Generic Name: polyethylene glycol electrolyte solution (pall ee ETH il een GLYE kol ee LEK troe lyte)
Brand Names: Colyte, Colyte with Flavor Packs, GoLYTELY, MoviPrep, NuLYTELY, NuLYTELY Cherry, NuLYTELY Lemon Lime, NuLYTELY Orange, NuLYTELY with Flavor Packs, PEG-3350 with Electolytes, TriLyte with Flavor Packs

What is NuLYTELY with Flavor Packs (polyethylene glycol electrolyte solution)?

Polyethylene glycol electrolyte solution is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements. This medication also contains potassium, sodium, and other minerals to replace electrolytes that are passed from the body in the stool.

Polyethylene glycol electrolyte solution is used to clean the bowel before colonoscopy, a barium x-ray, or other intestinal procedures.

Polyethylene glycol electrolyte solution may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about NuLYTELY with Flavor Packs (polyethylene glycol electrolyte solution)?

Do not use this medication if you are allergic to polyethylene glycol or any other electrolyte solutions (such as Pedialyte or Gatorade).

You should also not take polyethylene glycol electrolyte solution if you have a perforated bowel, a bowel obstruction or severe constipation, or colitis or toxic megacolon. If you have any these conditions, you could have dangerous or life-threatening side effects from polyethylene glycol electrolyte solution.

People with eating disorders (such as anorexia or bulimia) should not take polyethylene glycol electrolyte solution without the advice of a doctor.

Talk to your healthcare provider if you are not able to consume all of the solution. Incomplete cleansing of the bowel may affect the scheduled procedure.

What should I discuss with my health care provider before taking NuLYTELY with Flavor Packs (polyethylene glycol electrolyte solution)?

Do not use this medication if you are allergic to polyethylene glycol or any other electrolyte solutions (such as Pedialyte or Gatorade), or if you have:

• a perforated bowel;

• a bowel obstruction or severe constipation; or

• colitis or toxic megacolon.

If you have any these conditions, you could have dangerous or life-threatening side effects from polyethylene glycol electrolyte solution.

People with eating disorders (such as anorexia or bulimia) should not use this medication without the advice of a doctor.

Before taking polyethylene glycol electrolyte solution, tell your doctor if you are allergic to any drugs, or if you have:

• nausea or vomiting;

• trouble swallowing; or

• a history of bowel obstruction, diverticulitis, ulcerative colitis, or other chronic bowel disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take polyethylene glycol electrolyte solution.

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 polyethylene glycol electrolyte solution 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.

Older adults may be more likely to have serious side effects from this medicine.

How should I take NuLYTELY with Flavor Packs (polyethylene glycol electrolyte solution)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Do not take polyethylene glycol electrolyte solution if it has been less than 2 hours since you last ate solid food. For best results, take the medicine 3 to 4 hours after you last ate.

Do not add any flavorings to this medicine, such as sugar, honey, artificial sweetener, fruit juices, or other beverages.

Chilling the medicine in a refrigerator may make it taste better. Shake the liquid well just before you measure a dose. Drink this medicine in the exact portions at the exact time intervals prescribed by your doctor.

Polyethylene glycol electrolyte solution will produce watery diarrhea. Keep taking the medicine until your stool is watery and clear. In most cases, at least 3 liters of polyethylene glycol electrolyte solution is needed for the full effect.

The usual dose of the medication is 8 ounces every 10 minutes. Drink each portion as quickly as possible, rather than sipping it slowly. The first watery stool should appear within 1 hour after you start drinking polyethylene glycol electrolyte solution.

You may be instructed not to drink or eat anything before your medical test or procedure. Follow your doctor’s instructions about the type and amount of liquids you should drink for at least 24 hours before and after your test or procedure.

Throw away any polyethylene glycol electrolyte solution you have not used within 48 hours after it was mixed.

What happens if I miss a dose?

Talk to your doctor if you cannot drink all of the medication prescribed for you. Your test or procedure may need to be rescheduled if your bowel is not completely cleansed.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine at one time.

An overdose of this medication is not expected to produce life-threatening symptoms.

What should I avoid while taking NuLYTELY with Flavor Packs (polyethylene glycol electrolyte solution)?

Avoid taking other medications, vitamins, or mineral supplements within 1 hour before drinking polyethylene glycol electrolyte solution. Any medications you take just before a bowel cleansing will not be properly absorbed into your body.

Do not use other laxatives while using polyethylene glycol electrolyte solution unless your doctor has told you to.

NuLYTELY with Flavor Packs (polyethylene glycol electrolyte solution) 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 if you have any of these serious side effects:

• severe stomach pain or bloating;

• no bowel movement within 2 hours after use; or

• gagging, choking, or vomiting.

If you have any of these side effects, you may need to drink the medication more slowly, or stop using it for a short time.

Less serious side effects may include:

• mild stomach cramps, gas, or bloating;

• rectal pain or irritation;

• nausea; or

• passing gas.

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.

What other drugs will affect NuLYTELY with Flavor Packs (polyethylene glycol electrolyte solution)?

There may be other drugs that can interact with polyethylene glycol electrolyte solution. 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.

Where can I get more information?

• Your pharmacist can provide more information about polyethylene glycol electrolyte solution.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.02. Revision Date: 4/12/2009 4:38:59 PM.

