Bupropion Hydrochloride SR 150 mg Tablet, Film Coated, Extended Release, 60-count
Other active recalls for Bupropion Hydrochloride (different manufacturers) — 3 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Aminoketone class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- Bupropion is an antidepressant primarily used to treat major depressive disorder — that's clinical depression. Depending on which formulation you're prescribed, it may also be used...
- Most people don't notice a full effect immediately — antidepressant treatment for depression typically requires several months or longer. Your dose may also be increased gradually...
- Will bupropion make me feel better right away?
- The most common ones are dry mouth, nausea, trouble sleeping, dizziness, headache, and feeling anxious or agitated — especially early on. Many of these improve as your body adjusts...
Patient education
Supplement & herbal interactions
Bupropion may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 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.
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UNII ZT934N0X4W
A naturally occurring amino acid salt used as a reducing agent and antioxidant in medications. It helps prevent ingredient breakdown and may improve product stability during storage.
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UNII 4AQJ3LG584
A synthetic blue dye combined with aluminum to create a stable colorant. It's used in medicines and supplements to add blue color or create specific shades for product identification and appearance.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII 9XZ8H6N6OH
A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
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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.
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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.
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UNII G2M7P15E5P
Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
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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.
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UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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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.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
12 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.251 | $15.08 / 60 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.4128 | $24.77 / 60 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.3936 | $23.62 / 60 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Bupropion Hydrochloride 150 mg 68001-0519-03 | BluePoint | 500 tablets | $0.077 | AB3 | Availability likely | save 69% |
| Bupropion Hydrochloride (XL) 150 mg 24979-0101-02 | Upsher-Smith | 500 tablets | $0.078 | — | Discontinued | save 69% |
| Bupropion hydrochloride 150 mg 63304-0723-05 | Sun | 500 tablets | $0.079 | — | Discontinued | save 69% |
| Bupropion Hydrochloride XL 150 mg 42806-0348-05 | Epic | 500 tablets | $0.079 | AB3 | Availability likely | save 69% |
| Bupropion Hydrochloride 150 mg 69097-0071-12 | Cipla | 500 tablets | $0.079 | AB3 | Availability likely | save 69% |
| Bupropion Hydrochloride XL 150 mg 00591-3331-05 | Actavis | 500 tablets | $0.079 | AB3 | Availability likely | save 69% |
| Bupropion hydrochloride 150 mg 70010-0784-03 | Granules | 30 tablets | $0.079 | AB3 | Availability likely | save 69% |
| Bupropion Hydrochloride XL 150 mg 00904-7505-04 | Major | 1 tablet | $0.079 | AB3 | Availability likely | save 69% |
| bupropion hydrochloride 150 mg 16571-0862-03 | Rising | 30 tablets | $0.079 | AB3 | Availability likely | save 69% |
| Bupropion Hydrochloride XL 150 mg 69367-0288-05 | Westminster | 500 tablets | $0.079 | AB3 | Discontinued | save 69% |
| Bupropion Hydrochloride 150 mg 31722-0487-05 | Camber | 500 tablets | $0.079 | AB3 | Availability likely | save 69% |
| Bupropion Hydrochloride XL 150 mg 42806-0414-05 | Epic | 500 tablets | $0.079 | AB3 | Availability likely | save 69% |
| Bupropion Hydrochloride 150 mg 50268-0133-13 | AvPAK | 1 tablet | $0.079 | AB3 | Availability likely | save 69% |
| Bupropion Hydrochloride (XL) 150 mg 50228-0144-05 | ScieGen | 500 tablets | $0.079 | AB3 | Availability likely | save 69% |
| Bupropion Hydrochloride XL 150 mg 68180-0319-02 | Lupin | 500 tablets | $0.079 | AB3 | Availability likely | save 69% |
| Bupropion Hydrochloride 150 mg 60687-0782-01 | American | 1 tablet | $0.079 | AB3 | Availability likely | save 69% |
| Bupropion Hydrochloride XL 150 mg 82009-0051-05 | Quallent | 500 tablets | $0.079 | AB3 | Availability likely | save 69% |
| Bupropion Hydrochloride (XL) 150 mg 83301-0024-01 | Mullan | 30 tablets | $0.079 | AB3 | Availability likely | save 69% |
| Bupropion Hydrochloride 150 mg 16729-0443-10 | Accord | 30 tablets | $0.079 | AB3 | Availability likely | save 69% |
| Bupropion Hydrochloride XL 150 mg 70436-0010-02 | Slate | 500 tablets | $0.079 | AB3 | Availability likely | save 69% |
| Bupropion Hydrochloride 150 mg 42806-0415-01 | Epic | 100 tablets | $0.082 | AB1 | Availability likely | save 67% |
| Bupropion Hydrochloride 150 mg 59651-0847-01 | Aurobindo | 100 tablets | $0.082 | AB1 | Availability likely | save 67% |
| Bupropion Hydrochloride SR 150 mg 00591-3541-05 | Actavis | 500 tablets | $0.082 | AB1 | Availability likely | save 67% |
| Bupropion hydrochloride 150 mg 31722-0067-01 | Camber | 100 tablets | $0.082 | AB1 | Availability likely | save 67% |
