Generic Bupron SR ( Bupropion )

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Bupron SR is a sustained-release formulation of bupropion, an antidepressant used to treat major depressive disorder. It is also used to help people stop smoking, though that is a separate indication. The medication works by affecting the brain chemicals norepinephrine and dopamine, which are involved in mood and motivation.
A note on availability: Bupron SR is not approved by Health Canada and is not marketed in this country. In Canada, bupropion SR is sold under the brand name Wellbutrin SR and as generics such as Sandoz Bupropion SR. The dosing and safety information below reflects the product monographs and clinical data that apply to bupropion SR 150 mg.
The usual starting dose is 150 mg once daily in the morning. After three to four days, your doctor may raise the dose to 150 mg twice daily, with at least 8 hours between doses. The maximum daily dose is 300 mg. Do not take more than 150 mg at one time.
The administration form is sustained-release tablets containing 150 mg of bupropion hydrochloride. The tablet should be swallowed whole. Do not crush, chew, or split it, because that releases the drug too fast and increases the risk of a seizure.
Bupron SR does not work overnight. Some people notice improved energy in the first week or two, but the full antidepressant effect usually takes four to six weeks of steady dosing. Do not stop taking it just because you do not feel better in the first few days.
Alcohol should be avoided during treatment. Drinking heavily or stopping alcohol suddenly can increase the risk of seizures. If you drink regularly, talk to your doctor before starting this medication.
The most common side effects are insomnia, dry mouth, headache, nausea, and agitation.
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Common Use Bupron SR

Bupropion is an aminoketone antidepressant. It is thought to work by blocking the reuptake of norepinephrine and dopamine, which increases their availability in the brain. Unlike many antidepressants, it does not affect serotonin much, which is why it tends to cause fewer sexual side effects. Bupropion SR is approved in Canada for the treatment of major depressive disorder and for the prevention of seasonal major depressive episodes. It is also used for smoking cessation under the brand name Zyban, though the SR formulation for depression and the SR formulation for smoking cessation are not interchangeable. Bupropion is sometimes prescribed off-label for attention deficit hyperactivity disorder and for bipolar depression when combined with a mood stabilizer. It is not effective for obsessive-compulsive disorder or panic disorder, and it can actually make those conditions worse in some people.

Basic Bupron SR Information

• INN (International Nonproprietary Name): Bupropion hydrochloride
• Brand names available in Canada: Wellbutrin SR® (Bausch Health, Canada Inc.); generics include Sandoz Bupropion SR (Sandoz Canada Inc.), Apo-Bupropion SR (Apotex Inc.), Teva-Bupropion SR (Teva Canada Limited), PMS-Bupropion SR (Pharmascience Inc.), and Novo-Bupropion SR (Novopharm Limited). Bupron SR is not marketed in Canada; it is a brand available in other countries.
• ATC Code: N06AX12
• Forms and dosages: Sustained-release tablets – 150 mg. Wellbutrin XL is a different formulation available in 150 mg and 300 mg once-daily strengths.
• Manufacturers in Canada: Bausch Health, Canada Inc. (Wellbutrin SR), Sandoz Canada Inc. (Sandoz Bupropion SR), Apotex Inc. (Apo-Bupropion SR), Teva Canada Limited (Teva-Bupropion SR), Pharmascience Inc. (PMS-Bupropion SR), and Novopharm Limited (Novo-Bupropion SR). Bupron SR is manufactured by Sun Pharma for markets outside Canada.
• Registration status in Canada: Bupropion SR is approved by Health Canada under multiple DINs. Wellbutrin SR 150 mg is listed under DIN 02237825, with an original marketing date of December 3, 1997. Generic bupropion SR 150 mg is available under DINs including 02260239 (Novo-Bupropion SR) and 02313421 (PMS-Bupropion SR). Bupron SR itself is not approved by Health Canada and is not marketed in Canada.
• OTC / Rx classification: Prescription only (Rx) – not legally sold over-the-counter in Canadian pharmacies

Dosage & Direction

Take Bupron SR in the morning to reduce the chance of insomnia. If your doctor increases your dose to 150 mg twice daily, take the second dose in the late afternoon, at least 8 hours after the morning dose. Do not take it close to bedtime. Swallow the tablet whole with water. Do not chew, crush, or split it, because that releases the drug too fast and increases the risk of a seizure. You can take it with or without food. If it upsets your stomach, take it with a meal. The starting dose for depression is 150 mg once daily for about four days, then 150 mg twice daily as tolerated. The maximum daily dose is 300 mg, though some patients with severe depression may be prescribed up to 400 mg daily in divided doses under close medical supervision. For seasonal affective disorder, the usual starting dose is 150 mg once daily in the autumn, then increased to 300 mg once daily after one week if needed. If you have liver or kidney problems, your doctor will likely lower your dose or have you take it less often. Do not stop the medication suddenly without talking to your doctor. Tapering is usually not required with bupropion, but your doctor may want to monitor you for a few weeks after stopping.

