Wellbutrin withdrawal. Wellbutrin withdrawal side effects, withdrawal warnings, withdrawal precautions, withdrawal adverse effects, overdose, withdrawal symptoms and Wellbutrin natural alternatives. Before you begin the spiral down with Wellbutrin withdrawal, try giving your body what it really wants.

Wellbutrin

Below is a list of Wellbutrin withdrawal side effects. These Wellbutrin side effects can occur while taking the Wellbutrin before withdrawal or may become apparent once Wellbutrin withdrawal begins. It is imperative you use a Wellbutrin withdrawal plan designed to eliminate or reduce Wellbutrin withdrawal side effects. Once Wellbutrin withdrawal side effects begin, they are more difficult to get rid of.

1. Wellbutrin withdrawal - Anorexia – No longer having a desire to eat.
    

2. Wellbutrin withdrawal - Apothous Stomatitis – Painful red and swollen open sores on a mucus membrane of the mouth commonly called a canker sore.
    

3. Wellbutrin withdrawal - Ataxia – Loss of the ability to move the body with coordination.
    

4. Wellbutrin withdrawal - Arterial Fibrillation – A condition of abnormal twitching of the muscles in the blood vessels that moves the oxygenated blood from the heart to the rest of the body.  The unusual twitching is rapid and irregular and replaces the normal rhythm of contraction of the muscle, which sometimes causes a lack of circulation and pulse.
    

5. Wellbutrin withdrawal - Blood Cholesterol Increased – An abnormal condition where there is a greater amount in the blood of the oily/fatty substances known as cholesterol.   Cholesterol is a necessary part of living cells (along with proteins and carbohydrates).  Because cholesterol only slightly dissolves in water, it can build up on the walls of the blood vessels, therefore blocking/decreasing the amount of blood flow, which causes blood pressure to go up.  If not corrected, this condition is associated with coronary artery disease.
    

6. Wellbutrin withdrawal - Blood Creatinine Increased – A greater than normal number of creatinine or muscular chemical waste molecules in the blood.  Creatinine plays a major role in energy production in muscles.  Since creatinine levels are normally maintained by the kidneys, Blood Creatinine Increased is an indicator of kidney malfunction or failure.
    

7. Wellbutrin withdrawal - Blood in Stool – The blood that is in your bowel movement usually comes from any place along your digestive tract (from your mouth to your anus).  The stool can appear black and foul-smelling (usually from the upper part of your digestive tract) or red or maroon-colored (usually from the large intestine area).  Hemorrhoids are the usual cause for blood in the bowels.

8.    Wellbutrin withdrawal - Bundle Branch Block Right – These are specialized cells in the upper right heart chamber and are the heart’s pacemaker.  They send electrical signals to the heart that keeps it beating or contracting regularly.  Normally the signal goes to the lower heart chambers at the same time through the bundle of His (hiss) on both the left and right sides of the heart, so the lower chambers contract at the same time.  When the bundle is damaged on the right side, the signal does not fire at the same time as the left, which changes the pace of blood flow.  This can lead to a person fainting.

9. Wellbutrin withdrawal - Cardiac Failure – A heart disorder where the heart does not function as usual and may completely stop working.
    

10. Wellbutrin withdrawal - Cardiac Failure Congestive – The body is asking for the heart to supply more blood than it is capable of producing and maintaining.  Normally, a body can tolerate an increased amount of work for quite some time.  The condition is characterized by weakness, shortness of breath, and a fluid build-up in the body tissues causing swelling.
     

11. Wellbutrin withdrawal - Cold Sweat – The skin is clammy and moist and you feel chilled.  This is a reaction to a shock or pain as well as to fear and nervousness.
     

12. Wellbutrin withdrawal - Colitis – A condition where the large intestine becomes irritated from the use of the drug.
     

13. Wellbutrin withdrawal - Coronary Artery Disease – A condition where the blood vessels that mainly carry the blood away from the heart become clogged up or narrowed usually by fatty deposits.  The first symptom is pain spreading from the upper left body caused by not enough oxygen reaching the heart.
     

14. Wellbutrin withdrawal - Dehydration – An extreme loss of water from the body or the organs of the body as in sickness or not drinking enough fluids.
     

15. Wellbutrin withdrawal - Diplopia – The condition where a person is looking a one object and instead of normally seeing just the one object he sees two.  This is also call double vision.
     

