Lomotil (Atropine Sulfate / Atropine / Diphenoxylate Hydrochloride)

(dye fen ox' i late)

Diphenoxylate is used along with other measures, such as replacement of lost fluids and salts in the body, to treat diarrhea. Diphenoxylate should not be given to children younger than 2 years of age. Diphenoxylate is in a class of medications called antidiarrheal agents. It works by decreasing activity of the bowel.

Diphenoxylate comes as a tablet and solution (liquid) to take by mouth. It is usually taken as needed up to 4 times a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take diphenoxylate exactly as directed. Do not take more of it or take it more often than prescribed by your doctor. The solution comes in a container with a special dropper for measuring the dose. Ask your pharmacist if you have questions about how to measure a dose. Your diarrhea symptoms should improve within 48 hours of treatment with diphenoxylate. Your doctor may tell you to decrease your dose as your symptoms improve. If your symptoms do not improve or if they get worse within 10 days of treatment, call your doctor. Diphenoxylate can be habit-forming. Do not take a larger dose, take it more often, or for a longer period of time than your doctor tells you to. Atropine has been added to diphenoxylate tablets to cause unpleasant effects if this medication is taken in higher doses than recommended.

Before taking diphenoxylate,
• tell your doctor and pharmacist if you are allergic to diphenoxylate, atropine, any other medications, or any of the other ingredients in diphenoxylate tablets or solution. Ask your pharmacist 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: barbiturates such as phenobarbital or secobarbital (Seconal); or tranquilizers. Also tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar) or tranylcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with diphenoxylate, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor if you have jaundice (yellowing of the skin or eyes caused by liver problems); bloody diarrhea; diarrhea along with a fever, mucus in your stool, or abdominal cramps, pain, or swelling; or diarrhea that happens during or shortly after taking antibiotics. Your doctor will probably tell you not to take diphenoxylate.
• tell your doctor if you have Down syndrome (an inherited condition causing a range of developmental and physical problems), or if you have or have ever had ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum), liver, or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking diphenoxylate, call your doctor.
• before having surgery, including dental surgery, tell the doctor or dentist that you are taking this medicine.
• 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.
• ask your doctor about the safe use of alcoholic beverages while you are taking diphenoxylate. Alcohol can make the side effects from diphenoxylate worse.

Be sure to follow all dietary recommendations made by your doctor. Drink plenty of clear liquids to replace fluids lost while having diarrhea.

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

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

• nausea
• vomiting
• loss of appetite
• headache
• restlessness
• tiredness
• confusion
• changes in mood
• dryness of the skin, nose, or mouth

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• numbness in arms and legs
• decreased urination
• ongoing pain that begins in the stomach area, but may spread to the back
• abdominal bloating
• fast heart beat
• shortness of breath
• hives
• rash
• itching
• swelling of the eyes, face, tongue, lips, gums, mouth, hands, feet, ankles, or lower legs
• difficulty swallowing or breathing
• hoarseness

Diphenoxylate may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

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) and light. 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. 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

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.

Keep all appointments with your doctor. Do not let anyone else take your medication. Diphenoxylate is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions. 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. ¶ This branded product is no longer on the market. Generic alternatives may be available.