Paroxetine (Page 8 of 9)

14.5 Generalized Anxiety Disorder

The effectiveness of paroxetine in the treatment of generalized anxiety disorder (GAD) was demonstrated in two 8-week, multicenter, placebo-controlled studies (Studies 1 and 2) of adult outpatients with GAD (DSM-IV).


Study 1 was an 8-week study comparing fixed doses of paroxetine 20 mg or 40 mg daily with placebo. Doses of paroxetine 20 mg or 40 mg were both demonstrated to be statistically significantly superior to placebo on the Hamilton Rating Scale for Anxiety (HAM-A) total score.


There was not sufficient evidence in this study to suggest a greater benefit for the paroxetine 40 mg daily dose compared to the 20 mg daily dose.


Study 2 was a flexible-dose study comparing paroxetine 20 mg to 50 mg daily and placebo. Paroxetine demonstrated statistically significant superiority over placebo on the Hamilton Rating Scale for Anxiety (HAM-A) total score.


A third study, a flexible-dose study comparing paroxetine 20 mg to 50 mg daily to placebo, did not demonstrate statistically significant superiority of paroxetine over placebo on the Hamilton Rating Scale for Anxiety (HAM-A) total score, the primary outcome.


Subgroup analyses did not indicate differences in treatment outcomes as a function of race or gender. There were insufficient elderly patients to conduct subgroup analyses on the basis of age.


In a long-term trial, 566 patients meeting DSM-IV criteria for GAD, who had responded during a single-blind, 8-week acute treatment phase with paroxetine 20 mg to 50 mg daily, were randomized to continuation of paroxetine at their same dose, or to placebo, for up to 24 weeks of observation for relapse. Response during the single-blind phase was defined by having a decrease of ≥ 2 points compared to baseline on the CGI-Severity of Illness scale, to a score of ≤ 3. Relapse during the double-blind phase was defined as an increase of ≥ 2 points compared to baseline on the CGI-Severity of Illness scale to a score of ≥ 4, or withdrawal due to lack of efficacy. Patients continuing to receive paroxetine experienced a statistically significantly lower relapse rate over the subsequent 24 weeks compared to those receiving placebo.

14.6 Posttraumatic Stress Disorder

The effectiveness of paroxetine in the treatment of Posttraumatic Stress Disorder (PTSD) was demonstrated in two 12-week, multicenter, placebo-controlled studies (Studies 1 and 2) of adult outpatients who met DSM-IV criteria for PTSD. The mean duration of PTSD symptoms for the 2 studies combined was 13 years (ranging from 0.1 year to 57 years). The percentage of patients with secondary MDD or non-PTSD anxiety disorders in the combined 2 studies was 41% (356 out of 858 patients) and 40% (345 out of 858 patients), respectively. Study outcome was assessed by (1) the Clinician-Administered PTSD Scale Part 2 (CAPS-2) score and (2) the Clinical Global Impression-Global Improvement Scale (CGI-I). The CAPS-2 is a multi-item instrument that measures 3 aspects of PTSD with the following symptom clusters:
Reexperiencing/intrusion, avoidance/numbing and hyperarousal. The 2 primary outcomes for each trial were (1) change from baseline to endpoint on the CAPS-2 total score (17 items), and (2) proportion of responders on the CGI-I, where responders were defined as patients having a score of 1 (very much improved) or 2 (much improved).


Study 1 was a 12-week study comparing fixed doses of paroxetine 20 mg or 40 mg daily to placebo. Doses of paroxetine 20 mg and 40 mg were demonstrated to be statistically significantly superior to placebo on change from baseline for the CAPS-2 total score and on proportion of responders on the CGI-I. There was not sufficient evidence in this study to suggest a greater benefit for the 40 mg daily dose compared to the 20 mg daily dose.


Study 2 was a 12-week flexible-dose study comparing paroxetine 20 mg to 50 mg daily to placebo. Paroxetine was demonstrated to be significantly superior to placebo on change from baseline for the CAPS-2 total score and on proportion of responders on the CGI-I.


