Diphenoxylate Hcl And Atropine Sulfate Recall
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Questions & Answers
Side Effects & Adverse Reactions
THIS IS NOT AN INNOCUOUS DRUG AND DOSAGE RECOMMENDATIONS SHOULD BE STRICTLY ADHERED TO, ESPECIALLY IN CHILDREN. DIPHENOXYLATE HCl AND ATROPINE SULFATE IS NOT RECOMMENDED FOR CHILDREN UNDER 2 YEARS OF AGE. OVERDOSAGE MAY RESULT IN SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT BRAIN DAMAGE OR DEATH (SEE OVERDOSAGE). THEREFORE, KEEP THIS MEDICATION OUT OF THE REACH OF CHILDREN.
THE USE OF DIPHENOXYLATE HCl AND ATROPINE SULFATE SHOULD BE ACCOMPANIED BY APPROPRIATE FLUID AND ELECTROLYTE THERAPY, WHEN INDICATED. IF SEVERE DEHYDRATION OR ELECTROLYTE IMBALANCE IS PRESENT, THIS PRODUCT 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. DIPHENOXYLATE HCl AND ATROPINE SULFATE SHOULD BE USED WITH SPECIAL CAUTION IN YOUNG CHILDREN BECAUSE THIS AGE GROUP MAY BE PREDISPOSED TO DELAYED DIPHENOXYLATE TOXICITY AND BECAUSE OF THE GREATER VARIABILITY OF RESPONSE IN THIS AGE GROUP.
Antiperistaltic agents may prolong and/or worsen diarrhea associated with organisms that penetrate the intestinal mucosa (toxigenic E. Coli, Salmonella, Shigella), and pseudomembranous enterocolitis associated with broad-spectrum antibiotics. Antipersistaltic agents should not be used in these conditions.
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 HCl and atropine sulfate therapy should be discontinued promptly if abdominal distention occurs or if other untoward symptoms develop.
Since the chemical structure of diphenoxylate hydrochloride is similar to that of meperidine hydrochloride, the concurrent use of this product with monoamine oxidase (MAO) inhibitors may, in theory, precipitate hypertensive crisis.
This product 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. Diphenoxylate hydrochloride may potentiate the action of barbiturates, tranquilizers, and alcohol. Therefore, the patient should be closely observed when any of these are used concomitantly.
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FDA Safety Alerts
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There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
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INDICATIONS AND USAGE
Diphenoxylate hydrochloride and atropine sulfate tablets are effective as adjunctive therapy in the management of diarrhea
There is currently no drug history available for this drug.
Each tablet, for oral administration, contains:
Diphenoxylate Hydrochloride USP . . . . . . . . . . . 2.5 mg
Atropine Sulfate USP . . . . . . . . . . . . . . . . . . . . . 0.025 mg
In addition, each tablet, contains the following inactive ingredients: confectioner’s sugar, corn starch, lactose monohydrate, magnesium stearate and sodium starch glycolate.
Diphenoxylate hydrochloride, an antidiarrheal, is ethyl 1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecotate monohydrochloride and has the following structural formula:
C30H32N2O2•HCl M.W. 489.06
Atropine sulfate, an anticholinergic, is Benzeneacetic acid,-(hydroxymethyl)-8-methyl-8-azabicyclol [3.2.1] oct-3-yl ester, endo-±, sulfate(2:1) (salt), monohydrate and has the following structural formula:
C17H23NO3)2•H2SO4•H20 M.W. 694.85
A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage.