Paroxetine: Package Insert and Label Information (Page 5 of 6)

14.3 Panic Disorder

The effectiveness of paroxetine in the treatment of panic disorder (PD) was demonstrated in three 10- to 12-week multicenter, placebo-controlled studies of adult outpatients (Studies 1, 2, and 3). Patients had PD (DSM-IIIR), with or without agoraphobia. In these studies, paroxetine was shown to be statistically significantly more effective than placebo in treating PD by at least 2 out of 3 measures of panic attack frequency and on the Clinical Global Impression Severity of Illness score.

Study 1 was a 10-week dose-range finding study; patients received fixed doses of paroxetine 10 mg, 20 mg, or 40 mg daily or placebo. A statistically significant difference from placebo was observed only for the paroxetine 40 mg daily group. At endpoint, 76% of patients receiving paroxetine 40 mg daily were free of panic attacks, compared to 44% of placebo-treated patients.

Study 2 was a 12-week flexible-dose study comparing paroxetine 10 mg to 60 mg daily and placebo. At endpoint, 51% of paroxetine-treated patients were free of panic attacks compared to 32% of placebo-treated patients.

Study 3 was a 12-week flexible-dose study comparing paroxetine 10 mg to 60 mg daily to placebo in patients concurrently receiving standardized cognitive behavioral therapy. At endpoint, 33% of the paroxetine-treated patients showed a reduction to 0 or 1 panic attacks compared to 14% of placebo-treated patients.

In Studies 2 and 3, the mean paroxetine dose for completers at endpoint was approximately 40 mg daily.

Long-term efficacy of paroxetine in PD was demonstrated in an extension to Study 1. Patients who responded to paroxetine during the 10-week double-blind phase and during a 3-month double-blind extension phase were randomized to either paroxetine 10 mg, 20 mg, or 40 mg daily or placebo in a 3-month double-blind relapse prevention phase. Patients randomized to paroxetine were statistically significantly less likely to relapse than placebo-treated patients.

Subgroup analyses did not indicate that there were any differences in treatment outcomes as a function of age or gender.

14.4 Social Anxiety Disorder

The effectiveness of paroxetine in the treatment of social anxiety disorder (SAD) was demonstrated in three 12-week, multicenter, placebo-controlled studies (Studies 1, 2, and 3) of adult outpatients with SAD (DSM-IV). In these studies, the effectiveness of paroxetine compared to placebo was evaluated on the basis of (1) the proportion of responders, as defined by a Clinical Global Impression (CGI) Improvement score of 1 (very much improved) or 2 (much improved), and (2) change from baseline in the Liebowitz Social Anxiety Scale (LSAS).

Studies 1 and 2 were flexible-dose studies comparing paroxetine 20 mg to 50 mg daily and placebo. Paroxetine demonstrated statistically significant superiority over placebo on both the CGI Improvement responder criterion and the Liebowitz Social Anxiety Scale (LSAS). In Study 1, for patients who completed to week 12, 69% of paroxetine-treated patients compared to 29% of placebo-treated patients were CGI Improvement responders. In Study 2, CGI Improvement responders were 77% and 42% for the paroxetine- and placebo-treated patients, respectively.

Study 3 was a 12-week study comparing fixed doses of paroxetine 20 mg, 40 mg, or 60 mg daily with placebo. Paroxetine 20 mg was statistically significantly superior to placebo on both the LSAS Total Score and the CGI Improvement responder criterion; there were trends for superiority over placebo for the paroxetine 40 mg and 60 mg daily dose groups. There was no indication in this study of any additional benefit for doses higher than 20 mg daily.

Subgroup analyses generally did not indicate differences in treatment outcomes as a function of age, race, or gender.

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:
Unit dose packages of 100 (10 x 10) NDC 68084-044-01

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:
Unit dose packages of 100 (10 x 10) NDC 68084-045-01

Paroxetine Tablets USP, 30 mg are white to off-white, round-shaped, biconvex, film-coated tablets debossed with the logo of ‘ZC17’ on one side and plain on other side, and are supplied as follows:
Unit dose packages of 100 (10 x 10) NDC 68084-046-01

Paroxetine Tablets USP, 40 mg are white to off-white, round-shaped, biconvex, film-coated tablets debossed with the logo of ‘ZC18’ on one side and plain on other side, and are supplied as follows:
Unit dose packages of 100 (10 x 10) NDC 68084-047-01

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

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

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)].

To order more Medication Guides call American Health Packaging at 1-800-707-4621.

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Zydus Pharmaceuticals (USA) Inc. as follows:
(10 mg / 100 UD) NDC 68084-044-01 packaged from NDC 68382-097
(20 mg / 100 UD) NDC 68084-045-01 packaged from NDC 68382-098
(30 mg / 100 UD) NDC 68084-046-01 packaged from NDC 68382-099
(40 mg / 100 UD) NDC 68084-047-01 packaged from NDC 68382-001

Distributed by:
American Health Packaging Columbus, OH 43217

8004401/1121

Medication Guide

8004401/1121

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 than what is normal for you
  • other unusual changes in behavior or mood

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 tablets 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 real (hallucinations)
  • flushing
  • confusion
  • high body temperature (hyperthermia)
  • coma
  • shaking (tremors), stiff muscles, or muscle 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
  • dizziness
  • dry mouth
  • infection
  • problems sleeping
  • nausea
  • nervousness
  • sleepiness
  • sweating
  • shaking (tremor)
  • 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, USP? 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. To order more Medication Guides call American Health Packaging at 1-800-707-4621.

Distributed by:

American Health Packaging

Columbus, OH 43217

8004401/1121

This Medication Guide has been approved by the U.S. Food and Drug Administration.

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