Paroxetine

Generic Name: paroxetine (pa ROX a teen)
Brand Name: Paxil, Paxil CR, Pexeva

What is paroxetine?

Paroxetine is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Paroxetine affects chemicals in the brain that may become unbalanced.

Paroxetine is used to treat depression, obsessive-compulsive disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).

Paroxetine may also be used for purposes not listed in this medication guide.

Important information about paroxetine

You should not use paroxetine if you are also taking pimozide or thioridazine, or if you are being treated with methylene blue injection.

Do not use paroxetine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Video: Treatment for Depression

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using paroxetine. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not give paroxetine to anyone younger than 18 years old without the advice of a doctor. Paroxetine is not approved for treating depression in children.

Before taking paroxetine

You should not use this medicine if you are allergic to paroxetine, or if:

• you are also taking pimozide or thioridazine; or

• you are being treated with methylene blue injection.

Do not use paroxetine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine. After you stop taking paroxetine you must wait at least 14 days before you start taking an MAO inhibitor.

To make sure paroxetine is safe for you, tell your doctor if you have:

• liver or kidney disease;

• a bleeding or blood clotting disorder;

• seizures or epilepsy;

• narrrow-angle glaucoma; or

• bipolar disorder (manic depression), or a history of drug abuse or suicidal thoughts.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using paroxetine. Your family or other caregivers should also be alert to changes in your mood or symptoms.

FDA pregnancy category D. Taking an SSRI antidepressant during pregnancy may cause heart defects, serious lung problems, or other complications in the baby. However, you may have withdrawal symptoms or a relapse of depression if you stop taking your antidepressant. Tell your doctor right away if you become pregnant while taking paroxetine. Do not start or stop taking this medicine during pregnancy without your doctor's advice.

See also: Paroxetine pregnancy and breastfeeding warnings (in more detail)

Paroxetine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give paroxetine to anyone younger than 18 years old without the advice of a doctor. Paroxetine is not approved for treating depression in children.

How should I take paroxetine?

Take paroxetine exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

It may take up to 4 weeks before your symptoms improve. Keep using paroxetine as directed and tell your doctor if your symptoms do not improve.

Do not stop using paroxetine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using paroxetine. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture and heat.

See also: Paroxetine dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of paroxetine can be fatal.

What should I avoid while taking paroxetine?

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using an NSAID with paroxetine may cause you to bruise or bleed easily.

Drinking alcohol can increase some of the side effects of paroxetine.

Paroxetine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Paroxetine side effects

Get emergency medical help if you have any of these signs of an allergic reaction to paroxetine: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• unusual bone pain or tenderness, swelling or bruising;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), coughing up blood;

• agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, feeling unsteady, loss of coordination, fainting;

• very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, overactive reflexes, feeling like you might pass out;

• headache, trouble concentrating, memory problems, weakness, confusion, hallucinations, seizure, shallow breathing or breathing that stops; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common paroxetine side effects may include:

• mild headache, drowsiness, dizziness, sleep problems (insomnia), feeling restless or nervous;

• mild nausea, constipation, weight changes;

• decreased sex drive, impotence, or difficulty having an orgasm; or

• dry mouth, yawning, or ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Paroxetine side effects (in more detail)

Paroxetine Dosing Information

Usual Adult Dose of Paroxetine for Depression:

Immediate release tablets and suspension:
Initial dose: 20 mg orally once a day with or without food, usually in the morning.
Maintenance dose: 20 to 50 mg orally once a day with or without food, usually in the morning.
Dosage change: Dose may be increased in 10 mg per day increments at intervals of at least one week.

Extended release tablets:
Initial dose:
Paroxetine- naive patients: 25 mg orally once a day with or without food, usually in the morning.
Conversion: 30 mg immediate release paroxetine corresponds to 37.5 mg extended release tablets.
Maintenance dose: The initial dose may be increased to a maximum of 62.5 mg per day.
Dosage change: Dose may be increased in 12.5 mg per day increments at intervals of at least one week.
Caution: Extended release tablets should be swallowed whole and not chewed or crushed.

