Forfivo XL

• Edgemont Pharmaceuticals, LLC

Forfivo XL is part of the drug class:

• Other antidepressants

The most common side effects are:

• dry mouth
• nervousness
• constipation
• headache
• nausea and vomiting
• trouble sleeping
• dizziness
• shakiness
• fast heartbeat
• heavy sweating

If you have nausea, take your medicine with food.

Forfivo XL can cause serious side effects (see "Black Box Warning" and "Drug Precautions").

If you have trouble sleeping, do not take your medicine too close to bedtime. 

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• MAO inhibitors (isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate))
• Ticlopidine
• Clopidogrel
• Antivirals such as ritonavir, lopinavir, efavirenz
• Medications used to treat seizures such as carbamazepine, phenobarbital, and phenytoin
• Dopaminergic Drugs (levodopa and amantadine)
• Beta blockers such as metoprolol (Lopressor, Toprol XL)
• Medications for irregular heartbeat such as flecainide and propafenone 
• Medications for mental illness such as haloperidol (Haldol), risperidone (Risperdal), and thioridazine (Mellaril)
• Medications for seizures such as carbamazepine (Tegretol), phenobarbital (Luminal, Solfoton), and phenytoin (Dilantin)
• Other antidepressants such as desipramine (Norpramin), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), paroxetine (Paxil) and sertraline (Zoloft), fluoxetine (Prozac)

This is not a complete list of all drug interactions of Forfivo XL. Ask your doctor for more information.

Serious side effects can occur which include:

• Seizure: There is a chance of having a seizure (convulsion, fit) with this medication, especially in people with certain medical problems or who take certain medicines.
• High blood pressure (hypertension): Some people get high blood pressure, that can be severe, while taking Forfivo XL. 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.
• Manic episodes. Symptoms may include greatly increased energy, severe trouble sleeping, racing thoughts, reckless behavior, unusually grand ideas, excessive happiness or irritability, and talking more or faster than usual. 
• Vision problems. Symptoms may include eye pain, changes in vision, swelling or redness in or around the eye. 
• Unusual thoughts or behaviors: Some patients have unusual thoughts or behaviors while taking Forfivo XL, 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 doctor.
• Severe allergic reactions: Some people have severe allergic reactions to Forfivo XL. Stop taking Forfivo XL and call your doctor 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.

Do not take this medication if you:

• are allergic to the active ingredient in Forfivo XL or to any of the inactive ingredients.
• have or had an eating disorder such as anorexia nervosa or bulimia.
• have or had a seizure disorder or epilepsy.
• are taking any other form of bupropion already
• drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy) or benzodiazepines and you stop using them all of a sudden.
• have taken within the last 14 days medicine for depression called a monoamine oxidase inhibitor (MAOI), such as Nardil (phenelzine), Parnate (tranylcypromine), or Marplan (isocarboxazid).

Do not drink a lot of alcohol while taking Forfivo XL. If you usually drink a lot of alcohol, talk with your doctor before suddenly stopping. If you suddenly stop drinking alcohol, you may increase your risk of having seizures.

Do not drive a car or use heavy machinery until you know how this medication affects you. Forfivo XL can impair your ability to perform these tasks.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Forfivo XL there are no specific foods that you must exclude from your diet when receiving Forfivo XL.

Tell your doctor if you are breastfeeding or plan to breastfeed. Forfivo XL passes through your milk. It is not known if this medication can harm your baby.

Take Forfivo XL exactly as prescribed by your doctor.

• Take Forfivo XL at the same time each day.
• Take Forfivo XL once daily, with or without food. 
• Do not chew, cut, or crush Forfivo XL tablets.
• Do not take any other medicines while using Forfivo XL unless your doctor has told you it is okay.
• For treating depression, it may take several weeks for you to feel Forfivo XL is working. Once you feel better, it is important to keep taking Forfivo XL exactly as directed by your doctor. Call your doctor if you do not feel Forfivo XL is working for you.
• Do not change your dose or stop taking Forfivo XL without talking with your doctor first.

Do not drink alcohol while taking this medication.

Forfivo XL can impair your ability to do these things safely. Do not drive a car or use heavy machinery until you know how this medication affects you. 

If you take too much Forfivo XL call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Forfivo XL is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Bupropion is an antidepressant medication used to treat major depressive disorder and seasonal affective disorder. The Zyban brand of bupropion is used to help people stop smoking by reducing cravings and other withdrawal effects.

Bupropion may also be used for purposes not listed in this medication guide.

You should not take bupropion if you have seizures or an eating disorder, or if you have suddenly stopped using alcohol, seizure medication, or sedatives. If you take Wellbutrin for depression, do not also take Zyban to quit smoking.

