Diphenoxylate and atropine (Oral)

Diphenoxylate and atropine combination is used with other treatments (like fluid and electrolyte treatment) to treat severe diarrhea. Diphenoxylate helps stop diarrhea by slowing down how the intestines move.

Diphenoxylate is related to some narcotics and may lead to addiction if taken in doses larger than prescribed. If you take higher than normal doses of this combination, atropine will cause unpleasant effects.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular appointments to ensure that this medicine is working correctly and to look for any unwanted effects.

Diarrhea usually stops 2 days after starting this medicine. If your symptoms do not get better or if they worsen within 10 days of treatment, contact your doctor.

This medicine may cause serious stomach or bowel issues (for example, toxic megacolon). This risk is higher if you also have ulcerative colitis. Contact your doctor immediately if you experience bloating, constipation, loss of appetite, nausea, vomiting, or stomach pain.

Contact your doctor if you have dizziness, fast, shallow breathing, a fast, weak heartbeat, headache, muscle cramps, pale, clammy skin, thirst, extremely high fever or body temperature, a decrease in urine volume, a decrease in how often you urinate, trouble urinating, painful urination, dry skin and mouth. These may be signs of a condition called atropinism.

Speak with your doctor before using this medicine with alcohol or other medications that affect the central nervous system (CNS). Using alcohol or other CNS-affecting medications with diphenoxylate and atropine may increase the side effects of this medicine, such as dizziness, difficulty concentrating, drowsiness, unusual dreams, and sleep problems. Some examples of CNS-affecting medications include antihistamines or medications for allergies or colds, sedatives, tranquilizers, or sleeping medications, medications for depression, medications for anxiety, prescription pain medications or narcotics, medications for attention deficit and hyperactivity disorder, medications for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

If you think you or someone else may have taken too much of this medicine, seek emergency help immediately. Taking too much of this medicine may cause unconsciousness and possibly death. Signs or symptoms of an overdose include severe drowsiness, shortness of breath or difficulty breathing, fast heartbeat, and unusual warmth, dryness, and flushing of the skin.

This medicine may cause dizziness or drowsiness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless your doctor has discussed them with you. This includes both prescription and nonprescription (over-the-counter [OTC]) medicines, as well as herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine compared to the benefits it may provide. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also let your healthcare professional know if you have other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

So far, studies have not shown any specific problems that would limit the use of diphenoxylate and atropine combination in children 13 years and older. Safety and effectiveness have not been proven in children under 13 years old. This medicine should not be used in children under 6 years of age due to the risk of respiratory depression (serious breathing problems) or coma (loss of consciousness).

Geriatric

There is no information available about how age affects the use of diphenoxylate and atropine combination in older adults.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the possible benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. In these situations, your doctor may want to adjust the dose, or take other precautions. It is especially important that your healthcare professional knows if you are taking any of the medicines listed below when you are using this medicine. The following interactions have been chosen based on their potential significance and do not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or change some of the other medicines you take.

• Ambenonium
• Nalmefene
• Naltrexone
• Potassium Citrate
• Safinamide
• Samidorphan

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both of the medicines.

• Alfentanil
• Alprazolam
• Amantadine
• Amifampridine
• Amphetamine
• Benzhydrocodone
• Benzphetamine
• Bromazepam
• Bromopride
• Buprenorphine
• Bupropion
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbinoxamine
• Cetirizine
• Citalopram
• Clobazam
• Clonazepam
• Clopidogrel
• Clozapine
• Codeine
• Daridorexant
• Desmopressin
• Desvenlafaxine
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Diazepam
• Dihydrocodeine
• Donepezil
• Doxylamine
• Duloxetine
• Escitalopram
• Esketamine
• Fenfluramine
• Fentanyl
• Flibanserin
• Fluoxetine
• Fluvoxamine
• Furazolidone
• Gabapentin
• Gabapentin Enacarbil
• Gepirone
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Granisetron
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Iproniazid
• Isocarboxazid
• Ketamine
• Lacosamide
• Lasmiditan
• Lemborexant
• Levocetirizine
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofexidine
• Lorazepam
• Loxapine
• Macimorelin
• Magnesium Oxybate
• Meclizine
• Meperidine
• Metaxalone
• Methacholine
• Methadone
• Methamphetamine
• Methylene Blue
• Metoclopramide
• Midazolam
• Milnacipran
• Mirtazapine
• Moclobemide
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Olanzapine
• Ondansetron
• Oxycodone
• Oxymorphone
• Ozanimod
• Paroxetine
• Pentazocine
• Periciazine
• Phenelzine
• Phenobarbital
• Potassium Oxybate
• Pregabalin
• Primidone
• Procarbazine
• Quetiapine
• Rasagiline
• Remifentanil
• Remimazolam
• Revefenacin
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secretin Human
• Selegiline
• Sertraline
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Tiotropium
• Topiramate
• Tramadol
• Tranylcypromine
• Trazodone
• Vilazodone
• Vortioxetine
• Zolpidem
• Zuranolone

