Bupropion Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Depression

Bupropion hydrochloride:
Immediate-release tablets (Wellbutrin (R)):
Initial dose: 100 mg orally twice a day, increase if necessary after 3 days to 100 mg orally three times a day.
Maintenance dose: 100 mg orally three times a day
Maximum dose: 450 mg orally per day in up to 4 divided doses; single doses should not exceed 150 mg

Sustained-release tablets (Wellbutrin SR (R)):
Initial dose: 150 mg orally once a day in the morning, increase if necessary after 3 days to 150 mg orally twice a day.
Maintenance dose: 150 mg orally twice a day
Maximum dose: 200 mg orally twice a day; maximum single dose should not exceed 200 mg

Extended-release tablets (Wellbutrin XL (R)):
Initial dose: 150 mg orally once a day in the morning, increase if necessary after 4 days to 300 mg orally once a day.
Maintenance dose: 300 mg orally once a day
Maximum dose: 450 mg orally once a day

Bupropion hydrobromide:
Extended-release tablets (Aplenzin (R)):
Initial dose: 175 mg orally once a day in the morning, increase if necessary after 4 days to 348 mg orally once a day.
Maintenance dose: 348 mg orally once a day
Maximum dose: 522 mg orally once a day

Comments:
-Doses of immediate-release oral tablets should be given at least 6 hours apart.
-Doses of sustained-release oral tablets should be given at least 8 hours apart.
-Doses of extended-release oral tablets should be given at least 24 hours apart.
-Dose increases of the immediate-release tablet should not exceed 100 mg per day in a 3 day period.
-So as not to exceed the maximum single dose of 150 mg for immediate-release tablets, a dose of 100 mg orally four times a day (using the 100 mg tablet) may be administered.
-Bupropion hydrobromide (Aplenzin (R)) 174 mg oral tablet is equivalent to bupropion hydrochloride 150 mg.
-Patients should be periodically reviewed to determine the need for maintenance treatment and the appropriate dose for such treatment.

Use: Treatment of major depressive disorder

Usual Adult Dose for Seasonal Affective Disorder

Bupropion hydrochloride:
Extended-release tablets (Wellbutrin XL (R)):
Initial dose: 150 mg orally once a day in the morning, increased if necessary after 7 days to 300 mg orally once a day
Maintenance dose: 150 to 300 mg orally once a day
Maximum dose: 300 mg orally once a day

Bupropion hydrobromide:
Extended-release tablets (Aplenzin (R)):
Initial dose: 174 mg orally once a day, increased if necessary after 7 days to 348 mg orally once a day
Maintenance dose: 348 mg orally once a day
Maximum dose: 348 mg orally once a day

Comments:
-Treatment should be initiated in the autumn prior to the onset of depressive symptoms, continued through the winter season, and discontinued in early spring.
-If bupropion hydrochloride (Wellbutrin (R)) 300 mg orally per day is not tolerated, it should be reduced to 150 mg once a day.
-Patients taking bupropion hydrochloride 300 mg orally per day during the autumn-winter season should have their dose tapered to 150 mg once a day for 2 weeks prior to discontinuation.
-When discontinuing bupropion hydrobromide (Aplenzin (R)) in patients treated with 348 mg orally once a day, the dose should be reduced to 174 mg once a day prior to discontinuation.
-The timing of initiation and treatment duration for seasonal affective disorder should be individualized according to the patient's historical pattern of seasonal major depressive episodes.

Usual Adult Dose for Smoking Cessation

Bupropion hydrochloride (Zyban (R)):
Initial dose: 150 mg orally once a day for 3 days, increased to 150 mg orally twice a day
Maintenance dose: 150 mg orally twice a day
Maximum dose: Maximum total daily dose should not exceed 300 mg; maximum single dose should not exceed 150 mg
Duration: 7 to 12 weeks

Comments:
-Begin dosing one week before quit day; the target stop date should be set within the first 2 weeks of treatment, preferably in the second week.
-There should be an interval of at least 8 hours between doses.
-May be used with a nicotine transdermal system.
-If there is not effect after 12 weeks, treatment should be discontinued; longer treatment should be guided by the relative benefits and risks for the individual patient.

Renal Dose Adjustments

Consider reducing the dose and/or frequency.

