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diphenoxylate hydrochloride and atropine sulfate

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Overview

What is Diphenoxylate Hydrochloride and Atropine Sulfate?

Each diphenoxylate hydrochloride and atropine sulfate tablet, USP contains:

2.5 mg of diphenoxylate hydrochloride, USP (Warning: May be habit forming) (equivalent to 2.3 mg of diphenoxylate) and 0.025 mg of atropine sulfate, USP (equivalent to 0.01 mg of atropine)

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-(±)-alpha-(hydroxymethyl) benzeneacetic acid 8-methyl-8-azabicylo[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 diphenoxylate hydrochloride and atropine sulfate tablets include colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch (corn) and stearic acid.



What does Diphenoxylate Hydrochloride and Atropine Sulfate look like?



What are the available doses of Diphenoxylate Hydrochloride and Atropine Sulfate?

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What should I talk to my health care provider before I take Diphenoxylate Hydrochloride and Atropine Sulfate?

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How should I use Diphenoxylate Hydrochloride and Atropine Sulfate?

Diphenoxylate hydrochloride and atropine sulfate tablets are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.

Diphenoxylate hydrochloride and atropine sulfate tablets are recommended as adjunctive therapy for the management of diarrhea in patients 13 years of age and older. Consider the nutritional status and degree of dehydration in patients prior to initiating therapy with diphenoxylate hydrochloride and atropine sulfate tablets. The use of diphenoxylate hydrochloride and atropine sulfate tablets should be accompanied by appropriate fluid and electrolyte therapy, when indicated. If severe dehydration or electrolyte imbalance is present, do not administer diphenoxylate hydrochloride and atropine sulfate tablets until appropriate corrective therapy has been indicated (see ).


What interacts with Diphenoxylate Hydrochloride and Atropine Sulfate?

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What are the warnings of Diphenoxylate Hydrochloride and Atropine Sulfate?

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What are the precautions of Diphenoxylate Hydrochloride and Atropine Sulfate?

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What are the side effects of Diphenoxylate Hydrochloride and Atropine Sulfate?

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What should I look out for while using Diphenoxylate Hydrochloride and Atropine Sulfate?

Diphenoxylate hydrochloride and atropine sulfate tablets are contraindicated in:


What might happen if I take too much Diphenoxylate Hydrochloride and Atropine Sulfate?


How should I store and handle Diphenoxylate Hydrochloride and Atropine Sulfate?

Store at 20°C to 25°C (68°F to 77°F) [See USP controlled room temperature]. Protect from moisture.Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, USP are available containing 2.5 mg of diphenoxylate hydrochloride, USP (Warning: May be habit forming) and 0.025 mg of atropine sulfate, USP. The tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 43063-089-04 bottles of 4 tablets NDC 43063-089-06 bottles of 6 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Pharmacist:Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, USP are available containing 2.5 mg of diphenoxylate hydrochloride, USP (Warning: May be habit forming) and 0.025 mg of atropine sulfate, USP. The tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 43063-089-04 bottles of 4 tablets NDC 43063-089-06 bottles of 6 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Pharmacist:Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, USP are available containing 2.5 mg of diphenoxylate hydrochloride, USP (Warning: May be habit forming) and 0.025 mg of atropine sulfate, USP. The tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 43063-089-04 bottles of 4 tablets NDC 43063-089-06 bottles of 6 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Pharmacist:Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, USP are available containing 2.5 mg of diphenoxylate hydrochloride, USP (Warning: May be habit forming) and 0.025 mg of atropine sulfate, USP. The tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 43063-089-04 bottles of 4 tablets NDC 43063-089-06 bottles of 6 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Pharmacist:Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, USP are available containing 2.5 mg of diphenoxylate hydrochloride, USP (Warning: May be habit forming) and 0.025 mg of atropine sulfate, USP. The tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 43063-089-04 bottles of 4 tablets NDC 43063-089-06 bottles of 6 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Pharmacist:Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, USP are available containing 2.5 mg of diphenoxylate hydrochloride, USP (Warning: May be habit forming) and 0.025 mg of atropine sulfate, USP. The tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 43063-089-04 bottles of 4 tablets NDC 43063-089-06 bottles of 6 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Pharmacist:Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, USP are available containing 2.5 mg of diphenoxylate hydrochloride, USP (Warning: May be habit forming) and 0.025 mg of atropine sulfate, USP. The tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 43063-089-04 bottles of 4 tablets NDC 43063-089-06 bottles of 6 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Pharmacist:


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Clinical Information

Chemical Structure

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Clinical Pharmacology

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 diphenoxylate hydrochloride and atropine sulfate 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 compared with 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.

Non-Clinical Toxicology
Diphenoxylate hydrochloride and atropine sulfate tablets are contraindicated in:

Since a subtherapeutic dose of atropine has been added to diphenoxylate hydrochloride and atropine sulfate tablets, consideration should be given to the development of adverse reactions associated with of atropine (see ). Diphenoxylate hydrochloride and atropine sulfate tablets have caused atropinism (hyperthermia, tachycardia, urinary retention, flushing, dryness of the skin and mucous membranes) particularly in pediatric patients with Down’s syndrome. Diphenoxylate hydrochloride and atropine sulfate tablets are not indicated for use in pediatric patients (see and ). Monitor patients for signs of atropinism.

The following serious adverse reactions are described elsewhere in labeling:

At doses of diphenoxylate hydrochloride and atropine sulfate tablets, the following other adverse reactions have been reported; they are listed in decreasing order of severity, but not of frequency:

Nervous system: 

Allergic:

Gastrointestinal system: 

The following adverse reactions related to atropine sulfate are listed in decreasing order of severity, but not of frequency: hyperthermia, tachycardia, urinary retention, flushing, dryness of the skin and mucous membranes.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).