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both medicines may be necessary for your treatment. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the medicines.

• Arbutamine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect how you can use this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

• Diarrhea caused by antibiotics or an infection, including sepsis or
• Obstructive jaundice—Should not be used in patients with these conditions.

• Down's syndrome—May worsen side effects.

• Enlarged prostate or
• Gallbladder disease or
• Glaucoma or
• Heart disease or
• Hypertension (high blood pressure) or
• Kidney disease or
• Liver disease or
• Myasthenia gravis (severe muscle weakness) or
• Problems urinating or
• Stomach or bowel issues (e.g., blockage, hiatal hernia, ulcerative colitis) or
• Thyroid problems—Use with caution. May worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do occur, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Bloating
• confusion
• constipation
• cough
• decrease in the frequency of urination
• decrease in urine volume
• diarrhea
• difficulty in passing urine (dribbling)
• difficulty swallowing
• discouragement
• dizziness
• drowsiness
• dry skin and mouth
• extremely high fever or body temperature
• false or unusual sense of well-being
• fast, shallow breathing
• fast, weak heartbeat
• feeling of warmth
• feeling sad or empty
• headache
• hives, itching, skin rash
• irritability
• loss of appetite
• loss of interest or pleasure
• muscle cramps
• nausea
• numbness of the arms and legs
• painful urination
• pale, clammy skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the face, neck, arms and occasionally, upper chest
• restlessness
• seeing, hearing, or feeling things that are not there
• stomach cramps or pain
• thirst
• tightness in the chest
• trouble concentrating
• trouble sleeping
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• unusual tiredness or weakness
• vomiting
• weight loss

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Agitation
• back pain
• bigger, dilated, or enlarged pupils (black part of eye)
• blurred vision
• difficult or troubled breathing
• feeling of warmth
• fever
• garbled speech
• increased sensitivity of the eyes to light
• irregular, fast or slow, or shallow breathing
• loss of consciousness
• mood or mental changes
• pale or blue lips, fingernails, or skin
• seizures
• speech that is not understood
• stiff neck
• unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Lomocot
• Lomotil
• Lonox
• Vi-Atro

Available Dosage Forms:

• Tablet
• Solution

Therapeutic Class: Antidiarrheal

Pharmacologic Class: Atropine

Chemical Class: Diphenoxylate

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup.

In addition to using medicine for diarrhea, it is very important that you replace the fluid lost by the body and follow a proper diet. For the first 24 hours you should eat gelatin and drink plenty of caffeine-free clear liquids, such as ginger ale, decaffeinated cola, decaffeinated tea, and broth. During the next 24 hours you may eat bland foods, such as cooked cereals, bread, crackers, and applesauce. Fruits, vegetables, fried or spicy foods, bran, candy, caffeine, and alcoholic beverages may make the condition worse.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For severe diarrhea: For oral dosage form (oral liquid): Adults—At first, the dose is 5 milligrams (mg) (2 teaspoonfuls) three or four times a day. Then, your doctor may decrease your dose to 5 mg (2 teaspoonfuls) once a day, as needed. Children 12 years of age or younger—Use is not recommended. For oral dosage form (tablets): Adults and children 13 years of age and older—At first, the dose is 5 milligrams (mg) (2 tablets) four times a day. Then, your doctor may decrease your dose to 5 mg (2 tablets) once a day, as needed. Children 6 to younger than 13 years of age—Use and dose must be determined by your doctor. Children younger than 6 years of age—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.