Minds On Meds

Mental Health Medications

Antidepressants

Paxil, Page 9

Paxil (paroxetine) is indicated for the treatment of major depressive disorder, social anxiety disorder, obsessive compulsive disorder (OCD), panic disorder, generalized anxiety disorder, and posttraumatic stress disorder (PTSD).

Overdosage Management

No specific antidotes for paroxetine are known. Treatment should consist of those general measures employed in the management of overdosage with any drugs effective in the treatment of major depressive disorder.

Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended.Due to the large volume of distribution of this drug, forced diuresis, dialysis, hemoperfusion, or exchange transfusion are unlikely to be of benefit..

A specific caution involves patients who are taking or have recently taken paroxetine who might ingest excessive quantities of a tricyclic antidepressant. In such a case, accumulation of the parent tricyclic and/or an active metabolite may increase the possibility of clinically significant sequelae and extend the time needed for close medical observation (see PRECAUTIONS: Drugs Metabolized by Cytochrome CYP2D6).

In managing overdosage, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control center for additional information on the treatment of any overdose. Telephone numbers for certified poison control centers are listed in the Physicians’ Desk Reference (PDR).

DOSAGE AND ADMINISTRATION

Major Depressive Disorder

Usual Initial Dosage

PAXIL should be administered as a single daily dose with or without food, usually in the morning. The recommended initial dose is 20 mg/day. Patients were dosed in a range of 20 to 50 mg/day in the clinical trials demonstrating the effectiveness of PAXIL in the treatment of major depressive disorder. As with all drugs effective in the treatment of major depressive disorder, the full effect may be delayed. Some patients not responding to a 20-mg dose may benefit from dose increases, in 10-mg/day increments, up to a maximum of 50 mg/day. Dose changes should occur at intervals of at least 1 week.

Maintenance Therapy

There is no body of evidence available to answer the question of how long the patient treated with PAXIL should remain on it. It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Whether the dose needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown.

Systematic evaluation of the efficacy of PAXIL has shown that efficacy is maintained for periods of up to 1 year with doses that averaged about 30 mg.

Obsessive Compulsive Disorder

Usual Initial Dosage

PAXIL should be administered as a single daily dose with or without food, usually in the morning. The recommended dose of PAXIL in the treatment of OCD is 40 mg daily. Patients should be started on 20 mg/day and the dose can be increased in 10-mg/day increments. Dose changes should occur at intervals of at least 1 week. Patients were dosed in a range of 20 to 60 mg/day in the clinical trials demonstrating the effectiveness of PAXIL in the treatment of OCD. The maximum dosage should not exceed 60 mg/day.

Maintenance Therapy

Long-term maintenance of efficacy was demonstrated in a 6-month relapse prevention trial. In this trial, patients with OCD assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY: Clinical Trials). OCD is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Panic Disorder

Usual Initial Dosage

PAXIL should be administered as a single daily dose with or without food, usually in the morning. The target dose of PAXIL in the treatment of panic disorder is 40 mg/day. Patients should be started on 10 mg/day. Dose changes should occur in 10-mg/day increments and at intervals of at least 1 week. Patients were dosed in a range of 10 to 60 mg/day in the clinical trials demonstrating the effectiveness of PAXIL. The maximum dosage should not exceed 60 mg/day.

Maintenance Therapy

Long-term maintenance of efficacy was demonstrated in a 3-month relapse prevention trial. In this trial, patients with panic disorder assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY: Clinical Trials). Panic disorder is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Social Anxiety Disorder

Usual Initial Dosage

PAXIL should be administered as a single daily dose with or without food, usually in the morning. The recommended and initial dosage is 20 mg/day. In clinical trials the effectiveness of PAXIL was demonstrated in patients dosed in a range of 20 to 60 mg/day. While the safety of PAXIL has been evaluated in patients with social anxiety disorder at doses up to 60 mg/day, available information does not suggest any additional benefit for doses above 20 mg/day (see CLINICAL PHARMACOLOGY: Clinical Trials).

