Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Paroxetine may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.

You may have to take paroxetine for several weeks before you begin to feel better. Your doctor should check your progress at regular visits during this time. Also, if you are taking paroxetine for depression, you will probably need to continue taking it for at least 6 months to help prevent the depression from returning.

If you are taking the oral suspension form of paroxetine, shake the bottle well before measuring each dose. Use a small measuring cup or a measuring spoon to measure each dose. The teaspoons and tablespoons that are used for serving and eating food do not measure exact amounts.

If you are taking the extended-release tablet form of this medicine, swallow the tablet whole. Do not crush, break, or chew before swallowing.

Dosing

The dose of paroxetine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of paroxetine. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral suspension dosage form:
  • For treatment of depression:
    • Adults At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg (25 mL) a day.
    • Children Use and dose must be determined by your doctor.
    • Older adults At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg (20 mL) a day.
  • For treatment of generalized anxiety disorder:
    • Adults At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg (25 mL) a day.
    • Children Use and dose must be determined by your doctor.
    • Older adults At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg (20 mL) a day.
  • For treatment of obsessive-compulsive disorder:
    • Adults At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 60 mg (30 mL) a day.
    • Children Use and dose must be determined by your doctor.
    • Older adults At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg (20 mL) a day.
  • For treatment of panic disorder:
    • Adults At first, 10 milligrams (mg) (5 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 60 mg (30 mL) a day.
    • Children Use and dose must be determined by your doctor.
    • Older adults At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg (20 mL) a day.
  • For treatment of posttraumatic stress disorder:
    • Adults At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg (25 mL) a day.
    • Children Use and dose must be determined by your doctor.
    • Older adults At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg (20 mL) a day.
  • For treatment of social anxiety disorder:
    • Adults At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 60 mg (30 mL) a day.
    • Children Use and dose must be determined by your doctor.
    • Older adults At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg (20 mL) a day.

• For oral tablet dosage form:
  • For treatment of depression:
    • Adults At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg a day.
    • Children Use and dose must be determined by your doctor.
    • Older adults At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
  • For treatment of generalized anxiety disorder:
    • Adults At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg a day.
    • Children Use and dose must be determined by your doctor.
    • Older adults At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
  • For treatment of obsessive-compulsive disorder:
    • Adults At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 60 mg a day.
    • Children Use and dose must be determined by your doctor.
    • Older adults At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
  • For treatment of panic disorder:
    • Adults At first, 10 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 60 mg a day.
    • Children Use and dose must be determined by your doctor.
    • Older adults At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
  • For treatment of posttraumatic stress disorder:
    • Adults At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg a day.
    • Children Use and dose must be determined by your doctor.
    • Older adults At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.
  • For treatment of social anxiety disorder:
    • Adults At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 60 mg a day.
    • Children Use and dose must be determined by your doctor.
    • Older adults At first, 10 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 40 mg a day.

• For oral extended-release tablet dosage form:
  • For treatment of depression:
    • Adults At first, 25 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 62.5 mg a day.
    • Children Use and dose must be determined by your doctor.
    • Older adults At first, 12.5 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg a day.
  • For treatment of panic disorder:
    • Adults At first, 12.5 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 75 mg a day.
    • Children Use and dose must be determined by your doctor.
    • Older adults At first, 12.5 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 50 mg a day.
  • For treatment of social anxiety disorder:
    • Adults At first, 12.5 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 37.5 mg a day.
    • Children Use and dose must be determined by your doctor.
    • Older adults At first, 12.5 mg once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 37.5 mg a day.
  • For treatment of premenstrual dysphoric disorder:
    • Adults At first, 12.5 milligrams (mg) once a day, usually taken in the morning. Your doctor may increase your dose if needed. However, the dose usually is not more than 25 mg a day.
    • Children Use and dose must be determined by your doctor.
    • Older adults Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the tablet form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the oral suspension form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For paroxetine, the following should be considered:

Allergies Tell your doctor if you have ever had any unusual or allergic reaction to paroxetine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy Paroxetine has not been well studied in pregnant women. Paroxetine should only be used during pregnancy if the potential benefit outweighs the potential risk to the baby. Before taking this medicine, make sure your doctor knows if you are pregnant (especially if it is the third trimester) or if you may become pregnant.

Breast-feeding Paroxetine passes into the breast milk. However, the effects of this medicine in nursing babies are not known. Caution should be used if you are breast-feeding.

Children Paroxetine has not be shown to be safe and effective in children or adolescents, 18 years of age or younger. Children may be especially sensitive to the effects of paroxetine for the treatment of depression. This may increase the chance of a child planning to commit suicide or attempting to commit suicide. Talk to your doctor about the risks and benefits of taking this medication.

