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Bupropion Hydrobromide 522 mg Tablet, Extended Release, 30-count — NDC 68682-0582-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Bupropion Hydrobromide 522 mg Tablet, Extended Release, 30-count — NDC 68682-582-30 (Billing 68682-0582-30)

by Oceanside Pharmaceuticals · 30 TABLET, EXTENDED RELEASE in 1 BOTTLE

This is a package of 30 tablets of Bupropion Hydrobromide 522 mg Tablet, Extended Release from Oceanside Pharmaceuticals, marketed since Jun 2026 and currently FDA-listed. It is this product's only package size.

NDC 68682-0582-30
🏷️ FDA NDC (as labeled) 68682-582-30 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68682-582-30
Product NDC 68682-582
11-digit billing NDC 68682058230
RxCUI 993550, 993567, 993681
UNII E70G3G5863
Application # NDA022108
SPL Set ID 3ec04240-baef-44d7-8d73-a181171eec43
Established class (EPC) Aminoketone
Mechanism of action Dopamine Uptake Inhibitors; Norepinephrine Uptake Inhibitors
Physiologic effect Increased Dopamine Activity; Increased Norepinephrine Activity
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-06-29
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance BUPROPION HYDROBROMIDE
Quick answers
  • RxCUI (RxNorm): 993550
Why two NDCs? The FDA registers this code as 68682-582-30 — 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 → 68682-0582-30. 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 Aminoketone class.

Pharmacologic class Aminoketone
Drug family (ATC) Centrally acting antiobesity products, Other antidepressants
How it works Norepinephrine Uptake Inhibitors, Dopamine Uptake 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.

Clinical

📖 What it is MedlinePlus · NLM

Bupropion is used to treat depression. and seasonal affective disorder (SAD; episodes of depression that occur at the same time each year [usually in the fall and winter but rarely may occur in the spring or summer months]). Bupropion is also used to help people stop smoking. Bupropion is in a class of medications called antidepressants. It works by increasing certain types of activity in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Bupropion treats major depressive disorder. Some extended-release products, like Aplenzin and bupropion XL, can also prevent seasonal affective disorder, the depression that return...
  • Take it by mouth exactly as prescribed. XL tablets are taken once in the morning, with or without food, and must be swallowed whole. Your doctor will usually raise the dose gradual...
  • The most common ones are dry mouth, nausea, trouble sleeping, dizziness, headache, anxiety and tremor. Call your doctor right away if you have a seizure, new suicidal thoughts, sev...
  • It's best to limit or avoid alcohol. Rare neuropsychiatric events and lower alcohol tolerance have been reported. Never suddenly stop heavy drinking while on bupropion without talk...
📖 Read our full Bupropion guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

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

🧪 Full Bupropion nutrient depletion report →
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.

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.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68682-0582-30 You're viewing this Main listing 30 TABLET, EXTENDED RELEASE in 1 BOTTLE 2026-06-29 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Aplenzin 522 mg 00187-5812-07 Bausch 7 tablets — — FDA listed —
Bupropion Hydrobromide 522 mgthis 68682-0582-30 Oceanside 30 tablets — — FDA listed —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. 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

🏛️
2008
First FDA approval
Apr 2008
📍
2026
Currently FDA-listed
18 years listed
🔓
·
Listed protection lapsed
listed protections lapsed 2026
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: The latest listed FDA patent/protection lapsed Jun 2026 — those protections no longer apply, though a generic still needs FDA approval and a manufacturer to market it.
📅 FDA approved Apr 23, 2008 RLD RS

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 7569610 — method of use (U-997)
US 7569610 — method of use (U-997)
US 7569610 — method of use (U-997)
US 7241805 — drug product
US 7645802 — drug product
US 7572935 — drug product
US 7585897 — drug product
US 7645802 — drug product
US 7662407 — drug product
US 7572935 — drug product
US 7585897 — drug product
US 7662407 — drug product
US 7572935 — drug product
US 7671094 — drug product
US 7645802 — drug product
US 7671094 — drug product
US 7649019 — drug product
US 7649019 — drug product
US 7241805 — drug product
US 7671094 — drug product
US 7662407 — drug product
US 7585897 — drug product
US 7241805 — drug product
US 7649019 — drug product
2008 2010 2012 2014 2016 2018 2020 2022 2024 2026
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (24)
PatentTypeUse codeExpires
US 7569610 ↗ Method of use U-997 Jun 27, 2026
US 7569610 ↗ Method of use U-997 Jun 27, 2026
US 7569610 ↗ Method of use U-997 Jun 27, 2026
US 7241805 ↗ Drug product — Jun 27, 2026
US 7645802 ↗ Drug product — Jun 27, 2026
US 7572935 ↗ Drug product — Jun 27, 2026
US 7585897 ↗ Drug product — Jun 27, 2026
US 7645802 ↗ Drug product — Jun 27, 2026
US 7662407 ↗ Drug product — Jun 27, 2026
US 7572935 ↗ Drug product — Jun 27, 2026
US 7585897 ↗ Drug product — Jun 27, 2026
US 7662407 ↗ Drug product — Jun 27, 2026
US 7572935 ↗ Drug product — Jun 27, 2026
US 7671094 ↗ Drug product — Jun 27, 2026
US 7645802 ↗ Drug product — Jun 27, 2026
US 7671094 ↗ Drug product — Jun 27, 2026
US 7649019 ↗ Drug product — Jun 27, 2026
US 7649019 ↗ Drug product — Jun 27, 2026
US 7241805 ↗ Drug product — Jun 27, 2026
US 7671094 ↗ Drug product — Jun 27, 2026
US 7662407 ↗ Drug product — Jun 27, 2026
US 7585897 ↗ Drug product — Jun 27, 2026
US 7241805 ↗ Drug product — Jun 27, 2026
US 7649019 ↗ Drug product — Jun 27, 2026
Common questions
Is there a generic version of this drug?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for this drug. The latest listed protection lapsed in Jun 2026, so a generic is no longer blocked by listed patents/exclusivity — though one still needs FDA approval and a manufacturer willing to market it.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

What it looks like

Color white
ShapeRound
ImprintBR;522
Size11 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 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII 4W5IH7FLNY
    A clear, oily liquid derived from sebacic acid and butanol. It works as a plasticizer and solvent in pharmaceutical coatings and films, helping them stay flexible and smooth.
  • UNII 7Z8S9VYZ4B
    Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
  • UNII R8WTH25YS2
    Glyceryl dibehenate is a wax-like substance made from behenate fatty acids and glycerol. It functions as a binder and release-control agent in tablets and capsules, helping hold ingredients together and regulate how quickly the medicine dissolves and releases in your body.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.