Maintenance Therapy

There is no body of evidence available to answer the question of how long the patient treated with PAXIL should remain on it. Although the efficacy of PAXIL beyond 12 weeks of dosing has not been demonstrated in controlled clinical trials, social anxiety disorder is recognized as a chronic condition, and it is reasonable to consider continuation of treatment for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Generalized Anxiety Disorder

Usual Initial Dosage

PAXIL should be administered as a single daily dose with or without food, usually in the morning. In clinical trials the effectiveness of PAXIL was demonstrated in patients dosed in a range of 20 to 50 mg/day. The recommended starting dosage and the established effective dosage is 20 mg/day. There is not sufficient evidence to suggest a greater benefit to doses higher than 20 mg/day. Dose changes should occur in 10 mg/day increments and at intervals of at least 1 week.

Maintenance Therapy

Systematic evaluation of continuing PAXIL for periods of up to 24 weeks in patients with Generalized Anxiety Disorder who had responded while taking PAXIL during an 8-week acute treatment phase has demonstrated a benefit of such maintenance (see CLINICAL PHARMACOLOGY: Clinical Trials). Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.

Posttraumatic Stress Disorder

Usual Initial Dosage

PAXIL should be administered as a single daily dose with or without food, usually in the morning. The recommended starting dosage and the established effective dosage is 20 mg/day. In 1 clinical trial, the effectiveness of PAXIL was demonstrated in patients dosed in a range of 20 to 50 mg/day. However, in a fixed dose study, there was not sufficient evidence to suggest a greater benefit for a dose of 40 mg/day compared to 20 mg/day. Dose changes, if indicated, should occur in 10 mg/day increments and at intervals of at least 1 week.

Maintenance Therapy

There is no body of evidence available to answer the question of how long the patient treated with PAXIL should remain on it. Although the efficacy of PAXIL beyond 12 weeks of dosing has not been demonstrated in controlled clinical trials, PTSD is recognized as a chronic condition, and it is reasonable to consider continuation of treatment for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Special Populations

Treatment of Pregnant Women During the Third Trimester

Neonates exposed to PAXIL and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see WARNINGS: Usage in Pregnancy). When treating pregnant women with paroxetine during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering paroxetine in the third trimester.

Dosage for Elderly or Debilitated Patients, and Patients With Severe Renal or Hepatic Impairment

The recommended initial dose is 10 mg/day for elderly patients, debilitated patients, and/or patients with severe renal or hepatic impairment. Increases may be made if indicated. Dosage should not exceed 40 mg/day.

Switching Patients to or From a Monoamine Oxidase Inhibitor

At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with PAXIL. Similarly, at least 14 days should be allowed after stopping PAXIL before starting an MAOI.

Discontinuation of Treatment With PAXIL

Symptoms associated with discontinuation of PAXIL have been reported (see PRECAUTIONS: Discontinuation of Treatment With PAXIL). Patients should be monitored for these symptoms when discontinuing treatment, regardless of the indication for which PAXIL is being prescribed. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

NOTE: SHAKE SUSPENSION WELL BEFORE USING.

HOW SUPPLIED

Tablets

Film-coated, modified-oval as follows:

10-mg yellow, scored tablets engraved on the front with PAXIL and on the back with 10.

NDC 0029-3210-13 Bottles of 30

20-mg pink, scored tablets engraved on the front with PAXIL and on the back with 20.

NDC 0029-3211-13 Bottles of 30

30-mg blue tablets engraved on the front with PAXIL and on the back with 30.

NDC 0029-3212-13 Bottles of 30

40-mg green tablets engraved on the front with PAXIL and on the back with 40.

NDC 0029-3213-13 Bottles of 30

Store tablets between 15° and 30°C (59° and 86°F).

Oral Suspension

Orange-colored, orange-flavored, 10 mg/5 mL, in white bottles containing 250 mL.

NDC 0029-3215-48

Store suspension at or below 25°C (77°F).

PAXIL is a registered trademark of GlaxoSmithKline.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2011, GlaxoSmithKline. All rights reserved.

March 2011 PXL:58PI

Medication Guide

PAXIL® (PAX-il)

(paroxetine hydrochloride)

Tablets and Oral Suspension

Read the Medication Guide that comes with PAXIL before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about.

What is the most important information I should know about PAXIL?

