Bupropion Hydrochloride SR (Page 8 of 9)

16 HOW SUPPLIED/STORAGE AND HANDLING

Bupropion hydrochloride extended-release tablets, USP (SR), 150 mg of bupropion hydrochloride, are purple, blackberry flavored, round, biconvex, film coated tablets, debossed with ‘SG, 175’ on one side and plain on other side in


NDC 68071-2890-3 BOTTLES OF 30

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure (as required). Protect from light and moisture.

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 extended-release tablets (SR) is 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 extended-release tablets (SR) if they have a severe allergic reaction.

Seizure
Instruct patients to discontinue and not restart bupropion hydrochloride extended-release tablets (SR) 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.

As the dose is increased during initial titration to doses above 150 mg per day, instruct patients to take bupropion hydrochloride extended-release tablets (SR) in 2 divided doses, preferably with at least 8 hours between successive doses, to minimize the risk of seizures.

Angle-Closure Glaucoma
Patients should be advised that taking bupropion hydrochloride extended-release tablets (SR) 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 (SR) contains the same active ingredient (bupropion hydrochloride) found in ZYBAN, which is used as an aid to smoking cessation treatment, and that bupropion hydrochloride extended-release tablets (SR) should not be used in combination with ZYBAN or any other medications that contain bupropion (such as WELLBUTRIN, the immediate-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 extended-release tablets (SR) 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 (SR) does not adversely affect their performance, they should refrain from driving an automobile or operating complex, hazardous machinery. Bupropion hydrochloride extended-release tablets (SR) 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 (SR) 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 extended-release tablets (SR). Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to bupropion hydrochloride extended-release tablets (SR) during pregnancy [see Use in Specific Populations ( 8.1)] .

Storage Information
Instruct patients to store bupropion hydrochloride extended-release tablets (SR) at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure (as required). Protect from light and moisture.

Administration Information
Instruct patients to swallow bupropion hydrochloride extended-release tablets (SR) whole so that the release rate is not altered. Do not chew, divide, or crush tablets; they are designed to slowly release drug in the body. When patients take more than 150 mg/day, instruct them to take bupropion hydrochloride extended-release tablets (SR) in 2 doses at least 8 hours apart, to minimize the risk of seizures. 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 (SR) may have an odor. Bupropion hydrochloride extended-release tablets (SR) can be taken with or without food.

WELLBUTRIN, WELLBUTRIN XL, and ZYBAN are registered trademarks of the GSK group of companies.

The other brands listed are the trademarks of their respective owners.

Rx Only

Manufactured by:
ScieGen Pharmaceuticals, Inc.
Hauppauge, NY 11788, USA

Rev: 3/2021

MEDICATION GUIDE

Bupropion Hydrochloride Extended-Release Tablets, USP (SR) (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, (SR)?”

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?
    • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
    • Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
    • Keep all follow-up visits with your healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

C al l 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:

• new or worse irritability

• thoughts about suicide or dying • trouble sleeping (insomnia) • attempts to commit suicide • new or worse depression • acting aggressive, being angry, or violent • new or worse anxiety • acting on dangerous impulses • feeling very agitated or restless • an extreme increase in activity and talking (mania) • panic attacks • other unusual changes in behavior or mood

What else do I need to know about antidepressant medicines?

It is not known if bupropion hydrochloride extended-release tablets (SR) are safe and effective in children under the age of 18.

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, (SR) is 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:

• urge to smoke • frustration • restlessness • depressed mood • anger • decreased heart rate • trouble sleeping • feeling anxious • increased appetite • irritability • difficulty concentrating • weight gain

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 effect 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, (SR) 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, (SR). In many people, these symptoms went away after stopping bupropion hydrochloride extended-release tablets, (SR), but in some people symptoms continued after stopping bupropion hydrochloride extended-release tablets, (SR). It is important for you to follow-up with your healthcare provider until your symptoms go away. Before taking bupropion hydrochloride extended-release tablets, (SR) 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, (SR)?

The chance of having seizures increases with higher doses of bupropion hydrochloride extended-release tablets, (SR). For more information, see the sections “Who should not take bupropion hydrochloride extended-release tablets, (SR)?” and “What should I tell my healthcare provider before taking bupropion hydrochloride extended-release tablets, (SR)?” 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 tablets, (SR) unless your healthcare provider has said it is okay to take them.

