PAROXETINE - ORAL
(pair-OX-eh-teen)
COMMON BRAND NAME(S): Paxil
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Paroxetine Description
Paroxetine is a selective serotonin reuptake inhibitor (SSRI)
used to treat obsessive-compulsive disorder (OCD),
depression and panic disorder.
Paroxetine Pharmacology
Paroxetine is an orally administered antidepressant with a
chemical structure unrelated to other selective serotonin
reuptake inhibitors or to tricyclic, tetracyclic or other
available antidepressant agents.
The antidepressant action of paroxetine and its efficacy in
the treatment of 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.
Steady-state plasma concentrations of paroxetine are
generally achieved in 7 to 10 days, although it may take
substantially longer in an occasional patient.
AT LEAST 1 TO 2 WEEKS, and sometimes up to 4 weeks, may pass
before Paroxetine reaches its full effect.
Paroxetine Indications and Usage
Paroxetine is indicated for the treatment of depression,
obsessive-compulsive disorder (OCD), and panic disorder-with
or without agoraphobia.
Paroxetine Contraindications
Paroxetine is contraindicated in patients who are known to
be hypersensitive to the drug.
Monoamine Oxidase Inhibitors: Paroxetine should not be used
in combination with MAO inhibitors or within 2 weeks of
terminating treatment with MAO inhibitors. Treatment with
paroxetine should then be initiated cautiously and dosage
increased gradually until optimal response is reached. MAO
inhibitors should not be introduced within 2 weeks of
cessation of therapy with paroxetine.
Paroxetine Warnings
Potential for Interaction with Monoamine Oxidase Inhibitors:
In patients receiving another serotonin reuptake inhibitor
drug 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 that drug and have been started on a MAOI. Some
cases presented with features resembling neuroleptic
malignant syndrome. While there are no human data showing
such an interaction with Paroxetine, limited animal data on
the effects of combined use of paroxetine and MAOIs suggest
that these drugs may act synergistically to elevate blood
pressure and evoke behavioral excitation. Therefore it is
recommended that Paroxetine not be used in combination with
a MAOI, or within 14 days of discontinuing treatment with a
MAOI. At least 2 weeks should be allowed after stopping
Paroxetine before starting a MAOI.
Paroxetine Precautions
Activation of Mania/Hypomania: Paroxetine may trigger
hypomania or mania episodes in unipolar and bipolar
individuals. As with all antidepressants, Paroxetine should
be used cautiously in patients with a history of mania.
Suicide: The possibility of a suicide attempt is
inherent in depression and may persist until remission
occurs. Therefore, high risk patients should be closely
supervised throughout therapy and consideration should be
given to the possible need for hospitalization. In order to
minimize the opportunity for overdosage, prescriptions for
paroxetine should be written for the smallest quantity of
drug consistent with good patient management.
Seizures: Caution is recommended when the drug is
administered to patients with a history of seizures. The
drug should be discontinued in any patient who develops
seizures.
Hyponatremia: Several cases of hyponatremia have been
reported. The hyponatremia appeared to be reversible when
Paroxetine was discontinued. The majority of these
occurrences have been in elderly individuals, some in
patients taking diuretics or who were otherwise volume
depleted.
Abnormal Bleeding: There have been several reports of
abnormal bleeding (mostly ecchymosis and purpura) associated
with paroxetine treatment, including a report of impaired
platelet aggregation. While a causal relationship to
paroxetine is unclear, impaired platelet aggregation may
result from platelet serotonin depletion and contribute to
such occurrences.
Use in Patients with Concomitant Illness: Clinical
experience with Paroxetine in patients with certain
concomitant systemic illness is limited. Caution is
advisable in using Paroxetine in patients with diseases or
conditions that could affect metabolism or hemodynamic
responses.
Cardiac Conditions: Paroxetine has not been evaluated
or used to any appreciable extent in patients with a recent
history of myocardial infarction or unstable heart disease.
Clinical studies indicated Paroxetine does not cause any
clinically important changes in heart rate or blood pressure
or any significant ECG abnormalities.
Usage in Children: Do not give to children under 18
years old.
Pregnancy and Withdrawl: The effect of paroxetine on
labor and delivery in humans is unknown. Therefore,
Paroxetine should be used in women who are or might become
pregnant only if the clinical condition clearly justifies
potential risk to the fetus.
Like many other drugs, paroxetine is secreted in human milk,
and caution should be exercised when Paroxetine is
administered to a nursing woman.
Interference with Cognitive or Motor Performance: Any
psychoactive drug may impair judgment, thinking or motor
skills. Although in controlled studies Paroxetine 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 therapy does not affect their ability to
engage in such activities.
Paroxetine Drug Interactions
Tryptophan: As with other serotonin reuptake
inhibitors, an interaction between paroxetine and tryptophan
may occur when they are co-administered. Adverse
experiences, consisting primarily of headache, nausea,
sweating and dizziness, have been reported when tryptophan
was administered to patients taking Paroxetine.
