Common use
This medication is used to treat major depression related to mood disorders. It is also applied in the treatment of stress and body dysmorphic disorder.
Prevent chewing or cutting, crushing this medication.
Don't take the medication more often than it is prescribed. Don't give up taking it except on the advice of your physician.
It may need time for the medication to help.
Consult your doctor concerning appropriate dose for you.
Precautions
Before taking Paroxetine tell your doctor or chemist if you're allergic to it; or if you might have other allergies.
If you've got bipolar eye, confusion, liver or kidney problems advise your doctor or chemist.
During the pregnancy this treatment should be used only when ardently needed.
Women who are pregnant or may become pregnant shouldn't control this medicine as this medicament can be consumed by skin.
Contraindications
Paxil should not be used by pregnant/nursing women or kids as well as by the patients having demonstrated a response of hypersensitivity to Paroxetine.
Possible side effect
The most common side effects are anxiety, irregular heartbeat and rapid, tremor, blurred vision, vomiting, fever, diarrhoeia, etc.
A very serious allergic reaction seldom occurs. A lot of people using this medication don't have serious side effects.
Turn to your physician or pharmacist for more details.
In the event you detect the effects not listed here, contact your physician or pharmacist.
Drug interaction
Before using this drug tell your physician or pharmacist of all prescription and nonprescription/herbal products you may use,.
Paroxetine can interact with:
* MAO inhibitors: etc., Furazolidone, Isocarboxazid, Linezolid, Moclobemide Tranylcypromine
* Serotonin-norepinephrine reuptake inhibitors (SNRIs): Desvenlafaxine, Duloxetine, Milnacipram, Venlafaxine.
Turn to your physician or pharmacist for more details.
Lost dose
If you have missed your dose, take it as soon as you remember. If you see that it's near the time for another dose, skip the missed dose and resume your regular dosing schedule. Do not take your dose twice.
Overdose
If you believe you have used too much with this medicine seek emergency medical attention without delay. The symptoms of overdose typically include chest pain, nausea, irregular pulse, and feeling lightheaded or fainting.
Storage
Keep your medications at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store your drugs in the bathroom.
Disclaimer
We supply only general information about drugs which doesn't cover all directions, drug integrations that are potential, or precautions. Information at the website cannot be used for self-treatment and self diagnosis. Any special directions for a particular patient should be agreed responsible for the case with your health care advisor or doctor. We disclaim reliability of mistakes and this advice it could feature. We're not responsible for any indirect, direct, special or other indirect damage as an effect of any use of the information on this website as well as for consequences of self-treatment.
Paxil CR Advanced Patient Information
Consumer ratings reports for PAXIL CR. Includes 586 patient rankings on scale of 1-5, comments, side effects, dosage, sex, age, time taken. Page 1 of 10.
Depression. Conventional: 20 mg PO qDay initially; may increase by 10 mg/day qWeek not to exceed 50 mg/day. Paxil CR: 25 mg PO qDay initially; may increase by 12.5 mg.
Learn about clinical pharmacology for the drug Paxil-CR Paroxetine Hydrochloride.
The information included under the Adverse Findings
Observed in Short-Term, Placebo-Controlled Trials With PAXIL CR subsection of
ADVERSE REACTIONS is based on data from 11 placebo-controlled clinical trials.
Three of these studies were conducted in patients with major depressive
disorder, 3 studies were done in patients with panic disorder, 1 study was
conducted in patients with social anxiety disorder, and 4 studies were done in
female patients with PMDD. Two of the studies in major depressive disorder,
which enrolled patients in the age range 18 to 65 years, are pooled.
Information from a third study of major depressive disorder, which focused on
elderly patients 60 to 88 years, is presented separately as is the
information from the panic disorder studies and the information from the PMDD
studies. Information on additional adverse events associated with PAXIL CR and
the immediate-release formulation of paroxetine hydrochloride is included in a
separate subsection see Other Events Observed During the Clinical
Adverse Findings Observed In Short-Term,
Placebo-Controlled Trials With PAXIL CR
Adverse Events Associated With Discontinuation of
Treatment: Major Depressive Disorder
Ten percent 21/212 of patients treated with PAXIL CR
discontinued treatment due to an adverse event in a pool of 2 studies of
patients with major depressive disorder. The most common events 1
associated with discontinuation and considered to be drug related i.e., those
events associated with dropout at a rate approximately twice or greater for
PAXIL CR compared to placebo included the following:
of elderly patients with major depressive disorder, 13 13/104 of patients
treated with PAXIL CR discontinued due to an adverse event. Events meeting the
above criteria included the following:
patients treated with PAXIL CR in panic disorder studies discontinued treatment
due to an adverse event. Events meeting the above criteria included the
patients treated with PAXIL CR in the social anxiety disorder study
discontinued treatment due to an adverse event. Events meeting the above
criteria included the following:
Premenstrual Dysphoric Disorder
Spontaneously reported adverse
events were monitored in studies of both continuous and intermittent dosing of
PAXIL CR in the treatment of PMDD. Generally, there were few differences in the
adverse event profiles of the 2 dosing regimens. Thirteen percent 88/681 of
patients treated with PAXIL CR in PMDD studies of continuous dosing
discontinued treatment due to an adverse event.
