis, you have long-lasting inflammation in your pancreas.

        Other drugs are available that can treat exocrine pancreatic insufficiency (EPI)*. Some may be a better fit for you than others. If you’re interested in finding an alternative to Creon, talk with your doctor. They can tell you about other medications that may work well for you.

        Note: Some of the drugs listed below are used off-label to treat EPI caused by certain conditions. Off-label drug use is when an FDA-approved drug is used for a purpose other than what it’s approved for.

        Examples of alternative drugs that may be used to manage EPI include:

        • pancrelipase delayed-release capsules (Pancreaze, Pertzye, Zenpep)
        • pancrelipase tablets (Viokace)

        * For more information about EPI, and how Creon is used to treat it, see the “Creon uses” section below.

        As with all medications, the cost of Creon can vary. To find current prices for Creon in your area, check out GoodRx.com.

        The cost you find on GoodRx.com is what you may pay without insurance. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

        Keep in mind that you may be able to get a 90-day supply of Creon. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, talk with your doctor or your insurance company.

        Before approving coverage for Creon, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

        If you’re not sure if you’ll need to get prior authorization for Creon, talk with your insurance company.

        Financial and insurance assistance

        If you need financial support to pay for Creon, or if you need help understanding your insurance coverage, help is available.

        AbbVie, the manufacturer of Creon, offers two support programs that you may qualify for depending on your specific condition. It also offers the myAbbVie Assist program, which provides free medication to people who qualify. For more information and to find out if you’re eligible for support through any of these programs, visit the Creon website.

        Mail-order pharmacies

        Creon may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

        If recommended by your doctor, you may be able to receive a 90-day supply of Creon, so there’s less concern about running out of the medication. If you’re interested in this option, talk with your doctor and your insurance company. Some Medicare plans may help cover the cost of mail-order medications.

        If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

        Generic version

        Creon isn’t available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

        The Food and Drug Administration (FDA) approves prescription drugs such as Creon to treat certain conditions. Creon may also be used off-label for other conditions. Off-label drug use is when an FDA-approved drug is used for a purpose other than what it’s approved for.

        Creon for exocrine pancreatic insufficiency

        Creon is FDA-approved to treat exocrine pancreatic insufficiency (EPI) that’s caused by certain conditions. These specific conditions are described below.

        With EPI, your body doesn’t have pancreatic enzymes available like usual to help digest foods. (Pancreatic enzymes are substances that your pancreas makes to help break down fats, proteins, and carbohydrates from your diet.)

        Symptoms of EPI may include:

        • loose, bulky, or frequent stools
        • oil or mucus in your stools
        • smelly stools
        • gas, bloating, or abdominal (belly) pain
        • vomiting
        • weight loss

        Creon helps people with EPI by replacing the natural digestive enzymes in their small intestine.

        Creon for EPI that’s due to cystic fibrosis

        Creon is FDA-approved to manage exocrine pancreatic insufficiency (EPI) that’s caused by cystic fibrosis. For this use, Creon can be given to infants, children, and adults of all ages.

        About cystic fibrosis

        Cystic fibrosis (CF) is a genetic condition. (This means it’s passed down from parents to their children.) CF causes thick, sticky mucus in certain body parts, including the pancreas. With CF, the thick, sticky mucus clogs the duct (passageway) between your pancreas and small intestine. This blocks pancreatic enzymes from reaching your small intestine to help digest food.

        With CF, you can have maldigestion (poor digestion) and malabsorption (poor absorption), leading to issues including:

        • weight loss or poor growth
        • a decline in lung function that’s related to a low body weight
        • digestive problems such as abnormal stools, gas and bloating, or belly pain
        • lacking nutrition, especially from vitamins that are absorbed with fat from your diet

        Effectiveness for EPI due to cystic fibrosis

        The Cystic Fibrosis Foundation suggests brand-name pancreatic enzyme replacement therapy, such as Creon, for people of all ages with EPI due to CF.

        In addition, Creon has been found effective in clinical trials for this purpose. Two clinical trials studied the short-term effectiveness of Creon in managing EPI due to CF.

        One study included people who were ages 12 to 43 years. Some people took Creon (4,000 lipase units per gram of total fat intake) daily for 5 to 6 days. Then they switched to a placebo (no active treatment) for 5 to 6 additional days.

        Other people took the placebo for 5 to 6 days. Then they switched to Creon (at the same dosing as the other group) for 5 to 6 additional days. During the study, both groups of people ate a high-fat diet.

        In this study, researchers looked at the following outcomes:

        • Coefficient of fat absorption (CFA). This value comes from a stool test that measures how much fat your body absorbs from your diet. CFA increases as your body absorbs more fat.
        • Coefficient of nitrogen absorption (CNA). This value comes from a stool test that measures how much protein your body absorbs from your diet. CNA increases as your body absorbs more protein.

