What Are the Signs of a Fluoxetine Overdose?
Fluoxetine hydrochloride dispersible tablets, the indications are: depression, obsessive-compulsive disorder (OCD), bulimia nervosa: as an adjunct to psychotherapy to reduce bulimia and catharsis.
- Drug Name
- Fluoxetine Hydrochloride Dispersible Tablets
- Drug type
- Prescription drugs, medicines for medical workers' injuries
- Use classification
- Selective serotonin reuptake inhibitors
- Fluoxetine hydrochloride dispersible tablets, the indications are: depression, obsessive-compulsive disorder (OCD), bulimia nervosa: as an adjunct to psychotherapy to reduce bulimia and catharsis.
Ingredients of Fluoxetine Hydrochloride Dispersible Tablets
- Chemical name of fluoxetine hydrochloride: (±) -N-methyl-3-phenyl-3-[(, , -trifluoro-P-tolyl) -oxo] propylamine hydrochloride.
Chemical Structure:
Molecular formula: C 17 H 18 F 3 NO · HCl
Molecular weight: 345.79
Properties of Fluoxetine Hydrochloride Dispersible Tablets
- This product is a white oval tablet.
Indications of fluoxetine hydrochloride dispersible tablets
- Depression Obsessive-Compulsive Disorder (OCD)
Bulimia nervosa: used as an adjunct to psychotherapy to reduce bulimia and catharsis
Fluoxetine Hydrochloride Dispersible Tablets Specifications
- 20 mg (as fluoxetine)
Fluoxetine hydrochloride dispersible tablets
- For oral use only in adults <br Depression <br Adults and elderly patients: 20 mg to 60 mg daily. The recommended starting dose is 20 mg daily. Although high doses may increase the incidence of adverse reactions, if the treatment has not been effective for 3 weeks, you should consider increasing the drug dose.
The consensus reached by the WHO is that antidepressants continue to be treated for at least 6 months.
Obsessive-compulsive disorder < br Adults and elderly patients: 20 mg to 60 mg daily. The recommended starting dose is 20 mg daily. Although high doses may increase the incidence of adverse reactions, if the treatment is not effective after 2 weeks, you should consider increasing the drug dose. If there is no improvement after 10 weeks of treatment, a dressing change should be considered. If the effect is good, the maintenance dose can be adjusted according to individual differences. There is still no systematic research on how long fluoxetine treatment needs to be maintained. Considering that OCD is a chronic disease, maintenance treatment is recommended for patients who are effective for more than 10 weeks. The dosage should be carefully adjusted based on individual patient differences to maintain the treatment at the lowest effective dose. Regular evaluation of treatment should continue. Some clinicians have advocated that behavioral therapy can be combined with patients who are effective with medications.
The long-term efficacy (over 24 weeks) of OCD has not been proven.
Bulimia nervosa < br Adults and elderly patients: The recommended dose is 60 mg daily.
The long-term efficacy (over 3 months) of bulimia nervosa has not been proven.
All indications < br The recommended dosage can be increased or decreased as appropriate. Cases with daily doses above 80 mg have not been systematically evaluated.
Fluoxetine can be administered in single or divided doses. It can be taken with food or between meals.
When discontinued, the active ingredient will remain in the body for several weeks. This feature must be considered at the beginning and end of treatment. Most patients do not need to reduce the dose gradually.
Children: Because safety and efficacy are not yet clear, children and adolescents (under 18) are not recommended to use fluoxetine.
Elderly: It should be noted that the increase and daily dose should generally not exceed 40 mg. The maximum recommended daily dose is 60 mg.
For patients with impaired liver function (see [Pharmacokinetics]) or in combination with other drugs that may cause interactions (see [Drug interactions]), consider reducing the dose or the frequency of dosing (for example, 20 mg every other day) ).
Or as directed by your doctor.
Adverse reactions of fluoxetine hydrochloride dispersible tablets
- With the continued treatment of this product, the intensity and frequency of adverse reactions will decrease, and usually will not cause the treatment to stop.
As with other SSRIs, the common adverse reactions are as follows:
Whole body : allergies (such as pruritus, rash, rubella, allergic reactions, vasculitis, serum reactions, facial edema, etc.) (see [taboo] and [warning]), chills, serotonin syndrome, photosensitivity and very rare In some cases, erythema pleomorphic may develop Sjogren's syndrome or toxic epidermal necrolysis (Lyell syndrome).