The most common events 1 associated with
discontinuation in either group treated with PAXIL CR with an incidence rate
that is at least twice that of placebo in PMDD trials that employed a
continuous dosing regimen are shown in the following table. This table also
shows those events that were dose dependent indicated with an asterisk as
defined as events having an incidence rate with 25 mg of PAXIL CR that was at
least twice that with 12.5 mg of PAXIL CR as well as the placebo group.
a Events considered to be dose dependent are defined as
events having an incidence rate with 25 mg of PAXIL CR that was at least twice
that with 12.5 mg of PAXIL CR as well as the placebo group.
adverse events associated with the use of PAXIL CR in a pool of 2 trials
incidence of 5.0 or greater and incidence for PAXIL CR at least twice that
for placebo, derived from Table 2 were: Abnormal ejaculation, abnormal vision,
constipation, decreased libido, diarrhea, dizziness, female genital disorders,
nausea, somnolence, sweating, trauma, tremor, and yawning.
adverse events associated with the use of PAXIL CR in a study of elderly
patients with major depressive disorder were: Abnormal ejaculation,
constipation, decreased appetite, dry mouth, impotence, infection, libido
decreased, sweating, and tremor.
studies, the adverse events meeting these criteria were: Abnormal ejaculation,
somnolence, impotence, libido decreased, tremor, sweating, and female genital
disorders generally anorgasmia or difficulty achieving orgasm.
In the social anxiety disorder
study, the adverse events meeting these criteria were: Nausea, asthenia,
abnormal ejaculation, sweating, somnolence, impotence, insomnia, and libido
adverse events associated with the use of PAXIL CR either during continuous
dosing or luteal phase dosing incidence of 5 or greater and incidence for
PAXIL CR at least twice that for placebo, derived from Table 6 were: Nausea,
asthenia, libido decreased, somnolence, insomnia, female genital disorders,
sweating, dizziness, diarrhea, and constipation.
In the luteal phase dosing PMDD
trial, which employed dosing of 12.5 mg/day or 25 mg/day of PAXIL CR limited to the 2 weeks prior to the onset of
menses over 3 consecutive menstrual cycles, adverse events were evaluated
during the first 14 days of each off-drug phase. When the 3 off-drug phases
were combined, the following adverse events were reported at an incidence of 2
or greater for PAXIL CR and were at least twice the rate of that reported for
placebo: Infection 5.3 versus 2.5, depression 2.8 versus 0.8, insomnia
2.4 versus 0.8, sinusitis 2.4 versus 0, and asthenia 2.0 versus
events that occurred at an incidence of 1 or more among patients treated with
PAXIL CR, aged 18 to 65, who participated in 2 short-term 12-week
placebo-controlled trials in major depressive disorder in which patients were
dosed in a range of 25 mg to 62.5 mg/day. Table 3 enumerates adverse events
reported at an incidence of 5 or greater among elderly patients ages 60 to
88 treated with PAXIL CR who participated in a short-term 12-week
placebo-controlled trial in major depressive disorder in which patients were
dosed in a range of 12.5 mg to 50 mg/day. Table 4 enumerates adverse events
reported at an incidence of 1 or greater among patients 19 to 72 years
treated with PAXIL CR who participated in short-term 10-week
placebo-controlled trials in panic disorder in which patients were dosed in a
range of 12.5 mg to 75 mg/day. Table 5 enumerates adverse events reported at an
incidence of 1 or greater among adult patients treated with PAXIL CR who
participated in a short-term 12-week, double-blind, placebo-controlled trial
in social anxiety disorder in which patients were dosed in a range of 12.5 to
37.5 mg/day. Table 6 enumerates adverse events that occurred at an incidence of
1 or more among patients treated with PAXIL CR who participated in three,
12-week, placebo-controlled trials in PMDD in which patients were dosed at 12.5
mg/day or 25 mg/day and in one 12-week placebo-controlled trial in which
patients were dosed for 2 weeks prior to the onset of menses luteal phase
dosing at 12.5 mg/day or 25 mg/day. Reported adverse events were classified
using a standard COSTART-based Dictionary terminology.