| Bupropion Hydrochloride SR 150 mg 42806-0425-01 | Epic | 100 tablets | $0.082 | AB1 | Availability likely | save 67% |
| BuPROPion Hydrochloride 150 mg 68084-0708-25 | American | 1 tablet | $0.082 | AB1 | Availability likely | save 67% |
| bupropion hydrochloride SR 150 mg 00904-7465-61 | Major | 1 tablet | $0.082 | AB1 | Availability likely | save 67% |
| Bupropion Hydrochloride SR 150 mg 50228-0175-01 | ScieGen | 100 tablets | $0.082 | AB1 | Availability likely | save 67% |
| Bupropion Hydrochloride SR 150 mg 43598-0752-01 | Dr. | 100 tablets | $0.082 | AB1 | Availability likely | save 67% |
| Bupropion Hydrochloride SR 150 mg 70436-0059-01 | Slate | 100 tablets | $0.084 | AB1 | FDA listed | save 67% |
| Bupropion Hydrochloride (XL) 150 mg 43598-0655-05 | Dr | 500 tablets | $0.108 | AB3 | FDA listed | save 57% |
| Bupropion Hydrochloride (XL) 150 mg 69097-0875-02 | CIPLA | 30 tablets | $0.119 | — | FDA listed | save 52% |
| Bupropion hydrochloride (XL) 150 mg 00527-2415-32 | Lannett | 30 tablets | $0.119 | AB3 | FDA listed | save 52% |
| bupropion hydrochloride 150 mg 00591-3543-60 | Actavis | 60 tablets | $0.251 | — | Availability likely | — |
| Bupropion Hydrochloride SR 150 mgthis 42806-0413-60 | Epic | 60 tablets | $0.251 | AB2 | Availability likely | — |
| Bupropion Hydrochloride (Sr) 150 mg 43598-0863-10 | Dr. | 1000 tablets | — | AB2 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 50090-1150-00 | A-S | 60 tablets | — | AB2 | FDA listed | — |
| Bupropion Hydrochloride (Sr) 150 mg 50090-5101-00 | A-S | 60 tablets | — | AB2 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 50090-7322-00 | A-S | 60 tablets | — | AB2 | Discontinued | — |
| Bupropion Hydrochloride (SR) 150 mg 50228-0338-11 | ScieGen | 1000 tablets | — | AB2 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 47335-0954-13 | Sun | 500 tablets | — | — | FDA listed | — |
| Bupropion hydrochloride 150 mg 63187-0052-30 | Proficient | 30 tablets | — | — | FDA listed | — |
| Bupropion Hydrochloride 150 mg 63187-0713-30 | Proficient | 30 tablets | — | — | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 63187-0726-30 | Proficient | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride (Sr) 150 mg 69097-0878-02 | Cipla | 30 tablets | — | — | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 71205-0291-30 | Proficient | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 71205-0394-30 | Proficient | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 71205-0504-30 | Proficient | 30 tablets | — | AB3 | FDA listed | — |
| bupropion 150 mg 71205-0565-30 | Proficient | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride (XL) 150 mg 71205-0967-30 | Proficient | 30 tablets | — | — | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 71610-0576-30 | Aphena | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 43598-0537-01 | Dr. | 100 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 50090-4049-00 | A-S | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 63187-0766-30 | Proficient | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride (XL) 150 mg 76282-0480-05 | Exelan | 500 tablets | — | — | FDA listed | — |
| Bupropion hydrochloride 150 mg 80425-0300-01 | Advanced | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 82804-0080-30 | Proficient | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride (XL) 150 mg 82868-0097-96 | Northwind | 180 tablets | — | AB3 | FDA listed | — |
| Wellbutrin Xl 150 mg 00187-0730-07 | Bausch | 7 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 50090-5163-00 | A-S | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride (XL) 150 mg 50090-7110-00 | A-S | 90 tablets | — | — | FDA listed | — |
| bupropion 150 mg 51655-0357-26 | Northwind | 90 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 68071-3594-03 | NuCare | 30 tablets | — | AB3 | FDA listed | — |
| bupropion hydrochloride 150 mg 70518-4674-00 | REMEDYREPACK | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 71335-2378-01 | Bryant | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 50090-4747-00 | A-S | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 50090-6871-00 | A-S | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 50090-7113-00 | A-S | 90 tablets | — | AB3 | Discontinued | — |
| Bupropion Hydrochloride 150 mg 50090-7712-00 | A-S | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride (XL) 150 mg 63629-8474-01 | Bryant | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion hydrochloride 150 mg 70518-4081-01 | REMEDYREPACK | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion hydrochloride 150 mg 70518-4189-00 | REMEDYREPACK | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion hydrochloride 150 mg 71335-2457-01 | Bryant | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 71610-0990-30 | Aphena | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride (XL) 150 mg 72789-0120-90 | PD-Rx | 90 tablets | — | — | Discontinued | — |
| Bupropion Hydrochloride 150 mg 72789-0301-90 | PD-Rx | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride (XL) 150 mg 77771-0144-05 | RADHA | 500 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride (XL) 150 mg 83008-0082-30 | Quality | 30 tablets | — | AB3 | FDA listed | — |
| bupropion hydrochloride SR 150 mg 55154-0183-00 | Cardinal | 1 tablet | — | AB1 | FDA listed | — |
| Bupropion hydrochloride 150 mg 68788-4010-01 | Preferred | 100 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 68788-7786-01 | Preferred | 100 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride (XL) 150 mg 70518-3963-00 | REMEDYREPACK | 30 tablets | — | AB3 | Discontinued | — |
