What is Fludac?
Fludac (Fludac) is a selective serotonin reuptake inhibitors (SSRI) antidepressant. The way Fludac works is still not fully understood. It is thought to positively affect communication between nerve cells in the central nervous system and/or restore chemical balance in the brain.
Fludac is used to treat major depressive disorder, bulimia nervosa (an eating disorder) obsessive-compulsive disorder, and panic disorder.
Fludac is sometimes used together with another medication called olanzapine (Zyprexa). to treat depression caused by bipolar disorder (manic depression). This combination is also used to treat depression after at least 2 other medications have been tried without successful treatment of symptoms.
Fludac may also be used for purposes not listed in this medication guide.
Fludac indications
Major Depressive Disorder
Fludac is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years.
The usefulness of the drug in adult and pediatric patients receiving Fludac for extended periods should periodically be re-evaluated.
Obsessive Compulsive Disorder
Fludac is indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with Obsessive Compulsive Disorder (OCD).
The effectiveness of Fludac in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use Fludac for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Bulimia Nervosa
Fludac is indicated for the acute and maintenance treatment of binge-eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa.
The physician who elects to use Fludac for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Panic Disorder
Fludac is indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients.
The effectiveness of Fludac in long-term use, i.e., for more than 12 weeks, has not been established in placebo-controlled trials. Therefore, the physician who elects to use Fludac for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
How should I use Fludac?
Use Fludac delayed-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Fludac delayed-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Fludac delayed-release capsules refilled.
- Take Fludac delayed-release capsules by mouth with or without food.
- Swallow Fludac delayed-release capsules whole. Do not break, crush, or chew before swallowing.
- Taking Fludac delayed-release capsules at the same time each day will help you remember to take it.
- Continue to take Fludac delayed-release capsules even if you feel well. Do not miss any doses.
- Do not suddenly stop taking Fludac delayed-release capsules without checking with your doctor. Side effects may occur. They may include mental or mood changes, numbness or tingling of the skin, dizziness, confusion, headache, trouble sleeping, or unusual tiredness. You will be closely monitored when you start Fludac delayed-release capsules and whenever a change in dose is made.
- If you miss a dose of Fludac delayed-release capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Fludac delayed-release capsules.
Uses of Fludac in details
Fludac is used to treat depression, panic attacks, obsessive compulsive disorder, a certain eating disorder (bulimia), and a severe form of premenstrual syndrome (premenstrual dysphoric disorder).
This medication may improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living. It may decrease fear, anxiety, unwanted thoughts, and the number of panic attacks. It may also reduce the urge to perform repeated tasks (compulsions such as hand-washing, counting, and checking) that interfere with daily living. Fludac may lessen premenstrual symptoms such as irritability, increased appetite, and depression. It may decrease binging and purging behaviors in bulimia.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This drug is also used to treat a certain other eating disorder (anorexia nervosa), post traumatic stress disorder (PTSD), and certain nervous system/sleep disorders (cataplexy, narcolepsy). It may also be used to treat hot flashes that occur with menopause.
How to use Fludac
Read the Medication Guide provided by your pharmacist before you start using Fludac and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth as directed by your doctor, usually once daily in the morning. If you are taking this medication twice a day, your doctor may direct you to take it in the morning and at noon.
If you are taking Fludac for premenstrual problems, your doctor may direct you to take it every day of the month or just for the 2 weeks before your period through the first full day of your period. To help you remember, mark your calendar.
If you are using the liquid form of this medication, measure the dose carefully using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.
The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.
It is important to continue taking this medication as prescribed even if you feel well. Do not stop taking this medication without first consulting your doctor. Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased.
You should see some improvement in 1 to 2 weeks. It may take 4 to 5 weeks before you feel the full benefit.
Tell your doctor if your condition does not improve or if it worsens.