The prescriber should be aware
that these figures cannot be used to predict the incidence of side effects in
the course of usual medical practice where patient characteristics and other
factors differ from those that prevailed in the clinical trials. Similarly, the
cited frequencies cannot be compared with figures obtained from other clinical
investigations involving different treatments, uses, and investigators. The
cited figures, however, do provide the prescribing physician with some basis
for estimating the relative contribution of drug and nondrug factors to the
side effect incidence rate in the population studied.
Table 2: Treatment-Emergent Adverse Events Occurring
in 1 of Patients Treated With PAXIL CR in a Pool of 2 Studies in
aAdverse events for which the PAXIL CR
reporting incidence was less than or equal to the placebo incidence are not
included. These events are: Abnormal dreams, anxiety, arthralgia,
depersonalization, dysmenorrhea, dyspepsia, hyperkinesia, increased appetite,
myalgia, nervousness, pharyngitis, purpura, rash, respiratory disorder,
sinusitis, urinary frequency, and weight gain.
b 1 means greater than zero and less than 1.
d A wide variety of injuries with no obvious pattern.
e Pain in a variety of locations with no obvious pattern.
f Most frequently seasonal allergic symptoms.
iBased on the number of males or females.
j Mostly anorgasmia or delayed ejaculation.
k Mostly anorgasmia or delayed orgasm.
Adverse Events Occurring in 5
of Patients Treated With PAXIL CR in a Study of Elderly Patients With Major
a Adverse events for which the PAXIL CR
included. These events are nausea and respiratory disorder.
c Based on the number of males.
d Mostly anorgasmia or delayed ejaculation.
Table 4: Treatment-Emergent Adverse Events Occurring in 1 of Patients Treated With PAXIL CR in a Pool of 3 Panic Disorder Studiesa,b
Metabolic/N utritional Disorders
a Adverse events for which the reporting rate
for PAXIL CR was less than or equal to the placebo rate are not included. These
events are: Abnormal dreams, allergic reaction, back pain, bronchitis, chest
pain, concentration impaired, confusion, cough increased, depression,
dizziness, dysmenorrhea, dyspepsia, fever, flatulence, headache, increased
appetite, infection, menstrual disorder, migraine, pain, paresthesia,
pharyngitis, respiratory disorder, rhinitis, tachycardia, taste perversion,
thinking abnormal, urinary tract infection, and vomiting.
e Mostly muscle tightness or stiffness.
g Based on the number of male patients.
h Mostly anorgasmia or delayed ejaculation.
i Based on the number of female patients.
j Mostly anorgasmia or difficulty achieving orgasm.
Table 5: Treatment-Emergent Adverse Effects Occurring
in 1 of Patients Treated With PAXIL CR in a Social Anxiety
Metabolic/Nutritional Disorders
events are: Dysmenorrhea, flatulence, gastroenteritis, hypertonia, infection,
pain, pharyngitis, rash, respiratory disorder, rhinitis, and vomiting.
d Most frequently seasonal allergic symptoms.
f Based on the number of male patients.
g Mostly anorgasmia or delayed ejaculation.
h Based on the number of female patients.
i Mostly anorgasmia or difficulty achieving orgasm.
Table 6: Treatment-Emergent Adverse Events Occurring
in 1 of Patients Treated With PAXIL CR in a Pool of 3
Premenstrual Dysphoric Disorder Studies With Continuous Dosing or in 1
Premenstrual Dysphoric Disorder Study With Luteal Phase Dosinga,b,c
Metabolic and Nutritional Disorders Generalized
of PAXIL CR was less than or equal to the placebo rate are not included. These
events for continuous dosing are: Abdominal pain, back pain, pain, trauma,
weight gain, myalgia, pharyngitis, respiratory disorder, rhinitis, sinusitis,
pruritus, dysmenorrhea, menstrual disorder, urinary tract infection, and
vomiting. The events for luteal phase dosing are: Allergic reaction, back pain,
headache, infection, pain, trauma, myalgia, anxiety, pharyngitis, respiratory
disorder, cystitis, and dysmenorrhea.
c The luteal phase and continuous dosing PMDD trials were not
designed for making direct comparisons between the 2 dosing regimens.
