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Fluoxetine hydrochloride dispersible tablets (Prozac)

1. Depression: Prozac tablets are used to treat depressive symptoms with or without anxiety symptoms. 2. Obsessive compulsive disorder: Prozac tablets are used to treat obsessive-compulsive concepts and behaviors with or without depression. 3. Bulimia nervosa: Prozac tablets are used to relieve bulimia and catharsis with or without depression. More role
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Common name:
Fluoxetine hydrochloride dispersible tablets
Product No.:
B14200011123
Approval No.:
Gyzz j20160029 (inquired by the State Drug Administration)
Jianke price:
¥323.91
Product specification:
20mg*28s 20mg*28s
Manufacturer:
Patheon France (France) (repackaged by Lilly Suzhou Pharmaceutical Co., Ltd.)
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Product name Fluoxetine hydrochloride dispersible tablets (Prozac)
Main raw materials Fluoxetine hydrochloride.
Main role 1. Depression: Prozac tablets are used to treat depressive symptoms with or without anxiety symptoms. 2. Obsessive compulsive disorder: Prozac tablets are used to treat obsessive-compulsive concepts and behaviors with or without depression. 3. Bulimia nervosa: Prozac tablets are used to relieve bulimia and catharsis with or without depression.
Product specification 20mg*28s
Usage and dosage For adult oral use only. 1. Depression. Adult and elderly patients: 20mg ~ 60mg per day. The recommended starting dose is 20 mg per day. Although high dose may increase the occurrence of adverse reactions, if the treatment is not effective for 3 weeks, it should be considered to increase the drug dose. The consensus reached by who is that antidepressants should be treated continuously for at least 6 months. 2. Obsessive compulsive disorder. Adult and elderly patients: 20mg & mdash daily; 60mg。 The recommended starting dose is 20 mg per day. Although high dose may increase the occurrence of adverse reactions, if the treatment is not effective for 2 weeks, it should be considered to increase the drug dose. If there is still no improvement after 10 weeks of treatment, dressing change should be considered. If the curative effect is good, the dose can be adjusted according to individual differences for maintenance treatment. Liu Yu, there is still a lack of systematic research on how long fluoxetine treatment needs to be maintained. Considering that obsessive-compulsive disorder (OCD) is a chronic disease, it is recommended to maintain treatment for more than 10 weeks for patients with effective treatment. The dosage should be carefully adjusted according to the individual differences of patients to maintain the treatment with the lowest effective dose. Whether to continue treatment should be evaluated regularly. Some clinicians advocate that patients who are effective in drug therapy can be combined with behavioral therapy. The long-term efficacy of obsessive-compulsive disorder (OCD) (more than 24 weeks) has not been confirmed. 3. Adult and elderly patients with bulimia nervosa: the recommended dose is 60mg per day. The long-term efficacy of bulimia nervosa (more than 3 months) has not been confirmed. 4. All indications. The recommended dose can be increased or decreased as appropriate. The daily dose higher than 80mg was not systematically evaluated.
manufacturing enterprise Patheon France (France) (repackaged by Lilly Suzhou Pharmaceutical Co., Ltd.)
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[drug name] Fluoxetine hydrochloride dispersible tablets (Prozac)

[common name] Fluoxetine hydrochloride dispersible tablets

[specification and model] 20mg*28s

[manufacturer] Patheon France (France) (repackaged by Lilly Suzhou Pharmaceutical Co., Ltd.)

[drug type] Western medicine

[approval No.] Gyzz j20160029

[validity period] 24 months

[functional indications] 1. Depression: Prozac tablets are used to treat depressive symptoms with or without anxiety symptoms. 2. Obsessive compulsive disorder: Prozac tablets are used to treat obsessive-compulsive concepts and behaviors with or without depression. 3. Bulimia nervosa: Prozac tablets are used to relieve bulimia and catharsis with or without depression.

[usage and dosage] For adult oral use only. 1. Depression. Adult and elderly patients: 20mg ~ 60mg per day. The recommended starting dose is 20 mg per day. Although high dose may increase the occurrence of adverse reactions, if the treatment is not effective for 3 weeks, it should be considered to increase the drug dose. The consensus reached by who is that antidepressants should be treated continuously for at least 6 months. 2. Obsessive compulsive disorder. Adult and elderly patients: 20mg & mdash daily; 60mg。 The recommended starting dose is 20 mg per day. Although high dose may increase the occurrence of adverse reactions, if the treatment is not effective for 2 weeks, it should be considered to increase the drug dose. If there is still no improvement after 10 weeks of treatment, dressing change should be considered. If the curative effect is good, the dose can be adjusted according to individual differences for maintenance treatment. Liu Yu, there is still a lack of systematic research on how long fluoxetine treatment needs to be maintained. Considering that obsessive-compulsive disorder (OCD) is a chronic disease, it is recommended to maintain treatment for more than 10 weeks for patients with effective treatment. The dosage should be carefully adjusted according to the individual differences of patients to maintain the treatment with the lowest effective dose. Whether to continue treatment should be evaluated regularly. Some clinicians advocate that patients who are effective in drug therapy can be combined with behavioral therapy. The long-term efficacy of obsessive-compulsive disorder (OCD) (more than 24 weeks) has not been confirmed. 3. Adult and elderly patients with bulimia nervosa: the recommended dose is 60mg per day. The long-term efficacy of bulimia nervosa (more than 3 months) has not been confirmed. 4. All indications. The recommended dose can be increased or decreased as appropriate. The daily dose higher than 80mg was not systematically evaluated.