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 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.

Manufacturer & labeler

LabelerOceanside Pharmaceuticals
Application holderBAUSCH HEALTH US LLC
FDA applicationNDA022108 (NDA AUTHORIZED GENERIC)
Labeler code68682
First marketedJun 2026
Product typeHuman Prescription Drug
Portfolio87 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🔒 Controlled Substance 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 141 words ▾

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects aged 65 and older [see Warnings and Precautions (5.1) ] . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors.

Advise families and caregivers of the need for close observation and communicationwith the prescriber [see Warnings and Precautions (5.1)]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants.

Monitor for worsening and emergence of suicidal thoughts and behaviors. ( 5.1 )

🎯 Indications and Usage 207 words ▾

1 INDICATIONS AND USAGE Bupropion Hydrobromide Extended-Release Tablets are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. ( 1 )

1.1Major Depressive Disorder Bupropion Hydrobromide Extended-Release Tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies (14.1) ].

1.2Seasonal Affective Disorder Bupropion Hydrobromide Extended-Release Tablets are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD). The efficacy of bupropion hydrochloride extended-release tablets in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM [see Clinical Studies (14.2) ].

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION General Increase dose gradually to reduce seizure risk. ( 2.1 , 5.3 ) Major Depressive Disorder Starting dose: 174 mg once daily (equivalent to 150 mg bupropion HCl). Usual target dose: 348 mg once daily (equivalent to 300 mg bupropion HCl).

( 2.3 ) After 4 days, may increase the dose to 348 mg once daily. ( 2.3 ) Seasonal Affective Disorder Initiate treatment in the autumn prior to onset of seasonal depressive symptoms. ( 2.4 ) Starting dose: 174 mg once daily (equivalent to 150 mg bupropion HCl).

Usual target dose: 348 mg once daily (equivalent to 300 mg bupropion HCl). ( 2.4 ) After one week, may increase the dose to 348 mg once daily. ( 2.4 ) Continue treatment through the winter season.

( 2.4 ) Hepatic Impairment Moderate to severe hepatic impairment: Maximum dose 174 mg every other day ( 2.6 ) Mild hepatic impairment: Consider reducing the dose and/or frequency of dosing. ( 2.2 , 2.6 , 8.7 ) Renal Impairment Consider reducing the dose and/or frequency of dosing. ( 2.2 , 2.7 , 8.6 )

2.1General Instructions for Use To minimize the risk of seizure, increase the dose gradually [see Warnings and Precautions (5.3) ]. Bupropion Hydrobromide Extended-Release Tablets should be swallowed whole and not crushed, divided, or chewed. Bupropion Hydrobromide Extended-Release Tablets should be administered in the morning and may be taken with or without regard to meals.

2.2Equivalent Daily Doses of Bupropion hydrobromide and Bupropion hydrochloride See Table 1 for equivalent daily doses of bupropion hydrobromide and bupropion hydrochloride. Table 1: Equivalent Daily Doses of Bupropion hydrobromide and Bupropion hydrochloride Bupropion hydrobromide Bupropion hydrochloride 522 mg 450 mg 348 mg 300 mg 174 mg 150 mg

2.3Dosage for Major Depressive Disorder (MDD) The recommended starting dose for MDD is 174 mg once daily in the morning. After 4 days of dosing, the dose may be increased to the target dose of 348 mg once daily in the morning. It is generally agreed that acute episodes of depression require several months or longer of antidepressant treatment beyond the response in the acute episode.

It is unknown whether the bupropion hydrobromide extended-release tablets dose needed for maintenance treatment is identical to the dose that provided an initial response. Periodically reassess the need for maintenance treatment and the appropriate dose for such treatment.

2.4Dosage for Seasonal Affective Disorder (SAD) The recommended starting dose for SAD is 174 mg once daily. After 7 days of dosing, the dose may be increased to the target dose of 348 mg once daily in the morning. Doses above 300 mg of bupropion HCl extended-release (equivalent to bupropion hydrobromide extended-release tablets 348 mg) were not assessed in the SAD trials.

For the prevention of seasonal MDD episodes associated with SAD, initiate bupropion hydrobromide extended-release tablets in the autumn, prior to the onset of depressive symptoms. Continue treatment through the winter season. Taper and discontinue bupropion hydrobromide extended-release tablets in early spring.

For patients treated with 348 mg per day, decrease the dose to 174 mg once daily before discontinuing bupropion hydrobromide extended-release tablets. Individualize the timing of initiation, and duration of treatment should be individualized, based on the patient’s historical pattern of seasonal MDD episodes.

2.5To Discontinue Bupropion Hydrobromide Extended-Release Tablets, Taper the Dose When discontinuing treatment in patients treated with bupropion hydrobromide extended-release tablets 348 mg once daily, decrease the dose to 174 mg once daily prior to discontinuation.

2.6Dosage Adjustment in Patients with Hepatic Impairment In patients with moderate to severe hepatic impairment (Child-Pugh score: 7 to 15), the maximum dose is 174 mg every other day. In patients with mild hepatic impairment (Child-Pugh score: 5 to 6), consider reducing the dose and/or frequency of dosing… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 91 words ▾

3 DOSAGE FORMS AND STRENGTHS Bupropion Hydrobromide Extended-Release Tablets, 174 mg of bupropion hydrobromide, are white to off-white, round tablets printed on one side with black ink “BR” over “174”. Bupropion Hydrobromide Extended-Release Tablets, 348 mg of bupropion hydrobromide, are white to off-white, round tablets printed on one side with black ink “BR” over “348”. Bupropion Hydrobromide Extended-Release Tablets, 522 mg of bupropion hydrobromide, are white to off-white, round tablets printed on one side with black ink “BR” over “522”.

Extended-release tablets: 174 mg, 348 mg, 522 mg ( 3 )

⛔ Contraindications ~2 min read ▾

4 CONTRAINDICATIONS Bupropion Hydrobromide Extended-Release Tablets are contraindicated in patients with a seizure disorder. Bupropion Hydrobromide Extended-Release Tablets are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with bupropion hydrobromide extended-release tablets [see Warnings and Precautions (5.3) ]. Bupropion Hydrobromide Extended-Release Tablets are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see Warnings and Precautions (5.3) and Drug Interactions (7.3) ].