Do not use bupropion within 14 days before or 14 days after you have used an MAO inhibitor, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

In the U.S.

• Aplenzin
• Budeprion SR
• Budeprion XL
• Buproban
• Forfivo XL
• Wellbutrin
• Wellbutrin SR
• Wellbutrin XL
• Zyban

Available Dosage Forms:

• Tablet, Extended Release, 24 HR
• Tablet, Extended Release, 12 HR
• Tablet
• Tablet, Extended Release

Therapeutic Class: Antidepressant

Chemical Class: Aminoketone

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Headache.
• Belly pain.
• Shakiness.
• Feeling nervous and excitable.
• Strange or odd dreams.
• Upset stomach or throwing up.
• Hard stools (constipation).
• Gas.
• Dry mouth.
• Not able to sleep.
• Muscle or joint pain.
• Nose or throat irritation.
• Sweating a lot.
• Not hungry.
• A change in weight without trying.
• For some brands, you may see the tablet shell in your stool. For these brands, this is normal and not a cause for concern. If you have questions, talk with your doctor.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Commonly Observed Adverse Reactions in Controlled Clinical Trials of Sustained-release Bupropion Hydrochloride

Adverse reactions that occurred in at least 5% of patients treated with bupropion hydrochloride sustained-release (300 and 400 mg/day) and at a rate at least twice the placebo rate are listed below.

300 mg/day of bupropion hydrochloride sustained-release:  anorexia, dry mouth, rash, sweating, tinnitus, and tremor.

400 mg/day of bupropion hydrochloride sustained-release:  abdominal pain, agitation, anxiety, dizziness, dry mouth, insomnia, myalgia, nausea, palpitation, pharyngitis, sweating, tinnitus, and urinary frequency.

Forfivo XL is bioequivalent to three 150-mg tablets of WELLBUTRIN XL®, which has been demonstrated to have similar bioavailability both to the immediate-release and the sustained-release formulations of bupropion. The information included under this subsection and under subsection 6.2 is based primarily on data from controlled clinical trials with the sustained-release and extended-release formulations of bupropion hydrochloride.

Major Depressive Disorder

Adverse Reactions Leading to Discontinuation of Treatment with Bupropion Hydrochloride Immediate-release, Bupropion Hydrochloride Sustained-release, and Bupropion Hydrochloride Extended-release Formulations in Major Depressive Disorder Trials

In placebo-controlled clinical trials with bupropion hydrochloride sustained-release, 4%, 9%, and 11% of the placebo, 300 mg/day, and 400 mg/day groups, respectively, discontinued treatment because of adverse reactions. The specific adverse reactions leading to discontinuation in at least 1% of the 300-mg/day or 400-mg/day groups and at a rate at least twice the placebo rate are listed in Table 2.

In clinical trials with bupropion hydrochloride immediate-release, 10% of patients and volunteers discontinued due to an adverse reaction. Reactions resulting in discontinuation (in addition to those listed above for the sustained-release formulation) included vomiting, seizures, and sleep disturbances.

Adverse Reactions Occurring at an Incidence of > 1% in Patients Treated With Bupropion Hydrochloride Immediate-release or Bupropion Hydrochloride Sustained-release Formulations in Major Depressive Disorder Trials

Table 3 summarizes the adverse reactions that occurred in placebo-controlled trials in patients treated with bupropion hydrochloride sustained-release at 300 mg/day and 400 mg/day. These include reactions that occurred in either the 300-mg/day or 400-mg/day group at an incidence of 1% or more and were more frequent than in the placebo group.

The following additional adverse reactions occurred in controlled trials of bupropion hydrochloride immediate-release (300 to 600 mg/day) at an incidence of at least 1% more frequently than in the placebo group: cardiac arrhythmia (5% vs 4%), hypertension (4% vs 2%), hypotension (3% vs 2%), menstrual complaints (5% vs 1%), akathisia (2% vs 1%), impaired sleep quality (4% vs 2%), sensory disturbance (4% vs 3%), confusion (8% vs 5%), decreased libido (3% vs 2%), hostility (6% vs 4%), auditory disturbance (5% vs 3%), and gustatory disturbance (3% vs 1%).

Changes in Body Weight

Table 4 presents the incidence of body weight changes (≥ 5 lbs) in the short-term MDD trials using bupropion hydrochloride sustained-release. There was a dose-related decrease in body weight.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of bupropion hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body (General)chills, facial edema, edema, peripheral edema, musculoskeletal chest pain, photosensitivity, and malaise.

