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Paxil - Paroxetine

Paroxetine HCl is an orally administered antidepressant with a chemical structure unrelated to other selective serotonin reuptake inhibitors or to tricyclic, tetracyclic or other available antidepressant agents. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (Immediate-Release Tablets and Oral Suspension:) (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and (Controlled-Release Tablets:) (-) - (3S,4R)-4-[(p-fluorophenyl)-3-[(3,4-methylenedioxy) phenoxy]methyl]piperidine hydrochloride hemihydrate.

The empirical formula is C19H20FNO3HCl½H2O. The molecular weight is 374.8 (329.4 as free base).

Paroxetine HCl is an odorless, off-white powder, having a melting point range of 120-138°C and a solubility of 5.4 mg/ml in water.

Immediate-Release Tablets: Each film-coated Paxil tablet contains paroxetine HCl equivalent to paroxetine as follows: 10 mg: Yellow; 20 mg: Pink (scored); 30 mg: Blue, 40 mg: Green. Inactive ingredients consist of dibasic calcium phosphate dihydrate, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycols, polysorbate 80, sodium starch glycolate, titanium dioxide and one 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.

Oral Suspension: Each 5 ml of Paxil orange-colored, orange-flavored liquid contains paroxetine HCl 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.

Controlled-Release Tablets: Each enteric, film-coated, bilayer, controlled-release Paxil tablet contains paroxetine HCl equivalent to paroxetine as follows: 12.5 mg and 25 mg. One layer of the tablet consists of a degradable barrier layer and the other contains the active material in a hydrophilic matrix. The barrier layer is pale yellow and pink for the 12.5 mg and 25 mg strength tablets, respectively; the active layer is white.

Inactive ingredients consist of hydroxypropyl methylcellulose, polyvinylpyrrolidone, lactose monohydrate, magnesium stearate, colloidal silicon dioxide, glyceryl behenate, methacrylic acid copolymer type C, sodium lauryl sulfate, polysorbate 80, talc, triethyl citrate, and one or more of the following colorants: yellow ferric oxide, red ferric oxide.

INDICATIONS

Immediate-Release Tablets, Oral Suspension, and Controlled-Release Tablets

Depression

Paroxetine HCl is indicated for the treatment of depression.

The efficacy of paroxetine HCl in the treatment of a major depressive episode was established in 6-week controlled trials (for the immediate-release and oral suspension) and 12-week controlled trials (for the controlled-release tablets) of outpatients whose diagnoses corresponded most closely to the DSM-III category (for the immediate-release and oral suspension) and DSM-IV category (for the controlled-release tablets) of major depressive disorder
The antidepressant action of paroxetine HCl in hospitalized depressed patients has not been adequately studied.

Paroxetine HCl controlled-release tablets have not been systematically evaluated beyond 12 weeks in controlled clinical trials; however, the efficacy of immediate-release paroxetine HCl in maintaining an antidepressant response for up to 1 year was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use paroxetine HCl for extended periods should periodically re-evaluate for long-term usefulness of the drug for the individual patient.

Additional Information for Immediate-Release Tablets and Oral Suspension: A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sex drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.

The efficacy of paroxetine HCl in maintaining an antidepressant response for up to 1 year was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use paroxetine HCl for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Additional Information Controlled-Release Tablets: A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or loss of interest or pleasure in nearly all activities, representing a change from previous functioning, an includes the presence of at least five of the following nine symptoms during the same two week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.

Immediate-Release Tablets and Oral Suspension

Obsessive Compulsive Disorder

Paroxetine HCl is indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD) as defined in the DSM-IV. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.

The efficacy of paroxetine HCl was established in two 12-week trials with obsessive compulsive outpatients whose diagnoses corresponded most closely to the DSM-IIIR category of obsessive compulsive disorder (see CLINICAL STUDIES).

Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses or images (obsessions) that are ego-dystonic and/or repetitive, purposeful and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable.

Long-term maintenance of efficacy was demonstrated in a 6-month relapse prevention trial. In this trial, patients assigned to paroxetine showed a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use paroxetine HCl for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see

DOSAGE AND ADMINISTRATION
).