16. Wellbutrin withdrawal - Diverticulitis – There are pouches or sacs on the inside of the intestines that look like fingers.  This increases the area for the body to absorb nutrients as they pass through the intestines.  These sacs become irritated and swollen and end up trapping waste that would normally be eliminated, causing pain and constipation.
     

17. Wellbutrin withdrawal - Dysarthria – The inability to control the mouth muscles when forming words so the words are not clearly spoken and heard.
     

18. Wellbutrin withdrawal - Dyslipidemia – The normal fat metabolism in the blood is interfered with.
     

19. Wellbutrin withdrawal - Dysphagia – Trouble swallowing or the inability to swallow.
     

20. Wellbutrin withdrawal - Ecchymosis – When a blood vessel breaks and creates a purple discoloration of the skin.
     

21. Wellbutrin withdrawal - Edema – An abnormal build up of excess fluids in the cells, tissues, and the spaces between the tissues creating swelling.
     

22. Wellbutrin withdrawal - Edema Peripheral – The abnormal build up of fluids in the tissues of the ankles and legs causing painless swelling in the legs, ankles, and feet.  If you squeeze the swollen area it leaves an indentation on the skin for a few minutes.
     

23. Wellbutrin withdrawal - Ejaculation Delayed – The man is not able to release sperm either during sexual intercourse or with manual stimulation in the presence of his sexual partner in spite of his wish to do so.
     

24. Wellbutrin withdrawal - Ejaculation Dysfunction – A condition where the man has one or more of the following symptoms:  He is not able to have an erection, not able to have an orgasm, has a decreased interest in sex, is sexually inhibited, or it is painful to ejaculate sperm.
     

25. Wellbutrin withdrawal - Erectile Dysfunction – Incapable of having sexual intercourse.  Even though a man desires sex he is inhibited in his sexual activity and is unable to have or maintain an erection of the penis.
     

26. Wellbutrin withdrawal - Erythema – a skin redness caused by the swelling with blood of the tiny blood vessels of the skin as in burns.
     

27. Wellbutrin withdrawal - Erythematous Rash – Redness of the skin from the swelling of the tiny blood vessels with skin irritation (itching, burning, tingling, pain) and breakouts (eruptions).

28. Wellbutrin withdrawal - Esophageal Stenosis Acquired – The tube that moves food from the mouth to the stomach narrows.
     

29. Wellbutrin withdrawal - Exfoliative Dermatitis – The unusual and not normal condition of scaling and shedding of the skin cells.  The skin is usually red colored.
     

30. Wellbutrin withdrawal - Face Edema – The tissues of the face become swollen.
     

31. Wellbutrin withdrawal - Feeling Jittery – A physical sensation of nervous unease.
     

32. Wellbutrin withdrawal - Gastric Irritation – An inflamed and sore stomach.
     

33. Wellbutrin withdrawal - Gastric Ulcer – An open, irritated, and infected sore in the wall of the stomach.
     

34. Wellbutrin withdrawal - Gingivitis – Sore, swollen and red gums in the mouth that bleed easily.
     

35. Wellbutrin withdrawal - Glaucoma – The delicate nerve to the eye, the optic nerve, becomes easily damaged with the build-up of excess fluid pressure within the eyeball.  The first sign of glaucoma is loss of peripheral (side) vision.  It can progress to total blindness.
     

36. Wellbutrin withdrawal - Hepatic Steatosis – Excessive amounts of fat in the liver.
     

37. Wellbutrin withdrawal - Hyperhidrosis – The triggering of an excess of sweat being produced on the soles of the feet, the palms, or the underarms which can cause embarrassment or losing grip on a pen or other items.
     

38. Wellbutrin withdrawal - Hyperkeratosis – An abnormal enlargement of the skin tissues causing the skin cells to increase in size.
     

39. Wellbutrin withdrawal - Hyperlipidemia – An abnormally high number of fat cells in the blood.
     

40. Wellbutrin withdrawal - Hypertriglyceridemia – Too many triglycerides in the blood. 

Triglycerides are three fatty acids bound together in one molecule stored by the body and available to create high levels of energy when used. 

41. Wellbutrin withdrawal - Hypoesthesia – A partial loss of sensation or general loss of awareness.
     

42. Wellbutrin withdrawal - Impaired Gastric Emptying – The contents of the stomach are not passed into the intestines as normal due to the stomach losing the muscular strength to do so.
     

