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Fluoxetine 20 MG Oral Capsule

INDICATIONS AND USAGE Fluoxetine capsules, USP are indicated for the treatment of premenstrual dysphoric disorder (PMDD). The efficacy of fluoxetine in the treatment of PMDD was established in three placebo-controlled trials (see CLINICAL TRIALS ). 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 fluoxetine capsules 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 fluoxetine capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

Mylan Pharmaceuticals Inc.


4 years ago CAPSULE RED Mylan 5420 Fluoxetine 20 MG Oral Capsule

CAPSULE RED Mylan 5420

HOW SUPPLIED Fluoxetine capsules, USP are available containing fluoxetine hydrochloride, USP equivalent to 10 mg or 20 mg of fluoxetine. The 10 mg capsule is a hard-shell gelatin capsule with a blue green opaque cap and a blue green opaque body axially printed with MYLAN over 5410 in black ink on both the cap and the body. The capsule is filled with white to off-white powder. They are available as follows: NDC 0378-5410-28 bottles of 28 capsules The 20 mg capsule is a hard-shell gelatin capsule with a red opaque cap and a red opaque body axially printed with MYLAN over 5420 in black ink on both the cap and the body. The capsule is filled with white to off-white powder. They are available as follows: NDC 0378-5420-28 bottles of 28 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.


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Fluoxetine 10 MG Oral Capsule

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