Usual Adult Dose for Anxiety:

Immediate release tablets and suspension:
Initial dose: 20 mg orally once a day with or without food, usually in the morning.
Maintenance dose: Doses up to 60 mg orally once a day with or without food, usually in the morning, can be used.
Dosage change: Dose may be increased in 10 mg per day increments at intervals of at least one week.

Extended release tablets:
Initial dose: 12.5 mg orally once a day with or without food, usually in the morning.
Maintenance dose: The initial dose may be increased in 12.5 mg increments weekly, to a maximum of 37.5 mg per day.
Dosage change: May occur at intervals of at least one week.
Caution: Extended release tablets should be swallowed whole and not chewed or crushed.

Usual Adult Dose of Paroxetine for Panic Disorder:

Immediate release tablets and suspension:
Initial dose: 10 mg orally once a day with or without food, usually in the morning.
Maintenance dose: 40 mg orally once daily with or without food, usually in the morning. Doses up to 60 mg orally once a day in the morning can be used.
Dosage change: May occur in 10 mg per day increments at intervals of at least one week.

Extended release tablets:
Initial dose: Paroxetine- naive patients: 12.5 mg orally once a day with or without food, usually in the morning.
Maintenance dose: The initial dose may be increased in 12.5 mg per day increments at intervals of at least one week, to a maximum of 75 mg per day.
Caution: Extended release tablets should be swallowed whole and not chewed or crushed.

Usual Adult Dose for Premenstrual Dysphoric Disorder:

Extended release tablets:
Initial: 12.5 mg orally once a day with or without food, usually in the morning continuously, or alternatively, 12.5 mg orally once a day with or without food, usually in the morning during the luteal phase of the menstrual cycle (the 14 days prior to the anticipated start of menses).
Maintenance: Doses up to 25 mg once a day with or without food, usually in the morning, have been shown to be effective in clinical trials. Effectiveness for a period exceeding 3 menstrual cycles has not been evaluated in controlled trials. However, it is reasonable to consider continuation in a responding patient.
Dosage change: May occur at intervals of at least one week.
Caution: Extended release tablets should be swallowed whole and not chewed or crushed.

Usual Adult Dose of Paroxetine for Obsessive Compulsive Disorder:

Immediate release tablets and suspension:
Initial dose: 20 mg orally once a day with or without food, usually in the morning.
Maintenance dose: 40 mg orally once a day with or without food, usually in the morning. Doses up to 60 mg orally once a day in the morning can be used.
Dosage change: Dose may be increased in 10 mg per day increments at intervals of at least one week.

Usual Adult Dose for Post Traumatic Stress Disorder:

Immediate release tablets and suspension:
Initial dose: 20 mg orally once a day with or without food, usually in the morning.
Maintenance dose: 20 to 50 mg orally once a day with or without food, usually in the morning.
Dosage change: Dose may be increased in 10 mg per day increments at intervals of at least one week.

What other drugs will affect paroxetine?

Taking paroxetine with other drugs that make you sleepy or slow your breathing can increase these effects. Ask your doctor before taking paroxetine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety or seizures.

Many drugs can interact with paroxetine. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with paroxetine, especially:

• any other antidepressant;

• cimetidine;

• lithium;

• risperidone;

• St. John's wort;

• tamoxifen;

• theophylline;

• tryptophan (sometimes called L-tryptophan);

• a blood thinner such as warfarin, Coumadin;

• heart medication--digoxin, flecainide, encainide, propafenone;

• migraine headache medicine--sumatriptan, rizatriptan, and others;

• pain medication--fentanyl or tramadol; or

• a phenothiazine--chlorpromazine, haloperidol, promethazine, risperidone, and others.

This list is not complete and many other drugs can interact with paroxetine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

• Your pharmacist can provide more information about paroxetine.