| Bupropion Hydrochloride 150 mg 71335-1044-01 | Bryant | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 76420-0923-01 | Asclemed | 100 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride (XL) 150 mg 50090-7109-00 | A-S | 90 tablets | — | — | FDA listed | — |
| Bupropion Hydrochloride 150 mg 50090-7711-00 | A-S | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride (XL) 150 mg 68071-3927-03 | NuCare | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 68071-3932-03 | NuCare | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 68788-7807-01 | Preferred | 100 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 70010-0126-03 | Granules | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 70518-2458-00 | REMEDYREPACK | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 71335-1837-01 | Bryant | 60 tablets | — | AB1 | FDA listed | — |
| buPropion Hydrochloride XL 150 mg 72516-0035-03 | Oryza | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 80425-0461-01 | Advanced | 30 tablets | — | AB3 | FDA listed | — |
| bupropion hydrochloride SR 150 mg 43547-0289-06 | Solco | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion hydrochloride 150 mg 50090-7423-00 | A-S | 90 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 51655-0115-25 | Northwind | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 72789-0377-90 | PD-Rx | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 00615-8504-05 | NCS | 15 tablets | — | AB3 | FDA listed | — |
| Bupropion hydrochloride 150 mg 00615-8602-39 | NCS | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 00115-6811-02 | Amneal | 500 tablets | — | — | FDA listed | — |
| Bupropion Hydrochloride Sr 150 mg 43063-0744-30 | PD-Rx | 30 tablets | — | — | FDA listed | — |
| Bupropion Hydrochloride 150 mg 50090-6353-00 | A-S | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 51655-0098-26 | Northwind | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 67046-0699-03 | Coupler | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 71335-0135-01 | Bryant | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 72189-0134-30 | DIRECT | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 50090-6872-00 | A-S | 90 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 63629-8473-01 | Bryant | 500 tablets | — | AB1 | FDA listed | — |
| Bupropion hydrochloride 150 mg 68788-8769-01 | Preferred | 100 tablets | — | AB1 | FDA listed | — |
| Bupropion hydrochloride 150 mg 71335-2469-01 | Bryant | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 50090-6789-00 | A-S | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion hydrochloride (XL) 150 mg 69680-0157-30 | Vitruvias | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 70518-2022-02 | REMEDYREPACK | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 71335-1702-01 | Bryant | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 72162-1529-05 | Bryant | 500 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 43063-0913-30 | PD-Rx | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride (XL) 150 mg 72162-1526-05 | Bryant | 500 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 77771-0175-05 | Radha | 500 tablets | — | AB1 | FDA listed | — |
| Bupropion hydrochloride 150 mg 82804-0296-90 | Proficient | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 82868-0019-60 | Northwind | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion hydrochloride 150 mg 47335-0737-08 | Sun | 100 tablets | — | — | FDA listed | — |
| Bupropion Hydrochloride XL 150 mg 50090-7112-00 | A-S | 90 tablets | — | AB3 | Discontinued | — |
| Bupropion hydrochloride 150 mg 50090-7422-00 | A-S | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 68071-2890-03 | NuCare | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 68071-3559-09 | NuCare | 90 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 70518-4056-01 | REMEDYREPACK | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 71205-0550-30 | Proficient | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion hydrochloride 150 mg 67046-1273-03 | Coupler | 30 tablets | — | AB1 | FDA listed | — |
| bupropion hydrochloride 150 mg 71335-3153-01 | Bryant | 30 tablets | — | AB3 | FDA listed | — |
| Bupropion Hydrochloride 150 mg 59651-0511-05 | Aurobindo | 500 tablets | — | AB3 | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
🗺️ Medicaid utilization & spend
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 42806-0413-60 You're viewing this | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42806-413-60) | 2023-02-28 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS S UICIDALITY AND ANTIDEPRESSANT DRUGS Although bupropion hydrochloride extended-release tablets (SR) are not indicated for treatment of depression, it contains the same active ingredient as the antidepressant medications WELLBUTRIN ® , WELLBUTRIN SR ® , and WELLBUTRIN XL ® . 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 over age 24; there was a reduction in risk 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 communication with 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 ( 5.1 ) Monitor for worsening and emergence of suicidal thoughts and behaviors. ( 5.1 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Bupropion Hydrochloride Extended-Release Tablets (SR) are indicated as an aid to smoking cessation treatment. Bupropion Hydrochloride Extended-Release Tablets (SR) are an aminoketone agent indicated as an aid to smoking cessation treatment. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Starting dose: 150 mg per day for first 3 days. ( 2.1 ) General: Increase dose gradually to reduce seizure risk. ( 2.1 , 5.3 ) Begin dosing one week before quit day.
