Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, USP are available containing 2.5 mg of diphenoxylate hydrochloride, USP and 0.025 mg of atropine sulfate, USP. Tablets – white to off white, round, unscored tablets debossed with 'WL' on one side and '107' on the other side of the tablet and containing 2.5 mg of diphenoxylate hydrochloride and 0.025 mg of atropine sulfate, supplied as: NDC Number Size 75826-107-11 bottle of 10 75826-107-33 bottle of 30 75826-107-90 bottle of 90 75826-107-03 bottle of 100 75826-107-00 bottle of 1000 Store below 25°C (77°F). [See USP Controlled Room Temperature.]; PRINCIPAL DISPLAY PANEL - 1000 Tablet Bottle Label Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, USP CV 2.5 mg / 0.025 mg Rx Only 1000 Tablets PRINCIPAL DISPLAY PANEL - 1000 Tablet Bottle Label
- HOW SUPPLIED Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, USP are available containing 2.5 mg of diphenoxylate hydrochloride, USP and 0.025 mg of atropine sulfate, USP. Tablets – white to off white, round, unscored tablets debossed with 'WL' on one side and '107' on the other side of the tablet and containing 2.5 mg of diphenoxylate hydrochloride and 0.025 mg of atropine sulfate, supplied as: NDC Number Size 75826-107-11 bottle of 10 75826-107-33 bottle of 30 75826-107-90 bottle of 90 75826-107-03 bottle of 100 75826-107-00 bottle of 1000 Store below 25°C (77°F). [See USP Controlled Room Temperature.]
- PRINCIPAL DISPLAY PANEL - 1000 Tablet Bottle Label Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, USP CV 2.5 mg / 0.025 mg Rx Only 1000 Tablets PRINCIPAL DISPLAY PANEL - 1000 Tablet Bottle Label
Overview
Each diphenoxylate hydrochloride and atropine sulfate tablet, USP contains: 2.5 mg of diphenoxylate hydrochloride USP (equivalent to 2.3 mg of diphenoxylate) and 0.025 mg of atropine sulfate USP (equivalent to 0.01 mg of atropine) Diphenoxylate hydrochloride, an antidiarrheal, is ethyl 1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecotate monohydrochloride and has the following structural formula: Atropine sulfate, an anticholinergic, is endo-(±)-α-(hydroxymethyl) benzeneacetic acid 8-methyl-8- azabicyclo[3.2.1] oct-3-yl ester sulfate (2:1) (salt) monohydrate and has the following structural formula: A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage. Inactive ingredients of Diphenoxylate hydrochloride and atropine sulfate tablets include colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch and stearic acid. Chemical Structure Chemical Structure
Indications & Usage
Diphenoxylate hydrochloride and atropine sulfate is indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.
Dosage & Administration
Management of Diarrhea in Patients 13 Years of Age and Older Diphenoxylate hydrochloride and atropine sulfate is 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. The use of Diphenoxylate hydrochloride and atropine sulfate 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 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. Dosage after Initial Control of Diarrhea After initial control has been achieved, the Diphenoxylate hydrochloride and atropine sulfate dosage may be reduced to meet individual requirements. Control may often be maintained with as little as two Diphenoxylate hydrochloride and atropine sulfate tablets daily. Duration of Treatment If clinical improvement of chronic diarrhea after treatment with the maximum recommended daily dosage is not observed within 10 days, discontinue Diphenoxylate hydrochloride and atropine sulfate tablets as symptoms are unlikely to be controlled by further administration.
Warnings & Precautions
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 is 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 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 should be accompanied by appropriate fluid and electrolyte therapy, when indicated. If severe dehydration or electrolyte imbalance is present, Diphenoxylate hydrochloride and atropine sulfate should be withheld until appropriate corrective therapy has been initiated. Drug-induced inhibition of peristalsis may result in fluid retention in the intestine, which may further aggravate dehydration and electrolyte imbalance. Gastrointestinal Complications in Patients with Infectious Diarrhea Diphenoxylate Hydrochloride and Atropine Sulfate is contraindicated in patients with diarrhea associated with organisms that penetrate the GI mucosa (toxigenic E. coli, Salmonella, Shigella ), and pseudomembranous enterocolitis ( Clostridium difficile ) associated with broad-spectrum antibiotics (see CONTRAINDICATIONS ). Antiperistaltic agents, including Diphenoxylate hydrochloride and atropine sulfate, slow gastrointestinal motility and may enhance bacterial overgrowth and the release of bacterial exotoxins. Diphenoxylate hydrochloride and atropine sulfate has been reported to result in serious GI complications in patients with infectious diarrhea, including sepsis, prolonged and/or worsened diarrhea. Prolonged fever and the delay in the resolution of stool pathogens were reported in study of Shigellosis in adults who used Diphenoxylate hydrochloride and atropine sulfate vs. placebo. Toxic Megacolon in Patients with Acute Ulcerative Colitis In some patients with acute ulcerative colitis, agents that inhibit intestinal motility or prolong intestinal transit time have been reported to induce toxic megacolon. Consequently, patients with acute ulcerative colitis should be carefully observed and Diphenoxylate hydrochloride and atropine sulfate therapy should be discontinued promptly if abdominal distention occurs or if other untoward symptoms develop. Interaction with Meperidine Hydrochloride Since the chemical structure of diphenoxylate hydrochloride is similar to that of meperidine hydrochloride, the concurrent use of Diphenoxylate hydrochloride and atropine sulfate with monoamine oxidase (MAO) inhibitors may, in theory, precipitate hypertensive crisis. Hepatorenal Disease Diphenoxylate hydrochloride and atropine sulfate should be used with extreme caution in patients with advanced hepatorenal disease and in all patients with abnormal liver function since hepatic coma may be precipitated. Interaction with CNS Depressants Diphenoxylate hydrochloride may potentiate the action of other drugs that cause dizziness or drowsiness, including barbiturates, benzodiazepines and other sedatives/hypnotics, anxiolytics, and tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, and alcohol. Therefore, the patient should be closely observed when any of these are used concomitantly.
Contraindications
Diphenoxylate hydrochloride and atropine sulfate is 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.
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, 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 of the skin and mucous membranes.
Drug Interactions
Alcohol Alcohol may increase the CNS depressant effects of Diphenoxylate hydrochloride and atropine sulfate and may cause drowsiness (see WARNINGS ). Avoid concomitant use of Diphenoxylate hydrochloride and atropine sulfate with alcohol. Other Drugs that Cause CNS Depression The concurrent use of Diphenoxylate hydrochloride and atropine sulfate 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 (see WARNINGS ). Either Diphenoxylate hydrochloride and atropine sulfate 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 in patients who take MAOIs and monitor for signs and symptoms of hypertensive crisis (headache, hyperthermia, hypertension).
Storage & Handling
Store below 25°C (77°F). [See USP Controlled Room Temperature.]
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.