Digestive system : gastrointestinal dysfunction (such as diarrhea, nausea, vomiting, indigestion, difficulty swallowing, reversed taste), dry mouth, etc. Abnormal liver function tests are rare and hepatitis is rarely reported.
Nervous system : headache, abnormal sleep (such as abnormal dreams, insomnia, drowsiness), dizziness, anorexia, fatigue, euphoria, transient movement abnormalities (such as convulsions, ataxia, trembling, myoclonus, etc.), seizures and rare Of psychomotor restlessness / meditation (see [Cautions]). Serotonin syndrome is very rare.
Psychiatric disorders: hallucinations, manic reactions, confusion, agitation, anxiety and related symptoms (such as nervousness), diminished attention and thinking ability (such as disintegration of personality), panic attacks, extremely rare serotonin syndrome, suicidal ideation and behavior (These symptoms can be caused by underlying disease). Suicide concepts and suicidal behaviors were reported early during or after treatment with fluoxetine was discontinued (see [Cautions]).
Urinary system : urinary retention, frequent urination, etc.
Reproductive disorders : sexual dysfunction (such as delayed or lack of ejaculation, lack of orgasm), abnormal erectile penis, and galactorrhea.
Other symptoms : hair loss, yawning, abnormal vision (such as blurred vision, dilated pupils, etc.), sweating, vasodilation, arthralgia, myalgia, orthostatic hypotension, and stasis. Other bleeding manifestations (such as gynecological bleeding, gastrointestinal bleeding, and other skin or mucosal bleeding) are rarely reported (see [Notes]: Bleeding for details).
Transient hyponatremia : Very few patients develop transient hyponatremia (including blood sodium below 110 mmol / L) when they stop taking this product, and it is reversible. In some cases, it may be caused by imbalance of secretion of antidiuretic hormone. Most reports have been found in the elderly, patients taking diuretics, or patients who have been depleted for other reasons.
Respiratory system : pharyngitis and dyspnea. Lung adverse events are rare (including inflammatory changes in histopathology and / or fibrosis). Dyspnea may be the first and only symptom.
Withdrawal symptoms when fluoxetine treatment is stopped: Withdrawal of fluoxetine usually results in withdrawal symptoms. Dizziness, paresthesia (including paresthesia), sleep disturbances (including insomnia and dreaming), fatigue, agitation or anxiety, nausea and / or vomiting, tremors and headaches are the most commonly reported adverse reactions. These symptoms are generally mild to moderate and self-limiting. However, in some patients these symptoms may be severe and / or prolong the remission time (see [Cautions]). Therefore, when Baiyoujie treatment needs to be stopped, it is recommended to gradually reduce the dose (see [Dosage and Administration] and [Precautions].
Children and adolescents (see [Notes])
In pediatric clinical trials, suicide-related behaviors (suicide attempts and suicidal thoughts) and hostile behaviors were more common in the antidepressant group than in the placebo control group.
The safety of long-term use of fluoxetine over 19 brushes has not been systematically studied.
In pediatric clinical trials, there have been reports of manic and hypomanic reactions (fluoxetine 2.6%, placebo group 0%), most of which led to discontinuation. These patients had no previous history of mania and hypomania.
In a pediatric clinical trial, after 19 weeks of taking the drug, the fluoxetine group had a height increase of 1.1 cm less than the placebo control group (p = 0.004) and a weight gain of 1.1 kg less than the placebo control group (p = 0.008). ). Individual cases of growth retardation are reported in clinical applications.
Baiyoujie is used for individual case reports of children with delayed sexual maturity or sexual dysfunction. (See [Pharmacology and Toxicology])
It was also found in pediatric clinical trials that taking fluoxetine was accompanied by a decrease in alkaline phosphatase levels.
Contraindications of fluoxetine hydrochloride dispersible tablets
- Patients allergic to fluoxetine or its excipients are contraindicated.
Monoamine oxidase inhibitors (MAOI) : Among patients who have received selective serotonin reuptake inhibitor (SSRI) therapy concurrently with monoamine oxidase inhibitor (MAOI), and among patients who recently discontinued SSRI therapy and started monoamine oxidase inhibitor therapy Serious, sometimes even fatal, reactions. Fluoxetine treatment must begin 2 weeks after irreversible MAOI withdrawal.
In some cases, symptoms similar to serotonin syndrome, which is similar to neuroblocker malignant syndrome and may be diagnosed as such, may appear. Cyproheptadine or dantraline may be beneficial for the treatment of such patients. Responses to patients with MAOI include high fever, stiffness, myoclonus, instability of the autonomic nervous system with rapid fluctuations in vital signs, and changes in mental state, including extreme agitation, which may develop into delirium and coma.
