Bupropion Hydrochloride XL (Page 8 of 9)
14.2 Seasonal Affective Disorder
The efficacy of bupropion hydrochloride extended-release tablets (XL) in the prevention of seasonal major depressive episodes associated with SAD was established in 3 randomized, double-blind, placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern (as defined by DSM-IV criteria). Bupropion treatment was initiated prior to the onset of symptoms in the autumn (September to November). Treatment was discontinued following a 2 week taper that began during the first week of spring (fourth week of March), resulting in a treatment duration of approximately 4 to 6 months for the majority of patients. Patients were randomized to treatment with bupropion hydrochloride extended-release tablets (XL) or placebo. The initial bupropion dose was 150 mg once daily for 1 week, followed by up-titration to 300 mg once daily. Patients who were deemed by the investigator to be unlikely or unable to tolerate 300 mg once daily were allowed to remain on, or had their dose reduced to, 150 mg once daily. The mean bupropion doses in the 3 trials ranged from 257 mg to 280 mg per day. Approximately 59% of patients continued in the study for 3 to 6 months; 26% continued for < 3 months, 15% continued for > 6 months.
To enter the trials, patients must have had a low level of depressive symptoms, as demonstrated by a score of < 7 on the Hamilton Depression Rating Scale-17 (HAMD17) and a HAMD24 score of < 14. The primary efficacy measure was the Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorders (SIGH-SAD), which is identical to the HAMD24. The SIGH-SAD consists of the HAMD17 plus 7 items specifically assessing core symptoms of seasonal affective disorder: social withdrawal, weight gain, increased appetite, increased eating, carbohydrate craving, hypersomnia, and fatigability. The primary efficacy endpoint was the onset of a seasonal major depressive episode. The criteria for defining an episode included: 1) the investigator’s judgment that a major depressive episode had occurred or that the patient required intervention for depressive symptoms, or 2) a SIGH-SAD score of > 20 on 2 consecutive weeks. The primary analysis was a comparison of depression-free rates between the bupropion and placebo groups.
In these 3 trials, the percentage of patients who were depression-free (did not have an episode of MDD) at the end of treatment was significantly higher in the bupropion group than in the placebo group: 81.4% vs. 69.7%, 87.2% vs. 78.7%, and 84.0% vs. 69.0% for Trials 1, 2 and 3, respectively. For the 3 trials combined, the depression-free rate was 84.3% versus 72.0%, in the bupropion and placebo group, respectively.
16 HOW SUPPLIED/STORAGE AND HANDLING
Bupropion Hydrochloride Extended-Release Tablets, USP (XL) are available containing 150 mg or 300 mg of bupropion hydrochloride, USP.
The 150 mg tablets are supplied as white, round, film-coated, unscored tablets with “150 XL” imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows:
NDC 69367-288-09: bottles of 90 tablets
NDC 69367-288-05: bottles of 500 tablets
The 300 mg tablets are supplied as white, round, film-coated, unscored tablets with “300 XL” imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows:
NDC 69367-289-09: bottles of 90 tablets
NDC 69367-289-05: bottles of 500 tablets
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Bupropion hydrochloride extended-release tablets (XL) may have an odor.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Inform patients, their families, and their caregivers about the benefits and risks associated with treatment with bupropion hydrochloride extended-release tablets (XL) and counsel them in its appropriate use.
A patient Medication Guide about “Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions,” “Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions,” and “What Other Important Information Should I Know About bupropion hydrochloride extended-release tablets (XL)?” is available for bupropion hydrochloride extended-release tablets (XL). Instruct patients, their families, and their caregivers to read the Medication Guide and assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Advise patients regarding the following issues and to alert their prescriber if these occur while taking bupropion hydrochloride extended-release tablets (XL).
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 health 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 extended-release tablets (XL) 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 Hydrochloride Extended-Release Tablets and contact a healthcare professional if they experience such symptoms [see Warnings and Precautions (5.2)and Adverse Reactions (6.2)].
Severe Allergic Reactions
Educate patients on the symptoms of hypersensitivity and to discontinue bupropion hydrochloride extended-release tablets (XL) if they have a severe allergic reaction.
Seizure
Instruct patients to discontinue and not restart bupropion hydrochloride extended-release tablets (XL) if they experience a seizure while on treatment. Advise patients that the excessive use or the abrupt discontinuation of alcohol, benzodiazepines, antiepileptic drugs, or sedatives/hypnotics can increase the risk of seizure. Advise patients to minimize or avoid the use of alcohol.