The use of MAOIs (intended to treat psychiatric disorders) concomitantly with bupropion hydrobromide extended-release tablets or within 14 days of discontinuing treatment with bupropion hydrobromide extended-release tablets is contraindicated. There is an increased risk of hypertensive reactions when bupropion hydrobromide extended-release tablets are used concomitantly with MAOIs. The use of bupropion hydrobromide extended-release tablets within 14 days of discontinuing treatment with an MAOI is also contraindicated.

Starting bupropion hydrobromide extended-release tablets in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated [see Dosage and Administration ( 2.5 , 2.6 , 2.9 ), Warnings and Precautions (5.4) , and Drug Interactions (7.6) ]. Bupropion Hydrobromide Extended-Release Tablets are contraindicated in patients with known hypersensitivity to bupropion or other ingredients of bupropion hydrobromide extended-release tablets. Anaphylactoid/anaphylactic reactions and Stevens-Johnson Syndrome have been reported [see Warnings and Precautions (5.8) ].

Seizure disorder. ( 4 , 5.3 ) Current or prior diagnosis of bulimia or anorexia nervosa. ( 4 , 5.3 ) Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, antiepileptic drugs.

( 4 , 5.3 ) Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with bupropion hydrobromide extended-release tablets or within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start bupropion hydrobromide extended-release tablets in a patient who is being treated with linezolid or intravenous methylene blue. ( 4 , 7.6 ) Known hypersensitivity to bupropion or other ingredients of bupropion hydrobromide extended-release tablets.

( 4 , 5.8 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Neuropsychiatric Adverse Events During Smoking Cessation: Postmarketing reports of serious or clinically significant neuropsychiatric adverse events have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients attempting to quit smoking with bupropion hydrobromide extended-release tablets for the occurrence of such symptoms and instruct them to discontinue bupropion hydrobromide extended-release tablets and contact a healthcare provider if they experience such adverse events.

( 5.2 ) Seizure Risk: The risk is dose-related. Can minimize risk by limiting daily dose to 522 mg and gradually increasing the dose. Discontinue if seizure occurs.

( 4 , 5.3 , 7.3 ) Hypertension: Bupropion Hydrobromide Extended-Release Tablets can increase blood pressure. Monitor blood pressure before initiating treatment and periodically during treatment. ( 5.4 ) Activation of Mania/Hypomania: Screen patients for bipolar disorder and monitor for these symptoms.

( 5.5 ) Psychosis and Other Neuropsychiatric Reactions: Instruct patients to contact a healthcare professional if such reactions occur. ( 5.6 ) Angle-Closure Glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. ( 5.7 )

5.1Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.

There has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (Selective Serotonin Reuptake Inhibitors [SSRIs] and others) show that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders.

Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older. The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4,400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients.

There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively stable within age strata and across indications.

These risk differences (drug-placebo difference in the number of cases of suicidality per 1,000 patients treated) are provided in Table 2 . Table 2: Risk Differences in the Number of Suicidality Cases by Age Group in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and A… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Suicidal thoughts and behaviors in children, adolescents, and young adults [see Warnings and Precautions (5.1) ] Neuropsychiatric adverse events and suicide risk in smoking cessation treatment [see Warnings and Precautions (5.2) ] Seizure [see Warnings and Precautions (5.3) ] Hypertension [see Warnings and Precautions (5.4) ] Activation of mania or hypomania [see Warnings and Precautions (5.5 )] Psychosis and other neuropsychiatric events [see Warnings and Precautions (5.6) ] Angle-closure glaucoma [see Warnings and Precautions (5.7) ] Hypersensitivity reactions [see Warnings and Precautions (5.8) ] Most common adverse reactions are (incidence ≥5%; ≥2× placebo rate): dry mouth, nausea, insomnia, dizziness, pharyngitis, abdominal pain, agitation, anxiety, tremor, palpitation, sweating, tinnitus, myalgia, anorexia, urinary frequency, rash.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Commonly Observed Adverse Reactions in Controlled Clinical Trials of Sustained-Release Bupropion Hydrochloride Adverse reactions that occurred in at least 5% of patients treated with bupropion HCl sustained-release (300 mg and 400 mg per day) and at a rate at least twice the placebo rate are listed below.

300 mg/day of bupropion HCl sustained-release (equivalent to bupropion hydrobromide extended-release tablets 348 mg/day): anorexia, dry mouth, rash, sweating, tinnitus, and tremor. 400 mg/day of bupropion HCl sustained-release (equivalent to bupropion hydrobromide extended-release tablets 464 mg/day): abdominal pain, agitation, anxiety, dizziness, dry mouth, insomnia, myalgia, nausea, palpitation, pharyngitis, sweating, tinnitus, and urinary frequency. Bupropion Hydrobromide Extended-Release Tablets are bioequivalent to bupropion HCl extended-release, which has been demonstrated to have similar bioavailability both to the immediate-release formulation of bupropion and to the sustained-release formulation of bupropion.

The information included under this subsection and under subsection 6.2 is based primarily on data from controlled clinical trials with the sustained-release and extended-release formulations of bupropion hydrochloride. Major Depressive Disorder Adverse Reactions Leading to Discontinuation of Treatment with Bupropion HCl Immediate-Release, Bupropion HCl Sustained-Release, and Bupropion HCl Extended-Release in Major Depressive Disorder Trials In placebo-controlled clinical trials with bupropion HCl sustained-release, 4%, 9%, and 11% of the placebo, 300 mg/day and 400 mg/day groups, respectively, discontinued treatment because of adverse reactions.

The specific adverse reactions leading to discontinuation in at least 1% of the 300 mg/day or 400 mg/day groups and at a rate at least twice the placebo rate are listed in Table 3 . Table 3: Treatment Discontinuation Due to Adverse Reactions in Placebo-Controlled Trials in MDD Adverse Reaction Term Placebo (n=385) Bupropion HCl Sustained-Release 300 mg/day Equivalent to 348 mg/day bupropion HBr (n=376) Bupropion HCl Sustained-Release 400 mg/day Equivalent to 464 mg/day bupropion HBr (n=114) Rash 0.0% 2.4% 0.9% Nausea 0.3% 0.8% 1.8% Agitation 0.3% 0.3% 1.8% Migraine 0.3% 0.0% 1.8% In clinical trials with bupropion HCl immediate-release, 10% of patients and volunteers discontinued due to an adverse reaction.