Therefore, fluoxetine should not be combined with non-selective MAOI. Similarly, MAOI should be started at least 5 weeks after discontinuation of the drug. Long-term use and / or higher doses of fluoxetine may take longer before starting monoamine oxidase inhibitor therapy.
It is not recommended to use reversible MAOI (eg morphobexamide). Fluoxetine treatment can begin the day after reversible MAOI discontinuation.
Precautions for Fluoxetine Hydrochloride Dispersible Tablets
- Warning < br Children and adolescents under 18 years of age < br In clinical trials, the antidepressant group was more likely to have suicide-related behaviors (suicide attempts and suicidal thoughts) and hostility compared to the placebo control group behavior. (Mainly attacks, oppositions and anger). Biogen Solution is only suitable for the treatment of moderate to severe depressive episodes in children and adolescents aged 8 to 18 years. It is not intended for other indications. If Baiyoujie treatment should be given according to clinical needs, the performance of suicidal symptoms should be carefully observed during the treatment. There is limited data on long-term drug safety in adolescents, including the effects on growth, sexual maturity, cognitive, emotional, and behavioral development. (See [Pharmacology and Toxicology])
A 19-week clinical study found that taking fluoxetine reduced height and weight gain in adolescents (see [Adverse Reactions]). It has not been determined whether fluoxetine is sufficient to affect these people to reach normal adult height. The possibility of fluoxetine's effects on adolescent development cannot be ruled out (see [Pharmacology and Toxicology] and [Adverse Effects]). During the treatment and after treatment, attention should be paid to monitoring the growth and development indicators of adolescents (including height, weight and TANNER development stage). If one of them is found to lag behind normal development, it should be referred to a pediatrician.
Cases of mania and mild mania are often found in pediatric clinical trials (see [Adverse Reactions]). Regular monitoring of the occurrence of mania and mild mania is recommended. If mania occurs, discontinue treatment immediately.
Physicians should discuss the pros and cons of treatment with children / adolescents and / or their parents in detail when prescribing.
Primary rash allergic reactions: Rash, allergic reactions, and further systemic reactions, sometimes very severe (including skin, kidneys, liver, and lungs). Fluoxetine should be discontinued if a rash or other possible allergic symptoms cannot be determined.
Note <br /> Convulsive seizures: Convulsive seizures are a potential danger for antidepressants. Therefore, like other antidepressants, fluoxetine should be used with caution in patients with a previous history of seizures. Patients with seizures or increased frequency of seizures should discontinue medication immediately. Fluoxetine should be avoided in patients with unstable seizures / epilepsy, and intensive monitoring should be used in patients with stable epilepsy control.
Mania: Antidepressants should be used with caution in patients with a previous history of mania / hypomania. As with all antidepressants, they should be discontinued as soon as a manic episode occurs.
Liver / renal function: Fluoxetine is mainly metabolized by the liver and excreted by the kidneys. For patients with severe liver dysfunction, the dosage should be reduced, such as dosing every other day. After approximately 2 months of continuous administration (20 mg daily), patients with severe renal failure who need dialysis (glomerular filtration rate GFR <10 ml / min) have fluoxetine in plasma compared with controls with normal renal function. There was no difference between norfluoxetine levels.
Heart disease: An electrocardiogram of 312 patients taking this product was evaluated in a double-blind trial, and no cardiac block was found. However, the clinical experience of taking this product in patients with acute heart disease is still limited, so such patients should be used with caution.
Weight loss: Flupitin may cause weight loss, but is usually proportional to baseline weight.
Diabetes: Ilf4 blood glucose concentration can be affected by SSRI in diabetic patients. Hypoglycemia may occur during taking fluoxetine, followed by hyperglycemia after discontinuation. The dose of insulin and oral hypoglycemic agents should be adjusted enough.
Suicide / Suicide Concept or Clinical Deterioration: Depression is associated with an increased risk of suicidal thoughts, suicidal behaviors, and suicide (suicide-related events). This danger persists until the symptoms have significantly eased. Because the effect may not be apparent during the first few weeks or longer of treatment, patients should be closely monitored during this period until symptoms improve significantly. Clinical experience has shown that the risk of suicide may increase during the initial stages of recovery.
When Baiyoujie is used in other indications, it is also possible to increase the incidence of suicide-related events. These events may coexist with severe depressive episodes. Therefore, the suicide prevention measures followed by Baiyou and the treatment of depression are also applicable to the treatment of other indications.
