Diphenoxylate Hydrochloride And Atropine Sulfate Solution
Loading...Diphenoxylate Hydrochloride And Atropine Sulfate Solution Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 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, 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.
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 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.
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.
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.
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 Oral Solution USP is effective as adjunctive therapy in the management of diarrhea.
History
There is currently no drug history available for this drug.
Other Information
Each 5 mL oral solution contains:
Diphenoxylate Hydrochloride ....................................................................... 2.5 mg
Atropine Sulfate ........................................................................................ 0.025 mg
Alcohol .............................................................................................................. 15%
Inactive Ingredients:
The cherry-flavored oral solution contains alcohol, cherry flavor, citric acid (andydrous), FD and C Red No. 40, FD and C Yellow No. 6, glycerin, maltol, potassium sorbate, purified water and sorbitol solution.
Diphenoxylate hydrochloride, an antidiarrheal, is ethyl 1-(3-cyano-3,3-diphenylpropyl)-4-phenylisoni-pecotate monohydrochloride and has the following structural formula:
C30H32N2O2 · HCl M.W 489.05
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:
(C17H23NO3)2 · H2SO4 · H2O M.W. 694.83
A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage.
Sources
Diphenoxylate Hydrochloride And Atropine Sulfate Solution Manufacturers
-
Roxane Laboratories, Inc
![Diphenoxylate Hydrochloride And Atropine Sulfate Solution [Roxane Laboratories, Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Diphenoxylate Hydrochloride And Atropine Sulfate Solution | Roxane Laboratories, Inc
DO NOT EXCEED RECOMMENDED DOSAGE.
AdultsThe recommended initial dosage is 10 mL (two regular teaspoonfuls) of oral solution four times daily (20 mg per day). Most patients will require this dosage until initial control has been achieved, after which the dosage may be reduced to meet individual requirements. Control may often be maintained with as little as 5 mg (10 mL of solution) daily.
Clinical improvement of acute diarrhea is usually observed within 48 hours. If clinical improvement of chronic diarrhea after treatment with a maximum daily dose of 20 mg of diphenoxylate hydrochloride is not observed within 10 days, symptoms are unlikely to be controlled by further administration.
ChildrenDiphenoxylate hydrochloride and atropine sulfate is not recommended in children under 2 years of age and should be used with special caution in young children (seeWARNINGS and PRECAUTIONS). The nutritional status and degree of dehydration must be considered. In children under 13 years of age, use the oral solution. Do not use the tablets for this age group.
Only the plastic dropper should be used when measuring the oral solution for administration to children.
Dosage Schedule for ChildrenThe recommended initial total daily dosage of the oral solution for children is 0.3 to 0.4 mg/kg administered in four divided doses. The following table provides an approximate initial daily dosage recommendation for children.
Age Approximate Weight Dosage in mL (Years) (kg) (lbs.) (four times daily) 2 11-14 24-31 1.5-3.0 3 12-16 26-35 2.0-3.0 4 14-20 31-44 2.0-4.0 5 16-23 35-51 2.5-4.5 6-8 17-32 38-71 2.5-5.0 9-12 23-55 51-121 3.5-5.0These pediatric schedules are the best approximation of an average dose recommendation which may be adjusted downward according to the overall nutritional status and degree of dehydration encountered in the sick child. Reduction of dosage may be made as soon as initial control of symptoms has been achieved. Maintenance dosage may be as low as one-fourth of the initial daily dosage. If no response occurs within 48 hours, diphenoxylate hydrochloride and atropine sulfate is unlikely to be effective.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Login To Your Free Account