creon dr 24000 units
 

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Creon


1. Name Of The Medicinal Product

Creon® 10000 Capsules

Creon® 25000 Capsules

Creon® 40000 Capsules

2. Qualitative And Quantitative Composition

Creon 10000

Each capsule contains pancreatin 150 mg equivalent to:

Lipase 10,000 PhEur units

Amylase 8,000 PhEur units

Protease 600 PhEur units

Creon25000

Each capsule contains pancreatin PhEur 300 mg equivalent to:

Lipase 25,000 PhEur units

Amylase 18,000 PhEur units

Protease 1,000 PhEur units

Creon40000

Each capsule contains pancreatin PhEur 400 mg equivalent to:

Lipase 40,000 PhEur units

Amylase 25,000 PhEur units

Protease 1,600 PhEur units

3. Pharmaceutical Form

Creon 10000

Brown/clear capsules containing gastro-resistant granules.

Creon25000

Orange/colourless capsules filled with brownish minimicrospheres.

Creon 40000

Brown/clear size 00 capsules containing light brown, gastro-resistant granules.

4. 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:

Creon 40000 should only be used if the patient requires equal to or more than 40,000 lipase units per meal or snack. Creon 40000 should only be used in patients in whom the minimum effective dose has already been determined using lower strength pancreatic enzyme products.

Initially one or two capsules with meals. Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology.

Creon 10000 and 25000

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.

Creon 40000 only

The capsules should be swallowed whole.

It is important to ensure adequate hydration of patients at all times whilst dosing Creon .

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 Contraindications

Patients with known hypersensitivity to porcine proteins.

4.4 Special Warnings And Precautions For Use

The product is of porcine origin.

Oral medications should not be administered during the early stages of acute pancreatitis.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

There is inadequate evidence of safety in use during pregnancy and 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

Creon has no influence on the ability to drive or use machines.

4.8 Undesirable Effects

Diarrhoea, constipation, gastric discomfort, nausea and skin reactions have been reported occasionally in patients receiving enzyme replacement therapy.

Rarely cases of hyper-uricosuria and hyper-uricaemia have been reported with very high doses of pancreatin.

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 10000 and 25000 have not been implicated in the development of colonic damage. Experience with Creon 40000 in clinical use is limited. 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.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

The ATC code is A09A A (Enzyme preparations).

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.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Granules: Macrogol 4000, liquid paraffin, hypromellose phthalate, dibutyl phthalate, dimeticone.

Capsule shell: Gelatin, iron oxide (E172), titanium dioxide (E171).

6.2 Incompatibilities None known. 6.3 Shelf Life

Creon 10000 and 25000:

2 years

Creon 40000: 3

years

6.4 Special Precautions For Storage

Creon 10000:

Do not store above 30°C

Creon 25000:

Store below 25°C.

Creon 40000:

Do not store above 25°C. Keep container tightly closed.

6.5 Nature And Contents Of Container

Creon 10000, 25000 and 40000: HDPE tablet container with LDPE closure. Each container contains 100 capsules.

6.6 Special Precautions For Disposal And Other Handling

6.5

No special instructions.

Administrative Data 7. Marketing Authorisation Holder Solvay Healthcare Limited

Mansbridge Road

West End

Southampton

SO18 3JD

United Kingdom

8. Marketing Authorisation Number(S)

Creon 10000:

PL 00512/0149

Creon 25000:

PL 00512/0150

Creon 40000:

PL 00512/0177

9. Date Of First Authorisation/Renewal Of The Authorisation

Creon 10000 and 25000:

1 January 2001

Creon 40000:

5 July 2002

10. Date Of Revision Of The Text

Creon 10000: May 2002

Creon 25000: June 2003

Creon 40000: October 2002

Legal Category

Creon 10000: P

Creon 25000 and 40000: POM


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Creon Micro


Creon Micro

Pancreatin 60.12 mg
Gastro-resistant Granules

Important things you SHOULD know about Creon Micro Creon Micro is a pancreatic enzyme supplement for people whose bodies do not make enough enzymes to digest their food. Give the amount of the granules as prescribed by the doctor. Give Creon Micro with a meal or a snack and provide plenty of water. Do not give Creon Micro if the patient is allergic to pork or any pig product or any of the ingredients of Creon Micro (listed in section 6). If the patient experiences severe abdominal pain while taking Creon Micro, contact the doctor immediately. Most people do not have problems taking Creon Micro but side effects can occur. (see section 4)

Please read the rest of this leaflet carefully before you start giving these granules.

Keep this leaflet. You may need to read it again. If you have any further questions, ask a doctor or pharmacist. Do not pass it on to others. It may harm them, even if their symptoms are the same. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell a doctor or pharmacist. How to find the information you need 1. About Creon Micro

What Creon Micro is and how it works.

2. Before you give Creon Micro

Who can take Creon Micro?

Can you take Creon Micro if you are pregnant or breast feeding?

Driving or operating machinery.

3. How to give Creon Micro

How much Creon Micro you should give.

When you should give Creon Micro.

How you should give Creon Micro.

What to do if you give too much Creon Micro.

What to do if you forget a dose.

4. Possible side effects

Abdominal symptoms (such as abdominal pain).

Side effects and what to do if the patient gets them.

5. How to store Creon Micro

How and where to keep this medicine.

6. Further information

The ingredients in Creon Micro.

More information about cystic fibrosis and pancreatitis.

About Creon Micro What is Creon Micro Creon Micro is a high strength pancreatic enzyme supplement. Pancreatic enzyme supplements are used by people whose bodies do not make enough of their own enzymes to digest their food. Creon Micro granules contains a mixture of the natural enzymes which are used to digest food. The enzymes are taken from pig pancreas glands. How does Creon Micro work?

The enzymes in Creon Micro work by digesting food as it passes through the gut. So, you must give Creon Micro with a meal or a snack. This will allow the enzymes to mix thoroughly with the food.

Before you give Creon Micro Do not give Creon Micro if: The doctor has told you that the patient is in the early stages of inflammation of the pancreas (acute pancreatitis). The patient is allergic (or hypersensitive) to pork or any pig product or any of the ingredients of Creon Micro (listed in section 6).

If any of the above applies to the patient, do not give Creon Micro. Talk to the doctor or dietician again.

Talk to the doctor, if: you are pregnant or trying to get pregnant (Creon Micro can be used while breast feeding)

Please tell the doctor, dietician, or pharmacist if you think that the patient should not take Creon Micro for any other reason.

If the patient drives or use machines

It is unlikely that Creon Micro will affect the patient’s ability to drive or operate tools or machines.

How to give Creon Micro How much Creon Micro to give Always follow the doctor or dietician’s advice on how many granules to give. The usual starting dose is 100 mg. The maximum amount you may give should not be greater than 10,000 units lipase/kg/day. If the doctor advises you to increase the dose you give, you should do so slowly. If the patient still has fatty stools or abdominal pain, talk to the doctor or dietician. When to give Creon Micro Always give Creon Micro with a meal or a snack and provide plenty of water. (see section 1). How to give Creon Micro to babies and infants Mix the granules with a small amount of undiluted apple juice Provide plenty of liquid every day. Weaned infants Mix the granules with soft food (e.g. apple puree). Make sure the infant swallows all the granules immediately, without chewing. Provide plenty of liquid every day. How long to give Creon Micro

You should keep giving the medicine until the doctor tells you to stop. Many patients will need to take pancreatic enzyme supplements for the rest of their lives.

If you give the patient too much Creon Micro

If you give the patient too much Creon Micro, he/she should drink plenty of water and see the doctor immediately.

If you forget a dose

If you forget to give the medicine, wait until the next meal and give the usual dose. Do not try to make up for the dose that you have missed. Just give the next dose at the usual time.

Creon Micro Side Effects

Like all medicines, Creon Micro can cause side effects (unwanted effects or reactions), but not everyone gets them.

If the patient has severe or long-lasting abdominal pain, contact the doctor immediately.

If you notice any unusual abdominal symptoms while taking Creon Micro – contact the doctor.

Very common side effects (more than 1 in 10 patients): Stomach pains Common side effects (affect 1–10 patients out of 100): Diarrhoea Constipation Feeling or being sick Uncommon side effects (affect 1–10 patients out of 1000): Skin reactions, such as a rash or itching.

At extremely high doses, some patients have had high levels of uric acid in their blood and urine.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell a doctor or pharmacist.

How to store Creon Micro How and where to keep the medicine

Keep all medicines where children cannot reach or see them, preferably locked in a cupboard or medicine cabinet.

Do not store above 30 °C and keep in the original container. The enzymes in Creon Micro are natural products and their ability to digest food decreases over time. If the container is left in warm conditions (e. g. the glove compartment of a car), the digestive activity decreases faster.

Use Creon Micro within 12 weeks of opening the container.

Do not give Creon Micro capsules after the expiry date on the container.

Return all unused medicine to your pharmacist.

Further information The ingredients in Creon Micro

The active ingredient in Creon Micro is pancreatin.

Each scoop measure contains 100 mg. One measure of 100 mg contains gastro-resistant granules of pancreatin is equivalent to the following list of enzymes:

(Ph. Eur. Units per Capsule)

Lipase: 5,000
Amylase: 3,600
Protease: 200

The granules are coated with a mixture of the following ingredients: macrogol 4000, hypromellose phthalate, dimeticone, triethyl citrate and cetyl alcohol.

Each container contains about 200 measures.

The Marketing Authorisation holder is: Solvay Healthcare Ltd Southampton SO18 3JD UK The Manufacturer is: Solvay Pharmaceuticals GmbH 31535 Neustadt a. Rbge Germany More information about cystic fibrosis and pancreatitis

You can find out more about Cystic Fibrosis from the following organisation:

The CF Trust 11 London Road Bromley BR1 1BY

You can find out more about Pancreatitis from the following organisation:

Pancreatitis Supporters Network PO Box 8938 Birmingham B13 9FW

registered trade mark

This leaflet was last amended in September 2009.


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Ultrase MT 20


Generic Name: pancrelipase (oral) (pan kre LYE pace)
Brand Names: Cotazym, Creon, Dygase, Ku-Zyme, Ku-Zyme HP, Kutrase, Lapase, Palcaps 10, Pancrease MT 10, Pancrease MT 16, Pancrease MT 20, Pancrease MT 4, Pancrecarb MS-16, Pancrecarb MS-4, Pancrecarb MS-8, Panocaps, Panocaps MT 16, Ultrase, Ultrase MT 12, Ultrase MT 18, Ultrase MT 20, Viokase, Viokase 16, Zenpep

What is pancrelipase?

Pancrelipase is 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.

Pancrelipase 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.

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

Pancrelipase may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about pancrelipase? You should not take pancrelipase if you are allergic to pork proteins.

Before taking pancrelipase, tell your doctor if you have gout, kidney disease, a history of intestinal blockage, a sudden onset of pancreatitis, or worsening of chronic pancreatic disease.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

If you miss a dose of this medicine, skip the missed dose and wait until your next scheduled dose to take the medicine. Do not take extra medicine to make up the missed dose.

What should I discuss with my healthcare provider before taking pancrelipase? You should not take pancrelipase if you are allergic to pork proteins.

If you have any of these other conditions, you may need a pancrelipase dose adjustment or special tests:

kidney disease;

gout;

a history of blockage in your intestines;

a sudden onset of pancreatitis; or

worsening of chronic pancreatic disease.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether pancrelipase passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take pancrelipase?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Pancrelipase should be taken with a meal or snack. Take the medicine with a full glass of water or juice.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

You may open the pancrelipase capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store in the original container at room temperature (below 78 degrees F) for up to 12 weeks. Protect from moisture or high heat. Keep the bottle tightly closed when not in use. If the medication is exposed to temperatures between 78 and 104 degrees F, throw it away after 30 days. Do not use any pancrelipase that has been exposed to temperatures above 104 degrees F. What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include diarrhea or stomach upset.

What should I avoid while taking pancrelipase?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Pancrelipase side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.

Less serious side effects may include:

nausea or vomiting;

mild stomach pain or upset;

diarrhea or constipation;

bloating or gas.

greasy stools;

rectal irritation;

headache, dizziness;

cough; or

weight loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect pancrelipase?

There may be other drugs that can interact with pancrelipase. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Ultrase MT 20 resources Ultrase MT 20 Side Effects (in more detail)Ultrase MT 20 Use in Pregnancy & BreastfeedingDrug ImagesUltrase MT 20 Drug InteractionsUltrase MT 20 Support Group1 Review for Ultrase MT 20 - Add your own review/rating Pancrelipase Professional Patient Advice (Wolters Kluwer) Pancrelipase Prescribing Information (FDA) Pancrelipase Monograph (AHFS DI) Pancrelipase MedFacts Consumer Leaflet (Wolters Kluwer) Creon Prescribing Information (FDA) Creon Advanced Consumer (Micromedex) - Includes Dosage Information Creon MedFacts Consumer Leaflet (Wolters Kluwer) Creon Consumer Overview Creon 10 Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer) Dygase MedFacts Consumer Leaflet (Wolters Kluwer) Pancreaze Consumer Overview Pancreaze Prescribing Information (FDA) Zenpep Prescribing Information (FDA) Zenpep Consumer Overview Compare Ultrase MT 20 with other medications Chronic PancreatitisCystic FibrosisPancreatic Exocrine Dysfunction Where can I get more information? Your pharmacist can provide more information about pancrelipase.

See also: Ultrase MT 20 side effects (in more detail)


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Pancrease MT 10


Generic Name: pancrelipase (oral) (pan kre LYE pace)
Brand Names: Cotazym, Creon, Dygase, Ku-Zyme, Ku-Zyme HP, Kutrase, Lapase, Palcaps 10, Pancrease MT 10, Pancrease MT 16, Pancrease MT 20, Pancrease MT 4, Pancrecarb MS-16, Pancrecarb MS-4, Pancrecarb MS-8, Panocaps, Panocaps MT 16, Ultrase, Ultrase MT 12, Ultrase MT 18, Ultrase MT 20, Viokase, Viokase 16, Zenpep

What is pancrelipase?

Pancrelipase is 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.

Pancrelipase 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.

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

Pancrelipase may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about pancrelipase? You should not take pancrelipase if you are allergic to pork proteins.

Before taking pancrelipase, tell your doctor if you have gout, kidney disease, a history of intestinal blockage, a sudden onset of pancreatitis, or worsening of chronic pancreatic disease.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

If you miss a dose of this medicine, skip the missed dose and wait until your next scheduled dose to take the medicine. Do not take extra medicine to make up the missed dose.

