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Disulfiram 250 mg Tablet, 30-count — NDC 47781-0607-30 package photo

Disulfiram 250 mg Tablet, 30-count

by Alvogen Inc. · 30 TABLET in 1 BOTTLE, PLASTIC (47781-607-30)
NDC 47781-0607-30
🏷️ FDA NDC (as labeled) 47781-607-30 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 47781-607-30
Product NDC 47781-607
11-digit billing NDC 47781060730
NCPDP billing unit EA — each (per item)
RxCUI 197623
UNII TR3MLJ1UAI
UPC 0347781607302
Application # ANDA091681
SPL Set ID b90f8ff4-4fb3-46ab-8149-cb55f24a4044
Established class (EPC) Aldehyde Dehydrogenase Inhibitor
Mechanism of action Acetyl Aldehyde Dehydrogenase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-08-09
Route ORAL
Dosage form TABLET
Substance DISULFIRAM
GPI-14 62802040000325
GPI class Disulfiram
GCN Seq No 001192
GCN 02881
HICL code 000529
Ingredient (HICL) Disulfiram
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C0
Therapeutic class — intermediate (HIC2) Affect Fluid/Acid-Base Balance/Metabolic Systems
HIC3 code C0D
Therapeutic class — specific (HIC3) Anti-Alcoholic Preparations
AHFS code 91:02.00.00
AHFS class Alcohol Deterrents (91:02)
FDB label name DISULFIRAM 250 MG TABLET
FDB brand name Disulfiram
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 47781-607-30 — 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 → 47781-0607-30. 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 Aldehyde Dehydrogenase Inhibitor class.

Pharmacologic class Aldehyde Dehydrogenase Inhibitor
Drug family (ATC) Drugs used in alcohol dependence, Sulfur containing products
How it works Acetyl Aldehyde Dehydrogenase Inhibitors
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

LabelerAlvogen Inc.
Application holderALVOGEN INC
FDA applicationANDA091681 (ANDA)
Labeler code47781
First marketedAug 2013
Product typeHuman Prescription Drug
Portfolio51 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

Label name DISULFIRAM 250 MG TABLET Ingredient Disulfiram
📖 What it is MedlinePlus · NLM

Disulfiram is used to treat chronic alcoholism. It is in a class of medications called alcohol deterrents. It causes unpleasant effects when even small amounts of alcohol are consumed. These effects include flushing of the face, headache, nausea, vomiting, chest pain, weakness, blurred vision, mental confusion, sweating, choking, breathing difficulty, and anxiety. These effects begin about 10 minutes after alcohol enters the body and last for 1 hour or more. Disulfiram is not a cure for alcoholism, but discourages drinking.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Disulfiram doesn't reduce cravings the way some other medications do. Instead, it changes how your body handles alcohol — if you drink while taking it, you'll experience a really u...
  • What exactly does disulfiram do, and why would my doctor prescribe it?
  • That depends entirely on your recovery progress. Some people take disulfiram for months; others need it for a year or more. Your doctor will work with you to figure out when you've...
  • Unfortunately, yes — even hidden alcohol can trigger the reaction. That includes cooking sauces, vinegar, certain cough medicines, mouthwash, and even some aftershave lotions or ba...
📖 Read our full Disulfiram guide →
1
Nutrient depletion considerations

Disulfiram may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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
ShapeRound
Imprint607
Size13 mm
ScoringNot scored
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 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

