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Paxil®
(paroxetine hydrochloride) Tablets and Oral Suspension
Also see:
Celexa
Elavil Effexor Fluoxetine
Lexapro Paxil CR Prozac
Remeron Zoloft
Cymbalta
Drug Uses
Paxil is an agent in a newer class of
antidepressant medication known as selective serotonin reuptake inhibitors (SSRIs).
Depression and anxiety disorders might be caused by a chemical imbalance in the
brain. One of these chemicals is serotonin, which helps send electrical signals
from one nerve cell to another. In the process, serotonin is released from one
nerve cell (the sender) and travels to the next (the receiver), where it is
either absorbed or returns back to the original sender cell.
How Taken
Paxil comes as a tablet to take it orally.
It is usually taken once daily and may be taken with or without food. Do not
take more or less of it or take it more often than prescribed by your doctor.
Continue to take Paxil even if you feel well. Do not stop taking Paxil without
talking to your doctor, especially if you have taken large doses for a long
time. Your doctor probably will want to decrease your dose gradually. This drug
must be taken regularly for a few weeks before its full effect is felt.
Warnings/Precautions
Before taking Paxil, tell your doctor if
you have liver disease, kidney disease, seizures or epilepsy, or a manic
disorder or suicidal thoughts. You may not be able to take Paxil, or you may
need a dosage adjustment or special monitoring during treatment if you have any
of the conditions listed above. Paxil is in the FDA pregnancy category C. This
means that it is not known whether it will be harmful to an unborn baby. Do not
take Paxil without first talking to your doctor if you are pregnant or could
become pregnant during treatment. Paxil passes into breast milk and may affect a
nursing baby. Do not take Paxil without first talking to your doctor if you are
breast-feeding a baby.
Missed Dose
Take the missed dose as soon as you
remember it. However, if it is almost time for the next dose, skip the missed
dose and continue your regular dosing schedule. Do not take a double dose to
make up for a missed one.
Possible Side Effects
If you experience any of the following
serious side effects, stop taking Paxil and contact your doctor immediately or
seek emergency medical treatment: an allergic reaction (difficulty breathing;
closing of the throat; swelling of the lips, tongue, or face; or hives); an
irregular heartbeat or pulse; low blood pressure (dizziness, weakness); high
blood pressure (severe headache, blurred vision); unusual bleeding or bruising;
or fever or chills. Less serious side effects may be more likely to occur.
Continue to take Paxil and talk to your doctor if you experience headache;
tremor, nervousness, or anxiety; nausea, diarrhea, dry mouth, or changes in
appetite or weight; sleepiness or insomnia; or decreased sex drive, impotence,
or difficulty having an orgasm. Side effects other than those listed here may
also occur. Talk to your doctor about any side effect that seems unusual or that
is especially bothersome.
Storage
Store at controlled room temperature
between 20-25°C (68-77°F).
Overdose
Seek emergency medical attention if an
overdose is suspected. Symptoms of a Paxil overdose include nausea, vomiting,
tremor, seizures, agitation, drowsiness, hyperactivity, and enlarged pupils.
More Information
Use caution when driving, operating
machinery, or performing other hazardous activities. Paxil may cause dizziness
or drowsiness. If you experience dizziness or drowsiness, avoid these
activities. Use alcohol cautiously. Alcohol may increase drowsiness or dizziness
while taking Paxil.
Paxil (paroxetine hydrochloride) is an orally
administered psychotropic drug. It is the hydrochloride salt of a
phenylpiperidine compound identified chemically as
(-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate
and has the empirical formula of
C19H20FNO3•HCl•½H2O.
The molecular weight is 374.8 (329.4 as free base).
Paroxetine hydrochloride is an odorless,
off-white powder, having a melting point range of 120° to 138° C and a
solubility of 5.4 mg/mL in water.
Tablets: Each film-coated tablet contains paroxetine hydrochloride equivalent to
paroxetine as follows: 10 mg–yellow (scored); 20 mg–pink (scored); 30 mg–blue,
40 mg–green.
Inactive ingredients consist of dibasic calcium phosphate dihydrate,
hypromellose, magnesium stearate, polyethylene glycols, polysorbate 80, sodium
starch glycolate, titanium dioxide, and 1 or more of the following: D&C Red No.
30, D&C Yellow No. 10, FD&C Blue No. 2, FD&C Yellow No. 6.
Each 5 mL of orange-colored, orange-flavored liquid contains paroxetine
hydrochloride equivalent to paroxetine, 10 mg. Inactive ingredients consist of
polacrilin potassium, microcrystalline cellulose, propylene glycol, glycerin,
sorbitol, methyl paraben, propyl paraben, sodium citrate dihydrate, citric acid
anhydrate, sodium saccharin, flavorings, FD&C Yellow No. 6, and simethicone
emulsion, USP.
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and
behavior (suicidality) in children, adolescents, and young adults in short-term
studies of major depressive disorder (MDD) and other psychiatric disorders.
Anyone considering the use of Paxil or any other antidepressant in a child,
adolescent, or young adult must balance this risk with the clinical need.
Short-term studies did not show an increase in the risk of suicidality with
antidepressants compared to placebo in adults beyond age 24; there was a
reduction in risk with antidepressants compared to placebo in adults aged 65 and
older. Depression and certain other psychiatric disorders are themselves
associated with increases in the risk of suicide. Patients of all ages who are
started on antidepressant therapy should be monitored appropriately and observed
closely for clinical worsening, suicidality, or unusual changes in behavior.
Families and caregivers should be advised of the need for close observation and
communication with the prescriber. Paxil is not approved for use in pediatric
patients. (See WARNINGS: Clinical worsening and suicide risk, PRECAUTIONS:
Information for patients and precautions: Pediatric Use.)
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