Primary Disease Name: Depression
Primary Drug Name: Paxil
Chemical Drug Name: paroexetine hcl
What is Paxil?
PAXIL is an antidepressant that is the newest member of the family
of medications known as selective serotonin reuptake inhibitors
(SSRIs). As a result, PAXIL is able to provide effective and well-tolerated
therapy for depressed patients.
The U.S. Food and Drug Administration has approved PAXIL for the
treatment of major depressive disorder, generalized anxiety disorder
(GAD), social anxiety disorder (SAD), panic disorder, obsessive-compulsive
disorder (OCD) and posttraumatic stress disorder (PTSD).
For many patients, relief from symptoms such as depressed mood
or anxiety symptoms associated with depression may begin after taking
PAXIL for 1 or 2 weeks, but most people can expect to feel the full
benefits of PAXIL in 4 to 6 weeks.
For the greatest benefit, PAXIL should always be taken exactly as
prescribed by a healthcare professional or doctor. It is important
to continue taking PAXIL even after relief from depression begins.
People don't suddenly become depressed, and full recovery takes
time. Healthcare professionals or doctors may recommend continued
PAXIL treatment even if symptoms are improving or resolved, to help
keep the depression from coming back.
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Paxil Side Effects
Commonly Observed Adverse Events and Paxil Side Effects
Paxil Side Effects The most commonly observed adverse
events associated with the use of paroxetine (incidence of 5% or
greater and incidence for paroxetine HCl at least twice that for
placebo) were: asthenia, sweating, nausea, decreased appetite, somnolence,
dizziness, insomnia, tremor, nervousness, ejaculatory disturbance
and other male genital disorders.
Paxil Side Effects - Obsessive Compulsive Disorder:
The most commonly observed adverse events associated with the use
of paroxetine (incidence of 5% or greater and incidence for paroxetine
HCl at least twice that of placebo) were: nausea, dry mouth, decreased
appetite, constipation, dizziness, somnolence, tremor, sweating,
impotence, and abnormal ejaculation.
Paxil Side Effects - Panic Disorder: The most commonly
observed adverse events associated with the use of paroxetine (incidence
of 5% or greater and incidence for paroxetine HCl at least twice
that for placebo) were: asthenia, sweating, decreased appetite,
libido decreased, tremor, abnormal ejaculation, female genital disorders,
and impotence.
Paxil Side Effects - Social Anxiety Disorder: The
most commonly observed adverse events associated with the use of
paroxetine incidence of 5% or greater and (incidence for paroxetine
HCl at least twice that for placebo, derived from TABLE 4A, TABLE
4B, TABLE 4C, and TABLE 4D) were: sweating, nausea, dry mouth, constipation,
decreased appetite, somnolence, tremor, libido decreased, yawn,
abnormal ejaculation, female genital disorders, and impotence.
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Paxil Mechanism of Action
PAXIL (paroxetine HCl) is an agent in a newer class of antidepressant
medication known as selective serotonin reuptake inhibitors (SSRIs).
Depression and anxiety disorders might be caused by a chemical imbalance
in the brain. One of these chemicals is serotonin, which helps send
electrical signals from one nerve cell to another. In the process,
serotonin is released from one nerve cell (the sender) and travels
to the next (the receiver), where it is either absorbed or returns
back to the original sender cell.
When a person suffers from depression or anxiety disorders, there
could be a problem with the serotonin balance and its effect on
cell-to-cell communication.
PAXIL blocks serotonin from being reabsorbed back into the sender
nerve cell. This process increases the amount of serotonin available
to be absorbed by the receiver cell and can help message transmission
return to normal.
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Paxil Canada - Is Paxil from Canada Safe?
Canadian Interenet Pharmacies with the CIPA
seal are a part of the Canadian International Pharmacy Association
Canada and only ship drugs that are of the highest quality, and
as safe as in the United States.
CIPA Certified Canadian Pharmacies dispense only Health Canada approved
prescription drugs such as Paxil from Canada.
Health Canada is the equivalent to the US FDA and has standards
that match those of the FDA.