A third study, a flexible-dose study comparing paroxetine 20 mg to 50 mg daily to placebo, demonstrated paroxetine to be statistically significantly superior to placebo on change from baseline for CAPS-2 total score, but not on proportion of responders on the CGI-I.


The majority of patients in these trials were women (68% women: 377 out of 551 subjects in Study 1 and 66% women: 202 out of 303 subjects in Study 2). Subgroup analyses did not indicate differences in treatment outcomes as a function of gender. There were an insufficient number of patients who were 65 years and older or were non-Caucasian to conduct subgroup analyses on the basis of age or race, respectively.

16. HOW SUPPLIED/STORAGE AND HANDLING

Paroxetine Tablets USP, 10 mg are white to off-white, round-shaped, biconvex, film- coated tablets debossed with the logo of ‘ZC, 15 and bisect’ on one side and plain on other side, and are supplied as follows:


Boxes of 10×10 UD 100 NDC 63739-888-10


Paroxetine Tablets USP, 20 mg are white to off-white, round-shaped, biconvex, film- coated tablets debossed with the logo of ‘ZC, 16 and bisect’ on one side and plain on other side, and are supplied as follows:


Boxes of 10×10 UD 100 NDC 63739-963-10


Storage


Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).


Suicidal Thoughts and Behaviors


Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see Boxed Warning and Warnings and Precautions (5.1)].


Serotonin Syndrome


Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of paroxetine with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Instruct patients to contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interactions (7)].


Concomitant Medications


Advise patients 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 drug-drug interactions [see Warning and Precautions (5.3), Drug Interactions (7)].


Increased Risk of Bleeding


Inform patients about the concomitant use of paroxetine with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use has been associated with an increased risk of bleeding. Advise patients to inform their health care providers if they are taking or planning to take any prescription or over-the counter medications that increase the risk of bleeding [see Warnings and Precautions (5.5)].


Activation of Mania/Hypomania


Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions (5.6)].


Discontinuation Syndrome


Advise patients not to abruptly discontinue paroxetine and to discuss any tapering regimen with their healthcare provider. Inform patients that adverse reactions can occur when paroxetine is discontinued [see Warnings and Precautions (5.7)].


Sexual Dysfunction


Advise patients that use of paroxetine may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions (5.13)].


Allergic Reactions


Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing [see Adverse Reactions (6.1, 6.2)].

Embryo-Fetal Toxicity


Advise women of the potential risk to the fetus [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)]. Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy because of the risk to the fetus.


Nursing


Advise women to notify their healthcare provider if they are breastfeeding an infant [see Use In Specific Populations (8.3)].
Medication Guide available at www.zydususa.com/medguides or call 1-877-993-8779.

Manufactured by:
Cadila Healthcare Ltd.
India


Distributed by:
McKesson Corporation dba SKY Packaging
Memphis, TN 38141


Rev.: July 2023


21493-3

Medication Guide
Paroxetine (pa rox’ e teen) Tablets, USP

What is the most important information I should know about paroxetine tablets?
Paroxetine tablets can cause serious side effects, including:
• Increased risk of suicidal thoughts or actions. Paroxetine tablets and other antidepressant
medicines may increase suicidal thoughts and actions in some people 24 years of age and
younger, especially within the first few months of treatment or when the dose is changed.
Paroxetine tablets are not for use in children.
° Depression or other mental illnesses are the most important causes of suicidal thoughts
and actions.
How can I watch for and try to prevent suicidal thoughts and actions?
° Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts or
feelings or if you develop suicidal thoughts or actions. This is very important when an
antidepressant medicine is started or when the does is changed.
° Call your healthcare provider right away to report new or sudden changes in mood, behavior,
thoughts or feelings or if you develop suicidal thoughts or actions.
° Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare
provider between visits as needed, especially if you have concerns about symptoms.
Call your healthcare provider or get emergency medical help right away if you have any of the
following symptoms, especially if they are new, worse, or worry you:
° attempts to commit suicide ° acting on dangerous impulses
° acting aggressive or violent ° thoughts about suicide or dying
° new or worse depression ° new or worse anxiety or panic attacks
° feeling agitated, restless, angry, or irritable ° trouble sleeping
° an increase in activity and talking more ° other unusual changes in behavior or mood
than what is normal for you

