BUPROPION HCL 75MG 100 TAB
Generic: Bupropion Hydrochloride
BUPROPION HCL 75MG 100 TAB
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Identification
Bupropion Hydrochloride
Bupropion Hydrochloride
Apotex Corp
HUMAN PRESCRIPTION DRUG
Administration
TABLET, FILM COATED
ORAL
ANDA076143
Active Ingredients
| Ingredient | Strength |
|---|---|
| BUPROPION HYDROCHLORIDE | 75 mg/1 |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Clinical Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14 )]. Bupropion hydrochloride tablets are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Starting dose: 200 mg/day given as 100 mg twice daily ( 2.1 ) General: Increase dose gradually to reduce seizure risk. ( 2.1 , 5.3) After 3 days, may increase the dose to 300 mg/day, given as 100 mg 3 times daily at an interval of at least 6 hours between doses. ( 2.1 ) Usual target dose: 300 mg/day as 100 mg 3 times daily. ( 2.1 ) Maximum dose: 450 mg/day given as 150 mg 3 times daily. ( 2.1 ) Periodically reassess the dose and need for maintenance treatment. (2.1 ) Moderate to severe hepatic impairment: 75 mg once daily. ( 2.2 , 8.7) Mild hepatic impairment: Consider reducing the dose and/or frequency of dosing. ( 2.2 , 8.7 ) Renal impairment: Consider reducing the dose and/or frequency. ( 2.3 , 8.6 ) 2.1 General Instructions for Use To minimize the risk of seizure, increase the dose gradually [see Warnings and Precautions (5.3 )] . Increases in dose should not exceed 100 mg/day in a 3-day period. Bupropion hydrochloride tablets should be swallowed whole and not crushed, divided, or chewed. Bupropion hydrochloride tablets may be taken with or without food. The recommended starting dose is 200 mg/day, given as 100 mg twice daily. After 3 days of dosing, the dose may be increased to 300 mg/day, given as 100 mg 3 times daily, with at least 6 hours between successive doses. Dosing above 300 mg/day may be accomplished using the 75- or 100-mg tablets. A maximum of 450 mg/day, given in divided doses of not more than 150 mg each, may be considered for patients who show no clinical improvement after several weeks of treatment at 300 mg/day. Administer the 100-mg tablet 4 times daily to not exceed the limit of 150 mg in a single dose. It is generally agreed that acute episodes of depression require several months or longer of antidepressant drug treatment beyond the response in the acute episode. It is unknown whether the dose of bupropion hydrochloride tablets 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. 2.2 Dose Adjustment in Patients with Hepatic Impairment In patients with moderate to severe hepatic impairment (Child-Pugh score: 7 to 15), the maximum dose of bupropion hydrochloride tablets are 75 mg/day. In patients with mild hepatic impairment (Child-Pugh score: 5 to 6), consider reducing the dose and/or frequency of dosing [see Use in Specific Populations (8.7 ), Clinical Pharmacology ( 12.3 )] . 2.3 Dose Adjustment in Patients with Renal Impairment Consider reducing the dose and/or frequency of bupropion hydrochloride tablets in patients with renal impairment (Glomerular Filtration Rate [GFR] less than 90 mL/min) [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )] . 2.4 Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Antidepressant At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with bupropion hydrochloride tablets. Conversely, at least 14 days should be allowed after stopping bupropion hydrochloride tablets before starting an MAOI antidepressant [see Contraindications ( 4 ), Drug Interactions ( 7.6 )] . 2.5 Use of Bupropion Hydrochloride Tablets with Reversible MAOIs Such as Linezolid or Methylene Blue Do not start bupropion hydrochloride tablets in a patient who is being treated with a reversible MAOI such as linezolid or intravenous methylene blue. Drug interactions can increase the risk of hypertensive reactions. In a patient who requires more urgent treatment of a psychiatric condition, non-pharmacological interventions, including hospitalization, should be considered [see Contraindications ( 4 ), Drug Interactions ( 7.6 )] . In some cases, a patient already receiving therapy with bupropion hydrochloride tablets may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of hypertensive reactions in a particular patient, bupropion hydrochloride tablets should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with bupropion hydrochloride tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with bupropion hydrochloride tablets is unclear. The clinician should, nevertheless, be aware of the possibility of a drug interaction with such use [see Contraindications ( 4 ), Drug Interactions ( 7.6 )] .