( 2.1 ) After 3 days, increase the dose to 300 mg per day, given as 150 mg twice daily at an interval of at least 8 hours. ( 2.1 ) May be used with a nicotine transdermal system. ( 2.5 ) Moderate to severe hepatic impairment: 150 mg every other day.
( 2.6 , 8.7 ) Mild hepatic impairment: Consider reducing the dose and/or frequency of dosing. ( 2.6 , 8.7 ) Renal impairment: Consider reducing the dose and/or frequency. ( 2.7 , 8.6 )
2.1Usual Dosage Treatment with bupropion hydrochloride extended-release tablets (SR) should be initiated before the patient’s planned quit day, while the patient is still smoking , because it takes approximately 1 week of treatment to achieve steady-state blood levels of bupropion. The patient should set a “target quit date” within the first 2 weeks of treatment with bupropion hydrochloride extended-release tablets (SR). Dosing To minimize the risk of seizure: Begin dosing with one 150-mg tablet per day for 3 days.
Increase dose to 300 mg per day given as one 150-mg tablet twice each day with an interval of at least 8 hours between each dose. Do not exceed 300 mg per day. Bupropion hydrochloride extended-release tablets (SR) should be swallowed whole and not crushed, divided, or chewed, as this may lead to an increased risk of adverse effects including seizures [see Warnings and Precautions ( 5.3 )] .
Bupropion hydrochloride extended-release tablets (SR) may be taken with or without food [see Clinical Pharmacology ( 12.3 )] .
2.2Duration of Treatment Treatment with bupropion hydrochloride extended-release tablets (SR) should be continued for 7 to 12 weeks. If the patient has not quit smoking after 7 to 12 weeks, it is unlikely that he or she will quit during that attempt so treatment with bupropion hydrochloride extended-release tablets (SR) should probably be discontinued and the treatment plan reassessed. The goal of therapy with bupropion hydrochloride extended-release tablets (SR) is complete abstinence.
Discuss discontinuing treatment with bupropion hydrochloride extended-release tablets (SR) after 12 weeks if the patient feels ready but consider whether the patient may benefit from ongoing treatment. Patients who successfully quit after 12 weeks of treatment but do not feel ready to discontinue treatment should be considered for ongoing therapy with bupropion hydrochloride extended-release tablets (SR); longer treatment should be guided by the relative benefits and risks for individual patients. It is important that patients continue to receive counseling and support throughout treatment with bupropion hydrochloride extended-release tablets (SR) and for a period of time thereafter.
2.3Individualization of Therapy Patients are more likely to quit smoking and remain abstinent if they are seen frequently and receive support from their physicians or other healthcare professionals. It is important to ensure that patients read the instructions provided to them and have their questions answered. Physicians should review the patient’s overall smoking cessation program that includes treatment with bupropion hydrochloride extended-release tablets (SR).
Patients should be advised of the importance of participating in the behavioral interventions, counseling, and/or support services to be used in conjunction with bupropion hydrochloride extended-release tablets (SR) [see Medication Guide] . Patients who fail to quit smoking during an attempt may benefit from interventions to improve their chances for success on subsequent attempts. Patients who are unsuccessful should be evaluated to determine why they failed.
A new quit attempt should be encouraged when factors that contributed to failure can be eliminated or reduced, and conditions are more favorable.
2.4Maintenance Tobacco dependence is a chronic condition. S…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 150 mg - purple, film coated, round, biconvex tablets, debossed with “YH” and “111” on one side and plain on the other side. Tablets: 150 mg. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Bupropion Hydrochloride Extended-Release Tablets (SR) are contraindicated in patients with a seizure disorder. Bupropion Hydrochloride Extended-Release Tablets (SR) 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 the immediate-release formulation of bupropion [see Warnings and Precautions ( 5.3 )] . Bupropion Hydrochloride Extended-Release Tablets (SR) are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7.3 )] .
The use of MAOIs (intended to treat psychiatric disorders) concomitantly with Bupropion Hydrochloride Extended-Release Tablets (SR) or within 14 days of discontinuing treatment with Bupropion Hydrochloride Extended-Release Tablets (SR) is contraindicated. There is an increased risk of hypertensive reactions when Bupropion Hydrochloride Extended-Release Tablets (SR) are used concomitantly with MAOIs. The use of Bupropion Hydrochloride Extended-Release Tablets (SR) within 14 days of discontinuing treatment with an MAOI is also contraindicated.
Starting Bupropion Hydrochloride Extended-Release Tablets (SR) in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated [see Dosage and Administration ( 2.8 ), Warnings and Precautions ( 5.4 ), Drug Interactions ( 7.6 )] . Bupropion Hydrochloride Extended-Release Tablets (SR) are contraindicated in patients with a known hypersensitivity to bupropion or other ingredients of Bupropion Hydrochloride Extended-Release Tablets (SR). 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 Hydrochloride Extended-Release Tablets (SR) or within 14 days of stopping treatment with Bupropion Hydrochloride Extended-Release Tablets (SR). Do not use Bupropion Hydrochloride Extended-Release Tablets (SR) within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start Bupropion Hydrochloride Extended-Release Tablets (SR) 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 Hydrochloride Extended-Release Tablets (SR). ( 4 , 5.8 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Neuropsychiatric adverse events: 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 hydrochloride extended-release tablets (SR) for the occurrence of such symptoms and instruct them to discontinue bupropion hydrochloride extended-release tablets (SR) and contact a healthcare provider if they experience such adverse events.