What are paroxetine tablets?
Paroxetine tablets are prescription medicine used in adults to treat:
• A certain type of depression called Major Depressive Disorder (MDD)
• Obsessive Compulsive Disorder (OCD)
• Panic Disorder (PD)
• Social Anxiety Disorder (SAD)
• Generalized Anxiety Disorder (GAD)
• Posttraumatic Stress Disorder (PTSD)

Do not take paroxetine tablets if you:
• take a monoamine oxidase inhibitor (MAOI)
• have stopped taking an MAOI in the last 14 days
• are being treated with the antibiotic linezolid or the intravenous methylene blue
• are taking pimozide
• are taking thioridazine
• are allergic to paroxetine or any of the ingredients in paroxetine tablets. See the end of this
Medication Guide for a complete list of ingredients in paroxetine tablets.
Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI or one of these
medicines, including the antibiotic linezolid or intravenous methylene blue.
Do not start taking an MAOI for at least 14 days after you stop treatment with paroxetine
tablets.

Before taking paroxetine tablets, tell your healthcare provider about all your medical
conditions, including if you:
• have heart problems
• have or had bleeding problems
• have, or have a family history of, bipolar disorder, mania or hypomania
• have or had seizures or convulsions
• have glaucoma (high pressure in the eye)
• have low sodium levels in your blood
• have bone problems
• have kidney or liver problems
• are pregnant or plan to become pregnant. Paroxetine tablets may harm your unborn baby. Talk
to your healthcare provider about the risks to your unborn baby if you take paroxetine tablets
during pregnancy. Tell your healthcare provider right away if you become pregnant or think you
are pregnant during treatment with paroxetine tablets.
• are breastfeeding or plan to breastfeed. Paroxetine passes into your breast milk. Talk to your
healthcare provider about the best way to feed your baby during treatment with paroxetine
tablets.
Tell your healthcare provider about all the medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements.
Paroxetine tablets and some other medicines may affect each other causing possible serious side
effects. Paroxetine tablets may affect the way other medicines work and other medicines may affect
the way paroxetine tablet works.

Especially tell your healthcare provider if you take:
• medicines used to treat migraine headaches called triptans
• tricyclic antidepressants
• fentanyl
• lithium
• tramadol
• tryptophan
• buspirone
• amphetamines
• St. John’s Wort
• medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs
(NSAIDs), warfarin
• diuretics
• tamoxifen
• medicines used to treat mood, anxiety, psychotic, or thought disorders, including selective
serotonin reuptake (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs)

Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your
healthcare provider can tell you if it is safe to take paroxetine tablets with your other medicines.
Do not start or stop any other medicines during treatment with paroxetine tablets without talking to
your healthcare provider first. Stopping paroxetine tablets suddenly may cause you to have serious
side effects. See, “What are the possible side effects of paroxetine tablets?”
Know the medicines you take. Keep a list of them to show to your healthcare provider and
pharmacist when you get a new medicine.

How should I take paroxetine tablets?
• Take paroxetine tablets exactly as prescribed. Your healthcare provider may need to change
the dose of paroxetine tablets until it is the right dose for you.

• Take paroxetine tablet 1 time each day in the morning.
• Paroxetine tablets may be taken with or without food.
• If you take too much paroxetine tablets, call your poison control center at 1-800-222-1222 or
go to the nearest hospital emergency room right away.