What should I discuss with my healthcare provider before taking pancrelipase? You should not take pancrelipase if you are allergic to pork proteins.

If you have any of these other conditions, you may need a pancrelipase dose adjustment or special tests:

kidney disease;

gout;

a history of blockage in your intestines;

a sudden onset of pancreatitis; or

worsening of chronic pancreatic disease.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether pancrelipase passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take pancrelipase?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Pancrelipase should be taken with a meal or snack. Take the medicine with a full glass of water or juice.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

You may open the pancrelipase capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store in the original container at room temperature (below 78 degrees F) for up to 12 weeks. Protect from moisture or high heat. Keep the bottle tightly closed when not in use. If the medication is exposed to temperatures between 78 and 104 degrees F, throw it away after 30 days. Do not use any pancrelipase that has been exposed to temperatures above 104 degrees F. What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include diarrhea or stomach upset.

What should I avoid while taking pancrelipase?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Pancrelipase side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.

Less serious side effects may include:

nausea or vomiting;

mild stomach pain or upset;

diarrhea or constipation;

bloating or gas.

greasy stools;

rectal irritation;

headache, dizziness;

cough; or

weight loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect pancrelipase?

There may be other drugs that can interact with pancrelipase. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Pancrease MT 10 resources Pancrease MT 10 Side Effects (in more detail) Pancrease MT 10 Use in Pregnancy & Breastfeeding Drug Images Pancrease MT 10 Drug Interactions Pancrease MT 10 Support Group 0 Reviews for Pancrease MT0 - Add your own review/rating Pancrelipase Professional Patient Advice (Wolters Kluwer) Pancrelipase Prescribing Information (FDA) Pancrelipase Monograph (AHFS DI) Pancrelipase MedFacts Consumer Leaflet (Wolters Kluwer) Creon Prescribing Information (FDA) Creon Advanced Consumer (Micromedex) - Includes Dosage Information Creon MedFacts Consumer Leaflet (Wolters Kluwer) Creon Consumer Overview Creon 10 Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer) Dygase MedFacts Consumer Leaflet (Wolters Kluwer) Pancreaze Consumer Overview Pancreaze Prescribing Information (FDA) Zenpep Prescribing Information (FDA) Zenpep Consumer Overview Compare Pancrease MT 10 with other medications Chronic Pancreatitis Cystic Fibrosis Pancreatic Exocrine Dysfunction Where can I get more information? Your pharmacist can provide more information about pancrelipase.

See also: Pancrease MT0 side effects (in more detail)


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Pancrecarb MS-8


Generic Name: pancrelipase (oral) (pan kre LYE pace)
Brand Names: Cotazym, Creon, Dygase, Ku-Zyme, Ku-Zyme HP, Kutrase, Lapase, Palcaps 10, Pancrease MT 10, Pancrease MT 16, Pancrease MT 20, Pancrease MT 4, Pancrecarb MS-16, Pancrecarb MS-4, Pancrecarb MS-8, Panocaps, Panocaps MT 16, Ultrase, Ultrase MT 12, Ultrase MT 18, Ultrase MT 20, Viokase, Viokase 16, Zenpep

What is pancrelipase?

Pancrelipase is 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.

Pancrelipase 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.

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

Pancrelipase may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about pancrelipase? You should not take pancrelipase if you are allergic to pork proteins.

Before taking pancrelipase, tell your doctor if you have gout, kidney disease, a history of intestinal blockage, a sudden onset of pancreatitis, or worsening of chronic pancreatic disease.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

If you miss a dose of this medicine, skip the missed dose and wait until your next scheduled dose to take the medicine. Do not take extra medicine to make up the missed dose.

What should I discuss with my healthcare provider before taking pancrelipase? You should not take pancrelipase if you are allergic to pork proteins.

If you have any of these other conditions, you may need a pancrelipase dose adjustment or special tests:

kidney disease;

gout;

a history of blockage in your intestines;

a sudden onset of pancreatitis; or

worsening of chronic pancreatic disease.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether pancrelipase passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take pancrelipase?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Pancrelipase should be taken with a meal or snack. Take the medicine with a full glass of water or juice.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

You may open the pancrelipase capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store in the original container at room temperature (below 78 degrees F) for up to 12 weeks. Protect from moisture or high heat. Keep the bottle tightly closed when not in use. If the medication is exposed to temperatures between 78 and 104 degrees F, throw it away after 30 days. Do not use any pancrelipase that has been exposed to temperatures above 104 degrees F. What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include diarrhea or stomach upset.

What should I avoid while taking pancrelipase?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Pancrelipase side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.

Less serious side effects may include:

nausea or vomiting;

mild stomach pain or upset;

diarrhea or constipation;

bloating or gas.

greasy stools;

rectal irritation;

headache, dizziness;

cough; or

weight loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect pancrelipase?

There may be other drugs that can interact with pancrelipase. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Pancrecarb MS-8 resources Pancrecarb MS-8 Side Effects (in more detail) Pancrecarb MS-8 Use in Pregnancy & Breastfeeding Drug Images Pancrecarb MS-8 Drug Interactions Pancrecarb MS-8 Support Group 0 Reviews for Pancrecarb MS-8 - Add your own review/rating Pancrelipase Professional Patient Advice (Wolters Kluwer) Pancrelipase Prescribing Information (FDA) Pancrelipase Monograph (AHFS DI) Pancrelipase MedFacts Consumer Leaflet (Wolters Kluwer) Creon Prescribing Information (FDA) Creon Advanced Consumer (Micromedex) - Includes Dosage Information Creon MedFacts Consumer Leaflet (Wolters Kluwer) Creon Consumer Overview Creon 10 Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer) Dygase MedFacts Consumer Leaflet (Wolters Kluwer) Pancreaze Consumer Overview Pancreaze Prescribing Information (FDA) Zenpep Prescribing Information (FDA) Zenpep Consumer Overview Compare Pancrecarb MS-8 with other medications Chronic Pancreatitis Cystic Fibrosis Pancreatic Exocrine Dysfunction Where can I get more information? Your pharmacist can provide more information about pancrelipase.

See also: Pancrecarb MS-8 side effects (in more detail)


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Viokase 8


Generic Name: pancrelipase (oral) (pan kre LYE pace)
Brand Names: Cotazym, Creon, Dygase, Ku-Zyme, Ku-Zyme HP, Kutrase, Lapase, Palcaps 10, Pancrease MT 10, Pancrease MT 16, Pancrease MT 20, Pancrease MT 4, Pancrecarb MS-16, Pancrecarb MS-4, Pancrecarb MS-8, Panocaps, Panocaps MT 16, Ultrase, Ultrase MT 12, Ultrase MT 18, Ultrase MT 20, Viokase, Viokase 16, Zenpep

What is pancrelipase?

Pancrelipase is 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.

Pancrelipase 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.

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

Pancrelipase may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about pancrelipase? You should not take pancrelipase if you are allergic to pork proteins.

Before taking pancrelipase, tell your doctor if you have gout, kidney disease, a history of intestinal blockage, a sudden onset of pancreatitis, or worsening of chronic pancreatic disease.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

If you miss a dose of this medicine, skip the missed dose and wait until your next scheduled dose to take the medicine. Do not take extra medicine to make up the missed dose.

What should I discuss with my healthcare provider before taking pancrelipase? You should not take pancrelipase if you are allergic to pork proteins.

If you have any of these other conditions, you may need a pancrelipase dose adjustment or special tests:

kidney disease;

gout;

a history of blockage in your intestines;

a sudden onset of pancreatitis; or

worsening of chronic pancreatic disease.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether pancrelipase passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take pancrelipase?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Pancrelipase should be taken with a meal or snack. Take the medicine with a full glass of water or juice.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

You may open the pancrelipase capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store in the original container at room temperature (below 78 degrees F) for up to 12 weeks. Protect from moisture or high heat. Keep the bottle tightly closed when not in use. If the medication is exposed to temperatures between 78 and 104 degrees F, throw it away after 30 days. Do not use any pancrelipase that has been exposed to temperatures above 104 degrees F. What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include diarrhea or stomach upset.

What should I avoid while taking pancrelipase?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Pancrelipase side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.

Less serious side effects may include:

nausea or vomiting;

mild stomach pain or upset;

diarrhea or constipation;

bloating or gas.

greasy stools;

rectal irritation;

headache, dizziness;

cough; or

weight loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect pancrelipase?

There may be other drugs that can interact with pancrelipase. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Viokase 8 resources Viokase 8 Side Effects (in more detail) Viokase 8 Use in Pregnancy & Breastfeeding Viokase 8 Drug Interactions Viokase 8 Support Group 0 Reviews for Viokase 8 - Add your own review/rating Pancrelipase Professional Patient Advice (Wolters Kluwer) Pancrelipase Prescribing Information (FDA) Pancrelipase Monograph (AHFS DI) Pancrelipase MedFacts Consumer Leaflet (Wolters Kluwer) Creon Prescribing Information (FDA) Creon Advanced Consumer (Micromedex) - Includes Dosage Information Creon MedFacts Consumer Leaflet (Wolters Kluwer) Creon Consumer Overview Creon 10 Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer) Dygase MedFacts Consumer Leaflet (Wolters Kluwer) Pancreaze Consumer Overview Pancreaze Prescribing Information (FDA) Zenpep Prescribing Information (FDA) Zenpep Consumer Overview Compare Viokase 8 with other medications Chronic Pancreatitis Cystic Fibrosis Pancreatic Exocrine Dysfunction Where can I get more information? Your pharmacist can provide more information about pancrelipase.

See also: Viokase 8 side effects (in more detail)


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Palcaps 10


Generic Name: pancrelipase (oral) (pan kre LYE pace)
Brand Names: Cotazym, Creon, Dygase, Ku-Zyme, Ku-Zyme HP, Kutrase, Lapase, Palcaps 10, Pancrease MT 10, Pancrease MT 16, Pancrease MT 20, Pancrease MT 4, Pancrecarb MS-16, Pancrecarb MS-4, Pancrecarb MS-8, Panocaps, Panocaps MT 16, Ultrase, Ultrase MT 12, Ultrase MT 18, Ultrase MT 20, Viokase, Viokase 16, Zenpep

What is pancrelipase?

Pancrelipase is 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.

Pancrelipase 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.

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

Pancrelipase may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about pancrelipase? You should not take pancrelipase if you are allergic to pork proteins.

Before taking pancrelipase, tell your doctor if you have gout, kidney disease, a history of intestinal blockage, a sudden onset of pancreatitis, or worsening of chronic pancreatic disease.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

If you miss a dose of this medicine, skip the missed dose and wait until your next scheduled dose to take the medicine. Do not take extra medicine to make up the missed dose.

What should I discuss with my healthcare provider before taking pancrelipase? You should not take pancrelipase if you are allergic to pork proteins.

If you have any of these other conditions, you may need a pancrelipase dose adjustment or special tests:

kidney disease;

gout;

a history of blockage in your intestines;

a sudden onset of pancreatitis; or

worsening of chronic pancreatic disease.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether pancrelipase passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take pancrelipase?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Pancrelipase should be taken with a meal or snack. Take the medicine with a full glass of water or juice.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

You may open the pancrelipase capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store in the original container at room temperature (below 78 degrees F) for up to 12 weeks. Protect from moisture or high heat. Keep the bottle tightly closed when not in use. If the medication is exposed to temperatures between 78 and 104 degrees F, throw it away after 30 days. Do not use any pancrelipase that has been exposed to temperatures above 104 degrees F. What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include diarrhea or stomach upset.

What should I avoid while taking pancrelipase?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Pancrelipase side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.

Less serious side effects may include:

nausea or vomiting;

mild stomach pain or upset;

diarrhea or constipation;

bloating or gas.

greasy stools;

rectal irritation;

headache, dizziness;

cough; or

weight loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect pancrelipase?

There may be other drugs that can interact with pancrelipase. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Palcaps 10 resources Palcaps 10 Side Effects (in more detail) Palcaps 10 Use in Pregnancy & Breastfeeding Palcaps 10 Drug Interactions Palcaps 10 Support Group 0 Reviews for Palcaps0 - Add your own review/rating Pancrelipase Professional Patient Advice (Wolters Kluwer) Pancrelipase Prescribing Information (FDA) Pancrelipase Monograph (AHFS DI) Pancrelipase MedFacts Consumer Leaflet (Wolters Kluwer) Creon Prescribing Information (FDA) Creon Advanced Consumer (Micromedex) - Includes Dosage Information Creon MedFacts Consumer Leaflet (Wolters Kluwer) Creon Consumer Overview Creon 10 Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer) Dygase MedFacts Consumer Leaflet (Wolters Kluwer) Pancreaze Consumer Overview Pancreaze Prescribing Information (FDA) Zenpep Prescribing Information (FDA) Zenpep Consumer Overview Compare Palcaps 10 with other medications Chronic Pancreatitis Cystic Fibrosis Pancreatic Exocrine Dysfunction Where can I get more information? Your pharmacist can provide more information about pancrelipase.

See also: Palcaps0 side effects (in more detail)


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Cotazym-S


Generic Name: pancrelipase (oral) (pan kre LYE pace)
Brand Names: Cotazym, Creon, Dygase, Ku-Zyme, Ku-Zyme HP, Kutrase, Lapase, Palcaps 10, Pancrease MT 10, Pancrease MT 16, Pancrease MT 20, Pancrease MT 4, Pancrecarb MS-16, Pancrecarb MS-4, Pancrecarb MS-8, Panocaps, Panocaps MT 16, Ultrase, Ultrase MT 12, Ultrase MT 18, Ultrase MT 20, Viokase, Viokase 16, Zenpep

What is pancrelipase?

Pancrelipase is 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.

Pancrelipase 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.

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

Pancrelipase may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about pancrelipase? You should not take pancrelipase if you are allergic to pork proteins.

Before taking pancrelipase, tell your doctor if you have gout, kidney disease, a history of intestinal blockage, a sudden onset of pancreatitis, or worsening of chronic pancreatic disease.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

If you miss a dose of this medicine, skip the missed dose and wait until your next scheduled dose to take the medicine. Do not take extra medicine to make up the missed dose.

What should I discuss with my healthcare provider before taking pancrelipase? You should not take pancrelipase if you are allergic to pork proteins.

If you have any of these other conditions, you may need a pancrelipase dose adjustment or special tests:

kidney disease;

gout;

a history of blockage in your intestines;

a sudden onset of pancreatitis; or

worsening of chronic pancreatic disease.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether pancrelipase passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take pancrelipase?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Pancrelipase should be taken with a meal or snack. Take the medicine with a full glass of water or juice.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

You may open the pancrelipase capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store in the original container at room temperature (below 78 degrees F) for up to 12 weeks. Protect from moisture or high heat. Keep the bottle tightly closed when not in use. If the medication is exposed to temperatures between 78 and 104 degrees F, throw it away after 30 days. Do not use any pancrelipase that has been exposed to temperatures above 104 degrees F. What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include diarrhea or stomach upset.