Therefore, a comparison between the 2 dosing regimens of the PMDD trials of
incidence rates shown in Table 6 should be avoided.
d Mostly anorgasmia or difficulty achieving orgasm.
trials of common adverse events, defined as events with an incidence of
1 with 25 mg of PAXIL CR that was at least twice that with 12.5 mg of
Table 7: Incidence of Common Adverse Events in
Placebo, 12.5 mg, and 25 mg of PAXIL CR in a Pool of 3 Fixed-Dose PMDD Trials
A comparison of adverse event rates in a fixed-dose study
comparing immediate-release paroxetine with placebo in the treatment of major
depressive disorder revealed a clear dose dependency for some of the more
common adverse events associated with the use of immediate-release paroxetine.
desire, sexual performance, and sexual satisfaction often occur as
manifestations of a psychiatric disorder, they may also be a consequence of
pharmacologic treatment. In particular, some evidence suggests that SSRIs can
cause such untoward sexual experiences.
incidence and severity of untoward experiences involving sexual desire, performance,
and satisfaction are difficult to obtain; however, in part because patients and
physicians may be reluctant to discuss them. Accordingly, estimates of the
incidence of untoward sexual experience and performance cited in product
labeling, are likely to underestimate their actual incidence.
reporting symptoms of sexual dysfunction in the pool of 2 placebo-controlled
trials in nonelderly patients with major depressive disorder, in the pool of 3
placebo-controlled trials in patients with panic disorder, in the
placebo-controlled trial in patients with social anxiety disorder, and in the
intermittent dosing and the pool of 3 placebo-controlled continuous dosing
trials in female patients with PMDD are as follows:
controlled studies examining sexual dysfunction with paroxetine treatment.
Paroxetine treatment has been associated
with several cases of priapism. In those cases with a known outcome, patients
the precise risk of sexual dysfunction associated with the use of SSRIs,
physicians should routinely inquire about such possible side effects.
Significant weight loss may be
an undesirable result of treatment with paroxetine for some patients but, on
average, patients in controlled trials with PAXIL CR or the immediate-release
formulation, had minimal weight loss about 1 pound. No significant changes in
vital signs systolic and diastolic blood pressure, pulse, and temperature
were observed in patients treated with PAXIL CR, or immediate-release
paroxetine hydrochloride, in controlled clinical trials.
In an analysis of ECGs obtained
in 682 patients treated with immediate-release paroxetine and 415 patients
treated with placebo in controlled clinical trials, no clinically significant
changes were seen in the ECGs of either group.
placebo-controlled clinical trials, patients treated with PAXIL CR or placebo
exhibited abnormal values on liver function tests at comparable rates. In
particular, the controlled-release paroxetine-versus-placebo comparisons for
alkaline phosphatase, SGOT, SGPT, and bilirubin revealed no differences in the
percentage of patients with marked abnormalities.
In a study of elderly patients
with major depressive disorder, 3 of 104 patients treated with PAXIL CR and
none of 109 placebo patients experienced liver transaminase elevations of
Two of the patients treated with PAXIL CR dropped out of
the study due to abnormal liver function tests; the third patient experienced
normalization of transaminase levels with continued treatment. Also, in the
pool of 3 studies of patients with panic disorder, 4 of 444 patients treated
with PAXIL CR and none of 445 placebo patients experienced liver transaminase
elevations of potential clinical concern. Elevations in all 4 patients
decreased substantially after discontinuation of PAXIL CR. The clinical
significance of these findings is unknown.
In placebo-controlled clinical trials with the
immediate-release formulation of paroxetine, patients exhibited abnormal values
on liver function tests at no greater rate than that seen in placebo-treated
In pooled clinical trials of immediate-release paroxetine
hydrochloride, hallucinations were observed in 22 of 9,089 patients receiving
drug and in 4 of 3,187 patients receiving placebo.
Other Events Observed During The Clinical Development Of Paroxetine
The following adverse events were reported during the
clinical development of PAXIL CR and/or the clinical development of the
immediate-release formulation of paroxetine.
Adverse events for which frequencies are provided below
occurred in clinical trials with the controlled-release formulation of
paroxetine. During its premarketing assessment in major depressive disorder,
panic disorder, social anxiety disorder, and PMDD, multiple doses of PAXIL CR
were administered to 1,627 patients in phase 3 double-blind, controlled,
outpatient studies. Untoward events associated with this exposure were recorded
by clinical investigators using terminology of their own choosing.
