Diphenoxylate Hydrochloride And Atropine Sulfate

Diphenoxylate Hydrochloride And Atropine Sulfate

Diphenoxylate Hydrochloride 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 HYDROCHLORIDE 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 HYDROCHLORIDE 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 HYDROCHLORIDE 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. Antiperistaltic 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 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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Diphenoxylate hydrochloride and atropine sulfate tablets are effective as adjunctive therapy in the management of diarrhea.

History

There is currently no drug history available for this drug.

Other Information

Each tablet for oral administration contains:

diphenoxylate
hydrochloride, USP 2.5 mg
(Warning – May be habit forming)

atropine
sulfate, USP 0.025 mg

Diphenoxylate hydrochloride, an antidiarrheal, is ethyl 1-(3-cyano-3, 3-diphenylpropyl)-4-phenyl-isonipecotate monohydrochloride and has the following structure:

Diphenoxylate Hydrochloride Structural Formula

Atropine sulfate, an anticholinergic, is endo-(±)-alpha-(hydroxymethyl) benzeneacetic acid 8-methyl-8-azabicylo[3.2.1] oct-3-yl ester sulfate (2:1)] (salt) monohydrate and has the following structure:

Atropine Structural Formula

A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage.

Each tablet for oral administration contains the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch and stearic acid.

Diphenoxylate Hydrochloride And Atropine Sulfate Manufacturers


  • A-s Medication Solutions Llc
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [A-s Medication Solutions Llc]
  • Proficient Rx Lp
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [Proficient Rx Lp]
  • Lannett Co., Inc.
    Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate) Tablet [Lannett Co., Inc.]
  • Rebel Distributors Corp
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [Rebel Distributors Corp]
  • Physicians Total Care, Inc.
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [Physicians Total Care, Inc.]
  • Cardinal Health
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [Cardinal Health]
  • Redpharm Drug, Inc.
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [Redpharm Drug, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Dispensing Solutions, Inc.
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [Dispensing Solutions, Inc.]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Par Pharmaceutical, Inc.
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [Par Pharmaceutical, Inc.]
  • Mckesson Contract Packaging
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [Mckesson Contract Packaging]
  • Bryant Ranch Prepack
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [Bryant Ranch Prepack]
  • Pd-rx Pharmaceuticals, Inc.
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Greenstone Llc
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [Greenstone Llc]
  • A-s Medication Solutions Llc
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [A-s Medication Solutions Llc]
  • Mylan Institutional Inc.
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [Mylan Institutional Inc.]
  • Cardinal Health
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [Cardinal Health]
  • Preferred Pharmaceuticals, Inc
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [Preferred Pharmaceuticals, Inc]
  • Cadinal Health
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [Cadinal Health]
  • Apotheca, Inc
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [Apotheca, Inc]
  • Aidarex Pharmaceuticals Llc
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [Aidarex Pharmaceuticals Llc]
  • Kaiser Foundation Hospitals
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [Kaiser Foundation Hospitals]
  • Aphena Pharma Solutions – Tennessee, Llc
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [Aphena Pharma Solutions – Tennessee, Llc]
  • Mylan Pharmaceuticals Inc.
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [Mylan Pharmaceuticals Inc.]
  • Cardinal Health
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [Cardinal Health]
  • A-s Medication Solutions Llc
    Diphenoxylate Hydrochloride And Atropine Sulfate Tablet [A-s Medication Solutions Llc]

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