PAXIL and other antidepressant medicines may cause serious side effects, including:

1. Suicidal thoughts or actions:

  • PAXIL and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
  • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
  • Watch for these changes and call your healthcare provider right away if you notice:
    • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
    • Pay particular attention to such changes when PAXIL is started or when the dose is changed.

Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, 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 or talking more than what is normal for you
  • other unusual changes in behavior or mood

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. PAXIL may be associated with these serious side effects:

2. Serotonin Syndrome or Neuroleptic Malignant Syndrome-like reactions. This condition can be life-threatening and may include:

  • agitation, hallucinations, coma, or other changes in mental status
  • coordination problems or muscle twitching (overactive reflexes)
  • racing heartbeat, high or low blood pressure
  • sweating or fever
  • nausea, vomiting, or diarrhea
  • muscle rigidity

3. Severe allergic reactions:

  • trouble breathing
  • swelling of the face, tongue, eyes, or mouth
  • rash, itchy welts (hives), or blisters, alone or with fever or joint pain

4. Abnormal bleeding: PAXIL and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.

5. Seizures or convulsions

6. Manic episodes:

  • greatly increased energy
  • severe trouble sleeping
  • racing thoughts
  • reckless behavior
  • unusually grand ideas
  • excessive happiness or irritability
  • talking more or faster than usual

7. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.

8. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:

  • headache
  • weakness or feeling unsteady
  • confusion, problems concentrating or thinking, or memory problems

Do not stop PAXIL without first talking to your healthcare provider. Stopping PAXIL too quickly may cause serious symptoms including:

  • anxiety, irritability, high or low mood, feeling restless, or changes in sleep habits
  • headache, sweating, nausea, dizziness
  • electric shock-like sensations, shaking, confusion

What is PAXIL?

PAXIL is a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider. PAXIL is also used to treat:

  • Major Depressive Disorder (MDD)
  • Obsessive Compulsive Disorder (OCD)
  • Panic Disorder
  • Social Anxiety Disorder
  • Generalized Anxiety Disorder (GAD)
  • Posttraumatic Stress Disorder (PTSD)

Talk to your healthcare provider if you do not think that your condition is getting better with treatment using PAXIL.

Who should not take PAXIL?

Do not take PAXIL if you:

  • are allergic to paroxetine hydrochloride or any of the ingredients in PAXIL. See the end of this Medication Guide for a complete list of ingredients in PAXIL.
  • take a Monoamine Oxidase Inhibitor (MAOI), such as PARNATE® (tranylcypromine), NARDIL® (phenelzine), or the antibiotic ZYVOX® (linezolid). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI.
  • Do not take an MAOI within 2 weeks of stopping PAXIL.
  • Do not start PAXIL if you stopped taking an MAOI in the last 2 weeks.
  • People who take PAXIL close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:
    • high fever
    • uncontrolled muscle spasms
    • stiff muscles
    • rapid changes in heart rate or blood pressure
    • confusion
    • loss of consciousness (pass out)
  • take MELLARIL® (thioridazine). Do not take MELLARIL® together with PAXIL because this can cause serious heart rhythm problems or sudden death.
  • take the antipsychotic medicine pimozide (ORAP®) because this can cause serious heart problems.

What should I tell my healthcare provider before taking PAXIL? Ask if you are not sure.

Before starting PAXIL, tell your healthcare provider if you:

  • are pregnant, may be pregnant, or plan to become pregnant. There is a possibility that PAXIL may harm your unborn baby, including an increased risk of birth defects, particularly heart defects. Other risks may include a serious condition in which there is not enough oxygen in the baby’s blood. Your baby may also have certain other symptoms shortly after birth. Premature births have also been reported in some women who used PAXIL during pregnancy
  • are breastfeeding. PAXIL passes into your milk. Talk to your healthcare provider about the best way to feed your baby while taking PAXIL.
  • are taking certain drugs such as:
    • triptans used to treat migraine headache
    • other antidepressants (SSRIs, SNRIs, tricyclics, or lithium) or antipsychotics
    • drugs that affect serotonin, such as lithium, tramadol, tryptophan, St. John’s wort
    • certain drugs used to treat irregular heart beats
    • certain drugs used to treat schizophrenia
    • certain drugs used to treat HIV infection
    • certain drugs that affect the blood, such as warfarin, aspirin, and ibuprofen
    • certain drugs used to treat epilepsy
    • atomoxetine
    • cimetidine
    • fentanyl
    • metoprolol
    • pimozide
    • procyclidine
    • tamoxifen
  • have liver problems
  • have kidney problems
  • have heart problems
  • have or had seizures or convulsions
  • have bipolar disorder or mania
  • have low sodium levels in your blood
  • have a history of a stroke
  • have high blood pressure
  • have or had bleeding problems
  • have glaucoma (high pressure in the eye)