43. Wellbutrin withdrawal - Increased White Blood cell Count – This is an increase in the number of cells in the blood that are responsible for the removal of bacteria and other unwanted particles.  They fight disease and infection by enclosing foreign particles and removing them.  An example of a disease that would increase white blood cell count would be Leukemia.
     

44. Wellbutrin withdrawal - Insomnia – Not able to fall asleep or sleeping for a shorter time than desired, thus not being able to properly rest and feeling un-refreshed.  As a result, a person can become irritable, have difficulty concentrating and feel a lack of energy.  This can be caused by stimulants such as by caffeine or drugs or by mental anxiety and stress.  Mental stress can be communicated and relieved.
     

45. Wellbutrin withdrawal - Irritable Bowel Syndrome – A painful condition where the either the muscles or the nerves of the lower intestines, are not responding normally.  This results in an alternating condition of diarrhea followed by constipation, back and forth.
     

46. Wellbutrin withdrawal - Keratoconjunctivitis Sicca – A condition where the outer coating of the eyeball is dry because of a decrease in the normal amount of tears in the eye.  As a result, the eyeball and inside of the eyelid thickens and hardens sometimes causing the vision to be less sharp.
     

47. Wellbutrin withdrawal - Leukopenia – An unnaturally low number of white blood cells circulating in the blood.
     

48. Wellbutrin withdrawal - Loose Stools – The bowel movement is runny instead of formed.
     

49. Wellbutrin withdrawal - Lower Abdominal Pain – A hurtful irritation of the nerve endings in the area of the hipbones housing the lower digestive tract.  Pain usually means tissue damage.
     

50. Wellbutrin withdrawal - Lymphadenopathy – The lymph nodes, where the immune cells are located, become larger than is normal because of a high concentration of white blood cells.
     

51. Wellbutrin withdrawal - Macular Degeneration – The gradual loss of central vision, which is the sharpest vision while peripheral eyesight, is unaffected.
     

52. Wellbutrin withdrawal - Maculopathy – An abnormal condition of the yellow spot of the eye, which is located in the center of the inner lining of the eyeball and connected to the main nerve to the eye and is responsible for sharp vision.
     

53. Wellbutrin withdrawal - Mania – Unusually irrational, excessive and/or exaggerated behavior or moods ranging from enthusiasm, sexuality, gaiety, impulsiveness and irritability to violence.
     

54. Wellbutrin withdrawal - Melena – Abnormally darkly colored stools as a result of hemorrhaging in the digestive tract where the blood has interacted with the digestive juices creating the dark color in the bowel movement.
     

55. Wellbutrin withdrawal - Micturition Urgency – A sudden desire to urinate usually followed by leakage.
     

56. Wellbutrin withdrawal - Mood Swings – An emotional shifting as from a state of happiness to a state of depression for a period of time.
     

57. Wellbutrin withdrawal - Myocardial Infarction – The blood going to the heart is delayed or stopped causing middle muscle tissue in the heart wall to die.
     

58. Wellbutrin withdrawal - Nasopharyngitis – Irritation, redness and swelling tissues in the nose and the tube leading from the mouth to the voice box as well as the tubes leading to the ears.
     

59. Wellbutrin withdrawal - Nephropathy – An abnormally functioning or diseased kidney.
     

60. Wellbutrin withdrawal - Nervousness – Jumpy, jittery, anxious, and troubled with an irritable temperament.
     

61. Wellbutrin withdrawal - Night Sweats – The water-salt, waste product the skin releases is called sweat or perspiration.   With night sweats you become wide awake in the middle of the night shivering and cold and wet with your sheets/pajamas soaked in perspiration making it difficult to go back to sleep.
     

62. Wellbutrin withdrawal - Nightmare – Dreams that make you afraid or leave feelings of fear, terror, and upset long after waking up.
     

63. Wellbutrin withdrawal - Orgasm Abnormal – Unable to have an orgasm with normal sexual stimulation.
     

64. Wellbutrin withdrawal - Oropharyngeal Swelling – A swelling in the area from the soft part of the roof of the mouth to the back of the mouth.
     

65. Wellbutrin withdrawal - Pain in Extremity – A painful feeling in the legs, arms, hands, and feet.
     

66. Wellbutrin withdrawal - Pharyngolaryngeal Pain – Pain in the area of the respiratory tract (organs of breathing) from the throat to the voice box and above the windpipe.
     

