DrugBuyers.Com: Prozac

Fluoxetine hydrochloride is an antidepressant for oral administration; it is chemically unrelated to tricyclic, tetracyclic, or other available antidepressant agents. It is designated (±)-N-methyl-3-phenyl-3-[(a,a,a-trifluoro-p-tolyl)-oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79.

Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/ml in water.

Each Prozac Pulvule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 mcmol), 20 mg (64.7 mcmol), or 40 mg (129.3 mmol) of fluoxetine. The Pulvules also contain starch, gelatin, silicone, titanium dioxide, iron dioxide, and other inactive ingredients. The 10 mg and 20 mg Pulvules also contain FD&C blue no. 1, and the 40 mg Pulvule also contains FD&C blue no. 1 and FD&C yellow no. 6.

Each Prozac tablet contains fluoxetine HCl equivalent to 10 mg (32.3 mmol) of fluoxetine. The tablets also contain microcrystalline cellulose, magnesium stearate, crospovidone, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, and yellow iron oxide. In addition to the above ingredients, the 10 mg tablet contains FD&C blue no. 1 aluminum lake, and polysorbate 80.
The oral solution contains fluoxetine hydrochloride equivalent to 20 mg/5 ml (64.7 mcmol) of fluoxetine. It also contains alcohol 0.23%, benzoic acid, flavoring agent, glycerin, purified water, and sucrose.

INDICATIONS

Depression: Fluoxetine HCl is indicated for the treatment of depression. The efficacy of fluoxetine HCl was established in 5- and 6-week trials with depressed outpatients (³18 years of age) whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see CLINICAL STUDIES).

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 sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.

The antidepressant action of fluoxetine HCl in hospitalized depressed patients has not been adequately studied.

The efficacy of fluoxetine HCl in maintaining an antidepressant response for up to 38 weeks following 12 weeks of open-label acute treatment (50 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving fluoxetine HCl for extended periods should be reevaluated periodically.
Obsessive-Compulsive Disorder: Fluoxetine HCl is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; (i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning).

The efficacy of fluoxetine HCl was established in 13-week trials with obsessive-compulsive outpatients whose diagnoses corresponded most closely to the DSM-III-R category of obsessive-compulsive disorder.
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.

The effectiveness of fluoxetine HCl in long-term use (i.e., for more than 13 weeks) has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine HCl for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient

DOSAGE AND ADMINISTRATION

Depression

Initial Treatment: In controlled trials used to support the efficacy of fluoxetine, patients were administered morning doses ranging from 20 mg to 80 mg/day. Studies comparing fluoxetine 20, 40, and 60 mg/day to placebo indicate that 20 mg/day is sufficient to obtain a satisfactory antidepressant response in most cases. Consequently, a dose of 20 mg/day, administered in the morning, is recommended as the initial dose.

A dose increase may be considered after several weeks if no clinical improvement is observed. Doses above 20 mg/day may be administered on a once a day (morning) or b.i.d. schedule (i.e., morning and noon) and should not exceed a maximum dose of 80 mg/day.

As with other antidepressants, the full antidepressant effect may be delayed until 4 weeks of treatment or longer.

As with many other medications, a lower or less frequent dosage should be used in patients with hepatic impairment. A lower or less frequent dosage should also be considered for the elderly (see PRECAUTIONS, Geriatric Use), and for patients with concurrent disease or on multiple concomitant medications. Dosage adjustments for renal impairment are not routinely necessary (see CLINICAL PHARMACOLOGY, Liver Disease and Renal Disease, and PRECAUTIONS, Use in Patients with Concomitant Illness).

Maintenance/Continuation/Extended Treatment: It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacologic therapy. Whether the dose of antidepressant needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown.

Systematic evaluation of fluoxetine HCl has shown that its antidepressant efficacy is maintained for periods of up to 38 weeks following 12 weeks of open-label acute treatment (50 weeks total) at a dose of 20 mg/day (see CLINICAL STUDIES).

Obsessive-Compulsive Disorder

Initial Treatment: In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of obsessive-compulsive disorder, patients were administered fixed daily doses of 20, 40, or 60 mg of fluoxetine or placebo (see CLINICAL STUDIES). In one of these studies, no dose response relationship for effectiveness was demonstrated. Consequently, a dose of 20 mg/day, administered in the morning, is recommended as the initial dose. Since there was a suggestion of a possible dose response relationship for effectiveness in the second study, a dose increase may be considered after several weeks if insufficient clinical improvement is observed. The full therapeutic effect may be delayed until 5 weeks of treatment or longer.