Precautions

Seizures are the most serious risk with bupropion. The risk is dose-related and is higher in people who have a seizure disorder, a history of head trauma, a brain tumour, or an eating disorder. It is also higher if you drink heavily, stop alcohol or benzodiazepines abruptly, or take certain other medications. Do not take more than the prescribed dose, and do not chew or crush the tablets. If you have a seizure, stop taking the medication and get medical help right away. Bupropion can raise blood pressure. Tell your doctor if you have hypertension, and have your blood pressure checked regularly during treatment. Some people experience agitation, anxiety, or trouble sleeping, especially in the first few weeks. These effects often settle, but if they become severe or you feel like you cannot sit still, contact your doctor. Antidepressants can increase suicidal thoughts or behaviour, especially in children, adolescents, and young adults under 25, during the first weeks of treatment or after dose changes. If you or someone you care for notices worsening mood, new or increased thoughts of self-harm, or unusual behaviour changes, get help immediately. Bupropion is not recommended during pregnancy. Animal studies show a risk to the fetus, and the drug passes into breast milk. Women who could become pregnant should use effective contraception. Tell your doctor if you have diabetes, because bupropion can affect blood sugar control. It can also affect the results of urine tests for amphetamines, so tell any lab that you are taking this medication.

Contraindications

Do not take Bupron SR if you have a seizure disorder. It is also contraindicated if you have or have had bulimia or anorexia nervosa, because the risk of seizures is much higher in these conditions. Do not take it if you are undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs. Bupropion must not be used with monoamine oxidase inhibitors (MAOIs), including linezolid and intravenous methylene blue. A washout period of at least 14 days is required when switching between bupropion and an MAOI. Do not take Bupron SR if you are allergic to bupropion or any of the inactive ingredients in the tablet. The medication is not approved for use in children under 18 years of age for depression. It should not be used in patients with severe liver cirrhosis.

Possible Side Effects

More than 1 in 10 people experience insomnia and dry mouth. Headache, nausea, dizziness, agitation, anxiety, and constipation are also common. Some people notice increased sweating, tremor, or a fast heartbeat. These effects are often mild and may ease after the first few weeks, but if they bother you, talk to your doctor. Sexual side effects are less common with bupropion than with SSRIs, which is one reason it is sometimes chosen instead. Serious side effects are rare but require medical attention. Seizures, as mentioned above, are the most serious. Severe allergic reactions, including rash, hives, swelling of the face or throat, and difficulty breathing, need emergency care. Some people develop a rash, which can be a sign of a more serious skin reaction. Blurred vision, confusion, or hallucinations should be reported. Mania or hypomania can occur in people with bipolar disorder who take bupropion without a mood stabilizer. If you have bipolar disorder, tell your doctor before starting treatment. Weight loss is more common than weight gain with bupropion. If you notice significant weight loss or loss of appetite, tell your doctor.

Drug Interaction

Bupropion is metabolized by the liver enzyme CYP2B6, and it also inhibits CYP2D6. This means it can interact with a lot of medications. Do not take bupropion with MAO inhibitors, linezolid, or intravenous methylene blue, because of the risk of hypertensive crisis. Carbamazepine, phenobarbital, and phenytoin can lower bupropion levels and make it less effective. Cimetidine can raise the levels of some bupropion metabolites. Drugs metabolized by CYP2D6, including many antidepressants (such as desipramine, nortriptyline, fluoxetine, paroxetine), beta-blockers (such as metoprolol), antiarrhythmics (such as propafenone, flecainide), and antipsychotics (such as risperidone, haloperidol), can build up in your body when taken with bupropion. Your doctor may need to lower their doses. Bupropion can also affect tamoxifen, a breast cancer drug that needs CYP2D6 to work. This combination should be avoided if possible. Tell your doctor and pharmacist about every medication you take, including over-the-counter products, herbal remedies, and supplements.

Missed Dose

If you miss a dose of Bupron SR, skip it and take your next dose at the regular time. Do not take two doses at once to make up for a missed one. Taking a double dose can increase the risk of a seizure. If you miss several doses in a row, contact your doctor before restarting, because your body may need to adjust to the medication again.

Overdose

Overdose with bupropion is serious and can be life-threatening. Symptoms include seizures, hallucinations, loss of consciousness, fast or irregular heartbeat, and severe agitation. The risk of seizures is much higher after an overdose than during normal use. If you or someone else has taken too much Bupron SR, call 911 or go to the nearest emergency department immediately. Do not wait for symptoms to appear. Treatment in a hospital may include activated charcoal, intravenous fluids, and medications to control seizures. There is no specific antidote. Do not try to manage an overdose at home.

Storage

Store Bupron SR tablets at room temperature between 20 and 25 degrees Celsius (68 and 77 degrees Fahrenheit). Brief exposure to temperatures between 15 and 30 degrees Celsius (59 and 86 degrees Fahrenheit) is acceptable. Keep the container tightly closed and protect it from light and moisture. Do not store the tablets in the bathroom or near a sink. Keep out of reach of children and pets. Do not use after the expiry date on the label. Dispose of unused medication according to local guidelines.

Disclaimer

We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

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