Bupropion (Page 3 of 11)

Incidence of Seizure with Bupropion Use

When Bupropion Hydrochloride Extended-release (SR) tablets are dosed up to 300 mg/day, the incidence of seizure is approximately 0.1% (1/1,000) and increases to approximately 0.4% (4/1,000) at the maximum recommended dose of 400 mg/day.

The risk of seizure can be reduced if the dose of Bupropion Hydrochloride Extended-release (SR) tablets does not exceed 400 mg/day, given as 200 mg twice daily, and the titration rate is gradual.

5.4 Hypertension

Treatment with Bupropion Hydrochloride Extended-release (SR) tablets can result in elevated blood pressure and hypertension. Assess blood pressure before initiating treatment with Bupropion Hydrochloride Extended-release (SR) tablets and monitor periodically during treatment. The risk of hypertension is increased if Bupropion Hydrochloride Extended-release (SR) tablets are used concomitantly with MAOIs or other drugs that increase dopaminergic or noradrenergic activity [see Contraindications (4)].

Data from a comparative trial of the sustained-release formulation of bupropion HCl, nicotine transdermal system (NTS), the combination of sustained-release bupropion plus NTS, and placebo as an aid to smoking cessation suggest a higher incidence of treatment-emergent hypertension in patients treated with the combination of sustained-release bupropion and NTS. In this trial, 6.1% of subjects treated with the combination of sustained-release bupropion and NTS had treatment-emergent hypertension compared with 2.5%, 1.6%, and 3.1% of subjects treated with sustained-release bupropion, NTS, and placebo, respectively. The majority of these subjects had evidence of pre-existing hypertension. Three subjects (1.2%) treated with the combination of sustained-release bupropion and NTS and 1 subject (0.4%) treated with NTS had study medication discontinued due to hypertension compared with none of the subjects treated with sustained-release bupropion or placebo. Monitoring of blood pressure is recommended in patients who receive the combination of bupropion and nicotine replacement.

In a clinical trial of bupropion immediate-release in MDD subjects with stable congestive heart failure (N = 36), bupropion was associated with an exacerbation of pre-existing hypertension in 2 subjects, leading to discontinuation of bupropion treatment. There are no controlled trials assessing the safety of bupropion in patients with a recent history of myocardial infarction or unstable cardiac disease.

5.5 Activation of Mania/Hypomania

Antidepressant treatment can precipitate a manic, mixed, or hypomanic manic episode. The risk appears to be increased in patients with bipolar disorder or who have risk factors for bipolar disorder. Prior to initiating Bupropion Hydrochloride Extended-release (SR) tablets, screen patients for a history of bipolar disorder and the presence of risk factors for bipolar disorder (e.g., family history of bipolar disorder, suicide, or depression). Bupropion Hydrochloride Extended-release (SR) tablets are not approved for use in treating bipolar depression.

5.6 Psychosis and Other Neuropsychiatric Reactions

Depressed patients treated with Bupropion Hydrochloride Extended-release (SR) tablets have had a variety of neuropsychiatric signs and symptoms, including delusions, hallucinations, psychosis, concentration disturbance, paranoia, and confusion. Some of these patients had a diagnosis of bipolar disorder. In some cases, these symptoms abated upon dose reduction and/or withdrawal of treatment. Instruct patients to contact a healthcare professional if such reactions occur.

5.7 Angle-Closure Glaucoma

The pupillary dilation that occurs following use of many antidepressant drugs including Bupropion Hydrochloride Extended-release (SR) tablets may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

5.8 Hypersensitivity Reactions

Anaphylactoid/anaphylactic reactions have occurred during clinical trials with bupropion. Reactions have been characterized by pruritus, urticaria, angioedema, and dyspnea requiring medical treatment. In addition, there have been rare, spontaneous postmarketing reports of erythema multiforme, Stevens-Johnson syndrome, and anaphylactic shock associated with bupropion. Instruct patients to discontinue Bupropion Hydrochloride Extended-release (SR) tablets and consult a healthcare provider if they develop an allergic or anaphylactoid/anaphylactic reaction (e.g., skin rash, pruritus, hives, chest pain, edema, and shortness of breath) during treatment.