        Researchers reported the following results, which were taken from both groups of people in the study:

        With Creon treatmentWith placebo treatment
        Average CFA89%49%
        Average CNA86%49%

        Creon for EPI due to chronic pancreatitis, pancreatectomy, or other conditions

        Creon is FDA-approved to treat exocrine pancreatic insufficiency (EPI) that’s caused by:

          (long-lasting inflammation in your pancreas)
    • pancreatectomy (removal of all or part of your pancreas)
    • certain other conditions that may damage your pancreas, such as type 2 diabetes
    • Each of the conditions listed above cause EPI because they can affect the health of your pancreas.

      About chronic pancreatitis

      Chronic pancreatitis is an ongoing condition. With chronic pancreatitis, you have long-lasting inflammation in your pancreas. It happens when pancreatic enzymes damage your pancreas. The damage causes swelling that doesn’t go away or heal. This constant damage can affect how well the pancreas works.

      Sometimes the cause of chronic pancreatitis isn’t known. But the condition may be caused by:

        (heavy alcohol use and addiction) (hardened bile from the gallbladder)
  • certain medications, such as valproic acid or estrogen
  • certain genetic disorders pancreatitis
  • high level of triglycerides (type of fat in the blood)
  • other factors, such as having a high level of calcium in the blood
  • About pancreatectomy

    A pancreatectomy is a surgery to remove all or part of your pancreas. It’s typically done because of cancer or other medical issues, including chronic pancreatitis.

    After a partial pancreatectomy, you may not have enough pancreatic enzymes to break down your food. After a full pancreatectomy, you don’t have any pancreatic enzymes to break down your food. So with either of these surgeries, the ability of your pancreas to make enough digestive enzymes is affected.

    About other conditions that affect your pancreas

    Other factors and conditions can harm your pancreas and lead to EPI. Some examples include:

    Effectiveness for EPI due to chronic pancreatitis or pancreatectomy

    A clinical trial looked at using Creon for EPI due to either chronic pancreatitis or pancreatectomy. The trial included people who were ages 32 to 75 years.

    Everyone received a placebo (treatment with no active drug) for 5 days. Then they took a pancreatic enzyme replacement for 16 days. (The exact therapy taken during this period wasn’t specified, but keep in mind that Creon is a pancreatic enzyme placement.)

    After the first phase of the study, some people took Creon for 7 more days, while others took placebo for 7 more days. Both groups of people ate a diet that was very high in fat.

    • 72,000 lipase units with 3 large meals each day, and
    • 36,000 lipase units with 2 snacks each day

    In this study, researchers looked at the coefficient of fat absorption (CFA). This value comes from a stool test that measures how much fat your body absorbs from your diet. CFA increases as your body absorbs more fat.

    In the study, average change in CFA seen over a 28-day period was:

    Off-label uses for Creon

    In addition to the uses listed above, Creon may also be used off-label for other conditions. Off-label drug use is when an FDA-approved drug is used for a purpose other than what it’s approved for. Below are examples of off-label uses for Creon.

    Creon for IBS

    Pancreatic enzyme replacement therapies, such a Creon, aren’t approved to treat irritable bowel syndrome (IBS). And medical experts, such as the American Gastroenterological Association, don’t list these drugs in IBS medication guidelines. However, there’s some evidence that these therapies may help reduce IBS symptoms.

    IBS is a condition that affects the large intestine. Common IBS symptoms include belly pain, bloating or gas, and changes in stools. Typically, IBS treatment focuses first on lifestyle changes, such diet and stress management.

    In one European study, 6.1% of the people with IBS-D* also had exocrine pancreatic insufficiency (EPI)†, which Creon is used to treat. The researchers concluded pancreatic enzyme replacement therapy may lessen certain IBS symptoms.

    Another small study done in 2010 looked at how effective pancrelipase was in relieving IBS-D symptoms compared with a placebo (treatment with no active drug).

    Researchers reported that more people preferred pancrelipase than the placebo for long-term use. And people reported that certain IBS-D symptoms were significantly reduced with pancrelipase compared with no treatment. (Note: Creon contains enzymes called pancrelipase. But the pancrelipase product in this study wasn’t Creon.)

    More studies are needed to confirm whether Creon or other pancreatic enzyme replacement therapies can treat IBS. If you’d like to know more about IBS treatment options, talk with your doctor.

    * With IBS-D, you have diarrhea as your main symptoms of IBS.
    † For information about EPI, see the beginning of this “Creon uses” section above.

    Creon for acute pancreatitis

    Creon isn’t approved to treat acute pancreatitis. Instead, it’s approved to treat exocrine pancreatic insufficiency (EPI)* that’s due to chronic pancreatitis. In some cases, doctors may prescribe Creon off-label to treat acute pancreatitis. That said, in a recent treatment guideline, Creon isn’t recommended for managing acute pancreatitis.