Generic Name: benzocaine topical (BENZ oh kane TOP ik al)
Brand Names: Americaine, Americaine Anesthetic Lubricant, Americaine Hemorrhoidal, Anacaine, Anbesol Baby, Anbesol Cold Sore, Anbesol Gel, Anbesol Liquid, Anbesol Liquid Cool Mint, Anbesol Maximum Strength, Babee Teething Lotion, Benz-O-Sthetic, Benzo-O-Stetic, Boil Ease Pain Relieving, Cepacol Dual Relief Sore Throat Cherry, Cepacol Dual Relief Sore Throat Mint, Cepacol Extra Strength, Cepacol Extra Strength Cherry, Cepacol Extra Strength Cherry Sugar Free, Cepacol Extra Strength Citrus, Cepacol Extra Strength Honey Lemon, Cepacol Extra Strength Menthol, Cepacol Extra Strength Menthol Sugar Free, Cepacol Fizzlers, Dent-O-Kain, Dermoplast, Dermoplast Antibacterial, Detane, Foille Plus, Hurricaine, Hurricaine Kit, Hurricaine Snap-n-Go, Lanacane, Lanacane Maximum Strength, Lanacane with Aloe, Maintain, Medicone Maximum Strength, Num-Zit, Numzident, Orabase Baby Teething Gel, Orabase Gel-B, Orabase Lip Healer, Orabase with Benzocaine, Orajel, Orajel Baby, Orajel Baby Nighttime, Orajel D, Orajel Denture, Orajel Denture Plus, Orajel Maximum Strength, Orajel Maximum Strength PM, Orajel Mouth Sore Medicine, Orajel Mouth-Aid, Orajel Severe Pain Formula, Oral Pain Relief, OraMagic Plus, Outgro Pain Relief, Retre-Gel, Rid-A-Pain, Skeeter Stik, Solarcaine Aerosol, Sting-Kill, Topex, Trocaine, Vagisil Feminine Cream, zilactin-B

What is Num-Zit (benzocaine topical)?

Benzocaine is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.

Benzocaine topical is used to reduce pain or discomfort caused by minor skin irritations, sore throat, sunburn, teething pain, vaginal or rectal irritation, ingrown toenails, hemorrhoids, and many other sources of minor pain on a surface of the body. Benzocaine is also used to numb the skin or surfaces inside the mouth, nose, throat, vagina, or rectum to lessen the pain of inserting a medical instrument such as a tube or speculum.

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

What is the most important information I should know about Num-Zit (benzocaine topical)?

There are many brands and forms of benzocaine topical available and not all brands are listed on this leaflet.

An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops). Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Use the smallest amount of this medication needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

Do not use benzocaine topical if you have a blood cell disorder called methemoglobinemia.

Before using benzocaine topical, tell your doctor if you have any type of inherited enzyme deficiency, a breathing disorder such as asthma or emphysema, or if you smoke.

Call your doctor if your symptoms do not improve or if they get worse within the first 7 days of using benzocaine topical. Also call your doctor if your symptoms had cleared up but then came back.

If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.

What should I discuss with my health care provider before using Num-Zit (benzocaine topical)?

An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops). Do not use benzocaine topical if you have a blood cell disorder called methemoglobinemia.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use benzocaine topical:

• asthma, bronchitis, emphysema, or other breathing disorder;

• heart disease;

• a personal or family history of methemoglobinemia, or any genetic enzyme deficiency; or

• if you smoke.

FDA pregnancy category C. It is not known whether benzocaine topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. It is not known whether benzocaine topical 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. Do not use this medicine on a child younger than 1 year old.

How should I use Num-Zit (benzocaine topical)?

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

Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Use the smallest amount of medicine needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

This medication comes with instructions for safe and effective application. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

To treat minor skin conditions, apply a thin layer of benzocaine topical to the affected area up to 4 times per day. If using the spray, hold the container 6 to 12 inches away from the skin. Do not spray this medication onto your face. Spray it instead on your hands and then rub it onto the face, avoiding contact with your eyes.

To treat hemorrhoids, clean the area with soap and water before applying benzocaine topical. Apply the medication up to 6 times per day. If you are using the rectal suppository, try to empty your bowel and bladder before inserting the suppository. Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

Do not use benzocaine topical to treat large skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion.

Call your doctor if your symptoms do not improve or if they get worse within the first 7 days of using benzocaine topical. Also call your doctor if your symptoms had cleared up but then came back.

If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.

Store at room temperature away from moisture and heat. Do not allow the liquid form of this medicine to freeze.

What happens if I miss a dose?

Since benzocaine topical is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. 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. An overdose of benzocaine topical applied to the skin can cause life-threatening side effects such as uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

What should I avoid while taking Num-Zit (benzocaine topical)?

Benzocaine topical is for use only on the surface of your body, or just inside the vagina or rectum. Avoid getting this medication in your eyes. Avoid swallowing the gel, liquid, or ointment while applying it to your gums or the inside of your mouth. The throat spray or oral lozenge may be swallowed gradually during use.

Do not apply other medications to the same affected areas you treat with benzocaine topical, unless your doctor has told you otherwise.

Avoid eating within 1 hour after using benzocaine topical on your gums or inside your mouth.

Num-Zit (benzocaine topical) 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 benzocaine topical and call your doctor at once if you have any of these serious side effects:

• severe burning, stinging, or sensitivity where the medicine is applied;

• swelling, warmth, or redness;

• oozing, blistering, or any signs of infection; or

• headache, weakness, dizziness, breathing problems, fast heart rate, and gray or bluish colored skin (rare but serious side effects of benzocaine).

Less serious side effects may include:

• mild stinging, burning, or itching where the medicine is applied;

• skin tenderness or redness; or

• dry white flakes where the medicine was applied.

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 Num-Zit (benzocaine topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied benzocaine topical. But many drugs can interact with each other. 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.

Where can I get more information?

• Your pharmacist can provide more information about benzocaine topical.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.01. Revision Date: 05/17/2010 3:24:38 PM.

Generic Name: polyethylene glycol electrolyte solution (pall ee ETH il een GLYE kol ee LEK troe lyte)
Brand Names: Colyte, Colyte with Flavor Packs, GoLYTELY, MoviPrep, NuLYTELY, NuLYTELY Cherry, NuLYTELY Lemon Lime, NuLYTELY Orange, NuLYTELY with Flavor Packs, PEG-3350 with Electolytes, TriLyte with Flavor Packs

What is NuLYTELY (polyethylene glycol electrolyte solution)?