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, Warnings and Precautions ( 5.1 )] Neuropsychiatric symptoms 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: agitation, dry mouth, constipation, headache/migraine, nausea/vomiting, dizziness, excessive sweating, tremor, insomnia, blurred vision, tachycardia, confusion, rash, hostility, cardiac arrhythmias, and auditory disturbance. (6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 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 Adverse reactions were sufficiently troublesome to cause discontinuation of treatment with bupropion hydrochloride tablets in approximately 10% of the 2,400 subjects and healthy volunteers who participated in clinical trials during the product’s initial development. The more common events causing discontinuation include neuropsychiatric disturbances (3%), primarily agitation and abnormalities in mental status; gastrointestinal disturbances (2.1%), primarily nausea and vomiting; neurological disturbances (1.7%), primarily seizures, headaches, and sleep disturbances; and dermatologic problems (1.4%), primarily rashes. It is important to note, however, that many of these events occurred at doses that exceed the recommended daily dose. Commonly Observed Adverse Reactions Adverse reactions commonly encountered in subjects treated with bupropion hydrochloride tablets are agitation, dry mouth, insomnia, headache/migraine, nausea/vomiting, constipation, tremor, dizziness, excessive sweating, blurred vision, tachycardia, confusion, rash, hostility, cardiac arrhythmia, and auditory disturbance. Table 2 summarizes the adverse reactions that occurred in placebo-controlled trials at an incidence of at least 1% of subjects receiving bupropion hydrochloride tablets and more frequently in these subjects than in the placebo group. Table 2. Adverse Reactions Reported by at Least 1% of Subjects and at a Greater Frequency than Placebo in Controlled Clinical Trials Adverse Reaction Bupropion Hydrochloride Tablets (n = 323) % Placebo (n = 185) % Cardiovascular Cardiac arrhythmias Dizziness Hypertension Hypotension Palpitations Syncope Tachycardia 5.3 22.3 4.3 2.5 3.7 1.2 10.8 4.3 16.2 1.6 2.2 2.2 0.5 8.6 Dermatologic Pruritus Rash 2.2 8 0 6.5 Gastrointestinal Appetite increase Constipation Dyspepsia Nausea/vomiting 3.7 26 3.1 22.9 2.2 17.3 2.2 18.9 Genitourinary Impotence Mentrual complaints Urinary frequency 3.4 4.7 2.5 3.1 1.1 2.2 Musculoskeletal Arthritis 3.1 2.7 Neurological Akathisia Cutaneous temperature disturbance Dry mouth Excessive sweating Headache/migraine Impaired sleep quality Insomnia Sedation Sensory disturbance Tremor 1.5 1.9 27.6 22.3 25.7 4 18.6 19.8 4 21.1 1.1 1.6 18.4 14.6 22.2 1.6 15.7 19.5 3.2 7.6 Neuropsychiatric Agitation Anxiety Confusion Decreased libido Delusions Euphoria Hostility 31.9 3.1 8.4 3.1 1.2 1.2 5.6 22.2 1.1 4.9 1.6 1.1 0.5 3.8 Nonspecific Fever/chills 1.2 0.5 Special senses Auditory disturbance Blurred vision Gustatory disturbance 5.3 14.6 3.1 3.2 10.3 1.1 Other Adverse Reactions Observed during the Clinical Development of Bupropion Hydrochloride Tablets The conditions and duration of exposure to bupropion hydrochloride tablets varied greatly, and a substantial proportion of the experience was gained in open and uncontrolled clinical settings. During this experience, numerous adverse events were reported; however, without appropriate controls, it is impossible to determine with certainty which events were or were not caused by bupropion hydrochloride tablets. The following enumeration is organized by organ system and describes events in terms of their relative frequency of reporting in the database. The following definitions of frequency are used: 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. Cardiovascular: Frequent was edema; infrequent were chest pain, electrocardiogram (ECG) abnormalities (premature beats and nonspecific ST-T changes), and shortness of breath/dyspnea; rare were flushing, and myocardial infarction. Dermatologic: Infrequent was alopecia. Endocrine: Infrequent was gynecomastia; rare was glycosuria. Gastrointestinal: Infrequent were dysphagia, thirst disturbance, and liver damage/jaundice; rare was intestinal perforation. Genitourinary: Frequent was nocturia; infrequent were vaginal irritation, testicular swelling, urinary tract infection, painful erection, and retarded ejaculation; rare were enuresis, and urinary incontinence. Neurological: Frequent were ataxia/incoordination, seizure, myoclonus, dyskinesia, and dystonia; infrequent were mydriasis, vertigo, and dysarthria; rare were electroencephalogram (EEG) abnormality, and impaired attention. Neuropsychiatric: Frequent were mania/hypomania, increased libido, hallucinations, decrease in sexual function, and depression; infrequent were memory impairment, depersonalization, psychosis, dysphoria, mood instability, paranoia, and formal thought disorder; rare was suicidal ideation. Oral Complaints: Frequent was stomatitis; infrequent were toothache, bruxism, gum irritation, and oral edema. Respiratory: Infrequent were bronchitis and shortness of breath/dyspnea; rare was pulmonary embolism. Special Senses: Infrequent was visual disturbance; rare was diplopia. Nonspecific: Frequent were flu-like symptoms; infrequent was nonspecific pain; rare was overdose. Altered Appetite and W eight A weight loss of greater than 5 lbs. occurred in 28% of subjects receiving bupropion hydrochloride tablets. This incidence is approximately double that seen in comparable subjects treated with tricyclics or placebo. Furthermore, while 35% of subjects receiving tricyclic antidepressants gained weight, only 9.4% of subjects treated with bupropion hydrochloride tablets did. Consequently, if weight loss is a major presenting sign of a patient’s depressive illness, the anorectic and/or weight-reducing potential of bupropion hydrochloride tablets should be considered. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of bupropion hydrochloride tablets and are not described elsewhere in the label. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Body (General) Arthralgia, myalgia, and fever with rash and other symptoms suggestive of delayed hypersensitivity. These symptoms may resemble serum sickness [see Warnings and Precautions ( 5.8 )] . Cardiovascular Hypertension (in some cases severe), orthostatic hypotension, third degree heart block, and Brugada pattern/syndrome. Endocrine Hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, hyperglycemia, hypoglycemia. Gastrointestinal Esophagitis, hepatitis. Hemic and Lymphatic Ecchymosis, leukocytosis, leukopenia, thrombocytopenia. Altered PT and/or INR, infrequently associated with hemorrhagic or thrombotic complications, were observed when bupropion was coadministered with warfarin. Musculoskeletal Muscle rigidity/fever/rhabdomyolysis, muscle weakness. Nervous System Aggression, coma, completed suicide, delirium, dream abnormalities, paranoid ideation, paresthesia, parkinsonism, restlessness, suicide attempt, unmasking of tardive dyskinesia and aseptic meningitis. Skin and Sybcutaneous Tissue Disorders Stevens-Johnson syndrome, angioedema, exfoliative dermatitis, urticaria, acute generalized exanthematous pustulosis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Special Senses Tinnitus, increased intraocular pressure.
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. Neuropsychiatric Adverse Events and Suicide Risk in Smoking Cessation Treatment Although bupropion hydrochloride 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 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 tablets if they have a severe allergic reaction. Seizure Instruct patients to discontinue and not restart bupropion hydrochloride tablets 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 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 hydrochloride tablets contains the same active ingredient (bupropion hydrochloride) found in ZYBAN ® , which is used as an aid to smoking cessation treatment, and that bupropion hydrochloride tablets should not be used in combination with ZYBAN ® or any other medications that contain bupropion (such as WELLBUTRIN SR ® , the sustained-release formulation and 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-active drug like bupropion hydrochloride tablets may impair their ability to perform tasks requiring judgment or motor and cognitive skills. Advise patients that until they are reasonably certain that bupropion hydrochloride tablets do not adversely affect their performance, they should refrain from driving an automobile or operating complex, hazardous machinery. Bupropion hydrochloride tablets may lead to decreased alcohol tolerance. Concomitant Medications Counsel patients to notify their healthcare provider if they are taking or plan to take any prescription or over-the-counter drugs because bupropion hydrochloride tablets and other drugs may affect each others’ metabolisms. Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy with bupropion hydrochloride tablets. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to bupropion hydrochloride tablets during pregnancy [see Use in Specific Populations ( 8.1 )]. Storage Information Instruct patients to store bupropion hydrochloride tablets at room temperature, between 68°F and 77°F (20°C to 25°C) and keep the tablets dry and out of the light. Administration Information Instruct patients to take bupropion hydrochloride tablets in equally divided doses 3 or 4 times a day, with doses separated by at least 6 hours to minimize the risk of seizure. Instruct patients if they miss a dose, not to take an extra tablet to make up for the missed dose and to take the next tablet at the regular time because of the dose-related risk of seizure. Instruct patients that bupropion hydrochloride tablets should be swallowed whole and not crushed, divided, or chewed. Bupropion hydrochloride tablets can be taken with or without food. All registered trademarks in this document are the property of their respective owners. APOTEX INC. BUPROPION HYDROCHLORIDE TABLETS, USP 75 mg and 100 mg Manufactured by Manufactured for Apotex Inc. Apotex Corp. Toronto, Ontario Weston, Florida Canada M9L 1T9 USA 33326 Rev. 23
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.