I f you have a seizure while taking bupropion hydrochloride extended-release tablets, (SR), stop taking the tablets and call your healthcare provider right away. Do not take bupropion hydrochloride extended-release tablets, (SR) again if you have a seizure.

If you have any of the above symptoms of mania, call your healthcare provider.

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.

What are bupropion hydrochloride extended-release tablets, (SR)?

Bupropion hydrochloride extended-release tablets, (SR) are a prescription medicine used to treat adults with a certain type of depression called major depressive disorder.

Who should not take bupropion hydrochloride extended-release tablets, (SR)?

D o not take bupropion hydrochloride extended-release tablets, (SR) if you:

What should I tell my healthcare provider before taking bupropion hydrochloride extended-release tablets, (SR)?

Tell your healthcare provider if you have ever had depression, suicidal thoughts or actions, or other mental health problems. See “Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions.”

T ell your healthcare provider about all the medicines you take , including prescription and 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, (SR).

How should I take bupropion hydrochloride extended-release tablets, (SR)?

What should I avoid while taking bupropion hydrochloride extended-release tablets, (SR)?

What are possible side effects of bupropion hydrochloride extended-release tablets, (SR)?

Bupropion hydrochloride extended-release tablets, (SR) 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.

The most common side effects of bupropion hydrochloride extended-release tablets, (SR) include

If you have nausea, take your medicine with food. If you have trouble sleeping, do not take your medicine 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 (SR). 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 ScieGen Pharmaceuticals, Inc. at 1-855-724-3436.

How should I store bupropion hydrochloride extended-release tablets, (SR)?

Keep bupropion hydrochloride extended-release tablets, (SR) and all medicines out of the reach of children.

General information about bupropion hydrochloride extended-release tablets, (SR).

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use bupropion hydrochloride extended-release tablets, (SR) for a condition for which it was not prescribed. Do not give bupropion hydrochloride extended-release tablets, (SR) 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, (SR) 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, (SR), 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, (SR). 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, (SR) that is written for healthcare professionals.

For more information about bupropion hydrochloride extended-release tablets, (SR), call ScieGen Pharmaceuticals, Inc. at 1-855-724-3436.

What are the ingredients in bupropion hydrochloride extended-release tablets, USP (SR)?

Active ingredient: bupropion hydrochloride USP.

Inactive ingredients: copovidone, cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. In addition, the 100 mg tablet contains FD&C Blue No. 1 Brilliant Blue FCF Aluminium Lake, the 150 mg tablet contains FD&C Blue No. 2 Indigo Carmine Aluminium Lake and FD&C Red No. 40 Allura Red AC Aluminium Lake, and the 200 mg tablet contains FD&C Red No. 40 Allura Red AC Aluminium Lake. In addition, flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

WELLBUTRIN, WELLBUTRIN XL, and ZYBAN are registered trademarks of the GSK group of companies. The other brands listed are the trademarks of their respective owners.