    With pancreatitis, you have inflammation in your pancreas. Chronic pancreatitis is long-lasting condition. But acute pancreatitis is a short-term condition. Mild, acute pancreatitis often heals in a few days with rest and minor care measures. More severe cases may need surgery or other treatments.

    Certain people with moderate to severe acute pancreatitis have EPI. So it’s thought that pancreatic enzyme replacement therapy, such as Creon, may help with their recovery.

    One 2013 European study looked at using Creon to help with recovery in people with EPI due to acute pancreatitis. However, the study didn’t find a major difference between the number of days to recovery between people taking Creon and people taking the placebo. More research is needed to know whether Creon is safe and effective for this purpose.

    If you have questions about treatment options for acute pancreatitis, talk with your doctor.

    * For information about EPI, see the beginning of this “Creon uses” section above.

    Creon for unclogging feeding tubes

    Creon’s manufacturer doesn’t recommend using their drug to unclog feeding tubes. And the drug hasn’t been approved for this use.

    Sometimes, doctors prescribe and insert feeding tubes for people who can’t swallow whole foods. Feeding tubes may also be recommended for people who need extra calories and nutrition to stay healthy.

    Enteral feedings (tube feedings) give nutrition to people through a liquid that’s put through the feeding tube. The tube goes directly into their stomach or small intestine.

    Feeding tubes may be inserted into your body through your mouth. Or they may be inserted into a port in your belly that connects to your small intestine. Sometimes, feeding tubes can become clogged. And medical providers may use pancreatic enzyme replacement therapies mixed with other solutions to clear the tubes. (Creon is a pancreatic enzyme replacement therapy.)

    One 2014 study looked back through hospital records to learn how effective a dose of Creon was in unclogging feeding tubes compared with the standard pancreatic enzyme therapy Viokase. Researchers reported that about half of the tubes involved were successfully cleared with Creon. Viokase, on the other hand, cleared just over 70% of feeding tubes.

    If you have questions about how to clean your or your child’s feeding tube, talk with your doctor.

    Creon and children

    Creon is FDA-approved to treat exocrine pancreatic insufficiency (EPI)* in infants and children of all ages. Specifically, the drug is approved for EPI that’s due to:

    * For information about EPI, see the beginning of this “Creon uses” section above.

    Effectiveness of Creon in children

    Creon’s effectiveness in managing EPI due to cystic fibrosis in children was studied in a clinical trial. The study included children ages 7 to 11 years.

    Some children took Creon (4,000 lipase units per grams of total fat intake) daily for 5 to 6 days. Then they switched to taking a placebo (no active treatment) for 5 to 6 additional days. Other children took the placebo for 5 to 6 days.

    Then they switched to Creon (at the same dosing as the other group) for 5 to 6 additional days. During the study, both groups of children ate a high-fat diet.

    In this study, researchers looked at the following outcomes:

    • Coefficient of fat absorption (CFA). This value comes from a stool test that measures how much fat your body absorbs from your diet. CFA increases as your body absorbs more fat.
    • Coefficient of nitrogen absorption (CNA). This value comes from a stool test that measures how much protein your body absorbs from your diet. CNA increases as your body absorbs more protein.

    Researchers reported the following results, which were taken from both groups of children in the study:

    Creon treatmentPlacebo treatment
    Average CFA83%47%
    Average CNA80%45%

    Another study checked the short-term effectiveness of Creon in 18 infants and children with EPI caused by cystic fibrosis. In this study, ages ranged from 4 months to 6 years.

    Everyone in the study was given their usual pancreatic enzyme replacement therapy for an average of 18 days. Then they were given a Creon dose of 7,500 lipase units per kilogram of body weight per day for an average of 12 days. In this study, children had similar stool fat test results with both treatments.

    Here are answers to some frequently asked questions about Creon.

    Are there any foods I need to avoid while I’m taking Creon?

    Not necessarily. But remember, if you’re taking Creon, your body likely has trouble getting enough nutrients from food. So you should follow the diet plan recommended by your doctor. This way, you can stay healthy and feel your best.

    Also, keep in mind that your Creon dosage may be based on your fat intake. So fatty or greasy foods that aren’t accounted for in your Creon dosage may be harder for your body to break down. And this could lead to oily stools or other digestive symptoms.

    Don’t change your diet or your Creon dosage without first talking with your doctor. To fit your needs, they’ll adjust your Creon dosage or your diet plan.

    When can I stop taking Creon?

    Actually, Creon is usually a lifelong therapy. You’ll probably always need to take a pancreatic digestive enzyme, such as Creon, to help your body digest foods. This is because most of the conditions that Creon is used to manage are lifelong conditions.

    In some cases, if your condition is cured and your body heals, you may not need to use Creon anymore. For more information about this, see the question “Will Creon cure my condition?” below.

    Talk with your doctor about how long you can expect to take Creon for your condition.

    What happens if I take too much Creon?