Reactions resulting in discontinuation (in addition to those listed above for the sustained-release formulation) included vomiting, seizures, and sleep disturbances. Adverse Reactio… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS CYP2B6 inducers: Dose increase may be necessary if coadministered with CYP2B6 inducers (e.g., ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital, phenytoin) based on clinical exposure, but should not exceed the maximum dose. ( 7.1 ) Drugs metabolized by CYP2D6: Bupropion inhibits CYP2D6 and can increase concentrations of: antidepressants (e.g., venlafaxine, nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, sertraline), antipsychotics (e.g., haloperidol, risperidone, thioridazine), beta-blockers (e.g., metoprolol), and Type 1C antiarrhythmics (e.g., propafenone, flecainide).

Consider dose reduction when using with bupropion. ( 7.2 ) Drugs that lower seizure threshold: Dose bupropion hydrobromide extended-release tablets with caution. ( 5.3 , 7.3 ) Dopaminergic Drugs (levodopa and amantadine): CNS toxicity can occur when used concomitantly with bupropion hydrobromide extended-release tablets.

( 7.4 ) MAOIs: Increased risk of hypertensive reactions can occur when used concomitantly with bupropion hydrobromide extended-release tablets. ( 7.6 ) Drug-laboratory test interactions: Bupropion Hydrobromide Extended-Release Tablets can cause false-positive urine test results for amphetamines. ( 7.7 )

7.1Potential for Other Drugs to Affect Bupropion Hydrobromide Extended-Release Tablets Bupropion is primarily metabolized to hydroxybupropion by CYP2B6. Therefore, the potential exists for drug interactions between bupropion hydrobromide extended-release tablets and drugs that are inhibitors or inducers of CYP2B6. Inhibitors of CYP2B6 Ticlopidine and Clopidogrel: Concomitant treatment with these drugs can increase bupropion exposures but decrease hydroxybupropion exposure.

Based on clinical response, dosage adjustment of bupropion hydrobromide extended-release tablets may be necessary when coadministered with CYP2B6 inhibitors (e.g., ticlopidine or clopidogrel) [see Clinical Pharmacology (12.3) ]. Inducers of CYP2B6 Ritonavir, Lopinavir, and Efavirenz: Concomitant treatment with these drugs can decrease bupropion and hydroxybupropion exposure. Dosage increase of bupropion hydrobromide extended-release tablets may be necessary when coadministered with ritonavir, lopinavir, or efavirenz but should not exceed the maximum recommended dose [see Clinical Pharmacology (12.3) ].

Carbamazepine, Phenobarbital, Phenytoin: While not systemically studied, these drugs may induce metabolism of bupropion and may decrease bupropion exposure [see Clinical Pharmacology (12.3) ] . If bupropion is used concomitantly with a CYP inducer, it may be necessary to increase the dose of bupropion, but the maximum recommended dose should not be exceeded.

7.2Potential for Bupropion Hydrobromide Extended-Release Tablets to Affect Other Drugs Drugs Metabolized by CYP2D6 Bupropion and its metabolites (erythrohydrobupropion, threohydrobupropion, hydroxybupropion) are CYP2D6 inhibitors. Therefore, coadministration of bupropion hydrobromide extended-release tablets with drugs that are metabolized by CYP2D6 can increase the exposures of drugs that are substrates of CYP2D6. Such drugs include certain antidepressants (e.g., venlafaxine, nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, and sertraline), antipsychotics (e.g., haloperidol, risperidone, and thioridazine), beta-blockers (e.g., metoprolol), and Type 1C antiarrhythmics (e.g., propafenone, and flecainide).

When used concomitantly with bupropion hydrobromide extended-release tablets, it may be necessary to decrease the dose of these CYP2D6 substrates, particularly for drugs with a narrow therapeutic index. Drugs that require metabolic activation by CYP2D6 to be effective (e.g., tamoxifen), theoretically could have reduced efficacy when administered concomitantly with inhibitors of CYP2D6 such as bupropion. Patients treated concomitantly with bupropion hydrobromide extended-release tablets and such drugs may require increased doses of the drug [see Clinical Pharma… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. Risk Summary Data from epidemiological studies of pregnant women exposed to bupropion in the first trimester have not identified an increased risk of congenital malformations overall ( see Data) .

There are risks to the mother associated with untreated depression (see Clinical Considerations) . When bupropion was administered to pregnant rats during organogenesis, there was no evidence of fetal malformations at doses up to approximately 10 times the maximum recommended human dose (MRHD) of 450 mg/day. When given to pregnant rabbits during organogenesis, non-dose-related increases in incidence of fetal malformations and skeletal variations were observed at doses approximately equal to the MRHD and greater.

Decreased fetal weights were seen at doses twice the MRHD and greater (see Data) . The estimated background risk for major birth defects and miscarriage are unknown for the indicated population. All pregnancies have a background rate of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants during pregnancy at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants.

Consider the risks to the mother of untreated depression and potential effects on the fetus when discontinuing or changing treatment with antidepressant medications during pregnancy and postpartum. Data Human Data Data from the international bupropion Pregnancy Registry (675 first trimester exposures) and a retrospective cohort study using the United Healthcare database (1,213 first trimester exposures) did not show an increased risk for malformations overall. The Registry was not designed or powered to evaluate specific defects but suggested a possible increase in cardiac malformations.

No increased risk for cardiovascular malformations overall has been observed after bupropion exposure during the first trimester. The prospectively observed rate of cardiovascular malformations in pregnancies with exposure to bupropion in the first trimester from the international Pregnancy Registry was 1.3% (9 cardiovascular malformations/675 first-trimester maternal bupropion exposures), which is similar to the background rate of cardiovascular malformations (approximately 1%). Data from the United Healthcare database, which has a limited number of exposed cases with cardiovascular malformations, and a case-controlled study (6,853 infants with cardiovascular malformations and 5,753 with non-cardiovascular malformations) from the National Birth Defects Prevention Study (NBDPS) did not show an increased risk for cardiovascular malformations overall after bupropion exposure during the first trimester.

Study findings on bupropion exposure during the first trimester and risk left ventricular outflow tract obstruction (LVOTO) are inconsistent and do not allow conclusions regarding possible association. The United Healthcare database lacked sufficient power to evaluate this association; the NBDPS found increased risk for LVOTO (n = 10; adjusted odds ratio (OR) = 2.6; 95% CI 1.2, 5.7) and the Slone Epidemiology case… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. Risk Summary Data from epidemiological studies of pregnant women exposed to bupropion in the first trimester have not identified an increased risk of congenital malformations overall ( see Data) .

