Bupropion Hydrochloride SR (Page 4 of 10)

5.7 Angle-Closure Glaucoma

The pupillary dilation that occurs following use of many antidepressant drugs including bupropion 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 tablets (SR) 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:

  • 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)]

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.

Ad v e r se 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) %

BupropionHydrochloride 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 <1 <1 2 0
Musculoskeletal
Myalgia 4 3 5 3
Arthralgia 5 3 3 2
Nervous system
Insomnia 40 28 45 18
Dream abnormality 5 18 13 3
Anxiety 8 6 9 6
Disturbed concentration 9 3 9 4
Dizziness 10 2 8 6
Nervousness 4 <1 2 2
Tremor 1 <1 2 0
Dysphoria <1 1 2 1
Respiratory
Rhinitis 12 11 9 8
Increased cough 3 5 <1 1
Pharyngitis 3 2 3 0
Sinusitis 2 2 2 1
Dyspnea 1 0 2 1
Epistaxis 2 1 1 0
Skin
Application site reactiona 11 17 15 7
Rash 4 3 3 2
Pruritus 3 1 5 1
Urticaria 2 0 2 0
Special senses
Taste perversion 3 1 3 2
Tinnitus 1 0 <1 0

a Subjects randomized to bupropion hydrochloride extended-release tablets (SR) or placebo received placebo patches.

Adverse reactions in a 1-year maintenance trial and a 12-week COPD trial with bupropion hydrochloride extended-release tablets (SR) were quantitatively and qualitatively similar to those observed in the dose-response and comparator trials.

In the trial of patients without or with a history of psychiatric disorder, the most common adverse events in subjects treated with bupropion hydrochloride extended-release tablets (SR) were broadly similar to those observed in premarketing studies. Adverse events reported in greater than 10% of subjects treated with bupropion hydrochloride extended-release tablets (SR) in the entire study population were nausea, insomnia, and anxiety disorders. Additionally, the following psychiatric adverse events were reported in greater than 2% of patients in either treatment group (bupropion hydrochloride extended-release tablets (SR) vs. placebo) by cohort. For the non-psychiatric cohort, these adverse events were anxiety, nervousness, abnormal dreams, and insomnia. For the psychiatric cohort, these adverse events were agitation, anxiety, panic, abnormal dreams, insomnia, and crying.

Other Adverse Reactions Observed during the Clinical Development of Bupropion

In addition to the adverse reactions noted above, the following adverse reactions have been reported in clinical trials with the sustained-release formulation of bupropion in depressed subjects and in nondepressed smokers, as well as in clinical trials with the immediate-release formulation of bupropion.

Adverse reaction frequencies represent the proportion of subjects who experienced a treatment-emergent adverse reaction on at least one occasion in placebo-controlled trials for depression (n = 987) or smoking cessation (n = 1,013), or subjects who experienced an adverse reaction requiring discontinuation of treatment in an open-label surveillance trial with bupropion sustained-release tablets (n = 3,100). All treatment-emergent adverse reactions are included except those listed in Tables 2 and 3, those listed in other safety-related sections of the prescribing information, those subsumed under COSTART terms that are either overly general or excessively specific so as to be uninformative, those not reasonably associated with the use of the drug, and those that were not serious and occurred in fewer than 2 subjects.

Adverse reactions are further categorized by body system and listed in order of decreasing frequency according to the following definitions of frequency: Frequent adverse reactions are defined as those occurring in at least 1/100 subjects. Infrequent adverse reactions are those occurring in 1/100 to 1/1,000 subjects, while rare events are those occurring in less than 1/1,000 subjects.

Bod y (General): Frequent were asthenia, fever, and headache. Infrequent were chills, inguinal hernia, and photosensitivity. Rare was malaise.

Cardiovascular: Infrequent were flushing, migraine, postural hypotension, stroke, tachycardia, and vasodilation. Rare was syncope.

Digestive: Frequent were dyspepsia and vomiting. Infrequent were abnormal liver function, bruxism, dysphagia, gastric reflux, gingivitis, jaundice, and stomatitis.

Hemic and Lymphatic: Infrequent was ecchymosis.

M e tabolic and Nutritional: Infrequent were edema and peripheral edema.

M u sculoskeletal: Infrequent were leg cramps and twitching.

Nervous System: Frequent were agitation, depression, and irritability. Infrequent were abnormal coordination, CNS stimulation, confusion, decreased libido, decreased memory, depersonalization, emotional lability, hostility, hyperkinesia, hypertonia, hypesthesia, paresthesia, suicidal ideation, and vertigo. Rare were amnesia, ataxia, derealization, and hypomania.

Respiratory: Rare was bronchospasm.

S kin: Frequent was sweating.

Spe cial Senses: Frequent was blurred vision or diplopia. Infrequent were accommodation abnormality and dry eye.

Urogenital: Frequent was urinary frequency. Infrequent were impotence, polyuria, and urinary urgency.

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