Difenoxin and atropine (Oral)

Difenoxin and atropine combination medicine is used with other treatments to help adults with severe diarrhea. Difenoxin works by slowing down the movements of the intestines to stop diarrhea.

Because difenoxin is similar to some narcotics, it can be habit-forming if taken in larger doses than prescribed. To help reduce the risk of abuse, atropine (an anticholinergic) is included. If someone takes more than the normal dose of this combination, the atropine will cause unpleasant side effects, making it less likely they will take those higher doses again.

Difenoxin and atropine combination medicine should not be used in children. Children with diarrhea should receive solutions containing carbohydrates (sugars) and electrolytes (important salts) to replace the fluids and essential salts lost during diarrhea.

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

Your doctor should check your progress at regular visits if you will be taking this medicine regularly for a long time.

Check with your doctor if your diarrhea does not stop after 2 days or if you develop a fever.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.

If you think you or someone else in your home 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. Symptoms of overdose include severe drowsiness; fast heartbeat; shortness of breath or troubled breathing; and unusual warmth, dryness, and flushing of skin.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

In deciding to use a medicine, you and your doctor need to consider the risks versus the benefits of taking it. For this medicine, you should think about the following:

Allergies

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

Pediatric

This medicine should not be used in children. Children, especially very young children, are very sensitive to the effects of difenoxin and atropine, which may increase the chance of side effects. Additionally, the fluid loss from diarrhea can lead to a severe condition. It is important to ensure that enough liquids are provided to replace the fluids lost by the body. If you have any questions about this, consult your health care professional.

Geriatric

Elderly patients may be more likely to experience shortness of breath or difficulty breathing, as they are often more sensitive to the effects of difenoxin. The fluid loss from diarrhea can also lead to a severe condition. Therefore, elderly individuals should not take this medicine without first consulting their doctor. It is also crucial to ensure that enough liquids are taken to replace the fluids lost by the body. If you have any questions about this, consult your health care professional.

Breast Feeding

There are no adequate 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 never be used together, while others may be combined even if an interaction could happen. In such cases, your doctor may adjust the dose or take other precautions. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the following medicines. The following interactions are highlighted for their potential significance and are not all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to prescribe this medication or may change some of the other medicines you are taking.

• 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 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 taken around mealtime or with specific types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss the use of your medicine with food, alcohol, or tobacco with your healthcare professional.

Other Medical Problems

Other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical conditions, especially:

• Alcohol abuse (or history of) or
• Drug abuse (history of)—There is a higher chance that this medicine may become habit-forming

• Colitis (severe)—Using this medicine may lead to more serious issues in the colon

• Down's syndrome—Side effects may be more likely and severe in these patients

• Dysentery—This condition may worsen; a different kind of treatment may be necessary

• Emphysema, asthma, bronchitis, or other chronic lung disease—There is a higher chance that this medicine may cause breathing problems in patients with these conditions

• Enlarged prostate or
• Urinary tract blockage or difficult urination—Using this medicine may lead to urination problems

• Gallbladder disease or gallstones—This medicine may cause spasms in the biliary tract and worsen the condition

• Glaucoma—Using this medicine may result in severe eye pain; however, the risk of this happening is low

• Heart disease—This medicine may affect the heart, potentially worsening the condition

• Hiatal hernia—Atropine in this medicine may exacerbate this condition; however, the risk of this happening is low

• High blood pressure (hypertension)—Atropine in this medicine may increase blood pressure; however, the risk of this happening is low

• Intestinal blockage—This medicine may worsen the condition

• Kidney disease—Atropine in this medicine may accumulate in the body and cause side effects

• Liver disease—The risk of central nervous system (CNS) side effects, including coma, may be higher in patients with this condition

• Myasthenia gravis—This medicine may worsen the condition

• Overactive or underactive thyroid—Unwanted effects on breathing and heart rate may occur

• Overflow incontinence—This medicine may worsen the condition

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 need medical attention.

Check with your doctor right away if you notice any of the following side effects:

• Bloating
• constipation
• loss of appetite
• severe stomach pain with nausea and vomiting

Get emergency help immediately if you experience any of the following signs of overdose:

• Continuing blurred vision or changes in near vision
• Severe drowsiness
• Severe dryness of mouth, nose, and throat
• Fast heartbeat
• Severe shortness of breath or troubled breathing
• Unusual excitement, nervousness, restlessness, or irritability
• Unusual warmth, dryness, and flushing of skin

Some side effects may happen but usually do not need medical attention. These side effects may go away as your body gets used to the medicine. Your health care professional may also provide information on how to prevent or lessen some of these side effects. Talk to your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Less common or rare

• Blurred vision
• confusion
• difficult urination
• dizziness or lightheadedness
• drowsiness
• dryness of skin and mouth
• fever
• headache
• trouble sleeping
• unusual tiredness or weakness

After you stop using this medicine, it may still cause some side effects that need attention. During this time, check with your doctor right away if you notice any of the following side effects:

• Increased sweating
• muscle cramps
• nausea or vomiting
• shivering or trembling
• stomach cramps

Other side effects not listed may also happen in some patients. If you notice any other effects, talk to your healthcare professional.

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

In the U.S.

• Motofen

Available Dosage Forms:

• Tablet

Therapeutic Class: Antidiarrheal

Pharmacologic Class: Atropine

Chemical Class: Difenoxin

If this medicine upsets your stomach, your doctor may want you to take it with food.

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. If too much is taken, it may become habit-forming.

Importance of diet and fluids while treating diarrhea:

• 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.
• If too much fluid has been lost by the body due to the diarrhea a serious condition may develop. Check with your doctor as soon as possible if any of the following symptoms of too much fluid loss occur: Decreased urination Dizziness and lightheadedness Dryness of mouth Increased thirst Wrinkled skin

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 oral dosage form (tablets): For severe diarrhea: Adults and teenagers—The first dose is usually 2 milligrams (mg). After that, the dose is 1 mg taken after each loose stool or every three or four hours as needed. Do not take more than 8 mg in any twenty-four-hour period. Children—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.