Motofen (Oral)

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

Because difenoxin is related to some narcotics, it can become habit-forming if taken in larger doses than prescribed. To reduce the risk of misuse, atropine (an anticholinergic) has been included. If someone takes higher-than-normal doses of this combination, the atropine will cause unpleasant effects, making it less likely they will take such doses again.

Difenoxin and atropine combination medicine should not be used in children. For children with diarrhea, solutions of carbohydrates (sugars) and electrolytes (important salts) should be given to replace the fluids and important salts lost during diarrhea.

This medicine is available only with your 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 must consider the risks of taking the medicine compared to the benefits it may provide.

Allergies

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

Pediatric

This medicine should not be used in children. Children, especially very young ones, are more sensitive to the effects of difenoxin and atropine, which may increase the chance of side effects during treatment. Additionally, the fluid loss from diarrhea can lead to a severe condition. Therefore, it is crucial to provide enough fluids to replace what is lost. If you have questions about this, consult your health care professional.

Geriatric

Elderly patients may be more likely to experience shortness of breath or breathing difficulties, as they are usually more sensitive to the effects of difenoxin. The fluid loss caused by diarrhea can also lead to a severe condition. For this reason, elderly individuals should not use this medicine without consulting their doctor first. It is also essential that they drink enough fluids to replace what is lost. If you have questions about this, consult your health care professional.

Breast Feeding

There are not enough 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 taken together with caution. In cases where interactions might occur, your doctor may adjust the dose or take other precautions. It is important for your healthcare professional to know if you are taking any of the following medicines when you are using this medicine. The following interactions are significant and are not a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medication or adjust your other medicines.

• 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 frequency of one or both 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 it may be necessary to use both drugs for your treatment. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Arbutamine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used during or around meal times, as interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this medicine. Inform your doctor about any other medical problems you have, 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)—A more serious colon problem may develop if you use this medicine.

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

• Dysentery—This condition may worsen; a different type of treatment may be needed.

• Emphysema, asthma, bronchitis, or other chronic lung disease—There is a greater risk of breathing problems with this medicine in patients with these conditions.

• Enlarged prostate or
• Urinary tract blockage or difficult urination—Using this medicine may cause urination issues.

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

• Glaucoma—Severe eye pain may occur with this medicine, although the risk is low.

• Heart disease—This medicine may affect the heart and worsen the condition.

• Hiatal hernia—The atropine in this medicine may worsen this condition, although the risk is low.

• High blood pressure (hypertension)—The atropine in this medicine may increase blood pressure, although the risk is low.

• Intestinal blockage—This medicine may worsen the condition.

• Kidney disease—The 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 any of the following side effects occur:

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

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

• Blurred vision (continuing) or changes in near vision
• drowsiness (severe)
• dryness of mouth, nose, and throat (severe)
• fast heartbeat
• shortness of breath or troubled breathing (severe)
• unusual excitement, nervousness, restlessness, or irritability
• unusual warmth, dryness, and flushing of skin

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or 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 immediately if you notice the following side effects:

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

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.

• 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.