Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/62
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diphenoxylate hydrochloride and atropine sulfate (Tablet)
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| dailymed-instance:dosage |
DO NOT EXCEED RECOMMENDED DOSAGE. Adults: The recommended initial dosage is two tablets 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 (two tablets) 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. Children: Diphenoxylate HCl and Atropine Sulfate is not recommended in children under 2 years of age and should be used with special caution in young children . The nutritional status and degree of dehydration must be considered. In children under 13 years of age, use oral solution. Do not use tablets for this age group. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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| dailymed-instance:descripti... |
Each tablet, for oral administration, contains: Diphenxylate Hydrochloride������������������������������������������������2.5 mg (Warning-May be habit forming) Atropine Sulfate ..................................................................................... 0.025 mg Diphenoxylate hydrochloride, an antidiarrheal, is ethyl 1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecotate monohydrochloride and has the following structural formula: Molecular formula CHNO���HCl M.W. 489.05 Atropine sulfate, an anticholinergic, is endo-(��)-��-(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: Molecular formula (CHNO)���HSO���HO M.W. 694.83 A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, acacia, calcium stearate, methylcellulose, and corn starch.
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| dailymed-instance:clinicalP... |
Diphenoxylate is rapidly and extensively metabolized in man by ester hydrolysis to diphenoxylic acid (difenoxine), which is biologically active and the major metabolite in the blood. After a 5 mg oral dose of carbon-14 labeled diphenoxylate hydrochloride in ethanolic solution was given to three healthy volunteers, an average of 14% of the drug plus its metabolites was excreted in the urine and 49% in the feces over a four-day period. Urinary excretion of the unmetabolized drug constituted less than 1% of the dose, and diphenoxylic acid plus its glucuronide conjugate constituted about 6% of the dose. In a sixteen-subject cross-over bioavailability study, a linear relationship in the dose range of 2.5 to 10 mg was found between the dose of diphenoxylate hydrochloride (given as Diphenoxylate HCl and Atropine Sulfate Oral Solution) and the peak plasma concentration, the area under the plasma concentration-time curve, and the amount of diphenoxylic acid excreted in the urine. In the same study the bioavailability of the tablet compared with an equal dose of theliquid was approximately 90%. The average peak plasma concentration of diphenoxylic acid following ingestion of four 2.5 mg tablets was 163 ng/mL at about 2 hours, and the elimination half-life of diphenoxylic acid was approximately 12 to 14 hours. In dogs, diphenoxylate hydrochloride has a direct effect on circular smooth muscle of the bowel that conceivably results in segmentation and prolongation of gastrointestinal transit time. The clinical antidiarrheal action of diphenoxylate hydrochloride may thus be a consequence of enhanced segmentation that allows increased contact of the intraluminal contents with the intestinal mucosa.
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| dailymed-instance:contraind... |
Diphenoxylate HCl and Atropine Sulfate tablets are contraindicated in patients with:
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| dailymed-instance:supply |
Diphenoxylate Hydrochloride and Atropine Sulfate is available as a round, white, convex 2.5 mg/0.025 mg tablet, debossed LAN over 1170, supplied in bottles of 100, 500, and 1000 tablets. 100 Tablets NDC 0527-1170-01 500 Tablets NDC 0527-1170-05 1000 Tablets NDC 0527-1170-10 Store at controlled room temperature 20��-25��C (68��-77��F). (See USP) Dispense in a well-closed container as defined in the USP.
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| dailymed-instance:genericMe... |
diphenoxylate hydrochloride and atropine sulfate
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| dailymed-instance:fullName |
diphenoxylate hydrochloride and atropine sulfate (Tablet)
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| dailymed-instance:adverseRe... |
At therapeutic doses, the following 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. Allergic: anaphylaxis, angioneurotic edema, urticaria, swelling of the gums, pruritus. Gastrointestinal system: toxic megacolon, paralytic ileus, pancreatitis, vomiting, nausea, anorexia, abdominal discomfort. The following atropine sulfate effects are listed in decreasing order of severity, but not of frequency: hyperthermia, tachycardia, urinary retention, flushing, dryness of the skin and mucous membranes. These effects may occur, especially in children. THIS MEDICATION SHOULD BE KEPT IN A CHILD-RESISTANT CONTAINER AND OUT OF THE REACH OF CHILDREN SINCE AN OVERDOSAGE MAY RESULT IN SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT BRAIN DAMAGE OR DEATH.
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| dailymed-instance:indicatio... |
Diphenoxylate Hydrochloride and Atropine Sulfate tablets are effective as adjunctive therapy in the management of diarrhea.
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| dailymed-instance:name |
diphenoxylate hydrochloride and atropine sulfate
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