Consequently, concomitant use of Paroxetine with tryptophan
is not recommended.
Monoamine Oxidase Inhibitors: Paroxetine should not
be used in combination with MAO inhibitors or within 2 weeks
of terminating treatment with MAO inhibitors. Treatment with
paroxetine should then be initiated cautiously and dosage
increased gradually until optimal response is reached. MAO
inhibitors should not be introduced within 2 weeks of
cessation of therapy with paroxetine.
Warfarin: Preliminary data suggest that there may be
a pharmacodynamic interaction (that causes an increased
bleeding diathesis in the face of unaltered prothrombin
time) between paroxetine and warfarin. Since there is little
clinical experience, the concomitant administration of
Paroxetine and warfarin should be undertaken with caution.
Sumafriptan: There have been rare postmarketing
reports describing patients with weakness, hyperreflexia,
and incoordination following the use of a selective
serotonin reuptake inhibitor (SSRI) and sumatriptan. If
concomitant treatment with sumatriptan and an SSRI (e.g.,
fluoxetine, fluvoxamine, paroxetine, sertraline) is
clinically warranted, appropriate observation of the patient
is advised.
Drugs Affecting Hepatic Metabolism: The metabolism
and pharmacokinetics of paroxetine may be affected by the
induction or inhibition of drug-metabolizing enzymes.
Cimetidine, Phenobarbital, Phenytoin.
Drugs Metabolized by Cytochrome P450IID6: Many drugs,
including most antidepressants (paroxetine, other SSRls and
many tricyclics), are metabolized by the cytochrome P450
isozyme P45011D6. Concomitant use of Paroxetine with other
drugs metabolized by cytochrome P45011D6 has not been
formally studied but may require lower doses than usually
prescribed for either Paroxetine or the other drug.
Therefore, co-administration of Paroxetine with other drugs
that are metabolized by this isozyme, including certain
antidepressants (e.g., nortriptyline, amitriptyline,
imipramine, desipramine and fluoxetine), phenothiazines
(e.g., thioridazine) and Type iC antiarrhythmics (e.g.,
propafenone, flecainide and encainide), or that inhibit this
enzyme (e.g., quinidine), should be approached with caution.
Tricyclic Antidepressants (TCA): Caution is indicated
in the co-administration of tricyclic antidepressants (TCAs)
with Paroxetine, because paroxetine may inhibit TCA
metabolism. Plasma TCA concentrations may need to be
monitored, and the dose of TCA may need to be reduced, if a
TCA is co-administered with Paroxetine (see above—Drugs
Metabolized by Cytochrome P45011D6).
Lithium, Digoxin, Diazapam: Since there is little
clinical experience, the concurrent administration of
paroxetine and the above drugs should be undertaken with
caution.
BEFORE USING Paroxetine: INFORM YOUR DOCTOR OR PHARMACIST of
all prescription and over-the-counter medicine that you are
taking. This includes cyproheptadine, clozapine,
dexfenfluramine, fenfluramine, astemizole, terfenadine,
lithium, selegiline, tramadol, and medicines used to treat
depression. Inform your doctor of any other medical
conditions, allergies, pregnancy, or breast-feeding.
Paroxetine Adverse Reactions
When Paroxetine is Used for Depression: The most
commonly observed adverse events associated with the use of
Paroxetine were: asthenia, sweating, nausea, decreased
appetite, somnolence, dizziness, insomnia, tremor,
nervousness, ejaculatory disturbance and other male genital
disorders.
When Paroxetine is Used for OCD: The most commonly
observed adverse events associated with the use of
paroxetine were: nausea, dry mouth, decreased appetite,
constipation. dryness, somnolence, tremor, sweating,
impotence and abnormal ejaculation.
When Paroxetine is Used for Panic Disorder: The most
commonly observed adverse events associated with the use of
paroxetine were: asthenia, sweating, decreased appetite,
libido decreased, tremor, abnormal ejaculation, female
genital disorders and impotence.
Other rarer side effects that should be reported
immediately to your doctor: Diarrhea; difficulty in
speaking; drowsiness; dryness of mouth; fever; inability to
move eyes; increased sweating; increased thirst; lack of
energy; loss of or decrease in body movements; mood or
behavior changes; overactive reflexes; racing heartbeat;
restlessness; shivering or shaking; sudden or unusual body
or face movements; talking, feeling, and acting with
excitement and activity you cannot control.
Other possible Paroxetine side effects: Constipation;
decreased sexual ability; dizziness; headache; nausea;
problems in urinating; tremor; trouble in sleeping; unusual
tiredness or weakness; vomiting; anxiety or nervousness;
blurred vision; change in your sense of taste; decreased or
increased appetite; decreased sexual desire; fast or
irregular heartbeat; tingling, burning, or prickly
sensations; weight loss or gain
DO NOT DRINK ALCOHOL while you are taking Paroxetine.