Consequently, it is not possible to provide a meaningful estimate of the
proportion of individuals experiencing adverse events without first grouping
similar types of untoward events into a smaller number of standardized event
In the tabulations that follow, reported adverse events
were classified using a COSTART-based dictionary. The frequencies presented,
therefore, represent the proportion of the 1,627 patients exposed to PAXIL CR
who experienced an event of the type cited on at least 1 occasion while
receiving PAXIL CR. All reported events are included except those already
listed in Tables 2 through 7 and those events where a drug cause was remote. If
the COSTART term for an event was so general as to be uninformative, it was
deleted or, when possible, replaced with a more informative term. It is
important to emphasize that although the events reported occurred during
treatment with paroxetine, they were not necessarily caused by it.
Events are further categorized by body system and listed
in order of decreasing frequency according to the following definitions:
Frequent adverse events are those occurring on 1 or more occasions in at least
1/100 patients only those not already listed in the tabulated results from
placebo-controlled trials appear in this listing ; infrequent adverse events
are those occurring in 1/100 to 1/1,000 patients; rare events are those
occurring in fewer than 1/1,000 patients.
Adverse events for which frequencies are not provided
occurred during the premarketing assessment of immediate-release paroxetine in
phase 2 and 3 studies of major depressive disorder, obsessive compulsive
disorder, panic disorder, social anxiety disorder, generalized anxiety
disorder, and posttraumatic stress disorder. The conditions and duration of
exposure to immediate-release paroxetine varied greatly and included in
overlapping categories open and double-blind studies, uncontrolled and
controlled studies, inpatient and outpatient studies, and fixed-dose and
titration studies. Only those events not previously listed for
controlled-release paroxetine are included. The extent to which these events
may be associated with PAXIL CR is unknown.
Events are listed alphabetically within the respective
body system. Events of major clinical importance are also described in the
Body as a Whole: Infrequent were chills, face
edema, fever, flu syndrome, malaise; rare were abscess, anaphylactoid reaction,
anticholinergic syndrome, hypothermia; also observed were adrenergic syndrome,
Cardiovascular System: Infrequent were angina pectoris,
bradycardia, hematoma, hypertension, hypotension, palpitation, postural
hypotension, supraventricular tachycardia, syncope; rare were bundle branch
block; also observed were arrhythmia nodal, atrial fibrillation,
cerebrovascular accident, congestive heart failure, low cardiac output,
myocardial infarct, myocardial ischemia, pallor, phlebitis, pulmonary embolus,
supraventricular extrasystoles, thrombophlebitis, thrombosis, vascular
headache, ventricular extrasystoles.
Digestive System: Infrequent were bruxism,
dysphagia, eructation, gastritis, gastroenteritis, gastroesophageal reflux,
gingivitis, hemorrhoids, liver function test abnormal, melena, pancreatitis,
rectal hemorrhage, toothache, ulcerative stomatitis; rare were colitis,
glossitis, gum hyperplasia, hepatosplenomegaly, increased salivation,
intestinal obstruction, peptic ulcer, stomach ulcer, throat tightness; also
observed were aphthous stomatitis, bloody diarrhea, bulimia, cardiospasm,
cholelithiasis, duodenitis, enteritis, esophagitis, fecal impactions, fecal
incontinence, gum hemorrhage, hematemesis, hepatitis, ileitis, ileus, jaundice,
mouth ulceration, salivary gland enlargement, sialadenitis, stomatitis, tongue
Endocrine System: Infrequent were ovarian cyst,
testes pain; rare were diabetes mellitus, hyperthyroidism; also observed were
goiter, hypothyroidism, thyroiditis.
Hemic and Lymphatic System: Infrequent were
anemia, eosinophilia, hypochromic anemia, leukocytosis, leukopenia,
lymphadenopathy, purpura; rare were thrombocytopenia; also observed were
anisocytosis, basophilia, bleeding time increased, lymphedema, lymphocytosis,
lymphopenia, microcytic anemia, monocytosis, normocytic anemia,
Metabolic and Nutritional Disorders: Infrequent were
generalized edema, hyperglycemia, hypokalemia, peripheral edema, SGOT
increased, SGPT increased, thirst; rare were bilirubinemia, dehydration,
hyperkalemia, obesity; also observed were alkaline phosphatase increased, BUN
increased, creatinine phosphokinase increased, gamma globulins increased, gout,
hypercalcemia, hypercholesteremia, hyperphosphatemia, hypocalcemia,
hypoglycemia, hyponatremia, ketosis, lactic dehydrogenase increased,
non-protein nitrogen NPN increased.
Musculoskeletal System: Infrequent were arthritis,
bursitis, tendonitis; rare were myasthenia, myopathy, myositis; also observed
were generalized spasm, osteoporosis, tenosynovitis, tetany.