Panic Disorder

Paroxetine HCl is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.

The efficacy of paroxetine HCl was established in three 10- to 12-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see CLINICAL STUDIES).

Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks i.e., a discrete period of intense fear or discomfort in which 4 (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.

Long-term maintenance of efficacy was demonstrated in a 3-month relapse prevention trial. In this trial, patients with panic disorder assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who prescribes paroxetine HCl for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Social Anxiety Disorder

Paroxetine HCl is indicated for the treatment of social anxiety disorder, also known as social phobia, as defined in DSM-IV (300.23) Social anxiety disorder is characterized by a marked and persistent fear of one or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment.

The efficacy of paroxetine HCl was established in three 12-week trials in adult patients with social anxiety disorder (DSM-IV). Paroxetine HCl has not been studied in children or adolescents with social phobia (see CLINICAL STUDIES).

The effectiveness of paroxetine HCl in long-term treatment of social anxiety disorder, i.e., for more than 12 weeks, has not been systemically evaluated in adequate and well-controlled trials. Therefore, the physician who elects to prescribe paroxetine HCl for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see

DOSAGE AND ADMINISTRATION
).

DOSAGE AND ADMINISTRATION

Depression

Usual Initial Dosage: Immediate-Release Tablets and Oral Suspension Only: Paroxetine HCl immediate-release formulations should be administered as a single daily dose, with or without food, usually in the morning. The recommended initial dose is 20 mg/day. Patients were dosed in a range of 20 to 50 mg/day in the clinical trials demonstrating the antidepressant effectiveness of paroxetine HCl. As with all antidepressants, the full antidepressant effect may be delayed. Some patients not responding to a 20 mg dose may benefit from dose increases, in 10 mg/day increments, up to a maximum of 50 mg/day. Dose changes should occur at intervals of at least 1 week. Controlled-Release Tablets: Paroxetine HCl controlled-release tablets should be administered as a single daily dose, usually in the morning, with or without food. The recommended initial dose is 25 mg/day. Patients were dosed in a range of 25 mg to 62.5 mg/day in the clinical trials demonstrating the antidepressant effectiveness of paroxetine HCl controlled-release tablets. As with all antidepressants, the full antidepressant effect may be delayed. Some patients not responding to a 25 mg dose may benefit from dose increases, in 12.5 mg/day increments, up to a maximum of 62.5 mg/day. Dose changes should occur at intervals of at least 1 week.

Patients should be cautioned that the paroxetine HCl controlled-release tablet should not be chewed or crushed, and should be swallowed whole.

Maintenance Therapy: Immediate-Release Tablets, Oral Suspension, and Controlled-Release Tablets: There is no body of evidence available to answer the question of how long the patient treated with paroxetine HCl should remain on it. It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacologic therapy. Whether the dose of an antidepressant needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown.

Systematic evaluation of the efficacy of immediate-release paroxetine HCl has shown that efficacy is maintained for periods of up to 1 year with doses that averaged about 30 mg, which corresponds to a 37.5 mg dose of paroxetine HCl controlled-release tablets, based on relative bioavailability considerations (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

Obsessive Compulsive Disorder

Immediate-Release Tablets and Oral Suspension

Usual Initial Dosage: Paroxetine HCl should be administered as a single daily dose, with or without food, usually in the morning. The recommended dose of paroxetine HCl in the treatment of OCD is 40 mg daily. Patients should be started on 20 mg/day and the dose can be increased in 10 mg/day increments. Dose changes should occur at intervals of at least 1 week. Patients were dosed in a range of 20 to 60 mg/day in the clinical trials demonstrating the effectiveness of paroxetine HCl in the treatment of OCD. The maximum dosage should not exceed 60 mg/day.

Maintenance Therapy: Long-term maintenance of efficacy was demonstrated in a 6-month relapse prevention trial. In this trial, patients with OCD assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY). OCD is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Panic Disorder

Immediate-Release Tablets and Oral Suspension

Usual Initial Dosage: Paroxetine HCl should be administered as a single daily dose with or without food, usually in the morning. The target dose of paroxetine HCl in the treatment of panic disorder is 40 mg/day. Patients should be started on 10 mg/day. Dose changes should occur in 10 mg/day increments and at intervals of at least 1 week. Patients were dosed in a range of 10 to 60 mg/day in the clinical trials demonstrating the effectiveness of paroxetine HCl. The maximum dosage should not exceed 60 mg/day.