6 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 DailyMedingredient 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 eaPer package
Retail pharmacies payNADAC · weekly $1.819 $54.56 / 30 tablets
Medicaid paysCMS SDUD · 12 mo $1.96 $58.93 / 30 tablets
Medicare drug plans payPart D · Q2 2026 $2.25 $67.46 / 30 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $2.099 $1.572
▼ Down 9% over the last 24 months.
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
Disulfiram 250 mg 42794-0028-08 Sigmapharm 30 tablets $1.819 AB Availability likely
Disulfiram 250 mgthis 47781-0607-30 Alvogen 30 tablets $1.819 AB Availability likely
Disulfiram 250 mg 62135-0431-30 Chartwell 30 tablets $1.819 AB Availability likely
Disulfiram 250 mg 60429-0196-01 Golden 100 tablets AB FDA listed
Disulfiram 250 mg 63629-5466-01 Bryant 90 tablets AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2013
On the market since
Aug 2013
📍
2026
Currently FDA-listed
13 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 47781-0607-30, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
34.9K
Units reimbursed last 4 qtrs
1.2M
Gross reimbursed last 4 qtrs
$2.44M
Avg / prescription
$69.78
Avg / unit
$1.9643
Latest quarter Q4 2025
9.4KRx
Medicaid pays / ea
$1.9643
gross reimbursed
vs
NADAC / ea
$1.8185
acquisition cost
=
Spread
+$0.1458
+8% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
54% FFS 46% MCO
Fee-for-service · 18,871 Rx Managed care · 16,027 Rx
State Medicaid map
Alaska: 6,236 units · 851 per 100k residents AK Maine: 19,218 units · 1,378 per 100k residents ME Washington: 48,545 units · 621 per 100k residents WA Idaho: 15,485 units · 788 per 100k residents ID Montana: 6,499 units · 574 per 100k residents MT North Dakota: 5,963 units · 762 per 100k residents ND Minnesota: 44,555 units · 777 per 100k residents MN Wisconsin: 42,196 units · 714 per 100k residents WI Michigan: 79,337 units · 790 per 100k residents MI New York: 93,681 units · 479 per 100k residents NY Vermont: 9,632 units · 1,489 per 100k residents VT New Hampshire: 5,140 units · 367 per 100k residents NH Oregon: 31,391 units · 742 per 100k residents OR Nevada: 12,703 units · 398 per 100k residents NV Wyoming: no data reported WY South Dakota: 4,638 units · 505 per 100k residents SD Iowa: 18,659 units · 582 per 100k residents IA Illinois: 38,800 units · 309 per 100k residents IL Indiana: 44,746 units · 652 per 100k residents IN Ohio: 27,750 units · 235 per 100k residents OH Pennsylvania: 36,185 units · 279 per 100k residents PA New Jersey: 17,628 units · 190 per 100k residents NJ Massachusetts: 66,269 units · 947 per 100k residents MA California: 137,305 units · 352 per 100k residents CA Utah: 15,554 units · 455 per 100k residents UT Colorado: 48,668 units · 828 per 100k residents CO Nebraska: 9,933 units · 502 per 100k residents NE Missouri: 30,220 units · 488 per 100k residents MO Kentucky: 20,314 units · 449 per 100k residents KY West Virginia: 19,625 units · 1,109 per 100k residents WV Virginia: 29,828 units · 342 per 100k residents VA Maryland: 44,093 units · 713 per 100k residents MD Connecticut: 61,710 units · 1,706 per 100k residents CT Rhode Island: 28,355 units · 2,589 per 100k residents RI Arizona: 23,272 units · 313 per 100k residents AZ New Mexico: 9,736 units · 461 per 100k residents NM Kansas: 1,114 units · 37.9 per 100k residents KS Arkansas: 2,891 units · 94.3 per 100k residents AR Tennessee: 6,923 units · 97.2 per 100k residents TN North Carolina: 27,601 units · 255 per 100k residents NC South Carolina: 2,803 units · 52.2 per 100k residents SC Delaware: 5,105 units · 495 per 100k residents DE Oklahoma: 8,902 units · 220 per 100k residents OK Louisiana: 11,535 units · 252 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 3,510 units · 31.8 per 100k residents GA D.C.: no data reported DC Hawaii: 5,691 units · 397 per 100k residents HI Texas: 3,974 units · 13.0 per 100k residents TX Florida: 5,778 units · 25.6 per 100k residents FL
Units reimbursed · per 100k residents
13.02,589
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Rhode Island 2,589 /100k
2 Connecticut 1,706 /100k
3 Vermont 1,489 /100k
4 Maine 1,378 /100k
5 West Virginia 1,109 /100k
6 Massachusetts 947 /100k
7 Alaska 851 /100k
8 Colorado 828 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Disulfiram — the program that covers self-administered drugs. 3 manufacturers.
⚠️ 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 Disulfiram. 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
$708.6K
Claims incl. refills
6K
Beneficiaries
3.8K
Spend / beneficiary
$186.14
Spend / claim
$117.29
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 Disulfiram — the ingredient across all brands.

