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Motofen difenoxin and atropine sulfate 1 mg; .025 mg Tablet, 4-count — NDC 54766-0200-04 package photo

Motofen difenoxin and atropine sulfate 1 mg; .025 mg Tablet, 4-count

by Sebela Pharmaceuticals Inc. · 4 TABLET in 1 BLISTER PACK (54766-200-04)
NDC 54766-0200-04
🏷️ FDA NDC (as labeled) 54766-200-04 billing pads the product segment with a zero
This package
Contains4-count Pack sizes2 compare ↓
Also comes in: 100 tablets 54766-0200-10
Rx only Brand Discontinued CIV ⚠ Discontinued by firm
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 54766-200-04
Product NDC 54766-200
11-digit billing NDC 54766020004
RxCUI 1190738, 1190740
UNII VQZ63K01IW, 03J5ZE7KA5
UPC 0354766200106
Application # NDA017744
SPL Set ID 4cd3f029-a5e3-5812-e054-00144ff8d46c
Established class (EPC) Anticholinergic; Antidiarrheal; Cholinergic Muscarinic Antagonist
Mechanism of action Cholinergic Antagonists; Cholinergic Muscarinic Antagonists
DEA schedule CIV
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2017-04-11
Marketing end 2028-08-31
Route ORAL
Dosage form TABLET
Substance DIFENOXIN HYDROCHLORIDE; ATROPINE SULFATE
GPI-14 47100015100310
GPI class Motofen
Why two NDCs? The FDA registers this code as 54766-200-04 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 54766-0200-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Anticholinergic class.

Pharmacologic class Anticholinergic, Cholinergic Muscarinic Antagonist
Drug family (ATC) Belladonna alkaloids, tertiary amines, Anticholinergics, Antidotes
How it works Cholinergic Muscarinic Antagonists, Cholinergic Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerSebela Pharmaceuticals Inc.
Application holderLEGACY PHARMA INC SEZC
FDA applicationNDA017744 (NDA)
Labeler code54766
First marketedApr 2017
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio14 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Motofen contains two ingredients: difenoxin, which slows down movement in your intestines to reduce diarrhea, and a tiny amount of atropine added specifically to discourage misuse....
  • What exactly is Motofen and what is it supposed to do for me?
  • Motofen is meant to be a short-term fix — generally no more than 48 hours. If your diarrhea hasn't improved after two days, the label recommends not continuing this type of medicat...
  • How long should I take Motofen, and what if it isn't working?
📖 Read our full Atropine / Difenoxin guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white
ShapePENTAGON (5 sided)
Imprint0200;M
Size7 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII 776XM7047L
    Calcium stearate is a white powder derived from stearic acid and calcium. It works as a lubricant and glidant to help the medicine flow smoothly during manufacturing and prevent ingredients from sticking to equipment.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 100 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Motofen 1 mg/1; .025 mgthis 54766-0200-04 Sebela 4 tablets — — Discontinued —
Motofen 1 mg/1; .025 mg 83107-0011-10 Legacy 100 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2017
On the market since
Apr 2017
📍
2026
Currently FDA-listed
9 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Motofen — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Motofen. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$75K
Claims incl. refills
79
Beneficiaries
44
Spend / beneficiary
$1,705.02
Spend / claim
$949.63
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Motofen (this brand).

Top reported reactions

Vomiting4
Diarrhoea3
Nausea3
Pain3
Bone Disorder2
Fall2
Irritable Bowel Syndrome2

Age at onset

Adult1

Reporter sex

26 reports
Male · 48%
Female · 52%

Serious outcomes

Hospitalization10
Disabling1
Death1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
54766-0200-04 You're viewing this 4 TABLET in 1 BLISTER PACK (54766-200-04) — — 2017-04-11 Discontinued by firm
54766-0200-10 100 TABLET in 1 BOTTLE (54766-200-10) $6.91 / ea $691.34 2017-04-11 Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 54766-0200-04?
NDC 54766-0200-04 is a 4-count package — 4 tablet in 1 blister pack.
What is the difference between NDC 54766-0200-04 and NDC 54766-0200-10?
Both are Motofen difenoxin and atropine sulfate 1 mg; .025 mg Tablet — the drug itself is identical. NDC 54766-0200-04 is the 4-count package, while NDC 54766-0200-10 is the 100 tablets package.
What NDC number is used to bill for this package of Motofen difenoxin and atropine sulfate 1 mg; .025 mg Tablet?
Bill NDC 54766-0200-04 — the 11-digit billing format is 54766020004. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 54766-200-04, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 54766-0200-04, written without dashes as 54766020004. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 54766-0200-04, the first segment (54766) is the labeler code FDA assigned to Sebela Pharmaceuticals Inc.; the middle segment (0200) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 100 tablets (54766-0200-10). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Sebela Pharmaceuticals Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 23 words ▾

INDICATIONS AND USAGE MOTOFEN® is indicated as adjunctive therapy in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea.