Polyethylene glycol electrolyte solution is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements. This medication also contains potassium, sodium, and other minerals to replace electrolytes that are passed from the body in the stool.

Polyethylene glycol electrolyte solution is used to clean the bowel before colonoscopy, a barium x-ray, or other intestinal procedures.

Polyethylene glycol electrolyte solution may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about NuLYTELY (polyethylene glycol electrolyte solution)?

Do not use this medication if you are allergic to polyethylene glycol or any other electrolyte solutions (such as Pedialyte or Gatorade).

You should also not take polyethylene glycol electrolyte solution if you have a perforated bowel, a bowel obstruction or severe constipation, or colitis or toxic megacolon. If you have any these conditions, you could have dangerous or life-threatening side effects from polyethylene glycol electrolyte solution.

People with eating disorders (such as anorexia or bulimia) should not take polyethylene glycol electrolyte solution without the advice of a doctor.

Talk to your healthcare provider if you are not able to consume all of the solution. Incomplete cleansing of the bowel may affect the scheduled procedure.

What should I discuss with my health care provider before taking NuLYTELY (polyethylene glycol electrolyte solution)?

Do not use this medication if you are allergic to polyethylene glycol or any other electrolyte solutions (such as Pedialyte or Gatorade), or if you have:

• a perforated bowel;

• a bowel obstruction or severe constipation; or

• colitis or toxic megacolon.

If you have any these conditions, you could have dangerous or life-threatening side effects from polyethylene glycol electrolyte solution.

People with eating disorders (such as anorexia or bulimia) should not use this medication without the advice of a doctor.

Before taking polyethylene glycol electrolyte solution, tell your doctor if you are allergic to any drugs, or if you have:

• nausea or vomiting;

• trouble swallowing; or

• a history of bowel obstruction, diverticulitis, ulcerative colitis, or other chronic bowel disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take polyethylene glycol electrolyte solution.

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 polyethylene glycol electrolyte solution 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.

Older adults may be more likely to have serious side effects from this medicine.

How should I take NuLYTELY (polyethylene glycol electrolyte solution)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Do not take polyethylene glycol electrolyte solution if it has been less than 2 hours since you last ate solid food. For best results, take the medicine 3 to 4 hours after you last ate.

Do not add any flavorings to this medicine, such as sugar, honey, artificial sweetener, fruit juices, or other beverages.

Chilling the medicine in a refrigerator may make it taste better. Shake the liquid well just before you measure a dose. Drink this medicine in the exact portions at the exact time intervals prescribed by your doctor.

Polyethylene glycol electrolyte solution will produce watery diarrhea. Keep taking the medicine until your stool is watery and clear. In most cases, at least 3 liters of polyethylene glycol electrolyte solution is needed for the full effect.

The usual dose of the medication is 8 ounces every 10 minutes. Drink each portion as quickly as possible, rather than sipping it slowly. The first watery stool should appear within 1 hour after you start drinking polyethylene glycol electrolyte solution.

You may be instructed not to drink or eat anything before your medical test or procedure. Follow your doctor’s instructions about the type and amount of liquids you should drink for at least 24 hours before and after your test or procedure.

Throw away any polyethylene glycol electrolyte solution you have not used within 48 hours after it was mixed.

What happens if I miss a dose?

Talk to your doctor if you cannot drink all of the medication prescribed for you. Your test or procedure may need to be rescheduled if your bowel is not completely cleansed.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine at one time.

An overdose of this medication is not expected to produce life-threatening symptoms.

What should I avoid while taking NuLYTELY (polyethylene glycol electrolyte solution)?

Avoid taking other medications, vitamins, or mineral supplements within 1 hour before drinking polyethylene glycol electrolyte solution. Any medications you take just before a bowel cleansing will not be properly absorbed into your body.

Do not use other laxatives while using polyethylene glycol electrolyte solution unless your doctor has told you to.

NuLYTELY (polyethylene glycol electrolyte solution) 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 if you have any of these serious side effects:

• severe stomach pain or bloating;

• no bowel movement within 2 hours after use; or

• gagging, choking, or vomiting.

If you have any of these side effects, you may need to drink the medication more slowly, or stop using it for a short time.

Less serious side effects may include:

• mild stomach cramps, gas, or bloating;

• rectal pain or irritation;

• nausea; or

• passing gas.

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.

What other drugs will affect NuLYTELY (polyethylene glycol electrolyte solution)?

There may be other drugs that can interact with polyethylene glycol electrolyte solution. 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.

Where can I get more information?

• Your pharmacist can provide more information about polyethylene glycol electrolyte solution.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.02. Revision Date: 4/12/2009 4:38:59 PM.

Generic Name: Polyethylene Glycol/Electrolytes (pol-ee-ETH-i-leen GLYE-kole/e-LECK-troe-lites)
Brand Name: Example include NuLYTELY and TriLyte

NuLYTELY Solution is used for:

Cleaning out the bowel before surgery or other procedures. It may also be used for other conditions as determined by your doctor.

NuLYTELY Solution is a laxative. It works by causing the colon to move contents along more quickly.

Do NOT use NuLYTELY Solution if:

• you are allergic to any ingredient in NuLYTELY Solution
• you have appendicitis or a history of stomach or bowel disease (eg, blockage, retention, perforation, toxic inflammation, megacolon, ileus)

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

Before using NuLYTELY Solution:

Some medical conditions may interact with NuLYTELY Solution. 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
• if you have a throat (esophagus) disease, ulcerative colitis, heart disease (eg, irregular heartbeat, congestive heart failure), swallowing problems (eg, history of aspiration or regurgitation), impaired gag reflex, electrolyte imbalances (eg, high blood potassium levels), or rectal bleeding of unknown cause
• if you have a history of alcohol use

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

Ask your health care provider if NuLYTELY Solution 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 NuLYTELY Solution:

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

• Your doctor will tell you when to start using NuLYTELY Solution. Do not eat any solid foods for at least 2 hours before beginning NuLYTELY Solution. It is preferred that you do not eat for 3 to 4 hours before beginning NuLYTELY Solution.
• Drink only clear liquids and do not eat any solid foods from the time you start NuLYTELY Solution until your procedure is complete.
• Before using NuLYTELY Solution, fill the container with the amount of water indicated on the package label. Use lukewarm water to mix NuLYTELY Solution to help the medicine dissolve faster. Shake well.
• Chilling NuLYTELY Solution improves the taste. Do not chill NuLYTELY Solution if the patient is an infant. Do not add sugar, sweetening agents, or other additives to NuLYTELY Solution.
• Some of these products come with a Flavor Pack. If this product comes with a Flavor Pack and you wish to use it, add the contents of the Flavor Pack into the bottle before you add the water. If you do not use the Flavor Pack, throw it away.
• Shake well before each use.
• Drink 8 ounces (240 mL) of NuLYTELY Solution every 10 minutes until the stool is watery, clear, and free of all solid matter, or until the medicine is gone. At least 3 liters is usually required to produce the watery stool. It is best to drink all of NuLYTELY Solution. Be sure to follow the instructions provided by your doctor. It is best to drink each portion quickly rather than sipping it. Rinsing your mouth with mouthwash after each glass of medicine may help get rid of the taste.
• If the patient is a child, a different dosing schedule may be recommended. Follow the instructions provided by your doctor.
• Other medicines taken by mouth within 1 hour of taking NuLYTELY Solution may not be absorbed or be effective. Contact your doctor or pharmacist with any concerns you might have about taking your other medicines.
• If you miss a dose of NuLYTELY Solution, take it as soon as you remember. Continue to take it as directed by your doctor. Notify your doctor right away if you are unable to finish taking NuLYTELY Solution before your test.

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

Important safety information:

• The first bowel movement usually occurs about 1 hour after you begin drinking NuLYTELY Solution.
• Keep all doctor and lab appointments while you are taking NuLYTELY Solution.
• Use NuLYTELY Solution with caution in patients who are unconscious or partially conscious because they may be at greater risk for vomiting and inhaling NuLYTELY Solution.
• Use NuLYTELY Solution with caution in the ELDERLY; they may be more sensitive to its effects.
• Caution is advised when using NuLYTELY Solution in CHILDREN; they may be more sensitive to its effects, especially low blood sugar, low blood potassium levels, and dehydration. Monitor children carefully for symptoms of low blood sugar (eg, increased heartbeat, headache, chills, sweating, tremor, increased hunger, changes in vision, nervousness, weakness, dizziness, drowsiness, fainting). Tell the doctor right away if your child experiences any of these symptoms.
• NuLYTELY Solution should be used with extreme caution in CHILDREN younger than 6 months old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using NuLYTELY Solution while you are pregnant. It is not known if NuLYTELY Solution is found in breast milk. If you are or will be breast-feeding while you use NuLYTELY Solution, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of NuLYTELY Solution:

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:

Bloating; nausea; rectal irritation; stomach fullness or cramps; vomiting.

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); chest pain; hoarseness; muscle weakness; persistent or severe nausea and vomiting; severe bloating or abdominal swelling; severe stomach pain; slow or irregular heartbeat; vomiting of blood.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

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

Proper storage of NuLYTELY Solution:

Before mixing, store NuLYTELY Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. After preparing the solution, store NuLYTELY Solution in the refrigerator in a tightly closed container. Use within 48 hours. Discard any unused portion of NuLYTELY Solution. Keep NuLYTELY Solution out of the reach of children and away from pets.

General information:

• If you have any questions about NuLYTELY Solution, please talk with your doctor, pharmacist, or other health care provider.
• NuLYTELY Solution 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.

This information is a summary only. It does not contain all information about NuLYTELY Solution. 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.

Generic Name: polyethylene glycol electrolyte solution (pall ee ETH il een GLYE kol ee LEK troe lyte)
Brand Names: Colyte, Colyte with Flavor Packs, GoLYTELY, MoviPrep, NuLYTELY, NuLYTELY Cherry, NuLYTELY Lemon Lime, NuLYTELY Orange, NuLYTELY with Flavor Packs, PEG-3350 with Electolytes, TriLyte with Flavor Packs

What is NuLYTELY Cherry (polyethylene glycol electrolyte solution)?

Polyethylene glycol electrolyte solution is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements. This medication also contains potassium, sodium, and other minerals to replace electrolytes that are passed from the body in the stool.

Polyethylene glycol electrolyte solution is used to clean the bowel before colonoscopy, a barium x-ray, or other intestinal procedures.

Polyethylene glycol electrolyte solution may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about NuLYTELY Cherry (polyethylene glycol electrolyte solution)?

Do not use this medication if you are allergic to polyethylene glycol or any other electrolyte solutions (such as Pedialyte or Gatorade).

You should also not take polyethylene glycol electrolyte solution if you have a perforated bowel, a bowel obstruction or severe constipation, or colitis or toxic megacolon. If you have any these conditions, you could have dangerous or life-threatening side effects from polyethylene glycol electrolyte solution.

People with eating disorders (such as anorexia or bulimia) should not take polyethylene glycol electrolyte solution without the advice of a doctor.

Talk to your healthcare provider if you are not able to consume all of the solution. Incomplete cleansing of the bowel may affect the scheduled procedure.

What should I discuss with my health care provider before taking NuLYTELY Cherry (polyethylene glycol electrolyte solution)?

Do not use this medication if you are allergic to polyethylene glycol or any other electrolyte solutions (such as Pedialyte or Gatorade), or if you have:

• a perforated bowel;

• a bowel obstruction or severe constipation; or

• colitis or toxic megacolon.

If you have any these conditions, you could have dangerous or life-threatening side effects from polyethylene glycol electrolyte solution.

People with eating disorders (such as anorexia or bulimia) should not use this medication without the advice of a doctor.