Older adults In studies that have included elderly people, paroxetine did not cause different side effects or problems in older people than it did in younger adults. However, paroxetine may be removed from the body more slowly in elderly people. An older adult may need a lower dose than a younger adult.

Other medicines Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking paroxetine, it is especially important that your health care professional know if you are taking any of the following:

• Aspirin or
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (celecoxib [e.g., Celebrex], diclofenac [e.g., Voltaren], diflunisal [e.g., Dolobid], etodolac [e.g., Lodine], fenoprofen [e.g., Nalfon], flurbiprofen [e.g., Ansaid], ibuprofen [e.g., Advil, Motrin, Nuprin], indomethacin [e.g., Indocin], ketoprofen [e.g., Orudis, Oruvail], ketorolac [e.g., Toradol], meclofenamate [e.g., Meclomen], mefenamic acid [e.g., Ponstel], meloxicam [e.g., Mobic], nabumatone [e.g., Relafen], naproxen [e.g., Aleve, Anaprox, Naprosyn], oxaprozin [e.g., Daypro], phenylbutazone, piroxicam [e.g., Feldene], rofecoxib [e.g., Vioxx], sulindac [e.g., Clinoril], tolmetin [e.g., Tolectin], valdecoxib [e.g., Bextra]) Taking any of these medicines with paroxetine may cause bleeding problems.

• Buspirone (e.g., BuSpar) or
• Bromocriptine (e.g., Parlodel) or
• Dextromethorphan (cough medicine) or
• Levodopa (e.g., Sinemet) or
• Lithium (e.g., Eskalith) or
• Meperidine (e.g., Demerol) or
• Nefazodone (e.g., Serzone) or
• Pentazocine (e.g., Talwin) or
• Selective serotonin reuptake inhibitors, other (citalopram [e.g., Celexa], fluoxetine [e.g., Prozac], fluvoxamine [e.g., Luvox], sertraline [Zoloft]) or
• Street drugs (LSD, MDMA [e.g., ecstasy], marijuana) or
• Sumatriptan (e.g., Imitrex) or
• Tramadol (e.g., Ultram) or
• Trazodone (e.g., Desyrel) or
• Tryptophan or
• Venlafaxine (e.g., Effexor) Using these medicines with paroxetine may increase the chance of developing a rare, but very serious, unwanted effect known as the serotonin syndrome. This syndrome may cause confusion, diarrhea, fever, poor coordination, restlessness, shivering, sweating, talking or acting with excitement you cannot control, trembling or shaking, or twitching. If you develop these symptoms, contact your doctor as soon as possible.

• Moclobemide (e.g., Manerix) The risk of developing serious unwanted effects, including the serotonin syndrome, is increased. Use of moclobemide with paroxetine is not recommended. Also, it is recommended that 3 to 7 days be allowed between stopping treatment with moclobemide and starting treatment with paroxetine, and that 2 weeks be allowed between stopping treatment with paroxetine and starting treatment with moclobemide

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate]) Do not take paroxetine while you are taking or within 2 weeks of taking an MAO inhibitor, or you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, severe convulsions, or the serotonin syndrome. At least 14 days should be allowed between stopping treatment with one medicine (paroxetine or the MAO inhibitor) and starting treatment with the other

• St. John's Wort Taking this medication with paroxetine may increase the chance of side effects.

• Thioridazine (e.g., Mellaril) Taking thioridazine with paroxetine may cause serious heart problems.

• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Norpramin], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil]) Taking a tricyclic antidepressant together with paroxetine may increase the risk of side effects. Your doctor may need to adjust the dose of either medicine or check blood levels of the tricyclic antidepressant. Also, taking paroxetine with amitriptyline, clomipramine, or imipramine may increase the chance that the serotonin syndrome will develop

• Warfarin (e.g., Coumadin) or other medications that prevent the blood from clotting Taking these medicines with paroxetine may cause bleeding problems.

• Bipolar disorder (mood disorder with alternating episodes of mania and depression) or risk of May make condition worse. Your doctor will check you for this condition.

• Brain disease or damage or
• Mental retardation or
• Epilepsy or seizures (history of) The risk of seizures may be increased.

• Glaucoma, narrow angle Patients with this condition should use paroxetine with caution.

• Heart disease or
• Heart attack, recent Use must be determined by your doctor.

• Kidney disease, severe, or
• Liver disease, severe Higher blood levels of paroxetine may occur, increasing the chance of side effects

• Mania (history of) The condition may be activated