Hepatitis C Information Central

Description—Paroxetine (pa-ROX-uh-teen) is used to treat mental depression, obsessive-compulsive disorder, and panic disorder.

Paroxetine belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines are thought to work by increasing the activity of a certain chemical, called serotonin, in the brain.

This medicine is available only with your doctor's prescription, in the following dosage form:

Oral

•Tablets (U.S. and Canada)

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—Studies have not been done in pregnant women. However, studies in animals have shown that paroxetine may cause decreased survival rates of offspring when given in doses lower than the maximum human dose. Before taking this medicine, make sure your doctor knows if you are pregnant 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.

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

•Brain disease or damage, or mental retardation or

•Seizures (history of)—The risk of seizures may be increased

•Kidney disease, severe, or

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

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:

•Monoamine oxidase (MAO) inhibitors (furazolidone) [e.g., Furoxone], 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 MAO inhibitors, or you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, and severe convulsions; at least 14 days should be allowed between stopping treatment with one medicine 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

•Tryptophan—Taking this medicine while you are taking paroxetine may increase the risk of serious side effects; taking tryptophan while you are taking paroxetine is not recommended

•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

Proper Use/Preparation of this Medicine/Test—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.

Storage—To store this medicine:

•Keep out of the reach of children.

•Store away from heat and direct light.

•Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.

•Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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 dosage form (tablets):

-- 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.

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..

Precautions While/After Using Receiving 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 gradually reduce the amount you are taking before stopping completely. This is to decrease the chance of side effects.

Do not take paroxetine if you have taken a monoamine oxidase (MAO) inhibitor in the past 2 weeks. Do not start taking an MAO inhibitor within 2 weeks of stopping paroxetine. If you do, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, and severe convulsions.

This medicine could possibly add to the effects of alcohol and other CNS depressants (medicines that cause drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

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.

This medicine may cause dryness of the mouth. For temporary relief, use sugarless gum or candy, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Unwanted Effects—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. The serotonin syndrome 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; 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; red or purple patches on skin; talking, feeling, and acting with excitement and activity you cannot control

Rare—Symptoms of low blood sodium (usually two or more occur together) Confusion; drowsiness; dryness of mouth; increased thirst; lack of energy; convulsions (seizures)

Rare—Symptoms of serotonin syndrome (usually two or more occur together) Diarrhea; fever; increased sweating; mood or behavior changes; overactive reflexes; racing heartbeat; restlessness; shivering or shaking

Symptoms of overdose

Drowsiness (severe); dryness of mouth (severe); irritability; large pupils; nausea (severe); racing heartbeat; trembling or shaking (severe); vomiting (severe)

Other Side Effects

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 your sense of taste; decreased or increased appetite; decreased sexual desire; feeling of fast or irregular heartbeat; 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 lightheadedness; headache; increased sweating; muscle pain; nausea or vomiting; runny nose; trembling or shaking; trouble in sleeping; unusual tiredness or weakness; vision changes

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Source: Health Net