Prescription drugs from a Cipa Certified Canadian pharmacies are
just as good as those purchased in the United States and the generic
drugs, commonly purchased from online Canadian pharmacies, are of
the highest standard in the world. When purchasing your prescriptions
from an online Canadian Pharmacy you will notice that generic versions
of many popular brand names drugs are readily available.
Paxil from Canada and other Prescription drugs from Canada
points to note:
- All Drugs are approved by Health Canada
- Health Canada is Canada's equivilent to the FDA
- Canadian Generics are of the highest quality in the world
- Prescrition medications from Canada really are of the highest
quality in the world
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Paxil Clinical Pharmacology
The antidepressant action of paroxetine (and, for the immediate-release
tablets and oral suspension, its efficacy in the treatment of social
anxiety disorder (for the immediate-release formulations), obsessive
compulsive disorder [OCD], and panic disorder [PD]) is presumed
to be linked to potentiation of serotonergic activity in the central
nervous system resulting from inhibition of neuronal reuptake of
serotonin (5-hydroxy-tryptamine, 5-HT). Studies at clinically relevant
doses in humans have demonstrated that paroxetine blocks the uptake
of serotonin into human platelets. In vitro studies in animals also
suggest that paroxetine is a potent and highly selective inhibitor
of neuronal serotonin reuptake and has only very weak effects on
norepinephrine and dopamine neuronal reuptake. In vitro radioligand
binding studies indicate that paroxetine has little affinity for
muscarinic, alpha1-, alpha2-, beta-adrenergic-, dopamine (D2)-,
5-HT1-, 5-HT2- and histamine (H1)-receptors; antagonism of muscarinic,
histaminergic and alpha1-adrenergic receptors has been associated
with various anticholinergic, sedative and cardiovascular effects
for other psychotropic drugs.
Because the relative potencies of paroxetine's major metabolites
are at most 1/50 of the parent compound, they are essentially inactive.
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How to Take Paxil
PAXIL may be taken once a day -- either in the morning or the evening
-- with or without food. Talk to your doctor or pharmacist about
what they think is the best time of day for you. You might find
it most convenient to take PAXIL with breakfast or dinner, but you
may take it anytime.
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Paxil Dose / Supply
PAXIL is available in three doses. PAXIL comes as a 10mg tablet,
20mg tablet, & 30mg tablet. It is also available in a Controlled
Release delivery system form – PAXIL CR in 12.5mg, 25mg tablets
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Types of Depression
Depressive disorders come in different forms. There are several
different diagnoses for depression, mostly determined by the intensity
of the symptoms, the duration of the symptoms, and the specific
cause of the symptoms, if that is known.
Psychology Information Online provides information on the following
depressive disorders. Follow the title link for more information
about each type of depression:
1. Major Depression - This is the most serious
type of depression, in terms of number of symptoms and severity
of symptoms, but there are significant individual differences in
the symptoms and severity. You do not need to feel suicidal to have
a major depression, and you do not need to have a history of hospitalizations
either, although both of these factors are present in some people
with major depression. There is no official diagnosis of "moderate
depression."
2. Dysthymic Disorder - This refers to a low to
moderate level of depression that persists for at least two years,
and often longer. While the symptoms are not as severe as a major
depression, they are more enduring and resistant to treatment. Some
people with dysthymia develop a major depression at some time during
the course of their depression.
3. Unspecified Depression - This category is used
to help researchers who are studying other specific types of depression,
and do not want their data confounded with marginal diagnoses. It
includes people with a serious depression, but not quite severe
enough to have a diagnosis of a major depression. It also includes
people with chronic, moderate depression, which has not been present
long enough for a diagnosis of a Dysthymic disorder. (You get the
idea!)
4. Adjustment Disorder, with Depression - This
category describes depression that occurs in response to a major
life stressor or crisis.
5. Bipolar Depression - This type includes both
high and low mood swings, as well as a variety of other significant
symptoms not present in other depressions.
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Paxil Dosage and Administration
Depression
Usual Initial Dosage: Immediate-Release Tablets: Paroxetine
HCl immediate-release formulations should be administered as a single
daily dose, with or without food, usually in the morning. The recommended
initial dose is 20 mg/day. Patients were dosed in a range of 20
to 50 mg/day in the clinical trials demonstrating the antidepressant
effectiveness of paroxetine HCl. As with all antidepressants, the
full antidepressant effect may be delayed. Some patients not responding
to a 20 mg dose may benefit from dose increases, in 10 mg/day increments,
up to a maximum of 50 mg/day. Dose changes should occur at intervals
of at least 1 week.