Top reported reactions

Drug Interaction122
Fatigue83
Toxicity To Various Agents64
Nausea52
Confusional State48
Drug Abuse44
Psychiatric Symptom44

Age at onset

Neonate2
Child2
Adolescent2
Adult152
Elderly25

Reporter sex

1,124 reports
Male · 65%
Female · 35%
Unknown · 0%

Serious outcomes

Hospitalization531
Life-threatening91
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 111 46
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 Marketing startStatus
47781-0607-30 You're viewing this 30 TABLET in 1 BOTTLE, PLASTIC (47781-607-30) 2013-08-09 Active

📄 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.
🚨 Boxed Warning 29 words

WARNING Disulfiram should never be administered to a patient when he is in a state of alcohol intoxication, or without his full knowledge. The physician should instruct relatives accordingly.

🎯 Indications and Usage 71 words

INDICATIONS AND USAGE Disulfiram is an aid in the management of selected chronic alcohol patients who want to remain in a state of enforced sobriety so that supportive and psychotherapeutic treatment may be applied to best advantage. Disulfiram is not a cure for alcoholism. When used alone, without proper motivation and supportive therapy, it is unlikely that it will have any substantive effect on the drinking pattern of the chronic alcoholic.

⏱️ Dosage and Administration ~2 min read

DOSAGE AND ADMINISTRATION Disulfiram should never be administered until the patient has abstained from alcohol for at least 12 hours. Initial Dosage Schedule In the first phase of treatment, a maximum of 500 mg daily is given in a single dose for one to two weeks. Although usually taken in the morning, disulfiram may be taken on retiring by patients who experience a sedative effect.

Alternatively, to minimize, or eliminate, the sedative effect, dosage may be adjusted downward. Maintenance Regimen The average maintenance dose is 250 mg daily (range, 125 mg to 500 mg), it should not exceed 500 mg daily. Note: Occasionally patients, while seemingly on adequate maintenance doses of disulfiram, report that they are able to drink alcoholic beverages with impunity and without any symptomatology.

All appearances to the contrary, such patients must be presumed to be disposing of their tablets in some manner without actually taking them. Until such patients have been observed reliably taking their daily disulfiram tablets (preferably crushed and well mixed with liquid), it cannot be concluded that disulfiram is ineffective. Duration of Therapy The daily, uninterrupted administration of disulfiram must be continued until the patient is fully recovered socially and a basis for permanent self-control is established.

Depending on the individual patient, maintenance therapy may be required for months or even years. Trial with Alcohol During early experience with disulfiram, it was thought advisable for each patient to have at least one supervised alcohol-drug reaction. More recently, the test reaction has been largely abandoned.

Furthermore, such a test reaction should never be administered to a patient over 50 years of age. A clear, detailed and convincing description of the reaction is felt to be sufficient in most cases. However, where a test reaction is deemed necessary, the suggested procedure is as follows: After the first one to two weeks' therapy with 500 mg daily, a drink of 15 mL (1/2 oz) of 100 proof whiskey, or equivalent, is taken slowly.

This test dose of alcoholic beverage may be repeated once only, so that the total dose does not exceed 30 mL (1 oz) of whiskey. Once a reaction develops, no more alcohol should be consumed. Such tests should be carried out only when the patient is hospitalized, or comparable supervision and facilities, including oxygen, are available.

Management of Disulfiram-Alcohol Reaction In severe reactions, whether caused by an excessive test dose or by the patient's unsupervised ingestion of alcohol, supportive measures to restore blood pressure and treat shock should be instituted. Other recommendations include: oxygen, carbogen (95% oxygen and 5% carbon dioxide), vitamin C intravenously in massive doses (1 g) and ephedrine sulfate. Antihistamines have also been used intravenously.

Potassium levels should be monitored, particularly in patients on digitalis, since hypokalemia has been reported.

