Sarafem Indications, Dosage, Storage, Stability - Fluoxetine Hydrochloride

Sarafem Indications, Dosage, Storage, Stability - Fluoxetine Hydrochloride

INDICATIONS

SARAFEM is indicated for the treatment of premenstrual dysphoric disorder (PMDD). The efficacy of fluoxetine in the treatment of PMDD was established in two placebo-controlled trials (see Clinical Trials under CLINICAL PHARMACOLOGY).

The essential features of PMDD, according to the DSM-IV, include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating, and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant.

The effectiveness of SARAFEM in long-term use, that is, for more than 6 months, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use SARAFEM for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

DOSAGE AND ADMINISTRATION

Premenstrual Dysphoric Disorder—

Initial Treatment--The recommended dose of SARAFEM for the treatment of PMDD is 20 mg/day. In a study comparing fluoxetine 20 and 60 mg/day to placebo, both doses were proven to be effective but there was no statistically significant added benefit for the 60 mg/day compared to the 20 mg/day dose. Fluoxetine doses above 60 mg/day have not been systematically studied in patients with PMDD. The maximum fluoxetine dose should not exceed 80 mg/day.

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

Maintenance/Continuation Treatment--Systematic evaluation of SARAFEM has shown that its efficacy in PMDD is maintained for periods of up to 6 months at a dose of 20 mg/day (see Clinical Trials under CLINICAL PHARMACOLOGY). Patients should be periodically reassessed to determine the need for continued treatment.

HOW SUPPLIED

SARAFEM (fluoxetine hydrochloride) Pulvules® are available in 10 mg* and 20 mg* capsule strengths.

The 10 mg Pulvule has an opaque lavender body and cap, and is imprinted with "10 mg" on the body and "LILLY 3210" on the cap:

NDC 0002-3210-07 (PU3210) - Bottles of 2000

NDC 0002-3210-45 (PU3210) - Blisters of 28

The 20 mg Pulvule has an opaque pink body with opaque lavender cap, and is imprinted with "20 mg" on the body and "LILLY 3220" on the cap:

NDC 0002-3220-45 (PU3220) - Blisters of 28

__________________________________

* equivalent to fluoxetine base

† Identi-Dose (unit dose medication, Lilly)

Store at controlled room temperature, 15º to 30ºC (59º to 86ºF). Protect from light.

Literature revised July 11, 2000

Eli Lilly and Company Indianapolis, IN 46285, USA.,PV 3281 AMP PRINTED IN USA, Copyright © 2000, Eli Lilly and Company. All rights reserved.