PAXIL paroxetine hydrochloride
Refer to the “Also Known As” section to reference different products that include the same medication as PAXIL.
Brand Name: PAXIL
Generic Name: PAROXETINE HYDROCHLORIDE
Drug Type: HUMAN PRESCRIPTION DRUG
Dosage Form: TABLET, FILM COATED
Data Current As Of: 2018-12-17
indications & usage
major depressive disorder:
PAXIL is indicated for the treatment of major depressive disorder.
The efficacy of PAXIL in the treatment of a major depressive episode was established in 6‑week controlled trials of outpatients whose diagnoses corresponded most closely to the DSM‑III category of major depressive disorder (see CLINICAL PHARMACOLOGY: Clinical Trials). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: Change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.
The effects of PAXIL in hospitalized depressed patients have not been adequately studied.
The efficacy of PAXIL in maintaining a response in major depressive disorder for up to 1 year was demonstrated in a placebo‑controlled trial (see CLINICAL PHARMACOLOGY: Clinical Trials). Nevertheless, the physician who elects to use PAXIL for extended periods should periodically re‑evaluate the long‑term usefulness of the drug for the individual patient.
obsessive compulsive disorder:
PAXIL is indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD) as defined in the DSM‑IV. The obsessions or compulsions cause marked distress, are time‑consuming, or significantly interfere with social or occupational functioning.
The efficacy of PAXIL was established in two 12‑week trials with obsessive compulsive outpatients whose diagnoses corresponded most closely to the DSM‑IIIR category of obsessive compulsive disorder (see CLINICAL PHARMACOLOGY: Clinical Trials).
Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego‑dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable.
Long‑term maintenance of efficacy was demonstrated in a 6‑month relapse prevention trial. In this trial, patients assigned to paroxetine showed a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY: Clinical Trials). Nevertheless, the physician who elects to use PAXIL for extended periods should periodically re‑evaluate the long‑term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
PAXIL is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM‑IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.
The efficacy of PAXIL was established in three 10- to 12‑week trials in panic disorder patients whose diagnoses corresponded to the DSM‑IIIR category of panic disorder (see CLINICAL PHARMACOLOGY: Clinical Trials).
Panic disorder (DSM‑IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which 4 (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.
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). Nevertheless, the physician who prescribes PAXIL for extended periods should periodically re‑evaluate the long‑term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
social anxiety disorder:
PAXIL is indicated for the treatment of social anxiety disorder, also known as social phobia, as defined in DSM‑IV (300.23). Social anxiety disorder is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment.
The efficacy of PAXIL was established in three 12‑week trials in adult patients with social anxiety disorder (DSM‑IV). PAXIL has not been studied in children or adolescents with social phobia (see CLINICAL PHARMACOLOGY: Clinical Trials).
The effectiveness of PAXIL in long-term treatment of social anxiety disorder, i.e., for more than 12 weeks, has not been systematically evaluated in adequate and well‑controlled trials. Therefore, the physician who elects to prescribe PAXIL for extended periods should periodically re‑evaluate the long‑term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
generalized anxiety disorder:
PAXIL is indicated for the treatment of Generalized Anxiety Disorder (GAD), as defined in DSM‑IV. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
The efficacy of PAXIL in the treatment of GAD was established in two 8‑week placebo‑controlled trials in adults with GAD. PAXIL has not been studied in children or adolescents with Generalized Anxiety Disorder (see CLINICAL PHARMACOLOGY: Clinical Trials).
Generalized Anxiety Disorder (DSM‑IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following 6 symptoms: Restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance.
The efficacy of PAXIL in maintaining a response in patients with Generalized Anxiety Disorder, who responded during an 8-week acute treatment phase while taking PAXIL and were then observed for relapse during a period of up to 24 weeks, was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY: Clinical Trials). Nevertheless, the physician who elects to use PAXIL for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
posttraumatic stress disorder:
PAXIL is indicated for the treatment of Posttraumatic Stress Disorder (PTSD).
PTSD, as defined by DSM-IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response that involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks, or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning.
The efficacy of PAXIL in longer-term treatment of PTSD, i.e., for more than 12 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to prescribe PAXIL for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
The use of MAOIs intended to treat psychiatric disorders with PAXIL or within 14 days of stopping treatment with PAXIL is contraindicated because of an increased risk of serotonin syndrome. The use of PAXIL within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION).
Starting PAXIL in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS and DOSAGE AND ADMINISTRATION).
Concomitant use with thioridazine is contraindicated (see WARNINGS and PRECAUTIONS). Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS). PAXIL is contraindicated in patients with a hypersensitivity to paroxetine or any of the inactive ingredients in PAXIL.
drug abuse & dependence
controlled substance class:
PAXIL is not a controlled substance.
physical & psychologic dependence:
PAXIL 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 (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).
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. Visual problems
- eye pain
- changes in vision
- swelling or redness in or around the eye
Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.
4. 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
5. 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.
6. Seizures or convulsions
7. 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
8. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.
9. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:
- 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 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). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
- Do not take an MAOI within 2 weeks of stopping PAXIL unless directed to do so by your physician.
- Do not start PAXIL if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.
- 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:
- 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
- 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, 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:
- feeling anxious or trouble sleeping
- sexual problems
- not feeling hungry
- dry mouth
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 1-800-706-5575.
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 and PAXIL CR are registered trademarks of GlaxoSmithKline.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
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