Diphenoxylate and atropine

Generic name: Diphenoxylate And Atropine
Drug class: Antidiarrheals

Usage of Diphenoxylate and atropine

Diphenoxylate and atropine combination is used along with other measures (eg, fluid and electrolyte treatment) to treat severe diarrhea. Diphenoxylate helps stop diarrhea by slowing down the movements of the intestines.

Diphenoxylate is chemically related to some narcotics and may be habit-forming if taken in doses that are larger than prescribed. If higher than normal doses of the combination are taken, the atropine will cause unpleasant effects.

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

Diphenoxylate and atropine side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, 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.

Before taking Diphenoxylate and atropine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of diphenoxylate and atropine combination in children 13 years of age and older. Safety and efficacy have not been established in children younger than 13 years of age. This medicine should not be used in children younger than 6 years of age because of the risk for respiratory depression (severe breathing problem) or coma (loss of consciousness).

Geriatric

No information is available on the relationship of age to the effects of diphenoxylate and atropine combination in geriatric patients.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide 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 required 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 cause an increased risk of certain side effects, but using both drugs may be the best treatment 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

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Relate drugs

How to use Diphenoxylate and atropine

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.

Warnings

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

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

This medicine may cause serious stomach or bowel problems (eg, toxic megacolon). This is more likely if you also have ulcerative colitis. Check with your doctor right away if you have bloating, constipation, loss of appetite, nausea, vomiting, or stomach pain.

Check with 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, decrease in urine volume, decrease in frequency of urination, difficulty in passing urine, painful urination, dry skin and mouth. This may be signs of condition called atropinism.

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

If you think you or anyone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of this medicine may 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 they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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