Drug Information

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Brand Name
Common Name
diphenoxylate - atropine
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.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. 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.

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 4 years old. As soon as symptoms are brought under control, reduce the dose or stop taking the medication as directed by your doctor.

Swallow the tablets whole with a glass of water. Do not crush or chew the tablets. Drink plenty of water while you are taking this medication.

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.

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 2.5 mg of diphenoxylate HCl and 0.025 mg of atropine sulfate. Nonmedicinal ingredients: acacia, cornstarch, magnesium stearate, mineral oil, sorbitol, sucrose, and talc.

Who should NOT take this medication?

Do not take diphenoxylate - atropine if you:

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

Do not give this medication to children under 4 years of age.

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.

  • abdominal cramps
  • dizziness or lightheadedness
  • drowsiness
  • dry skin or mouth
  • flushing
  • general feeling of being unwell
  • headache
  • loss of appetite
  • nausea
  • tiredness
  • trouble sleeping
  • vomiting

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)
  • blurred vision or changes in near vision
  • breathing problems (difficult or slow breathing)
  • constipation
  • confusion
  • difficulty urinating
  • fast heartbeat
  • hallucinations (e.g., hearing or seeing things that aren’t there)
  • numbness or tingling in the hands or feet
  • signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • skin rash or itching
  • unusual excitement, nervousness, restlessness, or irritability

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

  • bloating (for people with ulcerative colitis)
  • coma (when too much is taken)
  • loss of consciousness/fainting
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)

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.

Alcohol and other medications that cause drowsiness: Do not combine diphenoxylate – atropine with alcohol or other medications (e.g., antidepressants, sleeping pills, anxiety medications) that cause drowsiness since additional drowsiness can occur and be dangerous.

Dependence: Physical dependence, psychological dependence, and abuse are possible at high doses. Do not take more of this medication than your doctor has prescribed. People with a history of past or current substance use problems may be at greater risk of developing abuse or addiction while taking this medication.

Drowsiness/reduced alertness: This medication may cause drowsiness or dizziness. Avoid activities that require mental alertness, such as driving or operating dangerous machinery until you know how this medication affects you.

Liver function: This medication can cause complications in people with decreased liver function. If you have liver disease such as cirrhosis, hepatitis, or decreased liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Ulcerative colitis: If you have active ulcerative colitis, this medication may cause a severe complication called toxic megacolon. If you experience sudden, rapid abdominal distension (bloating), or if you have any other symptoms that worry you, contact your doctor immediately. Toxic megacolon is a medical emergency and must be treated quickly.

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 less than 4 years of age.

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)
  • aclidinium
  • alcohol
  • amantadine
  • antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
  • antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  • atropine
  • azelastine
  • barbiturates (e.g., butalbital, phenobarbital)
  • belladonna
  • benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
  • benztropine
  • botulinum toxin
  • brimonidine
  • buprenorphine
  • buspirone
  • cannabis
  • chloral hydrate
  • darifenacin
  • disopyramide
  • efavirenz
  • fesoterodine
  • flavoxate
  • flibanserin
  • general anesthetics (medications used to put people to sleep before surgery)
  • glucagon
  • glycopyrrolate
  • ipratropium
  • kava kava
  • ketotifen
  • linezolid
  • metoclopramide
  • mirabegron
  • mirtazapine
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, rasagiline, selegiline, tranylcypromine)
  • muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)
  • nabilone
  • narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
  • nitroglycerin
  • oxybutynin
  • potassium chloride (solid oral forms such as tablets)
  • pramipexole
  • quinidine
  • ropinirole
  • scopolamine
  • secretin
  • seizure medications (e.g., carbamazepine, clobazam, felbamate, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide)
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
  • sodium oxybate
  • solifenacin
  • suvorexant
  • tapentadol
  • thalidomide
  • thiazide diuretics (water pills; e.g., hydrochlorothiazide, indapamide, metolazone)
  • tiotropium
  • tolterodine
  • tramadol
  • tranylcypromine
  • tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, imipramine)
  • trospium
  • umeclidinium
  • vilazodone
  • zolpidem
  • zopiclone

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.

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