What should I avoid while taking pancrelipase?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Pancrelipase side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.

Less serious side effects may include:

nausea or vomiting;

mild stomach pain or upset;

diarrhea or constipation;

bloating or gas.

greasy stools;

rectal irritation;

headache, dizziness;

cough; or

weight loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect pancrelipase?

There may be other drugs that can interact with pancrelipase. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Cotazym-S resources Cotazym-S Side Effects (in more detail) Cotazym-S Use in Pregnancy & Breastfeeding Drug Images Cotazym-S Drug Interactions Cotazym-S Support Group 0 Reviews for Cotazym-S - Add your own review/rating Pancrelipase Professional Patient Advice (Wolters Kluwer) Pancrelipase Prescribing Information (FDA) Pancrelipase Monograph (AHFS DI) Pancrelipase MedFacts Consumer Leaflet (Wolters Kluwer) Creon Prescribing Information (FDA) Creon Advanced Consumer (Micromedex) - Includes Dosage Information Creon MedFacts Consumer Leaflet (Wolters Kluwer) Creon Consumer Overview Creon 10 Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer) Dygase MedFacts Consumer Leaflet (Wolters Kluwer) Pancreaze Consumer Overview Pancreaze Prescribing Information (FDA) Zenpep Prescribing Information (FDA) Zenpep Consumer Overview Compare Cotazym-S with other medications Chronic Pancreatitis Cystic Fibrosis Pancreatic Exocrine Dysfunction Where can I get more information? Your pharmacist can provide more information about pancrelipase.

See also: Cotazym-S side effects (in more detail)


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Lipram


Generic Name: pancrelipase (oral) (pan kre LYE pace)
Brand Names: Cotazym, Creon, Dygase, Ku-Zyme, Ku-Zyme HP, Kutrase, Lapase, Palcaps 10, Pancrease MT 10, Pancrease MT 16, Pancrease MT 20, Pancrease MT 4, Pancrecarb MS-16, Pancrecarb MS-4, Pancrecarb MS-8, Panocaps, Panocaps MT 16, Ultrase, Ultrase MT 12, Ultrase MT 18, Ultrase MT 20, Viokase, Viokase 16, Zenpep

What is pancrelipase?

Pancrelipase is 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.

Pancrelipase 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.

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

Pancrelipase may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about pancrelipase? You should not take pancrelipase if you are allergic to pork proteins.

Before taking pancrelipase, tell your doctor if you have gout, kidney disease, a history of intestinal blockage, a sudden onset of pancreatitis, or worsening of chronic pancreatic disease.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

If you miss a dose of this medicine, skip the missed dose and wait until your next scheduled dose to take the medicine. Do not take extra medicine to make up the missed dose.

What should I discuss with my healthcare provider before taking pancrelipase? You should not take pancrelipase if you are allergic to pork proteins.

If you have any of these other conditions, you may need a pancrelipase dose adjustment or special tests:

kidney disease;

gout;

a history of blockage in your intestines;

a sudden onset of pancreatitis; or

worsening of chronic pancreatic disease.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether pancrelipase passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take pancrelipase?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Pancrelipase should be taken with a meal or snack. Take the medicine with a full glass of water or juice.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

You may open the pancrelipase capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store in the original container at room temperature (below 78 degrees F) for up to 12 weeks. Protect from moisture or high heat. Keep the bottle tightly closed when not in use. If the medication is exposed to temperatures between 78 and 104 degrees F, throw it away after 30 days. Do not use any pancrelipase that has been exposed to temperatures above 104 degrees F. What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include diarrhea or stomach upset.

What should I avoid while taking pancrelipase?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Pancrelipase side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.

Less serious side effects may include:

nausea or vomiting;

mild stomach pain or upset;

diarrhea or constipation;

bloating or gas.

greasy stools;

rectal irritation;

headache, dizziness;

cough; or

weight loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect pancrelipase?

There may be other drugs that can interact with pancrelipase. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Lipram resources Lipram Side Effects (in more detail) Lipram Use in Pregnancy & Breastfeeding Drug Images Lipram Drug Interactions Lipram Support Group 0 Reviews for Lipram - Add your own review/rating Pancrelipase Professional Patient Advice (Wolters Kluwer) Pancrelipase Prescribing Information (FDA) Pancrelipase Monograph (AHFS DI) Pancrelipase MedFacts Consumer Leaflet (Wolters Kluwer) Creon Prescribing Information (FDA) Creon Advanced Consumer (Micromedex) - Includes Dosage Information Creon MedFacts Consumer Leaflet (Wolters Kluwer) Creon Consumer Overview Creon 10 Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer) Dygase MedFacts Consumer Leaflet (Wolters Kluwer) Pancreaze Consumer Overview Pancreaze Prescribing Information (FDA) Zenpep Prescribing Information (FDA) Zenpep Consumer Overview Compare Lipram with other medications Chronic Pancreatitis Cystic Fibrosis Pancreatic Exocrine Dysfunction Where can I get more information? Your pharmacist can provide more information about pancrelipase.

See also: Lipram side effects (in more detail)


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Panocaps


Generic Name: pancrelipase (oral) (pan kre LYE pace)
Brand Names: Cotazym, Creon, Dygase, Ku-Zyme, Ku-Zyme HP, Kutrase, Lapase, Palcaps 10, Pancrease MT 10, Pancrease MT 16, Pancrease MT 20, Pancrease MT 4, Pancrecarb MS-16, Pancrecarb MS-4, Pancrecarb MS-8, Panocaps, Panocaps MT 16, Ultrase, Ultrase MT 12, Ultrase MT 18, Ultrase MT 20, Viokase, Viokase 16, Zenpep

What is pancrelipase?

Pancrelipase is 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.

Pancrelipase 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.

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

Pancrelipase may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about pancrelipase? You should not take pancrelipase if you are allergic to pork proteins.

Before taking pancrelipase, tell your doctor if you have gout, kidney disease, a history of intestinal blockage, a sudden onset of pancreatitis, or worsening of chronic pancreatic disease.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

If you miss a dose of this medicine, skip the missed dose and wait until your next scheduled dose to take the medicine. Do not take extra medicine to make up the missed dose.

What should I discuss with my healthcare provider before taking pancrelipase? You should not take pancrelipase if you are allergic to pork proteins.

If you have any of these other conditions, you may need a pancrelipase dose adjustment or special tests:

kidney disease;

gout;

a history of blockage in your intestines;

a sudden onset of pancreatitis; or

worsening of chronic pancreatic disease.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether pancrelipase passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take pancrelipase?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Pancrelipase should be taken with a meal or snack. Take the medicine with a full glass of water or juice.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

You may open the pancrelipase capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store in the original container at room temperature (below 78 degrees F) for up to 12 weeks. Protect from moisture or high heat. Keep the bottle tightly closed when not in use. If the medication is exposed to temperatures between 78 and 104 degrees F, throw it away after 30 days. Do not use any pancrelipase that has been exposed to temperatures above 104 degrees F. What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include diarrhea or stomach upset.

What should I avoid while taking pancrelipase?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Pancrelipase side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.

Less serious side effects may include:

nausea or vomiting;

mild stomach pain or upset;

diarrhea or constipation;

bloating or gas.

greasy stools;

rectal irritation;

headache, dizziness;

cough; or

weight loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect pancrelipase?

There may be other drugs that can interact with pancrelipase. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Panocaps resources Panocaps Side Effects (in more detail) Panocaps Use in Pregnancy & Breastfeeding Panocaps Drug Interactions Panocaps Support Group 0 Reviews for Panocaps - Add your own review/rating Panocaps Advanced Consumer (Micromedex) - Includes Dosage Information Pancrelipase Monograph (AHFS DI) Pancrelipase Prescribing Information (FDA) Pancrelipase Professional Patient Advice (Wolters Kluwer) Pancrelipase MedFacts Consumer Leaflet (Wolters Kluwer) Creon Prescribing Information (FDA) Creon MedFacts Consumer Leaflet (Wolters Kluwer) Creon Consumer Overview Creon 10 Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer) Dygase MedFacts Consumer Leaflet (Wolters Kluwer) Pancreaze Consumer Overview Pancreaze Prescribing Information (FDA) Zenpep Prescribing Information (FDA) Zenpep Consumer Overview Compare Panocaps with other medications Chronic Pancreatitis Cystic Fibrosis Pancreatic Exocrine Dysfunction Where can I get more information? Your pharmacist can provide more information about pancrelipase.

See also: Panocaps side effects (in more detail)


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Zenpep


Generic Name: pancrelipase (oral) (pan kre LYE pace)
Brand Names: Cotazym, Creon, Dygase, Ku-Zyme, Ku-Zyme HP, Kutrase, Lapase, Palcaps 10, Pancrease MT 10, Pancrease MT 16, Pancrease MT 20, Pancrease MT 4, Pancrecarb MS-16, Pancrecarb MS-4, Pancrecarb MS-8, Panocaps, Panocaps MT 16, Ultrase, Ultrase MT 12, Ultrase MT 18, Ultrase MT 20, Viokase, Viokase 16, Zenpep

What is pancrelipase?

Pancrelipase is 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.

Pancrelipase 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.

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

Pancrelipase may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about pancrelipase? You should not take pancrelipase if you are allergic to pork proteins.

Before taking pancrelipase, tell your doctor if you have gout, kidney disease, a history of intestinal blockage, a sudden onset of pancreatitis, or worsening of chronic pancreatic disease.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

If you miss a dose of this medicine, skip the missed dose and wait until your next scheduled dose to take the medicine. Do not take extra medicine to make up the missed dose.

What should I discuss with my healthcare provider before taking pancrelipase? You should not take pancrelipase if you are allergic to pork proteins.

If you have any of these other conditions, you may need a pancrelipase dose adjustment or special tests:

kidney disease;

gout;

a history of blockage in your intestines;

a sudden onset of pancreatitis; or

worsening of chronic pancreatic disease.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether pancrelipase passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take pancrelipase?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Pancrelipase should be taken with a meal or snack. Take the medicine with a full glass of water or juice.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

You may open the pancrelipase capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store in the original container at room temperature (below 78 degrees F) for up to 12 weeks. Protect from moisture or high heat. Keep the bottle tightly closed when not in use. If the medication is exposed to temperatures between 78 and 104 degrees F, throw it away after 30 days. Do not use any pancrelipase that has been exposed to temperatures above 104 degrees F. What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include diarrhea or stomach upset.

What should I avoid while taking pancrelipase?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Pancrelipase side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.

Less serious side effects may include:

nausea or vomiting;

mild stomach pain or upset;

diarrhea or constipation;

bloating or gas.

greasy stools;

rectal irritation;

headache, dizziness;

cough; or

weight loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect pancrelipase?

There may be other drugs that can interact with pancrelipase. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Zenpep resources Zenpep Side Effects (in more detail) Zenpep Use in Pregnancy & Breastfeeding Zenpep Drug Interactions Zenpep Support Group 0 Reviews for Zenpep - Add your own review/rating Zenpep Prescribing Information (FDA) Zenpep Advanced Consumer (Micromedex) - Includes Dosage Information Zenpep MedFacts Consumer Leaflet (Wolters Kluwer) Zenpep Consumer Overview Pancrelipase Professional Patient Advice (Wolters Kluwer) Pancrelipase Prescribing Information (FDA) Pancrelipase Monograph (AHFS DI) Pancrelipase MedFacts Consumer Leaflet (Wolters Kluwer) Creon Consumer Overview Creon Prescribing Information (FDA) Creon 10 Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer) Dygase MedFacts Consumer Leaflet (Wolters Kluwer) Pancreaze Consumer Overview Pancreaze Prescribing Information (FDA) Compare Zenpep with other medications Chronic Pancreatitis Cystic Fibrosis Pancreatic Exocrine Dysfunction Where can I get more information? Your pharmacist can provide more information about pancrelipase.

See also: Zenpep side effects (in more detail)


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vitamin E


Generic Name: vitamin E (VYE ta min E)
Brand names: Amino-Opti-E, Aqua-E, Aquasol E, Aquavite-E, Aqueous Vitamin E, E Pherol, E-400 Clear, Vita-Plus E Natural, Alpha E, Nutr-E-Sol, Centrum Singles-Vitamin E, TheraTears Nutrition (obsolete)

What is vitamin E?

Vitamin E is an antioxidant that occurs naturally in foods such as nuts, seeds, and leafy green vegetables. Vitamin E is important for many processes in the body.

Vitamin E is used to prevent and to treat a deficiency vitamin E. People with certain diseases may need extra vitamin E.

Vitamin E may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about vitamin E?

Before using vitamin E, tell your healthcare provider if you have liver disease, diabetes, active bleeding, a vitamin K deficiency, retinitis pigmentosa, chronic diarrhea, if you are being treated for cancer, or if you have a history of heart attack, stroke, blood clot, or recent surgery.

Do not use this product without a doctor's advice your doctor if you are pregnant or breast-feeding. Your dose needs may be different during pregnancy or while you are nursing a baby. Do not take vitamin E without a doctor's advice if you are using any type of medication to treat or prevent blood clots.

There are many other drugs that can interact with or be made less effective by vitamin E. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Stop taking vitamin E and call your doctor at once if you have any unusual bleeding or bruising, or if you feel like you might pass out. What should I discuss with my healthcare provider before taking vitamin E?

Before using vitamin E, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to take vitamin E if you have certain medical conditions.

You may need a dose adjustment or special tests if you have:

liver disease;

diabetes;

active or uncontrolled bleeding;

a vitamin K deficiency;

retinitis pigmentosa;

short bowel syndrome;

chronic diarrhea;

a history of heart attack, stroke, or blood clot;

if you have recently had surgery; or

if you are receiving cancer treatment (chemotherapy or radiation).

It is not known whether vitamin E is harmful to an unborn baby. Your dose needs may be different during pregnancy. Do not use this product without a doctor's advice if you are pregnant or plan to become pregnant while using vitamin E. It is not known whether vitamin E passes into breast milk or if it could harm a nursing baby. Your dose needs may be different while you are nursing. Do not use this product without a doctor's advice if you are breast-feeding a baby. How should I take vitamin E?

Take exactly as directed on the label, or as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended.

Take vitamin E with a full glass of water.

