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    K-Pek II (Loperamide) Liquid

    GENERIC NAME(S): Loperamide

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    WARNINGS:

    Improper use of this medication (overuse or abuse) may cause serious harm, such as fast/irregular heartbeat or death. Do not increase your dose, take it more often, or take it for longer than directed. Taking loperamide with certain other medications may also cause harm. See also Precautions, Drug Interactions, and Overdose sections.

    This medication is not approved for use in children younger than 2 years due to an increased risk of side effects (such as slow/shallow breathing, fast/irregular heartbeat).

    Who should not take K-Pek II (Loperamide) Liquid?
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    Uses

    This medication is used to treat sudden diarrhea (including traveler's diarrhea). It works by slowing down the movement of the gut. This decreases the number of bowel movements and makes the stool less watery. Loperamide is also used to reduce the amount of discharge in patients who have had an ileostomy. It is also used to treat ongoing diarrhea in people with inflammatory bowel disease.

    Loperamide treats only the symptoms, not the cause of the diarrhea (e.g., infection). Treatment of other symptoms and the cause of the diarrhea should be determined by your doctor.

    Do not use in children younger than 6 years unless directed by your doctor. See also Warning section.

    How to use K-Pek II (Loperamide) Liquid

    See also Warning section.

    If you are using the over-the-counter product to self-treat, read all the directions on the product package before taking this medication. If your doctor has prescribed this medication, follow your doctor's directions and the directions on your prescription label.

    Take this medication by mouth, usually after each loose stool or as directed by your doctor. Shake the bottle well before each use. Measure each dose carefully using the attached measuring cup. Do not use a household spoon since you may not get the correct dose.

    The dosage is based on your condition and response to treatment. In children, dosage is also based on age and weight. Adults should not use more than 8 milligrams in 24 hours if self-treating, or 16 milligrams in 24 hours if under a doctor's direction.

    Diarrhea can cause a serious loss of body water (dehydration). Drink plenty of fluids and minerals (electrolytes) to replace what is lost. Tell your doctor right away if you develop signs of dehydration (e.g., extreme thirst, decreased urination, muscle cramps, weakness, fainting). You may also need to change to a bland diet during this time to reduce irritation to your stomach/intestines. Consult your doctor or pharmacist for more information.

    Tell your doctor if your diarrhea does not improve after 2 days, if your condition worsens, or if you develop new symptoms. If you develop blood in the stool, fever, or an uncomfortable fullness/swelling of the stomach/abdomen, or if you think you may have a serious medical problem, seek immediate medical attention.

    If you are taking this medication under your doctor's direction for ongoing diarrhea, tell your doctor if your diarrhea continues after 10 days of treatment.

    Side Effects

    Dizziness, drowsiness, tiredness, or constipation may occur. If any of these effects persist or worsen, contact your doctor promptly.

    If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

    Stop taking this medication and get medical help right away if you have any very serious side effects, including: severe constipation/nausea/vomiting, stomach/abdominal pain, uncomfortable fullness of the stomach/abdomen, fast/irregular heartbeat, severe dizziness, fainting.

    A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

    This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

    In the US -

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

    In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

    Precautions

    Before taking loperamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

    This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: stomach/abdominal pain without diarrhea, bowel obstruction (e.g., ileus, megacolon, abdominal distention).

    Antibiotics may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. Symptoms include: persistent diarrhea, abdominal or stomach pain/cramping, or blood/mucus in your stool. This condition may occur weeks after antibiotic treatment has stopped. This medication may make this condition worse. Do not use this anti-diarrhea product, especially after recent antibiotic use, if you have the above symptoms without talking with your doctor first.

    This medication should not be used without seeing your doctor first if you have certain medical conditions. These symptoms/conditions may require other treatment before you can use this medication safely. Before using this medication, tell your doctor or pharmacist your medical history, especially of: black/tarry stool, blood/mucus in your stool, high fever, HIV infection/AIDS, liver problems, certain stomach/intestinal infections (e.g., Salmonella, Shigella), certain type of bowel disease (acute ulcerative colitis).

    Loperamide may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

    The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using loperamide, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

    Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using loperamide safely.

    This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

    Liquid forms of this product may contain sugar and/or alcohol. Caution is advised if you have diabetes, alcohol dependence, or liver disease. Ask your doctor or pharmacist about using this product safely.

    Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

    Children may be more sensitive to the effects of this drug, especially drowsiness. Children are also at a higher risk for dehydration. See also Warning and How to Use sections.

    During pregnancy, this medication should be used only if clearly needed. Discuss the risks and benefits with your doctor.

    This drug passes into breast milk but is unlikely to have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

    Interactions

    Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

    Some products that may interact with this drug include: pramlintide, recent/current antibiotic use, drugs that can cause constipation (e.g., anticholinergics such as belladonna/scopolamine/benztropine, antispasmodics such as glycopyrrolate/oxybutynin, potent narcotic pain medicines such as morphine, certain antihistamines such as diphenhydramine, tricyclic antidepressants such as amitriptyline), cholestyramine, ritonavir, saquinavir.

    Many drugs besides loperamide may affect the heart rhythm (QT prolongation), including amiodarone, chlorpromazine, haloperidol, methadone, moxifloxacin, pentamidine, procainamide, quinidine, sotalol, thioridazine, ziprasidone, among others.

    Overdose

    If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: difficult urination, slowed breathing, deep sleep, fast/irregular heartbeat, severe dizziness, fainting.

    Notes

    If your doctor has prescribed this medication for you, do not share it with others.

    Missed Dose

    If you are taking this drug on a regular schedule (not "as needed") and you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip themissed dose and resume your usual dosing schedule. Do not double the dose to catch up.

    Storage

    Refer to storage information printed on the package. Store at room temperature between 59-77 degrees F (15-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

    Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised January 2017. Copyright(c) 2017 First Databank, Inc.

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    Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

    CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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