Before taking polyethylene glycol electrolyte solution, tell your doctor if you are allergic to any drugs, or if you have:

• nausea or vomiting;

• trouble swallowing; or

• a history of bowel obstruction, diverticulitis, ulcerative colitis, or other chronic bowel disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take polyethylene glycol electrolyte solution.

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 polyethylene glycol electrolyte solution 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.

Older adults may be more likely to have serious side effects from this medicine.

How should I take NuLYTELY Cherry (polyethylene glycol electrolyte solution)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Do not take polyethylene glycol electrolyte solution if it has been less than 2 hours since you last ate solid food. For best results, take the medicine 3 to 4 hours after you last ate.

Do not add any flavorings to this medicine, such as sugar, honey, artificial sweetener, fruit juices, or other beverages.

Chilling the medicine in a refrigerator may make it taste better. Shake the liquid well just before you measure a dose. Drink this medicine in the exact portions at the exact time intervals prescribed by your doctor.

Polyethylene glycol electrolyte solution will produce watery diarrhea. Keep taking the medicine until your stool is watery and clear. In most cases, at least 3 liters of polyethylene glycol electrolyte solution is needed for the full effect.

The usual dose of the medication is 8 ounces every 10 minutes. Drink each portion as quickly as possible, rather than sipping it slowly. The first watery stool should appear within 1 hour after you start drinking polyethylene glycol electrolyte solution.

You may be instructed not to drink or eat anything before your medical test or procedure. Follow your doctor’s instructions about the type and amount of liquids you should drink for at least 24 hours before and after your test or procedure.

Throw away any polyethylene glycol electrolyte solution you have not used within 48 hours after it was mixed.

What happens if I miss a dose?

Talk to your doctor if you cannot drink all of the medication prescribed for you. Your test or procedure may need to be rescheduled if your bowel is not completely cleansed.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine at one time.

An overdose of this medication is not expected to produce life-threatening symptoms.

What should I avoid while taking NuLYTELY Cherry (polyethylene glycol electrolyte solution)?

Avoid taking other medications, vitamins, or mineral supplements within 1 hour before drinking polyethylene glycol electrolyte solution. Any medications you take just before a bowel cleansing will not be properly absorbed into your body.

Do not use other laxatives while using polyethylene glycol electrolyte solution unless your doctor has told you to.

NuLYTELY Cherry (polyethylene glycol electrolyte solution) 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 if you have any of these serious side effects:

• severe stomach pain or bloating;

• no bowel movement within 2 hours after use; or

• gagging, choking, or vomiting.

If you have any of these side effects, you may need to drink the medication more slowly, or stop using it for a short time.

Less serious side effects may include:

• mild stomach cramps, gas, or bloating;

• rectal pain or irritation;

• nausea; or

• passing gas.

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.

What other drugs will affect NuLYTELY Cherry (polyethylene glycol electrolyte solution)?

There may be other drugs that can interact with polyethylene glycol electrolyte solution. 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.

Where can I get more information?

• Your pharmacist can provide more information about polyethylene glycol electrolyte solution.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.02. Revision Date: 4/12/2009 4:38:59 PM.

Generic name: Hyoscyamine sulfate
Brand names: NuLev, Levbid, Levsinex, Anaspaz, Levsin

Why is NuLev prescribed?

Levsin is an antispasmodic medication given to help treat various stomach, intestinal, and urinary tract disorders that involve cramps, colic, or other painful muscle contractions. Because Levsin has a drying effect, it may also be used to dry a runny nose or to dry excess secretions before anesthesia is administered.

Together with morphine or other narcotics, Levsin is prescribed for the pain of gallstones or kidney stones. For inflammation of the pancreas, Levsin may be used to help control excess secretions and reduce pain. Levsin may also be taken in Parkinson’s disease to help reduce muscle rigidity and tremors and to help control drooling and excess sweating. The drug is sometimes prescribed during treatment for peptic ulcer.

Doctors also give Levsin as part of the preparation for certain diagnostic x-rays (for example, of the stomach, intestines, or kidneys).

Levsin comes in several forms, including regular tablets, tablets to be dissolved under the tongue, tablets that dissolve on the tongue (NuLev), sustained-release capsules (Levsinex Timecaps) and sustained-release tablets (Levbid), liquid, drops, and an injectable solution.

Most important fact about NuLev

Levsin may make you sweat less, causing your body temperature to increase and putting you at the risk of heatstroke. Try to stay inside as much as possible on hot days, and avoid warm places such as very hot baths and saunas.

How should you take NuLev?

If you take Levsin for a stomach disorder, you may also need to take antacid medication. However, antacids make Levsin more difficult for the body to absorb. To minimize this problem, take Levsin before meals and the antacid after meals.

Take Levsin exactly as prescribed. Although the sublingual tablets (Levsin/SL) are designed to be dissolved under the tongue, they may also be chewed or swallowed. The regular tablets should be swallowed. Levbid extended-release tablets should not be crushed or chewed. NuLev tablets should be placed on the tongue, allowed to disintegrate, then swallowed. They can be taken with or without water.

Levsin can cause dry mouth. For temporary relief, suck on a hard candy or chew gum.

• If you miss a dose…
  Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at once.

• Storage instructions…
  Store at room temperature. Protect NuLev tablets from moisture.

What side effects may occur?

Side effects cannot be anticipated. If any side effects develop or change in intensity, tell your doctor immediately. Only your doctor can determine whether it is safe for you to continue taking Levsin.

• Side effects may include:
  Allergic reactions, bloating, blurred vision, confusion, constipation, decreased sweating, dilated pupils, dizziness, drowsiness, dry mouth, excitement, headache, hives, impotence, inability to urinate, insomnia, itching, heart palpitations, lack of coordination, loss of sense of taste, nausea, nervousness, rapid heartbeat, skin reactions, speech problems, vomiting, weakness

Why should NuLev not be prescribed?