67. Wellbutrin withdrawal - Photopsia – A condition where a person see lights, sparks or colors in front of your eyes.
     

68. Wellbutrin withdrawal - Photosensitivity Reaction – An exaggerated sunburn reaction that is not normal in proportion to the amount of exposure to the light.
     

69. Wellbutrin withdrawal - Pollakiuria – Urinating much more frequently than normal – as often as once every five to fifteen minutes.
     

70. Wellbutrin withdrawal - Pressure of Speech – A condition where the individual cannot voice his ideas fast enough with the pressure of there being not enough time to say it.
     

71. Wellbutrin withdrawal - Pruritic Rash – Extremely itchy, red, swollen bumps on the skin.
     

72. Wellbutrin withdrawal - Pyrexia – Fever or the increase in body temperature that is usually a sign of infection.
     

73. Wellbutrin withdrawal - Retinal Detachment – The thin layer lining the back of the eyeball (the retina) detaches from the back of the eyeball.  This thin layer is like the film of a camera because it sends the images a person views to the brain.  When it detaches it causes a reduced ability to see.
     

74. Wellbutrin withdrawal - Rigors – Shivering or shaking of the body as if chilled, preventing normal responses.
     

75. Wellbutrin withdrawal - Skin Ulcer – An open sore or infected skin eruption with swelling, redness, pus, and irritation.
     

76. Wellbutrin withdrawal - Sleep Disorder – These are a list of sleep disorders such as teeth grinding, insomnia, jet lag, sleep walking, abnormally falling asleep during the middle of a conversation after a full night’s rest, uncontrolled body motions keeping one awake, etc.
     
77. Wellbutrin withdrawal - Suicide, Completed – An attempted attack on oneself that is life threatening results in death.
     

78. Wellbutrin withdrawal - Upper Respiratory Tract Infection – Where the organs of breathing near the mouth such as the nose and sinuses, become infected and are usually treated by antibiotics.
     

79. Wellbutrin withdrawal - Urinary Hesitation – Hard to start or hard to continue emptying one’s bladder.
     

80. Wellbutrin withdrawal - Urinary Incontinence – Urinating without intending to do so because of a weakening of the muscles in the hip area from the drug affecting the nerves or the drug blocking a persons thinking process.
     

81. Wellbutrin withdrawal - Urinary Retention – The inability to completely empty the bladder despite having the urge to do so.  This can lead to infections or damage to the urinary organs.
     

82. Wellbutrin withdrawal - Urine Flow Decreased – Dehydration of the body causing a lesser flow of urine than normal with the body reabsorbing the waste.
     

83. Wellbutrin withdrawal - Urine Output Decreased – A condition where the output of urine produced in a 24-hour period is less than 500 ml.
     

84. Wellbutrin withdrawal - Weight Decreased – Unintentional weight loss.
    
     
85. Wellbutrin withdrawal – Weight Increased – An unusual, usually rapid weight increase.

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Description

Antidepressant  

Wellbutrin hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The emperical formula is C₁₃H₁₈CINO*HCl. Wellbutrin powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa.

Wellbutrin is supplied for oral administration as 75 mg (yellow-gold) and 100 mg (red) film-coated tablets. Each tablet contains the labeled amount of Wellbutrin hydrochloride and the inactive ingredients: 75 mg tablet - D&C Yellow No. 10 Lake, FD&C Yellow No. 6 Lake, hydroxypropyl cellulose, hydroxypropyl methylcelluose, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide; 100 mg tablet - FD&C Red No. 40 Lake, FD&C Yellow No. 6 Lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.

Clinical Pharmacology

Wellbutrin produces dose-related CNS stimulant effects in animals, as evidenced by increased locomotor activity, increased rates of responding in various schedule-controlled operant behavior tasks, and, at high doses, induction of mild stereotyped behavior.

Wellbutrin causes convulsions in rodents and dogs at doses approximately tenfold the dose recommended as the human antidepressant dose.

Absorption, Distribution, Pharmacokinetics, Metabolism, and Elimination:

Oral bioavailability and single-dose pharmacokinetics:
In humans, following oral administration of Wellbutrin, peak plasma Wellbutrin concentrations are usually achieved within 2 hours, followed by a biphasic decline. The average half-life of the second (post-distributional) phase is approximately 14 hours, with a range of 8 to 24 hours. Six hours after a single dose, plasma Wellbutrin concentrations are approximately 30% of peak concentrations. Plasma Wellbutrin concentrations are dose-proportional following single doses of 100 to 250 mg; however, it is not known if the proportionality between dose and plasma level is maintained in chronic use.