Nervous System: Frequent were depression;
infrequent were amnesia, convulsion, depersonalization, dystonia, emotional
lability, hallucinations, hyperkinesia, hypesthesia, hypokinesia,
incoordination, libido increased, neuralgia, neuropathy, nystagmus, paralysis,
vertigo; rare were ataxia, coma, diplopia, dyskinesia, hostility, paranoid
reaction, torticollis, withdrawal syndrome; also observed were abnormal gait,
akathisia, akinesia, aphasia, choreoathetosis, circumoral paresthesia,
delirium, delusions, dysarthria, euphoria, extrapyramidal syndrome,
fasciculations, grand mal convulsion, hyperalgesia, irritability, manic
reaction, manic-depressive reaction, meningitis, myelitis, peripheral neuritis,
psychosis, psychotic depression, reflexes decreased, reflexes increased,
Respiratory System: Frequent were pharyngitis;
infrequent were asthma, dyspnea, epistaxis, laryngitis, pneumonia; rare were
stridor; also observed were dysphonia, emphysema, hemoptysis, hiccups,
hyperventilation, lung fibrosis, pulmonary edema, respiratory flu, sputum
Skin and Appendages: Frequent were rash;
infrequent were acne, alopecia, dry skin, eczema, pruritus, urticaria; rare
were exfoliative dermatitis, furunculosis, pustular rash, seborrhea; also
observed were angioedema, ecchymosis, erythema multiforme, erythema nodosum, hirsutism,
maculopapular rash, skin discoloration, skin hypertrophy, skin ulcer, sweating
decreased, vesiculobullous rash.
Special Senses: Infrequent were conjunctivitis,
earache, keratoconjunctivitis, mydriasis, photophobia, retinal hemorrhage,
tinnitus; rare were blepharitis, visual field defect; also observed were
amblyopia, anisocoria, blurred vision, cataract, conjunctival edema, corneal
ulcer, deafness, exophthalmos, glaucoma, hyperacusis, night blindness,
Urogenital System: Frequent were dysmenorrhea ;
infrequent were albuminuria, amenorrhea, breast pain,
cystitis, dysuria, prostatitis, urinary retention; rare were breast
enlargement, breast neoplasm, female lactation,
hematuria, kidney calculus, metrorrhagia , nephritis, nocturia,
pregnancy and puerperal disorders, salpingitis, urinary
incontinence, uterine fibroids enlarged ; also observed were breast
atrophy, ejaculatory disturbance, endometrial disorder, epididymitis,
fibrocystic breast, leukorrhea, mastitis, oliguria, polyuria, pyuria,
urethritis, urinary casts, urinary urgency, urolith, uterine spasm, vaginal
Based on the number of men and women as appropriate.
Voluntary reports of adverse events in patients taking
immediate-release paroxetine hydrochloride that have been received since market
introduction and not listed above that may have no causal relationship with the
drug include acute pancreatitis, elevated liver function tests the most severe
cases were deaths due to liver necrosis, and grossly elevated transaminases
associated with severe liver dysfunction, Guillain-Barré syndrome, Stevens-Johnson
syndrome, toxic epidermal necrolysis, priapism, syndrome of inappropriate ADH
secretion, symptoms suggestive of prolactinemia and galactorrhea;
extrapyramidal symptoms which have included akathisia, bradykinesia, cogwheel
rigidity, dystonia, hypertonia, oculogyric crisis which has been associated
with concomitant use of pimozide; tremor and trismus; status epilepticus, acute
renal failure, pulmonary hypertension, allergic alveolitis, anaphylaxis,
eclampsia, laryngismus, optic neuritis, porphyria, restless legs syndrome
RLS, ventricular fibrillation, ventricular tachycardia including torsade de
pointes, thrombocytopenia, hemolytic anemia, events related to impaired
hematopoiesis including aplastic anemia, pancytopenia, bone marrow aplasia,
and agranulocytosis, vasculitic syndromes such as Henoch-Schönlein purpura
and premature births in pregnant women. There has been a case report of an
elevated phenytoin level after 4 weeks of immediate-release paroxetine and phenytoin
coadministration. There has been a case report of severe hypotension when
immediate-release paroxetine was added to chronic metoprolol treatment.
PAXIL CR is not a controlled substance.
Physical And Psychologic Dependence
PAXIL CR 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 misuse or abuse of PAXIL CR e.g., development of
tolerance, incrementations of dose, drug-seeking behavior.