⏱️ Dosage and Administration 120 words ▾

DOSAGE AND ADMINISTRATION The recommended starting dose of MOTOFEN® tablets in adults is 2 tablets then 1 tablet after each loose stool or 1 tablet every 3 to 4 hours as needed, but the total dosage during any 24-hour treatment period should not exceed 8 tablets. In the treatment of diarrhea, if clinical improvement is not observed in 48 hours, continued administration of this type of medication is not recommended. For acute diarrheas and acute exacerbations of functional diarrhea, treatment beyond 48 hours is usually not necessary.

Studies in children below the age of 12 have been inadequate to evaluate the safety and effectiveness of MOTOFEN® in this age group. MOTOFEN® is contraindicated in children under 2 years of age.

⛔ Contraindications 97 words ▾

CONTRAINDICATIONS MOTOFEN® is contraindicated in patients with diarrhea associated with organisms that penetrate the intestinal mucosa (toxigenic E. coli, Salmonella species, Shigella ) and pseudomembranous colitis associated with broad spectrum antibiotics. Antiperistaltic agents should not be used in the conditions because they may prolong and/or worsen diarrhea. MOTOFEN® is contraindicated in children under 2 years of age because of the decreased margin of safety of drugs in this class in younger age groups.

MOTOFEN® is contraindicated in patients with a known hypersensitivity to difenoxin, atropine, or any of the inactive ingredients, and in patients who are jaundiced.

⚠️ Warnings ~1 min read ▾

WARNINGS MOTOFEN® IS NOT AN INNOCUOUS DRUG AND DOSAGE RECOMMENDATIONS SHOULD BE STRICTLY ADHERED TO. MOTOFEN® IS NOT RECOMMENDED FOR CHILDREN UNDER 2 YEARS OF AGE. OVERDOSAGE MAY RESULT IN SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT BRAIN DAMAGE OR DEATH (SEE OVERDOSAGE ).

THEREFORE, KEEP THIS MEDICATION OUT OF THE REACH OF CHILDREN. FLUID AND ELECTROLYTE BALANCE – THE USE OF MOTOFEN® DOES NOT PRECLUDE THE ADMINISTRATION OF APPROPRIATE FLUID AND ELECTROLYTE THERAPY. DEHYDRATION, PARTICULARLY IN CHILDREN, MAY FURTHER INFLUENCE THE VARIABILITY OF RESPONSE TO MOTOFEN® AND MAY PREDISPOSE TO DELAYED DIFENOXIN INTOXICATION.

DRUG-INDUCED INHIBITION OF PERISTALSIS MAY RESULT IN FLUID RETENTION IN THE COLON, AND THIS MAY FURTHER AGGRAVATE DEHYDRATION AND ELECTROLYTE IMBALANCE. IF SEVERE DEHYDRATION OR ELECTROLYTE IMBALANCE IS MANIFESTED, MOTOFEN® SHOULD BE WITHHELD UNTIL APPROPRIATE CORRECTIVE THERAPY HAS BEEN INITIATED. Ulcerative Colitis – In some patients with acute ulcerative colitis, agents which inhibit intestinal motility or delay intestinal transit time have been reported to induce toxic megacolon.

Consequently, patients with acute ulcerative colitis should be carefully observed and MOTOFEN® therapy should be discontinued promptly if abdominal distention occurs or if other untoward symptoms develop. Liver and Kidney Disease – MOTOFEN® should be used with extreme caution in patients with advanced hepatorenal disease and in all patients with abnormal liver function tests since hepatic coma may be precipitated. Atropine – A subtherapeutic dose of atropine has been added to difenoxin hydrochloride to discourage deliberate overdosage.

Usage of MOTOFEN® in recommended doses is not likely to cause prominent anticholinergic side effects, but MOTOFEN® should be avoided in patients in whom anticholinergic drugs are contraindicated. The warnings and precautions for use of anticholinergic agents should be observed. In children, signs of atropinism may occur even with recommended doses of MOTOFEN®, particularly in patients with Down’s Syndrome.

🤒 Adverse Reactions 219 words ▾

ADVERSE REACTIONS In view of the small amount of atropine present (0.025 mg/tablet), such effects such as dryness of the skin and mucous membranes, flushing, hyperthermia, tachycardia and urinary retention are very unlikely to occur, except perhaps in children. Many of the adverse effects reported during clinical investigation of MOTOFEN® are difficult to distinguish from symptoms associated with the diarrheal syndrome. However, the following events were reported at the stated frequencies: Gastrointestinal: Nausea, 1 in 15 patients; vomiting, 1 in 30 patients; dry mouth, 1 in 30 patients; epigastric distress, 1 in 100 patients; and constipation, 1 in 300 patients.