What are possible side effects of paroxetine tablets?
Paroxetine tablets can cause serious side effects, including:
• See, “ What is the most important information I should know about paroxetine tablets?”
• Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can
happen when you take paroxetine tablets with certain other medicines. See, “Who should not
take paroxetine tablets?” Call your healthcare provider or go to the nearest hospital
emergency room right away if you have any of the following signs and symptoms of serotonin
syndrome:
° agitation ° sweating
° seeing or hearing things that are not ° flushing
real (hallucinations) ° high body temperature (hyperthermia)
° confusion ° shaking (tremors), stiff muscles, or muscle
° coma twitching
° fast heart beat ° loss of coordination
° changes in blood pressure ° seizures
° dizziness ° nausea, vomiting, diarrhea

• Eye problems (angle-closure glaucoma). Paroxetine tablets may cause a type of eye problem
called angle-closure glaucoma in people with certain other eye conditions. You may want to
undergo an eye examination to see if you are at risk and receive preventative treatment if you
are. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or
redness in or around the eye.
• Medicine interactions. Taking paroxetine tablets with certain other medicines including
thioridazine and pimozide may increase the risk of developing a serious heart problem called QT
prolongation.
• Seizures (convulsions).
• Manic episodes. Manic episodes may happen in people with bipolar disorder who take
paroxetine tablets. Symptoms may include:
° greatly increased energy ° severe problems sleeping
° racing thoughts ° reckless behavior
° unusually grand ideas ° excessive happiness or irritability
° talking more or faster than usual
• Discontinuation syndrome. Suddenly stopping paroxetine tablets may cause you to have
serious side effects. Your healthcare provider may want to decrease your dose slowly. Symptoms
may include:
° nausea ° electric shock feeling (paresthesia)
° tiredness ° sweating
° tremor ° problems sleeping
° changes in your mood ° anxiety
° hypomania ° irritability and agitation
° confusion ° ringing in your ears (tinnitus)
° dizziness ° headache
° seizures

• Low sodium levels in your blood (hyponatremia). Low sodium levels in your blood that may be
serious and may cause death, can happen during treatment with paroxetine tablets. Elderly
people and people who take certain medicines may be at a greater risk for developing low
sodium levels in your blood. Signs and symptoms may include:
° headache
° difficulty concentrating
° memory changes
° confusion
° weakness and unsteadiness on your feet which can lead to falls
In more severe or more sudden cases, signs and symptoms include:
° seeing or hearing things that are not real (hallucinations)
° fainting
° seizures
° coma
° stopping breathing (respiratory arrest)
• Abnormal bleeding. Taking paroxetine tablets with aspirin, NSAIDs, or blood thinners may
increase this risk. Tell your healthcare provider about any unusual bleeding or bruising.
• Bone fractures.
• Sexual problems (dysfunction). Taking selective serotonin reuptake inhibitors (SSRIs), including
paroxetine, may cause sexual problems.

Symptoms in males may include:
° Delayed ejaculation or inability to have an ejaculation
° Decreased sex drive
° Problems getting or keeping an erection
Symptoms in females may include:
° Decreased sex drive
° Delayed orgasm or inability to have an orgasm
Talk to your healthcare provider if you develop any changes in your sexual function or if you have
any questions or concerns about sexual problems during treatment with paroxetine. There may be
treatments your healthcare provider can suggest.

The most common side effects of paroxetine tablets include:
• male and female sexual function problems • weakness (asthenia)
• constipation • decreased appetite
• diarrhea • dizzines
• dry mouth • nausea
• problems solving • sleepiness
• nervousness • shaking (tremor)
• sweating

• yawning


These are not all the possible side effects of paroxetine tablets.
Call your doctor for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.

How should I store paroxetine tablets?
• Store paroxetine tablets between 68°F to 77°F (20°C to 25°C).
Keep paroxetine tablets and all medicines out of the reach of children.

General information about the safe and effective use of paroxetine tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do
not take paroxetine tablets for a condition for which it was not prescribed. Do not give paroxetine
tablets to other people, even if they have the same symptoms that you have. It may harm them. You
may ask your healthcare provider or pharmacist for information about paroxetine tablets that is
written for healthcare professionals.

What are the ingredients in paroxetine tablets?
Active ingredient: paroxetine hydrochloride, USP
Inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose 6 cP, lactose anhydrous,
magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium
dioxide.
Medication Guide available at www.zydususa.com/medguides or call 1-877-993-8779.

Manufactured by:
Cadila Healthcare Ltd.
India


Distributed by:
McKesson Corporation dba SKY Packaging
Memphis, TN 38141


Rev.: July 2023

21493-3

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