Liver Dose Adjustments

Bupropion hydrochloride:
Immediate-release tablets (Wellbutrin (R)):
Mild liver dysfunction (Child-Pugh 5 to 6): Consider reducing the dose and/or frequency of dosing
Moderate to severe liver dysfunction (Child-Pugh 7 to 15): 75 mg orally once a day

Sustained-release tablets (Wellbutrin SR (R)):
Mild liver dysfunction (Child-Pugh score 5 to 6): Consider reducing the dose and/or frequency of dosing
Moderate to severe liver dysfunction (Child-Pugh score 7 to 15): 100 mg orally once a day or 150 mg orally every other day

Sustained-release tablets (Zyban(R)):
Mild liver dysfunction (Child-Pugh score 5 to 6): Consider reducing dose and/or frequency of dosing
Moderate to severe liver dysfunction (Child-Pugh score 7 to 15): 150 mg orally every other day

Extended-release tablets (Wellbutrin XL (R)):
Mild to moderate dysfunction (Child-Pugh score 5 to 6): Consider reducing the dose and/or frequency of dosing
Severe liver dysfunction (Child-Pugh score 7 to 15): 150 mg orally every other day

Bupropion hydrobromide:
Extended-release tablets (Aplenzin (R)):
Severe liver dysfunction: 174 mg orally every other day

Dose Adjustments

Dose adjustments should be made gradually to minimize the risk of seizure.

Consider reducing the dose and/or frequency in elderly patients.

Give the same total daily dose when possible when switching from immediate-release or sustained-release oral bupropion hydrochloride tablets to extended-release oral bupropion hydrochloride.

Equivalent daily doses of bupropion hydrobromide (Aplenzin (R)) and bupropion hydrochloride:
Bupropion hydrobromide 522 mg is equivalent to 450 mg bupropion hydrochloride
Bupropion hydrobromide 348 mg is equivalent to 300 mg bupropion hydrochloride
Bupropion hydrobromide 174 mg is equivalent to 150 mg bupropion hydrochloride

Precautions

US REMS: The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for bupropion (Zyban(R)). It includes a medication guide. For additional information:
http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM331982.pdf

US BOXED WARNING:
NEUROPSYCHIATRIC REACTIONS:
-Serious neuropsychiatric reactions have occurred in patients taking bupropion for smoking cessation. The majority of these reactions occurred during bupropion treatment, but some occurred in the context of discontinuing treatment. In many cases, a causal relationship to bupropion treatment is not certain, because depressed mood may be a symptom of nicotine withdrawal. However, some of these symptoms have occurred in patients taking bupropion who continued to smoke.
-The risks of bupropion should be weighed against the benefit of its use. Bupropion has been demonstrated to increase the likelihood of abstinence from smoking for as long as 6 months compared with treatment with placebo. The health benefits of quitting smoking are immediate and substantial.
-Although not all products containing the active ingredient of bupropion are approved as a smoking cessation aid, all patients taking bupropion should be observed for neuropsychiatric reactions and instructed to contact a healthcare provider if such reactions occur.
SUICIDALITY AND ANTIDEPRESSANT DRUGS:
-Although the brand Zyban (R) is not indicated for the treatment of depression, it contains the same active ingredient as the antidepressant medications Wellbutrin(R), Wellbutrin SR(R) and Wellbutrin XL(R). 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.
-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 observations and communication with the prescriber.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions

Dialysis

Data not available

Other Comments

Administration advice:
-All oral formulations should be swallowed whole and not crushed, divided, or chewed.
-Doses may be taken with or without food.

General:
-Periodically review the dose and need for maintenance treatment.
-The full antidepressant effect of this drug may not be evident for 4 weeks or longer.
-Monitoring for potential treatment-emergent elevations of blood pressure is recommended if combination therapy with nicotine transdermal system is used.
-Prophylactic treatment for seasonal affective disorder is not recommended in patients with infrequent episodes or whose seasonal depressive episodes are not associated with significant impairment.
-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. Physicians should also review the patient's overall smoking cessation program.

Monitoring:
-Cardiovascular: Hypertension
-Hepatic: Liver function
-Neurologic: Seizures
-Psychiatric: Suicidal ideation and behavior; re-emergence or worsening of symptoms of depression

Patient advice:
-If you, your family member, or caregiver notice symptoms such as agitation, hostility, depression, thoughts about suicide or dying, or changes in thinking or behavior that are out of character, contact your health provider right away.
-If you are using this medicine to help you quit smoking, only use it as part of a smoking cessation program.
-Do not drive or operate heavy machinery until you know how this drug affects you.

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