Rx Only

Manufactured by:
ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, USA

Rev: 3/2021

  • Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
  • A n tidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
  • A n tidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
  • A n tidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
    • all risks and benefits of quit-smoking medicines
    • all treatment choices for quitting smoking
    • Seizures: There is a chance of having a seizure (convulsion, fit) with bupropion hydrochloride extended-release tablets, (SR), especially in people:
      • with certain medical problems.
      • who take certain medicines.
    • High blood pressure (hypertension). Some people get high blood pressure, that can be severe, while taking bupropion hydrochloride extended-release tablets, (SR). The chance of high blood pressure may be higher if you also use nicotine replacement therapy (such as a nicotine patch) to help you stop smoking (see the section of this Medication Guide called “How should I take bupropion hydrochloride extended-release tablets, (SR)?”).
    • Manic episodes. Some people may have periods of mania while taking bupropion hydrochloride extended-release tablets (SR), including:
      • Greatly increased energy
      • Severe trouble sleeping
      • Racing thoughts
      • Reckless behavior
      • Unusually grand ideas
      • Excessive happiness or irritability
      • Talking more or faster than usual
    • Unusual thoughts or behaviors. Some patients have unusual thoughts or behaviors while taking bupropion hydrochloride extended-release tablets, (SR), including delusions (believe you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your healthcare provider.
    • Visual problems.
      • eye pain
      • changes in vision
      • swelling or redness in or around the eye
    • S evere allergic reactions. Some people can have severe allergic r eactions to bupropion hydrochloride extended-release tablets (SR). Stop taking bupropion hydrochloride extended-release tablets (SR) and call your healthcare provider right away if you get a rash, itching, hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, swelling of the lips or tongue, chest pain, or have trouble breathing. These could be signs of a serious allergic reaction.
    • have or had a seizure disorder or epilepsy.
    • have or had an eating disorder such as anorexia nervosa or bulimia.
    • are taking any other medicines that contain bupropion, including ZYBAN (used to help people stop smoking) WELLBUTRIN ® , WELLBUTRIN XL ® , APLENZIN ® , FORFIVO XL ®. Bupropion is the same active ingredient that is in bupropion hydrochloride extended-release tablets (SR).
    • drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines, and you stop using them all of a sudden.
    • take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
      • do not take an MAOI within 2 weeks of stopping bupropion hydrochloride extended-release tablets, (SR) unless directed to do so by your healthcare provider.
      • do not start bupropion hydrochloride extended-release tablets, (SR) if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider.
    • are allergic to the active ingredient in bupropion hydrochloride extended-release tablets, (SR), bupropion, or to any of the inactive ingredients. See the end of this Medication Guide for a complete list of ingredients in bupropion hydrochloride extended-release tablets, (SR).
    • Tell your healthcare provider about your other medical conditions including if you:
      • 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, (SR) during pregnancy.
        • Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with bupropion hydrochloride extended-release tablets, (SR).
        • If you become pregnant during treatment with bupropion hydrochloride extended-release tablets, (SR), 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, (SR). Bupropion hydrochloride 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, (SR).
    • Take bupropion hydrochloride extended-release tablets, (SR) exactly as prescribed by your healthcare provider. Do not change your dose or stop taking bupropion hydrochloride extended-release tablets, (SR) without talking to your healthcare provider first.
    • Swallow bupropion hydrochloride extended-release tablets, (SR) whole. Do not chew, cut, or crush bupropion hydrochloride extended-release tablets, (SR). If you do, the medicine will be released into your body too quickly. If this happens you may be more likely to get side effects including seizures. Tell your healthcare provider if you cannot swallow tablets.
    • Bupropion hydrochloride extended-release tablets, (SR ) tablets may have an odor. This is normal.
    • Take bupropion hydrochloride extended-release tablets, (SR) at the same time each day.
    • Take your doses of bupropion hydrochloride extended-release tablets, (SR) at least 8 hours apart.
    • You may take bupropion hydrochloride extended-release tablets, (SR) with or without food.
    • If you miss a dose, do not take an extra dose to make up for the dose you missed. Wait and take your next dose at the regular time. This is very important. Too much bupropion hydrochloride extended-release tablets, (SR) can increase your chance of having a seizure.
    • If you take too much bupropion hydrochloride extended-release tablets, (SR), or overdose, call your local emergency room or poison control center right away.
    • D o not take any other medicines while taking bupropion hydrochloride extended-release tablets, (SR) unless your healthcare provider has told you it is okay.
    • If you are taking bupropion hydrochloride extended-release tablets, (SR) for the treatment of major depressive disorder, it may take several weeks for you to feel that bupropion hydrochloride extended-release tablets, (SR) is working. Once you feel better, it is important to keep taking bupropion hydrochloride extended-release tablets, (SR) exactly as directed by your healthcare provider. Call your healthcare provider if you do not feel bupropion hydrochloride extended-release tablets, (SR) is working for you.
    • Limit or avoid using alcohol during treatment with bupropion hydrochloride extended-release tablets, (SR). If you usually drink a lot of alcohol, talk with your healthcare provider before suddenly stopping. If you suddenly stop drinking alcohol, you may increase your chance of having seizures.
    • Do not drive a car or use heavy machinery until you know how bupropion hydrochloride extended-release tablets, (SR) affects you. Bupropion hydrochloride extended-release tablets, (SR) can affect your ability to do these things safely.
    • headache • dizziness
    • dry mouth • sore throat
    • nausea • constipation
    • trouble sleeping
    • Store bupropion hydrochloride extended-release tablets, (SR) at room temperature between 20° and 25°C (68° to 77°F).
    • Keep bupropion hydrochloride extended-release tablets, (SR) dry and out of the light.

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