    Taking too much Creon may increase your risk for serious side effects such as:

    • fibrosing colonopathy (scarring or narrowing in your colon)
    • high level of uric acid in your blood

    For more information about fibrosing colonopathy and high level of uric acid in the blood, see the “Creon side effects” section above.

    Call your doctor right away if you have any symptoms of these conditions or if you think you’ve taken too much Creon.

    Does Creon cause weight loss?

    Creon helps your body process fats, proteins, and carbohydrates into calories (smaller parts that can be used for energy) and nutrition. Then your body stores any extra calories that aren’t used. And these extra calories may actually cause weight gain.

    So Creon may promote weight gain, not weight loss. Healthy weight gain has been seen in people with cystic fibrosis who use pancreatic enzyme replacement therapies. (Creon is a pancreatic enzyme replacement therapy.)

    If you have questions about weight changes with Creon treatment, talk with your doctor.

    Will Creon cure my condition?

    Creon doesn’t cure any of the health conditions it’s used to manage. Instead, it’s used in people with exocrine pancreatic enzyme insufficiency (EPI)* to replace pancreatic enzymes. (Pancreatic enzymes are substances that your pancreas makes to help break down fats, proteins, and carbohydrates from your diet.)

    Creon treats EPI that’s caused by:

    CF is a lifelong condition. So people with CF will have EPI their entire lives, and they’ll need lifelong pancreatic enzyme replacement therapy, such as Creon. Pancreatectomy also results in people needing to manage EPI for the rest of their life.

    Chronic pancreatitis, on the other hand, may or may not go away with time. If your pancreas heals from this condition, you may be able to digest foods without taking enzymes, such as Creon, for your lifetime.

    Talk with your doctor about how long you can expect to take Creon for your condition.

    * For more information about EPI and how Creon is used to treat it, see the “Creon uses” section above.

    Why do I have to keep track of what I’m eating while taking Creon?

    Creon helps your body process foods so they can be used for energy and nutrition. Your dosage of Creon may be based on certain factors, such as how much fat you eat. So it’s important to track your meals, snacks, and any symptoms or side effects you’re having with treatment. Then share this information with your doctor. This helps your doctor see if your Creon dosage is right for you.

    For example, if you’re having oily stools or other digestive symptoms, your Creon dosage may need to be adjusted. But don’t change your Creon dosage or diet without first talking with your doctor.

    Are over-the-counter enzyme supplements the same as Creon?

    No, digestive enzyme supplements or products available over-the-counter (OTC) at pharmacies or natural food stores aren’t the same as Creon.

    These other products may contain enzymes from fruits or other sources. But they don’t contain the same enzymes that are found in Creon. So the products can’t replace the enzymes your body needs to properly digest foods.

    Don’t use OTC products without your doctor’s instruction. And if Creon is prescribed for you, don’t use other products in place of Creon.

    Creon doesn’t interact with alcohol. But alcohol can damage your pancreas and lead to new or worsening exocrine pancreatic insufficiency (EPI)*, which Creon is used to manage.

    For example, alcohol misuse is a major cause of chronic pancreatitis (long-lasting inflammation in your pancreas). And Creon is approved to treat EPI that’s due to chronic pancreatitis.

    To help keep your pancreas as healthy as possible, you should avoid drinking alcohol. And if you have questions about drinking alcohol while using Creon, talk with your doctor.

    * For more information on EPI and how Creon is used to treat it, see the “Creon uses” section above.

    It’s possible that Creon interacts with other medications, herbs, or supplements. But no interactions with medications, herbs, or supplements have been reported.

    If you’re concerned about using other treatments with Creon, talk with your doctor or pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use.

    If you have questions or concerns about possible drug interactions with Creon, ask your doctor or pharmacist.

    Creon and foods

    There aren’t any foods that have been specifically reported to interact with Creon. So there aren’t any foods to avoid while you’re using this drug.

    But keep in mind that fatty or greasy foods that aren’t part of your recommended meal plan with Creon may be harder for your body to digest. In fact, eating these foods could lead to oily stools or other unpleasant symptoms. So stick with the diet you and your doctor create.

    If you have any questions about eating certain foods with Creon, talk with your doctor.

    Creon and lab tests

    Creon shouldn’t affect the results of any lab tests. During Creon treatment, your doctor may order tests to check for high levels of uric acid in your blood. Or your doctor may order a test to check for fat in your stool. (These tests help your doctor to know how well Creon is working for you.)

    If you have questions about how Creon may affect certain lab tests you’re having, talk with your doctor.

    Creon and vaccines

    In general, it’s OK to get a flu shot or other vaccines while you’re taking Creon.

    Creon therapy doesn’t affect your body’s ability to respond to a vaccine. But keep in mind that some people can’t get certain vaccines because of a health condition or allergy.

    Talk to your or your child’s doctor about staying up-to-date on vaccinations while you’re using Creon.