( 5.2 ) Seizure risk: The risk is dose-related. Can minimize risk by gradually increasing the dose and limiting daily dose to 300 mg. Discontinue if seizure occurs.
( 4 , 5.3 , 7.3 ) Hypertension: Bupropion hydrochloride extended-release tablets (SR) can increase blood pressure. Monitor blood pressure before initiating treatment and periodically during treatment, especially if used with nicotine replacement. ( 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 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 Although bupropion hydrochloride extended-release tablets (SR) are not indicated for treatment of depression, it contains the same active ingredient as the antidepressant medications WELLBUTRIN ® , WELLBUTRIN SR ® , and WELLBUTRIN XL ® . Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. 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 MDD and other psychiatric disorders.
Short-term clinical trials did not show an increase in the risk of suicidality with antidepressants compared with placebo in adults beyond age 24; there was a reduction with antidepressants compared with 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 subjects. 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 subjects.
There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger subjects 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 differe…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Suicidal thoughts and behaviors in adolescents and young adults [see Boxed Warning, W arnings 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 reactions [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 (incidence ≥5% and ≥1% more than placebo rate) are insomnia, rhinitis, dry mouth, dizziness, nervous disturbance, anxiety, nausea, constipation, and arthralgia.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Epic Pharma, LLC at 1-888-374-2791 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 with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse Reactions Leading to Discontinuation of Treatment Adverse reactions were sufficiently troublesome to cause discontinuation of treatment in 8% of the 706 subjects treated with bupropion hydrochloride extended-release tablets (SR) and 5% of the 313 patients treated with placebo.
The more common events leading to discontinuation of treatment with bupropion hydrochloride extended-release tablets (SR) included nervous system disturbances (3.4%), primarily tremors, and skin disorders (2.4%), primarily rashes. Commonly Observed Adverse Reactions The most commonly observed adverse reactions consistently associated with the use of bupropion hydrochloride extended-release tablets (SR) were dry mouth and insomnia. The incidence of dry mouth and insomnia may be related to the dose of bupropion hydrochloride extended-release tablets (SR).
The occurrence of these adverse reactions may be minimized by reducing the dose of bupropion hydrochloride extended-release tablets (SR). In addition, insomnia may be minimized by avoiding bedtime doses. Adverse reactions reported in the dose-response and comparator trials are presented in Table 2 and Table 3, respectively.
Reported adverse reactions were classified using a COSTART-based dictionary. Table 2. Adverse Reactions Reported by at Least 1% of Subjects and at a Greater Frequency than Placebo in the Dose-Response Trial Adverse Reaction Bupropion Hydrochloride Extended-Release Tablets (SR) 100 to 300 mg/day ( n=461) % P lacebo ( n=150) % Body (General) Neck pain 2 <1 Allergic reaction 1 0 Cardiovascular Hot flashes 1 0 Hypertension 1 <1 Digestive Dry mouth 11 5 Increased appetite 2 <1 Anorexia 1 <1 Musculoskeletal Arthralgia 4 3 Myalgia 2 1 Nervous system Insomnia 31 21 Dizziness 8 7 Tremor 2 1 Somnolence 2 1 Thinking abnormality 1 0 Respiratory Bronchitis 2 0 Skin Pruritus 3 <1 Rash 3 <1 Dry skin 2 0 Urticaria 1 0 Special senses Taste perversion 2 <1 Table 3.
Adverse Reactions Reported by at Least 1% of Subjects on Active Treatment and at a Greater Frequency than Placebo in the Comparator Trial Adverse Experience (COSTART Term) Bupropion Hydrochloride Extended-Release Tablets (SR) 300 mg/day ( n=243) % Nicotine Transdermal System (NTS) 21 mg/day (n=243) % Bupropion Hydrochloride Extended-Release Tablets (SR) and NTS (n=244) % Placebo (n=159) % Body Abdominal pain 3 4 1 1 Accidental injury 2 2 1 1 Chest pain <1 1 3 1 Neck pain 2 1 <1 0 Facial edema <1 0 1 0 Cardiovascular Hypertension 1 <1 2 0 Palpitations 2 0 1 0 Digestive Nausea 9 7 11 4 Dry mouth 10 4 9 4 Constipation 8 4 9 3 Diarrhea 4 4 3 1 Anorexia 3 1 5 1 Mouth ulcer 2 1 1 1 Thirst…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS CYP2B6 inducers: Dose increase may be necessary if coadministered with CYP2B6 inducers (e.g., ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital and phenytoin) based on clinical response, but should not exceed the maximum recommended 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 ) Digoxin: May decrease plasma digoxin levels. Monitor digoxin levels.
( 7.2 ) Drugs that lower seizure threshold: Dose bupropion hydrochloride extended-release tablets (SR) with caution. ( 5.3 , 7.3 ) Dopaminergic drugs (levodopa and amantadine): Central nervous system (CNS) toxicity can occur when used concomitantly with bupropion hydrochloride extended-release tablets (SR). ( 7.4 ) MAOIs: Increased risk of hypertensive reactions can occur when used concomitantly with bupropion hydrochloride extended-release tablets (SR).
