Clarification of Answer by
bobbie7-ga
on
17 Dec 2005 14:10 PST
Kitlandis,
Thank you for your clarification.
Please let me know if this is the information you're looking for.
Best regards,
Bobbie7
WELLBUTRIN (GlaxoSmithKline)
(bupropion hydrochloride) Tablets
?Cardiovascular Effects: In clinical practice, hypertension, in some
cases severe, requiring acute treatment, has been reported in patients
receiving bupropion alone and in combination with nicotine replacement
therapy. These events have been observed in both patients with and
without evidence of preexisting hypertension.
Data from a comparative study of the sustained-release formulation of
bupropion (ZYBANŽ Sustained-Release Tablets), nicotine transdermal
system (NTS), the combination of sustained-release bupropion plus NTS,
and placebo as an aid to smoking cessation suggest a higher incidence
of treatment-emergent hypertension in patients treated with the
combination of sustained-release bupropion and NTS. In this study,
6.1% of patients treated with the combination of sustained-release
bupropion and NTS had treatment-emergent hypertension compared to
2.5%, 1.6%, and 3.1% of patients treated with sustained-release
bupropion, NTS, and placebo, respectively. The majority of these
patients had evidence of preexisting hypertension. Three patients
(1.2%) treated with the combination of ZYBAN and NTS and one patient
(0.4%) treated with NTS had study medication discontinued due to
hypertension compared to none of the patients treated with ZYBAN or
placebo. Monitoring of blood pressure is recommended in patients who
receive the combination of bupropion and nicotine replacement.
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. Bupropion was well tolerated in depressed patients who
had previously developed orthostatic hypotension while receiving
tricyclic antidepressants and was also generally well tolerated in a
group of 36 depressed inpatients with stable congestive heart failure
(CHF). However, bupropion was associated with a rise in supine blood
pressure in the study of patients with CHF, resulting in
discontinuation of treatment in 2 patients for exacerbation of
baseline hypertension.?
Table 1. Treatment-Emergent Adverse Experience Incidence in
Placebo-Controlled Clinical Trials * (Percent of Patients Reporting)
Adverse Experience Wellbutrin Patients Placebo Patients
(n = 323) (n = 185)
Hypertension 4.3 1.6
PDR.net
http://www.pdr.net/druginformation/DocumentSearch.aspx?documentId=32704600
The same information is available from the FDA at the following link:
See page 9, 14 and 16
http://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4065b1-20-tab11A-Wellbutrin-Tabs-SLR028.pdf
PROZAC (Lilly)
FLUOXETINE HYDROCHLORIDE
?Other Events Observed in Clinical Trials
Cardiovascular System -- Frequent: hemorrhage, hypertension,
palpitation; Infrequent: angina pectoris, arrhythmia, congestive heart
failure, hypotension, migraine, myocardial infarct, postural
hypotension, syncope, tachycardia, vascular headache; Rare: atrial
fibrillation, bradycardia, cerebral embolism, cerebral ischemia,
cerebrovascular accident, extrasystoles, heart arrest, heart block,
pallor, peripheral vascular disorder, phlebitis, shock,
thrombophlebitis, thrombosis, vasospasm, ventricular arrhythmia,
ventricular extrasystoles, ventricular fibrillation.?
Postintroduction Reports
?Voluntary reports of adverse events temporally associated with Prozac
that have been received since market introduction and that may have no
causal relationship with the drug include the following: aplastic
anemia, atrial fibrillation, cataract, cerebral vascular accident,
cholestatic jaundice, confusion, dyskinesia (including, for example, a
case of buccal-lingual-masticatory syndrome with involuntary tongue
protrusion reported to develop in a 77-year-old female after 5 weeks
of fluoxetine therapy and which completely resolved over the next few
months following drug discontinuation), eosinophilic pneumonia,
epidermal necrolysis, erythema nodosum, exfoliative dermatitis,
gynecomastia, heart arrest, hepatic failure/necrosis,
hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia,
kidney failure, misuse/abuse, movement disorders developing in
patients with risk factors including drugs associated with such events
and worsening of preexisting movement disorders, neuroleptic malignant
syndrome-like events, optic neuritis, pancreatitis, pancytopenia,
priapism, pulmonary embolism, pulmonary hypertension, QT prolongation,
serotonin syndrome (a range of signs and symptoms that can rarely, in
its most severe form, resemble neuroleptic malignant syndrome),
Stevens-Johnson syndrome, sudden unexpected death, suicidal ideation,
thrombocytopenia, thrombocytopenic purpura, vaginal bleeding after
drug withdrawal, ventricular tachycardia (including torsades de
pointes-type arrhythmias), and violent behaviors.?
OVERDOSAGE
Human Experience
?Worldwide exposure to fluoxetine hydrochloride is estimated to be
over 38 million patients (circa 1999). Of the 1578 cases of overdose
involving fluoxetine hydrochloride, alone or with other drugs,
reported from this population, there were 195 deaths.
Among 633 adult patients who overdosed on fluoxetine hydrochloride
alone, 34 resulted in a fatal outcome, 378 completely recovered, and
15 patients experienced sequelae after overdosage, including abnormal
accommodation, abnormal gait, confusion, unresponsiveness,
nervousness, pulmonary dysfunction, vertigo, tremor, elevated blood
pressure, impotence, movement disorder, and hypomania. The remaining
206 patients had an unknown outcome.?
Animal Experience
?In a separate single-dose study, the ECG of dogs given high doses did
not reveal prolongation of the PR, QRS, or QT intervals. Tachycardia
and an increase in blood pressure were observed.?
http://www.pdr.net/druginformation/DocumentSearch.aspx?documentId=46003430
The same information is available at RXList at this link:
http://www.rxlist.com/cgi/generic/fluoxetine_od.htm
ADVIL (Wyeth)
Ibuprofen Tablets
Active Ingredient: Each tablet, caplet, gel caplet, or liquigel
capsule contains Ibuprofen 200 mg
Ask a doctor before use if you have:
?Problems or serious side effects from taking pain relievers or fever reducers
Stomach problems that last or come back, such as heartburn, upset stomach, or pain
ulcers
Bleeding problems
High blood pressure, heart or kidney disease, are taking a diuretic,
or are over 65 years of age ?
http://www.pdr.net/druginformation/DocumentSearch.aspx?documentId=90412550
The same information is available here:
http://www.advil.com/products/advil/tablet_label.asp
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