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. PAXIL and some medicines may interact with each other, may not work as well, or may cause serious side effects.

Your healthcare provider or pharmacist can tell you if it is safe to take PAXIL with your other medicines. Do not start or stop any medicine while taking PAXIL without talking to your healthcare provider first.

If you take PAXIL, you should not take any other medicines that contain paroxetine hydrochloride, including PAXIL CR and PEXEVA® (paroxetine mesylate).

How should I take PAXIL?

  • Take PAXIL exactly as prescribed. Your healthcare provider may need to change the dose of PAXIL until it is the right dose for you.
  • PAXIL may be taken with or without food.
  • If you are taking PAXIL Oral Suspension, shake the suspension well before use.
  • If you miss a dose of PAXIL, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of PAXIL at the same time.
  • If you take too much PAXIL, call your healthcare provider or poison control center right away, or get emergency treatment.
  • Do not stop taking PAXIL suddenly without talking to your doctor (unless you have symptoms of a severe allergic reaction). If you need to stop taking PAXIL, your healthcare provider can tell you how to safely stop taking it.

What should I avoid while taking PAXIL?

PAXIL can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how PAXIL affects you. Do not drink alcohol while using PAXIL.

What are possible side effects of PAXIL?

PAXIL may cause serious side effects, including all of those described in the section entitled “What is the most important information I should know about PAXIL?”

Common possible side effects in people who take PAXIL include:

  • nausea
  • sleepiness
  • weakness
  • dizziness
  • feeling anxious or trouble sleeping
  • sexual problems
  • sweating
  • shaking
  • not feeling hungry
  • dry mouth
  • constipation
  • infection
  • yawning

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of PAXIL. For more information, ask your healthcare provider or pharmacist.

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 or 1-800-332-1088.

How should I store PAXIL?

  • Store PAXIL Tablets at room temperature between 59º and 86ºF (15º and 30ºC).
  • Store PAXIL Oral Suspension at or below 77ºF (25ºC).
  • Keep PAXIL away from light.
  • Keep bottle of PAXIL closed tightly.

Keep PAXIL and all medicines out of the reach of children.

General information about PAXIL

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PAXIL for a condition for which it was not prescribed. Do not give PAXIL to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about PAXIL. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about PAXIL that is written for healthcare professionals.

For more information about PAXIL call 1-888-825-5249 or go to www.us.gsk.com.

What are the ingredients in PAXIL?

Active ingredient: paroxetine hydrochloride

Inactive ingredients in tablets: dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, polyethylene glycols, polysorbate 80, sodium starch glycolate, titanium dioxide, and 1 or more of the following: D&C Red No. 30 aluminum lake, D&C Yellow No. 10 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 6 aluminum lake.

Inactive ingredients in suspension for oral administration: polacrilin potassium, microcrystalline cellulose, propylene glycol, glycerin, sorbitol, methylparaben, propylparaben, sodium citrate dihydrate, citric acid anhydrous, sodium saccharin, flavorings, FD&C Yellow No. 6 aluminum lake, and simethicone emulsion, USP.

PAXIL, PAXIL CR and PARNATE are registered trademarks of GlaxoSmithKline. The other brands listed are trademarks of their respective owners and are not trademarks of GlaxoSmithKline. The makers of these brands are not affiliated with and do not endorse GlaxoSmithKline or its products.

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

GlaxoSmithKline

Research Triangle Park, NC 27709

©2011, GlaxoSmithKline. All rights reserved.

March 2011 PXL:5MG