Maintenance Therapy: Long-term maintenance of efficacy was demonstrated in a 3-month relapse prevention trial. In this trial, patients with panic disorder assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY). Panic disorder is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Social Anxiety Disorder

Immediate-Release Tablets and Oral Suspension

Usual Initial Dosage: Paroxetine HCl should be administered as a single daily dose with or without food, usually in the morning. The recommended and initial dosage is 20 mg/day. In clinical trials the effectiveness of paroxetine HCl was demonstrated in patients dosed in a range of 20 to 60 mg/day. While the safety of paroxetine HCl has been evaluated in patients with social anxiety disorder at doses up to 60 mg/day, available information does not suggest any additional benefit for doses above 20 mg/day (see CLINICAL PHARMACOLOGY).

Maintenance Therapy: There is no body of evidence available to answer the question of how long the patient treated with paroxetine HCl should remain on it. Although the efficacy of paroxetine HCl beyond 12 weeks of dosing has not been demonstrated in controlled clinical trials, social anxiety disorder is recognized as a chronic condition, and it is reasonable to consider continuation of treatment for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Immediate-Release Tablets, Oral Suspension, and Controlled-Release Tablets

Dosage for Elderly or Debilitated, and Patients with Severe Renal or Hepatic Impairment: The recommended initial dose is 10 mg/day (immediate-release tablets and oral suspension) and 12.5 mg/day (controlled-release tablets) for elderly patients, debilitated patients, and/or patients with severe renal or hepatic impairment. Increases may be made if indicated. Dosage should not exceed 40 mg/day (immediate-release tablets and oral suspension) and 50 mg/day (controlled-release tablets).

Switching Patients to or From a Monoamine Oxidase Inhibitor: At least 14 days should elapse between discontinuation of a MAOI and initiation of paroxetine HCl therapy. Similarly, at least 14 days should be allowed after stopping paroxetine HCl before starting an MAOI.

HOW SUPPLIED

Paxil Immediate-Release Tablets

Film-coated, modified-oval as follows:

10 mg Tablets: Yellow tablets engraved on the front with PAXIL and on the back with 10.

20 mg Tablets: Pink, scored tablets engraved on the front with PAXIL and on the back with 20.

30 mg Tablets: Blue tablets engraved on the front with PAXIL and on the back with 30.

40 mg Tablets: Green tablets engraved on the front with PAXIL and on the back with 40.

Storage: Store tablets 15-30°C (59-86°F).

Paxil Oral Suspension

Orange-colored, orange-flavored, 10 mg/5ml.

Storage: Store suspension at or below 25°C (77°F).

NOTE: SHAKE SUSPENSION WELL BEFORE USING.

Paxil CR (Controlled-Release Tablets)

Paxil CR is supplied as an enteric film-coated, controlled-release, bilayer round tablet.

12.5 mg Tablets: Pale yellow and white tablets, printed with Paxil CR and 12.5.

25 mg Tablets: Pink and white tablets, printed with Paxil CR and 25.

Storage: Store at controlled room temperature between 20-25°C (68-77°F).

PATIENT INFORMATION

Paroxetine HCl is used to treat depression, panic disorder and obsessive-compulsive disorders. Paroxetine HCl should not be taken if you are currently taking monoamine oxidase inhibitors. If you have been prescribed a monoamine oxidase inhibitor by another physician please call them for advice. Any drug which affects the central nervous system can cause drowsiness or lethargy. This drug has rarely been associated with this effect but caution is warranted while driving or operating machinery. Avoid drinking alcohol. Please consult with your physician or pharmacist whenever you are using another medication, especially over-the-counter medications since there may be interactions. Paroxetine is generally taken once a day, in the morning. It may take 4 or more weeks before improvement is symptoms is seen. You are encouraged to continue therapy until advised by your physician to stop.

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