Diphenoxylate Hydrochloride And Atropine Sulfate


Direct_rx
Human Prescription Drug
NDC 61919-405
Diphenoxylate Hydrochloride And Atropine Sulfate is a human prescription drug labeled by 'Direct_rx'. National Drug Code (NDC) number for Diphenoxylate Hydrochloride And Atropine Sulfate is 61919-405. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Diphenoxylate Hydrochloride And Atropine Sulfate drug includes Atropine Sulfate - .025 mg/1 Diphenoxylate Hydrochloride - 2.5 mg/1 . The currest status of Diphenoxylate Hydrochloride And Atropine Sulfate drug is Active.

Drug Information:

Drug NDC: 61919-405
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Diphenoxylate Hydrochloride And Atropine Sulfate
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Diphenoxylate Hydrochloride And Atropine Sulfate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Direct_rx
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Tablet
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:ATROPINE SULFATE - .025 mg/1
DIPHENOXYLATE HYDROCHLORIDE - 2.5 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 12 Jun, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 17 Jan, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: ANDA086727
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Direct_Rx
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1190572
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
UNII:03J5ZE7KA5
W24OD7YW48
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:Anticholinergic [EPC]
Antidiarrheal [EPC]
Cholinergic Antagonists [MoA]
Cholinergic Muscarinic Antagonist [EPC]
Cholinergic Muscarinic Antagonists [MoA]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.
DEA Schedule:CV
This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
61919-405-3030 TABLET in 1 BOTTLE (61919-405-30)12 Jun, 2019N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Diphenoxylate hydrochloride and atropine sulfate diphenoxylate hydrochloride and atropine sulfate diphenoxylate hydrochloride diphenoxylate atropine sulfate atropine sucrose sodium starch glycolate type a potato magnesium stearate starch, corn lactose monohydrate anhydrous lactose 490

Indications and Usage:

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

Warnings:

Respiratory and/or cns depression in pediatric patients less than 6 years of age cases of severe respiratory depression and coma, leading to permanent brain damage or death have been reported in patients less than 6 years of age who received diphenoxylate hydrochloride and atropine sulfate tablets. diphenoxylate hydrochloride and atropine sulfate tablets are contraindicated in patients less than 6 years of age due to these risks (see contraindications). anticholinergic and opioid-toxicities toxicities associated with the atropine and diphenoxylate components of this product have been reported. the initial presenting symptoms may be delayed by up to 30 hours due to prolonged gastric emptying time induced by the diphenoxylate hydrochloride. clinical presentations vary in terms of which toxicity (anticholinergic vs. opioid) will present first or predominate; non-specific findings have been reported and include symptoms such as drowsiness (see overdosage). dehydration and electrolyte imbal
ance 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, diphenoxylate hydrochloride and atropine sulfate tablets should be withheld until appropriate corrective therapy has been initiated. drug-induced inhibition of peristalsis may result in fluid retention in the intestine, which may further aggravate dehydration and electrolyte imbalance. gastrointestinal complications in patients with infectious diarrhea diphenoxylate hydrochloride and atropine sulfate tablets are contraindicated in patients with diarrhea associated with organisms that penetrate the gi mucosa (toxigenic e. coli, salmonella, shigella), and pseudomembranous enterocolitis (clostridium difficile) associated with broad-spectrum antibiotics (see contraindications). antiperistaltic agents, including diphenoxylate hydrochloride and atropine sulfate, slow gastrointestinal motility and may enhance bacterial overgrowth and the release of bacterial exotoxins. diphenoxylate hydrochloride and atropine sulfate has been reported to result in serious gi complications in patients with infectious diarrhea, including sepsis, prolonged and/or worsened diarrhea. prolonged fever and the delay in the resolution of stool pathogens were reported in study of shigellosis in adults who used diphenoxylate hydrochloride and atropine sulfate vs. placebo. toxic megacolon in patients with acute ulcerative colitis in some patients with acute ulcerative colitis, agents that inhibit intestinal motility or prolong intestinal transit time have been reported to induce toxic megacolon. consequently, patients with acute ulcerative colitis should be carefully observed and diphenoxylate hydrochloride and atropine sulfate therapy should be discontinued promptly if abdominal distention occurs or if other untoward symptoms develop. interaction with meperidine hydrochloride since the chemical structure of diphenoxylate hydrochloride is similar to that of meperidine hydrochloride, the concurrent use of diphenoxylate hydrochloride and atropine sulfate tablets with monoamine oxidase (mao) inhibitors may, in theory, precipitate hypertensive crisis. hepatorenal disease diphenoxylate hydrochloride and atropine sulfate tablets should be used with extreme caution in patients with advanced hepatorenal disease and in all patients with abnormal liver function since hepatic coma may be precipitated. interaction with cns depressants diphenoxylate hydrochloride may potentiate the action of other drugs that cause dizziness or drowsiness, including barbiturates, benzodiazepines and other sedatives/hypnotics, anxiolytics, and tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, and alcohol. therefore, the patient should be closely observed when any of these are used concomitantly.