Patients who have a history of suicide-related events and had an apparent suicidal concept before receiving treatment have a higher risk of suicidal thoughts and attempts, and should be closely monitored during treatment. A meta-analysis of a clinical trial of a placebo-controlled antidepressant in an adult patient with a psychiatric disorder showed that the risk of suicidal behavior in the antidepressant group compared with the placebo control group was lower in patients younger than 25 years of age increase.
Closely monitor the patient. This is especially true for high-risk patients and should be combined with medication, especially during early treatment and subsequent dose adjustment. Patients (and their caregivers) should be alert to any clinical deterioration, suicidal behaviors, or abnormal changes in attitudes and behaviors, and should seek immediate medical attention if these symptoms occur.
Inability to sit still / psychomotor restlessness: The use of fluoxetine may be accompanied by the symptoms of inability to sit still, which is characterized by the subjective experience of unpleasant or painful restlessness, requiring walking, often accompanied by being able to sit still or stand still. The above conditions most often occur during the first few weeks of treatment, and patients with such symptoms may increase symptoms if they increase their dose.
Withdrawal symptoms after SSRI treatment is discontinued: Withdrawal reactions are more common when the treatment is discontinued , especially when abrupt discontinuation (see [Adverse Reaction]). In clinical trials, the incidence of withdrawal-related adverse events was approximately 60% in both the fluoxetine and placebo groups. 17% of the fluoxetine group and 12% of the placebo group were more severe.
The risk of a discontinuation response is related to several factors, including treatment dose, cycle, and rate of decrement. Common withdrawal reactions include dizziness, sensory disturbances (including paresthesias), sleep disturbances (insomnia and dreams), weakness, agitation or anxiety, nausea and / or vomiting, tremors, and headaches. Most patients have mild to moderate symptoms, but some patients may have more severe symptoms. Withdrawal reactions usually occur within a few days before the withdrawal. Symptoms are generally self-limiting and usually resolve within two weeks after discontinuation of the drug. Some patients may have unresolved delays (2 to 3 months or longer). According to the needs of patients, it is recommended that the dosage of Baiyoujie should be gradually reduced and the drug should be discontinued within at least 1 to 2 weeks. (See [Adverse reactions] and [Usage and dosage]).
Bleeding: Skin bleeding, such as bruising and purpura, has been reported in patients taking SSRI. Bruising is rarely reported in patients taking fluoxetine. Other bleeding symptoms, such as gynecological bleeding, gastrointestinal bleeding, and other skin or mucosal bleeding, are rarely reported. It should be reminded that patients taking SSRI, especially oral anticoagulants, drugs known to affect platelet function (such as atypical antipsychotics-clozapine, phenothiazines, most tricyclic antidepressants) Patients who require drugs, aspirin, non-steroidal anti-inflammatory drugs, or other drugs that increase the likelihood of bleeding, as well as patients with a previous history of bleeding, should be monitored more.
Electroconvulsive therapy: Prolonged seizures have rarely been reported in patients receiving Fuzhou fluoxetine, but caution must be exercised.
St. John's Wort: When selective serotonin reuptake inhibitors (SSRI) are used in combination with herbal preparations including St. John's wort (Hyperitamine) and serotonin, it may increase serotonergic effects such as 5 -Serotonin syndrome.
In the treatment of fluoxetine, especially when combined with serotoninergic drugs (including L-tryptophan) and / or antipsychotics, rare cases of serotonin syndrome or similar neuroblocker malignant synthesis Sign. Because of these conditions (clinical symptoms include fever, stiffness, myoclonus, instability of the autonomic nervous system with rapid fluctuations in vital signs, and changes in mental state, the latter includes confusion, irritability, extreme agitation until The development of delirium and coma) can be life-threatening, so if this happens, you should immediately stop fluoxetine treatment and give symptomatic supportive treatment.
Due to the use of sorbitol in this preparation, patients with rare hereditary fructose intolerance are contraindicated.
Effects on driving and mechanical operation <br /> Although fluoxetine has not been found to affect the psychomotor behavior of healthy volunteers, any psychoactive drug may affect human judgment and skills. Patients should therefore be warned to avoid driving or operating dangerous machinery until the patient is fairly confident that their behavior is not affected.