The chewable tablet must be chewed completely before you swallow it.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

You may take vitamin E with or without food. You do not need to eat extra fat to help your body absorb vitamin E.

The recommended dietary allowance of vitamin E increases with age. Follow your healthcare provider's instructions. You may also consult the National Academy of Sciences "Dietary Reference Intake" or the U.S. Department of Agriculture's "Dietary Reference Intake" (formerly "Recommended Daily Allowances" or RDA) listings for more information.

Store at room temperature away from moisture and heat.

See also: Vitamin E dosage (in more detail)

What happens if I miss a dose?

Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include unusual bleeding or bruising.

What should I avoid while taking vitamin E?

Avoid taking other vitamins, mineral supplements, or nutritional products without your doctor's advice.

Vitamin E side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop taking vitamin E and call your doctor at once if you have a serious side effect such as:

feeling like you might pass out;

easy bruising; or

unusual bleeding (nose, mouth, vagina, or rectum).

Less serious side effects may include:

nausea, diarrhea, stomach cramps;

tired feeling;

headache;

blurred vision; or

mild rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Vitamin E Dosing Information

Usual Adult Dose for Vitamin E Deficiency:

Treatment: 60 to 75 units orally once daily.
Prevention: 30 units orally once daily.

Usual Adult Dose for Tardive Dyskinesia:

600 to 1600 units orally per day.

Usual Adult Dose for Sickle Cell Anemia:

450 units orally per day.

Usual Adult Dose for Alzheimer's Disease:

1000 units orally twice daily.

Usual Adult Dose for Dietary Supplement:

Oral liquid formulation (AQUA-E): 200 units (10 mL) orally once daily.

Usual Pediatric Dose for Vitamin E Deficiency:

1 unit/kg/day orally of water-miscible vitamin E.

Usual Pediatric Dose for Retinopathy Prophylaxis:

Prevention of retinopathy of prematurity or Bronchopulmonary dysplasia (BPD) secondary to oxygen therapy: 15 to 30 units/kg/day to maintain plasma levels between 1.5 to 2 mcg/mL (may need as high as 100 units/kg/day). Note: AAP considers this use investigational and routine use is not recommended.

Usual Pediatric Dose for Cystic Fibrosis:

100 to 400 units/day orally.

Usual Pediatric Dose for Dietary Supplement:

Dosing: 1 unit vitamin E = 1 mg dl-alpha-tocopherol acetate.
Oral:
Adequate Intake (AI):
1 to less than 6 months: 4 units daily
6 to less than 12 months: 5 units daily
Recommended Daily Allowance (RDA):
1 to 3 years: 6 units daily
4 to 8 years: 7 units daily
9 to 13 years: 11 units daily
13 years and Older: 15 units daily

What other drugs will affect vitamin E? Do not take vitamin E without a doctor's advice if you are using any type of medication to treat or prevent blood clots, such as:

heparin, warfarin (Coumadin);

alteplase (Activase), tenecteplase (TNKase), urokinase (Abbokinase);

argatroban (Acova), bivalirudin (Angiomax), lepirudin (Refludan);

dalteparin (Fragmin), enoxaparin (Lovenox), fondaparinux (Arixtra); or

abciximab (ReoPro), anagrelide (Agrylin), cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine, Aggrenox), eptifibatide (Integrelin), prasugrel (Effient), ticlopidine (Ticlid), tirofiban (Aggrastat).

The following drugs can interact with or be made less effective by vitamin E. Tell your doctor if you are using any of these:

cyclosporine (Gengraf, Neoral, Sandimmune);

diazepam (Valium) and other sedatives;

fluoxetine (Prozac) and other antidepressants;

mineral oil, orlistat (alli, Xenical);

an antibiotic such as clarithromycin (Biaxin), doxycycline (Doryx, Vibramycin), trimethoprim (Bactrim, Septra, SMX-TMP), and others;

antifungal medication such as itraconazole (Sporanox) or ketoconazole (Extina, Ketozole, Nizoral, Xolegal);

cholesterol-lowering medicines such as atorvastatin (Lipitor), cholestyramine (Questran), colestipol (Colestid), simvastatin (Zocor, Simcor), lovastatin (Mevacor, Advicor), pravastatin (Pravachol), niacin (Niaspan, Slo-Niacin), and others;

heart or blood pressure medications such as diltiazem (Cartia, Cardizem), losartan (Cozaar), propranolol (Inderal), verapamil (Calan, Covera, Isoptin), and others;

HIV medicines such as fosamprenavir (Lexiva), ritonavir (Norvir, Kaletra), and others;

narcotic medication such as fentanyl (Actiq, Duragesic, Fentora);

seizure medication such as carbamazepine (Carbatrol, Tegretol), phenobarbital (Solfoton), phenytoin (Dilantin), and others; or

stomach acid reducers such as cimetidine (Tagamet), omeprazole (Prilosec), lansoprazole (Prevacid), and others.

This list is not complete and there are many other drugs that can interact with vitamin E. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More vitamin E resources Vitamin E Dosage Vitamin E Use in Pregnancy & Breastfeeding Vitamin E Drug Interactions Vitamin E Support Group 2 Reviews for Vitamin E - Add your own review/rating Vitamin E Natural MedFacts for Professionals (Wolters Kluwer) Vitamin E Natural MedFacts for Consumers (Wolters Kluwer) Vitamin E Monograph (AHFS DI) vitamin e Advanced Consumer (Micromedex) - Includes Dosage Information Compare vitamin E with other medications Alzheimer's Disease Anemia, Sickle Cell Cystic Fibrosis Dietary Supplementation Nocturnal Leg Cramps Retinopathy Prophylaxis Tardive Dyskinesia Vitamin E Deficiency Where can I get more information? Your pharmacist can provide more information about vitamin E.
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Viokase


Pronunciation: PAN-kree-LYE-pase
Generic Name: Pancrelipase
Brand Name: Viokase
Viokase is used for:

Improving food digestion in patients who cannot digest food properly because they have a pancreas problem (exocrine pancreatic insufficiency) caused by cystic fibrosis or certain other conditions.

Viokase is a digestive enzyme combination. It works by helping the body to digest protein, starch, and fat.

Do NOT use Viokase if: you are allergic to any ingredient in Viokase, including pork proteins you have inflammation of the pancreas (pancreatitis) or a flare-up of long-term pancreas problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Viokase:

Some medical conditions may interact with Viokase. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances (including trypsin, pancreatin, or pancrelipase) if you have gout, high uric acid levels, or a history of kidney problems if you have a history of pancreas problems, stomach or bowel problems (eg, blockage, short bowel syndrome, Crohn disease), or asthma if you have trouble swallowing tablets

Some MEDICINES MAY INTERACT with Viokase. However, no specific interactions with Viokase are known at this time.

Ask your health care provider if Viokase may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Viokase:

Use Viokase as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Viokase by mouth with each meal or a snack as directed by your doctor. Swallow Viokase whole. Do not break, crush, chew, or hold Viokase in your mouth before swallowing. Doing so may increase the risk of mouth irritation from Viokase. Take Viokase with a full glass of water or other fluid. Do not breathe in any powder from this tablet. It may cause irritation of the nose or throat. Do not change brands or dosage forms of Viokase without first checking with your doctor. If you miss a dose of Viokase, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once or take a dose without a snack or a meal.

Ask your health care provider any questions you may have about how to use Viokase.

Important safety information: Viokase may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Viokase with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do NOT take more than the recommended dose without checking with your doctor. Viokase may increase the risk of developing a rare, serious condition called fibrosing colonopathy. When this occurs, it is usually with high doses over a long period of time. It has been most commonly reported in children with cystic fibrosis. Contact your doctor right away if you experience unusual or severe nausea, vomiting, or stomach pain, or severe or persistent loose stools, constipation, or diarrhea. Viokase comes from pork (pig) pancreas tissue. There is an extremely rare risk of developing a viral disease from this product. No cases of viral disease from pork pancreas products have been identified. PREGNANCY and BREAST-FEEDING: It is not known if Viokase can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Viokase while you are pregnant. It is not known if Viokase is found in breast milk. If you are or will be breast-feeding while you use Viokase, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Viokase:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; gas; headache; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); painful, swollen joints; severe or persistent loose stools, diarrhea, or constipation; severe or unusual nausea, vomiting, or stomach pain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Viokase side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Viokase:

Store Viokase at room temperature, up to 77 degrees F (25 degrees C). Store in the original container away from heat, moisture, and light. Do not store in the bathroom. Keep Viokase out of the reach of children and away from pets.

General information: If you have any questions about Viokase, please talk with your doctor, pharmacist, or other health care provider. Viokase is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Viokase. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Viokase resources Viokase Side Effects (in more detail) Viokase Use in Pregnancy & Breastfeeding Viokase Drug Interactions Viokase Support Group 0 Reviews for Viokase - Add your own review/rating Viokase Advanced Consumer (Micromedex) - Includes Dosage Information Pancrelipase Professional Patient Advice (Wolters Kluwer) Pancrelipase Prescribing Information (FDA) Pancrelipase Monograph (AHFS DI) Creon Consumer Overview Creon Prescribing Information (FDA) Pancreaze Consumer Overview Pancreaze Prescribing Information (FDA) Zenpep Prescribing Information (FDA) Zenpep Consumer Overview Compare Viokase with other medications Chronic Pancreatitis Cystic Fibrosis Pancreatic Exocrine Dysfunction
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Formula E 400


Generic Name: vitamin e (Oral route)

VYE-ta-min E

Commonly used brand name(s)

In the U.S.

Alpha-E Aqua Gem-E Aquasol E D-Alpha Gems E-400 E-600 E-Gems Formula E 400 Gamma E-Gems Gamma E Plus Key-E Natural Vitamin Blend E-400IU Nutr-E-Sol

Available Dosage Forms:

Liquid Solution Tablet Capsule, Liquid Filled Tablet, Chewable Powder for Solution Capsule

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin E (class)

Uses For Formula E 400

Vitamins are compounds that you must have for growth and health. They are needed in only small amounts and are available in the foods that you eat. Vitamin E prevents a chemical reaction called oxidation, which can sometimes result in harmful effects in your body. It is also important for the proper function of nerves and muscles.

Some conditions may increase your need for vitamin E. These include:

Intestine disease Liver disease Pancreas disease Surgical removal of stomach

Increased need for vitamin E should be determined by your health care professional.

Infants who are receiving a formula that is not fortified with vitamin E may be likely to have a vitamin E deficiency. Also, diets high in polyunsaturated fatty acids may increase your need for vitamin E.

Claims that vitamin E is effective for treatment of cancer and for prevention or treatment of acne, aging, loss of hair, bee stings, liver spots on the hands, bursitis, diaper rash, frostbite, stomach ulcer, heart attacks, labor pains, certain blood diseases, miscarriage, muscular dystrophy, poor posture, sexual impotence, sterility, infertility, menopause, sunburn, and lung damage from air pollution have not been proven. Although vitamin E is being used to prevent certain types of cancer, there is not enough information to show that this is effective.

Lack of vitamin E is extremely rare, except in people who have a disease in which it is not absorbed into the body.

Vitamin E is available without a prescription.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Vitamin E is found in various foods including vegetable oils (corn, cottonseed, soybean, safflower), wheat germ, whole-grain cereals, and green leafy vegetables. Cooking and storage may destroy some of the vitamin E in foods.

Vitamin supplements alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods. For example, small amounts of fat are needed so that vitamin E can be absorbed into the body.

The daily amount of vitamin E needed is defined in several different ways.

For U.S.— Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy). Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs). For Canada— Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Vitamin E is available in various forms, including d- or dl-alpha tocopheryl acetate, d- or dl-alpha tocopherol, and d- or dl-alpha tocopheryl acid succinate. In the past, the RDA for vitamin E have been expressed in Units. This term has been replaced by alpha tocopherol equivalents (alpha-TE) or milligrams (mg) of d-alpha tocopherol. One Unit is equivalent to 1 mg of dl-alpha tocopherol acetate or 0.6 mg d-alpha tocopherol. Most products available in stores continue to be labeled in Units.

Normal daily recommended intakes in milligrams (mg) of alpha tocopherol equivalents (mg alpha-TE) and Units for vitamin E are generally defined as follows:

                                                  Persons U.S. Canada mg
alpha-TE Units mg
alpha-TE Units   Infants and children
Birth to 3 years of
age 3–6 5–10 3–4 5–6.7 4 to 6 years of age 7 11.7 5 8.3 7 to 10 years of age 7 11.7 6–8 10–13 Adolescent and adult
males 10 16.7 6–10 10–16.7 Adolescent and adult
females 8 13 5–7 8.3–11.7 Pregnant females 10 16.7 8–9 13–15 Breast-feeding
females 11–12 18–20 9–10 15–16.7 Before Using Formula E 400

If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts. You should check with your health care professional if you are giving your baby an unfortified formula. In that case, the baby must get the vitamins needed some other way. Some studies have shown that premature infants may have low levels of vitamin E. Your health care professional may recommend a vitamin E supplement.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts.

Pregnancy Pregnancy Category Explanation All Trimesters A Adequate studies in pregnant women have not shown an increased risk of fetal abnormalities. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this dietary supplement, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this dietary supplement with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Dicumarol

Using this dietary supplement with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Warfarin Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this dietary supplement. Make sure you tell your doctor if you have any other medical problems, especially:

Bleeding problems—Vitamin E, when taken in doses greater than 800 Units a day for long periods of time, may make this condition worse Proper Use of vitamin e

This section provides information on the proper use of a number of products that contain vitamin e. It may not be specific to Formula E 400. Please read with care.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral solution dosage form: To prevent the following deficiencies in infants: Infants receiving a formula high in polyunsaturated fatty acids—15 to 25 Units per day or 7 Units per 32 ounces of formula. Infants with certain colon problems—15 to 25 Units per kilogram (kg) (6.8 to 11 Units per pound) of body weight per day. The water-soluble form of vitamin E must be used. Infants of normal birthweight—5 Units per 32 ounces of formula. For oral dosage forms (capsules, tablets, oral solution): To prevent deficiency for individuals (other than infants), the amount taken by mouth is based on normal daily recommended intakes: For the U.S. Adult and teenage males—10 milligrams (mg) of alpha tocopherol equivalents (mg alpha-TE) or 16.7 Units per day. Adult and teenage females—8 mg alpha-TE or 13 Units per day. Pregnant females—10 mg alpha-TE or 16.7 Units per day. Breast-feeding females—11 to 12 mg alpha-TE or 18 to 20 Units per day. Children 4 to 10 years of age—7 mg alpha-TE or 11.7 Units per day. Children birth to 3 years of age—3 to 6 mg alpha-TE or 5 to 10 Units per day. For Canada Adult and teenage males—6 to 10 mg alpha-TE or 10 to 16.7 Units per day. Adult and teenage females—5 to 7 mg alpha-TE or 8.3 to 11.7 Units per day. Pregnant females—8 to 9 mg alpha-TE or 13 to 15 Units per day. Breast-feeding females—9 to 10 mg alpha-TE or 15 to 16.7 Units per day. Children 7 to 10 years of age—6 to 8 mg alpha-TE or 10 to 13 Units per day. Children 4 to 6 years of age—5 mg alpha-TE or 8.3 Units per day. Children birth to 3 years of age—3 to 4 mg alpha-TE or 5 to 6.7 Units per day. To treat deficiency: Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on the severity of deficiency.