Fludac description
Fludac is the first agent of the class of antidepressants known as selective serotonin-reuptake inhibitors (SSRIs). Fludac is a racemic mixture of the R- and S- enantiomers and are of equivalent pharmacologic activity. Despite distinct structural differences between compounds in this class, SSRIs possess similar pharmacological activity. As with other antidepressant agents, several weeks of therapy may be required before a clinical effect is seen. SSRIs are potent inhibitors of neuronal serotonin reuptake. They have little to no effect on norepinephrine or dopamine reuptake and do not antagonize α- or β-adrenergic, dopamine D2 or histamine H1 receptors. During acute use, SSRIs block serotonin reuptake and increase serotonin stimulation of somatodendritic 5-HT1A and terminal autoreceptors. Chronic use leads to desensitization of somatodendritic 5-HT1A and terminal autoreceptors. The overall clinical effect of increased mood and decreased anxiety is thought to be due to adaptive changes in neuronal function that leads to enhanced serotonergic neurotransmission. Side effects include dry mouth, nausea, dizziness, drowsiness, sexual dysfunction and headache. Side effects generally occur within the first two weeks of therapy and are usually less severe and frequent than those observed with tricyclic antidepressants. Fludac may be used to treat major depressive disorder (MDD), moderate to severe bulimia nervosa, obsessive-compulsive disorder (OCD), premenstrual dysphoric disorder (PMDD), panic disorder with or without agoraphobia, and in combination with olanzapine for treatment-resistant or bipolar I depression. Fludac is the most anorexic and stimulating SSRI.
Fludac dosage
Major Depressive Disorder
Initial Treatment
Adult — Initiate Fludac 20 mg/day orally in the morning. Consider a dose increase after several weeks if insufficient clinical improvement is observed. Administer doses above 20 mg/day once daily in the morning or twice daily (i.e., morning and noon).The maximum Fludac dose should not exceed 80 mg/day.
In controlled trials used to support the efficacy of Fludac, patients were administered morning dosesranging from 20 to 80 mg/day. Studies comparing Fludac 20, 40, and 60 mg/day to placebo indicatethat 20 mg/day is sufficient to obtain a satisfactory response in Major Depressive Disorder in mostcases.
Pediatric (children and adolescents) — Initiate Fludac 10 or 20 mg/day. After 1 week at 10 mg/day, increase the dose to 20 mg/day. However, due to higher plasma levels in lower weight children, the starting and target dose in this group may be 10 mg/day. Consider a dose increase to 20 mg/day after several weeks if insufficient clinical improvement is observed. In the short-term (8 to 9 week) controlled clinical trials of Fludac supporting its effectiveness in the treatment of Major Depressive Disorder, patients were administered Fludac doses of 10 to 20 mg/day.
All patients — As with other drugs effective in the treatment of Major Depressive Disorder, the full effect may be delayed until 4 weeks of treatment or longer.
Periodically reassess to determine the need for maintenance treatment.
Weekly Dosing — Initiate Fludac Weekly capsules 7 days after the last daily dose of Fludac 20 mg.
If satisfactory response is not maintained with Fludac Weekly, consider reestablishing a daily dosing regimen.
Switching Patients to a Tricyclic Antidepressant (TCA) — Dosage of a TCA may need to be reduced, andplasma TCA concentrations may need to be monitored temporarily when Fludac is coadministered or has been recently discontinued.
Obsessive Compulsive Disorder
Initial Treatment
Adult — Initiate Fludac 20 mg/day, orally in the morning. Consider a dose increase after several weeks if insufficient clinical improvement is observed. The full therapeutic effect may be delayed until 5 weeks of treatment or longer. Administer doses above 20 mg/day once daily in the morning or twice daily (i.e., morning and noon). A dose range of 20 to 60 mg/day is recommended; however, doses of up to 80 mg/day have been well tolerated in open studies of OCD. The maximum Fludac dose should not exceed 80 mg/day.
In the controlled clinical trials of Fludac supporting its effectiveness in the treatment of OCD, patients were administered fixed daily doses of 20, 40, or 60 mg of Fludac or placebo. In one of these studies, no dose-response relationship for effectiveness was demonstrated.
Pediatric (children and adolescents) — In adolescents and higher weight children, initiate treatment with a dose of 10 mg/day. After 2 weeks, increase the dose to 20 mg/day. Consider additional dose increases after several more weeks if insufficient clinical improvement is observed. A dose range of 20 to 60 mg/day is recommended.
In lower weight children, initiate treatment with a dose of 10 mg/day. Consider additional dose increases after several more weeks if insufficient clinical improvement is observed. A dose range of 20 to 30 mg/day is recommended. Experience with daily doses greater than 20 mg is very minimal, and there is no experience with doses greater than 60 mg.
In the controlled clinical trial of Fludac supporting its effectiveness in the treatment of OCD, patients were administered Fludac doses in the range of 10 to 60 mg/day.
Periodically reassess to determine the need for treatment.
Bulimia Nervosa
Initial Treatment — Administer Fludac 60 mg/day in the morning. For some patients it may be advisable to titrate up to this target dose over several days. Fludac doses above 60 mg/day have not been systematically studied in patients with bulimia. In the controlled clinical trials of Fludac supporting its effectiveness in the treatment of Bulimia Nervosa, patients were administered fixed daily Fludac doses of 20 or 60 mg, or placebo. Only the 60 mg dose was statistically significantly superior to placebo in reducing the frequency of binge-eating and vomiting.
