Class Name(s):

• 56:08 Antidiarrhea Agents

Pronunciation:

• (dye fen ox' i late)

Brand Name(s):

• Colonaid^® (as a combination product containing Atropine, Diphenoxylate)¶
• Di-Atro^® (as a combination product containing Atropine, Diphenoxylate)¶
• Lo-Trol^® (as a combination product containing Atropine, Diphenoxylate)¶
• Logen^® (as a combination product containing Atropine, Diphenoxylate)¶
• Lomanate^® (as a combination product containing Atropine, Diphenoxylate)¶
• Lomotil^® (as a combination product containing Atropine, Diphenoxylate)
• Lonox^® (as a combination product containing Atropine, Diphenoxylate)¶
• Low-Quel^® (as a combination product containing Atropine, Diphenoxylate)¶; also available generically

WHY is this medicine prescribed?

Diphenoxylate is used along with other treatments such as fluid and electrolyte replacement for the treatment of 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.

HOW should this medicine be used?

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 oral 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 and stop taking diphenoxylate.

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.

Are there OTHER USES for this medication?

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

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 while taking diphenoxylate and atropine Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• 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), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar) or tranylcypromine (Parnate).
• the following nonprescription products may interact with diphenoxylate and atropine: allergy medications (diphenhydramine, loratadine, fexofenadine, chlorpheniramine or cetirizine). Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking diphenoxylate and atropine. Do not start any of these medications while taking diphenoxylate and atropine without discussing with your healthcare provider.
• 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 breastfeeding. 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 medication 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.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

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.

What SIDE EFFECTS can this medicine cause?

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
• stomach discomfort

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

• numbness in arms and legs
• ongoing pain that begins in the stomach area but may spread to the back
• stomach bloating
• 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
• seeing things or hearing voices that do not exist

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

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).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://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:

• fever, fast heartbeat, decreased urination, flushing, dryness of the skin, nose, or mouth
• dryness of the skin, nose, or mouth
• changes in the size of pupils (black circles in the middle of the eyes)
• uncontrollable eye movements
• restlessness
• flushing
• fever
• fast heart beat
• decreased reflexes
• excessive tiredness
• difficulty breathing
• loss of consciousness
• seizures
• difficulty speaking
• seeing things or hearing voices that do not exist

What should I know about STORAGE and DISPOSAL of 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. Discard any remaining solution 90 days after opening the bottle.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are taking diphenoxylate.

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.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: June 20, 2024.