For individuals taking the oral liquid form of this dietary supplement:

This preparation should be taken by mouth even though it comes in a dropper bottle. This dietary supplement may be dropped directly into the mouth or mixed with cereal, fruit juice, or other food. Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the dietary supplement in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Formula E 400 Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

With doses greater than 400 Units a day and long-term use Blurred vision diarrhea dizziness headache nausea or stomach cramps unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Formula E 400 resources Formula E 400 Use in Pregnancy & BreastfeedingFormula E 400 Drug InteractionsFormula E 400 Support Group2 Reviews for Formula E 400 - Add your own review/rating Compare Formula E 400 with other medications Alzheimer's DiseaseAnemia, Sickle CellCystic FibrosisDietary SupplementationNocturnal Leg CrampsRetinopathy ProphylaxisTardive DyskinesiaVitamin E Deficiency
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Nutr-E-Sol


Generic Name: vitamin e (Oral route)

VYE-ta-min E

Commonly used brand name(s)

In the U.S.

Alpha-E Aqua Gem-E Aquasol E D-Alpha Gems E-400 E-600 E-Gems Formula E 400 Gamma E-Gems Gamma E Plus Key-E Natural Vitamin Blend E-400IU Nutr-E-Sol

Available Dosage Forms:

Liquid Solution Tablet Capsule, Liquid Filled Tablet, Chewable Powder for Solution Capsule

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin E (class)

Uses For Nutr-E-Sol

Vitamins are compounds that you must have for growth and health. They are needed in only small amounts and are available in the foods that you eat. Vitamin E prevents a chemical reaction called oxidation, which can sometimes result in harmful effects in your body. It is also important for the proper function of nerves and muscles.

Some conditions may increase your need for vitamin E. These include:

Intestine disease Liver disease Pancreas disease Surgical removal of stomach

Increased need for vitamin E should be determined by your health care professional.

Infants who are receiving a formula that is not fortified with vitamin E may be likely to have a vitamin E deficiency. Also, diets high in polyunsaturated fatty acids may increase your need for vitamin E.

Claims that vitamin E is effective for treatment of cancer and for prevention or treatment of acne, aging, loss of hair, bee stings, liver spots on the hands, bursitis, diaper rash, frostbite, stomach ulcer, heart attacks, labor pains, certain blood diseases, miscarriage, muscular dystrophy, poor posture, sexual impotence, sterility, infertility, menopause, sunburn, and lung damage from air pollution have not been proven. Although vitamin E is being used to prevent certain types of cancer, there is not enough information to show that this is effective.

Lack of vitamin E is extremely rare, except in people who have a disease in which it is not absorbed into the body.

Vitamin E is available without a prescription.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Vitamin E is found in various foods including vegetable oils (corn, cottonseed, soybean, safflower), wheat germ, whole-grain cereals, and green leafy vegetables. Cooking and storage may destroy some of the vitamin E in foods.

Vitamin supplements alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods. For example, small amounts of fat are needed so that vitamin E can be absorbed into the body.

The daily amount of vitamin E needed is defined in several different ways.

For U.S.— Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy). Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs). For Canada— Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Vitamin E is available in various forms, including d- or dl-alpha tocopheryl acetate, d- or dl-alpha tocopherol, and d- or dl-alpha tocopheryl acid succinate. In the past, the RDA for vitamin E have been expressed in Units. This term has been replaced by alpha tocopherol equivalents (alpha-TE) or milligrams (mg) of d-alpha tocopherol. One Unit is equivalent to 1 mg of dl-alpha tocopherol acetate or 0.6 mg d-alpha tocopherol. Most products available in stores continue to be labeled in Units.

Normal daily recommended intakes in milligrams (mg) of alpha tocopherol equivalents (mg alpha-TE) and Units for vitamin E are generally defined as follows:

                                                  Persons U.S. Canada mg
alpha-TE Units mg
alpha-TE Units   Infants and children
Birth to 3 years of
age 3–6 5–10 3–4 5–6.7 4 to 6 years of age 7 11.7 5 8.3 7 to 10 years of age 7 11.7 6–8 10–13 Adolescent and adult
males 10 16.7 6–10 10–16.7 Adolescent and adult
females 8 13 5–7 8.3–11.7 Pregnant females 10 16.7 8–9 13–15 Breast-feeding
females 11–12 18–20 9–10 15–16.7 Before Using Nutr-E-Sol

If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts. You should check with your health care professional if you are giving your baby an unfortified formula. In that case, the baby must get the vitamins needed some other way. Some studies have shown that premature infants may have low levels of vitamin E. Your health care professional may recommend a vitamin E supplement.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts.

Pregnancy Pregnancy Category Explanation All Trimesters A Adequate studies in pregnant women have not shown an increased risk of fetal abnormalities. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this dietary supplement, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this dietary supplement with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Dicumarol

Using this dietary supplement with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Warfarin Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this dietary supplement. Make sure you tell your doctor if you have any other medical problems, especially:

Bleeding problems—Vitamin E, when taken in doses greater than 800 Units a day for long periods of time, may make this condition worse Proper Use of vitamin e

This section provides information on the proper use of a number of products that contain vitamin e. It may not be specific to Nutr-E-Sol. Please read with care.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral solution dosage form: To prevent the following deficiencies in infants: Infants receiving a formula high in polyunsaturated fatty acids—15 to 25 Units per day or 7 Units per 32 ounces of formula. Infants with certain colon problems—15 to 25 Units per kilogram (kg) (6.8 to 11 Units per pound) of body weight per day. The water-soluble form of vitamin E must be used. Infants of normal birthweight—5 Units per 32 ounces of formula. For oral dosage forms (capsules, tablets, oral solution): To prevent deficiency for individuals (other than infants), the amount taken by mouth is based on normal daily recommended intakes: For the U.S. Adult and teenage males—10 milligrams (mg) of alpha tocopherol equivalents (mg alpha-TE) or 16.7 Units per day. Adult and teenage females—8 mg alpha-TE or 13 Units per day. Pregnant females—10 mg alpha-TE or 16.7 Units per day. Breast-feeding females—11 to 12 mg alpha-TE or 18 to 20 Units per day. Children 4 to 10 years of age—7 mg alpha-TE or 11.7 Units per day. Children birth to 3 years of age—3 to 6 mg alpha-TE or 5 to 10 Units per day. For Canada Adult and teenage males—6 to 10 mg alpha-TE or 10 to 16.7 Units per day. Adult and teenage females—5 to 7 mg alpha-TE or 8.3 to 11.7 Units per day. Pregnant females—8 to 9 mg alpha-TE or 13 to 15 Units per day. Breast-feeding females—9 to 10 mg alpha-TE or 15 to 16.7 Units per day. Children 7 to 10 years of age—6 to 8 mg alpha-TE or 10 to 13 Units per day. Children 4 to 6 years of age—5 mg alpha-TE or 8.3 Units per day. Children birth to 3 years of age—3 to 4 mg alpha-TE or 5 to 6.7 Units per day. To treat deficiency: Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on the severity of deficiency.

For individuals taking the oral liquid form of this dietary supplement:

This preparation should be taken by mouth even though it comes in a dropper bottle. This dietary supplement may be dropped directly into the mouth or mixed with cereal, fruit juice, or other food. Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the dietary supplement in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Nutr-E-Sol Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

With doses greater than 400 Units a day and long-term use Blurred vision diarrhea dizziness headache nausea or stomach cramps unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Nutr-E-Sol side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Nutr-E-Sol resources Nutr-E-Sol Side Effects (in more detail)Nutr-E-Sol Use in Pregnancy & BreastfeedingNutr-E-Sol Drug InteractionsNutr-E-Sol Support Group0 Reviews for Nutr-E-Sol - Add your own review/rating Nutr-E-Sol Concise Consumer Information (Cerner Multum) Amino-Opti-E Concise Consumer Information (Cerner Multum) Aquasol E Monograph (AHFS DI) Vitamin E Natural MedFacts for Professionals (Wolters Kluwer) Vitamin E Natural MedFacts for Consumers (Wolters Kluwer) Compare Nutr-E-Sol with other medications Alzheimer's DiseaseAnemia, Sickle CellCystic FibrosisDietary SupplementationNocturnal Leg CrampsRetinopathy ProphylaxisTardive DyskinesiaVitamin E Deficiency
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Metalyse 8,000 units


Metalyse

8,000 units powder and solvent for solution for injection

Tenecteplase

Read all of this leaflet carefully before you start receiving this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet:

1. What METALYSE is and what it is used for
2. Before you receive METALYSE
3. How is METALYSE administered
4. Possible side effects
5. How to store METALYSE
6. Further information

What Metalyse Is And What It Is Used For

METALYSE is a powder and solvent for solution for injection. This means that each pack contains:

one vial of 8,000 units METALYSE powder and one pre-filled syringe containing 8 ml water for injections.

Before use, the solvent (water for injections) is added to the powder to form a solution that is given by injection.

METALYSE belongs to a group of medicines called thrombolytic agents. These medicines help to dissolve blood clots. Tenecteplase is a recombinant fibrin-specific plasminogen activator.

METALYSE is used to treat myocardial infarctions (heart attacks) within 6 hours after the onset of symptoms and helps to dissolve the blood clots that have formed in the blood vessels of the heart. This helps to prevent the damage caused by heart attacks and has been shown to save lives.

Before You Receive Metalyse

METALYSE will not be prescribed and given by your doctor

if you have previously had a sudden life-threatening allergic reaction (severe hypersensitivity) to the active ingredient tenecteplase, to gentamicin (a trace residue from the manufacturing process) or any of the other ingredients of METALYSE. If treatment with Metalyse is nevertheless considered to be necessary, facilities for reanimation should be immediately available in case of need; if you have, or have recently had, an illness that increases your risk of bleeding (haemorrhage), including: a bleeding disorder or tendency to bleed (haemorrhage) stroke (cerebrovascular event) very high, uncontrolled blood pressure a head injury severe liver disease a stomach ulcer (peptic ulcer) varicose veins in the gullet (oesophageal varices) abnormality of the blood vessels (e.g. an aneurysm) certain tumours inflammation of the lining around the heart (pericarditis); inflammation or infection of the heart valves (endocarditis); if you are taking tablets/capsules used to “thin” the blood, such as warfarin or coumarin (anti-coagulants); if you have an inflamed pancreas (pancreatitis); if you have recently had major surgery including surgery to your brain or spine; if you have been given cardiopulmonary resuscitation (chest compressions) for more than 2 minutes duration, in the last two weeks. Your doctor will take special care with METALYSE if you have had any allergic reaction other than a sudden life-threatening allergic reaction (severe hypersensitive) to the active substance tenecteplase, to gentamicin (a trace residue from the manufacturing process), or to any of the other ingredients of Metalyse (see section 6: “Further information”); if you have high blood pressure; if you have problems with circulation of blood in the brain (cerebrovascular disease); if you have had gastrointestinal (gut) or genitourinary bleeding within the last ten days (this may cause blood in stools or urine); if you have a heart valve abnormality (e.g. mitral stenosis) with an abnormal heart rhythm (e.g. atrial fibrillation); if you have had an intramuscular injection in the last two days; if you are aged over 75 years; if you weigh less than 60 kg. Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Ask your doctor for advice before you are given METALYSE.

How Is Metalyse Administered

The doctor calculates your dose of METALYSE according to your bodyweight, based on the following scheme:

Bodyweight less than 60kg 6,000 units

Bodyweight 60 to 70kg 7,000 units

Bodyweight 70 to 80kg 8,000 units

Bodyweight 80 to 90kg 9,000 units

Bodyweight above 90kg 10,000 units

Your doctor will give you medication to prevent blood clotting in addition to METALYSE, as soon as possible after your chest pain starts.

METALYSE is given by a single injection into a vein by a doctor who is experienced in the use of this type of drug.

Your doctor will give METALYSE as soon as possible after your chest pain starts as a single dose.

Repetition is not recommended.

Possible Side Effects

Like all medicines, METALYSE can cause side effects, although not everybody gets them.

Evaluation of side effects is based on the following frequencies:

very common: affects more than 1 user in 10

common: affects 1 to 10 users in 100

uncommon: affects 1 to 10 users in 1,000

rare: affects 1 to 10 users in 10,000

very rare: affects less than 1 user in 10,000

not known: frequency cannot be estimated from the available data

The side effects described below have been experienced by people given METALYSE:

Very Common:

bleeding

Common:

bleeding at the injection or puncture site nosebleeds genitourinary bleeding (you may notice blood in your urine) bruising gastro-intestinal bleeding (e.g. bleeding from the stomach or bowel)

Uncommon:

irregular heart beat (reperfusion arrhythmias), sometimes leading to cardiac arrest internal bleeding in the abdomen (retroperitoneal bleeding) bleeding in the brain (cerebral haemorrhage). Death or permanent disability may occur following bleeding in the brain or other serious bleeding events bleeding in the eyes (eye haemorrhage)

Rare:

low blood pressure (hypotension) bleeding in the lungs (pulmonary haemorrhage) hypersensitivity (anaphylactoid reactions) e.g. rash, hives (urticaria), swelling of the throat bleeding into the area surrounding the heart (haemopericardium) blood clot in the lung (pulmonary embolism) and in the vessels of other organ systems (thrombotic embolisation)

Not known :

fat embolism (clots consisting of fat) nausea vomiting body temperature increased (fever) blood transfusions as consequence of bleedings

As with other thrombolytic agents, the following events have been reported as sequelae of myocardial infarction and/or thrombolytic administration:

Very common:

Low blood pressure (hypotension) Irregular heart beat Chest pain (angina pectoris)

Common:

Further heart attack (recurrent ischaemia) Heart failure Shock due to heart failure Inflammation of the lining around the heart Fluid in the lungs (pulmonary oedema)

Uncommon:

Heart arrest Problem with the heart valve or heart lining (mitral valve incompetence, pericardial effusion) Blood clot in the veins (venous thrombosis) Fluid between the heart lining and the heart (cardiac tamponade) Rupture of the heart muscle (myocardial rupture)

Rare:

Blood clot in the lung (pulmonary embolism)

These cardiovascular events can be life-threatening and may lead to death.