Angle-Closure Glaucoma
Patients should be advised that taking bupropion hydrochloride extended-release tablets (XL) 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 extended-release tablets (XL) contains the same active ingredient (bupropion) found in ZYBAN, which is used as an aid to smoking cessation treatment, and that bupropion hydrochloride extended-release tablets (XL) should not be used in combination with ZYBAN or any other medications that contain bupropion hydrochloride (such as Bupropion Hydrochloride Tablets SR, the sustained-release formulation, Bupropion Hydrochloride Tablets, the immediate-release formulation, and APLENZIN, a bupropion hydrobromide formulation). 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 extended-release tablets (XL) 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 extended-release tablets (XL) do not adversely affect their performance, they should refrain from driving an automobile or operating complex, hazardous machinery. Bupropion hydrochloride extended-release tablets (XL) treatment 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 extended-release tablets (XL) and other drugs may affect each other’s metabolism.
Pregnancy
Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy with bupropion hydrochloride extended-release tablets (XL). Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to bupropion hydrochloride extended-release tablets (XL) during pregnancy [see Use in Specific Populations (8.1)].
Administration Information
Instruct patients to swallow bupropion hydrochloride extended-release tablets (XL) whole so that the release rate is not altered. 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 extended-release tablets (XL) should be swallowed whole and not crushed, divided, or chewed. Bupropion hydrochloride extended-release tablets (XL) should be administered in the morning and may be taken with or without food.
All product/brand names are the trademarks of their respective owners.
Manufactured by:
CSPC Ouyi Pharmaceutical Co., Ltd.
Shijiazhuang, Hebei, China, 052160
Distributed by:
Westminster Pharmaceuticals, LLC
Nashville, TN 37217
Rev. 04/2023
| MEDICATION GUIDE
BUPROPION HYDROCHLORIDE Extended-Release Tablets, USP (XL) (bue proe’ pee on hye” droe klor’ ide) |
| IMPORTANT: Be sure to read the three sections of this Medication Guide. The first section is about the risk of suicidal thoughts and actions with antidepressant medicines; the second section is about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with medicines used to quit smoking; and the third section is entitled “What Other Important Information Should I Know About Bupropion Hydrochloride Extended-Release Tablets (XL)?” |
| Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions This section of the Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? 1. Antidepressant medicines may increase the risk of suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment. 2. Depression or other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. 3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
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| Call your healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:
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What else do I need to know about antidepressant medicines?
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| Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions This section of the Medication Guide is only about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with drugs used to quit smoking. Although bupropion hydrochloride extended-release tablets (XL) are not a treatment for quitting smoking, it contains the same active ingredient (bupropion hydrochloride) as ZYBAN® which is used to help patients quit smoking. Talk to your healthcare provider or your family member’s healthcare provider about:
When you try to quit smoking, with or without bupropion you may have symptoms that may be due to nicotine withdrawal, including:
Some people have even experienced suicidal thoughts when trying to quit smoking without medication. Sometimes quitting smoking can lead to worsening of mental health problems that you already have, such as depression. Some people have had serious side effects while taking bupropion to help them quit smoking, including: New or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depression, or suicidal thoughts or actions. Some people had these symptoms when they began taking bupropion, and others developed them after several weeks of treatment, or after stopping bupropion. These symptoms happened more often in people who had a history of mental health problems before taking bupropion than in people without a history of mental health problems. Stop taking bupropion hydrochloride extended-release tablets (XL) and call your healthcare provider right away if you, your family, or caregiver notice any of these symptoms. Work with your healthcare provider to decide whether you should continue to take bupropion hydrochloride extended-release tablets (XL). In many people, these symptoms went away after stopping bupropion hydrochloride extended-release tablets (XL), but in some people symptoms continued after stopping bupropion hydrochloride extended-release tablets (XL). It is important for you to follow-up with your healthcare provider until your symptoms go away. Before taking bupropion hydrochloride extended-release tablets (XL) , tell your healthcare provider if you have ever had depression or other mental health problems. You should also tell your healthcare provider about any symptoms you had during other times you tried to quit smoking, with or without bupropion. |
| What Other Important Information Should I Know About Bupropion Hydrochloride Extended-Release Tablets (XL)?
○ with certain medical problems. ○ who take certain medicines. The chance of having seizures increases with higher doses of bupropion hydrochloride extended-release tablets (XL). For more information, see the sections “Who should not take bupropion hydrochloride extended-release tablets (XL)?” and “What should I tell my healthcare provider before taking bupropion hydrochloride extended-release tablets (XL)?” Tell your healthcare provider about all of your medical conditions and all the medicines you take. Do not take any other medicines while you are taking bupropion hydrochloride extended-release tablets (XL) unless your healthcare provider has said it is okay to take them. If you have a seizure while taking bupropion hydrochloride extended-release tablets (XL), stop taking the tablets and call your healthcare provider right away. Do not take bupropion hydrochloride extended-release tablets (XL) again if you have a seizure.
○ Greatly increased energy ○ Severe trouble sleeping ○ Racing thoughts ○ Reckless behavior ○ Unusually grand ideas ○ Excessive happiness or irritability ○ Talking more of faster than usual If you have any of the above symptoms of mania, call your healthcare provider.