Do not take Levsin if you have ever had an allergic reaction to it or similar drugs such as scopolamine. Also, you should not be given Levsin if you have any of the following:

Bowel or digestive tract obstruction or paralysis
Glaucoma (excessive pressure in the eyes)
Myasthenia gravis (a disorder in which muscles become weak and tire easily)
Ulcerative colitis (severe bowel inflammation)
Urinary obstruction

Levsin is not appropriate if you have diarrhea, especially if you have a surgical opening to the bowels (an ileostomy or colostomy).

Special warnings about NuLev

Be careful using Levsin if you have an overactive thyroid gland, heart disease, congestive heart failure, irregular heartbeats, high blood pressure, or kidney disease.

Because Levsin may make you dizzy or drowsy, or blur your vision, do not drive, operate other machinery, or do any other hazardous work while taking NuLev.

While you are taking Levsin, you may experience confusion, disorientation, short-term memory loss, hallucinations, difficulty speaking, lack of coordination, coma, an exaggerated sense of well-being, decreased anxiety, fatigue, sleeplessness and agitation. These symptoms should disappear 12 to 48 hours after you stop taking the drug.

People who must avoid phenylalanine should note that NuLev tablets contain this substance.

Possible food and drug interactions when taking NuLev

If Levsin is taken with certain other drugs, the effects of either drug could be increased, decreased, or altered. It is especially important to check with your doctor before combining Levsin with the following:

Amantadine
Antacids
Antidepressant drugs such as amitriptyline, imipramine, phenelzine, and tranylcypromine
Antihistamines such as diphenhydramine
Major tranquilizers such as chlorpromazine and haloperidol
Other antispasmodic drugs such as dicyclomine
Potassium supplements

Special information if you are pregnant or breastfeeding

If you are pregnant or plan to become pregnant, inform your doctor immediately. Although it is not known whether Levsin can cause birth defects, pregnant women should avoid all drugs except those necessary to health.

Levsin appears in breast milk. Your doctor may ask you to forgo breastfeeding when taking NuLev.

Recommended dosage for NuLev

LEVSIN, LEVSIN/SL, AND NULEV TABLETS

Adults and Children 12 Years of Age and Older

The usual dose is 1 to 2 tablets every 4 hours or as needed. Do not take more than 12 tablets in 24 hours.

Children 2 to Under 12 Years of Age

The usual dose is one-half to 1 tablet every 4 hours or as needed. Do not give a child more than 6 tablets in 24 hours.

LEVSIN ELIXIR

Adults and Children 12 Years of Age and Older

The recommended dosage is 1 to 2 teaspoonfuls every 4 hours or as needed, but no more than 12 teaspoonfuls in 24 hours.

Children 2 to 12 Years of Age

Dosage is by body weight. Doses may be given every 4 hours or as needed. Do not give a child more than 6 teaspoonfuls in 24 hours.

WEIGHT	DOSE
22 pounds	1/4 teaspoon
44 pounds	1/2 teaspoon
88 pounds	3/4 teaspoon
110 pounds	1 teaspoon

LEVSIN DROPS

Adults and Children 12 Years of Age and Older

The recommended dosage is 1 to 2 milliliters every 4 hours or as needed, but no more than 12 milliliters in 24 hours.

Children 2 to 12 Years of Age

The usual dosage is one-quarter to 1 milliliter every 4 hours or as needed. Do not give a child more than 6 milliliters in 24 hours.

Children under 2 Years of Age

Your doctor will determine the dosage based on body weight. The doses may be repeated every 4 hours or as needed.

WEIGHT	USUAL DOSE	DO NOT EXCEED IN 24 HOURS
7.5 pounds	4 drops	24 drops
11 pounds	5 drops	30 drops
15 pounds	6 drops	36 drops
22 pounds	8 drops	48 drops

LEVSINEX TIMECAPS

Adults and Children 12 Years of Age and Older

The recommended dosage is 1 to 2 capsules every 12 hours. Your doctor may adjust the dosage to 1 capsule every 8 hours if needed. Do not take more than 4 capsules in 24 hours.

LEVBID EXTENDED-RELEASE TABLETS

Adults and Children 12 Years of Age and Older

The dosage is 1 to 2 tablets every 12 hours. The tablets are scored so that you can break them in half if your doctor wants you to. Do not crush or chew them. You should not take more than 4 tablets in 24 hours.

Overdosage

Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately.

• Symptoms of Levsin overdose may include:
  Blurred vision, dilated pupils, dizziness, dry mouth, excitement, headache, hot dry skin, nausea, swallowing difficulty, vomiting

Generic Name: Hyoscyamine (HYE-oh-SYE-a-meen)
Brand Name: Examples include NuLev and Symax FasTabs

NuLev Orally Disintegrating Tablets are used for:

Treating certain stomach, intestinal, and bladder conditions, including spasms. It is also used to control stomach secretions and cramps. It is also used to relieve the symptoms of colic, runny nose, and Parkinson-like problems. It is also used to treat excessive sweating or saliva production. It may also be used for other conditions as determined by your doctor.

NuLev Orally Disintegrating Tablets are an anticholinergic agent. It works by decreasing the motion of muscles in the stomach, intestines, and bladder. It also decreases the production of stomach acid.

