Fluoxetine Hydrochloride Capsules for Depression Attack

• Transport Package: Box
• Specification: 20mg*14tab/box
• Trademark: FUL
• Origin: China
• Model NO.: FC112
• Production Capacity: 10000PCS/ Month

Product Description

Item Name:Fluoxetine Hydrochloride Capsules
Molecular formula:C₁₇H₁₈F₃NO·HCl

Item Description

Item nanme: Fluoxetine Hydrochloride Capsules
Item character: This product is white.

Indication:
Depression attack; obsession; Bulimia nervosa.

Item specifications: 20mg*14tab/box

Usage and dosage: For adults.
Depressive episode
Adult and elderly patients: it is recommended to take 20mg daily. If necessary, the drug dose should be evaluated and adjusted during the first 3 to 4 weeks of treatment to achieve the clinically appropriate dose. Although higher doses may increase the possibility of adverse reactions, in some patients, the maximum dose of 60mg can be gradually increased due to the lack of obvious curative effect of 20mg dose (see [clinical trial]). We must carefully adjust the dose according to the situation of each patient to maintain the lowest effective dose.
Patients with depression must be treated for at least six months to ensure that their symptoms disappear.
obsession
Adult and elderly patients: the recommended dose is 20mg per day. For some patients, if the response to 20 mg dose is not sufficient after two weeks of treatment, the dose can be gradually increased to the maximum dose of 60 mg, but increasing the dose will increase the possibility of adverse reactions.
If no improvement is found within 10 weeks, the treatment of fluoxetine must be reconsidered. If a good therapeutic effect is obtained, the treatment can be continued, but the dose should be adjusted according to the individual. Although there is no systematic study to answer the question of how long fluoxetine treatment needs to last, OCD is a chronic disease, and patients with effective treatment can consider extending the treatment period to more than 10 weeks. We must carefully adjust the dose according to the situation of each patient to maintain the lowest effective dose. The need for treatment must be reassessed on a regular basis. Some clinicians advocate the combination of behavioral therapy for patients with effective drug treatment. The long-term efficacy of fluoxetine in the treatment of OCD (more than 24 weeks) has not been verified.
Bulimia nervosa
Adult and elderly patients: 60 mg daily is recommended. The long-term efficacy (more than 3 months) in patients with bulimia nervosa has not been verified.
All indications: the recommended dose can be increased or decreased appropriately. There was no systematic evaluation of doses higher than 80 mg per day.
Fluoxetine can be taken with meals or between meals, and can be given in single or multiple doses.
The active ingredients remained in the body for several weeks. This characteristic must be considered at the beginning and end of treatment.
Children: since the safety and efficacy of the drug in children and adolescents (under 18 years old) are not clear, it is not recommended to use it in this population.
Elderly patients: when increasing the dose, care must be taken, usually the daily dose should not exceed 40 mg.
The maximum recommended dose is 60 mg per day.
For liver dysfunction (see pharmacokinetics) or administration, it may be associated with Prozac ® Patients with drug interactions (see [drug interactions]) should consider reducing the dose or frequency of the drug (e.g., 20 mg every 2 days).
Stop taking Prozac ® Withdrawal symptoms: sudden withdrawal must be avoided. When you stop Prozac ® In order to reduce the risk of withdrawal reaction (see [precautions] and [adverse reactions]), the dosage must be gradually reduced within 1 to 2 weeks. If the patient has symptoms of intolerance after reducing the dosage or stopping the treatment, the previous dosage can be considered. After that, doctors can continue to reduce the dosage at a more moderate rate.