There are risks to the mother associated with untreated depression (see Clinical Considerations) . When bupropion was administered to pregnant rats during organogenesis, there was no evidence of fetal malformations at doses up to approximately 10 times the maximum recommended human dose (MRHD) of 450 mg/day. When given to pregnant rabbits during organogenesis, non-dose-related increases in incidence of fetal malformations and skeletal variations were observed at doses approximately equal to the MRHD and greater.

Decreased fetal weights were seen at doses twice the MRHD and greater (see Data) . The estimated background risk for major birth defects and miscarriage are unknown for the indicated population. All pregnancies have a background rate of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants during pregnancy at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants.

Consider the risks to the mother of untreated depression and potential effects on the fetus when discontinuing or changing treatment with antidepressant medications during pregnancy and postpartum. Data Human Data Data from the international bupropion Pregnancy Registry (675 first trimester exposures) and a retrospective cohort study using the United Healthcare database (1,213 first trimester exposures) did not show an increased risk for malformations overall. The Registry was not designed or powered to evaluate specific defects but suggested a possible increase in cardiac malformations.

No increased risk for cardiovascular malformations overall has been observed after bupropion exposure during the first trimester. The prospectively observed rate of cardiovascular malformations in pregnancies with exposure to bupropion in the first trimester from the international Pregnancy Registry was 1.3% (9 cardiovascular malformations/675 first-trimester maternal bupropion exposures), which is similar to the background rate of cardiovascular malformations (approximately 1%). Data from the United Healthcare database, which has a limited number of exposed cases with cardiovascular malformations, and a case-controlled study (6,853 infants with cardiovascular malformations and 5,753 with non-cardiovascular malformations) from the National Birth Defects Prevention Study (NBDPS) did not show an increased risk for cardiovascular malformations overall after bupropion exposure during the first trimester.

Study findings on bupropion exposure during the first trimester and risk left ventricular outflow tract obstruction (LVOTO) are inconsistent and do not allow conclusions regarding possible association. The United Healthcare database lacked sufficient power to evaluate this association; the NBDPS found increased risk for LVOTO (n = 10; adjusted odds ratio (OR) = 2.6; 95% CI 1.2, 5.7) and the Slone Epidemiology case control study did not find in… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 46 words ▾

8.4Pediatric Use Safety and effectiveness in the pediatric population have not been established. When considering the use of bupropion hydrobromide extended-release tablets in a child or adolescent, balance the potential risks with the clinical need [see Boxed Warning and Warnings and Precautions (5.1) ] .

🧓 Geriatric Use 178 words ▾

8.5Geriatric Use Of the approximately 6,000 patients who participated in clinical trials with bupropion hydrochloride sustained-release tablets (depression and smoking cessation studies), 275 were ≥65 years old and 47 were ≥75 years old. In addition, several hundred patients ≥65 years of age participated in clinical trials using the immediate-release formulation of bupropion hydrochloride (depression studies). No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

Reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Bupropion is extensively metabolized in the liver to active metabolites, which are further metabolized and excreted by the kidneys. The risk of adverse reactions may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, it may be necessary to consider this factor in dose selection; it may be useful to monitor renal function [see Dosage and Administration (2.7) , Use in Specific Populations (8.6) , and Clinical Pharmacology (12.3) ] .

🆘 Overdosage 171 words ▾

10 OVERDOSAGE

10.1Human Overdose Experience Overdoses of up to 30 grams or more of bupropion have been reported. Seizure was reported in approximately one third of all cases. Other serious reactions reported with overdoses of bupropion alone included hallucinations, loss of consciousness, mental status changes, sinus tachycardia, ECG changes such as conduction disturbances or arrhythmias, clonus, myoclonus, and hyperreflexia.

Fever, muscle rigidity, rhabdomyolysis, hypotension, stupor, coma, and respiratory failure have been reported mainly when bupropion was part of multiple drug overdoses. Although most patients recovered without sequelae, deaths associated with overdoses of bupropion alone have been reported in patients ingesting large doses of the drug. Multiple uncontrolled seizures, bradycardia, cardiac failure, and cardiac arrest prior to death were reported in these patients.

10.2Overdosage Management Consult a Certified Poison Control Center for up-to-date guidance and advice. Call 1-800-222-1222 or refer to www.poison.org. There are no known antidotes for bupropion. In case of an overdose, provide supportive care, including close medical supervision and monitoring. Consider the possibility of multiple drug overdose.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of bupropion is unknown, as is the case with other antidepressants. However, it is presumed that this action is mediated by noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the neuronal uptake of norepinephrine and dopamine and does not inhibit monoamine oxidase or the reuptake of serotonin.

12.3Pharmacokinetics Bupropion is a racemic mixture. The pharmacologic activity and pharmacokinetics of the individual enantiomers have not been studied. Following chronic dosing of bupropion hydrobromide extended-release tablets 348 mg once-daily tablets, the mean peak steady-state plasma concentration and area under the curve of bupropion were 134.3 (±38.2) ng/mL and 1409 (±346) ng•hr/mL, respectively.

Steady-state plasma concentrations of bupropion were reached within 8 days. The elimination half-life (±SD) of bupropion after a single dose is 21.3 (±6.7) hours. In a study comparing 10-day dosing with bupropion hydrobromide extended-release tablets 348 mg once-daily and bupropion HCl extended-release 300 mg once-daily, (following a 3-day titration with bupropion HCl extended-release 150 mg once-daily), bupropion hydrobromide extended-release tablets peak plasma concentration and area under the curve for bupropion and the 3 metabolites (hydroxybupropion, threohydrobupropion, and erythrohydrobupropion) were equivalent to bupropion HCl extended-release 300 mg, with the average being 8 to 14% lower.

In a single-dose study, two bupropion hydrobromide extended-release tablets 174 mg once-daily and one bupropion hydrobromide extended-release tablet 348 mg once-daily were evaluated. Equivalence was demonstrated for peak plasma concentration and area under the curve for bupropion and the 3 metabolites. A multidose study compared 14-day dosing with bupropion hydrobromide extended-release tablets 522 mg once-daily to dosing with three bupropion hydrobromide extended-release tablets 174 mg once-daily, following a 3-day titration with one bupropion hydrobromide extended-release tablet 174 mg once-daily, and a succeeding 5-day titration with two bupropion hydrobromide extended-release tablets 174 mg once-daily.

Equivalence was demonstrated for peak plasma concentration and area under the curve for bupropion and the 3 metabolites. These findings demonstrate that bupropion hydrobromide extended-release tablets 174 mg, 348 mg, and 522 mg are dose proportional. Absorption Following single oral administration of bupropion hydrobromide extended-release tablets to healthy volunteers, the median time to peak plasma concentrations for bupropion was approximately 5 hours.