Dosage and Administration:

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. the use of this product 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 warnings). initial and maximum recommended dosage in patients 13 years of age and older the initial adult dosage is two diphenoxylate hydrochloride and atropine sulfate tablets four times daily (maximum total daily dose of 20 mg per day of diphenoxylate hydrochloride). most patients will require this dosage until ini
tial control of diarrhea has been achieved. clinical improvement of acute diarrhea is usually observed within 48 hours. dosage after initial control of diarrhea after initial control has been achieved, the diphenoxylate hydrochloride and atropine sulfate dosage may be reduced to meet individual requirements. control may often be maintained with as little as two diphenoxylate hydrochloride and atropine sulfate tablets daily. duration of treatment if clinical improvement of chronic diarrhea after treatment with the maximum recommended daily dosage is not observed within 10 days, discontinue diphenoxylate hydrochloride and atropine sulfate tablets as symptoms are unlikely to be controlled by further administration.

Contraindications:

Diphenoxylate hydrochloride and atropine sulfate tablets are contraindicated in: • pediatric patients less than 6 years of age due to the risks of respiratory and central nervous system (cns) depression (see warnings). • patients with diarrhea associated with pseudomembranous enterocolitis (clostridium difficile) or other enterotoxin-producing bacteria due to the risk of gastrointestinal (gi) complications, including sepsis (see warnings). • patients with known hypersensitivity to diphenoxylate or atropine. • patients with obstructive jaundice.

Adverse Reactions:

The following serious adverse reactions are described elsewhere in the labeling: • respiratory and/or cns depression (see warnings) • anticholinergic and opioid-toxicities, including atropinism (see warnings and precautions) • dehydration and electrolyte imbalance (see warnings) • gi complications in patients with infectious diarrhea (see warnings) • toxic megacolon in patients with acute ulcerative colitis (see warnings) at therapeutic 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: nervous system: numbness of extremities, euphoria, depression, malaise/lethargy, confusion, sedation/drowsiness, dizziness, restlessness, headache, hallucination. allergic: anaphylaxis, angioneurotic edema, urticaria, swelling of the gums, pruritus. gastrointestinal system: megacolon, paralytic ileus, pancreatitis, vomiting, nausea, anorexia, a
bdominal discomfort. 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.

Overdosage:

Diagnosis overdosage can be life-threatening. symptoms of overdosage may include opioid and/or anticholinergic effects including respiratory depression, coma, delirium, lethargy, dryness of the skin and mucous membranes, mydriasis or miosis, flushing, hyperthermia, tachycardia, hypotonia, tachypnea, toxic encephalopathy, seizures and incoherent speech. respiratory depression has been reported up to 30 hours after ingestion and may recur despite an initial response to narcotic antagonists. treat all possible diphenoxylate hydrochloride and atropine sulfate overdosages as serious and maintain medical observation/hospitalization until patients become asymptomatic without naloxone use. treatment a pure narcotic antagonist (e.g., naloxone) should be used in the treatment of respiratory depression caused by diphenoxylate hydrochloride and atropine sulfate. refer to the prescribing information for naloxone. consider diphenoxylate hydrochloride and atropine sulfate toxicity even in settings of negative toxicology tests. following initial improvement of respiratory function, repeated doses of naloxone hydrochloride may be required to counteract recurrent respiratory depression. if over-exposure occurs, call your poison control center at 1-800-222-1222 for current information of the management of poisoning or overdosage.

How Supplied:

Diphenoxylate hydrochloride and atropine sulfate tablets usp are available as round white tablets debossed ‘490’ on one side and plain on the other side. each tablet contains 2.5 mg of diphenoxylate hydrochloride and 0.025 mg of atropine sulfate and are supplied as: bottle of 100 tablets bottle of 1,000 tablets store at 20° to 25°c (68° to 77°f); excursions permitted to 15° to 30°c (59° to 86°f) [see usp controlled room temperature]. manufactured by: ani pharmaceuticals, inc. baudette, mn 56623 9981 rev 03/18

Package Label Principal Display Panel:

405-30


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