( 7.6 ) Drug-laboratory test interactions: Bupropion hydrochloride extended-release tablets (SR) can cause false-positive urine test results for amphetamines.( 7.8 )
7.1Potential for Other Drugs to Affect Bupropion Hydrochloride Extended-Release Tablets (SR) Bupropion is primarily metabolized to hydroxybupropion by CYP2B6. Therefore, the potential exists for drug interactions between bupropion hydrochloride extended-release tablets (SR) and drugs that are inhibitors or inducers of CYP2B6. Inhibitors of CYP2B6 Ticlopidine and Clopidogrel: Concomitant treatment with these drugs can increase bupropion exposure but decrease hydroxybupropion exposure.
Based on clinical response, dosage adjustment of bupropion hydrochloride extended-release tablets (SR) 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 hydrochloride extended-release tablets (SR) may be necessary when coadministered with ritonavir, lopinavir, or efavirenz [see Clinical Pharmacology ( 12.3 )] but should not exceed the maximum recommended dose.
Carbamazepine, Phenobarbital, Phenytoin: While not systematically studied, these drugs may induce the 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 Hydrochloride Extended-Release Tablets (SR) to Affect Other Drugs Drugs Metabolized by CYP2D6 Bupropion and its metabolites (erythrohydrobupropion, threohydrobupropion, hydroxybupropion) are CYP2D6 inhibitors. Therefore, coadministration of bupropion hydrochloride extended-release tablets (SR) 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, thioridazine), beta-blockers (e.g., metoprolol), and Type 1C antiarrhythmics (e.g., propafenone and flecainide).
When used concomitantly with bupropion hydrochloride extended-release tablets (SR), 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…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: Use only if benefit outweighs potential risk to the fetus. ( 8.1 )
8.1Pregnancy Pregnancy Category C. Risk Summary Data from epidemiological studies of pregnant women exposed to bupropion in the first trimester indicate no increased risk of congenital malformations overall. All pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss.
No clear evidence of teratogenic activity was found in reproductive developmental studies conducted in rats and rabbits; however, in rabbits, slightly increased incidences of fetal malformations and skeletal variations were observed at doses approximately 2 times the maximum recommended human dose (MRHD) and greater and decreased fetal weights were seen at doses three times the MRHD and greater. Bupropion hydrochloride extended-release tablets (SR) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Clinical Considerations Pregnant smokers should be encouraged to attempt cessation using educational and behavioral interventions before pharmacological approaches are used. 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. 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 and a case-control study (6,853 infants with cardiovascular malformations and 5,763 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 for left ventricular outflow tract obstruction (LVOTO) are inconsistent and do not allow conclusions regarding a possible association. The United Healthcare database lacked sufficient power to evaluate this association; the NBDPS found increased risk for LVOTO (n=10; adjusted OR=2.6; 95% CI: 1.2, 5.7), and the Slone Epidemiology case control study did not find increased risk for LVOTO. Study findings on bupropion exposure during the first trimester and risk for ventricular septal defect (VSD) are inconsistent and do not allow conclusions regarding a possible association.
The Slone Epidemiology Study found an increased risk for VSD following first trimester maternal bupropion exposure (n=17; adjusted OR=2.5; 95% CI: 1.3, 5.0) but did not find increased risk for any other cardiovascular malformations studied (including LVOTO as above). The NBDPS and United Healthcare database study did not find an association between first trimester maternal bupropion exposure and VSD. For the findings of LVOTO and VSD, the studies were limited by the small number of exposed cases, inconsistent findings among studies, and the potential for chance findings from multiple comparisons in case control studies.
Animal Data : In studies conducted in rats and rabbits, bupropion was administered orally during the period of organogenesis at doses of up to 450 and 150 mg per kg per day, respectively (approximately 15 and 10 times the MRHD respectively, on a mg per m 2 basis). No clear evidence of teratogenic activity was found in either species; however, in rabbits, slightly increased incidences of fetal malformations and skeletal variatio…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Category C. Risk Summary Data from epidemiological studies of pregnant women exposed to bupropion in the first trimester indicate no increased risk of congenital malformations overall. All pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss.
No clear evidence of teratogenic activity was found in reproductive developmental studies conducted in rats and rabbits; however, in rabbits, slightly increased incidences of fetal malformations and skeletal variations were observed at doses approximately 2 times the maximum recommended human dose (MRHD) and greater and decreased fetal weights were seen at doses three times the MRHD and greater. Bupropion hydrochloride extended-release tablets (SR) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Clinical Considerations Pregnant smokers should be encouraged to attempt cessation using educational and behavioral interventions before pharmacological approaches are used. 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. 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 and a case-control study (6,853 infants with cardiovascular malformations and 5,763 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 for left ventricular outflow tract obstruction (LVOTO) are inconsistent and do not allow conclusions regarding a possible association. The United Healthcare database lacked sufficient power to evaluate this association; the NBDPS found increased risk for LVOTO (n=10; adjusted OR=2.6; 95% CI: 1.2, 5.7), and the Slone Epidemiology case control study did not find increased risk for LVOTO. Study findings on bupropion exposure during the first trimester and risk for ventricular septal defect (VSD) are inconsistent and do not allow conclusions regarding a possible association.
