Vi-Atro (Oral)

Diphenoxylate and atropine combination is used with other treatments (for example, fluid and electrolyte treatment) to manage severe diarrhea. Diphenoxylate works by slowing down the movements of the intestines to help stop diarrhea.

Diphenoxylate is related to some narcotics and can become habit-forming if taken in larger doses than prescribed. Taking higher than normal doses of the combination can lead to unpleasant effects caused by atropine.

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

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

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

This medicine may cause serious stomach or bowel problems (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, reduced urine volume, less frequent urination, trouble passing urine, painful urination, or dry skin and mouth. These may be signs of a condition called atropinism.

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

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

This medicine may make you dizzy or drowsy. 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 you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor will need to consider the risks of taking the medicine along with the benefits it may provide. For this medicine, the following should be considered:

Allergies

Let your doctor know if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional 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

Current studies have not shown any specific problems that would limit the use of diphenoxylate and atropine combination in children aged 13 and older. Safety and effectiveness have not been established for children younger than 13 years of age. This medicine should not be used in children younger than 6 years of age due to the risk of respiratory depression (severe breathing problems) or coma (loss of consciousness).

Geriatric

There is no information available regarding the effects of diphenoxylate and atropine combination in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction could happen. In these cases, your doctor might adjust the dose, or other precautions may be needed. When you are taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or adjust 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 change the dose or how often you use 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 taking both medicines may be the best option for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Arbutamine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used 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. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell 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 passing urine or
• Stomach or bowel problems (e.g., blockage, hiatal hernia, ulcerative colitis) or
• Thyroid problems—Use with caution. May worsen these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away 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 happen 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.