Adverse reactions
As continuous treatment may reduce the intensity and frequency of adverse reactions, adverse reactions will not generally lead to interruption of treatment.
As with other SSRIs, the adverse reactions are as follows:
Whole body: allergies (e.g., itching, rash, rubella, allergic reaction, vasculitis, serum reaction, facial edema, etc.) - (see [taboo] and [warning]), cold war, serotonin syndrome, photosensitive reaction, toxic epidermal necrosis dissolution (Lyell syndrome) are rare, and polymorphous erythema.
Digestive system: gastrointestinal dysfunction (e.g., diarrhea, nausea, vomiting, dyspepsia, dysphagia, reversed taste), dry mouth. There are few reports of abnormal liver function detection, and few reports of hepatitis.
Nervous system: headache, sleep abnormality (for example, abnormal dream, insomnia), dizziness, anorexia, fatigue (for example, sleepiness, sleepiness), euphoria, transient abnormal movement (for example, convulsion, ataxia, shushua, myoclonus), convulsion and rare psychomotor restlessness / sitting failure (see [precautions]. Hallucinations, manic reactions, confusion of consciousness, agitation, anxiety and related symptoms (such as tension), decreased attention and thinking (e.g., personality disintegration), panic attacks, suicidal concepts and behaviors (which can be caused by potential diseases), and serotonin syndrome is rare.
* urogenital system: urinary retention, frequent urination.
Reproductive disorder: sexual dysfunction (delayed or lack of ejaculation, lack of orgasm), persistent erectile penis, lactation.
Others: hair loss, yawn, visual abnormality (such as blurred vision, large pupil dispersion), stasis (see [precautions]), sweating, vasodilation, joint pain, muscle pain, postural hypotension, ecchymosis, other bleeding manifestations (e.g., gynecological bleeding, gastrointestinal bleeding and other skin or mucosal bleeding) are rare (see [precautions], bleeding).
Hyponatremia once: stopping the treatment of Baiyoujie ® At the time, a few patients had hyponatremia (including less than 110mmol/l) and showed reversible after fluoxetine was stopped. Some cases may be caused by dyssecretion of antidiuretic hormone. Most of the reports were reported in the elderly and those who took diuretics or other causes of fluid depletion.
Respiratory system: pharyngitis, dyspnea. Adverse pulmonary events (including different histopathologic inflammatory processes and / or fibrosis) are rarely reported. Dyspnea may be the only symptom that first occurs.
Withdrawal symptoms of fluoxetine treatment when stopped: the withdrawal of fluoxetine usually produces withdrawal symptoms. Dizziness, sensory disorders (including sensory abnormalities), sleep disorders (including insomnia and multiple dreams), fatigue, anxiety or anxiety, nausea and / or vomiting, tremor and headache are the most frequently reported adverse reactions. These symptoms are generally mild to moderate and self limiting, however in some patients they may be severe and / or extend the remission time (see [note]. So, when the best solution ® When treatment needs to stop, it is recommended to gradually reduce the dose (see [usage and dosage] and [precautions].

Taboo:
It is forbidden for patients allergic to fluoxetine or any of its ingredients.
Monoamine oxidase inhibitor (MAOI): severe and sometimes fatal reactions have been reported in patients receiving selective serotonin reuptake inhibitor (SSRI) therapy combined with MAOI, and in patients who have recently terminated SSRI therapy and started MAOI therapy. Fluoxetine treatment must begin 2 weeks after irreversible MAOI withdrawal and the day after reversible maoi-a withdrawal.
In some cases, the symptoms are similar to serotonin syndrome in blood. Cyproheptadine or dantroline may be useful in such patients. The reactions of patients with MAOI include high fever, stiffness, myoclonus, autonomic nervous system instability with rapid fluctuations of vital signs, and changes in mental state, including extreme agitation, which may develop into delirium and coma.
Therefore, fluoxetine can not be used with non selective MAOI. Similarly, monoamine oxidase inhibitor therapy should be started at least 5 weeks after fluoxetine is stopped. If it is a long-term use of fluoxetine and / or a higher dose, it may take a longer time interval.
Fluoxetine in combination with reversible MAOI (e.g., moclobemide) is not recommended. Fluoxetine treatment can be started the day after reversible MAOI withdrawal.

