Fluoxetine Hydrochloride Capsules

Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI) that can effectively inhibit neurons from taking up serotonin from the synaptic cleft, increase the amount of this neurotransmitter that can be actually utilized in the cleft, thereby improving emotional states and treating depressive disorders.

The main ingredient of this product is: fluoxetine hydrochloride.

This product is a hard capsule, and the contents are white powder.

This product is suitable for the remission period of depression, and is used for consolidation treatment and maintenance treatment.

For oral administration in adults. 1. Adults and elderly patients with depressive episodes: It is recommended to take a dose of 20 mg per day. If necessary, evaluate and adjust the drug dose within the first 3 to 4 weeks of treatment to achieve a clinically appropriate dose. Although higher doses may increase the likelihood of adverse reactions, in some patients, due to the lack of significant efficacy with a 20 mg dose, the dose can be gradually increased to a maximum dose of 60 mg (see [Clinical Trials]). The dose must be adjusted carefully according to the situation of each patient so that the patient maintains the lowest effective dose. Patients with depression must continue treatment for at least 6 months to ensure that their symptoms disappear. 2. Adults and elderly patients with obsessive-compulsive disorder: The recommended dose is 20 mg per day. For some patients, if the response to the 20 mg dose is insufficient after two weeks of treatment, the dose can be gradually increased to a maximum dose of 60 mg, but increasing the dose will increase the likelihood of adverse reactions. If no improvement is found within 10 weeks, treatment with fluoxetine must be reconsidered. If a good therapeutic effect is obtained, treatment can be continued, but the dose should be adjusted based on the individual. Although there are no systematic studies to answer the question of how long fluoxetine treatment should be maintained, OCD is a chronic condition and patients who respond to treatment may consider extending treatment to more than 10 weeks. The dose must be carefully adjusted according to the individual patient's situation to maintain the patient at the lowest effective dose. The need for treatment must be reassessed regularly. Some clinicians advocate the combination of behavioral therapy for patients who respond to drug treatment. The long-term efficacy (more than 24 weeks) of fluoxetine in the treatment of OCD has not been verified. 3. Adult and elderly patients with bulimia nervosa: A dose of 60 mg per day is recommended. Long-term efficacy (more than 3 months) in patients with bulimia nervosa has not been verified. All indications: The recommended dose can be appropriately increased or decreased. Doses higher than 80 mg per day have not been systematically evaluated. Fluoxetine can be taken with or between meals and can be taken in single or divided doses. After stopping the medication, the active ingredient of the drug remains in the body for several weeks. This feature must be considered when starting and ending treatment. Children: Since the safety and efficacy of using it in children and adolescents (under 18 years old) have not been established, it is not recommended for use in this population. Elderly patients: When increasing the dose, caution must be exercised. The daily dose should not exceed 40 mg. The maximum recommended dose is 60 mg per day. For patients with impaired liver function (see [Pharmacokinetics]) or taking drugs that may interact with Prozac (see [Drug Interactions]), it is necessary to consider reducing the dose or reducing the frequency of use (for example, taking 20 mg every 2 days). Withdrawal symptoms when stopping Prozac: Abrupt discontinuation of the drug must be avoided. When stopping Prozac treatment, in order to reduce the risk of withdrawal reactions (see [Precautions] and [Adverse Reactions]), the dose must be gradually reduced over a period of 1 to 2 weeks. If the patient develops symptoms of intolerance after the dose is reduced or when the treatment is stopped, it may be considered to resume the previous dose. After that, the doctor can continue to reduce the dose at a more moderate rate.