Controlled-Release Tablets: Paroxetine
HCl controlled-release tablets should be administered as a single
daily dose, usually in the morning, with or without food. The recommended
initial dose is 25 mg/day. Patients were dosed in a range of 25
mg to 62.5 mg/day in the clinical trials demonstrating the antidepressant
effectiveness of paroxetine HCl controlled-release tablets. As with
all antidepressants, the full antidepressant effect may be delayed.
Some patients not responding to a 25 mg dose may benefit from dose
increases, in 12.5 mg/day increments, up to a maximum of 62.5 mg/day.
Dose changes should occur at intervals of at least 1 week.
Patients should be cautioned that the paroxetine HCl controlled-release
tablet should not be chewed or crushed, and should be swallowed
whole.
Maintenance Therapy: Immediate-Release Tablets,
Controlled-Release Tablets: There is no body of evidence available
to answer the question of how long the patient treated with paroxetine
HCl should remain on it. It is generally agreed that acute episodes
of depression require several months or longer of sustained pharmacologic
therapy. Whether the dose of an antidepressant needed to induce
remission is identical to the dose needed to maintain and/or sustain
euthymia is unknown.
Systematic evaluation of the efficacy of immediate-release paroxetine
HCl has shown that efficacy is maintained for periods of up to 1
year with doses that averaged about 30 mg, which corresponds to
a 37.5 mg dose of paroxetine HCl controlled-release tablets.
Obsessive Compulsive Disorder
Immediate-Release Tablets and Oral Suspension
Usual Initial Dosage: Paroxetine HCl should be administered as a
single daily dose, with or without food, usually in the morning.
The recommended dose of paroxetine HCl in the treatment of OCD is
40 mg daily. Patients should be started on 20 mg/day and the dose
can be increased in 10 mg/day increments. Dose changes should occur
at intervals of at least 1 week. Patients were dosed in a range
of 20 to 60 mg/day in the clinical trials demonstrating the effectiveness
of paroxetine HCl in the treatment of OCD. The maximum dosage should
not exceed 60 mg/day.
Maintenance Therapy: Long-term maintenance of efficacy
was demonstrated in a 6?month relapse prevention trial. In this
trial, patients with OCD assigned to paroxetine demonstrated a lower
relapse rate compared to patients on placebo. OCD is a chronic condition,
and it is reasonable to consider continuation for a responding patient.
Dosage adjustments should be made to maintain the patient on the
lowest effective dosage, and patients should be periodically reassessed
to determine the need for continued treatment.
Panic Disorder
Immediate-Release Tablets and Oral Suspension
Usual Initial Dosage: Paroxetine HCl should be administered as a
single daily dose with or without food, usually in the morning.
The target dose of paroxetine HCl in the treatment of panic disorder
is 40 mg/day. Patients should be started on 10 mg/day. Dose changes
should occur in 10 mg/day increments and at intervals of at least
1 week. Patients were dosed in a range of 10 to 60 mg/day in the
clinical trials demonstrating the effectiveness of paroxetine HCl.
The maximum dosage should not exceed 60 mg/day.
Maintenance Therapy: Long-term maintenance of efficacy
was demonstrated in a 3?month relapse prevention trial. In this
trial, patients with panic disorder assigned to paroxetine demonstrated
a lower relapse rate compared to patients on placebo. Panic disorder
is a chronic condition, and it is reasonable to consider continuation
for a responding patient. Dosage adjustments should be made to maintain
the patient on the lowest effective dosage, and patients should
be periodically reassessed to determine the need for continued treatment.
Social Anxiety Disorder
Immediate-Release Tablets and Oral Suspension
Usual Initial Dosage: Paroxetine HCl should be administered as a
single daily dose with or without food, usually in the morning.