Cardiovascularpostural hypotension, hypertension, stroke, vasodilation, syncope, complete atrioventricular block, extrasystoles, myocardial infarction, phlebitis, and pulmonary embolism.

Digestiveabnormal liver function, bruxism, gastric reflux, gingivitis, glossitis, increased salivation, jaundice, mouth ulcers, stomatitis, thirst, edema of tongue, colitis, esophagitis, gastrointestinal hemorrhage, gum hemorrhage, hepatitis, intestinal perforation, liver damage, pancreatitis, and stomach ulcer.

Endocrinehyperglycemia, hypoglycemia, and syndrome of inappropriate antidiuretic hormone secretion.

Hemic and Lymphaticecchymosis, anemia, leukocytosis, leukopenia, lymphadenopathy, pancytopenia, and thrombocytopenia. Altered PT and/or INR, associated with hemorrhagic or thrombotic complications, were observed when bupropion was coadministered with warfarin.

Metabolic and Nutritionalglycosuria.

Musculoskeletalleg cramps, fever/rhabdomyolysis, and muscle weakness.

Nervous Systemabnormal coordination, depersonalization, emotional lability, hyperkinesia, hypertonia, hypesthesia, vertigo, amnesia, ataxia, derealization, abnormal electroencephalogram (EEG), aggression, akinesia, aphasia, coma, dysarthria, dyskinesia, dystonia, euphoria, extrapyramidal syndrome, hypokinesia, increased libido, neuralgia, neuropathy, paranoid ideation, restlessness, suicide attempt, and unmasking tardive dyskinesia.

Respiratorybronchospasm and pneumonia.

Skinmaculopapular rash, alopecia, angioedema, exfoliative dermatitis, and hirsutism.

Special Sensesaccommodation abnormality, dry eye, deafness, increased intraocular pressure, angle-closure glaucoma, and mydriasis.

Urogenitalimpotence, polyuria, prostate disorder, abnormal ejaculation, cystitis, dyspareunia, dysuria, gynecomastia, menopause, painful erection, salpingitis, urinary incontinence, urinary retention, and vaginitis.

Human Overdose Experience

Overdoses of up to 30 g or more of bupropion have been reported. Seizure was reported in approximately one third of all cases. Other serious reactions reported with overdoses of bupropion alone included hallucinations, loss of consciousness, sinus tachycardia, and ECG changes such as conduction disturbances or arrhythmias. Fever, muscle rigidity, rhabdomyolysis, hypotension, stupor, coma, and respiratory failure have been reported mainly when bupropion was part of multiple drug overdoses.

Although most patients recovered without sequelae, deaths associated with overdoses of bupropion alone have been reported in patients ingesting large doses of the drug. Multiple uncontrolled seizures, bradycardia, cardiac failure, and cardiac arrest prior to death were reported in these patients.

Overdosage Management

Consult a Certified Poison Control Center for up-to-date guidance and advice. Telephone numbers for certified poison control centers are listed in the Physicians’ Desk Reference (PDR). Call 1-800-222-1222 or refer to www.poison.org.

There are no known antidotes for bupropion. In case of an overdose, provide supportive care, including close medical supervision and monitoring. Consider the possibility of multiple drug overdose.

• Take Forfivo XL exactly as prescribed by your doctor.
• Do not chew, cut, or crush Forfivo XL tablets. 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. You must swallow the tablets whole. Tell your healthcare provider if you cannot swallow medicine tablets.
• You may take Forfivo XL with or without food.
• If you take too much Forfivo XL, or overdose, call your healthcare provider or go to the nearest hospital emergency room right away.
• Do not take any other medicines while using Forfivo XL unless your healthcare provider has told you it is okay.
• If you are taking Forfivo XL for the treatment of major depressive disorder, it may take several weeks for you to feel that Forfivo XL is working. Once you feel better, it is important to keep taking Forfivo XL exactly as directed by your doctor. Call your healthcare provider if you do not feel Forfivo XL is working for you.
• Do not change your dose or stop taking Forfivo XL without talking with your healthcare provider first.

• Do not drink alcohol while taking Forfivo XL.
• Do not drive a car or use heavy machinery until you know how Forfivo XL affects you. Forfivo XL can impair your ability to perform these tasks.

Common side effects of Forfivo XL include: dizziness, insomnia, nausea, pharyngitis, weight loss, and xerostomia. Other side effects include: abdominal pain, agitation, anxiety, arthralgia, chest pain, migraine, myalgia, palpitations, skin rash, tinnitus, tremor, urinary frequency, hypertension, anorexia, diaphoresis, dysgeusia, and flushing. See below for a comprehensive list of adverse effects.