Paxil CR

What is the most important information I should know about Paxil CR?

• While you are taking Paxil CR you may need to be monitored for worsening symptoms of depression and/or suicidal thoughts at the start of therapy or when doses are changed. This concern about the increased risk of suicidal thoughts or behaviors may be greater if you are 18 years of age or younger and are taking Paxil CR. In patients younger than 18 years, the period of risk may extend beyond start of therapy or when doses are changed. Your doctor may want you to monitor for the following symptoms: anxiety, panic attacks, difficulty sleeping, irritability, hostility, impulsivity, severe restlessness, and mania (mental and/or physical hyperactivity). These symptoms may be associated with the development of worsening symptoms of depression and/or suicidal thoughts or actions. Contact your healthcare provider if you develop any new or worsening mental health symptoms during treatment with Paxil CR. Do not stop taking Paxil CR.
• Do not stop taking Paxil CR without first talking to your doctor. It may take 4 weeks or more for you to start feeling better and unpleasant side effects may be experienced if you stop taking Paxil CR suddenly.
  

What is Paxil CR?

• Paxil CR is in a class of drugs called selective serotonin reuptake inhibitors. Paxil CR affects chemicals in the brain that may become unbalanced and cause depression, panic or anxiety, or obsessive or compulsive symptoms.
• Paxil CR is used to treat depression, obsessive-compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder (social phobia), posttraumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).
• Paxil CR may also be used for purposes other than those listed in this medication guide.
  

What should I discuss with my healthcare provider before taking Paxil CR?

• While you are taking Paxil CR you may need to be monitored for worsening symptoms of depression and/or suicidal thoughts at the start of therapy or when doses are changed. This concern about the increased risk of suicidal thoughts or behaviors may be greater if you are 18 years of age or younger and are taking Paxil CR. In patients younger than 18 years, the period of risk may extend beyond start of therapy or when doses are changed. Your doctor may want you to monitor for the following symptoms: anxiety, panic attacks, difficulty sleeping, irritability, hostility, impulsivity, severe restlessness, and mania (mental and/or physical hyperactivity). These symptoms may be associated with the development of worsening symptoms of depression and/or suicidal thoughts or actions. Contact your healthcare provider if you develop any new or worsening mental health symptoms during treatment with Paxil CR. Do not stop taking Paxil CR.
• Do not take Paxil CR if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) during the last 2 weeks. Serious, and sometimes fatal, reactions have occurred when these medicines have been used together. Also, do not take Paxil CR if you are taking thioridazine (Mellaril). Dangerous, even fatal irregular heartbeats may occur if these medicines are taken together. You must wait 5 weeks after stopping Paxil CR before taking thioridazine (Mellaril).
• Before taking Paxil CR, tell your doctor if you have
  · liver disease,
  · kidney disease,
  · seizures or epilepsy, or
  · a manic disorder or suicidal thoughts.
• You may not be able to take Paxil CR, or you may need a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
• Paxil CR is in the FDA pregnancy category C. Babies exposed to Paxil CR and/or other drugs of the same class during the third trimester of pregnancy may develop medical complications. Discuss the risks with your doctor. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment.
• Paxil CR passes into breast milk and may affect a nursing baby. Do not take Paxil CR without first talking to your doctor if you are breast-feeding a baby.
  

How should I take Paxil CR?

• Take Paxil CR exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take each dose with water.
• Swallow the controlled-release tablets (Paxil CR) whole, without crushing or chewing. They are specially formulated to release the medication slowly in the body.
• Shake the suspension well before measuring a dose. To ensure that you get the correct dose, measure the suspension with a dose-measuring cup or spoon, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
• Paxil CR may be taken with or without food
• Try to take Paxil CR at the same time each day.
• Do not stop taking Paxil CR without first talking to your doctor. It may take 4 weeks or more for you to start feeling better and unpleasant side effects may be experienced if you stop taking Paxil CR suddenly.
• Store Paxil CR at room temperature away from moisture and heat.
  

What happens if I miss a dose?

• Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication unless otherwise directed by your doctor.
  

What happens if I overdose?

• Seek emergency medical attention if an overdose is suspected.
• Symptoms of a Paxil CR overdose include nausea, vomiting, tremor, seizures, agitation, drowsiness, hyperactivity, and enlarged pupils.
  

What should I avoid while taking Paxil CR?

• Use caution when driving, operating machinery, or performing other hazardous activities. Paxil CR may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.
• Use alcohol cautiously. Alcohol may increase drowsiness or dizziness while taking Paxil CR.
  

What are the possible side effects of Paxil CR?

• If you experience any of the following serious side effects, stop taking Paxil CR and contact your doctor immediately or seek emergency medical treatment:
  · an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  · an irregular heartbeat or pulse;
  · low blood pressure (dizziness, weakness);
  · high blood pressure (severe headache, blurred vision);
  · unusual bleeding or bruising; or
  · fever or chills.
• Less serious side effects may be more likely to occur. Continue to take Paxil CR and talk to your doctor if you experience
  · headache;
  · tremor, nervousness, or anxiety;
  · nausea, diarrhea, dry mouth, or changes in appetite or weight;
  · sleepiness or insomnia; or
  · decreased sex drive, impotence, or difficulty having an orgasm.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
  

What other drugs will affect Paxil CR?

• Do not take Paxil CR if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) during the last 2 weeks. Serious, and sometimes fatal, reactions have occurred when these medicines have been used together. Also, do not take Paxil CR if you are taking thioridazine (Mellaril). Dangerous, even fatal irregular heartbeats may occur if these medicines are taken together. You must wait 5 weeks after stopping Paxil CR before taking thioridazine (Mellaril).
• Before taking Paxil CR, tell your doctor if you are taking any of the following medicines:
  · a benzodiazepine such as diazepam (Valium), alprazolam (Xanax), chlordiazepoxide (Librium), clorazepate (Tranxene), temazepam (Restoril), triazolam (Halcion), and others;
  · a tricyclic antidepressant such as amitriptyline (Elavil), imipramine (Tofranil), doxepin (Sinequan), nortriptyline (Pamelor), and others;
  · a phenothiazine such as chlorpromazine (Thorazine), fluphenazine (Prolixin), mesoridazine (Serentil), perphenazine (Trilafon), prochlorperazine (Compazine), and others;
  · almotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig);
  · carbamazepine (Tegretol) or phenytoin (Dilantin);
  · lithium (Lithobid, Eskalith, others);
  · theophylline (Theobid, Theolair, Theochron, Elixophyllin, and others);
  · warfarin (Coumadin);
  · digoxin (Lanoxin); or
  · cimetidine (Tagamet, Tagamet HB).
• You may not be able to take Paxil CR, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.
• Drugs other than those listed here may also interact with Paxil CR. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.
  

Where can I get more information?

• Your pharmacist has additional information about Paxil CR written for health professionals that you may read.