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Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Trade Name : Diphenoxylate Hydrochloride and Atropine Sulfate

REMEDYREPACK INC.

TABLET

Strength 2.5.025 mg/1mg/1

DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]

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Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate) which is also known as Diphenoxylate Hydrochloride and Atropine Sulfate and Manufactured by REMEDYREPACK INC.. It is available in strength of 2.5; .025 mg/1; mg/1 per ml. Read more

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Each diphenoxylate hydrochloride and atropine sulfate tablet contains:
  • 2.5 mg of diphenoxylate hydrochloride USP (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-(u00b1)-u03b1-(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 diphenoxylate hydrochloride and atropine sulfate tablets include acacia, corn starch, magnesium stearate, sorbitol, sucrose, and talc.
  • 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.
  • Diphenoxylate hydrochloride and atropine sulfate is indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.
  • Diphenoxylate hydrochloride and atropine sulfate is contraindicated in:
  • No data
  • No data
  • The following serious adverse reactions are described elsewhere in labeling:
  • At n n n doses of diphenoxylate hydrochloride and atropine sulfate, the following other adverse reactions have been reported; they are listed in decreasing order of severity, but not of frequency:n nn
  • 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.
  • No data
  • No data
  • No data
  • Tablets u2014
  • Store below 25u00b0C (77u00b0F).
  • This product's label may have been updated. For current full prescribing information, please visit www.greenstonellc.com.
  • LAB-0517-4.0n n n Revised March 2018n nn
  • DRUG: Diphenoxylate Hydrochloride and Atropine Sulfate
  • GENERIC: Diphenoxylate Hydrochloride and Atropine Sulfate
  • DOSAGE: TABLET
  • ADMINSTRATION: ORAL
  • NDC: 70518-2135-0
  • COLOR: white
  • SHAPE: ROUND
  • SCORE: No score
  • SIZE: 6 mm
  • IMPRINT: SEARLE;61
  • PACKAGING: 30 in 1 BLISTER PACK
  • ACTIVE INGREDIENT(S):
  • INACTIVE INGREDIENT(S):

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