    Creon is approved to treat exocrine pancreatic insufficiency (EPI) that’s caused by certain conditions, including cystic fibrosis. In any case, with EPI, your body doesn’t have pancreatic enzymes available like usual to help digest foods. (Pancreatic enzymes are substances that your pancreas makes to help break down fats, proteins, and carbohydrates from your diet.)

    To learn more about EPI and the conditions that cause it, see the “Creon uses” section above.

    What Creon does

    Creon contains pancrelipase, which is a mixture of pancreatic enzymes including lipases, proteases, and amylases. (These enzymes are digestive enzymes.) Creon capsules pass through your stomach and then open and release their contents inside your small intestine.

    So when taken with food, your body uses Creon’s enzymes to process fats, proteins, and carbohydrates into smaller parts. Your body can then absorb these smaller parts and use them for energy, nutrition, and growth.

    How long does it take to work?

    Creon helps your body digest food once it reaches your small intestine. Each Creon dose works right away with the meal or snack you took it with, so you should take Creon right before you eat.

    How long does Creon stay in your system?

    Creon is a pancreatic enzyme replacement therapy. This means it acts like your body’s own digestive enzymes.

    Once you take Creon, it stays in your digestive tract to help break down food during mealtimes. The enzymes help break down your food into smaller parts that your body can use for energy or nutrition.

    Each Creon dose only works for a short period of time with each meal or snack. So you must take another dose of Creon with your next meal or snack.

    Do not use more Creon than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

    Taking too much Creon may increase your risk for serious side effects such as:

    • fibrosing colonopathy (scarring or narrowing in your colon)
    • high level of uric acid in your blood

    For more information about fibrosing colonopathy and high level of uric acid in the blood, see the “Creon side effects” section above.

    What to do in case you take too much Creon

    If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

    You should take Creon according to your doctor’s or healthcare provider’s instructions.

    When to take

    Always take Creon with meals or snacks. And try to take the drug at the start of your meal or snack. Always swallow the capsules whole and wash them down with water or another liquid.

    Don’t take more Creon each day than your doctor prescribes for you. If you add extra meals or snacks into your diet plan, talk with your doctor. But don’t change your Creon dosage without your doctor’s instruction.

    If you miss a dose of Creon, wait to take the drug until your next meal. Don’t double up your Creon dose or take it without food.

    To help make sure you don’t miss a dose, keep a Creon supply with you at all times. Store it in your desk at work or school. Or tuck it in your bag or purse. Just make sure to keep Creon capsules cool and dry.

    Taking Creon with food

    Creon must be taken with food. It can only help break down food if it’s taken with your meal or snack. After it’s taken, Creon passes through your stomach and then releases digestive enzymes into your small intestine. (Your food is digested and absorbed inside your small intestine.)

    You don’t need to take Creon with things that don’t need to be digested, such as:

    • coffee or tea without creamer
    • soft drinks, such as soda or diet soda
    • hard candy, such as peppermints
    • chewing gum

    Can Creon be crushed, split, or chewed?

    Never crush or chew Creon capsules or their contents. The enzymes contained in Creon may be released in your mouth and lose their ability to digest food in your digestive tract. Plus, the enzymes may irritate your mouth or tongue.

    If you or your child has trouble swallowing pills, you can sprinkle the contents of Creon capsules on a small amount of applesauce, banana, or other soft acidic foods. Then swallow the mixture right away without chewing it. (Don’t pre-mix the contents of Creon capsules to take later.) And wash it down with plenty of water or another liquid.

    When you take pancrelipase, the active ingredient in Creon, it mostly stays in your digestive tract. Only a tiny amount is absorbed into the rest of your body. So Creon use in pregnant people isn’t thought to expose the fetus to the drug. But the actual risks of using this medication during pregnancy aren’t known.

    Creon hasn’t been studied in pregnant people. However, reports from pregnant females using the drug haven’t shown any major birth defects, miscarriages, or other serious events.

    Talk with your doctor about using Creon during pregnancy. They can help you weigh the risks and benefits of taking this drug while you’re pregnant.

    Creon and fertility

    It isn’t known if Creon affects fertility in people using this drug . (Fertility is the ability to become pregnant or get someone pregnant.) If you’re trying to get pregnant, talk with your doctor about conceiving while using Creon.

    It’s worth noting that cystic fibrosis (CF) can affect fertility in both men and women. If you’re managing CF with Creon, you may want talk with your doctor about your family planning desires.

    It isn’t known for sure if Creon is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Creon.

    For more information about taking Creon during pregnancy, see the “Creon and pregnancy” section above.

    It isn’t known if Creon’s active ingredient, pancrelipase will:

    • pass into human breast milk
    • affect a child who’s breastfed
    • alter breast milk production

    When you take pancrelipase, it mostly stays in your digestive tract. Only a tiny amount is absorbed into the rest of your body. So Creon isn’t expected to pass into the breast milk of lactating females. But the actual risks of using Creon while breastfeeding aren’t known.

