Motofen 1 mg-0.025 mg tablet

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Medication name

Generic name:
Difenoxin/atropine - oral

Pronunciation
(DYE-fen-OX-in/AT-roe-peen)

Brand name(s)
Motofen

Uses

This medication is used to treat diarrhea. It helps to decrease the number and frequency of bowel movements. It works by slowing the movement of the intestines. Difenoxin is similar to opioid pain relievers, but it acts mainly to slow the gut. Atropine belongs to a class of drugs known as anticholinergics, which help to dry up body fluids and also slow gut movement.

This medication should not be used to treat diarrhea caused by certain types of infection (such as C. difficile-associated diarrhea following antibiotic therapy). Talk to your doctor for more details.

This drug is not recommended for use in children younger than 2 years due to an increased risk of very serious side effects.

How to use

Take this medication by mouth as directed by your doctor, usually after each loose stool, or every 3 or 4 hours as needed. Dosage is based on your medical condition and response to therapy. For adults, do not take more than 8 milligrams of difenoxin in any 24-hour period. If you need to continue treatment once your diarrhea is controlled, your doctor may direct you to lower your dosage. Do not increase your dose, take it more often, or use it for longer than prescribed.

It is important that you drink the proper amount of fluids and minerals (electrolytes) to prevent dehydration. Tell your doctor right away if you develop signs of dehydration (such as extreme thirst, decreased urination, muscle cramps, weakness, fainting). You may also need to change to a bland diet during this time to reduce irritation to your stomach/intestines. Consult your doctor or pharmacist for more information.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as stomach cramps, nausea, vomiting). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used this medication for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Inform your doctor if your condition does not improve after 2 days.

Side effects

Drowsiness, dizziness, headache, tiredness, blurred vision, dry mouth, and loss of appetite may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

  • stomach/abdominal pain or swelling
  • severe nausea
  • vomiting
  • mental/mood changes (such as confusion, depression)
  • restlessness
  • numbness/tingling of arms/legs

Get medical help right away if you have any very serious side effects, including:

  • eye pain/swelling/redness
  • vision changes (such as seeing rainbows around lights at night, blurred vision)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking difenoxin with atropine, tell your doctor or pharmacist if you are allergic to either drug; or to hyoscyamine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • liver disease (such as obstructive jaundice, cirrhosis)
  • current dehydration or mineral imbalance
  • a certain type of bowel disease (acute ulcerative colitis)
  • personal or family history of glaucoma (angle-closure type)

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Children, especially those with Down's syndrome, may be more sensitive to the side effects of this product. Very serious (possibly fatal) effects may occur if too much of this medication is taken by children.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Drug interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

  • ambenonium
  • MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine)
  • naltrexone
  • potassium tablets/capsules
  • pramlintide

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, muscle weakness, fast heartbeat, high fever, unusually fast/slow/irregular breathing, seizures, loss of consciousness.

Notes

Do not share this medication with others. Sharing it is against the law.

Missed dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised November 2022.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.