Bupropion 150 mg extended -release tablets*

What Bupropion is used for :

• Bupropion is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).

Do not use Bupropion :

• In patients with a seizure disorder
• In patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with the immediate-release formulation of bupropion 
• Inpatients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs 
• The use of MAOIs (intended to treat psychiatric disorders) concomitantly with bupropion or within 14 days of discontinuing treatment with bupropion is contraindicated.
• There is an increased risk of hypertensive reactions when bupropion is used concomitantly with MAOIs.
• The use of bupropion within 14 days of discontinuing treatment with an MAOI is also contraindicated.
• Starting bupropion in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated 
• In patients with known hypersensitivity to bupropion or other ingredients of bupropion.
• Anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported 

Warnings and Precautions :

• Neuropsychiatric adverse events during smoking cessation
• Seizure risk: The risk is dose-related.
• Can minimize risk by gradually increasing the dose and limiting daily dose to 400 mg.
• Discontinue if seizure occurs
• Hypertension: can increase blood pressure.
• Monitor blood pressure before initiating treatment and periodically during treatment
• Activation of mania/Hypomania: Screen patients for bipolar disorder and monitor for these symptoms
• Psychosis and other neuropsychiatric reactions: Instruct patients to contact a healthcare professional if such reactions occur
• Angle-closure glaucoma: Angle-closure glaucoma has occurred in patients with untreated 

Possible Side Effects :

• Stop using the product and seek immediate medical attention if you develop throat tightness or swelling of the eyes, face, lips or tongue, feel faint, or have difficulty breathing.
• Stop using the product if you develop hives or itching of the face or body. 

Other Medicines and Bupropion :

• CYP2B6 inducers: Dose increase may be necessary if co-administered with CYP2B6 inducers (e.g., ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital, and phenytoin) based on clinical response, but should not exceed the maximum recommended dose
• Drugs metabolized by CYP2D6: Bupropion inhibits CYP2D6 and can increase concentrations of: antidepressants (e.g., venlafaxine, nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, sertraline), antipsychotics (e.g., haloperidol, risperidone, thioridazine), beta-blockers (e.g., metoprolol), and Type 1C antiarrhythmics (e.g., propafenone, flecainide). Consider dose reduction when using with bupropion
• Digoxin: May decrease plasma digoxin levels. Monitor digoxin levels
• Drugs that lower seizure threshold: Dose with caution 
• Dopaminergic drugs (levodopa and amantadine): CNS toxicity can occur when used concomitantly with this medicine
• MAOIs: Increased risk of hypertensive reactions can occur when used concomitantly with this medicine Drug-laboratory test interactions

How to Use Bupropion :

• The usual adult target dose for BUPROPION SR is 300 mg/day, given as 150 mg twice daily.
• 
  Initiate dosing with 150 mg/day given as a single daily dose in the morning.
  
• 
  After 3 days of dosing, the dose may be increased to the 300-mg/day target dose, given as 150 mg twice daily.
  
• 
  There should be an interval of at least 8 hours between successive doses.
• A maximum of 400 mg/day, given as 200 mg twice daily, may be considered for patients in whom no clinical improvement is noted after several weeks of treatment at 300 mg/day.
• To avoid high peak concentrations of bupropion and/or its metabolites, do not exceed 200 mg in any single dose.

How to Store Bupropion  :

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton.
• The expiry date refers to the last day of that month.
• Store between 20° to 25°C. Store in the original container.
• Keep the container tightly closed.
• Do not use Bupropion if you notice any deterioration or damage to the outer packaging.
• Do not throw away any medicines via wastewater or household waste.

Dosage form and route of administration of Bupropion 150 mg, 300 mg extended release tablets should be prescribed according to therapeutic indication and disease severity of each individual patient.