Active material: Fluoxetine
When ATH: N06AB03
CCF: Antidepressant
When CSF: 02.02.04
Manufacturer: ALSI Pharma Company Inc. (Russia)
Pharmaceutical form, composition and packaging
Capsules hard gelatin, №4, with white body and a blue cap; содержимое капсул – гранулы белого или почти белого цвета.
|
1 caps. |
| fluoxetine hydrochloride |
11.2 mg, |
| that corresponds to the content of fluoxetine |
10 mg |
Excipients: lactose, microcrystalline cellulose, colloidal silicon dioxide (aэrosyl), talc, magnesium stearate.
Ingredients of the capsule shell: Titanium dioxide, Brilliant Black, Patent blue, Ponceau 4R, azoruʙin, gelatin.
10 PC. – упаковки ячейковые контурные (1) – пачки картонные.
10 PC. – упаковки ячейковые контурные (2) – пачки картонные.
10 PC. – упаковки ячейковые контурные (3) – пачки картонные.
10 PC. – упаковки ячейковые контурные (4) – пачки картонные.
10 PC. – упаковки ячейковые контурные (5) – пачки картонные.
Capsules hard gelatin, №4, with white body and blue cap; содержимое капсул – гранулы белого или почти белого цвета.
|
1 caps. |
| fluoxetine hydrochloride |
22.4 mg, |
| that corresponds to the content of fluoxetine |
20 mg |
Excipients: lactose, microcrystalline cellulose, colloidal silicon dioxide (aэrosyl), talc, magnesium stearate.
Ingredients of the capsule shell: Titanium dioxide, Brilliant Black, Patent blue, Ponceau 4R, azoruʙin, gelatin.
10 PC. – упаковки ячейковые контурные (1) – пачки картонные.
10 PC. – упаковки ячейковые контурные (2) – пачки картонные.
10 PC. – упаковки ячейковые контурные (3) – пачки картонные.
10 PC. – упаковки ячейковые контурные (4) – пачки картонные.
10 PC. – упаковки ячейковые контурные (5) – пачки картонные.
Pharmacological action
Antidepressants, selective serotonin reuptake inhibitor. It improves mood, reduce tension, anxiety and a sense of fear, eliminates dysphoria. It does not cause orthostatic hypotension, Sedation, nekardiotoksichen. Persistent clinical effect after 1-2 weeks of treatment.
Testimony
Depression (независимо от степени депрессивного расстройства – слабая, moderate, heavy), Bulimia, anorexia, alcoholism, obsessive-compulsive disorder.
Contraindications
Hypersensitivity, CRF (CC less than 10 ml / min), severe hepatic insufficiency, suicidal thoughts, simultaneous MAO inhibitors (in the previous 2 Sun), pregnancy, lactation. Diabetes, epileptic syndrome of different genesis and epilepsy (incl. history), Parkinson's disease, compensated kidney and / or liver failure, kaxeksija.
Side effects
From the nervous system: dizziness, headache, drowsiness or insomnia, slackness, fatigue, asthenia, tremor, ažitaciâ, anxiety, suicidal tendencies (inherent in patients with depressive disorders), mania or gipomaniya. From the digestive system: decreased appetite, dry mouth or hypersalivation, nausea, diarrhea. Allergic reactions: skin rash, hives. Other: increased perspiration, loss of flesh, decreased libido, systemic disorders of the lung, kidney or liver disease, vaskulity.Peredozirovka. Symptoms: nausea, vomiting, state of excitement, convulsions. Treatment: gastric lavage, appointment of activated carbon, при судорогах – анксиолитических ЛС (trankvilizatorov), simptomaticheskaya therapy.
Dosing and Administration
Inside, при депрессии начальная доза – 20 mg / day 1 time, morning; if necessary increase dose at weekly 20 mg / day. The maximum daily dose - 80 mg 2-3 admission. При булимии и для пожилых пациентов – 60 mg 3 admission, при навязчивых состояниях – 20-60 mg / day. Поддерживающая терапия – 20 mg / day. A course of treatment - 3-4 Sun.
Cautions
In the treatment of patients with deficiency of body weight should be considered anorectic effects (possible the progressive loss of body weight). У больных сахарным диабетом назначение флуоксетина повышает риск развития гипогликемии и гипергликемии – при его отмене. In this regard, the dose of insulin and / or any other. hypoglycemic drugs, Administered orally, It should be adjusted. Prior to the significant improvement in the treatment of patients should be under a doctor's supervision. During treatment should refrain from receiving ethanol and Occupation potentially hazardous activities, require attention and speed of mental and motor responses. The interval between the end of MAO inhibitor therapy and initiation of treatment with fluoxetine should be at least 14 days; между окончанием лечения флуоксетином и началом терапии ингибиторами МАО – не менее 5 Sun. In diseases of the liver and in the elderly, treatment should begin with 1/2 dose.
Cooperation
It enhances the effects of alprazolam, diazepama, ethanol and hypoglycemic drugs. Increases in plasma concentration of phenytoin, tricyclic antidepressants, Maprotiline, trazodone 2 times (necessary to 50% reduce the dose of tricyclic antidepressants, while the application). Against the background of electroconvulsive therapy may develop prolonged seizures. Tryptophan enhances the serotonergic properties of fluoxetine (increased agitation, motor restlessness, disorders of the gastrointestinal tract). MAO inhibitors increase the risk of serotonin syndrome (hyperthermia, chills, increased perspiration, myoclonus, hyperreflexia, tremor, diarrhea, impaired coordination of movements, vegetative lability, excitation, delirium and coma). PM, providing a depressing effect on the central nervous system, increase the risk of side effects and increased inhibitory action on the central nervous system. In an application with drugs, has a high degree of protein binding, especially with anticoagulants and digitoxin, possible to increase the plasma concentrations of free (unbound) Drugs and an increased risk of adverse effects.