Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4090
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Lomotil (Tablet)
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| dailymed-instance:dosage |
DO NOT EXCEED RECOMMENDED DOSAGE. Adults: The recommended initial dosage is two Lomotil tablets four times daily or 10 ml (two regular teaspoonfuls) of Lomotil liquid 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 or 10 ml of liquid) 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: Lomotil is not recommended in children under 2 years of age and should be used with special caution in young children (see
Warnings
and
Precautions). The nutritional status and degree of dehydration must be considered. In children under 13 years of age, use Lomotil liquid. Do not use Lomotil tablets for this age group. Only the plastic dropper should be used when measuring Lomotil liquid for administration to children. Dosage schedule for children: The recommended initial total daily dosage of Lomotil liquid 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. These 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, Lomotil is unlikely to be effective. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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| dailymed-instance:descripti... |
Each Lomotil tablet and each 5 ml of Lomotil liquid for oral use contains: diphenoxylate hydrochloride 2.5 mg 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: 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: A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage. Inactive ingredients of Lomotil tablets include acacia, corn starch, magnesium stearate, sorbitol, sucrose, and talc. Inactive ingredients of Lomotil liquid include cherry flavor, citric acid, ethyl alcohol 15%, FD&C Yellow No. 6, glycerin, sodium phosphate, sorbitol, and water.
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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 16-subject crossover 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 Lomotil liquid) 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 comparedwith an equal dose of the liquid 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... |
Lomotil is contraindicated in patients with
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Tablets���round, white, with SEARLE debossed on one side and 61 on the other side and containing 2.5 mg of diphenoxylate hydrochloride and 0.025 mg of atropine sulfate, supplied as: NDC Number Size 0025-0061-31 bottle of 100 0025-0061-51 bottle of 500 0025-0061-52 bottle of 1,000 0025-0061-55 bottle of 2,500 0025-0061-34 carton of 100 unit dose Liquid���containing 2.5 mg of diphenoxylate hydrochloride and 0.025 mg of atropine sulfate per 5 ml; bottles of 2 fl oz (NDC Number 0025-0066-02). Dispense only in original container. A plastic dropper calibrated in increments of 1/2 ml (1/4 mg) with a capacity of 2 ml (1 mg) accompanies each 2-oz bottle of Lomotil liquid. Only this plastic dropper should be used when measuring Lomotil liquid for administration to children.
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| dailymed-instance:genericMe... |
diphenoxylate hydrochloride and atropine sulfate
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| dailymed-instance:fullName |
Lomotil (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... |
Lomotil is effective as adjunctive therapy in the management of diarrhea.
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Lomotil
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