In case of bleeding in the brain events related to the nervous system have been reported e.g. drowsiness (somnolence), speech disorders, palsy of parts of the body (hemiparesis) and fits (convulsions).

Tell your doctor immediately if you think you are experiencing any of these side effects.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Metalyse

Keep out of the reach and sight of children.

Do not store above 30°C.

Keep the container in the outer carton in order to protect from light.

Once METALYSE has been reconstituted it may be stored for 24 hours at 2-8°C and 8 hours at 30°C. However, for microbiological reasons your doctor will normally use the reconstituted solution for injection immediately.

Do not use METALYSE after the expiry date which is stated on the label/carton.

Further Information What METALYSE contains The active substance is tenecteplase. One vial contains 8,000 units of tenecteplase. One pre-filled syringe contains 8 ml of water for injections. The other ingredients are L-arginine, phosphoric acid and polysorbate 20. The METALYSE solvent is water for injections. Gentamicin is contained as trace residue from the manufacturing process. What METALYSE looks like and contents of the pack

The folding box contains one vial with a lyophilised powder, one ready for use syringe with a solvent, one vial adapter and one needle.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG Birkendorfer Strasse 65 D-88397 Biberach/Riss Germany

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom Boehringer Ingelheim Ltd. Tel:+44 1344 424 600

This leaflet was last approved in 06/2010

Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu

74366-01


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urofollitropin


Generic Name: urofollitropin (UE roe FOL i TROE pin)
Brand names: Bravelle, Metrodin, Fertinex

What is urofollitropin?

Urofollitropin is a purified form of a hormone called follicle-stimulating hormone (FSH). FSH is important in the development of follicles (eggs) that are produced by the ovaries in women.

Urofollitropin is used to treat infertility in women whose own natural FSH is not sufficient in stimulating follicles to mature. Urofollitropin also is used to help the ovaries produce multiple eggs for use in "in vitro" fertilization.

Urofollitropin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about urofollitropin? Some women using this medicine have developed a condition called ovarian hyperstimulation syndrome (OHSS). This syndrome may be more likely to occur within the first 10 days after receiving the last dose in a treatment cycle. OHSS can be a life-threatening condition. Call your doctor right away if you have any symptoms of OHSS: severe pelvic pain, swelling of the hands or legs, stomach pain and swelling, shortness of breath, weight gain, diarrhea, nausea or vomiting, and urinating less than usual.

Using this medicine can increase your chances of having a multiple pregnancy (twins, triplets, quadruplets, etc). A multiple pregnancy is a high-risk pregnancy for the mother and for the babies. Follow your doctor's instructions about any special care you may need during your pregnancy.

Although urofollitropin can help you become pregnant, this medication is in the FDA pregnancy category X. This means that using the medication once you are pregnant can cause birth defects in the baby. Do not use this medication if you are pregnant. Tell your doctor right away if you become pregnant during treatment. What should I discuss with my healthcare provider before using urofollitropin?

Urofollitropin will not cause ovulation (production of an egg by the ovaries). You may need to receive other medications to stimulate ovulation.

You should not use this medication if you are allergic to urofollitropin medications, or if you have:

infertility that is not caused by lack of ovulation;

a condition called primary ovarian failure;

unusual vaginal bleeding;

an ovarian cyst;

a tumor of your pituitary gland;

an untreated or uncontrolled disorder of your thyroid or adrenal gland; or

if you are pregnant.

Using this medicine can increase your chances of having a multiple pregnancy (twins, triplets, quadruplets, etc). A multiple pregnancy is a high-risk pregnancy for the mother and for the babies. Follow your doctor's instructions about any special care you may need during your pregnancy.

Although urofollitropin can help you become pregnant, this medication is in the FDA pregnancy category X. This means that using the medication once you are pregnant can cause birth defects in the baby. Do not use this medication if you are pregnant. Tell your doctor right away if you become pregnant during treatment. It is not known whether urofollitropin passes into breast milk. Do not use urofollitropin without telling your doctor if you are breast-feeding a baby. How should I use urofollitropin?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Urofollitropin is given as an injection under the skin or into a muscle. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Urofollitropin comes as a powder and liquid (diluent) that must be mixed together before you draw your dose into a syringe.

Do not shake the mixture. Vigorous shaking can ruin the medicine. Do not draw your urofollitropin dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it does not clear after mixing, or if it has any particles in it. Call your doctor for a new prescription.

After giving the injection, throw away any portion of the mixed medicine that is not used right away. Do not save it for later use.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

To be sure this medication is helping your condition, your doctor will need to check you on a regular basis. Do not miss any scheduled appointments.

Infertility is often treated with a combination of different drugs. For best results, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.

If you store urofollitropin at home, keep it at room temperature away from light, moisture, and heat. What happens if I miss a dose?

Call your doctor if you miss a dose of urofollitropin.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a urofollitropin overdose are not known.

What should I avoid while using urofollitropin?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using urofollitropin.

Urofollitropin side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Some women using this medicine have developed a condition called ovarian hyperstimulation syndrome (OHSS). This syndrome may be more likely to occur within the first 10 days after receiving the last dose in a treatment cycle. OHSS can be a life-threatening condition. Stop using urofollitropin and call your doctor at once if you have any symptoms of OHSS:

severe pelvic pain;

swelling of your hands or legs;

stomach pain and swelling;

shortness of breath;

weight gain;

nausea, vomiting, diarrhea; or

urinating less than usual.

Less serious side effects may include:

mild stomach upset, constipation;

mild pelvic pain, cramps;

breast tenderness;

skin rash;

hot flashes;

acne; or

pain, swelling, redness, itching, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Urofollitropin Dosing Information

Usual Adult Dose for Follicle Stimulation:

Fertinex in Assisted Reproductive Technologies:
150 international units subcutaneously per day until sufficient follicular development is obtained. In most case, therapy should not exceed 10 days.
Fertinex in polycystic Ovary Syndrome:
75 to 300 international units subcutaneously per day depending on patient response. A response in generally evident after 5 to 7 days.
Bravelle:
150 international units subcutaneously daily for first 5 days. Depending on patient response, dose may be adjusted once every 2 days by 75 to 150 international units per adjustment. The maximum daily dose should not exceed 450 international units and in most cases dosing beyond 12 days is not recommended.

What other drugs will affect urofollitropin?

There may be other drugs that can interact with urofollitropin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More urofollitropin resources Urofollitropin Side Effects (in more detail) Urofollitropin Use in Pregnancy & Breastfeeding Urofollitropin Drug Interactions Urofollitropin Support Group 0 Reviews for Urofollitropin - Add your own review/rating urofollitropin Intramuscular, Subcutaneous, Injection Advanced Consumer (Micromedex) - Includes Dosage Information Urofollitropin Professional Patient Advice (Wolters Kluwer) Bravelle Prescribing Information (FDA) Bravelle MedFacts Consumer Leaflet (Wolters Kluwer) Fertinex MedFacts Consumer Leaflet (Wolters Kluwer) Compare urofollitropin with other medications Female Infertility Follicle Stimulation Where can I get more information? Your pharmacist can provide more information about urofollitropin.

See also: urofollitropin side effects (in more detail)


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Nystatin Powder


Dosage Form: powder
Nystatin Topical Powder, USP

FOR TOPICAL USE ONLY
NOT FOR OPTHALMIC USE

Rx Only
P5196 04/06

Nystatin Powder Description

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei.

Structural formula:

Nystatin topical powder is for dermatologic use.

Nystatin topical powder contains 100,000 USP nystatin units per gram dispersed in talc.

Nystatin Powder - Clinical Pharmacology Phamacokinetics

Nystatin is not absorbed from intact skin or mucous membrane.

Microbiology

Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi, including Candida albicans, C. parapsilosis, C. tropicalis, C. guilliermondi, C. pseudotropicalis, C. krusei, Torulopsis glabrata, Tricophyton rubrum, T. mentagrophytes.

Nystatin acts by binding to sterols in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components. On repeated subculturing with increasing levels of nystatin, Candida albicans does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy. However, other species of Candida (C. tropicalis, C. guilliermondi, C. krusei, and C. stellatoides) become quite resistant on treatment with nystatin and simultaneously become cross resistant to amphotericin as well. This resistance is lost when the antibiotic is removed.

Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

Indications and Usage for Nystatin Powder

Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.

This preparation is not indicated for systemic, oral, intravaginal, or ophthalmic use.

Contraindications

Nystatin topical powder is contraindicated in patients with a history of hypersensitivity to any of its components.

Precautions General

Nystatin topical powder should not be used for the treatment of systemic, oral, intravaginal, or ophthalmic infections.

If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens.

Information for Patients

Patients using this medication should receive the following information and instructions:

The patient should be instructed to use this medication as directed (including the replacement of missed doses). This medication is not for any disorder other than that for which it is prescribed. Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed. If symptoms of irritation develop, the patient should be advised to notify the physician promptly. Laboratory Tests

If there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed to determine the mutagenicity of nystatin or its effects on male or female fertility.

Pregnancy

Teratogenic Effects - Category C

Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether these preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin topical preparations should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

Nursing Mothers

It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.

Pediatric Use

Safety and effectiveness have been established in the pediatric population from birth to 16 years (see DOSAGE AND ADMINISTRATION).

Geriatric Use

Clinical studies with nystatin topical powder did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Adverse Reactions

The frequency of adverse events reported in patients using nystatin topical preparations is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application (see PRECAUTIONS, General).

Nystatin Powder Dosage and Administration

Very moist lesions are best treated with the topical dusting powder.

Adults and Pediatric Patients (Neonates and Older):

Apply to candidal lesions two or three times daily until healing is complete. For fungal infection of the feet caused by Candida species, the powder should be dusted on the feet, as well as in all footwear.

How is Nystatin Powder Supplied

Nystatin topical powder, USP, is supplied as 100,000 units nystatin per gram, packaged as follows:

NDC 58177-839-45 15 gram bottle

NDC 58177-839-46 30 gram bottle

NDC 58177-839-61 60 gram bottle

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] Avoid excessive heat 40°C (104°F). Keep tightly closed.

Manufactured by
KV Pharmaceutical Co. for
ETHEX Corporation
St. Louis, MO 63044

P5196 4/06

Principal Displacy Panel 15 g Bottle Label

NDC 58177-839-45

Nystatin Topical
Powder,USP

100,000 USP
units per gram

15 grams Rx Only

P5194-1 01/06

ETHEX ETHEX

Principal Displacy Panel 30 g Bottle Label

NDC 58177-839-46

Nystatin Topical
Powder,USP

100,000 USP
units per gram

30 grams Rx Only

ETHEX ETHEX

Principal Displacy Panel 60 g Bottle Label

NDC 58177-839-61

Nystatin Topical
Powder,USP

100,000 USP
units per gram

60 grams Rx Only

ETHEX ETHEX


NYSTATIN 
nystatin  powder Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 58177-839 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Nystatin (Nystatin) Nystatin 100000 [USP'U]  in 1 g Inactive Ingredients Ingredient Name Strength Talc   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 58177-839-45 15 g In 1 BOTTLE None 2 58177-839-46 30 g In 1 BOTTLE None 3 58177-839-61 60 g In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065321 10/13/2009
Labeler - Ethex Corporation (615424686) Registrant - KV Pharmaceutical Co. (006291405) Establishment Name Address ID/FEI Operations KV Pharmaceutical Co. (Westport) 152053658 manufacture Establishment Name Address ID/FEI Operations KV Pharmaceutical Co. (ECI) 034060843 analysis Revised: 10/2010Ethex Corporation More Nystatin Powder resources Nystatin Powder Use in Pregnancy & Breastfeeding Nystatin Powder Support Group 6 Reviews for Nystatin - Add your own review/rating Compare Nystatin Powder with other medications Cutaneous Candidiasis Vaginal Yeast Infection
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penicillin G potassium


Generic Name: penicillin G potassium (PEN i SIL in G poe TAS ee um)
Brand Names: Pfizerpen

What is penicillin G potassium?

Penicillin G potassium is a fast-acting antibiotic that fights bacteria in your body.

Penicillin G potassium is used to treat many different types of severe infections, including strep and staph infections, diphtheria, meningitis, gonorrhea, and syphilis.

Penicillin G potassium is also used to prevent infections of the heart valves in people with certain heart conditions who need to have dental work or surgery.

Penicillin G potassium may also be used for purposes not listed in this medication guide.

What is the most important information I should know about penicillin G potassium? You should not use this medication if you are allergic to penicillin. Tell your doctor if you have ever had an allergic reaction to a cephalosporin antibiotic such as Ceftin, Cefzil, Omnicef, Keflex, and others.

Before using penicillin G potassium, tell your doctor if you have asthma or a history of allergies, liver disease, kidney disease, or heart disease.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Penicillin G potassium will not treat a viral infection such as the common cold or flu.

After you have finished your treatment with penicillin G potassium, your doctor may want to do tests to make sure your infection has completely cleared up.

What should I discuss with my healthcare provider before taking penicillin G potassium? You should not use this medication if you are allergic to penicillin. Tell your doctor if you have ever had an allergic reaction to a cephalosporin antibiotic such as Ceftin, Cefzil, Omnicef, Keflex, and others.

To make sure you can safely use penicillin G potassium, tell your doctor if you have any of these other conditions:

asthma or a history of allergies;

liver disease;

kidney disease; or

heart disease.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Penicillin G potassium can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take penicillin G potassium?

Penicillin G potassium is injected into a muscle or into a vein through an IV. You may be shown how to use an injection at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Penicillin G potassium may also be injected into the membrane surrounding the lungs, or into the fluid surrounding the spinal cord. The medicine must be given slowly through an IV infusion, and can take up to 24 hours to complete.

Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Penicillin G potassium will not treat a viral infection such as the common cold or flu.

If you use this medication long-term, your blood may need to be tested to make sure the medicine is not causing harmful effects. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

This medication can cause false results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using penicillin G potassium.

After you have finished your treatment with penicillin G potassium, your doctor may want to do tests to make sure your infection has completely cleared up.

Store the powder at room temperature away from moisture and heat. After mixing the powder with a diluent, store in the refrigerator and use it within 7 days. Do not freeze. Penicillin G potassium that is supplied as a frozen solution should be stored in a deep freezer at a temperature of 4 degrees below 0 (F).

Thaw the solution either in a refrigerator or at room temperature. Do not heat the medicine to thaw it more quickly.