Do NOT use NuLev Orally Disintegrating Tablets if:

• you are allergic to any ingredient in NuLev Orally Disintegrating Tablets
• you have severe esophagus problems (eg, irritation, narrowing); a blockage of the stomach, bowel, or bladder; bowel motility problems; or severe bowel problems (eg, severe ulcerative colitis, toxic megacolon)
• you have glaucoma, myasthenia gravis, or certain severe heart problems (eg, decreased blood flow to the heart)

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

Before using NuLev Orally Disintegrating Tablets:

Some medical conditions may interact with NuLev Orally Disintegrating Tablets. 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
• if you have nerve problems, prostate problems, esophagus problems (eg, reflux), stomach or bowel problems, heart or blood vessel problems (eg, fast or irregular heartbeat, heart failure, coronary heart disease), hiatal hernia, kidney problems, an overactive thyroid, high blood pressure, urinary problems, paralysis, or brain damage, or you are at risk for glaucoma
• if you have diarrhea or fever, have been very ill, or are in poor health
• if you have phenylketonuria

Some MEDICINES MAY INTERACT with NuLev Orally Disintegrating Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Amantadine, other anticholinergics (eg, scopolamine), antihistamines (eg, diphenhydramine), haloperidol, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), phenothiazines (eg, thioridazine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of NuLev Orally Disintegrating Tablets’s side effects
• Narcotic pain medicines (eg, codeine) or potassium chloride because the risk of their side effects may be increased by NuLev Orally Disintegrating Tablets
• Ketoconazole or metoclopramide because their effectiveness may be decreased by NuLev Orally Disintegrating Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if NuLev Orally Disintegrating Tablets 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 NuLev Orally Disintegrating Tablets:

Use NuLev Orally Disintegrating Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• NuLev Orally Disintegrating Tablets are usually taken 30 to 60 minutes before a meal. Follow your doctor’s specific instructions for taking NuLev Orally Disintegrating Tablets.
• Place the tablet on the tongue and allow it to dissolve and then swallow. Some brands of NuLev Orally Disintegrating Tablets may also be chewed. Ask your pharmacist if your brand may be chewed.
• NuLev Orally Disintegrating Tablets may be taken with or without water.
• If you also take antacids, take NuLev Orally Disintegrating Tablets before meals and the antacid after meals, unless directed otherwise by your doctor.
• If you miss a dose of NuLev Orally Disintegrating Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use NuLev Orally Disintegrating Tablets.

Important safety information:

• NuLev Orally Disintegrating Tablets may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use NuLev Orally Disintegrating Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using NuLev Orally Disintegrating Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke may occur.
• Drink plenty of fluids, maintain good oral hygiene, and suck on sugarless hard candy to relieve dry mouth.
• Proper dental care is important while you are taking NuLev Orally Disintegrating Tablets. Brush and floss your teeth and visit the dentist regularly.
• NuLev Orally Disintegrating Tablets may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
• Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.
• Tell your doctor or dentist that you take NuLev Orally Disintegrating Tablets before you receive any medical or dental care, emergency care, or surgery.
• Use NuLev Orally Disintegrating Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, trouble urinating, dry mouth, drowsiness, agitation, confusion, excitability, or memory problems.
• Caution is advised when using NuLev Orally Disintegrating Tablets in CHILDREN; they may be more sensitive to its effects, including excitability.
• Some of these products should not be used in CHILDREN younger than 6 years old. Ask your pharmacist if your brand may be used in children younger than 6 years old. Check with your doctor if you have questions about giving NuLev Orally Disintegrating Tablets to your child.
• NuLev Orally Disintegrating Tablets should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is not known if NuLev Orally Disintegrating Tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using NuLev Orally Disintegrating Tablets while you are pregnant. NuLev Orally Disintegrating Tablets are found in breast milk. If you are or will be breast-feeding while taking NuLev Orally Disintegrating Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of NuLev Orally Disintegrating Tablets:

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:

Bloated feeling; blurred vision; constipation; decreased sweating; dizziness; drowsiness; dry mouth; enlarged pupils; excitability; headache; nausea; nervousness; trouble sleeping; weakness.

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); agitation; behavior changes; confusion; decreased sexual ability; diarrhea; difficulty focusing eyes; disorientation; exaggerated sense of well-being; fast or irregular heartbeat; hallucinations; loss of consciousness; loss of coordination; memory loss; mental or mood changes; severe or persistent trouble sleeping; speech changes; taste changes or loss; trouble urinating; unusual tiredness or weakness; vision changes; vomiting.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include disorientation; excessive thirst or excitability; fever; hot, dry skin; seizures; severe dry mouth; severe or persistent blurred vision, dizziness, headache, nausea, or vomiting; trouble breathing or swallowing.

Proper storage of NuLev Orally Disintegrating Tablets:

Store NuLev Orally Disintegrating Tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep NuLev Orally Disintegrating Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about NuLev Orally Disintegrating Tablets, please talk with your doctor, pharmacist, or other health care provider.
• NuLev Orally Disintegrating Tablets are 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.

This information is a summary only. It does not contain all information about NuLev Orally Disintegrating Tablets. 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.

Generic Name: hydrocortisone (Topical application route)

hye-droe-KOR-ti-sone

Commonly used brand name(s):

In the U.S.

• Ala-Cort
• Ala-Scalp HP
• Anusol HC
• Aquanil HC
• Beta HC
• Caldecort
• Cetacort
• Corta-Cap
• Cortagel Extra Strength
• Cortaid
• CortAlo With Aloe
• Corticaine
• Corticool Maximum Strength
• Cortizone-10
• Cortizone-5
• Cotacort
• Delacort
• Dermarest
• Dermtex-HC
• Foille Cort
• Gly-Cort
• Hydrozone Plus
• Hytone
• Instacort-10
• Ivy Soothe
• IvyStat
• Keratol HC
• Kericort 10
• Lacticare-HC
• Locoid
• Locoid Lipocream
• Medi-Cortisone Maximum Strength
• Microcort
• Mycin Scalp
• Neutrogena T/Scalp
• NuCort
• Nupercainal HC
• Nutracort
• Pandel
• Pediaderm HC Kit
• Preparation H Hydrocortisone
• Proctocream-HC
• Recort Plus
• Sarnol-HC Maximum Strength
• Scalacort
• Scalpcort
• Summer’s Eve Specialcare
• Texacort
• Therasoft Anti-Itch & Dermatitis
• U-Cort
• Westcort

In Canada

• Barriere-Hc
• Cortate
• Cort-Eze
• Cortoderm Mild Ointment
• Cortoderm Regular Ointment
• Emo-Cort
• Emo-Cort Scalp Solution
• Hydrocortisone Cream
• Novo-Hydrocort
• Novo-Hydrocort Cream
• Prevex Hc
• Sarna Hc

Available Dosage Forms:

• Solution
• Cream
• Spray
• Lotion
• Ointment
• Pad
• Liquid
• Gel/Jelly
• Kit
• Foam
• Stick
• Paste

Therapeutic Class: Corticosteroid, Weak

Pharmacologic Class: Adrenal Glucocorticoid

Uses For NuCort

Hydrocortisone topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available both over-the-counter (OTC) and with your doctor’s prescription.