[adverse reactions] With continuous treatment, the intensity and frequency of adverse reactions may be reduced, and adverse reactions generally will not lead to the interruption of treatment. Like other selective serotonin reuptake inhibitors (SSRI), common adverse reactions are as follows: 1. Systemic: allergies (e.g., itching, rash, rubella, allergic reaction, vasculitis, serum reaction, facial edema, etc.) (see [taboo] and [warning]), chills, serotonin syndrome, photosensitive reaction and very rare cases, erythema multiforme may develop into Sjogren's syndrome or toxic epidermal necrosis and laxity (Lyell syndrome). 2. Digestive system: gastrointestinal dysfunction (such as diarrhea, nausea, vomiting, dyspepsia, dysphagia, taste reversal), dry mouth, etc. Abnormal liver function is rare, and idiopathic hepatitis is rarely reported. 3. Nervous system: headache, abnormal sleep (such as abnormal dream, insomnia, sleepiness), dizziness, anorexia, fatigue, euphoria, transient abnormal movement (such as convulsions, ataxia, tremor, myoclonus), spasm and rare psychomotor restlessness / sedentary inability (see [precautions]). Serotonin syndrome is very rare. 4. Psychiatric disorders: hallucinations, manic reactions, confusion, agitation, anxiety and related symptoms (e.g., tension), decreased attention and thinking ability (e.g., depersonalization), panic attacks, extremely rare serotonin syndrome, suicidal ideas and behaviors (these symptoms can be caused by potential diseases), etc.

[precautions] 1. Warn children and adolescents under the age of 18. In clinical trials, the antidepressant treatment group was more prone to suicide related behaviors (suicide attempts and suicidal thoughts) and hostile behaviors (mainly aggression, antagonistic behavior and anger) than the placebo control group. Prozac is only applicable to the treatment of moderate and severe depressive episodes in children and adolescents aged 8 to 18, and is not used for other indications. If Prozac should be given according to clinical needs, the manifestations of suicidal symptoms should be carefully observed during the treatment. There is limited information on the long-term drug safety of adolescents, including the impact on growth and development, sexual maturity, cognition, emotion and behavior. (see [pharmacology and toxicology]) in a 19 week clinical study, it was found that taking fluoxetine reduced the height and weight gain of adolescents (see [adverse reactions]). It has not been determined whether fluoxetine affects the height of these people to reach normal adults. The possibility of the effect of fluoxetine on adolescent development cannot be ruled out (see [pharmacology and toxicology] and [adverse reactions]). During and after treatment, attention should be paid to monitoring the growth and development indicators of adolescents (including height, weight and Tanner development stage). If it is found that one of them lags behind the normal development, it should be referred to a pediatrician for treatment. 2. Manic and mild manic cases are often found in pediatric clinical trials (see [adverse reactions]). It is suggested to conduct regular clinical examination on the occurrence of mania and mild mania. In case of mania, stop the medication immediately. When prescribing, doctors should discuss the advantages and disadvantages of treatment with children / adolescent patients and / or their parents in detail. Please read the instructions carefully and follow the doctor's advice.

[taboo] 1. It can be banned for patients allergic to fluoxetine or any of its ingredients. 2. Monoamine oxidase inhibitor (MAOI): it is reported that patients treated with selective serotonin reuptake inhibitor (SSRI) are combined with monoamine oxidase inhibitor (MAOI) And severe and sometimes fatal reactions in patients who recently terminated SSRI treatment and began monoamine oxidase inhibitor treatment. Fluoxetine treatment must be started 2 weeks after irreversible MAOI withdrawal. 3. Some cases show similar serotonin syndrome (similar and possibly diagnosed as nerve blocker malignant syndrome) Cyproheptadine or dantroline may be beneficial to the treatment of such patients. The reactions of patients with MAOI include high fever, stiffness, myoclonus, instability of autonomic nervous system with rapid fluctuations of vital signs, and changes in mental state, including confusion of consciousness, irritability and extreme agitation, which may develop into delirium and coma. Therefore, fluoxetine cannot be used It can be used in combination with non selective MAOI. Similarly, MAOI can only be used after stopping the drug for at least 5 weeks. If fluoxetine is used for a long time and / or at a high dose, it may take a longer interval to start monoamine oxidase inhibitor treatment. 4. The combination of reversible MAOI (e.g. moclobemide) is not recommended. The treatment of fluoxetine can be started the day after the withdrawal of reversible MAOI.

[listing Permit Holder] Pathonfrance (France) (repackaged by Lilly Suzhou Pharmaceutical Co., Ltd.)

[packaging unit] box

[main ingredients] Fluoxetine hydrochloride.

[character] This product is white oval tablets.

[applicable population] unlimited

[medication for pregnant and lactating women] 1. Pregnant women: a large number of data show that fluoxetine has no teratogenic effect on humans. Fluoxetine can be used during pregnancy, but it still needs attention, especially in the third trimester of pregnancy or at the beginning of delivery. Because it has been reported that fluoxetine has the following effects on newborns: irritability, tremor, hypotension, continuous crying, difficulty sucking or difficulty sleeping. These symptoms may be serotonin The occurrence 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). 2. Breast feeding: Fluoxetine and its metabolite norfluoxetine can be secreted into breast milk. Adverse events of suckling infants have been reported. If fluoxetine is necessary, breast feeding should be stopped; however, if breast feeding is to be continued, the lowest effective dose of fluoxetine should be used.

[medication for children] It is not recommended to use it in children and adolescents (under 18 years old) because the safety and efficacy have not been determined.

[medication for elderly patients] The daily dose should not exceed 40mg. The maximum recommended daily dose is 60mg. See [usage and dosage].

[storage] Store at room temperature of 15 ~ 25 ℃.

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    Fluoxetine hydrochloride dispersible tablets (Prozac)

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