देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
FLUOXETINE HYDROCHLORIDE (UNII: I9W7N6B1KJ) (FLUOXETINE - UNII:01K63SUP8D)
Mylan Pharmaceuticals Inc.
FLUOXETINE HYDROCHLORIDE
FLUOXETINE 10 mg
ORAL
PRESCRIPTION DRUG
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 b
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.
Abbreviated New Drug Application
FLUOXETINE HYDROCHLORIDE- FLUOXETINE HYDROCHLORIDE CAPSULE Mylan Pharmaceuticals Inc. ---------- MEDICATION GUIDE FLUOXETINE CAPSULES, USP (floo oxʹ e teen) 10 mg and 20 mg Read the Medication Guide that comes with fluoxetine capsules before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or you want to learn more about. Fluoxetine capsules are in a class of drugs called selective serotonin reuptake inhibitors (SSRIs), which are often used for the treatment of depression and anxiety disorders. Although fluoxetine capsules are not a treatment for depression, it contains fluoxetine hydrochloride, the same active ingredient in some antidepressants. What is the most important information I should know about fluoxetine capsules? Fluoxetine capsules and other antidepressant medicines may cause serious side effects including: 1. Suicidal thoughts or actions: • Fluoxetine capsules and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed. • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. • Watch for these changes and call your healthcare provider right away if you notice: • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. • Pay particular attention to such changes when fluoxetine capsules are started or when the dose is changed. Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you: • attempts to commit suicide • acti पूरा दस्तावेज़ पढ़ें
FLUOXETINE HYDROCHLORIDE- FLUOXETINE HYDROCHLORIDE CAPSULE MYLAN PHARMACEUTICALS INC. ---------- WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS: ANTIDEPRESSANTS INCREASED THE RISK COMPARED TO PLACEBO OF SUICIDAL THINKING AND BEHAVIOR (SUICIDALITY) IN CHILDREN, ADOLESCENTS AND YOUNG ADULTS IN SHORT-TERM STUDIES OF MAJOR DEPRESSIVE DISORDER (MDD) AND OTHER PSYCHIATRIC DISORDERS. ANYONE CONSIDERING THE USE OF FLUOXETINE CAPSULES OR ANY OTHER ANTIDEPRESSANT IN A CHILD, ADOLESCENT, OR YOUNG ADULT MUST BALANCE THIS RISK WITH THE CLINICAL NEED. SHORT-TERM STUDIES DID NOT SHOW AN INCREASE IN THE RISK OF SUICIDALITY WITH ANTIDEPRESSANTS COMPARED TO PLACEBO IN ADULTS BEYOND AGE 24; THERE WAS A REDUCTION IN RISK WITH ANTIDEPRESSANTS COMPARED TO PLACEBO IN ADULTS AGED 65 AND OLDER. DEPRESSION AND CERTAIN OTHER PSYCHIATRIC DISORDERS ARE THEMSELVES ASSOCIATED WITH INCREASES IN THE RISK OF SUICIDE. PATIENTS OF ALL AGES WHO ARE STARTED ON ANTIDEPRESSANT THERAPY SHOULD BE MONITORED APPROPRIATELY AND OBSERVED CLOSELY FOR CLINICAL WORSENING, SUICIDALITY, OR UNUSUAL CHANGES IN BEHAVIOR. FAMILIES AND CAREGIVERS SHOULD BE ADVISED OF THE NEED FOR CLOSE OBSERVATION AND COMMUNICATION WITH THE PRESCRIBER. FLUOXETINE IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS WITH MDD AND OBSESSIVE COMPULSIVE DISORDER (OCD). (SEE WARNINGS, PRECAUTIONS: INFORMATION FOR PATIENTS AND PRECAUTIONS: PEDIATRIC USE.) DESCRIPTION Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration; fluoxetine was initially developed and marketed as an antidepressant (Prozac , fluoxetine capsules, USP). It is designated (±)-_N_-methyl-3-phenyl-3-[(α,α,α-trifluoro-_p_-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C H F NO•HCl. Its molecular weight is 345.79. The structural formula is: Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride, USP equivalent to 10 mg (32.3 µmol) or 20 mg (64.7 µmol) of fl पूरा दस्तावेज़ पढ़ें