    If you’re breastfeeding or planning to breastfeed, talk with your doctor about using Creon. They can help you weigh the risks and benefits of taking this drug.

    Before taking Creon, talk with your doctor about your health history. Creon may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

    • Fibrosing colonopathy. Fibrosing colonopathy is narrowing or scarring of the colon that can be dangerous. Creon should be used with caution in people with this condition. If you have this condition and use Creon, your dosage of the drug and the health of your colon should be closely monitored.
    • Gout, high uric acid level, or kidney disease. Creon can increase uric acid levels in the blood. This can worsen gout or other conditions. The levels of uric acid may be even higher in people with impaired kidney function. If you have any of these conditions and use Creon, your dosage of the drug and your overall health should be closely monitored.
    • Allergy to pork. Creon is made from the pancreas of pigs. So if you have a pork allergy, you could also be allergic to Creon. Ask your doctor if Creon is the right treatment option for you.
    • Other allergies. If you’ve had an allergic reaction to Creon or any of its ingredients, you shouldn’t take Creon. Ask your doctor what other medications are better options for you.
    • Pregnancy. Creon hasn’t been studied in pregnant people. However, the drug isn’t expected to cause harm if it’s used during pregnancy. For more information, see the “Creon and pregnancy” section above.
    • Breastfeeding. Creon hasn’t been studied in people who are breastfeeding. But the drug isn’t expected to pass into breastmilk or affect children who are breastfed. For more information, see the “Creon and breastfeeding” section above.

    Note: For more information about the potential negative effects of Creon, see the “Creon side effects” section above.

    When you get Creon from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

    The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

    Storage

    How long a medication remains good can depend on many factors, including how and where you store the medication.

    Creon should be stored at room temperature (59°F to 77°F/15°C to 25°C). It should be kept in a tightly sealed container away from heat or moisture. Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.

    Disposal

    If you no longer need to take Creon and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

    This article provides several useful tips on medication disposal. You can also ask your pharmacist for information about how to dispose of your medication.

    Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.


    This photo of USS Creon ARL 11 is exactly as you see it with the matte printed around it. You will have the choice of two print sizes, either 8″x10″ or 11″x14″. The print will be ready for framing, or you can add an additional matte of your own choosing then you can mount it in a larger frame. Your personalized print will look awesome when you frame it.

    We can PERSONALIZE your print or the USS Creon ARL 11 with your name, rank and years served and there is no ADDITIONAL CHARGE for this option. After you place your order you can simply email us or indicate in the notes section of your payment what you would like printed. For example:

    United States Navy Sailor
    YOUR NAME HERE
    Proudly Served: Your Years Here

    This would make a nice gift for yourself or that special Navy veteran you may know, therefore, it would be fantastic for decorating the home or office wall.

    The watermark “Great Naval Images” will NOT be on your print.

    Media Type Used:

    The USS Creon ARL 11 photo is printed on Archival-Safe Acid-Free canvas using a high-resolution printer and should last many years. The unique natural woven texture canvas offers a special and distinctive look that can only be captured on canvas. Most sailors loved his ship. It was his life. Where he had a tremendous responsibility and lived with his closest shipmates. As one gets older, the appreciation for the ship and the Navy experience will get stronger. The personalized print shows ownership, accomplishment and an emotion that never goes away. When you walk by the print you will feel the person or the Navy experience in your heart.

    We have been in business since 2005 and our reputation for having great products and customer satisfaction is indeed exceptional. You will, therefore, enjoy this product guaranteed.


    For Healthcare Professionals

    Applies to pancrelipase: oral capsule, oral capsule extended release, oral delayed release capsule, oral powder for reconstitution, oral tablet, oral tablet extended release

    General

    The most commonly reported side effects included gastrointestinal complaints, abdominal pain, and headaches. [Ref]

    Gastrointestinal

    Bowel stricture formation occasionally occurred in children with cystic fibrosis who received high doses.

    Moderate duodenitis and gastritis occurred in a patient with exocrine pancreatic insufficiency due to cystic fibrosis 16 days after completing treatment with 4000 lipase units/gram fat ingested per day for 5 to 6 days, followed by placebo for an additional 5 to 6 days. [Ref]

    Very common (10% or more): Gastrointestinal complaints (up to 55%), abdominal pain (up to 18%), vomiting (up to 12%)

    Common (1% to 10%): Abdominal discomfort, abdominal distention, abdominal pain upper, abdominal tenderness, abnormal feces, anal pruritus, ascites, constipation, diarrhea, dyspepsia, early satiety, flatulence, frequent bowel movements, nausea

    Uncommon (0.1% to 1%): Bowel stricture formation

    Frequency not reported: Duodenitis, fibrosing colonopathy, gastritis, steatorrhea, strictures of the ileocecum

    Postmarketing reports: Distal intestinal obstruction syndrome (DIOS) [Ref]

    Nervous system

    Very common (10% or more): Headache (up to 15%)

