Drugplain

Diphenoxylate Hydrochloride and Atropine Sulfate .025 mg/1

diphenoxylate hydrochloride and atropine sulfate · TABLET · Aphena Pharma Solutions - Tennessee, LLC

1 Recall on Record
Plain English

Diphenoxylate hydrochloride and atropine sulfate is a prescription oral tablet used to treat diarrhea by slowing intestinal movement. The medication combines an antidiarrheal agent with atropine to reduce cramping and other gastrointestinal symptoms.

Key Facts

Brand Name
Diphenoxylate Hydrochloride and Atropine Sulfate
Generic Name
diphenoxylate hydrochloride and atropine sulfate
NDC Code (Product)
71610-809
Manufacturer
Aphena Pharma Solutions - Tennessee, LLC
Strength
.025 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
DEA Schedule
Schedule V (Controlled)
Application #
ANDA213413
Marketing Start
03/15/2020

Recall History

1 Recall on Record
Class I10/20/2017

Pfizer Inc.

SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective92 reports
macular degeneration60 reports
nausea53 reports
off label use43 reports
weight decreased42 reports
pain41 reports
malaise34 reports
abdominal pain33 reports
pyrexia33 reports
headache32 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Diphenoxylate hydrochloride and atropine sulfate tablets are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.

Dosage & Administration

DOSAGE AND ADMINISTRATION Management of Diarrhea in Patients 13 Years of Age and Older Diphenoxylate hydrochloride and atropine sulfate tablets are recommended as adjunctive therapy for the management of diarrhea in patients 13 years of age and older. Consider the nutritional status and degree of dehydration in patients prior to initiating therapy with diphenoxylate hydrochloride and atropine sulfate tablets. The use of diphenoxylate hydrochloride and atropine sulfate tablets should be accompanied by appropriate fluid and electrolyte therapy, when indicated. If severe dehydration or electrolyte imbalance is present, do not administer diphenoxylate hydrochloride and atropine sulfate tablets until appropriate corrective therapy has been indicated (see WARNINGS ). Initial and Maximum Recommended Dosage in Patients 13 Years of Age and Older The initial adult dosage is 2 diphenoxylate hydrochloride and atropine sulfate tablets four times daily (maximum total daily dose of 20 mg per day of diphenoxylate hydrochloride). Most patients will require this dosage until initial control of diarrhea has been achieved. Clinical improvement of acute diarrhea is usually observed within 48 hours. Dos…

Warnings

WARNINGS Respiratory and/or CNS Depression in Pediatric Patients Less Than 6 Years of Age Cases of severe respiratory depression and coma, leading to permanent brain damage or death have been reported in patients less than 6 years of age who received diphenoxylate hydrochloride and atropine sulfate tablets . Diphenoxylate hydrochloride and atropine sulfate tablets are contraindicated in patients less than 6 years of age due to these risks (see CONTRAINDICATIONS ). Anticholinergic and Opioid-Toxicities Toxicities associated with the atropine and diphenoxylate components of diphenoxylate hydrochloride and atropine sulfate tablets have been reported. The initial presenting symptoms may be delayed by up to 30 hours due to prolonged gastric emptying time induced by diphenoxylate hydrochloride. Clinical presentations vary in terms of which toxicity (anticholinergic vs. opioid) will present first or predominate; non-specific findings have been reported and include symptoms such as drowsiness (see OVERDOSAGE ). Dehydration and Electrolyte Imbalance The use of diphenoxylate hydrochloride and atropine sulfate tablets should be accompanied by appropriate fluid and electrolyte therapy, when in…

Contraindications

CONTRAINDICATIONS Diphenoxylate hydrochloride and atropine sulfate tablets are contraindicated in: Pediatric patients less than 6 years of age due to the risks of respiratory and central nervous system (CNS) depression (see WARNINGS ). Patients with diarrhea associated with pseudomembranous enterocolitis (Clostridium difficile) or other enterotoxin-producing bacteria due to the risk of gastrointestinal (GI) complications, including sepsis (see WARNINGS ). Patients with known hypersensitivity to diphenoxylate or atropine. Patients with obstructive jaundice.

