SUMMARY
DIPHENOXYLATE HYDROCHLORIDE and ATROPINE SULFATE TABLETS USP CV
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.
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.
A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage.
diphenoxylate and atropine (diphenoxylate/atropine) is indicated for the following:
Diphenoxylate Hydrochloride and Atropine Sulfate tablets are effective as adjunctive therapy in the management of diarrhea.
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NEWS HIGHLIGHTSMedia Articles Related to Diphenoxylate and Atropine (Diphenoxylate / Atropine)
Implementation Research Is The Biggest Priority To Advance The Global Plan To Reduce Child Diarrhea Source: GastroIntestinal / Gastroenterology News From Medical News Today [2013.05.14] While considerable recent progress has been made against childhood diarrheal diseases, the number of children dying from diarrhoea remains unacceptably high. This week, PLOS Medicine publishes a report based upon the work of over 150 international experts who convened to review and discuss research priorities to address this global problem...
Antihistamine Meds May Raise Risk for Diarrheal Illness Source: MedicineNet Allergy Specialty [2013.04.01] Title: Antihistamine Meds May Raise Risk for Diarrheal Illness Category: Health News Created: 3/29/2013 6:35:00 PM Last Editorial Review: 4/1/2013 12:00:00 AM
Diarrhea Source: MedicineNet Amyloidosis Specialty [2013.02.14] Title: Diarrhea Category: Diseases and Conditions Created: 12/31/1997 12:00:00 AM Last Editorial Review: 2/14/2013 12:00:00 AM
Diarrhea and Digestive Distress Pictures Slideshow: Problem Foods to Avoid Source: MedicineNet Abdominal Pain Specialty [2013.02.06] Title: Diarrhea and Digestive Distress Pictures Slideshow: Problem Foods to Avoid Category: Slideshows Created: 2/6/2013 12:00:00 AM Last Editorial Review: 2/6/2013 12:00:00 AM
Unneeded Antibiotics May Lead to Diarrheal Illness, Study Finds Source: MedicineNet Clostridium Difficile Colitis Specialty [2013.01.16] Title: Unneeded Antibiotics May Lead to Diarrheal Illness, Study Finds Category: Health News Created: 1/15/2013 2:36:00 PM Last Editorial Review: 1/16/2013 12:00:00 AM
Published Studies Related to Diphenoxylate and Atropine (Diphenoxylate / Atropine)
Pretreatment with Diphenoxylate Hydrochloride/Atropine Sulfate (Lomotil) does not Decrease Physiologic Bowel FDG Activity on PET/CT Scans of the Abdomen and Pelvis. [2009.03] CONCLUSIONS: Pretreatment with Lomotil prior to PET/CT scanning confers no benefit toward the reduction of physiologic FDG uptake by the small bowel and colon.
Are one or two dangerous? Diphenoxylate-atropine exposure in toddlers. [2008.01] Lomotil (Pfizer Inc., New York, NY) (diphenoxylate-atropine) is said to be potentially toxic to toddlers with exposure to as little as one to two tablets. A review of the data on diphenoxylate-atropine poisonings from the American Association of Poison Control Centers annual reports, review articles, and case series disputes this view.
Diphenoxylate-atropine (Lomotil) overdose in children: an update (report of eight cases and review of the literature) [1991.05] Eight pediatric accidental overdoses of diphenoxylate-atropine (Lomotil) are reported, and 28 literature cases are reviewed. This overdose is primarily an opioid intoxication, occasionally associated with atropine toxicity.Recommended treatment is intravenous naloxone for depressed or inadequate respirations, followed by continuous intravenous naloxone infusion, prompt gastric lavage, repeated administration of activated charcoal, and close monitoring for 24 hours.
Effect of liquid diphenoxylate hydrochloride and atropine sulfate (Lomotil) instillations on dynamics and function of continent cecal urinary reservoirs. [1987.10] We assessed the impact of twice daily instillations of 10 ml...
Clinical Trials Related to Diphenoxylate and Atropine (Diphenoxylate / Atropine)
Diphenoxylate / Atropine to Decrease FDG Activity During F-18 FDG PET [Completed]
2-[18F]-fluoro-2-deoxyD-glucose positron emission tomography (FDG PET) has proven to be a
valuable clinical tool for the staging and surveillance of lymphoma. 1-6 Occasionally, lymph
nodes in the mesentery and retroperitoneum can be difficult to distinguish from normal bowel
activity on PET scans despite three-plane and cine maximal image projection (MIP) imaging.
This uncertainty limits the clinical usefulness of PET in some cases of lymphoma. 7-8 In
addition, bowel activity can also hinder interpretation of PET scans in other types of solid
tumors including melanoma and colorectal cancer. 6,9,10 Our goal is to determine how well
diphenoxylate/atropine 5mg/0. 05mg (Lomotil) decreases bowel activity and how this decrease
impacts clinical decision-making, specifically for lymphoma staging and surveillance. This is
a prospective, randomized, double-blinded study involving 60 patients undergoing PET scans
for newly diagnosed or recurrent, untreated lymphoma.
LOSS- Louisiana Obese Subjects Study [Active, not recruiting]
LOSS is a pragmatic clinical evaluation of intensive medical approaches to weight loss for
individuals with extreme obesity (body mass index [BMI] 40-60 kg/m2). The intensive medical
treatment is designed to produce 25% weight loss from baseline and to maintain at least 20%
weight loss from baseline. The intensive medical treatment is compared to a usual care
treatment model where individuals utilize self directed approaches to weight loss. The
active treatment period is three years, followed by two years of observation.
Study to Evaluate the Likeability, Safety, and Abuse Potential of NRP 104 in Adults With Histories of Stimulant Abuse [Completed]
This research is being done to evaluate if NRP104 is a safe drug. The other purpose is to
learn if NRP104 produces a high and any other effects like amphetamine and other stimulant
drugs that are abused. This information will give some indication if NRP104 can be abused.
NRP104 is an investigational drug. This means that it has not been approved by the U. S. Food
and Drug Administration (FDA). Healthy people, between the ages of 18 and 55 with histories
of substance abuse that include stimulant drugs, may join. Amphetamines are drugs that are
used most often to treat attention deficit hyperactivity disorder (ADHD) in children, to
treat narcolepsy (excessive sleepiness) and for weight loss.
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