Doses above 20 mg/day may be administered on a once a day (i.e., morning) or b.i.d. schedule (i.e., morning and noon). A dose range of 20 to 60 mg/day is recommended, however, doses of up to 80 mg/day have been well tolerated in open studies of OCD. The maximum fluoxetine dose should not exceed 80 mg/day.

As with the use of fluoxetine HCl in depression, a lower or less frequent dosage should be used in patients with hepatic impairment. A lower or less frequent dosage should also be considered for the elderly (see PRECAUTIONS, Geriatric Use), and for patients with concurrent disease or on multiple concomitant medications. Dosage adjustments for renal impairment are not routinely necessary (see CLINICAL PHARMACOLOGY, Liver Disease and Renal Disease and PRECAUTIONS, Use in Patients with Concomitant Illness).

Maintenance/Continuation Treatment: While there are no systematic studies that answer the question of how long to continue fluoxetine HCl, OCD is a chronic condition and it is reasonable to consider continuation for a responding patient. Although the efficacy of fluoxetine HCl after 13 weeks has not been documented in controlled trials, patients have been continued in therapy under double-blind conditions for up to an additional 6 months without loss of benefit. However, 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 treatment.

Bulimia Nervosa

Initial Treatment: In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of bulimia nervosa, patients were administered fixed daily fluoxetine doses of 20 or 60 mg, or placebo (see CLINICAL STUDIES). Only the 60 mg dose was statistically significantly superior to placebo in reducing the frequency of binge-eating and vomiting. Consequently, the recommended dose is 60 mg/day, administered in the morning. For some patients it may be advisable to titrate up to this target dose over several days. Fluoxetine doses above 60 mg/day have not been systematically studied in patients with bulimia.

As with the use of fluoxetine HCl in depression and OCD, a lower or less frequent dosage should be used in patients with hepatic impairment. A lower or less frequent dosage should also be considered for the elderly (see PRECAUTIONS, Geriatric Use), and for patients with concurrent disease or on multiple concomitant medications. Dosage adjustments for renal impairment are not routinely necessary (see CLINICAL PHARMACOLOGY, Liver Disease and Renal Disease, and PRECAUTIONS, Use in Patients with Concomitant Illness).

Maintenance/Continuation Treatment: While there are no systematic studies that answer the question of how long to continue fluoxetine HCl, bulimia is a chronic condition and it is reasonable to consider continuation for a responding patient. Although the efficacy of fluoxetine HCl after 16 weeks has not been documented in controlled trials, some patients have been continued in therapy under double- blind conditions for up to an additional 6 months without loss of benefit. However, patients should be periodically reassessed to determine the need for continued treatment.

Switching Patients to a Tricyclic Antidepressant (TCA)

Dosage of a TCA may need to be reduced, and plasma TCA concentrations may need to be monitored temporarily when fluoxetine is coadministered or has been recently discontinued (see DRUG INTERACTIONS, Other Antidepressants).

Switching Patients to or From a Monoamine Oxidase Inhibitor

At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with fluoxetine HCl. In addition, at least 5 weeks, perhaps longer, should be allowed after stopping fluoxetine HCl before starting an MAOI (see CONTRA

INDICATIONS
and PRECAUTIONS).

HOW SUPPLIED

The 10 mg Prozac Pulvule is opaque green and green, imprinted with DISTA 3104 on the cap and Prozac 10 mg on the body.

The 20 mg Prozac Pulvule is an opaque green cap and off-white body, imprinted with DISTA 3105 on the cap and Prozac 20 mg on the body.

40 mg Prozac Pulvule: Opaque green cap and opaque orange body, imprinted with DISTA 3107 on the cap and Prozac 40 mg on the body.

Prozac Liquid, Oral Solution: 20 mg per 5 ml with mint flavor.

10 mg Prozac Tablet: Green, elliptical shaped, and scored with PROZAC 10 debossed on opposite side of score.

Dispense in a tight, light-resistant container.

Storage: Store at controlled room temperature, 59° to 86°F (15° to 30°C).

PATIENT INFORMATION

Fluoxetine is used for the treatment of depression, obsessive-compulsive disorder, and bulimia.

Notify your physician if you are pregnant or breast-feeding.

Do not take any other drugs, including over-the-counter medicines and alcohol, without consulting your physician.

Fluoxetine may cause dizziness or drowsiness, use caution while driving or operating hazardous machinery.

May cause rash or hive, notify your physician if these occur.

May cause anxiety, nervousness, drowsiness, dizziness, lightheadedness, insomnia, fatigue, or weakness, tremor, and sweating, stomache complaints, including anorexia, nausea, and diarrhea.

May be taken with or without food.

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