BUPROPION - ORAL (byou-PRO-pee-on)
COMMON BRAND NAME(S): Wellbutrin
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Wellbutrin
Indications
and Usage
Wellbutrin
is indicated for the
treatment of depression.
A physician considering Wellbutrin for the management of a
patient's first episodes of depression should be aware that
the drug may cause generalized seizures with an approximate
incidence of 0.4% (4/1000). This incidence of seizures may
exceed that of other marketed antidepressants by as much as
fourfold. This relative risk is only an approximate estimate
because no direct comparative studies have been conducted.
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.
Wellbutrin
Contraindications
Wellbutrin
is contraindicated in patients with a seizure disorder.
Wellbutrin is also contraindicated in patients with a current
or prior diagnosis of
bulimia or anorexia nervosa
because of a higher incidence of seizures noted in such
patients treated with Wellbutrin. The concurrent
administration of Wellbutrin and a monoamine oxidase (MAO)
inhibitor is contraindicated. At least 14 days should elapse
between discontinuation of an MAO inhibitor and initiation
of treatment with Wellbutrin. Wellbutrin is contraindicated in
patients who have shown an allergic response to it.
Wellbutrin Warnings
Seizures:
Wellbutrin is associated with seizures in approximately 0.4%
(4/1000) of patients treated at doses up to 450 mg/day. This
incidence of seizures may exceed that of other marketed
antidepressants by as much as fourfold. This relative risk
is only an approximate estimate because no direct
comparative studies have been conducted. The estimate
seizure incidence for Wellbutrin increases almost tenfold
between 450 and 600 mg/day, which is twice the usually
required daily dose (300 mg) and one and one-third the
maximum recommended daily dose (450 mg). Given the wide
variability among individuals and their capacity to
metabolize and eliminate drugs, this disproportionate
increase in seizure incidence with dose incrementation calls
for caution in dosing.
In trial studies: 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.
Wellbutrin
Precautions
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 treatmen
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.
Wellbutrin
Drug
Interactions
No systematic data have
been collected on the consequences of the concomitant
administration of Wellbutrin and other drugs.
Studies in animals
demonstrate that the acute toxicity of buproprion is
enhanced by the MAO inhibitor phenelzine.
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.
BEFORE USING Wellbutrin: INFORM YOUR DOCTOR OR PHARMACIST of all
prescription and over-the-counter medicine that you are
taking. This includes monoamine oxide (MAO) inhibitors, HIV
protease inhibitors, and Zyban. Inform your doctor of any
other medical conditions including seizures, allergies,
pregnancy, or breast-feeding.
Pregnancy & Nursing:
There are no adequate and
well-controlled studies in pregnant women. Because animal
reproduction studies are not always predictive of human
response, Wellbutrin should be used during pregnancy only if
clearly needed. 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.
Use in the Elderly:
Wellbutrin has not been systematically evaluated in older
patients.
Wellbutrin Adverse
Reactions
Adverse events commonly
encountered in patients treated with Wellbutrin are
agitation, dry mouth, insomnia, headache/migraine,
nausea/vomiting, constipation, and tremor.
Adverse events were
sufficiently troublesome to cause discontinuation of
treatment with Wellbutrin in approximately ten percent of the
2400 patients and volunteers who participated in clinical
trials during the product's initial development. The more
common events causing discontinuation include
neuropsychiatric disturbances (3.0%), primarily agitation
and abnormalities in mental status; gastrointestinal
disturbances (2.1%), primarily nausea and vomiting;
neurological disturbances (1.7%), primarily seizures,
headaches, and sleep disturbances; and dermatologic problems
(1.4%), primarily rashes. It is important to note, however,
that many of these events occurred at doses that exceed the
recommended daily dose.
Cardiovascular:
Frequent was edema; infrequent were chest pain, EKG
abnormalities, and shortness of breath/dyspnea; rare were
flushing, pallor, phlebitis, and myocardial infarction.
Dermatologic:
Frequent were nonspecific rashes; infrequent were alopecia
and dry skin; rare were change in hair color, hirsutism, and
acne.
Endocrine:
Infrequent was gynecomastia; rare were glycosuria and
hormone level change.
Gastrointestinal:
Infrequent were dysphagia, thirst disturbance, and liver
damage/jaundice; rare were rectal complaints, colitis, G.I.
bleeding, intestinal perforation, and stomach ulcer.
Genitourinary:
Frequent was nocturia; infrequent were vaginal irritation,
testicular swelling, urinary tract infection, painful
erection, and retarded ejaculation; rare were dysuria,
enuresis, urinary incontinence, menopause, ovarian disorder,
pelvic infection, cystitis, dysparenuia, and painful
ejaculation.
Musculoskeletal:
Rare was musculoskeletal chest pain.
Physical/Psychological
Dependence:
Controlled clinical studies conducted in normal volunteers,
in subjects with a history of multiple drug abuse, and in
depressed patients showed some increase in motor activity
and agitation/excitement.
In a population of
individuals experienced with drugs of abuse, a single dose
of 400 mg Wellbutrin produced mild amphetamine-like activity
as compared to placebo on the morphine-benzedrine subscale
of the Addiction Research Center Index (ARCI) and a score
intermediate between placebo and amphetamine on the Liking
Scale of the ARCI. These scales measure general feelings of
euphoria and drug desirability.
Findings in clinical
trials, however, are not known to predict the abuse
potential of drugs reliably. Nonetheless, evidence from
single-dose studies does suggest that the recommended daily
dosage of Wellbutrin when administered in divided doses is
not likely to be especially reinforcing to amphetamine or
stimulant abusers. However, higher doses, which could not be
tested because of the risk of seizure, might be modestly
attractive to those who abuse stimulant drugs.