Contraindications 56 words

CONTRAINDICATIONS Patients who are receiving or have recently received metronidazole, paraldehyde, alcohol, or alcohol-containing preparations, e.g., cough syrups, tonics and the like, should not be given disulfiram. Disulfiram is contraindicated in the presence of severe myocardial disease or coronary occlusion, psychoses, and hypersensitivity to disulfiram or to other thiuram derivatives used in pesticides and rubber vulcanization.

⚠️ Warnings ~1 min read

WARNINGS Disulfiram should never be administered to a patient when he is in a state of alcohol intoxication, or without his full knowledge. The physician should instruct relatives accordingly. The patient must be fully informed of the disulfiram-alcohol reaction.

He must be strongly cautioned against surreptitious drinking while taking the drug, and he must be fully aware of the possible consequences. He should be warned to avoid alcohol in disguised forms, i.e., in sauces, vinegars, cough mixtures, and even in aftershave lotions and back rubs. He should also be warned that reactions may occur with alcohol up to 14 days after ingesting disulfiram.

The Disulfiram-Alcohol Reaction Disulfiram plus alcohol, even small amounts, produce flushing, throbbing in head and neck, throbbing headache, respiratory difficulty, nausea, copious vomiting, sweating, thirst, chest pain, palpitation, dyspnea, hyperventilation, tachycardia, hypotension, syncope, marked uneasiness, weakness, vertigo, blurred vision, and confusion. In severe reactions there may be respiratory depression, cardiovascular collapse, arrhythmias, myocardial infarction, acute congestive heart failure, unconsciousness, convulsions, and death.

The intensity of the reaction varies with each individual, but is generally proportional to the amounts of disulfiram and alcohol ingested. Mild reactions may occur in the sensitive individual when the blood alcohol concentration is increased to as little as 5 mg to 10 mg per 100 mL. Symptoms are fully developed at 50 mg per 100 mL, and unconsciousness usually results when the blood alcohol level reaches 125 mg to 150 mg.

The duration of the reaction varies from 30 to 60 minutes, to several hours in the more severe cases, or as long as there is alcohol in the blood. Concomitant Conditions Because of the possibility of an accidental disulfiram-alcohol reaction, disulfiram should be used with extreme caution in patients with any of the following conditions: diabetes mellitus, hypothyroidism, epilepsy, cerebral damage, chronic and acute nephritis, hepatic cirrhosis or insufficiency.

🤒 Adverse Reactions 163 words

ADVERSE REACTIONS (See CONTRAINDICATIONS , WARNINGS , and PRECAUTIONS .) OPTIC NEURITIS, PERIPHERAL NEURITIS, POLYNEURITIS, AND PERIPHERAL NEUROPATHY MAY OCCUR FOLLOWING ADMINISTRATION OF DISULFIRAM. Multiple cases of hepatitis, including both cholestatic and fulminant hepatitis, as well as hepatic failure resulting in transplantation or death, have been reported with administration of disulfiram. Occasional skin eruptions are, as a rule, readily controlled by concomitant administration of an antihistaminic drug.

In a small number of patients, a transient mild drowsiness, fatigability, impotence, headache, acneform eruptions, allergic dermatitis, or a metallic or garlic-like aftertaste may be experienced during the first two weeks of therapy. These complaints usually disappear spontaneously with the continuation of therapy, or with reduced dosage. Psychotic reactions have been noted, attributable in most cases to high dosage, combined toxicity (with metronidazole or isoniazid), or to the unmasking of underlying psychoses in patients stressed by the withdrawal of alcohol.

To report SUSPECTED ADVERSE REACTIONS, contact Alvogen, Inc. at 1-866-770-3024 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~1 min read

Drug Interactions Disulfiram appears to decrease the rate at which certain drugs are metabolized and therefore may increase the blood levels and the possibility of clinical toxicity of drugs given concomitantly. DISULFIRAM SHOULD BE USED WITH CAUTION IN THOSE PATIENTS RECEIVING PHENYTOIN AND ITS CONGENERS, SINCE THE CONCOMITANT ADMINISTRATION OF THESE TWO DRUGS CAN LEAD TO PHENYTOIN INTOXICATION. PRIOR TO ADMINISTERING DISULFIRAM TO A PATIENT ON PHENYTOIN THERAPY, A BASELINE PHENYTOIN SERUM LEVEL SHOULD BE OBTAINED.

