The following information is intended to supplement, not substitute, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that using Paxil or Paxil CR is safe or appropriate for you.

Brand Name: Paxil, Paxil CR

Generic Name: (paroxetine)

What are Paxil and Paxil CR used for? Paxil is in a class of drugs called select serotonin reuptake inhibitors (SSRI). Paxil is an antidepressant medication used to relieve symptoms of depression, generalized anxiety disorder and social anxiety disorder (social phobia), obsessive-compulsive disorders, panic attacks, posttraumatic stress disorder (PTSD) and premenstrual dysphoric disorder (PMDD). Paxil CR (controlled-release) is used to treat depression and panic attacks.

FDA Warnings for paroxetine hcl: The FDA issued a public health alert for Paxil in March 2004 warning that paroxetine hcl can lead to deeper depression and suicide. The FDA recommends that health care providers warn patients, their families and their caregivers to be alert for agitation, irritability, suicide and worsening depression while using Paxil. The FDA also recommends that health care providers closely monitor adult and children treated with paroxetine hcl for worsening of depression or suicidal tendencies, especially at the beginning of therapy or when the dose either increases or decreases.

The FDA issued a Public Health Advisory in October 2003 about increased reports of suicidal thinking, suicide attempts, hostility and self-harm in children using Paxil. The FDA urges that Paxil be used with caution in children. Parents of children using Paxil should consult the prescribing physician immediately to discuss the suicide risks involved in taking Paxil.

It should be noted that the safety and effectiveness of Paxil in pediatric patients has not been established. In clinical trials, only Prozac (fluoxetine) has been found effective for children.

General Paxil Precautions:
_ Paxil may cause dizziness. If you experience dizziness, avoid driving, operating machinery, or performing other hazardous activities.
_ Rise slowly when rising from a sitting or lying position to prevent dizziness or possible falls.
_ Do not take Paxil if you have taken a monoamine oxidase inhibitor (MAOI) within the last 14 days. A dangerous drug interaction can occur if paroxetine hcl is combined with MAO inhibitors.
_ Dangerous, even fatal, irregular heartbeats may occur if paroxetine hcl is taken with thioridazine. You must wait 5 weeks after stopping paroxetine hcl before taking thioridazine.
_ It is not known whether Paxil will harm an unborn baby or a nursing baby.
_ Paxil may impair judgment, thinking, or motor skills. Patients using paroxetine hcl should exercise caution until they have adapted to therapy.
_ If you skip the missed dose and take only the next one as directed. Do not take a double dose of Paxil. Overdose is possible.

Paxil can cause serious side effects. Only you can decide if Paxil is the best means of treating depression symptoms. It is important for people currently taking Paxil to discuss side effect concerns with their physician.

Paxil Side Effects:
_ Agitation.
_ Irritability.
_ Deepened depression.
_ Increased risk of suicide.
_ Upset stomach.
_ Drowsiness.
_ Weakness.
_ Anxiety.
_ Insomnia or sleeplessness.
_ Nightmares.
_ Anorexia.
_ Dry mouth.
_ Sensitivity to sunlight.
_ Changes in appetite or weight.
_ Headache.
_ Constipation.
_ Difficulty urinating or frequent urination.
_ Ejaculation problems.
_ Impotence.
_ Changes in sex drive or ability.
_ Difficulty reaching orgasm.
_ Decreased libido.
_ Blurred vision.
_ Excessive sweating.
_ Jaw, neck, and back muscle spasms.
_ Slow or difficult speech.
_ Shuffling walk.
_ Tremors.
_ Fever.
_ Severe skin rash.
_ Irregular heartbeat.
_ Increase in blood cholesterol levels.

Contact your doctor immediately if you experience: An allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, face, or tongue; or hives). Stop taking Paxil and contact your doctor immediately or seek emergency medical treatment if you also experience a fast or irregular heartbeat, jaw, neck or back muscle spasms, shuffling walk, slow or difficult speech, persistent fine tremor or inability to sit still, fever or severe skin rash. Contact your doctor immediately if you experience yellowing of the skin or eyes.

Symptoms of overdose may include: Symptoms of a Paxil overdose include dizziness, numbness, drowsiness, coma, nausea, vomiting, tremors, rapid pounding or irregular heartbeats, seizures, blurred vision, hallucinations and unconsciousness.

Before taking Paxil, tell your doctor if you have or ever had:
_ Seizures.
_ Liver disease.
_ Kidney disease.
_ Heart disease.
_ High blood pressure.
_ Suicidal thoughts.
_ Glaucoma.
_ Bleeding or blood clotting problems.
_ Enlarged prostate.
_ Difficulty urinating.
_ An overactive thyroid gland.

What should I avoid while taking Paxil?
_ Use alcohol cautiously while taking Paxil. Alcohol may increase drowsiness and dizziness.
_ Cigarette smoking and tobacco products may decrease the effectiveness of this drug.
_ Paxil may make your skin sensitive to sunlight. Avoid unnecessary or prolonged exposure to sunlight.

What other drugs will affect paroxetine hcl? Paxil can increase the effects of many other drugs, leading to serious side effects. If taking Paxil, talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines. Do not take paroxetine hcl with the following medicines without your doctor’s approval:
_ Benzodiazepine such as diazepam, alprazolam, chlordiazepoxide, clorazepate, temazepam or triazolam.
_ Monoamine oxidase inhibitors (MAOI).
_ Other antidepressants.
_ Phenothiazine such as chlorpromazine, fluphenazine, mesoridazine, perphenazine prochlorperazine.
_ Warfarin.
_ Lithium.
_ Seizure medications containing carbamazepine (Tegretol) or phenytoin (Dilantin).
_ Thioridazine.
_ Cisapride.
_ Pimozide.
_ Almotriptan.
_ Frovatriptan.
_ Sumatriptan.
_ Naratriptan.
_ Rizatriptan.
_ Zolmitriptan.
_ Theophylline.
_ Digoxin.
_ Cimetidine.
_ Drugs other than the above listed may also interact with Paxil. Talk to your doctor and pharmacist before taking any prescription, over-the-counter medicines or natural supplements.

People seeking depression relief should carefully evaluate Paxil information and side effects before deciding to take Paxil. Consult your healthcare professional before using Paxil.

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*This antidepressant drug information does not endorse Paxil, diagnose patients or recommend therapy. The information contained herein is not intended to cover all possible warnings, uses, precautions, drug interactions, allergic reactions, or adverse side effects of Paxil. If you have questions about the drugs you are taking, check with your health care provider or pharmacist. The information provided should not be construed to indicate that Paxil is safe, effective or appropriate.

Do not stop taking Paxil without first talking to your doctor. Your doctor may need to gradually reduce the dose before stopping Paxil completely. Suddenly stopping paroxetine hcl may cause unpleasant and potentially serious side effects.

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