Penicillin G potassium that is thawed in the refrigerator should be used within 14 days. If you have thawed the medicine at room temperature, you must use it within 24 hours. Do not refreeze.

Once the solution has been thawed, it should look clear. Do not use the medicine if it looks cloudy or has particles in it, or if the medicine container leaks. Call your doctor or pharmacist for a new prescription.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include confusion, agitation, hallucinations, or seizure (convulsions).

What should I avoid while taking penicillin G potassium?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking this medication and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Penicillin G potassium side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

diarrhea that is watery or bloody;

blood in your urine;

feeling like you might pass out;

fever, chills, swollen glands, body aches, flu symptoms, rash or itching, muscle or joint pain, night sweats, general ill feeling;

white patches or sores inside your mouth or on your lips;

urinating less than usual or not at all;

skin rash with bruising, severe tingling, numbness, pain, muscle weakness;

swelling in your hands or feet;

pale or yellowed skin, dark colored urine, fever, confusion or weakness;

easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

twitching or uncontrollable muscle movements; or

increased thirst, feeling restless, increased urination, muscle pain or weakness, irregular heart rate, weak pulse, tingly feeling, feeling light-headed, fainting, or seizure (convulsions).

Less serious side effects may include:

overactive reflexes;

nausea, vomiting;

black or hairy tongue; or

pain, swelling, bruising, or irritation around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Penicillin G potassium Dosing Information

Usual Adult Dose for Streptococcal Infection:

Serious infections due to susceptible strains of streptococci (including Streptococcus pneumoniae): 12 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Such infections include septicemia, empyema, pneumonia, pericarditis, endocarditis, and meningitis.

Usual Adult Dose for Bacterial Infection:

Serious infections due to susceptible strains of staphylococci: 5 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Such infections include septicemia, empyema, pneumonia, pericarditis, endocarditis, and meningitis.
Pasteurella infections (including bacteremia and meningitis): 4 million to 6 million units/day IV in divided doses every 4 to 6 hours for 2 weeks

Usual Adult Dose for Pneumonia:

Serious infections due to susceptible strains of streptococci: 12 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Serious infections due to susceptible strains of staphylococci: 5 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection

Usual Adult Dose for Septicemia:

Serious infections due to susceptible strains of streptococci: 12 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Serious infections due to susceptible strains of staphylococci: 5 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection

Usual Adult Dose for Endocarditis:

Serious infections due to susceptible strains of streptococci: 12 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Serious infections due to susceptible strains of staphylococci: 5 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Erysipelothrix rhusiopathiae: 2 million to 20 million units/day IV in divided doses every 4 to 6 hours for 4 to 6 weeks
Listeria monocytogenes: 15 million to 20 million units/day IV in divided doses every 4 to 6 hours for 4 weeks

Usual Adult Dose for Meningitis:

Serious infections due to susceptible strains of streptococci: 12 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Serious infections due to susceptible strains of staphylococci: 5 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Listerial meningitis: 15 million to 20 million units/day IV in divided doses every 4 to 6 hours for 2 weeks
Pasteurella meningitis: 4 million to 6 million units/day IV in divided doses every 4 to 6 hours for 2 weeks

Usual Adult Dose for Meningitis -- Meningococcal:

Meningococcal meningitis and/or septicemia: 1 million to 2 million units IM every 2 hours or 20 million to 30 million units/day as a continuous IV infusion for at least 10 to 14 days
If meningococcal meningitis is suspected, immediate treatment with penicillin is required, and should be started before lumbar puncture confirmation of the diagnosis. The mortality of this disease is 50% within the first 24 hours.

Usual Adult Dose for Meningitis -- Pneumococcal:

Serious infections due to susceptible strains: 12 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection

Usual Adult Dose for Neurosyphilis:

Manufacturers recommendation: 2 million to 4 million units IV every 4 hours for 10 to 14 days
Centers for Disease Control and Prevention (CDC) recommendation: 3 million to 4 million units IV every 4 hours or 18 million to 24 million units/day as a continuous infusion for 10 to 14 days
Many experts recommend additional therapy with penicillin G benzathine 2.4 million units IM once a week for up to 3 weeks following completion of IV therapy.

Usual Adult Dose for Actinomycosis:

Cervicofacial disease: 1 million to 6 million units/day IV in divided doses every 4 to 6 hours
Thoracic and abdominal disease: 10 million to 20 million units/day IV in divided doses every 4 to 6 hours
Duration: Prolonged therapy (1.5 to 18 months or longer) may be necessary. Four to 6 weeks followed by oral therapy for 6 to 12 months, depending on the nature and severity of the infection, has been recommended for patients with pulmonary actinomycosis or other severe infections caused by the organism.

Usual Adult Dose for Inhalation Bacillus anthracis:

Treatment of penicillin-susceptible anthrax:
As the result of naturally occurring or endemic anthrax exposure: Minimum of 8 million units/day IV in divided doses every 6 hours; higher doses may be needed depending on susceptibility of organism
Dosages up to 20 million units/day IV have been used to treat anthrax septicemia and intestinal, pulmonary, and meningeal anthrax. Some clinicians recommend 8 million to 12 million units/day in divided doses every 4 to 6 hours for the treatment of anthrax due to natural or endemic anthrax exposures.
Duration: At least 14 days after symptoms abate
As the result of exposure to B anthracis spores during biologic warfare or bioterrorism: 4 million units IV every 4 hours; oral therapy may be substituted once the patient's clinical condition improves
Treatment of inhalation anthrax should be started with a multiple-drug parenteral regimen that includes ciprofloxacin or doxycycline plus 1 or 2 additional antibiotics with activity against the causative organism. A multiple-drug parenteral regimen is also recommended for initial treatment of cutaneous anthrax if there are signs of systemic involvement, extensive edema, or lesions on the head or neck. Due to concerns regarding resistance, penicillin alone is not recommended for inhalation anthrax that occurs as the result of biologic warfare or bioterrorism since high concentrations of the organism are expected, but it can be included in appropriate combination therapies.
Duration: 60 days (including IV and oral therapy)

Usual Adult Dose for Cutaneous Bacillus anthracis:

Treatment of penicillin-susceptible anthrax:
As the result of naturally occurring or endemic anthrax exposure: Minimum of 8 million units/day IV in divided doses every 6 hours; higher doses may be needed depending on susceptibility of organism
Dosages up to 20 million units/day IV have been used to treat anthrax septicemia and intestinal, pulmonary, and meningeal anthrax. Some clinicians recommend 8 million to 12 million units/day in divided doses every 4 to 6 hours for the treatment of anthrax due to natural or endemic anthrax exposures.
Duration: At least 14 days after symptoms abate
As the result of exposure to B anthracis spores during biologic warfare or bioterrorism: 4 million units IV every 4 hours; oral therapy may be substituted once the patient's clinical condition improves
Treatment of inhalation anthrax should be started with a multiple-drug parenteral regimen that includes ciprofloxacin or doxycycline plus 1 or 2 additional antibiotics with activity against the causative organism. A multiple-drug parenteral regimen is also recommended for initial treatment of cutaneous anthrax if there are signs of systemic involvement, extensive edema, or lesions on the head or neck. Due to concerns regarding resistance, penicillin alone is not recommended for inhalation anthrax that occurs as the result of biologic warfare or bioterrorism since high concentrations of the organism are expected, but it can be included in appropriate combination therapies.
Duration: 60 days (including IV and oral therapy)

Usual Adult Dose for Botulism:

Adjunctive therapy to antitoxin: 20 million units/day IV in divided doses every 4 to 6 hours
Wound botulism (as an adjunct to antitoxin, supportive care, and surgical debridement): 2 million units IV every 4 hours plus metronidazole 250 mg IV every 6 hours

Usual Adult Dose for Tetanus:

Adjunctive therapy to human tetanus immune globulin: 20 million units/day in divided doses every 4 to 6 hours

Usual Adult Dose for Clostridial Infection:

Gas gangrene (debridement and/or surgery as indicated): 20 million units/day in divided doses every 4 to 6 hours

Usual Adult Dose for Diphtheria:

As an adjunct to antitoxin and to prevent carrier state: 2 million to 3 million units/day IV in divided doses every 4 to 6 hours for 10 to 12 days
To eliminate carrier state: 300,000 to 400,000 units/day IM in divided doses for 10 to 12 days

Usual Adult Dose for Fusospirochetosis:

Severe infections of the oropharynx (Vincent's), lower respiratory tract, and genital area: 5 million to 10 million units/day IV in divided doses every 4 to 6 hours

Usual Adult Dose for Bacteremia:

Pasteurella bacteremia: 4 million to 6 million units/day IV in divided doses every 4 to 6 hours for 2 weeks

Usual Adult Dose for Rat-bite Fever:

Infections due to Streptobacillus moniliformis (rat-bite fever or Haverhill fever) or Spirillum minus (rat-bite fever): 12 million to 20 million units/day IV in divided doses every 4 to 6 hours for 3 to 4 weeks

Usual Adult Dose for Lyme Disease -- Neurologic:

Early Lyme disease with acute neurologic disease manifested by meningitis or radiculopathy: 18 million to 24 million units/day IV in divided doses every 4 hours
Late Lyme disease and associated neurologic disease affecting the CNS or peripheral nerve disease (e.g., neuropathy, encephalopathy) and documented by CSF analysis: 18 million to 24 million units/day IV in divided doses every 4 to 6 hours
Duration: 14 to 28 days
Penicillin G is recommended as an alternative to IV ceftriaxone. Ceftriaxone is considered the parenteral drug of choice.

Usual Adult Dose for Lyme Disease -- Carditis:

Third-degree atrioventricular (AV) heart block or a PR interval exceeding 0.3 seconds: 18 million to 24 million units/day IV in divided doses every 4 to 6 hours, with cardiac monitoring and a temporary pacemaker for complete heart block
Duration: 14 to 21 days
Penicillin G is recommended as an alternative to IV ceftriaxone. Ceftriaxone is considered the parenteral drug of choice.

Usual Adult Dose for Lyme Disease -- Arthritis:

Recurrent arthritis after oral treatment: 18 million to 24 million units/day IV in divided doses every 4 hours for 14 to 28 days
Penicillin G is recommended as an alternative to IV ceftriaxone for patients with late Lyme disease who have arthritis and objective proof of neurologic disease. It is also recommended as an alternative for patients with persistent or recurrent arthritis after oral treatment; IV therapy is only recommended in those patients whose arthritis showed no improvement or worsened. Ceftriaxone is considered the parenteral drug of choice.

Usual Adult Dose for Prevention of Perinatal Group B Streptococcal Disease:

5 million units IV at onset of labor or after membrane rupture followed by 2.5 million units IV every 4 hours until delivery

Usual Adult Dose for Leptospirosis:

1.5 million units IV every 6 hours for 7 days

Usual Adult Dose for Deep Neck Infection:

2 million to 4 million units IV or IM every 4 to 6 hours for 2 to 3 weeks, depending on the nature and severity of the infection
The addition of metronidazole to high-dose penicillin therapy is recommended by many experts to treat parapharyngeal infections because of the increasing frequency of penicillin-resistant anaerobes. Removal of abscessed material is also necessary for successful treatment.

Usual Adult Dose for Skin or Soft Tissue Infection:

Erysipelas: 1 million to 2 million units IV every 4 to 6 hours
Streptococcal cellulitis: 1 million to 2 million units IV every 6 hours for 7 to 10 days

Usual Adult Dose for Aspiration Pneumonia:

2 million to 3 million units IV every 4 to 6 hours plus metronidazole 500 mg IV every 8 hours for 7 to 14 days, depending on the nature and severity of the infection

Usual Adult Dose for Joint Infection:

2 million to 3 million units IV every 4 hours for 2 weeks, depending on the nature and severity of the infection

Usual Adult Dose for Gonococcal Infection -- Disseminated:

Infections (such as meningitis, endocarditis, arthritis, etc.) caused by penicillin-susceptible organisms: 10 million units/day IV in divided doses every 4 to 6 hours
Duration: Depends on the nature and severity of the infection
Due to resistance, penicillin G is not recommended by the CDC. Ceftriaxone is the drug of choice.

Usual Adult Dose for Gram Negative Infection:

Gram-negative bacillary bacteremia (Escherichia coli, Enterobacter aerogenes, Alcaligenes faecalis, Salmonella, Shigella, and Proteus mirabilis): 20 million to 80 million units per day
Penicillin G is not the drug of choice in the treatment of gram-negative bacillary infections. Other more effective anti-infectives are usually used for the treatment of these infections.

Usual Pediatric Dose for Bacterial Infection:

American Academy of Pediatrics (AAP) recommendations:
Neonates:
7 days or less:
2000 g or less: 25,000 to 50,000 units/kg IM or IV every 12 hours
Greater than 2000 g: 25,000 to 50,000 units/kg IM or IV every 8 hours
Greater than 7 days:
Less than 1200 g: 25,000 to 50,000 units/kg IM or IV every 12 hours
1200 to 2000 g: 25,000 to 50,000 units/kg IM or IV every 8 hours
Greater than 2000 g: 25,000 to 50,000 units/kg IM or IV every 6 hours
Infants and children:
Mild to moderate infections: 100,000 to 250,000 units/kg/day IM or IV in divided doses every 4 to 6 hours
Severe infections: 250,000 to 400,000 units/kg/day IM or IV in 4 to 6 divided doses
Maximum dose: 24 million units/day

Usual Pediatric Dose for Endocarditis:

Manufacturers recommendation:
Serious infections, such as pneumonia and endocarditis, due to susceptible strains of streptococci (including S pneumoniae) and meningococcus: 150,000 to 300,000 units/kg/day IV in divided doses every 4 to 6 hours
The duration of therapy depends on the nature and severity of the infection.

Usual Pediatric Dose for Pneumonia:

Manufacturers recommendation:
Serious infections, such as pneumonia and endocarditis, due to susceptible strains of streptococci (including S pneumoniae) and meningococcus: 150,000 to 300,000 units/kg/day IV in divided doses every 4 to 6 hours
The duration of therapy depends on the nature and severity of the infection.

Usual Pediatric Dose for Streptococcal Infection:

Manufacturers recommendation:
Serious infections, such as pneumonia and endocarditis, due to susceptible strains of streptococci (including S pneumoniae) and meningococcus: 150,000 to 300,000 units/kg/day IV in divided doses every 4 to 6 hours
The duration of therapy depends on the nature and severity of the infection.