The absolute bioavailability of Wellbutrin tablets in humans has not been determined because an intravenous formulation for human use is not available.

However, it appears likely that only a small proportion of any orally administered dose reaches the systemic circulation intact. For example, the absolute bioavailability of Wellbutrin in animals (rats and dogs) ranges from 5% to 20%.

Metabolism:
Following oral administration of 200 mg of ¹⁴C-Wellbutrin, 87% and 10% of the radioactive dose were recovered in the urine and feces, respectively. However, the fraction of the oral dose of Wellbutrin excreted unchanged was only 0.5%, a finding documenting the extensive metabolism of Wellbutrin.

Several of the known metabolites of Wellbutrin are pharmacologically active, but their potency and toxicity relative to Wellbutrin have not been fully characterized. However, because of their longer elimination half-lives, the plasma concentrations of at least two of the known metabolites can be expected, especially in chronic use, to be very much higher than the plasma concentration of Wellbutrin. This is of potential clinical importance because factors or conditions altering metabolic capacity (e.g., liver disease, congestive heart failure, age, concomitant medications, etc.) or elimination may be expected to influence the degree and extend of accumulation of these active metabolites.

Furthermore, Wellbutrin has been shown to induce its own metabolism in three animal species (mice, rats, and dogs) following subchronic administration. If induction also occurs in humans, the relative contribution of Wellbutrin and its metabolites to the clinical effects of Wellbutrin may be changed in chronic use.

Plasma and urinary metabolites so far identified include biotransformation products formed via reduction of the carbonyl group and/or hydroxylation of the tert-butyl group of Wellbutrin. Four basic metabolites have been identified.

They are the erythro- and threo-amino alcohols of Wellbutrin, the erythro-amino diol of Wellbutrin, and a morpholinol, metabolite (formed from hydroxylation of the tert-butyl group of Wellbutrin).

The morpholinol metabolite appears in the systemic circulation almost as rapidly as the parent drug following a single oral dose. Its peak level is three times the peak level of the parent drug; it has a half life on the order of 24 hours; and its AUC 0 to 60 hours is about 15 times that of Wellbutrin.

The threo-amino alcohol metabolite has a plasma concentration time profile similar to that of the morpholinol metabolite. The erythro-amino alcohol and the erythro-amino diol metabolites generally cannot be detected in the systemic circulation following a single oral dose of the parent drug. The morpholinol and the threo-amino alcohol metabolites have been found to be half as potent as Wellbutrin in animal screening tests for antidepressant drugs.

During a chronic dosing study in 14 depressed patients with left ventricular dysfunction, it was found that there was substantial interpatient variability (two- to five-fold) in the trough steady-state concentrations of Wellbutrin
and the morpholinol and threo-amino alcohol metabolites. In addition, the steady-state plasma concentrations of these metabolites were 10 to 100 times the steady-state concentrations of the parent drug.

The effect of other disease states and altered organ function on the metabolism and/or elimination of Wellbutrin
 has not been studied in detail. However, the elimination of the major metabolites of Wellbutrin may be affected by reduced renal or hepatic function because they are moderately polar compounds and are likely to undergo conjugation in the liver prior to urinary excretion. The preliminary results of a comparative single-dose pharmacokinetic study in normal versus cirrhotic patients indicated that half-lives of the metabolites were prolonged by cirrhosis and that the metabolites accumulated to levels two to three times those in normals.

The effect of age on plasma concentrations of Wellbutrin and its metabolites has not been characterized.

In vitro tests show that Wellbutrin is 80% or more bound to human albumin at plasma concentrations up to 800 micromolar (200 mcg/mL).

Indications And Usage   Back to top of page

The efficacy of Wellbutrin has been established in three placebo-controlled trials, including two of approximately 3 weeks duration in depressed inpatients, and one of approximately 6 weeks duration in depressed outpatients. The depressive disorder of the patients studied corresponds most closely to the Major Depression category of the APA Diagnostic and Statistical Manual III.

Major Depression implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.