The presence of food did not affect the peak concentration and time to peak plasma concentration of bupropion; the area under the curve was increased by 19%. Distribution In vitro tests demonstrated that bupropion is 84% bound to human plasma proteins at concentrations up to 200 mcg/mL. The extent of protein binding of the hydroxybupropion metabolite is similar to that for bupropion, whereas the extent of protein binding of the threohydrobupropion metabolite is about half that of bupropion.

Metabolism Bupropion is extensively metabolized in humans. Three metabolites are active: hydroxybupropion, which is formed via hydroxylation of the tert -butyl group of bupropion, and the amino-alcohol isomers threohydrobupropion and erythrohydrobupropion, which are formed via reduction of the carbonyl group. In vitro findings suggest that CYP2B6 is the principal isoenzyme involved in the formation of hydroxybupropion, while cytochrome P450 enzymes are not involved in the formation of threohydrobupropion.

Oxidation of the bupropion side chain results in the formation of a glycine conjugate of meta-chlorobenzoic acid, which is then excreted as the major urinary metabolite. The potency and toxicity of the metabolites relative to bupropion have not been fully characterized. However, it has been d… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 58 words ▾

12.1Mechanism of Action The mechanism of action of bupropion is unknown, as is the case with other antidepressants. However, it is presumed that this action is mediated by noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the neuronal uptake of norepinephrine and dopamine and does not inhibit monoamine oxidase or the reuptake of serotonin.

📦 How Supplied / Storage and Handling 119 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Bupropion Hydrobromide Extended-Release Tablets, 174 mg of bupropion hydrobromide, are white to off-white, round tablets printed on one side with black ink “BR” over “174” in bottles of 30 tablets (NDC 68682-580-30). Bupropion Hydrobromide Extended-Release Tablets, 348 mg of bupropion hydrobromide, are white to off-white, round tablets printed on one side with black ink “BR” over “348” in bottles of 30 tablets (NDC 68682-581-30). Bupropion Hydrobromide Extended-Release Tablets, 522 mg of bupropion hydrobromide, are white to off-white, round tablets printed on one side with black ink “BR” over “522” in bottles of 30 tablets (NDC 68682-582-30).

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

📦 Storage and Handling 18 words ▾

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

📋 Description 179 words ▾

11 DESCRIPTION Bupropion Hydrobromide Extended-Release Tablets, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-2-(tert-butylamino)-3'-chloropropiophenone hydrobromide.

The molecular weight is 320.6. The molecular formula is C 13 H 18 ClNO•HBr. Bupropion hydrobromide powder is white or almost white, crystalline, and soluble in water.

It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is: Bupropion Hydrobromide Extended-Release Tablets are supplied for oral administration as 174 mg, 348 mg, and 522 mg white to off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrobromide and the inactive ingredients: ethylcellulose, glyceryl dibehenate, polyvinyl alcohol, polyethylene glycol, povidone, and dibutyl sebacate.

Carnauba wax is included in the 174 mg and 348 mg strengths. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. chemical structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Instruct patients, their families, and/or their caregivers to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down.

Advise families and caregivers of patients to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.

Neuropsychiatric Adverse Events and Suicide Risk in Smoking Cessation Treatment Although bupropion hydrobromide extended-release tablets are not indicated for smoking cessation treatment, it contains the same active ingredient as ZYBAN which is approved for this use. Inform patients that some patients have experienced changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation and suicide when attempting to quit smoking while taking bupropion.

Instruct patients to discontinue bupropion hydrobromide extended-release tablets and contact a healthcare professional if they experience such symptoms [see Warnings and Precautions (5.2) and Adverse Reactions (6.2) ] . Severe Allergic Reactions Educate patients on the symptoms of hypersensitivity and to discontinue bupropion hydrobromide extended-release tablets if they have a severe allergic reaction. Seizure Instruct patients to discontinue and not restart bupropion hydrobromide extended-release tablets if they experience a seizure while on treatment.

Advise patients that the excessive use or the abrupt discontinuation of alcohol, benzodiazepines, antiepileptic drugs, or sedatives/hypnotics can increase the risk of seizure. Advise patients to minimize or avoid the use of alcohol. Angle-Closure Glaucoma Patients should be advised that taking bupropion hydrobromide extended-release tablets can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma.

Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible [see Warnings and Precautions (5.7) ] .

Bupropion-Containing Products Educate patients that bupropion hydrobromide extended-release tablets contain the same active ingredient (bupropion) found in ZYBAN, which is used as an aid to smoking cessation treatment, and that bupropion hydrobromide extended-release tablets should not be used in combination with ZYBAN or any other medications that contain bupropion hydrochloride (such as WELLBUTRIN XL, the extended-release formulation, WELLBUTRIN SR, the sustained-release formulation, and WELLBUTRIN, the immediate-release formulation).

In addition, there are a number of generic bupropion HCl products for the immediate, sustained, and extended-release formulations. Potential for Cognitive and Motor Impairment Advise patients that any CNS-active drug like bupropion hydrobromide extended-release tablets may impair their ability to perform tasks requiring judgment o… [Excerpted — this section continues on DailyMed.]

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Bupropion Hydrobromide Extended-Release Tablets IMPORTANT: Be sure to read the three sections of this Medication Guide. The first section is about the risk of suicidal thoughts and actions with antidepressant medicines; the second section is about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with medicines used to quit smoking; and the third section is entitled “What Other Important Information Should I Know About Bupropion Hydrobromide Extended-Release Tablets?” Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions This section of the Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines.

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? Antidepressant medicines may increase the risk of suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment. Depression or other serious mental illnesses are the most important causes of suicidal thoughts and actions.

Some people may have a particularly high risk of having suicidal thoughts or actions . These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.

Keep all follow-up visits with your healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying attempts to commit suicide new or worse depression new or worse anxiety feeling very agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood What else do I need to know about antidepressant medicines?

Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms. Antidepressants are medicines used to treat depression and other illnesses.

It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants. Antidepressant medicines have other side effects.

Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member. Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes.

Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider. It is not known if bupropion hydrobromide extended-release tablets is safe and effective in children under the age of 18.

Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions This section of the Medication Guide is only about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with drugs used to quit smoking. Although bupropion hydrobromide extended-release tabl… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Bupropion is a racemic mixture. The pharmacologic activity and pharmacokinetics of the individual enantiomers have not been studied. Following chronic dosing of bupropion hydrobromide extended-release tablets 348 mg once-daily tablets, the mean peak steady-state plasma concentration and area under the curve of bupropion were 134.3 (±38.2) ng/mL and 1409 (±346) ng•hr/mL, respectively.

Steady-state plasma concentrations of bupropion were reached within 8 days. The elimination half-life (±SD) of bupropion after a single dose is 21.3 (±6.7) hours. In a study comparing 10-day dosing with bupropion hydrobromide extended-release tablets 348 mg once-daily and bupropion HCl extended-release 300 mg once-daily, (following a 3-day titration with bupropion HCl extended-release 150 mg once-daily), bupropion hydrobromide extended-release tablets peak plasma concentration and area under the curve for bupropion and the 3 metabolites (hydroxybupropion, threohydrobupropion, and erythrohydrobupropion) were equivalent to bupropion HCl extended-release 300 mg, with the average being 8 to 14% lower.

In a single-dose study, two bupropion hydrobromide extended-release tablets 174 mg once-daily and one bupropion hydrobromide extended-release tablet 348 mg once-daily were evaluated. Equivalence was demonstrated for peak plasma concentration and area under the curve for bupropion and the 3 metabolites. A multidose study compared 14-day dosing with bupropion hydrobromide extended-release tablets 522 mg once-daily to dosing with three bupropion hydrobromide extended-release tablets 174 mg once-daily, following a 3-day titration with one bupropion hydrobromide extended-release tablet 174 mg once-daily, and a succeeding 5-day titration with two bupropion hydrobromide extended-release tablets 174 mg once-daily.

Equivalence was demonstrated for peak plasma concentration and area under the curve for bupropion and the 3 metabolites. These findings demonstrate that bupropion hydrobromide extended-release tablets 174 mg, 348 mg, and 522 mg are dose proportional. Absorption Following single oral administration of bupropion hydrobromide extended-release tablets to healthy volunteers, the median time to peak plasma concentrations for bupropion was approximately 5 hours.

The presence of food did not affect the peak concentration and time to peak plasma concentration of bupropion; the area under the curve was increased by 19%. Distribution In vitro tests demonstrated that bupropion is 84% bound to human plasma proteins at concentrations up to 200 mcg/mL. The extent of protein binding of the hydroxybupropion metabolite is similar to that for bupropion, whereas the extent of protein binding of the threohydrobupropion metabolite is about half that of bupropion.

Metabolism Bupropion is extensively metabolized in humans. Three metabolites are active: hydroxybupropion, which is formed via hydroxylation of the tert -butyl group of bupropion, and the amino-alcohol isomers threohydrobupropion and erythrohydrobupropion, which are formed via reduction of the carbonyl group. In vitro findings suggest that CYP2B6 is the principal isoenzyme involved in the formation of hydroxybupropion, while cytochrome P450 enzymes are not involved in the formation of threohydrobupropion.

Oxidation of the bupropion side chain results in the formation of a glycine conjugate of meta-chlorobenzoic acid, which is then excreted as the major urinary metabolite. The potency and toxicity of the metabolites relative to bupropion have not been fully characterized. However, it has been demonstrated in an antidepressant screening test in mice that hydroxybupropion is one half as potent as bupropion, while threohydrobupropion and erythrohydrobupropion are 5-fold less potent than bupropion.

This may be of clinical importance, because the plasma concentrations of the metabolites are as high or higher than those of bupropion. At steady state, peak plasma concentration of hydroxybupropion occu… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Major Depressive Disorder The efficacy of bupropion in the treatment of major depressive disorder was established with the immediate-release formulation of bupropion hydrochloride in two 4-week, placebo-controlled trials in adult inpatients with MDD and in one 6-week, placebo-controlled trial in adult outpatients with MDD. In the first study, the bupropion dose range was 300 mg to 600 mg per day administered in 3 divided doses; 78% of patients were treated with doses of 300 mg to 450 mg per day. The trial demonstrated the efficacy of bupropion as measured by the Hamilton Depression Rating Scale (HAMD) total score, the HAMD depressed mood item (item 1), and the Clinical Global Impressions-Severity Scale (CGI-S).

The second study included 2 fixed doses of bupropion (300 mg and 450 mg per day) and placebo. This trial demonstrated the efficacy of bupropion for only the 450 mg dose. The efficacy results were significant for the HAMD total score and the CGI-S severity score, but not for HAMD item 1.

In the third study, outpatients were treated with bupropion 300 mg per day. This study demonstrated the efficacy of bupropion as measured by the HAMD total score, the HAMD item 1, the Montgomery-Asberg Depression Rating Scale (MADRS), the CGI-S score, and the CGI-Improvement Scale (CGI-I) score. A longer-term, placebo-controlled, randomized withdrawal trial demonstrated the efficacy of bupropion HCl sustained-release in the maintenance treatment of MDD.

The trial included adult outpatients meeting DSM-IV criteria for MDD, recurrent type, who had responded during an 8-week open-label trial of bupropion 300 mg per day. Responders were randomized to continuation of bupropion 300 mg per day or placebo for up to 44 weeks of observation for relapse. Response during the open-label phase was defined as a CGI-Improvement Scale score of 1 (very much improved) or 2 (much improved) for each of the final 3 weeks.

Relapse during the double-blind phase was defined as the investigator’s judgment that drug treatment was needed for worsening depressive symptoms. Patients in the bupropion group experienced significantly lower relapse rates over the subsequent 44 weeks compared to those in the placebo group. Although there are no independent trials demonstrating the efficacy of bupropion hydrobromide extended-release tablets or bupropion HCl extended-release in the acute treatment of MDD, studies have demonstrated similar bioavailability between the immediate-, sustained-, and extended-release formulations of bupropion HCl under steady-state conditions (i.e., the exposures [C max and AUC] for bupropion and its metabolites are similar among the 3 formulations).

Furthermore, clinical studies have demonstrated that bupropion hydrobromide extended-release tablets are bioequivalent to bupropion HCl extended-release.

14.2Seasonal Affective Disorder The efficacy of bupropion hydrochloride extended-release in the prevention of seasonal major depressive episodes associated with SAD was established in 3 randomized, double-blind, placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern (as defined by DSM-IV criteria). Bupropion treatment was initiated prior to the onset of symptoms in the autumn (September to November). Treatment was discontinued following a 2-week taper that began during the first week of spring (fourth week of March), resulting in a treatment duration of approximately 4 to 6 months for the majority of patients.