Before Using NuCort

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, 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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydrocortisone topical in the pediatric population. However, because of this medicine’s toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor’s instructions very carefully.

Geriatric

No information is available on the relationship of age to the effects of hydrocortisone topical in geriatric patients.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cushing’s syndrome (adrenal gland disorder) or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or
• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

Proper Use of hydrocortisone

This section provides information on the proper use of a number of products that contain hydrocortisone. It may not be specific to NuCort. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

To use:

• Wash your hands with soap and water before and after using this medicine.
• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.
• With the lotion, shake it well before using.
• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.
• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

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 redness, itching, and swelling of the skin:
  • For topical dosage form (cream):
    • Adults—Apply to the affected area of the skin two or three times per day.
    • Children—Apply to the affected area of the skin two or three times per day.
  • For topical dosage form (lotion):
    • Adults—Apply to the affected area of the skin two to four times per day.
    • Children—Apply to the affected area of the skin two to four times per day.
  • For topical dosage form (ointment):
    • Adults—Apply to the affected area of the skin three or four times per day.
    • Children—Apply to the affected area of the skin three or four times per day.
  • For topical dosage form (solution):
    • Adults—Apply to the affected area of the skin three or four times per day.
    • Children—Apply to the affected area of the skin three or four times per day.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine 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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using NuCort

It is very important that your doctor check your or your child’s progress at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child’s symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Do not use cosmetics or other skin care products on the treated areas.

NuCort 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 immediately if any of the following side effects occur:

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin
• irritation
• itching, scaling, severe redness, soreness, or swelling of the skin
• redness and scaling around the mouth
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)
• thinning, weakness, or wasting away of the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Acne or pimples
• burning and itching of the skin with pinhead-sized red blisters
• burning, itching, and pain in hairy areas, or pus at the root of the hair
• increased hair growth on the forehead, back, arms, and legs
• lightening of normal skin color
• lightening of treated areas of dark skin
• reddish purple lines on the arms, face, legs, trunk, or groin
• softening of the skin

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.

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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.

Generic Name: hydrocortisone topical (hye droe KOR ti sone)
Brand Names: Ala-Cort, Ala-Scalp HP, Aquanil HC, Beta HC, Caldecort, Cortaid, Cortaid Intensive Therapy, Cortaid Maximum Strength, Cortaid with Aloe, Cortalo with Aloe, Corticaine, Cortizone for Kids, Cortizone-10, Cortizone-10 Intensive Healing Formula, Cortizone-10 Plus, Cortizone-5, Dermarest Dricort, Dermarest Eczema Medicated, Dermarest Plus Anti-Itch, Dermtex HC, Genasone/Aloe, Gly-Cort, Gynecort Maximum Strength, Hycort, Hydrocortisone 1% In Absorbase, Hydrocortisone with Aloe, Hydrocortisone-Aloe, Hytone, Instacort, Itch-X Lotion, Locoid, Locoid Lipocream, Locoid Lotion, Massengill Medicated Soft Cloth, MD Hydrocortisone, Neutrogena T-Scalp, NuCort with Aloe, NuZon, Pandel, Recort Plus, Rederm, Sarnol-HC, Scalacort, Texacort, U-Cort, Westcort

What is NuCort with Aloe (hydrocortisone topical)?

Hydrocortisone is a topical steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Hydrocortisone topical is used to treat inflammation of the skin caused by a number of conditions such as allergic reactions, eczema, or psoriasis.

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

What is the most important information I should know about NuCort with Aloe (hydrocortisone topical)?

There are many brands and forms of hydrocortisone topical available and not all brands are listed on this leaflet.

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor’s instructions.

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.

Do not use this medication on a child without a doctor’s advice. Children are more sensitive to the effects of hydrocortisone topical.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

What should I discuss with my healthcare provider before using NuCort with Aloe (hydrocortisone topical)?

Do not use this medication if you are allergic to hydrocortisone.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

FDA pregnancy category C. It is not known whether hydrocortisone topical is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether hydrocortisone topical 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. Do not use this medication on a child without a doctor’s advice. Children are more sensitive to the effects of hydrocortisone topical.

How should I use NuCort with Aloe (hydrocortisone topical)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger or smaller amounts, or use it for longer than recommended.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Wash your hands before and after each application, unless you are using hydrocortisone topical to treat a hand condition.

Apply a small amount to the affected area and rub it gently into the skin.

Avoid using this medication on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor’s instructions. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days. It is important to use hydrocortisone topical regularly to get the most benefit. Store hydrocortisone topical at room temperature away from moisture and heat.

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, or if anyone has accidentally swallowed it. An overdose of hydrocortisone topical applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while using NuCort with Aloe (hydrocortisone topical)?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use hydrocortisone topical on sunburned, windburned, irritated, or broken skin. Also avoid using this medication in open wounds.

Avoid using skin products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

NuCort with Aloe (hydrocortisone topical) 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 hydrocortisone topical and call your doctor at once if you have any of these serious side effects:

• blurred vision, or seeing halos around lights;

• uneven heartbeats;

• sleep problems (insomnia);

• weight gain, puffiness in your face; or

• feeling tired.

Less serious side effects may include:

• skin redness, burning, itching, or peeling;

• thinning of your skin;

• blistering skin; or

• stretch marks.

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 NuCort with Aloe (hydrocortisone topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied hydrocortisone. But many drugs can interact with each other. 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.

Where can I get more information?

• Your pharmacist can provide more information about hydrocortisone topical.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 8.03. Revision Date: 08/14/2009 11:55:43 AM.