    Common (1% to 10%): Dizziness

    Postmarketing reports: Dull headache [Ref]

    A dull headache was reported by a patient receiving treatment with ursodeoxycholic acid concomitantly. The event resolved without sequelae after discontinuation of this drug. [Ref]

    Metabolic

    Common (1% to 10%): Blood cholesterol decreased, blood glucose increased, decreased appetite, diabetes mellitus, diabetes mellitus including subtypes, hyperglycemia, hypoglycemia, weight decreased

    Frequency not reported: Hyperuricemia [Ref]

    Hepatic

    Common (1% to 10%): ALT increased, AST increased, biliary tract stones, blood alkaline phosphatase increased, cholangitis, GGT increased, hydrocholecystis

    Postmarketing reports: Asymptomatic liver enzyme elevations [Ref]

    Hematologic

    Common (1% to 10%): Anemia, hematocrit, hemoglobin, red blood cell count, increased white blood cell count

    Frequency not reported: Transient neutropenia with/without clinical sequelae [Ref]

    Respiratory

    Common (1% to 10%): Bronchitis, cough, nasopharyngitis, oropharyngeal pain, respiratory tract infection

    Postmarketing reports: Asthma [Ref]

    Other

    Common (1% to 10%): Asthenia, malaise, pain, pyrexia

    Frequency not reported: Fatigue [Ref]

    Dermatologic

    Common (1% to 10%): Pruritus, rash, skin reactions

    Frequency not reported: Itching, urticaria/hives

    Postmarketing reports: Blotchy/red facial rash [Ref]

    Musculoskeletal

    Common (1% to 10%): Arthralgia, back pain, musculoskeletal pain

    Postmarketing reports: Muscle spasm, myalgia [Ref]

    Cardiovascular

    Common (1% to 10%): Contusion, hypertension, peripheral edema [Ref]

    Oncologic

    Common (1% to 10%): Metastases to specific sites, recurrent pancreatic carcinoma

    Postmarketing reports: Recurrence of preexisting carcinoma [Ref]

    Psychiatric

    Common (1% to 10%): Insomnia, irritability [Ref]

    Renal

    Common (1% to 10%): Renal cyst [Ref]

    Immunologic

    Common (1% to 10%): Viral infection [Ref]

    Hypersensitivity

    A patient with a known history of allergy to another pancrelipase (the active ingredient contained in Creon) product developed a mild allergic reaction, including red, blotchy facial rash and itching. The event resolved without sequelae after discontinuation of this drug. [Ref]

    Frequency not reported: Anaphylactic reactions, hypersensitivity

    Postmarketing reports: Anaphylaxis, mild allergic reactions, severe allergic reactions [Ref]

    Genitourinary

    Frequency not reported: Hyperuricosuria [Ref]

    Ocular

    Postmarketing reports: Blurred vision [Ref]

    References

    1. "Product Information. Ultrase (pancrelipase)." Scandipharm Inc, Birmingham, AL.

    2. "Product Information. Cotazym-S (pancrelipase)." Organon, West Orange, NJ.

    3. "Product Information. Creon 10 (pancrelipase)." Solvay Pharmaceuticals Inc, Marietta, GA.

    4. Cerner Multum, Inc. "Australian Product Information." O 0

    5. "Product Information. Zymase (pancrelipase)." Organon, West Orange, NJ.

    6. "Product Information. Pancrease (pancrelipase)." McNeil Pharmaceutical, Raritan, NJ.

    7. "Product Information. Cotazym (pancrelipase)." Organon, West Orange, NJ.

    8. "Product Information. Viokase (pancrelipase)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

    9. "Product Information. Pancrease MT (pancrelipase)." McNeil Pharmaceutical, Raritan, NJ.

    10. "Product Information. Creon 5 (pancrelipase)." Solvay Pharmaceuticals Inc, Marietta, GA.

    11. "Product Information. Ku-zyme (pancrelipase)." Schwarz Pharma, Mequon, WI.

    12. "Product Information. Creon 20 (pancrelipase)." Solvay Pharmaceuticals Inc, Marietta, GA.

    13. "Product Information. Ultrase MT (pancrelipase)." Scandipharm Inc, Birmingham, AL.


    5.1 Fibrosing Colonopathy

    Fibrosing colonopathy has been reported following treatment with different pancreatic enzyme products. 5, 6 Fibrosing colonopathy is a rare, serious adverse reaction initially described in association with high-dose pancreatic enzyme use, usually over a prolonged period of time and most commonly reported in pediatric patients with cystic fibrosis. The underlying mechanism of fibrosing colonopathy remains unknown. Doses of pancreatic enzyme products exceeding 6,000 lipase units/kg of body weight per meal have been associated with colonic stricture in children less than 12 years of age. 1 Patients with fibrosing colonopathy should be closely monitored because some patients may be at risk of progressing to stricture formation. It is uncertain whether regression of fibrosing colonopathy occurs. 1 It is generally recommended, unless clinically indicated, that enzyme doses should be less than 2,500 lipase units/kg of body weight per meal (or less than 10,000 lipase units/kg of body weight per day) or less than 4,000 lipase units/g fat ingested per day [see Dosage and Administration (2.1)].

