Loperamide

Nonprescription (over-the-counter) loperamide is used to control acute diarrhea (loose stools that come on suddenly and usually lasts less than 2 weeks), including travelers' diarrhea. Prescription loperamide is also used to control acute diarrhea and also ongoing diarrhea associated with inflammatory bowel disease (IBD; condition in which the lining of all or part of the intestine is swollen, irritated, or has sores). Prescription loperamide is also used to reduce the amount of fluid in people with ileostomies (surgery to create an opening for waste to leave the body through the abdomen). Loperamide is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel and by slowing down the movement of the bowel to decrease the number of bowel movements.

Loperamide comes as a tablet, capsule, and as a suspension or solution (liquid) to take by mouth. Nonprescription (over-the-counter) loperamide usually is taken immediately after each loose bowel movement but not more than the 24-hour maximum amount described on the label. Prescription loperamide is sometimes taken on a schedule (one or more times a day). Follow the directions on the package or on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take loperamide exactly as directed.

If you are giving loperamide to your child, read the package label carefully to make sure that it is the right product for the age of the child. Loperamide should not be given to a child younger than 2 years of age. Check the package label to find out how much medication the child needs. If you know how much your child weighs, give the dose that matches that weight on the chart. If you don't know your child's weight, give the dose that matches your child's age. Ask your child's doctor if you don't know how much medication to give your child.

If you are taking loperamide liquid, do not use a household spoon to measure your dose. Use the measuring cup that came with the medication or use a spoon made especially for measuring liquid medication.

If you are taking loperamide for acute diarrhea and your symptoms get worse or if your diarrhea lasts longer than 48 hours, stop taking this medication and call your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking loperamide,

• tell your doctor and pharmacist if you are allergic to loperamide, any other medications, or any of the ingredients in loperamide products. Check the package label for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antibiotics such as clarithromycin (Biaxin, in PrevPac) and erythromycin (E.E.S., Ery-Tab, Eryc, others); certain antifungals such as itraconazole (Onmel, Sporanox) and ketoconazole; cimetidine (Tagamet), gemfibrozil (Lopid); quinine (Qualaquin), ranitidine (Zantac), ritonavir (Norvir, in Kaletra), or saquinavir (Invirase). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had ulcerative colitis (condition in which sores develop in the intestines causing pain and diarrhea). or colitis (swelling of the intestine caused by certain bacteria). Also, tell your doctor if you have a fever, blood or mucus in the stool, black stools, or stomach pain without diarrhea. Your doctor will probably tell you not to take loperamide or give it your child if you have one or more of these conditions.

• tell your doctor if you have acquired immunodeficiency syndrome (AIDS) or if you have or have ever had liver disease.

• tell your doctor and pharmacist if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking loperamide, call your doctor.

• you should know that this drug may make you drowsy and dizzy. Do not drive a car or operate machinery until you know how this drug affects you.

Drink plenty of water or other clear fluids to replace fluids lost while having diarrhea.

If you are taking scheduled doses of loperamide, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

• Loperamide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • constipation

  • fatigue

• If you or someone taking loperamide experience any of the following symptoms, call your/their doctor immediately or get emergency medical treatment:

  • rash

  • red, peeling or blistering skin

  • hives

  • itching

  • wheezing

  • difficulty breathing

  • fever

  • stomach pain or swelling

  • bloody stools

• If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• nausea

• inability to urinate

• fainting

• fast, pounding, or irregular heartbeat

• unresponsiveness

• confusion

• narrowing of the pupils

• slow and shallow breathing

• shortness of breath

Ask your pharmacist any questions you have about taking this medicine.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Imodium^® Multi-Symptom Relief (containing Loperamide, Simethicone)