Dependence and Withdrawl: Paroxetine is not a
controlled substance. Paroxetine has not been systematically
studied in animals or humans for its potential for abuse,
tolerance or physical dependence. While the clinical trials
did not reveal any tendency for any drug-seeking behavior,
these observations were not systematic and it is not
possible to predict on the basis of this limited experience
the extent to which a CNS-active drug will be misused,
diverted and/or abused once marketed. Consequently, patients
should be evaluated carefully for history of drug abuse, and
such patients should be observed closely for signs of
Paroxetine misuse or abuse (e.g., development of tolerance,
incrementations of dose drug-seeking behavior).
Paroxetine Overdose
Signs and Symptoms: Overdose with Paroxetine (up to
2000 mg) alone and in combination with other drugs has been
reported. Signs and symptoms of overdose with Paroxetine
include nausea, vomiting, sedation, dizziness, sweating, and
facial flush. There are no reports of coma or convulsions
following overdosage with Paroxetine alone. A fatal outcome
has been reported rarely when Paroxetine was taken in
combination with other agents, or when taken alone. Other
symptoms of overdose may include fast heartbeat and dilated
pupils.
Treatment: If you or someone you know may have used
more than the recommended dose of Paroxetine, contact your
local poison control center or emergency room immediately.
Maintain adequate airway, empty stomach contents, and treat
symptomatically.
Treatment should be supportive and in response to clinical
signs and symptoms. Respiration, pulse and blood pressure
should be monitored and supported by general measures when
necessary. Immediate gastric lavage should be performed
followed by administration of activated charcoal.
Paroxetine Dosage
Do not exceed the recommended dosage or take Paroxetine for
longer than prescribed. Continue to take Paroxetine even if
you feel better. Do not miss any doses.
At least 1-2 weeks, and sometimes up to 4 weeks, may pass
before Paroxetine reaches its full effect.
Follow the directions for using Paroxetine provided by your
doctor.
Store Paroxetine at room temperature, away from heat and
light.
Paroxetine may be taken on an empty stomach or with food.
If you miss a dose of Paroxetine, and you are taking it in
the morning, take it during the afternoon if you remember.
If you do not remember until the next morning, skip the
missed dose and go back to your regular dosing schedule. If
you miss a dose and you are taking a daily dose at bedtime
and do not remember until the next day, skip the missed dose
and go back to your regular dosing schedule. Do not take 2
doses at once.
Additional Information:: Do not share Paroxetine with others
for whom it was not prescribed. Do not use Paroxetine for
other health conditions. Keep Paroxetine out of the reach of
children.
IF USING Paroxetine FOR AN EXTENDED PERIOD OF TIME, obtain
refills before your supply runs out.
For Depression:
Adults: Usual Initial Dosage: Paroxetine should be
administered as a single daily dose, 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.
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.
Maintenance Therapy: There is no body of evidence
available to answer the question of how long the patient
treated with Paroxetine 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
euthyrnia is unknown. Systematic evaluation of the efficacy
of Paroxetine has shown that efficacy is maintained for
periods of up to 1 year with doses that averaged about 30
mg.
For Obsessive-Compulsive Disorder (OCD):
Adults: Paroxetine should be administered as a single
daily dose, usually in the morning. The recommended dose of
Paroxetine 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 in the treatment of OCD.
Maintenance Therapy: 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.
For Panic Disorder:
Adults: Paroxetine should be administered as a single
daily dose, usually in the morning. The target dose of
Paroxetine 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/week 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. The maximum dosage should not exceed 60 mg/day.
Maintenance Therapy: 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.
Elderly or Debilitated, and Patients with Severe Renal or
Hepatic Impairment: The recommended initial dose is 10
mg/ day for elderly patients, debilitated patients, and/o(
patients with, severe renal or hepatic impairment. Increases
may be made if indicated. Dosage should not exceed 40
mg/day. Switching Patients to or from a Monoamine Oxidese
Inhbitor: At least 14 days should elapse between
discontinuation of a MACI and initiation of Paroxetine
therapy. Similarly, at least 14 days should be allowed after
stopping Paroxetine before starting a MAOI.
Children under 18 years of age: The use of paroxetine
in children under 18 years of age is not recommended as
safety and efficacy have not been established in this
population.
How Paroxetine Supplied
Tablets: Each film-coated tablet contains
paroxetine hydrochloride equivalent to paroxetine as
follows: 10 mg, 20 mg, 30 mg, 40 mg.
Suspension for Oral Administration: Each 5 mL of
orange-colored, orange-flavored liquid contains paroxetine
hydrochloride equivalent to paroxetine, 10mg.
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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 Paroxetine.
