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PAXIL
PAXIL ONLINE
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—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 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
breastfeeding.
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. |
Proper Use of This Medicine
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 (20mL) 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. |
| |
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| | | | |
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| 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. |
| |
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| | | | |
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| 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. |
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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 suddenly stop taking your paroxetine. If you
have been instructed to stop taking paroxetine, ask you healthcare
professional how to slowly decrease the dose. This is to decrease
the chance of having discontinuation symptoms such as agitation,
breathing problems, chest pain, confusion, diarrhea, dizziness or
light-headedness, fast heartbeat, 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.
If you do, you may develop confusion, agitation, restlessness,
stomach or intestinal symptoms, sudden high body temperature,
extremely high blood pressure, severe convulsions, or the
serotonin syndrome.
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; chest congestion; chest pain;
chills; cold sweats; confusion;
difficulty breathing; dizziness, faintness, or
lightheadedness when getting up from a lying or sitting
position; fast, pounding, or irregular heartbeat or
pulse; muscle pain or weakness; skin rash |
|
| Rare
| Absence of or decrease in body movements; bigger,
dilated, or enlarged pupils [black part of eye];
difficulty in speaking; inability to move eyes;
incomplete, sudden, or unusual body or facial movements;
increased sensitivity of eyes to light; 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 |
|
| Incidence not determined
| Back, leg, or stomach pains; bleeding gums;
blindness; blistering, peeling, loosening of skin;
bloated, full feeling ; bloody or black, tarry
stools; bloody urine; blue-yellow color
blindness; blurred vision; coma;
constipation; cough or hoarseness; dark urine;
decreased frequency or amount of urine ; decreased
vision; depression ; difficulty opening the
mouth; difficulty swallowing; electric shock
sensations ; epileptic seizure that will not stop;
excessive muscle tone; eye pain; fainting;
fixed position of eye; fluid-filled skin blisters;
general body swelling; general feeling of tiredness
or weakness ; headache; high fever;
hives; inability to move arms and legs ;
inability to sit still; increased blood pressure;
increased sweating; increased thirst;
incremental or ratchet-like movement of muscle;
indigestion; itching skin; joint pain;
lab results that show problems with liver;
light-colored stools; lockjaw; loss of
appetite; loss of bladder control; low blood
pressure; lower back or side pain; muscle
spasm, especially of neck and back; muscle tension
or tightness; nausea; need to keep moving;
nosebleeds; painful knees and ankles; painful
or difficult urination; painful or prolonged
erection of the penis; pale skin; puffiness or
swelling of the eyelids or around the eyes, face, lips, or
tongue ; raised red swellings on the skin, the
buttocks, legs, or ankles; red irritated eyes;
rigid muscles; seizure or coma late in pregnancy;
sensitivity to the sun; skin redness or soreness;
skin sores, welts or blisters; skin thinness;
sore throat; sores, ulcers, or white spots on lips
or in mouth; swelling of breasts; swollen or
painful glands; shortness of breath; slow
heart rate; slow movement; slow reflexes;
spasms of throat; stiff muscles; stomach pain;
sudden numbness and weakness in the arms and legs;
swelling of face, fingers, lower legs; tightness in
chest; unexpected or excess milk flow from breasts;
unusual bleeding or bruising; unusual or decreased
blood cell production; unusual tiredness or
weakness; vomiting; weight gain;
wheezing; yellowing of the eyes or skin |
|
| Symptoms of overdose
| Dizziness; drowsiness; dryness of mouth;
flushing of face; irritability; large pupils;
nausea; racing heartbeat; trembling or
shaking; vomiting |
|
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
| Acid or sour stomach; belching; decreased
appetite; decreased sexual ability or desire;
excess air or gas in stomach or intestines;
heartburn; nervousness; pain or tenderness
around eyes and cheekbones ; passing gas;
problems in urinating; runny or stuffy nose;
sexual problems, especially ejaculatory disturbances;
sleepiness or unusual drowsiness; stomach
discomfort, upset, or pain; sweating; trauma;
trembling or shaking; trouble in sleeping |
|
| Less common
| Abnormal dreams; anxiety; bladder pain;
body aches or pain; change in sense of taste;
changes in vision; cloudy urine; confusion ;
congestion; difficulty in focusing eyes;
difficulty in moving; discouragement, feeling sad or
empty; drugged feeling; dryness of throat;
excessive muscle tone; fainting or loss of
consciousness; fast or irregular breathing;
feeling of unreality; feeling of warmth or heat;
flushing or redness of skin, especially on face and neck;
frequent urge to urinate; headache, severe and
throbbing; heavy bleeding; increase in body
movements; increased appetite; irritability;
itching, pain, redness, or swelling of eye or eyelid;
itching of the vagina or genital area; lack of
emotion; loss of interest or pleasure; loss of
memory; lump in throat; menstrual changes;
menstrual pain or cramps; muscle twitching or
jerking; pain during sexual intercourse;
problems with memory; problems with tooth;
rhythmic movement of muscles; sense of detachment
from self or body; severe sunburn; slow
heartbeat; sneezing; thick, white vaginal
discharge with no odor or with a mild odor;
tightness in throat; tingling, burning, or prickling
sensations; trouble concentrating; voice
changes; watering of eyes; weight loss;
yawn |
|
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:
| Abnormal dreams; agitation, confusion, or
restlessness; burning, crawling, itching, numbness,
prickling, "pins and needles" , or tingling
feelings; diarrhea; dizziness or light-headedness;
electric shock sensations; fear; headache;
increased sweating; muscle pain; nausea or
vomiting; nervousness; 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.
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