The recommended and initial dosage is 20 mg/day. In clinical trials
the effectiveness of paroxetine HCl was demonstrated in patients
dosed in a range of 20 to 60 mg/day. While the safety of paroxetine
HCl has been evaluated in patients with social anxiety disorder
at doses up to 60 mg/day, available information does not suggest
any additional benefit for doses above 20 mg/day.
Maintenance Therapy: There is no body of evidence
available to answer the question of how long the patient treated
with paroxetine HCl should remain on it. Although the efficacy of
paroxetine HCl beyond 12 weeks of dosing has not been demonstrated
in controlled clinical trials, social anxiety disorder is recognized
as a chronic condition, and it is reasonable to consider continuation
of treatment for a responding patient. Dosage adjustments should
be made to maintain the patient on the lowest effective dosage,
and patients should be periodically reassessed to determine the
need for continued treatment.
Immediate-Release Tablets, Oral Suspension, and Controlled-Release
Tablets
Dosage for Elderly or Debilitated, and Patients with Severe Renal
or Hepatic Impairment: The recommended initial dose is 10 mg/day
(immediate-release tablets and oral suspension) and 12.5 mg/day
(controlled-release tablets) for elderly patients, debilitated patients,
and/or patients with severe renal or hepatic impairment. Increases
may be made if indicated. Dosage should not exceed 40 mg/day (immediate-release
tablets and oral suspension) and 50 mg/day (controlled-release tablets).
Switching Patients to or From a Monoamine Oxidase Inhibitor:
At least 14 days should elapse between discontinuation of a MAOI
and initiation of paroxetine HCl therapy. Similarly, at least 14
days should be allowed after stopping paroxetine HCl before starting
an MAOI.
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Paxil Storage
Keep Paxil medication in the container it came in, tightly closed,
and out of reach of children. Store it at room temperature and away
from excess heat and moisture (not in the bathroom). Throw away
any medication that is outdated or no longer needed. Talk to your
pharmacist about the proper disposal of your medication.
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Paxil Warnings
Potential for Interaction with Monoamine Oxidase Inhibitors
In patients receiving serotonin reuptake inhibitor drugs in combination
with a monoamine oxidase inhibitor (MAOI), there have been reports
of serious, sometimes fatal, reactions including hyperthermia, rigidity,
myoclonus, autonomic instability with possible rapid fluctuations
of vital signs, and mental status changes that include extreme agitation
progressing to delirium and coma. These reactions have also been
reported in patients who have recently discontinued SSRI treatment
and have been started on a MAOI. Some cases presented with features
resembling neuroleptic malignant syndrome.
Furthermore, limited
animal data on the effects of combined use of SSRIs and MAOIs suggest
that these drugs may act synergistically to elevate blood pressure
and evoke behavioral excitation. Therefore, it is recommended that
Paxil should not be used in combination with a MAOI, or within
14 days of discontinuing treatment with a MAOI. Similarly, at least
14 days should be allowed after stopping Paxil before starting
a MAOI.
Serotonin syndrome has been reported in two patients who were concomitantly
receiving linezolid an antibiotic which is a reversible non-selective
MAOI.
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Paxil Precautions
General
Discontinuation of Treatment with Paxil
During marketing of Paxil and other SSRIs and SNRIs (Serotonin
and Norepinephrine Reuptake Inhibitors), there have been spontaneous
reports of adverse events occurring upon discontinuation of these
drugs, particularly when abrupt, including the following: dysphoric
mood, irritability, agitation, dizziness, sensory disturbances (e.g.
paresthesias such as electric shock sensations), anxiety, confusion,
headache, lethargy, emotional lability, insomnia, and hypomania.
While these events are generally self-limiting, there have been
reports of serious discontinuation symptoms.
Patients should be monitored for these symptoms when discontinuing
treatment with Paxil. A gradual reduction in the dose rather than
abrupt cessation is recommended whenever possible. If intolerable
symptoms occur following a decrease in the dose or upon discontinuation
of treatment, then resuming the previously prescribed dose may be
considered. Subsequently, the physician may continue decreasing
the dose but at a more gradual rate
Abnormal Bleeding
Published case reports have documented the occurrence of bleeding
episodes in patients treated with psychotropic drugs that interfere
with serotonin reuptake. Subsequent epidemiological studies, both
of the case-control and cohort design, have demonstrated an association
between use of psychotropic drugs that interfere with serotonin
reuptake and the occurrence of upper gastrointestinal bleeding.