SUBSEQUENT TO INITIATION OF DISULFIRAM THERAPY, SERUM LEVELS OF PHENYTOIN SHOULD BE DETERMINED ON DIFFERENT DAYS FOR EVIDENCE OF AN INCREASE OR FOR A CONTINUING RISE IN LEVELS. INCREASED PHENYTOIN LEVELS SHOULD BE TREATED WITH APPROPRIATE DOSAGE ADJUSTMENT. It may be necessary to adjust the dosage of oral anticoagulants upon beginning or stopping disulfiram, since disulfiram may prolong prothrombin time.

Patients taking isoniazid when disulfiram is given should be observed for the appearance of unsteady gait or marked changes in mental status, the disulfiram should be discontinued if such signs appear. In rats, simultaneous ingestion of disulfiram and nitrite in the diet for 78 weeks has been reported to cause tumors, and it has been suggested that disulfiram may react with nitrites in the rat stomach to form a nitrosamine, which is tumorigenic. Disulfiram alone in the rat's diet did not lead to such tumors.

The relevance of this finding to humans is not known at this time.

🤰 Pregnancy 37 words

Usage In Pregnancy The safe use of this drug in pregnancy has not been established. Therefore, disulfiram should be used during pregnancy only when, in the judgement of the physician, the probable benefits outweigh the possible risks.

🧒 Pediatric Use 12 words

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 88 words

Geriatric Use A determination has not been made whether controlled clinical studies of disulfiram included sufficient numbers of subjects aged 65 and over to define a difference in response from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 25 words

OVERDOSAGE No specific information is available on the treatment of overdosage with disulfiram. It is recommended that the physician contact the local Poison Control Center.

🧬 Clinical Pharmacology 185 words

CLINICAL PHARMACOLOGY Disulfiram produces a sensitivity to alcohol which results in a highly unpleasant reaction when the patient under treatment ingests even small amounts of alcohol. Disulfiram blocks the oxidation of alcohol at the acetaldehyde stage. During alcohol metabolism following disulfiram intake, the concentration of acetaldehyde occurring in the blood may be 5 to 10 times higher than that found during metabolism of the same amount of alcohol alone.

Accumulation of acetaldehyde in the blood produces a complex of highly unpleasant symptoms referred to hereinafter as the disulfiram-alcohol reaction. This reaction, which is proportional to the dosage of both disulfiram and alcohol, will persist as long as alcohol is being metabolized. Disulfiram does not appear to influence the rate of alcohol elimination from the body.

Disulfiram is absorbed slowly from the gastrointestinal tract and is eliminated slowly from the body. One (or even two) weeks after a patient has taken his last dose of disulfiram, ingestion of alcohol may produce unpleasant symptoms. Prolonged administration of disulfiram does not produce tolerance; the longer a patient remains on therapy, the more exquisitely sensitive he becomes to alcohol.

📦 How Supplied / Storage and Handling 62 words

HOW SUPPLIED Disulfiram Tablets, USP are white, round, unscored tablets debossed 607. Bottle of 30 NDC 47781-607-30 Dispense in a tight, light-resistant container as defined in the USP. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. Manufactured by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 USA Distributed by: Alvogen, Inc. Morristown, NJ 07960 USA PI607-03 Rev. 01/2020 PKG02698

📋 Description 79 words

DESCRIPTION Disulfiram is an alcohol antagonist drug. CHEMICAL NAME: bis(diethylthiocarbamoyl) disulfide. STRUCTURAL FORMULA: Disulfiram occurs as a white to off-white, odorless, and almost tasteless powder, soluble in water to the extent of about 20 mg in 100 mL, and in alcohol to the extent of about 3.8 g in 100 mL.

Each tablet for oral administration contains 250 mg disulfiram, USP. Tablets also contain colloidal silicon dioxide, anhydrous lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and stearic acid.

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