Fluoxetine hydrochloride dispersible tablets for pregnant and lactating women
- Pregnant women: Numerous data indicate that fluoxetine has no teratogenic effects on humans. Fluoxetine can be used during pregnancy, but care should be taken, especially at the end of pregnancy or at the beginning of childbirth. Because fluoxetine has been reported to have the following effects on newborns: irritability, tremor, hypotonia, persistent crying, difficulty sucking, or difficulty sleeping. These symptoms suggest a serotonergic effect or withdrawal syndrome. The onset 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).
Lactating mother : Fluoxetine and norfluoxetine, its metabolite, can be secreted into breast milk. Adverse events in infants have been reported. If fluoxetine must be taken, breastfeeding should be stopped; however, if breastfeeding is to be continued, fluoxetine should be taken at the lowest effective dose.
Fluoxetine hydrochloride dispersible tablets for children
- Because its safety and efficacy in children and adolescents (under 18 years of age) are not clear, it is not recommended for use in this group.
Fluoxetine hydrochloride dispersible tablets for elderly
- Increasing the dose should be done with caution, and the daily dose should generally not exceed 40 mg. The maximum recommended daily dose is 60 mg. See [Usage and Dosage].
Drug interactions of fluoxetine hydrochloride dispersible tablets
- Drug interactions have only been studied in adults.
Half-life : Longer elimination half-lives of fluoxetine and norfluoxetine should be considered when analyzing pharmacodynamic and pharmacokinetic interactions between drugs (for example, when changing from fluoxetine to other antidepressants) (See [Pharmacokinetics] for details).
Monoamine oxidase inhibitors : (see [Contraindications]).
Compatibility Taboo : MAOI-A (see [taboo])
Note when sharing:
MAOI-B (Selegiline) : Risk of serotonin syndrome, clinical monitoring is recommended.
Phenytoin sodium: Changes in plasma concentrations have been found when combined with fluoxetine. Toxicity has been reported in some cases. If this drug is needed in combination, a conservative dose adjustment strategy is recommended and clinical status monitored.
Serotonin agonists : This product and serotonin agonists (such as serotonin noradrenaline reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), tramadol, triptan Combination) may increase the risk of serotonin syndrome. The combination of triptans increases the risk of coronary spasm and hypertension.
Lithium salt and tryptophan : It has been reported that serotonin syndrome can occur when lithium salt and tryptophan are used in combination with SSRIs. Be very careful when using this product with these drugs. When fluoxetine is used in combination with lithium salts, more careful and frequent monitoring is required.
CYP2D6 enzyme : similar to tricyclic antidepressants and other selective serotonin antidepressants, fluoxetine is metabolized by the liver cytochrome CYP2D6 isoenzyme system, so drugs metabolized by this enzyme system may lead to drugs interaction. If combined with other drugs that are mainly metabolized by this isoenzyme and the treatment window is narrow (such as flucaramine, encaramine, carbamazepine, and tricyclic antidepressants), the starting dose should be reduced or the therapeutic dose Adjusted to the lower limit of the treatment range. The same principle applies if you have taken fluoxetine in the last 5 weeks.
Oral anticoagulants : Occasionally, when fluoxetine is used in combination with oral anticoagulants, the anticoagulant effect changes (test data and / or clinical signs and symptoms), of different types, but all include increased bleeding symptoms. Patients who are taking warfarin should be carefully monitored for coagulation status when starting or stopping fluoxetine treatment (see [Notes]: Bleeding for details).
Electroconvulsive therapy (ECT) : Prolonged seizures in patients receiving fluoxetine when receiving electroconvulsive therapy are rarely reported, but caution is also required.
Ethanol : In regular tests, this product does not increase the level of ethanol in the blood or enhance the effect of ethanol. However, SSRI therapy is not recommended in combination with ethanol.
St. John's Wort : Like other SSRIs, this product may interact with the herb, St. John's Wort (Hyperitamine), which can lead to increased adverse reactions.
Fluoxetine hydrochloride dispersible tablets overdose
- Overdose of fluoxetine alone is usually mild. Symptoms of overdose include nausea, vomiting, seizures, cardiovascular dysfunction (from asymptomatic arrhythmia to cardiac arrest), pulmonary dysfunction, and central nervous system dysfunction (from excitement to coma). Reports of death from overdose of this product alone are extremely rare. It is recommended to discontinue the drug immediately and monitor the heart and vital signs, supplemented by general symptomatic and supportive treatment. No specific antidote for this product.
Forced diuresis, dialysis, blood perfusion, and fluid exchange are not ideal. The combined effect of activated carbon and sorbitol is the same as or even better than emetic and gastric lavage. When dealing with overdose, consider the possibility of taking multiple drugs at the same time. Patients who have taken or are taking this product at the same time have taken an excessive amount of tricyclic drugs at the same time, and should observe closely and extend the observation period.