Effectiveness of Wellbutrin in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Wellbutrin for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Contraindications   Back to top of page

Warnings   Back to top of page

During the initial development, 25 among approximately 2400 patients treated with Wellbutrin experienced seizures. At the time of seizure, seven patients were receiving daily doses of 450 mg or below for an incidence of 0.33% (3/1000) within the recommended dose range. Twelve patients experienced seizures at 600 mg per day (2.3% incidence); six additional patients has seizures at daily doses between 600 and 900 mg (2.8% incidence).

A separate, prospective study was conducted to determine the incidence of seizure during an 8-week treatment exposure in approximately 3200 additional patients who received daily doses of up to 450 mg. Patients were permitted to continue treatment beyond 8 weeks if clinically indicated. Eight seizures occurred during the initial 8-week treatment period and five seizures were reported in patients continuing treatment beyond 8 weeks, resulting in a total seizure incidence of 0.4%.

The risk of seizure appears to be strongly associated with dose and the presence of predisposing factors. A significant seizure, CNS tumor, concomitant medications that lower seizure threshold, etc.) was present in approximately one-half of the patients experiencing a seizure. Sudden and large increments in dose may contribute to increased risk. While many seizures occurred early in the course of treatment, some seizures did occur after several weeks at fixed dose.

Recommendations for reducing the risk of seizure:
Retrospective analysis of clinical experience gained during the development of Wellbutrin suggests that the risk of seizure may be minimized if (1) the total daily dose of Wellbutrin does not exceed 450 mg, (2) the daily dose is administered t.i.d., with each single dose not to exceed 150 mg to avoid high peak concentrations of Wellbutrin and/or its metabolites, and (3) the rate of incrementation of dose is very gradual. Extreme caution should be used when Wellbutrin is (1) administered to patients with a history of seizure, cranial trauma, or other predisposition(s) toward seizure, or (2) prescribed with other agents (e.g., antipsychotics, other antidepressants, etc.) or treatment regimens (e.g., abrupt discontinuation of a benzodiazepine) that lower seizure threshold.

Potential for Hepatotoxicity:
In rats receiving large doses of Wellbutrin chronically, there was an increase in incidence of hepatic hyperplastic nodules and hepatocellular hypertrophy. In dogs receiving large doses of Wellbutrin chronically, various histologic changes were seen in the liver, and laboratory tests suggesting mild hepatocellular injury were noted. Although scattered abnormalities in liver function tests were detected in patients participating in clinical trials, there is no clinical evidence that Wellbutrin
 acts as a hepatotoxin in humans.

Precautions   Back to top of page

General:

Agitation and Insomnia: A substantial proportion of patients treated with Wellbutrin experience some degree of increased restlessness, agitation, anxiety, and insomnia, especially shortly after initiation of treatment. In clinical studies, these symptoms were sometimes of sufficient magnitude to require treatment with sedative/hypnotic drugs. In approximately 2% of patients, symptoms were sufficiently severe to require discontinuation of treatment with Wellbutrin
.

Psychosis, Confusion, and Other Neuropsychiatric Phenomena: Patients treated with Wellbutrin have been reported to show a variety of neuropsychiatric signs and symptoms including delusions, hallucinations, psychotic episodes, confusion, and paranoia. Because of the uncontrolled nature of many studies, it is impossible to provide a precise estimate of the extent of risk imposed by treatment with Wellbutrin. In several cases, neuropsychitric phenomena abated upon dose reduction and/or withdrawal of treatment.

Activation of Psychosis and/or Mania: Antidepressants can precipitate manic episodes in Bipolar Manic Depressive patients during the depressed phase of their illness and may activate latent psychosis in other susceptible patients. Wellbutrin is expected to pose similar risks.

Altered Appetite and Weight: A weight loss of greater than 5 pounds occurred in 28% of patients receiving Wellbutrin. This incidence is approximately double that seen in comparable patients treated with tricyclics or placebo. Furthermore, while 34.5% of patients receiving tricyclic antidepressants gained weight, only 9.4% of patients treated with Wellbutrin did. Consequently, if weight loss is a major presenting sign of a patient's depressive illness, the anorectic and/or weight reducing potential of Wellbutrin should be considered.

Suicide: The possibility of a suicide attempt is inherent in depression and may persist until significant remission occurs. Accordingly, prescriptions for Wellbutrin should be written for the smallest number of tablets consistent with good patient management.