Read the Paxil-CR paroxetine hydrochloride Side Effects Center for a complete guide to possible side effects.
Paxil-CR (Paroxetine Hydrochloride) Drug Information: Side Effects and Drug Interactions - Prescribing Information at RxList
Paxil CR official prescribing information for healthcare professionals. Includes: indications, dosage, adverse reactions, pharmacology and more.
Learn about drug side effects and interactions for the drug Paxil-CR Paroxetine Hydrochloride.
Generic Name: paroxetine Oral route
Oral route Tablet;Tablet, Extended Release;Suspension
Antidepressants can increase the risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder and other psychiatric disorders. This risk was not observed in patients older than 24 years, and the risk was reduced in patients 65 years or older. Closely monitor patients of all ages for clinical worsening and emergence of suicidal thoughts and behaviors. Paroxetine hydrochloride is not approved for use in pediatric patients
Antidepressants increase the risk of suicidal thinking and behavior.. There is an increased risk in children, adolescents, and young adults in short-term studies with major depressive disorder and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared with placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared with placebo in adults aged 65 or older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients.
Therapeutic Class: Antidepressant
Pharmacologic Class: Serotonin Reuptake Inhibitor
Paroxetine is used to treat depression, obsessive-compulsive disorder OCD, panic disorder, generalized anxiety disorder GAD, social anxiety disorder also known as social phobia, premenstrual dysphoric disorder PMDD, and posttraumatic stress disorder PTSD. Brisdelle is used only to treat moderate to severe hot flashes caused by menopause.
Paroxetine belongs to a group of medicines known as selective serotonin reuptake inhibitors SSRIs. These medicines are thought to work by increasing the activity of the chemical called serotonin in the brain.
This medicine is available only with your doctor s prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of paroxetine in the pediatric population. Safety and efficacy have not been established.
Use of Brisdelle is not indicated in the pediatric population.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of paroxetine in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults, and are more likely to have hyponatremia low sodium in the blood, which may require caution and an adjustment in the dose for patients receiving paroxetine.
Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Bipolar disorder mood disorder with mania and depression, or risk of or
Glaucoma angle-closure type or
Hyponatremia low sodium in the blood or
Seizures, history of Use with caution. May make these conditions worse.
Liver disease, severe Use with caution. The effects may be increased because of slower removal of the medicine from the body.
This section provides information on the proper use of a number of products that contain paroxetine. It may not be specific to Paxil CR. Please read with care.
Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine should come with a Medication Guide. Follow the instructions carefully. Ask your doctor if you have any questions.
Paroxetine may be taken with or without food.
You may have to take paroxetine for a month or longer before you begin to feel better.
If you are taking the oral suspension, shake the bottle well before measuring each dose. Use a small measuring cup or a measuring spoon to measure each dose. The teaspoons and tablespoons that are used for serving and eating food do not measure exact amounts.
Swallow the tablet or extended-release tablet whole. Do not crush, break, or chew it.
Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
The dose of this medicine will be different for different patients. Follow your doctor s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For oral dosage form capsules :
For moderate to severe hot flashes caused by menopause:
Adults 7.5 milligrams mg once a day, at bedtime.
Children Use is not recommended.
For oral dosage form suspension :
Adults At first, 20 milligrams mg 10 milliliters mL once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg 25 mL per day.
Older adults At first, 10 mg 5 mL once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg 20 mL per day.
Children Use and dose must be determined by your doctor.
For generalized anxiety disorder:
For obsessive-compulsive disorder:
Adults At first, 20 milligrams mg 10 milliliters mL once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg 30 mL per day.
Adults At first, 10 milligrams mg 5 milliliters mL once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg 30 mL per day.
For posttraumatic stress disorder:
Older adults At first, 10 mg 5 mL once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 40 mg 20 mL per day.
Adults At first, 20 milligrams mg 10 milliliters mL once a day, usually taken in the morning.
Older adults At first, 10 mg 5 mL once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 20 mg 10 mL per day.
For oral dosage form tablets :
Adults At first, 20 milligrams mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg per day.
Older adults At first, 10 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg per day.
Older adults At first, 10 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 40 mg per day.
Adults At first, 20 milligrams mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 60 mg per day.
Adults At first, 10 milligrams mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
Adults At first, 20 milligrams mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 50 mg per day.
Adults At first, 20 milligrams mg once a day, usually taken in the morning.
Older adults At first, 10 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 20 mg per day.
For oral dosage form extended-release tablets :
Adults At first, 25 milligrams mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 62.5 mg per day.
Older adults At first, 12.5 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg per day.