Wellbutrin Overdose
Signs and Symptoms:
There has been limited
clinical experience with overdosage of Wellbutrin. Thirteen
overdoses occurred during clinical trials. Twelve patients
ingested 850 to 4200 mg and recovered without significant
sequelae. Another patient who ingested 9000 mg of Wellbutrin
and 300 mg of tranylcypromine experienced a grand mal
seizure and recovered without further sequelae.
Since introduction,
overdoses of Wellbutrin up to 17,500 mg have been reported.
Seizure was reported in approximately one-third of all
cases. Other serious reactions reported with overdoses of
Wellbutrin alone included hallucinations, loss of
consciousness, and tachycardia. Fever, muscle rigidity,
rhabdomyolysis, hypotension, stupor, coma, and respiratory
failure have been reported when Wellbutrin was part of
multiple drug overdoses.
Although most patients
recovered without sequelae, deaths associated with overdoses
of Wellbutrin alone have been reported rarely in patients
ingesting massive doses of Wellbutrin. Multiple uncontrolled
seizures, bradycardia, cardiac failure, and cardiac arrest
prior to death were reported in these patients.
Treatment:
Following suspected
overdose, hospitalization is advised. If the patient is
conscious, vomiting should be induced by syrup of ipecac.
Activated charcoal also may be administered every 6 hours
during the first 12 hours after ingestion. Baseline
laboratory values should be obtained. Electrocardiogram and
EEG monitoring also are recommended for the next 48 hours.
Adequate fluid intake should be provided.
If the patient is
stuporous, comatose, or convulsing, airway intubation is
recommended prior to undertaking gastric lavage. Although
there is little clinical experience with lavage following an
overdose of Wellbutrin, it is likely to be of benefit within
the first 12 hours after ingestion since absorption of the
drug may not yet be complete.
Wellbutrin Dosage
Several weeks (1-4) may
pass before your condition improves.
How to Use Wellbutrin
Follow the directions for using Wellbutrin provided by
your doctor. Space your doses evenly throughout the day.
-
Store
Wellbutrin at room temperature in a tightly-closed
container, away from heat and light.
-
Continue
to take Wellbutrin even if you feel better.
-
Do not
miss any doses. If you miss a dose of Wellbutrin, take
it as soon as you remember. Take the remaining doses for
the day at evenly spaced intervals at least 4 hours apart.
Do not take 2 doses at once.
Additional Information:
Do not share Wellbutrin with others for whom it was not
prescribed. Do not use Wellbutrin for other health
conditions. Keep Wellbutrin out of the reach of children.
It is particularly
important to administer Wellbutrin in a manner most likely to
minimize the risk of seizure (see WARNINGS). Increases in
dose should not exceed 100 mg/day in a 3-day period. Gradual
escalation in dosage is also important if agitation, motor
restlessness, and insomnia, often seen during the initial
days of treatment, are to be minimized. If necessary, these
effects may be managed by temporary reduction of dose or the
short-term administration of an intermediate to long-acting
sedative hypnotic. A sedative hyponotic usually is not
required beyond the first week of treatment. Insomnia may
also be minimized by avoiding bedtime doses. If distressing,
untoward effects supervene, dose escalation should be
stopped.
No single dose of
Wellbutrin should exceed 150 mg. Wellbutrin should be
administered t.i.d., preferably with at least 6 hours
between successive doses.
The usual adult dose is
300 mg/day, given t.i.d. Dosing should begin at 200 mg/day,
given as 100 mg b.i.d. Based on clinical response, this dose
may be increased to 300 mg/day, given as 100 mg t.i.d., no
sooner than 3 days after beginning therapy
Increasing the Dosage
Above 300 mg/Day:
As with other antidepressants, the full antidepressant
effect of Wellbutrin may not be evident until 4 weeks of
treatment or longer. An increase in dosage, up to a maximum
of 450 mg/day, given in divided doses of not more than 150
mg each, may be considered for patients in whom no clinical
improvement is noted after several weeks of treatment at 300
mg/day. Dosing above 300 mg/day may be accomplished using
the 75 or 100 mg tablets. The 100 mg tablet must be
administered q.i.d., with at least 4 hours between
successive doses, in order not to exceed the limit of 150 mg
in a single dose. Wellbutrin should be discontinued in
patients who do not demonstrate an adequate response after
an appropriate period of treatment at 450 mg/day.
Elderly Patients:
In general, older patients are known to metabolize drugs
more slowly and to be more sensitive to the anticholinergic,
sedative, and cardiovascular side effects of antidepressant
drugs. Clinical trials enrolled several hundred patients 60
years of age and older. The experience with these patients
and younger ones was similar.
Maintenance:
The lowest dose that maintains remission is recommended.
Although it is not known how long the patient should remain
on Wellbutrin, it is generally recognized that acute episodes
of depression require several months or longer of
antidepressant drug treatment.
IF YOU WILL BE USING
Wellbutrin FOR AN EXTENDED PERIOD OF TIME, be sure to obtain
necessary refills before your supply runs out.
How
Wellbutrin is
Supplied
Tablets are supplied for
oral administration as 100-mg and 150-mg.
Popular Misspellings - Ellbutrin,
Ewllbutrin, Wallbutrin, Webutrin, Weelbutrin, Weellbutrin,
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Wellburtin, Wellbutin, Wellbutirn, Wellbutran, Wellbutren,
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Wellbuttrin, Wellbuutrin, Wellubtrin, Wellutrin, Willbutrin,
Wlelbutrin, Wllbutrin, Wwellbutrin
IMPORTANT NOTE: This information is intended to
supplement, not substitute for, the expertise and judgment of
your physician, pharmacist or other healthcare professional.
It should not be construed to indicate that use of the
drug is
safe, appropriate, or effective for you. Consult your
healthcare professional before using Wellbutrin.