The intensity and frequency of adverse reactions may decrease with continued treatment, and adverse reactions generally do not lead to interruption of treatment. Like other selective serotonin reuptake inhibitors (SSRIs), adverse reactions are as follows: 1. Systemic: allergies (e.g., itching, rash, urticaria, allergic reactions, vasculitis, serological reactions, facial edema, etc.) (see [Contraindications] and [Precautions]), chills, serotonin syndrome, photosensitivity reactions, and in very rare cases, erythema multiforme may develop into Stevens-Johnson syndrome or toxic epidermal necrolysis (Lyell syndrome). 2. Digestive system: gastrointestinal dysfunction (e.g., diarrhea, nausea, vomiting, indigestion, dysphagia, taste reversal), dry mouth, etc. Rarely, liver function test abnormalities, idiopathic hepatitis is rarely reported. 3. Nervous system: headache, abnormal sleep (e.g., abnormal dreams, insomnia), dizziness, anorexia, fatigue (e.g., drowsiness, sleepiness), euphoria, transient abnormal movements (e.g., convulsions, ataxia, tremors, myoclonus), seizures, and rare psychomotor restlessness/akathisia (see [Precautions]). Hallucinations, manic reactions, confusion, agitation, anxiety and related symptoms (e.g., tension), decreased attention and thinking ability (e.g., depersonalization), panic attacks, serotonin syndrome are extremely rare, suicidal thoughts and behaviors (these symptoms may be caused by underlying diseases). Suicidal thoughts and behaviors have been reported during or early after cessation of fluoxetine treatment (see [Precautions]). 4. Urogenital system: urinary retention, frequent urination. 5. Reproductive disorders: sexual dysfunction (delayed or absent ejaculation, lack of orgasm), priapism, and galactorrhea. 6. Others: hair loss, yawning, visual abnormalities (e.g., blurred vision, mydriasis), sweating, vasodilation, arthralgia, myalgia, postural hypotension, and ecchymosis. Other bleeding manifestations (e.g., gynecological bleeding, gastrointestinal bleeding, and other skin or mucosal bleeding) have been rarely reported (see [Precautions], Bleeding). Transient hyponatremia: A very small number of patients experience transient hyponatremia (including blood sodium below 110mmol/L) when discontinuing Prozac, and this is reversible after discontinuation. Some cases may be caused by an imbalance in antidiuretic hormone secretion. Most reports occur in the elderly and patients taking diuretics or patients with fluid depletion due to other reasons. (1) Respiratory system: pharyngitis and dyspnea. Pulmonary adverse events are rare (including inflammatory changes and/or fibrosis of different tissue pathologies). Dyspnea may be the only symptom at first. (2) Withdrawal symptoms when fluoxetine treatment is discontinued: Withdrawal symptoms usually occur when fluoxetine is discontinued. Dizziness, sensory disturbances (including paresthesias), sleep disorders (including insomnia and dreaminess), fatigue, agitation or anxiety, nausea and/or vomiting, tremor and headache are the most commonly reported adverse reactions. Generally, these symptoms are mild to moderate and self-limited, however, in some patients these symptoms may be severe and/or prolong the duration of relief (see [Precautions]). Therefore, when treatment with Prozac needs to be discontinued, it is recommended to gradually reduce the dose (see [Dosage and Administration] and [Precautions]). Children and adolescents (see [Precautions]) In pediatric clinical trials, suicide-related behaviors (suicidal attempts and suicidal thoughts) and hostile behaviors were more common in the antidepressant treatment group than in the placebo control group. The safety of long-term use of fluoxetine for more than 19 weeks has not been systematically studied. In pediatric clinical trials, there have been reports of manic and hypomanic reactions (2.6% in the fluoxetine group and 0% in the placebo group), most of which led to discontinuation of the drug. These patients had no history of mania or hypomania. In a pediatric clinical trial, after 19 weeks of medication, the height growth of the fluoxetine group was 1.1 cm less than that of the placebo control group (p=0.004), and the weight growth was 1.1 kg less than that of the placebo control group (p=0.008). There are individual case reports of growth retardation in clinical applications. There are individual case reports of delayed sexual maturation or sexual dysfunction in children using Prozac. (See [Pharmacology and Toxicology]) In pediatric clinical trials, it was also found that taking fluoxetine was accompanied by a decrease in alkaline phosphatase levels.

Patients hypersensitive to fluoxetine or any of its components are contraindicated. Monoamine oxidase inhibitors (MAOIs): Severe, sometimes fatal, reactions have been reported in patients receiving selective serotonin reuptake inhibitors (SSRIs) concurrently with MAOIs and in patients who have recently discontinued SSRI therapy and are starting MAOIs. Fluoxetine treatment must be started 2 weeks after discontinuation of irreversible MAOIs and the day after discontinuation of reversible MAOI-A. Some cases have presented with features resembling serotonin syndrome (similar to and possibly diagnostic of neuroleptic malignant syndrome). Cyproheptadine or dantrolene may be beneficial in the treatment of such patients. Reactions in patients taking MAOIs have included hyperthermia, rigidity, myoclonus, autonomic nervous system instability with rapid fluctuations in vital signs, and changes in mental status, including confusion, irritability, and extreme agitation that may progress to delirium and coma. Therefore, fluoxetine should not be used concomitantly with non-selective MAOIs. Likewise, at least 5 weeks should be allowed after discontinuation of fluoxetine before starting an MAOI. Longer intervals may be necessary if fluoxetine is used chronically and/or at higher doses. Concomitant use of reversible MAOIs (e.g., moclobemide) is not recommended. Fluoxetine treatment can be started the day after reversible MAOIs are discontinued.

Precautions for children: Since the safety and efficacy of fluoxetine in children and adolescents (under 18 years old) have not been clearly established, it is not recommended for use in this population. Precautions for pregnancy and lactation: 1. A large amount of data on exposure to fluoxetine during pregnancy does not show that fluoxetine has teratogenic effects. Fluoxetine can be used during pregnancy, but it should be used with caution, especially in the late pregnancy or before delivery, because of the appearance of: irritability, tremor, hypotonia, continuous crying, sucking or sleeping difficulties in newborns. These symptoms may be manifestations of serotonergic effects or a withdrawal syndrome. The time of occurrence and duration of these symptoms may be related to the long half-life of fluoxetine (4-6 days) and its active metabolite norfluoxetine (4-16 days). 2. Lactation: Fluoxetine and its metabolites can be secreted into breast milk. Adverse events have been reported in breastfed infants. If fluoxetine must be taken, it is recommended to stop breastfeeding; however, if breastfeeding continues, the lowest effective dose of fluoxetine should be given for treatment. Elderly precautions: When increasing the dose, be careful, usually the daily dose should not exceed 40 mg. The maximum recommended dose is 60 mg per day.

When fluoxetine is used in combination with tricyclic antidepressants (TCAs), the steady-state blood concentration of TCAs will be more than doubled. When used in combination with phenytoin, the blood concentration of phenytoin will increase and symptoms of phenytoin poisoning will appear. Lithium and fluoxetine can increase or decrease the blood concentration of lithium. The simultaneous use of diazepam may prolong the half-life of diazepam. Fluoxetine may increase the blood concentration of drugs that bind to plasma proteins or are metabolized by the liver cytochrome P450 isoenzyme (P450ⅡD6).

Store at room temperature, below 25°C.

20mg (calculated as fluoxetine)

24 months.

Suzhou Yushi Pharmaceutical Co., Ltd.

• Founded in:

  2003-04-02

• Address:

  No. 188, Nanhu Avenue, Nanhu Industrial Zone, Xinzhuang, Changshu City

• Tax NO.:

  913205817473463096

• Registered Funds:

  38 million yuan

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