Matters needing attention:
Children and adolescents under 18
In clinical trials, antidepressants treatment group was more likely to commit suicide related behaviors (suicide attempts and suicidal ideas) than placebo control groups, and hostile behaviors (mainly attacks, antagonistic behaviors and anger). The best solution is only suitable for the treatment of moderate and severe depression in children and adolescents aged 8 to 18 years old, and not for other indications. If the treatment should be given with polyoxol according to clinical needs, the manifestations of suicide symptoms should be observed carefully during the treatment. There is limited information on the safety of long-term drug use among adolescents, including the impact on growth, sexual maturity, cognition, emotion and behavior development( See [pharmacology and toxicology])
In a 19 week clinical study, fluoxetine reduced height and weight gain in adolescents (see adverse reactions). It has not been determined whether fluoxetine affects the height of these people to normal adults. The possibility of fluoxetine's effect on puberty development cannot be ruled out (see [pharmacology toxicology] and [adverse reactions]. During and after treatment, the growth and development indicators of adolescents (including height, weight and Taner development stage) should be monitored. If one of them is found to be lagging behind normal development, it should be referred to a pediatrician for treatment.
Manic and mild manic cases are often found in clinical trials in Pediatrics (see adverse reactions). It is suggested that the occurrence of manic and mild mania should be monitored regularly. If manic occurs, stop the medicine immediately.
Doctors should discuss the advantages and disadvantages of the treatment in detail with children / adolescent patients and / or their parents when prescribing.
Rash and allergic reactions: rash, allergic reactions and further systemic reactions, sometimes very serious (including skin, kidney, liver and lung), have been reported. If rash or other possible allergic phenomena occur and the cause cannot be determined, the best solution should be stopped ®. Convulsions: convulsions are a potential risk for antidepressants. Therefore, fluoxetine is used with caution in patients with convulsive seizures, as with other antidepressants. Fluoxetine should be stopped because of the increase of frequency of convulsions or convulsions. Fluoxetine should be avoided for unstable convulsions / epilepsy patients. If it is used in well controlled epilepsy patients, attention should be paid to the supervision.
Mania: antidepressants should be used carefully in patients with manic / mild manic history. As with all antidepressants, patients with mania should immediately stop fluoxetine.
Liver / renal function: fluoxetine is mainly metabolized in the liver and excreted through the kidney. For patients with liver dysfunction, the dosage should be reduced, such as taking the medicine the next day. When fluoxetine was given 20mg daily for 2 months, there was no difference between the plasma levels of fluoxetine and norfluxetine in patients with severe renal failure requiring dialysis (GFR [10ml / min) and those with normal renal function.
Heart disease: in a double-blind trial, 312 patients who took fluoxetine were assessed for ECG without cardiac block. However, there is limited clinical study on fluoxetine in patients with acute heart disease, so they should be careful.
Weight loss: fluoxetine may cause weight loss, but is usually proportional to baseline weight.
Diabetes: SSRI can affect blood glucose concentration in diabetic patients. Take polyoxol ® During the period, hypoglycemia may occur, and hyperglycemia will occur after stopping the drug. The dosage of insulin and oral hypoglycemic drugs should be adjusted.
Suicide / suicide concept: depression is associated with the increased risk of suicide, self injury and suicide (suicide related events). This risk will only terminate after a significant symptom relief has occurred. No improvement of symptoms occurred in the first few weeks or longer of the treatment, during which patients should be closely monitored until the symptoms improve. Clinical experience shows that the risk of suicide may increase in the early stages of disease recovery.
Using the best solution ® Other mental diseases treated may also be associated with increased risk of suicide related events. In addition, these mental disorders may be associated with depression. The attention in the treatment of depression patients is also applicable to other mental disorders.
Patients with a history of suicide related events or those who showed significant suicide ideas before treatment have higher risk of suicide or suicidal tendency. They should be carefully monitored during treatment. In addition, the risk of suicide in young and middle-aged patients may increase.
Patients (and their caregivers) should be alert to the occurrence of these events and should be treated immediately once these symptoms appear.
Sit still / psychomotor restlessness: fluoxetine is related to the occurrence of sit down failure, which is manifested as a subjective disgust or irritability, and frequent exercise is accompanied by the inability to sit or stand still. It is most likely to occur in the first few weeks of treatment. It may be harmful to increase the dose of the drug to patients with these symptoms.
Withdrawal symptoms after SSRI treatment stop: when treatment stops, especially when it stops suddenly, withdrawal symptoms often occur( See adverse reactions). In clinical trials, the incidence of adverse events in patients who were discontinued was about 60% in fluoxetine and placebo groups. Of these adverse events, 17% of the patients in the fluoxetine group were serious and 12% in the placebo group.
The risk of withdrawal symptoms may be determined by several factors, including the duration and dose of treatment, and the rate of dose reduction. Dizziness, sensory disorders (including sensory abnormalities), sleep disorders (including insomnia and multiple dreams), fatigue, anxiety or anxiety, nausea and / or vomiting, tremor and headache are the most frequently reported withdrawal reactions. These symptoms are generally mild to moderate, but in some patients they may be very severe. These symptoms usually occur in the first few days after the treatment is stopped. These symptoms are generally self limiting and usually relieved within 2 weeks, but may be prolonged in some individuals (2-3 months or longer). Therefore, when stopping treatment, it should be gradually reduced within a period of 1 to 2 weeks according to the needs of the patient (see "best solution ® Withdrawal symptoms when stopping, usage and dosage).
Bleeding: skin bleeding, such as Yugong and purpura, has been reported in patients taking SSRI. Taking the best solution ® In the patients, Yu - Fu was reported as a rare adverse event. Other bleeding manifestations (e.g., gynecological bleeding, gastrointestinal bleeding, and other skin or mucous bleeding) are reported as rare. Patients taking SSRI should be reminded to note that drugs known to affect platelet function (such as atypical antipsychotics such as clozapine, phenothiazine, most tricyclic antidepressants, aspirin, NSAIDs) or other drugs that increase the risk of bleeding, or for patients with a history of bleeding disease, should be reminded.
Ect: the prolonged seizure time of patients receiving the treatment of convulsion with fluoxetine is rarely reported, but caution is also needed.
St. John's Grass: when selective serotonin reuptakes inhibitors and herbal preparations, used in conjunction with herbs including St. John's (Forsythia perforatum), it may lead to increased serotonin functions, such as the presence of serotonin syndrome.
It is reported that the occurrence of adverse events such as serotonin syndrome or nerve block malignant syndrome is related to fluoxetine treatment, especially when used in combination with other serotonin energy (such as L-tryptophan, etc.) and / or antipsychotics. As these syndromes may lead to potentially life threatening situations, these adverse events (manifested as a group of symptoms such as high fever, ankylosis, muscle spasm, plant nervous instability with possible rapid fluctuations in vital signs, changes in mental state, including confusion of consciousness, irritability, and extreme anxiety developing to delirium and coma) occur, Fluoxetine treatment should be stopped and supportive symptomatic treatment should be started.
Impact on driving and mechanical operation
Although no solution has been found ® It may affect the mental movement behavior of normal people, but any drugs that affect the spirit may affect the judgment ability and skills of people. Therefore, patients should be warned to avoid driving or operating dangerous machinery until they are quite sure that their behavior is not affected.