Adults At first, 12.5 milligrams mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 75 mg per day.
For premenstrual dysphoric disorder:
Adults At first, 12.5 milligrams mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 25 mg per day.
Older adults and children Use and dose must be determined by your doctor.
Adults At first, 12.5 milligrams mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 37.5 mg per day.
Older adults At first, 12.5 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 37.5 mg per day.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using Paxil CR
It is important that your doctor check your progress at regular visits to allow changes in your dose and help reduce any side effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
Do not take paroxetine with a monoamine oxidase MAO inhibitor eg, isocarboxazid Marplan, linezolid Zyvox, methylene blue injection, phenelzine Nardil, selegiline Eldepryl, tranylcypromine Parnate. Do not start taking paroxetine during the 2 weeks after you stop a MAO inhibitor and wait 2 weeks after stopping paroxetine before you start taking a MAO inhibitor. If you take them together or do not wait 2 weeks, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions.
Do not take pimozide Orap or thioridazine Mellaril while you are taking this medicine. Using these medicines together can cause very serious heart problems.
Paroxetine may cause a serious condition called serotonin syndrome if taken together with some medicines. Do not use paroxetine with buspirone Buspar, fentanyl Abstral, Duragesic, lithium Eskalith, Lithobid, tryptophan, St. John s wort, or some pain or migraine medicines eg, rizatriptan, sumatriptan, tramadol, Frova, Imitrex, Maxalt, Relpax, Ultram, Zomig. Check with your doctor first before taking any other medicines with paroxetine.
This medicine may decrease the amount of sperm men make and affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.
Paroxetine may cause some teenagers and young adults to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder manic-depressive or has tried to commit suicide.
Do not suddenly stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This will decrease the chance of having withdrawal symptoms such as agitation, breathing problems, chest pain, confusion, diarrhea, dizziness or lightheadedness, fast heartbeat, headache, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble in sleeping, trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting.
Check with your doctor right away if you develop the following symptoms during the first few weeks of treatment with paroxetine: inability to sit still, need to keep moving, or restlessness.
The use of alcohol is not recommended in patients who are taking paroxetine.
Paroxetine may cause some people to become drowsy or have blurred vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see clearly.
Hyponatremia low sodium in the blood may occur with this medicine. Check with your doctor right away if you have confusion, difficulty concentrating, headaches, memory problems, weakness, and unsteadiness.
This medicine may increase your risk for bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, such as aspirin, nonsteroidal antiinflammatory agents, also called NSAIDs eg, diclofenac, ibuprofen, naproxen, Advil, Aleve, Celebrex, Voltaren, or warfarin Coumadin, Jantoven.
This medicine may increase the risk of bone fractures. Tell your doctor if you have unexplained bone pain, tenderness, swelling, or bruising. Also, ask your doctor about ways to keep your bones strong to help prevent fractures.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription over-the-counter OTC medicines and herbal eg, St. John s wort or vitamin supplements.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
fast, pounding, or irregular heartbeat or pulse
Absence of or decrease in body movements
bigger, dilated, or enlarged pupils black part of the eye
incomplete, sudden, or unusual body or facial movements
increased sensitivity of the eyes to light
red or purple patches on the skin
talking, feeling, and acting with excitement and activity you cannot control
trembling or shaking, or twitching
blistering, peeling, or loosening of the skin
decreased frequency or amount of urine
inability to move the arms and legs
incremental or ratchet-like movement of the muscle
muscle spasm, especially of the neck and back
painful or difficult urination
painful or prolonged erection of the penis
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
raised red swellings on the skin, the buttocks, legs, or ankles
sores, ulcers, or white spots on the lips or in the mouth
sudden numbness and weakness in the arms and legs
swelling of the face, fingers, or lower legs
unexpected or excess milk flow from the breasts
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
decreased sexual ability or desire
pain or tenderness around the eyes and cheekbones
sexual problems, especially ejaculatory disturbances
sleepiness or unusual drowsiness
discouragement, feeling sad, or empty
headache, severe and throbbing
itching of the vagina or genital area
itching, pain, redness, or swelling of the eye or eyelid
pain during sexual intercourse
sense of detachment from self or body
thick, white vaginal discharge with no odor or with a mild odor
tingling, burning, or prickling sensations
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Side effects in more detail
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Learn about the potential side effects of Paxil CR paroxetine. Includes common and rare side effects information for consumers and healthcare professionals.
Paroxetine, also known by the trade names Paxil and Seroxat among others, is an antidepressant of the selective serotonin reuptake inhibitor SSRI class.