Drug Profiles:
paroxetine HCl
Paxil®

CAUTION: Federal law prohibits dispensing without prescription.

Before Using This Medicine
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-
One study looked at the babies of 97 women who took paroxetine either at the beginning of pregnancy or through the entire pregnancy. This study found no harmful effects of paroxetine on the babies. However, more study is needed to be sure that paroxetine is safe to use during pregnancy. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant. FDA Pregnancy Category C.

Breast-feeding-
Paroxetine passes into the breast milk. However, the effects of this medicine in nursing babies are not known.

Children-
Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of paroxetine in children with use in other age groups.

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:

• Astemizole (e.g., Hismanal)—Taking astemizole while you are using paroxetine may lead to a serious change in the rhythm of your heartbeat
• Buspirone (e.g., BuSpar)
• Bromocriptine (e.g., Parlodel)
• Dextromethorphan (cough medicine)
• Levodopa (e.g., Sinemet)
• Lithium (e.g., Eskalith)
• Meperidine (e.g., Demerol)
• Nefazodone (e.g., Serzone)
• Pentazocine (e.g., Talwin)
• 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)
• Sumatriptan (e.g., Imitrex, Amerge, Maxalt, Zomig, Axert, Frova)
• Tramadol (e.g., Ultram)
• Trazodone (e.g., Desyrel)
• Tryptophan
• 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. Using tryptophan with paroxetine is not recommended
• Moclobemide (e.g., Manerex)—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) inhibitors (furazolidone [e.g., Furoxone], 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
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], 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)—Taking this medicine together with paroxetine may cause bleeding problems; your doctor may need to adjust the dosage of either medicine

Other medical problems-
The presence of other medical problems may affect the use of venlafaxine. Make sure you tell your doctor if you have any other medical problems, especially:

• Brain disease or damage
• Mental retardation
• Seizures (history of)—The risk of seizures may be increased
• Kidney disease, severe
• Liver disease, severe—Higher blood levels of paroxetine may occur, increasing the chance of side effects
• Mania (history of)—The condition may be activated

Proper Use of This Medicine
It is important to use this medicine properly:

• Take this medicine only as directed by your doctor
• 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
• 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 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 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 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 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 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 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.

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.

Precautions While Using This Medicine

• It is important that your doctor check your progress at regular visits, to allow for changes in your dose and to help reduce any side effects.
• Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely. This is to decrease the chance of having discontinuation symptoms such as agitation, confusion, diarrhea, dizziness or light-headedness, headache, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble in sleeping, trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting.
• Do not take paroxetine if you have taken a monoamine oxidase (MAO) inhibitor (furazolidone, phenelzine, procarbazine, selegiline, tranylcypromine) in the past 2 weeks. Do not start taking an MAO inhibitor within 2 weeks of stopping paroxetine
• Paroxetine has not been shown to add to the effects of alcohol. However, use of alcohol is not recommended in patients who are taking paroxetine.
• Paroxetine may cause some people to become drowsy or have blurred vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see clearly.

Side Effects of This Medicine
Along with its needed effects, a medicine may cause some unwanted effects. One rare but serious unwanted effect that may occur with paroxetine use is the serotonin syndrome. This syndrome (group of symptoms) is more likely to occur shortly after the dose of paroxetine is increased.

Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Less common: Agitation; fast or irregular heartbeat; muscle pain or weakness; skin rash
• Rare: Absence of or decrease in body movements; difficulty in speaking; inability to move eyes; incomplete, sudden, or unusual body or facial movements; low blood sodium (confusion, convulsions [seizures], drowsiness, dryness of mouth, increased thirst, lack of energy); red or purple patches on skin; serotonin syndrome (confusion, diarrhea, fever, poor coordination, restlessness, shivering, sweating, talking and acting with excitement you cannot control, trembling or shaking, twitching); talking, feeling, and acting with excitement and activity you cannot control

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common: Constipation; decreased sexual ability; diarrhea; dizziness; drowsiness; dryness of mouth; headache; increased sweating; nausea; problems in urinating; trembling or shaking; trouble in sleeping; unusual tiredness or weakness; vomiting
• Less common: Anxiety or nervousness; blurred vision; change in sense of taste; decreased or increased appetite; decreased sexual desire; tingling, burning, or prickling sensations; weight loss or gain

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice any of the following side effects:

• Agitation, confusion, or restlessness; diarrhea; dizziness or light-headedness; headache; increased sweating; muscle pain; nausea or vomiting; runny nose; trembling or shaking; trouble in sleeping; unusual tiredness or weakness; vision changes

Brand Names-

U.S. and Canada: Paxil®