    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. Patients 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.


    ARL 44

    Authored By: Staff Writer | Last Edited: 09/25/2018 | Content ©www.MilitaryFactory.com | The following text is exclusive to this site.

    Before World War 2, the nation of France was the world's second producer of combat tanks behind only the Soviet Union. However, the German invasion of France and subsequent years of war destroyed all manner of French pride, infrastructure and armored vehicle output. It was only after the liberation of Paris proper in 1944 that attention was quickly given to the re-establishment of serial tank production to promote France as a viable military power once again.

    Major hurdles greeted such an initiative for French armored doctrine and design lacked much when compared to her contemporaries. Even before the war, few of the available French tanks were capable of matching the offensive doctrine of the German Army. Many of these were designed with the lessons learned from World War 1 and French armored warfare rules drove many of these designs to failure at the hands of the Germans - even the fabled Char B1 heavy tank series, one of the most powerful of its day but a riddled with tactical liabilities. Now with Germany cleared out of the French capital, attention was paid by to the formation of a new heavy tank design headed by specialists from APX and AMX with production to be handled by ARL. As such, the tank would be christened the "ARL 44" to mark both manufacturer and year. New concepts being proven throughout the war would be factored into the tank's design to make a more modern end-product.

    In February of 1945, the design was fleshed out to dictate a heavy tank system of 48 tons, heavy sloped armor measuring some 120mm thick and a proven large-caliber main gun in a traversing turret. By May of 1945, the war in Europe had drawn to a close and the Empire of Japan collapsed in August to bring about an end to World War 2 altogether. Regardless of the world situation, the French heavy tank program continued with whatever resources could be obtained. The French government commissioned for sixty ARL 44 heavy tanks and work began on pilot vehicles required to prove the ARL product sound. ACL produced the turret, which initially mounted an American 76mm main gun - available in some number by this stage in the post-war world. While this selection of main gun was adequate by then-modern standards, it severely lacked the penetrative powers of other guns being fielded by the Germans, Soviets and the British. As such, a new turret - this based on the Schneider Char F1-type turret - was installed to mount a more potent 90mm DCA45 main gun. The 90mm DCA main gun was, in fact, based on a naval warship anti-aircraft cannon and packed a greater punch than that of the American 75mm. The selection of the 90mm armament delayed development of the required turret, thusly delaying the ARL 44 program in whole. Key to the success of the ARL 44 was to be its selection of powerplant. As war-torn France - and its aching military industry - still reeled from the German occupation, it was decided to use captured German Maybach gasoline-fueled engines. Armor was 120mm at its thickest and the tank would be crewed by five personnel - a driver, commander, gunner, loader and machine gunner/radio operator - with point defense handled by a pair of MAC31 Chatellerault machine guns. With the main armament now finalized, the initial pilot vehicle was rolled out for formal evaluations in March of 1946. The French concerns of FAMH and Renault were also tabbed with production of hulls beginning in 1946.

    Externally, the ARL 44's design was more akin to a tank design of the 1920s and 1930s than a modern post-war initiative. The design was characterized by its multi-wheeled, long-running track systems straddling either side of the sharp-lined hull. The turret was set at amidships an sported a long-barreled 90mm main gun system capped by a single-baffled muzzle brake. The turret featured slightly sloped sides with an overhang at the rear facing for improved internal space. As completed, the vehicle weighed in at 55 tons and was given a 35.5 foot running length, an 11.6 foot width and a 10.5 foot height. Power was supplied by a single Maybach HL 230 series gasoline-fueled engine of 575 horsepower, yielding a top vehicle speed of 35 kmh and an operational range of approximately 350 kilometers. The vehicle utilized a vertical spring coil suspension system which limited top speed and cross-country qualities.

    The delay in turret design and develop led to delays in actual turret production even though plenty of ARL 44 hulls had been readied within time (these ending up in storage for the time being). The first ARL 44 hull did not have its turret installed until 1949 by which time the French ARL 44 concept was evermore obsolete by world standards. As such, serial production of the type was severely limited despite the need for a capable indigenous fighting vehicle. The ARL 44 led a short and rather uneventful existence in the history of armored warfare and made an appearance in 1951 on parade to celebrate Bastille Day. By 1953, all sixty ARL 44 Heavy Tanks were retired from French Army service, these being directly replaced by the American M47 Patton series of medium tanks from America - being offered on free lease to Allies in Europe with the arrival of the M48 Pattons. Nevertheless, both French engineers and heavy industry took away valuable lessons learned in her design, development and construction - forging a new direction in French Cold War tank design for decades to come.


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