Medication for pregnant and lactating women:
Pregnant women: a large number of data show that fluoxetine has no teratogenic effect on human beings. Fluoxetine can be used during pregnancy, but attention should be paid to it, especially in late pregnancy or before delivery. Because it has been reported that fluoxetine has the following effects on newborns: irritability, tremor, hypotonia, continuous crying, difficulty in sucking or sleeping. These symptoms suggest that it may be serotonergic effect or withdrawal syndrome. The time and duration of these symptoms may be related to the longer half-life of fluoxetine (4-6 days) and its active metabolite norfluoxetine (4-16 days).
Lactation: Fluoxetine and its metabolites can be secreted into breast milk. Adverse events in infants have been reported. If it is necessary to take fluoxetine, breastfeeding should be stopped; However, if breastfeeding is to continue, the minimum effective dose of fluoxetine should be used.

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Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd is a comprehensive enterprise which integrates R & D, production and construction of pharmaceutical production equipments, development and transfer of biotechnology, and cooperative production and sales of drugs and vaccines. The self-developed pharmaceutical production equipment branded FUL has been put into operation in many well-known pharmaceutical enterprises such as SINOPHARM, CSPC and also cooperates with many well-known pharmaceutical enterprises in production and sales, including pharmaceutical intermediates, APIs and finished drug preparations.

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At present Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd has the SINOPHARM authorization to sell its intermediates and APIs,and has the authorizations of CSPC & HUABEI PHARM sell its finished drug preparations;then FUL is the only manufacture in China which can supply the complete service from pharmaceutical produciton lines,intermediates and APIs to finished drug preparations and vaccines.Then we are seeking the professional pharmaceutical enterprices to work together for further cooperations.




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