○ eye pain ○ changes in vision ○ swelling or redness in or around the eye Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.
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| What is bupropion hydrochloride extended-release tablets (XL)? Bupropion Hydrochloride Extended-Release Tablets is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder and for the prevention of autumn-winter seasonal depression (seasonal affective disorder). |
| Who should not take bupropion hydrochloride extended-release tablets (XL)? Do not take bupropion hydrochloride extended-release tablets (XL) if you:
○ do not take an MAOI within 2 weeks of stopping bupropion hydrochloride extended-release tablets (XL) unless directed to do so by your healthcare provider. ○ do not start bupropion hydrochloride extended-release tablets (XL) if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider.
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| What should I tell my healthcare provider before taking bupropion hydrochloride extended-release tablets (XL)? Tell your healthcare provider if you have ever had depression, suicidal thoughts or actions, or other mental health problems. You should also tell your healthcare provider about any symptoms you had during other times you tried to quit smoking, with or without bupropion hydrochloride extended-release tablets (XL). See “Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions.”
○ have liver problems, especially cirrhosis of the liver. ○ have kidney problems. ○ have, or have had, an eating disorder such as anorexia nervosa or bulimia. ○ have had a head injury. ○ have had a seizure (convulsion, fit). ○ have a tumor in your nervous system (brain or spine). ○ have had a heart attack, heart problems, or high blood pressure. ○ are a diabetic taking insulin or other medicines to control your blood sugar. ○ drink alcohol. ○ abuse prescription medicines or street drugs. ○ are pregnant or plan to become pregnant. Talk to your healthcare provider about the risk to your unborn baby if you take bupropion hydrochloride extended-release tablets (XL) during pregnancy. ○ Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with bupropion hydrochloride extended-release tablets (XL). ○ If you become pregnant during treatment with bupropion hydrochloride extended-release tablets (XL), talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-844-405-6185. ○ are breastfeeding or plan to breastfeed during treatment with bupropion hydrochloride extended-release tablets (XL). Bupropion hydrochloride extended-release tablets (XL) passes into your milk. Talk to your healthcare provider about the best way to feed your baby during treatment with bupropion hydrochloride extended-release tablets (XL). Tell your healthcare provider about all the medicines you take, including prescription, over-the-counter medicines, vitamins, and herbal supplements. Many medicines increase your chances of having seizures or other serious side effects if you take them while you are taking bupropion hydrochloride extended-release tablets (XL). |
| How should I take Bupropion Hydrochloride Extended-Release Tablets ?
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| What should I avoid while taking bupropion hydrochloride extended-release tablets (XL)?
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| What are possible side effects of bupropion hydrochloride extended-release tablets (XL)? Bupropion hydrochloride extended-release tablets (XL) can cause serious side effects. See the sections at the beginning of this Medication Guide for information about serious side effects of bupropion hydrochloride extended-release tablets (XL). The most common side effects of bupropion hydrochloride extended-release tablets (XL) include:
If you have trouble sleeping, do not take bupropion hydrochloride extended-release tablets (XL) too close to bedtime. Tell your healthcare provider right away about any side effects that bother you. These are not all the possible side effects of bupropion hydrochloride extended-release tablets (XL). For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Westminster Pharmaceuticals, LLC at 1-844-221-7294. |
| How should I store bupropion hydrochloride extended-release tablets (XL)? Store bupropion hydrochloride extended-release tablets (XL) at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep bupropion hydrochloride extended-release tablets (XL) and all medicines out of the reach of children. |
General information about the safe and effective use of bupropion hydrochloride extended-release tablets (XL) Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use bupropion hydrochloride extended-release tablets (XL) for a condition for which it was not prescribed. Do not give bupropion hydrochloride extended-release tablets (XL) to other people, even if they have the same symptoms you have. It may harm them. If you take a urine drug screening test, bupropion hydrochloride extended-release tablets (XL) may make the test result positive for amphetamines. If you tell the person giving you the drug screening test that you are taking bupropion hydrochloride extended-release tablets (XL), they can do a more specific drug screening test that should not have this problem. This Medication Guide summarizes important information about bupropion hydrochloride extended-release tablets (XL). If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about bupropion hydrochloride extended-release tablets (XL) that is written for health professionals. |
| What are the ingredients in bupropion hydrochloride extended-release tablets (XL)? Active ingredient: bupropion hydrochloride Inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, glyceryl behenate, ethyl cellulose, methacrylic acid copolymer, silicon dioxide and copovidone, The tablets are printed with edible black ink. All other product/brand names are the trademarks of their respective owners. Manufactured by: CSPC Ouyi Pharmaceutical Co., Ltd. Shijiazhuang, Hebei, China, 052160 Made in China Distributed by: Westminster Pharmaceuticals, LLC Nashville, TN 37217 Rev. 04/2023 |
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