The Slone Epidemiology Study found an increased risk for VSD following first trimester maternal bupropion exposure (n=17; adjusted OR=2.5; 95% CI: 1.3, 5.0) but did not find increased risk for any other cardiovascular malformations studied (including LVOTO as above). The NBDPS and United Healthcare database study did not find an association between first trimester maternal bupropion exposure and VSD. For the findings of LVOTO and VSD, the studies were limited by the small number of exposed cases, inconsistent findings among studies, and the potential for chance findings from multiple comparisons in case control studies.
Animal Data : In studies conducted in rats and rabbits, bupropion was administered orally during the period of organogenesis at doses of up to 450 and 150 mg per kg per day, respectively (approximately 15 and 10 times the MRHD respectively, on a mg per m 2 basis). No clear evidence of teratogenic activity was found in either species; however, in rabbits, slightly increased incidences of fetal malformations and skeletal variations were observed at the lowest dose tested (25 mg per kg per day, approximately 2 times the MRHD on a mg per…
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in the pediatric population have not been established [see Boxed Warning, Warnings and Precautions ( 5.1 )].
🧓 Geriatric Use ▾
8.5Geriatric Use Of the approximately 6,000 subjects who participated in clinical trials with bupropion sustained-release tablets (depression and smoking cessation trials), 275 were aged ≥65 years and 47 were aged ≥75 years. In addition, several hundred subjects aged ≥65 years participated in clinical trials using the immediate-release formulation of bupropion (depression trials). 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 ), Clinical Pharmacology ( 12.3 )] .
🆘 Overdosage ▾
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 (including QRS prolongation) 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. Ensure an adequate airway, oxygenation, and ventilation.
Monitor cardiac rhythm and vital signs. Induction of emesis is not recommended.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The exact mechanism by which bupropion hydrochloride extended-release tablets (SR) enhances the ability of patients to abstain from smoking is not known but is presumed to be related to noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the neuronal reuptake of norepinephrine and dopamine, and does not inhibit the reuptake of serotonin. Bupropion does not inhibit monoamine oxidase.
12.3Pharmacokinetics Bupropion is a racemic mixture. The pharmacological activity and pharmacokinetics of the individual enantiomers have not been studied. The mean elimination half-life (±SD) of bupropion after chronic dosing is 21 (±9) hours, and steady-state plasma concentrations of bupropion are reached within 8 days.
Absorption The absolute bioavailability of bupropion hydrochloride extended-release tablets (SR) in humans has not been determined because an intravenous formulation for human use is not available. However, it appears likely that only a small proportion of any orally administered dose reaches the systemic circulation intact. In rat and dog studies, the bioavailability of bupropion ranged from 5% to 20%.
In humans, following oral administration of bupropion hydrochloride extended-release tablets (SR), peak plasma concentration (C max ) of bupropion is usually achieved within 3 hours. Bupropion hydrochloride extended-release tablets (SR) can be taken with or without food. Bupropion C max and AUC were increased by 11% to 35%, and 16% to 19%, respectively, when bupropion hydrochloride extended-release tablets (SR) were administered with food to healthy volunteers in three trials.
The food effect is not considered clinically significant. Distribution In vitro tests show that bupropion is 84% bound to human plasma proteins at concentrations up to 200 mcg per 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 seen with 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 as or higher than those of bupropion. Following a single-dose administration of bupropion hydrochloride extended-release tablets (SR) in humans, C max of hydroxybupropion occurs approximately 6 hours post-dose and is approximately 10 times the peak level of the parent drug at steady state. The elimination half-life of hydroxybupropion is approximately 20 (±5) hours and its AUC at steady state is about 17 times that of bupropion.
The times to peak concentrations for the erythrohydrobupropion and threohydrobupropion metabolites are similar to that of the hydroxybupropion metabolite. However, their elimination half-lives are longer, 33 (±10) and 37 (±13) hours, respectively, and steady-state AUCs are 1.5 and 7 times that of bupropion, respectively. Bupropion and its metabolites exhibit linear k…
🧬 Mechanism of Action ▾
12.1Mechanism of Action The exact mechanism by which bupropion hydrochloride extended-release tablets (SR) enhances the ability of patients to abstain from smoking is not known but is presumed to be related to noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the neuronal reuptake of norepinephrine and dopamine, and does not inhibit the reuptake of serotonin. Bupropion does not inhibit monoamine oxidase.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Bupropion Hydrochloride Extended-Release Tablets, USP (SR), 150 mg of bupropion hydrochloride, are purple, film coated, round, biconvex tablets, debossed with “YH” and “111” on one side and plain on the other side in bottles of 60 tablets (NDC 42806-413-60). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture.
Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Keep out of the reach of children.
📋 Description ▾
11 DESCRIPTION SECTION Bupropion Hydrochloride Extended-Release Tablets, USP (SR) are a non-nicotine aid to smoking cessation. Bupropion Hydrochloride Extended-Release Tablets, USP (SR) are chemically unrelated to nicotine or other agents currently used in the treatment of nicotine addiction. Initially developed and marketed as an antidepressant (WELLBUTRIN ® [bupropion hydrochloride] tablets and WELLBUTRIN SR ® [bupropion hydrochloride] sustained-release tablets), Bupropion Hydrochloride Extended-Release Tablets, USP (SR) are also chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents.
Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2.
The molecular formula is C 13 H 18 ClNO•HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa.
The structural formula is: Bupropion Hydrochloride Extended-Release Tablets, USP (SR) are supplied for oral administration as 150-mg (purple), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, L-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc and titanium dioxide. In addition, the 150-mg tablet contains FD&C Blue No.
2 aluminum lake and FD&C Red No. 40 aluminum lake. FDA approved dissolution test specifications differ from USP. chemical-structure.jpg
💬 Information for Patients ▾
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 healthcare 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 [see Boxed Warning, Warnings and Precautions ( 5.1 )] .
Neuropsychiatric Adverse Events and Suicide Risk in Smoking Cessation Treatment 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 hydrochloride extended-release tablets (SR). Instruct patients to discontinue bupropion hydrochloride extended-release tablets (SR) and contact a healthcare professional if they experience such symptoms [see Warnings and Precautions ( 5.2 ), Adverse Reactions ( 6.2 )] .
Severe Allergic Reactions Educate patients on the symptoms of hypersensitivity and to discontinue bupropion hydrochloride extended-release tablets (SR) if they have a severe allergic reaction to bupropion hydrochloride extended-release tablets (SR). Seizure Instruct patients to discontinue bupropion hydrochloride extended-release tablets (SR) and not restart it if they experience a seizure while on treatment. Advise patients that the excessive use or abrupt discontinuation of alcohol, benzodiazepines, antiepileptic drugs, or sedatives/hypnotics can increase the risk of seizure.
Advise patients to minimize or avoid use of alcohol. Angle-Closure Glaucoma Patients should be advised that taking bupropion hydrochloride extended-release tablets (SR) 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 hydrochloride extended-release tablets (SR) contain the same active ingredient (bupropion hydrochloride) found in WELLBUTRIN ® , WELLBUTRIN SR ® , and WELLBUTRIN XL ® , which are used to treat depression and that bupropion hydrochloride extended-release tablets (SR) should not be used in conjunction with any other medications that contain bupropion (such as WELLBUTRIN ® , the immediate-release formulation; WELLBUTRIN SR ® , the sustained-release formulation; WELLBUTRIN XL ® or FORFIVO XL ® , the extended-release formulations; and APLENZIN ® , the extended-release formulation of bupropion hydrobromide).
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-acti…
💬 Medication Guide ▾
MEDICATION GUIDE MEDICATION GUIDE Bupropion Hydrochloride (bue proe' pee on hye'' droe klor' ide) Extended-Release Tablets, USP (SR) IMPORTANT: Be sure to read the three sections of this Medication Guide. The first section is about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with medicines used to quit smoking; the second section is about the risk of suicidal thoughts and actions with antidepressant medicines; and the third section is entitled “What Other Important Information Should I Know About Bupropion Hydrochloride Extended-Release Tablets (SR)?” 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.
Talk to your healthcare provider or your family member’s healthcare provider about: all risks and benefits of quit-smoking medicines. all treatment choices for quitting smoking. When you try to quit smoking, with or without bupropion hydrochloride extended-release tablets (SR), you may have symptoms that may be due to nicotine withdrawal, including: urge to smoke frustration restlessness depressed mood anger decreased heart rate trouble sleeping feeling anxious increased appetite irritability difficulty concentrating weight gain Some people have even experienced suicidal thoughts when trying to quit smoking without medication.
Sometimes quitting smoking can lead to worsening of mental health problems that you already have, such as depression. Some people have had serious side effects while taking bupropion hydrochloride extended-release tablets (SR) to help them quit smoking, including: New or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depression, suicidal thoughts or actions. Some people had these symptoms when they began taking bupropion hydrochloride extended-release tablets (SR), and others developed them after several weeks of treatment, or after stopping bupropion hydrochloride extended-release tablets (SR).
These symptoms happened more often in people who had a history of mental health problems before taking bupropion hydrochloride extended-release tablets (SR) than in people without a history of mental health problems. Stop taking bupropion hydrochloride extended-release tablets (SR) and call your healthcare provider right away if you, your family, or caregiver notices any of these symptoms. Work with your healthcare provider to decide whether you should continue to take bupropion hydrochloride extended-release tablets (SR).
In many people, these symptoms went away after stopping bupropion hydrochloride extended-release tablets (SR), but in some people symptoms continued after stopping bupropion hydrochloride extended-release tablets (SR). It is important for you to follow-up with your healthcare provider until your symptoms go away. Before taking bupropion hydrochloride extended-release tablets (SR), tell your healthcare provider if you have ever had depression or other mental health problems.
You should also tell your healthcare provider about any symptoms you had during other times you tried to quit smoking, with or without bupropion hydrochloride extended-release tablets (SR). Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions Although bupropion hydrochloride extended-release tablets (SR) are not a treatment for depression, it contains bupropion, the same active ingredient as the antidepressant medications WELLBUTRIN ® , WELLBUTRIN SR ® , and WELLBUTRIN XL ® .
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 s…