Difenoxin HCl-Atropine

Difenoxin HCl-Atropine is a combination medication indicated as adjunctive therapy in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea.

• Difenoxin HCl-Atropine is available under the following different brand names: Motofen

Common side effects of Difenoxin HCl-Atropine include:

• drowsiness
• dizziness
• headache
• tiredness
• blurred vision
• dry mouth
• loss of appetite
• nausea
• vomiting
• upset stomach
• constipation
• light-headedness
• nervousness
• insomnia
• burning sensation in the eyes

Serious side effects of Difenoxin HCl-Atropine include:

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

Rare side effects of Difenoxin HCl-Atropine include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects or health problems that may oCur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablets: Schedule IV

• 1 mg/0.025 mg

Diarrhea

Adult and geriatric dosage

• Initially, 2 mg (2 tabs) orally, then 1 mg (1 tab) every 3-4 hours or as needed for loose stool; no more than 8 mg/day

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Difenoxin HCl-Atropine has severe interactions with the following drug:
  • alvimopan
• Difenoxin HCl-Atropine has serious interactions with at least 27 other drugs
• Difenoxin HCl-Atropine has moderate interactions with at least 254 other drugs
• Difenoxin HCl-Atropine has minor interactions with at least 31 other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Children younger than 2 years
• Hypersensitivity, infectious diarrhea, jaundice
• GI obstruction, hemorrhage, intestinal atony, myasthenia gravis, obstructive uropathy, reflux esophagitis, ulcerative colitis

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Difenoxin HCl-Atropine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Difenoxin HCl-Atropine?”

Cautions

• Closed-angle glaucoma, esophageal achalasia
• Hepatorenal disease, abnormal liver function
• Improvement of symptoms within 48 hours; if not, unlikely to be effective
• Do not exceed the recommended dosage; reduce the initial dosage for maintenance
• Pregnancy, breastfeeding

Pregnancy and Lactation

• Use with caution if the benefits outweigh the risks during pregnancy
• Lactation
  • The drug enters breast milk and is not recommended