Clinical trial of fluoxetine hydrochloride dispersible tablets
- Depression: In a number of placebo and active drug controlled clinical trials in patients with depression, the Hamilton Depression Scale (HAM-D) was used as an evaluation tool and it has been shown that fluoxetine is significantly better than placebo. In these studies, fluoxetine was significantly more effective (referring to a 50% reduction in HAM-D score) and remission rate than placebo.
Obsessive-compulsive disorder: Short-term trials (less than 24 weeks) have shown that fluoxetine is more effective than placebo. The therapeutic dose is 20 mg daily, but higher doses (40 or 60 mg daily) are more effective. Long-term results (an extension of three short-term studies and a relapse prevention study) did not find this effect.
Bulimia: Short-term studies (less than 16 weeks) show the efficacy of fluoxetine at 60 mg daily for bulimia and catharsis in outpatients meeting the diagnostic criteria for DSM-III-R bulimia Significantly better than placebo. However, long-term efficacy has not been determined.
Two placebo-controlled studies of patients meeting the DSM-IV premenstrual anxiety disorder (PMDD) diagnostic criteria selected patients with severe symptoms that impaired their social and professional functions and interpersonal skills, excluding oral administration Birth control pills. In the first study, continuous treatment with fluoxetine at 20 mg daily for 6 menstrual cycles resulted in improvement in the main efficacy indicators (irritability, anxiety, and bad mood). In the second study, when the drug was discontinued during the luteal phase (20 mg daily, 14 days) for 3 menstrual cycles, the main efficacy index (daily score of problem severity) was also improved. However, based on the above studies, no firm conclusions can be drawn about the efficacy and duration of treatment.
Pharmacology and Toxicology of Fluoxetine Hydrochloride Dispersible Tablets
- Fluoxetine is a selective serotonin reuptake inhibitor, which may explain its mechanism of action. Fluoxetine has no binding on other receptors, such as 1- , 2- , and adrenergic; 5-hydroxytryptamine; dopaminergic; histamine 1; muscarinic: GABA receptors.
In vitro and animal test strips have not found this product to have carcinogenic, mutagenic or reproductive damage.
Pharmacokinetics of Fluoxetine Hydrochloride Dispersible Tablets
- Absorption -Fluoxetine is well absorbed from the gastrointestinal tract after oral administration. Eating does not affect its bioavailability.
Distribution -Fluoxetine binds to plasma proteins in large quantities (about 95%) and is widely distributed (apparent distribution volume of 20 to 40 l / kg). Steady-state plasma concentrations were reached after several weeks of administration. The steady-state plasma concentration after continuous administration was similar to that at 4 to 5 weeks.
Metabolism -Fluoxetine fits a nonlinear pharmacokinetic equation with liver first-pass effects. Peak plasma concentration was reached 6-8 hours after taking the drug. Fluoxetine is mainly metabolized by the polymorphic CYP2D6 enzyme. Fluoxetine is basically metabolized by the liver, and demethylfluoxetine (demethylfluoxetine) is produced through demethylation.
Elimination -The elimination half-life of fluoxetine is 4-6 days, and norfluoxetine is 4-16 days. The long half-life makes it possible to maintain the effect for 5 to 6 weeks after stopping the drug. This product is mainly (about 60%) excreted by the kidneys. Fluoxetine can be secreted into breast milk.
High-risk population and elderly: Compared with healthy subjects and young subjects, the pharmacokinetic parameters did not change.
· Liver insufficiency: The half-life of fluoxetine and norfluoxetine in patients with liver dysfunction (alcoholic cirrhosis) increased to 7 and 12 days, respectively. Consideration must be given to reducing the dose or frequency of medication.
· Patients with renal insufficiency: The pharmacokinetic parameters of a single dose of fluoxetine in patients with mild, moderate and severe (anuria) renal insufficiency are not different from those of healthy volunteers. However, after repeated dosing, a steady state peak plasma concentration was seen to increase.
Fluoxetine Hydrochloride Dispersible Tablets Storage
- Store at room temperature (15-25 ° C).
Packaging of fluoxetine hydrochloride dispersible tablets
- Aluminum plastic packaging, 7 pieces, 14 pieces, 28 pieces / box.
Validity of Fluoxetine Hydrochloride Dispersible Tablets
- 24 months
Standard for Fluoxetine Hydrochloride Dispersible Tablets
- Import drug registration standard JX20080047 [1]