BUPROPION HCI
EXTENDED-RELEASE TABLETS USP (SR)
PRODUCT DETAILS
- Strength: Available in 100 mg, 150 mg and 200 mg tablets
- Therapeutic Class: Antidepressant
NDC Numbers:
100 mg | Bottle of 100: 70436-058-01
100 mg | Bottle of 500: 70436-058-02
150 mg | Bottle of 100: 70436-059-01
150 mg | Bottle of 250: 70436-059-22
150 mg | Bottle of 500: 70436-059-02
200 mg | Bottle of 100: 70436-060-01
Available through your wholesaler:
NDC: 70436-058-01
Cardinal Health: 5673413
McKesson: 1570027
Amerisource: 10249744
NDC: 70436-058-02
Cardinal Health: 5673421
McKesson: 1570035
Amerisource: 10249713
NDC: 70436-059-01
Cardinal Health: 5673439
McKesson: 1570043
Amerisource: 10249742
NDC: 70436-059-22
Cardinal Health: 5687926
McKesson: 1584648
Amerisource: 10252107
NDC: 70436-059-02
Cardinal Health: 5673447
McKesson: 1570050
Amerisource: 10249743
NDC: 70436-060-01
Cardinal Health: 5673454
McKesson: 1570068
Amerisource: 10249745
| Strength | NDC | Package Size |
|---|---|---|
| 100 mg | 70436-058-01 | Bottle of 100 |
| 100 mg | 70436-058-02 | Bottle of 500 |
| 150 mg | 70436-059-01 | Bottle of 100 |
| 150 mg | 70436-059-22 | Bottle of 250 |
| 150 mg | 70436-059-02 | Bottle of 500 |
| 200 mg | 70436-060-01 | Bottle of 100 |
100 mg – light blue, film coated, round, biconvex tablets, debossed with “YH” and “133” on one side and plain on the other side.
150 mg – purple, film coated, round, biconvex tablets, debossed with “YH” and “177” on one side and plain on the other side.
200 mg – pink, film coated, round, biconvex tablets, debossed with “YH” and “132” on one side and plain on the other side.
Store at 20° to 25°C (68° to 77°F). Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.
IMPORTANT SAFETY INFORMATION FOR: BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR)
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
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 reduction in risk with antidepressant use in subjects aged 65 and older.
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.
Bupropion Hydrochloride Extended-Release Tablets (SR) are contraindicated in:
- Patients with seizure
- Patients with a current or prior diagnosis of bulimia or anorexia nervosa
- Patients undergoing discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic
- The use of Monoamine Oxidase Inhibitors (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. 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 methylene blue is
- Patients with known hypersensitivity to bupropion or other ingredients in Bupropion Hydrochloride Extended-Release Tablets (SR). Anaphylactoid/anaphylactic reaction and Stevens-Johnson syndrome has been
Bupropion Hydrochloride Extended-Release Tablets (SR) are not approved for smoking cessation treatment; however, it contains the same active ingredient as the smoking cessation medication ZYBAN. Serious neuropsychiatric adverse events have been reported in patients taking bupropion for smoking cessation including changes in mood (including depression and mania), psychosis, hallucination, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide.
Bupropion Hydrochloride Extended-Release Tablets (SR) can cause seizure. The risk of seizures is dose-related. The dose should not exceed 400 mg/day. The dose should be increased gradually and Bupropion Hydrochloride Extended-Release Tablets (SR) should be discontinued if a patient experiences a seizure.
Treatment with Bupropion Hydrochloride Extended-Release Tablets (SR) can result in elevated blood pressure. Blood pressure should be evaluated at initial time of treatment and periodically during treatment.
The most common adverse reactions (incidence ≥ 5% and ≥ 2% more than placebo rate) are: headache, dry mouth, nausea, insomnia, dizziness, pharyngitis, constipation, agitation, anxiety, abdominal pain, tinnitus, tremor, palpitation, myalgia, sweating, rash, and anorexia.
Please see the package insert for Bupropion Hydrochloride Extended Release Tablets (SR) for full prescribing information.