Drug Interactions

Drug Interactions Alcohol Alcohol may increase the CNS depressant effects of diphenoxylate hydrochloride and atropine sulfate tablets and may cause drowsiness (see WARNINGS ). Avoid concomitant use of diphenoxylate hydrochloride and atropine sulfate tablets with alcohol. Other Drugs that Cause CNS Depression The concurrent use of diphenoxylate hydrochloride and atropine sulfate tablets with other drugs that cause CNS depression (e.g., barbiturates, benzodiazepines, opioids, buspirone, antihistamines, muscle relaxants), may potentiate the effects of diphenoxylate hydrochloride and atropine sulfate tablets (see WARNINGS ). Either diphenoxylate hydrochloride and atropine sulfate tablets or the other interacting drug should be chosen, depending on the importance of the drug to the patient. If CNS-acting drugs cannot be avoided, monitor patients for CNS adverse reactions. MAO Inhibitors Diphenoxylate may interact with monoamine oxidase inhibitors (MAOIs) and precipitate a hypertensive crisis . Avoid use of diphenoxylate hydrochloride and atropine sulfate tablets in patients who take MAOIs and monitor for signs and symptoms of hypertensive crisis (headache, hyperthermia, hypertension).

Adverse Reactions

ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in labeling: Respiratory and/or CNS depression (see WARNINGS ) Anticholinergic and opioid-toxicities, including atroponism (see WARNINGS and PRECAUTIONS ) Dehydration and electrolyte imbalance (see WARNINGS ) GI Complications in patients with infectious diarrhea (see WARNINGS ) Toxic megacolon in patients with acute ulcerative colitis (see WARNINGS ) At therapeutic doses of diphenoxylate hydrochloride and atropine sulfate tablets, the following other adverse reactions have been reported; they are listed in decreasing order of severity, but not of frequency: Nervous system: numbness of extremities, euphoria, depression, malaise/lethargy, confusion, sedation/drowsiness, dizziness, restlessness, headache, hallucination Allergic: anaphylaxis, angioneurotic edema, urticaria, swelling of the gums, pruritus Gastrointestinal system: megacolon, paralytic ileus, pancreatitis, vomiting, nausea, anorexia, abdominal discomfort The following adverse reactions related to atropine sulfate are listed in decreasing order of severity, but not of frequency: hyperthermia, tachycardia, urinary retention, flushing, dryness …

Frequently Asked Questions

What is Diphenoxylate Hydrochloride and Atropine Sulfate used for?

Diphenoxylate hydrochloride and atropine sulfate is a prescription oral tablet used to treat diarrhea by slowing intestinal movement. The medication combines an antidiarrheal agent with atropine to reduce cramping and other gastrointestinal symptoms.

Is Diphenoxylate Hydrochloride and Atropine Sulfate a controlled substance?

Yes, Diphenoxylate Hydrochloride and Atropine Sulfate is classified as CV under the DEA Controlled Substances Act.

What is the generic name for Diphenoxylate Hydrochloride and Atropine Sulfate?

The generic name for Diphenoxylate Hydrochloride and Atropine Sulfate is diphenoxylate hydrochloride and atropine sulfate. There are 1 other brand versions of diphenoxylate hydrochloride and atropine sulfate.

What is the NDC code for Diphenoxylate Hydrochloride and Atropine Sulfate .025 mg/1?

The NDC (National Drug Code) for Diphenoxylate Hydrochloride and Atropine Sulfate .025 mg/1 is 71610-809, listed by Aphena Pharma Solutions - Tennessee, LLC.

Product NDC

71610-809

Package NDC

71610-809-53

Other Diphenoxylate Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)