Patients were randomized to treatment with bupropion HCl extended-release or placebo. The initial bupropion dose was 150 mg once daily for 1 week, followed by up-titration to 300 mg once daily. Patients who were deemed by the investigator to be unlikely or unable to tolerate 300 mg once daily were allowed to remain on, or had their dose reduced to, 150 mg once daily.

The mean bupropion doses in the 3 trials ranged from 257 mg to 280 mg per day. Approximately 59% of p… [Excerpted — this section continues on DailyMed.]

🔒 Drug Abuse and Dependence ~1 min read ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance Bupropion is not a controlled substance.

9.2Abuse Humans Controlled clinical studies of bupropion HCl immediate-release conducted in normal volunteers, in subjects with a history of multiple drug abuse, and in depressed patients demonstrated an increase in motor activity and agitation/excitement. In a population of individuals experienced with drugs of abuse, a single dose of 400 mg bupropion produced mild amphetamine-like activity as compared to placebo on the Morphine-Benzedrine Subscale of the Addiction Research Center Inventories (ARCI), and a score intermediate between placebo and amphetamine on the Liking Scale of the ARCI.

These scales measure general feelings of euphoria and drug desirability. Findings in clinical trials, however, are not known to reliably predict the abuse potential of drugs. Nonetheless, evidence from single-dose studies does suggest that the recommended daily dosage of bupropion when administered in divided doses is not likely to be significantly reinforcing to amphetamine or CNS stimulant abusers.

However, higher doses (that could not be tested because of the risk of seizure) might be modestly attractive to those who abuse CNS stimulant drugs. Bupropion hydrochloride extended-release tablets are intended for oral use only. The inhalation of crushed tablets or injection of dissolved bupropion has been reported.

Seizures and/or cases of death have been reported when bupropion has been administered intranasally or by parenteral injection. Animals Studies in rodents and primates demonstrated that bupropion exhibits some pharmacologic actions common to psychostimulants. In rodents, it has been shown to increase locomotor activity, elicit a mild stereotyped behavioral response, and increase rates of responding in several schedule-controlled behavior paradigms.

In primate models assessing the positive reinforcing effects of psychoactive drugs, bupropion was self-administered intravenously. In rats, bupropion produced amphetamine-like and cocaine-like discriminative stimulus effects in drug discrimination paradigms used to characterize the subjective effects of psychoactive drugs.

🔒 Controlled Substance 9 words ▾

9.1Controlled Substance Bupropion is not a controlled substance.

🧪 Nonclinical Toxicology 215 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Lifetime carcinogenicity studies were performed in rats and mice at doses up to 300 and 150 mg/kg/day bupropion hydrochloride, respectively. These doses are approximately 6 and 2 times the maximum recommended human dose (MRHD), respectively, on a mg/m 2 basis. In the rat study there was an increase in nodular proliferative lesions of the liver at doses of 100 to 300 mg/kg/day of bupropion hydrochloride (approximately 2 to 6 times the MRHD on a mg/m 2 basis); lower doses were not tested.

The question of whether or not such lesions may be precursors of neoplasms of the liver is currently unresolved. Similar liver lesions were not seen in the mouse study, and no increase in malignant tumors of the liver and other organs was seen in either study. Mutagenesis Bupropion produced a positive response (2 to 3 times control mutation rate) in 2 of 5 strains in one Ames bacterial mutagenicity assay, but was negative in another.

Bupropion produced an increase in chromosomal aberrations in 1 of 3 in vivo rat bone marrow cytogenetic studies. Impairment of Fertility A fertility study in rats at doses up to 300 mg/kg/day revealed no evidence of impaired fertility (approximately 6 times the MRHD on a mg/m 2 basis).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 212 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Lifetime carcinogenicity studies were performed in rats and mice at doses up to 300 and 150 mg/kg/day bupropion hydrochloride, respectively. These doses are approximately 6 and 2 times the maximum recommended human dose (MRHD), respectively, on a mg/m 2 basis. In the rat study there was an increase in nodular proliferative lesions of the liver at doses of 100 to 300 mg/kg/day of bupropion hydrochloride (approximately 2 to 6 times the MRHD on a mg/m 2 basis); lower doses were not tested.

The question of whether or not such lesions may be precursors of neoplasms of the liver is currently unresolved. Similar liver lesions were not seen in the mouse study, and no increase in malignant tumors of the liver and other organs was seen in either study. Mutagenesis Bupropion produced a positive response (2 to 3 times control mutation rate) in 2 of 5 strains in one Ames bacterial mutagenicity assay, but was negative in another.

Bupropion produced an increase in chromosomal aberrations in 1 of 3 in vivo rat bone marrow cytogenetic studies. Impairment of Fertility A fertility study in rats at doses up to 300 mg/kg/day revealed no evidence of impaired fertility (approximately 6 times the MRHD on a mg/m 2 basis).

📄 Package Label / Principal Display Panel 163 words ▾

PRINCIPAL DISPLAY PANEL - 174 mg Tablet Bottle Label NDC 68682-580-30 Rx only BUPROPION HYDROBROMIDE EXTENDED-RELEASE TABLETS 174 mg WARNING: Do not use with other medicines that contain bupropion. Federal Law requires dispensing of bupropion hydrobromide with the Medication Guide attached to this bottle. ONCE DAILY 30 Tablets OCEANSIDE PHARMACEUTICALS 90017300 20005943 174mg label

PRINCIPAL DISPLAY PANEL - 348 mg Tablet Bottle Label NDC 68682-581-30 Rx only BUPROPION HYDROBROMIDE EXTENDED-RELEASE TABLETS 348 mg WARNING: Do not use with other medicines that contain bupropion. Federal Law requires dispensing of bupropion hydrobromide with the Medication Guide attached to this bottle. ONCE DAILY 30 Tablets OCEANSIDE PHARMACEUTICALS 90017400 20005941 348 mg label

PRINCIPAL DISPLAY PANEL - 522 mg Tablet Bottle Label NDC 68682-582-30 Rx only BUPROPION HYDROBROMIDE EXTENDED-RELEASE TABLETS 522 mg WARNING: Do not use with other medicines that contain bupropion. Federal Law requires dispensing of bupropion hydrobromide with the Medication Guide attached to this bottle. ONCE DAILY 30 Tablets OCEANSIDE PHARMACEUTICALS 90017500 20005940 522mg label

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

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← 68682-0581-30 · Oceanside 68682-0650-20 · Oceanside →
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