There are reports of arthralgia, myalgia, fever with rash, and other serum sickness-like symptoms suggestive of delayed hypersensitivity.

6 ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

6.1 Clinical 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

In placebo-controlled clinical trials, 4%, 9%, and 11% of the placebo, 300-mg/day, and 400-mg/day groups, respectively, discontinued treatment due to 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 2.

Table 2. Treatment Discontinuations Due to Adverse Reactions in Placebo-Controlled Trials
Adverse Reaction Placebo (n=385) Bupropion Hydrochloride Extended-release (SR) tablets 300 mg/day (n=376) Bupropion Hydrochloride Extended-release (SR) tablets 400 mg/day (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%

Commonly Observed Adverse Reactions

Adverse reactions from Table 3 occurring in at least 5% of subjects treated with Bupropion Hydrochloride Extended-release (SR) tablets and at a rate at least twice the placebo rate are listed below for the 300- and 400-mg/day dose groups.

Bupropion Hydrochloride Extended-release (SR) tablets 300 mg/day:

Anorexia, dry mouth, rash, sweating, tinnitus, and tremor.

Bupropion Hydrochloride Extended-release (SR) tablets 400 mg/day:

Abdominal pain, agitation, anxiety, dizziness, dry mouth, insomnia, myalgia, nausea, palpitation, pharyngitis, sweating, tinnitus, and urinary frequency.

Adverse reactions reported in placebo-controlled trials are presented in Table 3. Reported adverse reactions were classified using a COSTART-based Dictionary.

Table 3. Adverse Reactions Reported by at Least 1% of Subjects and at a Greater Frequency than Placebo in Controlled Clinical Trials
*
Incidence based on the number of female subjects. — Hyphen denotes adverse events occurring in greater than 0 but less than 0.5% of subjects.

Body System/Adverse Reaction

Bupropion Hydrochloride Extended-release (SR) tablets 300 mg/day(n = 376)

Bupropion Hydrochloride Extended-release (SR) tablets 400 mg/day (n = 114)

Placebo(n = 385)

Body (General)

Headache

26%

25%

23%

Infection

8%

9%

6%

Abdominal pain

3%

9%

2%

Asthenia

2%

4%

2%

Chest pain

3%

4%

1%

Pain

2%

3%

2%

Fever

1%

2%

Cardiovascular

Palpitation

2%

6%

2%

Flushing

1%

4%

Migraine

1%

4%

1%

Hot flashes

1%

3%

1%

Digestive

Dry mouth

17%

24%

7%

Nausea

13%

18%

8%

Constipation

10%

5%

7%

Diarrhea

5%

7%

6%

Anorexia

5%

3%

2%

Vomiting

4%

2%

2%

Dysphagia

0%

2%

0%

Musculoskeletal

Myalgia

2%

6%

3%

Arthralgia

1%

4%

1%

Arthritis

0%

2%

0%

Twitch

1%

2%

Nervous system

Insomnia

11%

16%

6%

Dizziness

7%

11%

5%

Agitation

3%

9%

2%

Anxiety

5%

6%

3%

Tremor

6%

3%

1%

Nervousness

5%

3%

3%

Somnolence

2%

3%

2%

Irritability

3%

2%

2%

Memory decreased

3%

1%

Paresthesia

1%

2%

1%

Central nervous system stimulation

2%

1%

1%

Respiratory

Pharyngitis

3%

11%

2%

Sinusitis

3%

1%

2%

Increased cough

1%

2%

1%

Skin

Sweating

6%

5%

2%

Rash

5%

4%

1%

Pruritus

2%

4%

2%

Urticaria

2%

1%

0%

Special senses

Tinnitus

6%

6%

2%

Taste perversion

2%

4%

Blurred vision or diplopia

3%

2%

2%

Urogenital

Urinary frequency

2%

5%

2%

Urinary urgency

2%

0%

Vaginal hemorrhage *

0%

2%

Urinary tract infection

1%

0%

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