Use in Patients with Systemic Illness:
There is no clinical experience establishing the safety of Wellbutrin in patients with a recent history of myocardial infarction or unstable heart disease. Therefore, care should be exercised if it is used in these groups. Wellbutrin was well tolerated in patients who has previously developed orthostatic hypotension while receiving tricyclic antidepressants.

Because Wellbutrin HCl and its metabolites are almost completely excreted through the kidney and metabolites are likely to undergo conjugation in the liver prior to urinary excretion, treatment of patients with renal or hepatic, impairment should be initiated at reduced dosage as Wellbutrin and its metabolites may accumulate in such patients beyond concentrations expected in patients without renal or hepatic impairment. The patient should be closely monitored for possible toxic effects of elevated blood and tissue levels of drug and metabolites.

Information for Patients:
Physicians are advised to discuss the following issues with patients:

Patients should be instructed to take Wellbutrin in equally divided doses three or four times a day to minimize the risk of seizure.

Patients should be told that any CNS-active drug like Wellbutrin may impair their ability to perform tasks requiring judgment or motor and cognitive skills. Consequently, until they are reasonably certain that Wellbutrin
 does not adversely affect their performance, they should refrain from driving an automobile or operating complex, hazardous machinery.

Patients should be told that the use and cessation of use of alcohol may alter the seizure threshold, and, therefore, that the consumption of alcohol should be minimized, and, if possible, avoided completely.

Patients should be advised to inform their physician if they are taking or plan to take any prescription or over-the-counter drugs. Concern is warranted because Wellbutrin and other drugs may affect each others metabolism.

Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy.

Drug Interactions:
No systematic data have been collected on the consequences of the concomitant administration of Wellbutrin
and other drugs.

However, animal data suggest that Wellbutrin may be an inducer of drug metabolizing enzymes. This may be of potential clinical importance because the blood levels of co-administered drugs may be altered.

Alternatively, because Wellbutrin is extensively metabolized, the co-administration of other drugs may affect its clinical activity. In particular, care should be exercised when administering drugs known to affect hepatic drug-metabolizing enzyme systems (e.g., carbamazepine, cimetidine, phenobarbital, phenytoin).

Studies in animals demonstrate that the acute toxicity of buproprion is enhanced by the MAO inhibitor phenelzine (see CONTRAINDICATIONS).

Limited clinical data suggest a higher incidence of adverse experiences in patients receiving concurrent administration of Wellbutrin and L-dopa. Administration of Wellbutrin to patients receiving L-dopa concurrently should be undertaken with caution, using small initial doses and small gradual dose increases.

Concurrent administration of Wellbutrin and agents which lower seizure threshold should be undertaken only with extreme caution (see WARNINGS). Low initial dosing and small gradual dose increases should be employed.

Carcinogenesis, Mutagenesis, Impairment of Fertility:
Lifetime carcinogenicity studies were performed in rats and mice at doses up to 300 and 150 mg/kg/day, respectively. In the rat study there was an increase in nodular proliferative lesions of the liver at doses of 100 to 300 mg/kg/day; lower doses were not tested. The question of whether or not such lesions may be precursors of neoplasms of the liver is currently unresolved. Similar liver lesions were not seen in the mouse study, and no increase in malignant tumors of the liver and other organs was seen in either study.

Wellbutrin produced a borderline positive response (2 to 3 times control mutation rate) in some strains in the Ames bacterial mutagenicity test, and a high oral dose (300, but not 100 or 200 mg/kg) produced a low incidence of chromosomal aberrations in rats. The relevance of these results in estimating the risk of human exposure to therapeutic doses is unknown.

A fertility study was performed in rats; no evidence of impairment of fertility was encountered at oral doses up to 300 mg/kg/day.

Pregnancy: Teratogenic Effects:
Pregnancy Category B: Reproduction studies have been performed in rabbits and rats at doses up to 15 to 45 times the human daily dose and have revealed no definitive evidence of impaired fertility or harm to the fetus due to Wellbutrin. (In rabbits, a slightly increased incidence of fetal abnormalities was seen in two studies, but there was no increase in any specific abnormality.) There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery:
The effect of Wellbutrin on labor and delivery in humans is unknown.

Nursing Mothers:
Because of the potential for serious adverse reactions in nursing infants from Wellbutrin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use:
The safety and effectiveness of Wellbutrin in individuals under 18 years old have not been established.

Use in the Elderly:
Wellbutrin has not been systematically evaluated in older patients.

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