Paroxetine

Generic Name: paroxetine (pa ROX a teen)
Brand Names: 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

Do not take paroxetine together with pimozide (Orap), thioridazine (Mellaril), linezolid (Zyvox), methylene blue (Urolene Blue), or a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). A dangerous drug interaction could occur, leading to serious side effects.

Before you take paroxetine, tell your doctor if you have liver or kidney disease, a bleeding or blood clotting disorder, seizures, glaucoma, bipolar disorder, or a history of drug abuse or suicidal thoughts.

There are many other drugs that can cause serious or life threatening medical problems if you take them together with paroxetine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Paroxetine may cause heart defects or serious lung problems in a newborn if you take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you become pregnant while taking paroxetine, do not stop taking the medication without first talking to your doctor.

You may have thoughts about suicide when you first start taking an antidepressant such as paroxetine, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

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.

Before taking paroxetine

Do not take paroxetine together with pimozide (Orap), thioridazine (Mellaril), linezolid (Zyvox), methylene blue (Urolene Blue), or a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). A dangerous drug interaction could occur, leading to serious side effects. You must wait at least 14 days after stopping an MAO inhibitor before you can take paroxetine. After you stop taking paroxetine, you must wait at least 14 days before you start taking an MAOI.

To make sure you can safely take paroxetine, tell your doctor if you have any of these other conditions:

• 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.

You may have thoughts about suicide while taking an antidepressant such as paroxetine, especially if you are younger than 24 years old. Tell your doctor if you have worsening depression or suicidal thoughts during the first several weeks of treatment with paroxetine , or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

FDA pregnancy category D. Paroxetine may cause heart defects or serious lung problems in a newborn if you take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you become pregnant while taking paroxetine, do not stop taking the medication without first talking to your doctor. Paroxetine can pass into breast milk and may harm a nursing baby. Do not use paroxetine without telling your doctor if you are breast-feeding a baby.

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

How should I take paroxetine?

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

You may take paroxetine with or without food. Try to take the medicine at the same time each day.

Do not crush, chew, or break an extended-release paroxetine tablet. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose measuring spoon or medicine cup, not with a regular table spoon. 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 after 4 weeks of treatment.

You may have withdrawal symptoms (such as agitation, dizziness, numbness or tingling, ringing in your ears, confusion, or behavior changes) after you stop taking paroxetine. Do not stop taking this medication suddenly without first talking to your doctor.

Store paroxetine 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.

Overdose symptoms may include extreme drowsiness, vomiting, tremor, confusion, decreased urination, blurred vision, rapid heartbeat, aggression, seizures, and coma.

What should I avoid while taking paroxetine?

Drinking alcohol can increase some of the side effects of paroxetine. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

See also: Paroxetine and alcohol (in more detail)

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 a serious side effect while taking paroxetine such as:

• 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, 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;

• nausea, vomiting, diarrhea, loss of appetite, feeling unsteady, loss of coordination; or

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

Less serious paroxetine side effects may include:

• feeling restless or nervous;

• mild headache, drowsiness, dizziness;

• sleep problems (insomnia);

• mild nausea, constipation, diarrhea;

• 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 Paroxetine Dose 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 Paroxetine 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 Paroxetine Dose 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 Paroxetine 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 Paroxetine Dose 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 Paroxetine 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?

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures or anxiety can add to sleepiness caused by paroxetine. Tell your doctor if you regularly use any of these medicines, or any other antidepressant.

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, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others. Taking an NSAID with paroxetine may cause you to bruise or bleed easily.

Many drugs can interact with paroxetine. Below is just a partial list. Tell your doctor if you are using:

• a blood thinner such as warfarin (Coumadin, Jantoven);

• cimetidine (Tagamet);

• fentanyl (Abstral, Actiq, Duragesic, Fentora, Onsolis);

• fosamprenavir (Lexiva);

• linezolid (Zyvox);

• ritonavir (Norvir, Kaletra);

• St. John's wort;

• tamoxifen (Nolvadex, Soltamox);

• theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl);

• tramadol (Ultram, Ultracet);

• tryptophan (also called L-tryptophan);

• heart medication such as digoxin (digitalis, Lanoxin), quinidine (Quin-G), procainamide (Pronestyl), disopyramide (Norpace), flecaininde (Tambocor), mexiletine (Mexitil), propafenone, (Rythmol), and others;

• any other antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), citalopram (Celexa), desipramine (Norpramin), doxepin (Sinequan), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), imipramine (Tofranil), nortriptyline (Pamelor), sertraline (Zoloft), and others;

• medicine to treat psychiatric disorders, such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), haloperidol (Haldol), lithium (Lithobid, Eskalith), perphenazine (Trilafon), or risperidone (Risperdal); or

• almotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex, Treximet), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig).

This list is not complete and other drugs may interact with paroxetine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about paroxetine.