Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Tablets — round, flat-faced radius-edged, white tablet with M in a box on one side and containing 2.5 mg of diphenoxylate hydrochloride USP and 0.025 mg of atropine sulfate USP, supplied as: Unit dose packages of 100 (10 x 10) NDC 60687-890-01 Store below 25°C (77°F). FOR YOUR PROTECTION: Do not use if blister is torn or broken. This product's label may have been updated. Contact American Health Packaging to order more inserts at 1-800-707-4621 or check https://dailymed.nlm.nih.gov for updated online information about the product. Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2020 Mallinckrodt.; Package/Label Display Panel – Carton – 2.5 mg/0.025 mg NDC 60687- 890 -01 Diphenoxylate Hydrochloride and Atropine Sulfate CV Tablets USP 2.5 mg/0.025 mg* 100 Tablets (10 x 10) Rx Only *Each Tablet Contains: diphenoxylate hydrochloride USP 2.5 mg (equivalent to 2.3 mg of diphenoxylate); atropine sulfate USP 0.025 mg (equivalent to 0.01 mg of atropine). Warning - May be habit forming. Usual Dosage: See full prescribing information. Pharmacist: Caution patient not to exceed dose. Special Note: Diphenoxylate Hydrochloride and Atropine Sulfate Tablets are not recommended for children under 6 years of age. Store below 25°C (77°F). FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 0406-1236, SpecGx LLC. Distributed by: American Health Packaging, Columbus, Ohio 43217 789001 0489001/0325 2.5 mg 0.025 mg Diphenoxylate Atropine Tablets Carton; Package/Label Display Panel – Blister – 2.5 mg/0.025 mg Diphenoxylate Hydrochloride and Atropine Sulfate Tablet USP CV 2.5 mg/0.025 mg 2.5 mg 0.025 mg Diphenoxylate Atropine Tablet Blister
- HOW SUPPLIED Tablets — round, flat-faced radius-edged, white tablet with M in a box on one side and containing 2.5 mg of diphenoxylate hydrochloride USP and 0.025 mg of atropine sulfate USP, supplied as: Unit dose packages of 100 (10 x 10) NDC 60687-890-01 Store below 25°C (77°F). FOR YOUR PROTECTION: Do not use if blister is torn or broken. This product's label may have been updated. Contact American Health Packaging to order more inserts at 1-800-707-4621 or check https://dailymed.nlm.nih.gov for updated online information about the product. Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2020 Mallinckrodt.
- Package/Label Display Panel – Carton – 2.5 mg/0.025 mg NDC 60687- 890 -01 Diphenoxylate Hydrochloride and Atropine Sulfate CV Tablets USP 2.5 mg/0.025 mg* 100 Tablets (10 x 10) Rx Only *Each Tablet Contains: diphenoxylate hydrochloride USP 2.5 mg (equivalent to 2.3 mg of diphenoxylate); atropine sulfate USP 0.025 mg (equivalent to 0.01 mg of atropine). Warning - May be habit forming. Usual Dosage: See full prescribing information. Pharmacist: Caution patient not to exceed dose. Special Note: Diphenoxylate Hydrochloride and Atropine Sulfate Tablets are not recommended for children under 6 years of age. Store below 25°C (77°F). FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 0406-1236, SpecGx LLC. Distributed by: American Health Packaging, Columbus, Ohio 43217 789001 0489001/0325 2.5 mg 0.025 mg Diphenoxylate Atropine Tablets Carton
- Package/Label Display Panel – Blister – 2.5 mg/0.025 mg Diphenoxylate Hydrochloride and Atropine Sulfate Tablet USP CV 2.5 mg/0.025 mg 2.5 mg 0.025 mg Diphenoxylate Atropine Tablet Blister
Overview
Each Diphenoxylate Hydrochloride and Atropine Sulfate Tablet 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 silicified microcrystalline cellulose, pregelatinized starch, and magnesium stearate. Chemical Structure Chemical Structure
Indications & 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
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 two 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 tablets 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 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 indicated. If severe dehydration or electrolyte imbalance is present, diphenoxylate hydrochloride and atropine sulfate tablets 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 tablets are 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 tablets, slow gastrointestinal motility and may enhance bacterial overgrowth and the release of bacterial exotoxins. Diphenoxylate hydrochloride and atropine sulfate tablets have 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 tablets 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 tablets 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 tablets with monoamine oxidase (MAO) inhibitors may, in theory, precipitate hypertensive crisis. Hepatorenal Disease Diphenoxylate hydrochloride and atropine sulfate tablets 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 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.
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 of the skin and mucous membranes.
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).
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