In two studies, concurrent use of a nonsteroidal anti-inflammatory
drug (NSAID) or aspirin potentiated the risk of bleeding. Although
these studies focused on upper gastrointestinal bleeding, there
is reason to believe that bleeding at other sites may be similarly
potentiated. Patients should be cautioned regarding the risk of
bleeding associated with the concomitant use of Paxil with NSAIDS,
aspirin, or other drugs that affect coagulation.
Hyponatremia
One case of hyponatremia has been reported in association with Paxil
treatment. Several cases of hyponatremia or SIADH (syndrome of inappropriate
antidiuretic hormone secretion) have been reported in association
with racemic citalopram. All patients with these events have recovered
with discontinuation of escitalopram or citalopram and/or medical
intervention. Hyponatremia and SIADH have also been reported in
association with other marketed drugs effective in the treatment
of major depressive disorder.
Activation of Mania/Hypomania
In placebo-controlled trials of Paxil in major depressive disorder,
activation of mania/hypomania was reported in one (0.1%) of 715
patients treated with Paxil and in none of the 592 patients treated
with placebo. One additional case of hypomania has been reported
in association with Paxil treatment. Activation of mania/hypomania
has also been reported in a small proportion of patients with major
affective disorders treated with racemic citalopram and other marketed
drugs effective in the treatment of major depressive disorder. As
with all drugs effective in the treatment of major depressive disorder,
Paxil should be used cautiously in patients with a history of
mania.
Seizures
Although anticonvulsant effects of racemic citalopram have been
observed in animal studies, Paxil has not been systematically
evaluated in patients with a seizure disorder. These patients were
excluded from clinical studies during the product’s premarketing
testing. In clinical trials of Paxil, cases of convulsion have
been reported in association with Paxil treatment. Like other
drugs effective in the treatment of major depressive disorder, Paxil
should be introduced with care in patients with a history of seizure
disorder.
Suicide
The possibility of a suicide attempt is inherent in major depressive
disorder and may persist until significant remission occurs. Close
supervision of high risk patients should accompany initial drug
therapy. As with all drugs effective in the treatment of major depressive
disorder, prescriptions for Paxil should be written for the smallest
quantity of tablets consistent with good patient management, in
order to reduce the risk of overdose.
Interference with Cognitive and Motor Performance
In a study in normal volunteers, Paxil 10 mg/day did not produce
impairment of intellectual function or psychomotor performance.
Because any psychoactive drug may impair judgment, thinking, or
motor skills, however, patients should be cautioned about operating
hazardous machinery, including automobiles, until they are reasonably
certain that Paxil therapy does not affect their ability to engage
in such activities.
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Paxil Information for Patients
Physicians are advised to discuss the following issues with patients
for whom they prescribe paroxetine HCl.
Interference with Cognitive and Motor Performance: Any psychoactive
drug may impair judgment, thinking or motor skills. Although in
controlled studies immediate-release paroxetine HCl has not been
shown to impair psychomotor performance, patients should be cautioned
about operating hazardous machinery, including automobiles, until
they are reasonably certain that paroxetine HCl therapy does not
affect their ability to engage in such activities.
Completing Course of Therapy: While patients may notice improvement
with paroxetine HCl therapy in 1 to 4 weeks, they should be advised
to continue therapy as directed.
Concomitant Medication: Patients should be advised to inform their
physician if they are taking, or plan to take, any prescription
or over-the-counter drugs, since there is a potential for interactions.
Alcohol: Although immediate-release paroxetine HCl has not been
shown to increase the impairment of mental and motor skills caused
by alcohol, patients should be advised to avoid alcohol while taking
paroxetine HCl.
Pregnancy: Patients should be advised to notify their physician
if they become pregnant or intend to become pregnant during therapy.
Nursing: Patients should be advised to notify their physician if
they are breast-feeding an infant (see Nursing Mothers).
Additional Information for Controlled-Release Tablets: Paroxetine
HCl controlled-release tablets should not be chewed or crushed,
and should be swallowed whole.
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Side Effects
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