Central Nervous System: Dizziness and light-headedness, 1 in 20 patients; drowsiness, 1 in 25 patients; and headache, 1 in 40 patients; tiredness, nervousness, insomnia and confusion ranged from 1 in 200 to 1 in 600 patients. Other less frequent reactions: Burning eyes and blurred vision occurred in a few cases. The following adverse reactions have been reported in patients receiving chemically-related drugs: numbness of extremities, euphoria, depression, sedation, anaphylaxis, angioneurotic edema, urticaria, swelling of the gums, pruritus, toxic megacolon, paralytic ileus, pancreatitis, and anorexia.

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.

🔄 Drug Interactions 114 words ▾

Drug Interactions Since the chemical structure of difenoxin hydrochloride is similar to meperidine hydrochloride, the concurrent use of MOTOFEN® with monoamine oxidase inhibitors may, in theory, precipitate a hypertensive crisis. MOTOFEN® may potentiate the action of barbiturates, tranquilizers, narcotics, and alcohol. When these medications are used concomitantly with MOTOFEN®, the patient should be closely monitored.

Diphenoxylate hydrochloride, from which the principal active metabolite difenoxin is derived, was found to inhibit the hepatic microsomal enzyme system at a dose of 2 mg/kg/day in studies conducted with male rats. Therefore, difenoxin has the potential to prolong the biological half-lives of drugs for which the rate of elimination is dependent on the microsomal drug metabolizing enzyme system.

🤰 Pregnancy 109 words ▾

Pregnancy/Teratogenic Effects Pregnancy Category C. Reproduction studies in rats and rabbits with doses at 31 and 61 times the human therapeutic dose respectively, on a mg/kg basis, demonstrated no evidence of teratogenesis due to MOTOFEN®. Pregnant rats receiving oral doses of difenoxin hydrochloride/atropine 20 times the maximum human dose had an increase in delivery time as well as a significant increase in the percent of stillbirths.

Neonatal survival in rats was also reduced with most deaths occurring within four days of delivery. There are no well controlled studies in pregnant women. MOTOFEN® should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus.

🧒 Pediatric Use 38 words ▾

Pediatric Use SAFETY AND EFFECTIVENESS IN CHILDREN BELOW THE AGE OF 12 HAVE NOT BEEN ESTABLISHED. MOTOFEN® IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS OF AGE. See OVERDOSAGE section for information on hazards from accidental poisoning in children.

🆘 Overdosage ~1 min read ▾

Diagnosis and Treatment In the event of overdosage (initial signs may include dryness of the skin and mucous membranes, flushing, hyperthermia and tachycardia followed by lethargy or coma, hypotonic reflexes, nystagmus, pinpoint pupils and respiratory depression) gastric lavage, establishment of a patent airway and possibly mechanically assisted respiration are advised. The narcotic antagonist naloxone may be used in the treatment of respiratory depression caused by narcotic analgesics of pharmacologically related compounds such as MOTOFEN® tablets.

When naloxone is administered intravenously, the onset of action is generally apparent within two minutes. Naloxone may be administered subcutaneously or intramuscularly providing a slightly less rapid onset of action but a more prolonged effect. To counteract respiratory depression caused by MOTOFEN® overdosage, the following dosage schedule for naloxone should be followed: Adult Dosage: The usual initial adult dose of naloxone is 0.4 mg (one mL) administered intravenously.

If respiratory function does not adequately improve after the initial dose, the same IV dose may be repeated at two-to-three minute intervals. Children: The usual adult dose of naloxone for children is 0.01 mg/kg of body weight administered intravenously and repeated at two-to-three minute intervals if necessary. Since the duration of action of difenoxin hydrochloride is longer than that of naloxone, improvement of respiration following administration may be followed by recurrent respiratory depression.

Consequently, continuous observation is necessary until the effect of difenoxin hydrochloride on respiration (which effect may persist for many hours) has passed. Supplemental intramuscular doses of naloxone may be utilized to produce a longer lasting effect. TREAT ALL POSSIBLE MOTOFEN® OVERDOSAGES AS SERIOUS AND MAINTAIN MEDICAL OBSERVATION FOR AT LEAST 48 HOURS, PREFERABLY UNDER CONTINUOUS HOSPITAL CARE.

Although signs of overdosage and respiratory depression may not be evident soon after ingestion of difenoxin hydrochloride, respiratory depression may occur from 12 to 30 hours later.

