Detailed Drug Information:

DRUG CLASS AND MECHANISM: Paroxetineis an anti-depressant drug that affects the chemicals that nerves in the brain useto communicate with one another. These chemical messengers, calledneurotransmitters, are released by one nerve and taken up by other nerves.Neurotransmitters that are released but not taken up by other nerves aretaken up by the nerves that release them ("reuptake"). Manyexperts believe that it is an imbalance among the amounts of the differentneurotransmitters that are released that causes depression. Paroxetineworks by inhibiting the reuptake of serotonin by the nerves that releaseit, an action which allows more serotonin to be available to be taken upby other nerves. Paroxetine is in a class of drugs called selectiveserotonin reuptake inhibitors (SSRIs), a class that also containsfluoxetine (Prozac) and sertraline (Zoloft).

PREPARATIONS: Tablets (oval): 10 mg (yellow), 20 mg (pink), 30 mg (blue),and 40 mg (green). Paxil CR, a controlled release form of paroxetine, is available in tablets of 12.5, 25, and 37.5 mg.

STORAGE: Tablets should be kept at room temperature, 15-30°C(59-86°F).

PRESCRIBED FOR: Paroxetine is indicated for the management of depression, obsessive-compulsive disorders,panic disorders, and premenstrual dysphoric disorder.

DOSING: Paroxetine is given as a single daily dose, usually inthe morning. As with all anti-depressants, the full effect may not occuruntil after a few weeks of therapy. Doses for obsessive-compulsivedisorders and panic disorders are often higher than those for depression.Doses often are adjusted to find the optimal dose. Elderly patients,debilitated persons, and patients with certain kidney or liver diseasesmay need lower doses because they metabolize and eliminate paroxetine moreslowly and, therefore, are prone to develop high blood levels.

DRUG INTERACTIONS: All SSRIs, including paroxetine, shouldnot be taken with any of the MAO (mono-amine oxidase)inhibitor-class ofanti-depressants, for example, isocarboxazid (Marplan), phenelzine(Nardil), tranylcypromine (Parnate), and procarbazine (Matulane). Suchcombinations may lead to confusion, high blood pressure, tremor, andincreased activity. This same type of interaction may also occur withselegiline (Eldepryl), fenfluramine (Pondimin), and dexfenfluramine (Redux). The anti-ulcer medication, cimetidine (Tagamet) can increase theamount of paroxetine in the blood, possibly leading to side effects.Paroxetine may increase the risk of bleeding in patients taking warfarin (Coumadin) although the mechanism for the interaction is not known.Tryptophan can cause headaches, nausea, sweating, and dizziness when takenwith any SSRI. Phenytoin (Dilantin) and phenobarbital may decrease theamount of paroxetine in the body and possibly reducing its effectiveness.

Paxil CR is approved for continuous or intermittent therapy for premenstrual dysphoric disorder. For intermittent therapy, women take Pacil CR once daily during only the two-week period prior to the onset of their menstrual cycle rather than throughout the month.

PREGNANCY: There are no adequate studies of paroxetine inpregnant women.

NURSING MOTHERS: It is not known if paroxetine is secreted in breast milk.

SIDE EFFECTS: The most commonly noted side effects associated with paroxetine are anxiety, sweating, nausea, decreased appetite, somnolence (sleepiness), dizziness, insomnia, and male sexual disturbances. Dry mouth occurs in about 18% of patients taking paroxetine.

The withdrawal of treatment with many anti-depressants has been associated with troublesome symptoms. Symptoms have been particularly frequent with anti-depressants, like paroxetine, classified as SSRI's. Specifically, the incidence of symptoms upon withdrawal is between 17% and 30% with paroxetine and fluvoxamine (Luvox), but less than 5% with other SSRI's.

The most common symptoms of withdrawal have been dizziness,tiredness, tingling of the extremities, nausea, vivid dreams, irritability, and poor mood. Other symptoms have included visual disturbances and headaches.

Withdrawal reactions have been reported upon withdrawing SSRI's after an average of 12 to 36 weeks of treatment, but after as few as 5 weeks. Although most authorities have recommended that treatment be discontinued by tapering the SSRI (by gradually reducing the dose), symptoms have occurred despite tapering. Symptoms generally appear within a few days of discontinuing medication and persist for an average of 12 days (up to 21 days). They are relieved within 24 hours by re-administering the medication that was discontinued.

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