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).

The Brisdelle brand of paroxetine is used to treat hot flashes related to menopause. Brisdelle is not for treating any other conditions.

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

Important information

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 start or stop taking this medicine during pregnancy without your doctor"s advice.

Do not use an MAO inhibitor within 14 days before or after you take paroxetine. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

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.

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.

Do not give paroxetine to anyone younger than 18 years old without the advice of a doctor. This medicine is not approved for use in children.

Before taking this medicine

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 an MAO inhibitor within 14 days before or after you take paroxetine. 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:

• heart disease, high blood pressure, history of stroke;

• liver or kidney disease;

• a bleeding or blood clotting disorder;

• seizures or epilepsy;

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

• narrow-angle glaucoma; or

• low levels of sodium in your blood.

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 paroxetine 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: Pregnancy and breastfeeding warnings (in more detail)

Paroxetine can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Do not give paroxetine to anyone younger than 18 years old without the advice of a doctor. This medicine 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 liquid medicine with the dosing syringe provided, or 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 the medication 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, heat, and light.

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.

This medication 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:

• racing thoughts, decreased need for sleep, unusual risk-taking behavior, feelings of extreme happiness or sadness, being more talkative than usual;

• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;

• unusual bone pain or tenderness, swelling or bruising;

• changes in weight or appetite;

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

• high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;

• low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, loss of coordination, feeling unsteady;

• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, fainting; 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:

• vision changes;

• weakness, drowsiness, dizziness;

• sweating, anxiety, shaking;

• sleep problems (insomnia);

• loss of appetite, constipation;

• dry mouth, yawning; or

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

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: 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 of Paroxetine 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 of Paroxetine 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 of Paroxetine 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.

Usual Adult Dose for Postmenopausal Symptoms:

Approved indication for paroxetine marketed as Brisdelle (R) only: Treatment of moderate to severe vasomotor symptoms associated with menopause:
7.5 mg orally once daily at bedtime with or without food

What other drugs will affect paroxetine?

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking paroxetine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with paroxetine, especially:

• atomoxetine, cimetidine (Tagamet), metoprolol, procyclidine, St. John"s wort, tamoxifen;

• tryptophan (sometimes called L-tryptophan);

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

• heart rhythm medicine;

• HIV or AIDS medications;

• narcotic pain medicine--fentanyl, tramadol;

• medicine to treat mood disorders, thought disorders, or mental illness--such as lithium, other antidepressants, or antipsychotics;

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

• seizure medicine--carbamazepine, phenytoin.

This list is not complete. Other drugs may interact with paroxetine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.