🧬 Clinical Pharmacology 135 words ▾

CLINICAL PHARMACOLOGY Animal studies have shown that difenoxin hydrochloride manifests its antidiarrheal effect by slowing intestinal motility. The mechanism of action is by a local effect on the gastrointestinal wall. Difenoxin is the principal active metabolite of diphenoxylate.

Following oral administration of MOTOFEN®, difenoxin is rapidly and extensively absorbed. Mean peak plasma levels of approximately 160 ng/mL occurred within 40 to 60 minutes in most patients following an oral dose of 2 mg. Plasma levels decline to less than 10% of their peak values within 24 hours and to less than 1% of their peak values within 72 hours.

This decline parallels the appearance of difenoxin and its metabolites in the urine. Difenoxin is metabolized to an inactive hydroxylated metabolite. Both the drug and its metabolites are excreted, mainly as conjugates, in urine and feces.

📦 How Supplied / Storage and Handling 52 words ▾

HOW SUPPLIED MOTOFEN® is available as a white, dye-free, five-sided, scored tablet with “0200” on the scored side and "M" on the other side. Each tablet contains 1 mg difenoxin and 0.025 mg atropine sulfate. Supplied in bottles of 100 tablets (NDC 54766-200-10). Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

📋 Description 94 words ▾

DESCRIPTION Each five-sided dye free MOTOFEN® tablet contains: 1 mg of difenoxin (equivalent to 1.09 mg of difenoxin hydrochloride) and 0.025 mg of atropine sulfate (equivalent to 0.01 mg of atropine). Difenoxin hydrochloride, 1-(3-cyano-3,3-diphenylpropyl)-4-phenyl-4-piperidinecarboxylic acid monohydrochloride, is an orally administered antidiarrheal agent which is chemically related to the narcotic meperidine. The structural formula is: Atropine sulfate is present to discourage deliberate overdose.

Atropine sulfate, an anticholinergic, is benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester, endo-(±)-, (2:1) (salt), monohydrate and has the following structural formula: Inactive Ingredients: calcium stearate, cellulose, lactose, corn starch. Difenoxin Hydrochloride Atropine Sulfate

💬 Information for Patients ~2 min read ▾

PRECAUTIONS CAUTION PATIENTS TO ADHERE STRICTLY TO RECOMMENDED DOSAGE SCHEDULES. THE MEDICATION SHOULD BE KEPT OUT OF REACH OF CHILDREN SINCE ACCIDENTAL OVERDOSAGE MAY RESULT IN SEVERE, EVEN FATAL, RESPIRATORY DEPRESSION. MOTOFEN® may produce drowsiness or dizziness.

The patient should be cautioned regarding activities requiring mental alertness, such as driving or operating dangerous machinery. Drug Interactions Since the chemical structure of difenoxin hydrochloride is similar to meperidine hydrochloride, the concurrent use of MOTOFEN® with monoamine oxidase inhibitors may, in theory, precipitate a hypertensive crisis. MOTOFEN® may potentiate the action of barbiturates, tranquilizers, narcotics, and alcohol.

When these medications are used concomitantly with MOTOFEN®, the patient should be closely monitored. Diphenoxylate hydrochloride, from which the principal active metabolite difenoxin is derived, was found to inhibit the hepatic microsomal enzyme system at a dose of 2 mg/kg/day in studies conducted with male rats. Therefore, difenoxin has the potential to prolong the biological half-lives of drugs for which the rate of elimination is dependent on the microsomal drug metabolizing enzyme system.

Carcinogenesis, Mutagensis, Impairment of Fertility No evidence of carcinogenesis was found in a long-term study of difenoxin hydrochloride/atropine in the rat. In this 104 week study, rats received dietary doses of 0, 1.25, 2.5, or 5 mg/kg/day difenoxin/atropine (20:1 ratio). No experiments have been conducted to determine the mutagenic potential of MOTOFEN®.

MOTOFEN® did not significantly impair fertility in rats. Pregnancy/Teratogenic Effects Pregnancy Category C. Reproduction studies in rats and rabbits with doses at 31 and 61 times the human therapeutic dose respectively, on a mg/kg basis, demonstrated no evidence of teratogenesis due to MOTOFEN®.

Pregnant rats receiving oral doses of difenoxin hydrochloride/atropine 20 times the maximum human dose had an increase in delivery time as well as a significant increase in the percent of stillbirths. Neonatal survival in rats was also reduced with most deaths occurring within four days of delivery. There are no well controlled studies in pregnant women.

MOTOFEN® should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus. Nursing Mothers Because of the potential for serious adverse reactions in nursing infants from MOTOFEN®, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use SAFETY AND EFFECTIVENESS IN CHILDREN BELOW THE AGE OF 12 HAVE NOT BEEN ESTABLISHED.

MOTOFEN® IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS OF AGE. See OVERDOSAGE section for information on hazards from accidental poisoning in children.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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