How does this medication work? What will it do for me?

Diphenoxylate - atropine is used to treat diarrhea that is not caused by infection with bacteria. This medication works by slowing down the movement of the bowels.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each round, white tablet, with "SEARLE" debossed on one side and "61" on the other side, contains diphenoxylate HCl 2.5 mg and atropine sulfate 0.025 mg. Nonmedicinal ingredients: acacia, cornstarch, magnesium stearate, mineral oil, sorbitol, sucrose, and talc.

How should I use this medication?

The usual initial adult dose of diphenoxylate - atropine is 5 mg (2 tablets) 3 or 4 times daily to a maximum of 20 mg (8 tablets) taken in 24 hours. The children's dose is based on age and approximate body weight. This medication should not be used by children under 2 years old. As soon as symptoms are brought under control, reduce the dose or stop taking the medication as directed by your doctor.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Diphenoxylate - atropine should not be taken by anyone who:

  • is allergic to diphenoxylate, atropine, or any of the ingredients of the medication
  • is being treated for diarrhea associated with pseudomembranous enterocolitis (diarrhea caused by antibiotic treatment) or for diarrhea caused by enterotoxin-producing bacteria
  • has jaundice (a liver condition causing yellowing of skin and eyes)

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • confusion
  • dizziness or lightheadedness
  • drowsiness
  • dryness of skin and mouth
  • fever
  • headache
  • increased body temperature
  • nausea

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • bloating (for people without ulcerative colitis)
  • constipation
  • depression
  • difficulty urinating
  • loss of appetite
  • numbness in the hands or feet
  • stomach pain (severe) with nausea and vomiting
  • swelling of the gums

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • bloating (for people with ulcerative colitis)
  • blurred vision or changes in near vision
  • drowsiness (severe)
  • dryness of mouth, nose, and throat (severe)
  • fast heartbeat
  • skin rash or itching
  • shortness of breath or difficulty breathing (severe)
  • unusual excitement, nervousness, restlessness, or irritability
  • unusual warmth, dryness, and flushing of the skin

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Dependence: Addiction to this medication may be possible at high dosages. Do not exceed the recommended dosage.

Drowsiness/reduced alertness: This medication may produce drowsiness or dizziness. Avoid activities that require mental alertness, such as driving or operating dangerous machinery until you ensure that the medication does not affect you in this way.

Medical conditions: People with acute ulcerative colitis should stop taking this medication and contact their doctor right away if abdominal distension (bloating) occurs, or if they have any other symptoms that worry them. People with liver disease should be closely monitored by their doctors while taking this medication.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children under 2 years of age. Children over 2 years of age should be closely monitored by their doctor while taking this medication.

What other drugs could interact with this medication?

There may be an interaction between diphenoxylate - atropine and any of the following:

  • acetylcholinesterase inhibitors (e.g., donepezil, galantamine, rivastigmine)
  • alcohol
  • barbiturates (e.g., phenobarbital)
  • droperidol
  • haloperidol
  • MAO inhibitors (e.g., phenelzine, tranylcypromine)
  • methotrimeprazine
  • phenothiazines (e.g., chlorpromazine, perphenazine)
  • potassium chloride (solid oral forms such as tablets)
  • tranquilizers (e.g., diazepam, alprazolam)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.