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    Komposisi:

    Fluoxetine

    Bentuk sediaan:

    Kapsul 10 mg dan 20 mg

    Farmakologi:

    menghambat re-uptake serotonin (5-hydroxytryptamine; 5-HT) pada celah sinap pada SSP. Fluoxetine maupun metabolit aktifnya norfluoxetine memiliki farmakokinetik yang berbeda, tapi sama-sama berperan dalam menghambat re-uptake Serotonin. Absorbsi per-oral (80-95%), tidak dipengaruhi makanan dalam lambung, kadar puncak dicapai dalam waktu 6-8 jam, waktu paruh Fluoxetine : 1,9 hari, Norfluoxetine : 7 hari. 60-80% akan diekskresikan melalui urin dan 15% melalui feses

    Indikasi:

    Depresi, Obsessive-Compulsive Disorder (OCD), Bulimia Nervosa, PMDD.

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    Dosis:

    - Dosis awal 20 mg perhari (1 x 1 kapsul perhari) pagi atau malam hari.

    - Dosis dapat ditingkatkan menjadi 40 mg per hari (1 x 2 kapsul) hingga 80 mg per hari, diberikan 1x kali sehari atau dosis terbagi, tergantung respon pasien.

    - Efektivitas Fluoxetine terlihat dalam 5 - 6 minggu.

    - Tidak perlu menyesuaikan dosis pada orang tua dan orang gemuk.

    - Pada gangguan hati (sirosis hati) dan gangguan ginjal ringan sampai sedang perlu menyesuaikan dosis yaitu 1 x ½ kapsul.

    - Dosis pemeliharaan selama beberapa bulan.

    Kontraindikasi:

    Hipersensitif terhadap Fluoxetine, gangguan ginjal berat, wanita menyusui dan hamil, pemberian bersamaan dengan Monoamin Oksidase Inhibitor (MAOI)

    Peringatan dan Perhatian:

    - Gangguan Hati (Sirosis Hati) dan gangguan Ginjal ringan sampai sedang → dosis : Separuhnya (1 x ½ kapsul)

    - Anak-anak : keamanan dan efektivitas KALXETIN® belum diketahui dengan jelas.

    Efek Samping:

    Efek samping ringan, paling sering (20-25%) mual, gugup, insomnia.

     

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    KALXETIN

     

    Composition:

    Fluoxetine hydrochloride (equivalent to fluoxetine)

    Presentation:

    10 mg capsule/Box : 3 stripes @ 10 capsules 20 mg capsule/Box : 3 stripes @ 10 capsules

    Pharmacology:

    Fluoxetine is a new oral antidepressant which inhibits CNS neuronal uptake of serotonin

    Indications:

    Treatment of depression. Its efficacy is established for outpatients with major depressive disorder treated for 5 to 6 weeks

    Contraindications:

    Hypersensitivity to fluoxetin

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    Dosage:

    Initial dose 20 mg/day (morning) If no clinical improvement is observed after several weeks, the dose may be increased. Doses above 20 mg/day should be given bid (ie, morning and noon) Maximum dose of 80 mg/day should not be exceeded

    Warning and Precautions:

    - Fluoxetine may cause rash in 4 % of patients - Fluoxetine may cause significant weight loss (more than 5% of body weight) in 13% of patients - Fluoxetine may activate mania/hypomania in approximately 1% of patients - Fluoxetine has not been evaluated in patients with a recent history of myocardial infarction or unstable heart disease - In patients with liver cirrhosis, a lower or less frequent dose should be used - Use with caution in patients with severe renal impairment - Any psychoactive drug, including fluoxetine, may impair judgment, thinking, or motor skills, and patients should be cautioned about operating hazardous machinery, including motor vehicle, until they are reasonably certain that the drug treatment does not affect them adversely - There are no adequate and well-controlled studies pregnant women. Therefore, this drug should be used during pregnancy only if clearly needed - The effect of fluoxetine on labor and delivery in humans is unknown - Excretion of fluoxetine and its metabolites in human milk is unknown, therefore this drug should be used with caution in nursing women - Safety and efficacy of fluoxetine in children have not been established - No unusual adverse age - related events have been identified in elderly patients - In patients with diabetes, Fluoxetine may alter glycemic control

    Adverse events:

    The most commonly observed adverse events were : - Nervous system complaints, including anxiety, nervousness, and insomnia - Drowsiness and fatigue or asthenia - Tremor - Sweating - GI complaints, including anorexia, nausea, and diarrhea - Dizziness or lightheadedness - Chills - Increased appetite - Weight loss - Abnormal dream and agitation - Bronchitis, rhinitis and yawn

    Drugs Interaction:

    - Data on the effects of the combined use fluoxetine and MAO inhibitors are limited, therefore their combined use should be avoided. At least 14 days should elapse between discontinuation of a MAOI and initiation of fluoxetine treatment, and at least 5 weeks should elapse between discontinuation of fluoxetine and initiation of therapy with a MAOI - Concurrent administration with diazepam may prolong the elimination half-life of diazepam - Displacement of plasma protein binding may occur when fluoxetine is used in combination with other drugs which are tightly bound to plasma proteins (eg, warfarin, digitoxin), resulting in increased free plasma levels and potentially adverse effects - Combination of fluoxetine and tryptophan may cause agitation, restlessness, and GI distress

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