Usual Pediatric Dose for Meningitis -- Meningococcal:

Manufacturers recommendation: 250,000 units/kg/day IV in divided doses every 4 hours for 7 to 14 days, depending on the nature and severity of the infection
Maximum dose: 12 million to 20 million units/day

Usual Pediatric Dose for Meningitis -- Pneumococcal:

Manufacturers recommendation: 250,000 units/kg/day IV in divided doses every 4 hours for 7 to 14 days, depending on the nature and severity of the infection
Maximum dose: 12 million to 20 million units/day
AAP recommendation:
1 month or older: 250,000 to 400,000 units/kg/day IV in 4 to 6 divided doses

Usual Pediatric Dose for Meningitis -- Streptococcus Group B:

AAP recommendation:
Neonates 7 days or younger: 250,000 to 450,000 units/kg/day IV in 3 divided doses
Neonates older than 7 days: 450,000 units/kg/day IV in 4 divided doses

Usual Pediatric Dose for Congenital Syphilis:

Less than 1 month (symptomatic neonates and neonates with proven or presumed congenital syphilis): 50,000 units/kg IV every 12 hours during the first 7 days of life and every 8 hours thereafter for 10 days total; if more than 1 day of therapy is missed in patients with proven or highly probable disease, the entire course should be repeated
1 month or older: 50,000 units/kg IV every 4 to 6 hours for 10 days; some clinicians recommend following this regimen with penicillin G benzathine 50,000 units/kg IM once a week for 1 to 3 weeks

Usual Pediatric Dose for Neurosyphilis:

Manufacturers recommendation:
1 month or older: 50,000 units/kg IV every 4 to 6 hours for 10 to 14 days
CDC recommendation:
Adolescents: 3 million to 4 million units IV every 4 hours or 18 million to 24 million units/day as a continuous infusion for 10 to 14 days; many experts recommend additional therapy with penicillin G benzathine 2.4 million units IM once a week for up to 3 weeks following completion of IV therapy

Usual Pediatric Dose for Inhalation Bacillus anthracis:

Treatment of penicillin-susceptible anthrax:
As the result of naturally occurring or endemic anthrax exposure:
Children: Some clinicians recommend 100,000 to 150,000 units/kg/day in divided doses every 4 to 6 hours.
Duration: At least 14 days after symptoms abate
As the result of exposure to B anthracis spores during biologic warfare or bioterrorism:
Children less than 12 years: 50,000 units/kg IV every 6 hours; oral therapy may be substituted once the patient's clinical condition improves
Treatment of inhalation anthrax should be started with a multiple-drug parenteral regimen that includes ciprofloxacin or doxycycline plus 1 or 2 additional antibiotics with activity against the causative organism. A multiple-drug parenteral regimen is also recommended for initial treatment of cutaneous anthrax if there are signs of systemic involvement, extensive edema, or lesions on the head or neck. Due to concerns regarding resistance, penicillin alone is not recommended for inhalation anthrax that occurs as the result of biologic warfare or bioterrorism since high concentrations of the organism are expected, but it can be included in appropriate combination therapies.
Duration: 60 days (including IV and oral therapy)

Usual Pediatric Dose for Cutaneous Bacillus anthracis:

Treatment of penicillin-susceptible anthrax:
As the result of naturally occurring or endemic anthrax exposure:
Children: Some clinicians recommend 100,000 to 150,000 units/kg/day in divided doses every 4 to 6 hours.
Duration: At least 14 days after symptoms abate
As the result of exposure to B anthracis spores during biologic warfare or bioterrorism:
Children less than 12 years: 50,000 units/kg IV every 6 hours; oral therapy may be substituted once the patient's clinical condition improves
Treatment of inhalation anthrax should be started with a multiple-drug parenteral regimen that includes ciprofloxacin or doxycycline plus 1 or 2 additional antibiotics with activity against the causative organism. A multiple-drug parenteral regimen is also recommended for initial treatment of cutaneous anthrax if there are signs of systemic involvement, extensive edema, or lesions on the head or neck. Due to concerns regarding resistance, penicillin alone is not recommended for inhalation anthrax that occurs as the result of biologic warfare or bioterrorism since high concentrations of the organism are expected, but it can be included in appropriate combination therapies.
Duration: 60 days (including IV and oral therapy)

Usual Pediatric Dose for Diphtheria:

Manufacturers recommendation:
As an adjunct to antitoxin and to prevent carrier state: 150,000 to 250,000 units/kg/day IV in divided doses every 6 hours for 7 to 10 days
AAP recommendation:
As an adjunct to antitoxin: 100,000 to 150,000 units/kg/day IV in 4 divided doses for 14 days

Usual Pediatric Dose for Rat-bite Fever:

Infections due to S moniliformis (rat-bite fever or Haverhill fever [with endocarditis]) or S minus (rat-bite fever): 150,000 to 250,000 units/kg/day in divided doses every 4 hours for 4 weeks

Usual Pediatric Dose for Lyme Disease -- Neurologic:

Children: 200,000 to 400,000 units/kg/day IV in divided doses every 4 to 6 hours for 14 to 28 days
Maximum dose: 18 million to 24 million units/day
Penicillin G is recommended as an alternative to IV ceftriaxone or IV cefotaxime for patients with early Lyme disease who have acute neurologic disease manifested by meningitis or radiculopathy. It is also recommended as an alternative for patients with late Lyme disease and associated neurologic disease affecting the CNS or peripheral nerve disease (e.g., neuropathy, encephalopathy) and documented by CSF analysis. Ceftriaxone is considered the parenteral drug of choice.

Usual Pediatric Dose for Lyme Disease -- Carditis:

Third-degree AV heart block or a PR interval exceeding 0.3 seconds during early Lyme disease:
Children: 200,000 to 400,000 units/kg/day IV in divided doses every 4 to 6 hours for 14 to 21 days
Maximum dose: 18 million to 24 million units/day
Ceftriaxone is considered the parenteral drug of choice.

Usual Pediatric Dose for Lyme Disease -- Arthritis:

Children: 200,000 to 400,000 units/kg/day IV in divided doses every 4 hours for 14 to 28 days
Maximum dose: 18 million to 24 million units/day
Penicillin G is recommended as an alternative to IV ceftriaxone or IV cefotaxime for patients with late Lyme disease who have arthritis and objective proof of neurologic disease. It is also recommended as an alternative for patients with persistent or recurrent arthritis after oral treatment; IV therapy is only recommended in those patients whose arthritis showed no improvement or worsened. Ceftriaxone is considered the parenteral drug of choice.

Usual Pediatric Dose for Gonococcal Infection -- Disseminated:

Penicillin-susceptible strains:
Less than 45 kg:
Arthritis: 100,000 units/kg/day in 4 divided doses for 7 to 10 days
Meningitis: 250,000 units/kg/day in divided doses every 4 hours for 10 to 14 days
Endocarditis: 250,000 units/kg/day in divided doses every 4 hours for 4 weeks
45 kg or more:
Arthritis, meningitis, endocarditis: 10 million units/day in 4 divided doses; duration depends on the type of infection
Due to resistance, penicillin G is not recommended by the CDC. Ceftriaxone is the drug of choice.

What other drugs will affect penicillin G potassium?

Tell your doctor about all other medications you use, especially:

aspirin or indomethacin (Indocin);

birth control pills;

methotrexate (Rheumatrex, Trexall(;

probenecid (Benemid);

an antibiotic such as chloramphenicol (Chloromycetin) or erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin);

a diuretic (water pill) such as furosemide (Lasix) or ethacrynic acid (Edecrin);

sulfa drugs (Bactrim, Septra, Sulfatrim, SMX-TMP, and others); or

a tetracycline antibiotic, such as doxycycline (Doryx, Oracea, Periostat, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

This list is not complete and other drugs may interact with penicillin G potassium. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More penicillin G potassium resources Penicillin G potassium Side Effects (in more detail) Penicillin G potassium Use in Pregnancy & Breastfeeding Drug Images Penicillin G potassium Drug Interactions Penicillin G potassium Support Group 11 Reviews for Penicillin G potassium - Add your own review/rating Penicillin G Potassium MedFacts Consumer Leaflet (Wolters Kluwer) Pfizerpen Prescribing Information (FDA) Pfizerpen Advanced Consumer (Micromedex) - Includes Dosage Information Compare penicillin G potassium with other medications Actinomycosis Anthrax Anthrax Prophylaxis Aspiration Pneumonia Bacterial Infection Clostridial Infection Congenital Syphilis Cutaneous Bacillus anthracis Deep Neck Infection Diphtheria Endocarditis Fusospirochetosis, Trench Mouth Joint Infection Leptospirosis Lyme Disease, Arthritis Lyme Disease, Carditis Lyme Disease, Erythema Chronicum Migrans Lyme Disease, Neurologic Meningitis Meningitis, Meningococcal Meningitis, Pneumococcal Neurosyphilis Otitis Media Pneumonia Prevention of Perinatal Group B Streptococcal Disease Rat-bite Fever Rheumatic Fever Prophylaxis Skin Infection Strep Throat Syphilis, Early Syphilis, Latent Tertiary Syphilis Tonsillitis/Pharyngitis Upper Respiratory Tract Infection Where can I get more information? Your pharmacist can provide more information about penicillin G potassium.

See also: penicillin G potassium side effects (in more detail)


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interferon gamma-1b


Generic Name: interferon gamma-1b (in ter FEER on GAM a)
Brand Names: Actimmune

What is interferon gamma-1b?

Interferon gamma-1b is made from human proteins. Interferons help the body fight viral infections.

Interferon gamma-1b is a specific interferon used to prevent infections in people with a condition called chronic granulomatous disease. Interferon gamma-1b is also used to treat a congenital bone disorder called osteopetrosis.

Interferon gamma-1b may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about interferon gamma-1b? Do not use this medication if you are allergic to interferon gamma-1b, or to drug products made from E. Coli bacteria.

Before using interferon gamma-1b, tell your doctor if you are allergic to any drugs, or if you have heart rhythm problems, congestive heart failure, history of heart disease or blood clots, or epilepsy or another seizure disorder.

Interferon gamma-1b is usually given three times weekly. Do not use the medication every day unless your doctor has told you to.

Store interferon gamma-1b in the refrigerator but do not allow it to freeze. Throw away any interferon gamma-1b that has been out of the refrigerator for more than 12 hours. Do not put it back into the refrigerator.

To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled appointments.

What should I discuss with my healthcare provider before using interferon gamma-1b? You should not use this medication if you are allergic to interferon gamma-1b, or to drug products made from E. Coli bacteria.

Before using interferon gamma-1b, tell your doctor if you are allergic to any drugs, or if you have:

heart rhythm problems;

congestive heart failure;

history of heart disease or blood clots; or

epilepsy or other seizure disorder.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use interferon gamma-1b.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether interferon gamma-1b passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use interferon gamma-1b?

Interferon gamma-1b is given as an injection under the skin of your upper arm or thigh. Your doctor, nurse, or other healthcare provider will give you this injection. You may be given instructions on how to use your injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Interferon gamma-1b is usually given 3 times weekly. Do not use the medication every day unless your doctor has told you to.

Use a different place on your arm or thigh each time you give yourself an injection. Your doctor will show you the places on your body where you can safely inject the medication. Do not inject interferon gamma-1b into the same place two times in a row.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled appointments.

A single use vial of interferon gamma-1b is for one dose only. After measuring your dose from the vial, throw the bottle away even if there is still some medication left in it.

Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine. Do not draw your interferon gamma-1b dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription. Store interferon gamma-1b in the refrigerator but do not allow it to freeze. Throw away any interferon gamma-1b that has been out of the refrigerator for more than 12 hours. Do not put it back into the refrigerator. What happens if I miss a dose?

Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include confusion, drowsiness, dizziness, loss of balance or coordination, or flu-like symptoms.

What should I avoid while using interferon gamma-1b?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using interferon gamma-1b.

Interferon gamma-1b side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using interferon gamma-1b and call your doctor at once if you have any of these serious side effects:

fever, chills, body aches, flu symptoms;

easy bruising or bleeding, unusual weakness;

feeling light-headed, fainting;

fast or uneven heart rate; or

sudden numbness or weakness, especially on one side of the body.

Less serious side effects may include:

problems with memory or concentration;

weakness, tired feeling, lack of coordination;

pain or redness where the injection was given;

nausea, vomiting, diarrhea;

muscle or joint pain; or

headache.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Interferon gamma-1b Dosing Information

Usual Adult Dose for Osteopetrosis:

BSA: greater than 0.5 m2
50 mcg/m2 (1 million intl units/m2) subcutaneously three times weekly.
BSA: less than or equal to 0.5 m2
1.5 mcg/kg/dose subcutaneously three times weekly.

Usual Adult Dose for Chronic Granulomatous Disease:

BSA: greater than 0.5 m2
50 mcg/m2 (1 million intl units/m2) subcutaneously three times weekly.
BSA: less than or equal to 0.5 m2
1.5 mcg/kg/dose subcutaneously three times weekly.

Usual Adult Dose for Idiopathic Pulmonary Fibrosis:

Study (n = 9)
200 mcg subcutaneously three times weekly (in combination with prednisolone 7.5 mg/day) for 12 months.

Usual Adult Dose for Cutaneous T-cell Lymphoma:

Case study (Granulomatous slack skin)
2,000,000 units IV daily for 14 days.

Usual Pediatric Dose for Chronic Granulomatous Disease:

Greater than or equal to 1 year old:
BSA: greater than 0.5 m2
50 mcg/m2 (1 million intl units/m2) subcutaneously three times weekly.
BSA: less than or equal to 0.5 m2
1.5 mcg/kg/dose subcutaneously three times weekly
Less than 1 year old: no data available

What other drugs will affect interferon gamma-1b?

There may be other drugs that can affect interferon gamma-1b. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More interferon gamma-1b resources Interferon gamma-1b Side Effects (in more detail) Interferon gamma-1b Use in Pregnancy & Breastfeeding Interferon gamma-1b Drug Interactions Interferon gamma-1b Support Group 0 Reviews for Interferon gamma-1b - Add your own review/rating Interferon Gamma-1b Professional Patient Advice (Wolters Kluwer) Interferon Gamma-1B MedFacts Consumer Leaflet (Wolters Kluwer) Actimmune Prescribing Information (FDA) Actimmune Monograph (AHFS DI) Actimmune Advanced Consumer (Micromedex) - Includes Dosage Information Compare interferon gamma-1b with other medications Chronic Granulomatous Disease Cutaneous T-cell Lymphoma Idiopathic Pulmonary Fibrosis Osteopetrosis Rheumatoid Arthritis Where can I get more information? Your pharmacist can provide more information about interferon gamma-1b.

See also: interferon gamma-1b side effects (in more detail)


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