Periodically reassess to determine the need for maintenance treatment.
Panic Disorder
Initial Treatment — Initiate treatment with Fludac 10 mg/day. After one week, increase the dose to 20 mg/day. Consider a dose increase after several weeks if no clinical improvement is observed. Fludac doses above 60 mg/day have not been systematically evaluated in patients with Panic Disorder. In the controlled clinical trials of Fludac supporting its effectiveness in the treatment of Panic Disorder, patients were administered Fludac doses in the range of 10 to 60 mg/day. The most Frequently administered dose in the 2 flexible-dose clinical trials was 20 mg/day.
Periodically reassess to determine the need for continued treatment.
Fludac And Olanzapine In Combination: Depressive Episodes Associated With Bipolar I Disorder
When using Fludac and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax.
Adult — Administer Fludac in combination with oral olanzapine once daily in the evening, without regard to meals, generally beginning with 5 mg of oral olanzapine and 20 mg of Fludac. Make dosage adjustments, if indicated, according to efficacy and tolerability within dose ranges of Fludac 20 to 50 mg and oral olanzapine 5 to 12.5 mg. Antidepressant efficacy was demonstrated with olanzapine and Fludac in combination with a dose range of olanzapine 6 to 12 mg and Fludac 25 to 50 mg. Safety of co-administration of doses above 18 mg olanzapine with 75 mg Fludac has not been evaluated in clinical studies. Periodically re-examine the need for continued pharmacotherapy.
Children and adolescents (10 -17 years of age) — Administer olanzapine and Fludac combination once daily in the evening, generally beginning with 2.5 mg of olanzapine and 20 mg of Fludac. Make dosage adjustments, if indicated, according to efficacy and tolerability. Safety of co-administration of doses above 12 mg of olanzapine with 50 mg of Fludac has not been evaluated in pediatric clinical studies. Periodically re-examine the need for continued pharmacotherapy.
Safety and efficacy of Fludac in combination with olanzapine was determined in clinical trials supporting approval of Symbyax (fixed-dose combination of olanzapine and Fludac). Symbyax is dosed between 3 mg/25 mg (olanzapine/Fludac) per day and 12 mg/50 mg (olanzapine/Fludac) per day. The following table demonstrates the appropriate individual component doses of Fludac and olanzapine versus Symbyax. Adjust dosage, if indicated, with the individual components according to efficacy and tolerability.
Table 1: Approximate Dos e Corres pondence Between Symbyax and the Combination of Fludac and Olanzapine
| For Symbyax (mg/day) | Use in Combination | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Olanzapine (mg/day) | Fludac (mg/day) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 3 mg olanzapine/25 mg Fludac | 2.5 | 20 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 6 mg olanzapine/25 mg Fludac | 5 | 20 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 12 mg olanzapine/25 mg Fludac | 10+2.5 | 20 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 6 mg olanzapine/50 mg Fludac | 5 | 40+10 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 12 mg olanzapine/50 mg Fludac | 10+2.5 | 40+10 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Protect from light.Storage And HandlingStore at Controlled Room Temperature, 15° to 30°C (59° to 86°F). Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA. Revised: Oct 2014 s Fludac interactionsSee also: Fludac, as with other SSRIs, interacts with a range of other drugs mainly due to its inhibitory activity on the hepatic cytochrome P-450 isoenzymes. Tryptophan: Combination with tryptophan may result in adverse reactions, including agitation, restlessness and GI distress. MAOIs and Other Antidepressants: See Warnings. Lithium: There have been reports of increase and decrease of lithium levels when used concomitantly with Fludac. Cases of toxicity have been reported. Monitoring of lithium levels should be regularly conducted. Selegiline: An irreversible inhibitor of MAO type B. It should not be given in combination with Fludac. Follow the recommendations for shifting to MAOIs from treatment with Fludac. Benzodiazepines: Fludac increases the plasma concentrations of some benzodiazepines. Fludac is tightly bound to plasma proteins. Concomitant use with another drug also tightly bound to proteins may produce a shift in plasma concentration and may then potentially cause side effects. Displacement of Fludac by other tightly-bound drugs may likewise produce adverse events. Thioridazine: Studies suggest that drugs which inhibit CYP2D6 eg, SSRIs, including Fludac, will produce elevated plasma levels of thioridazine. Thioridazine administration produces a dose-related prolongation of the QTc interval, which is associated with serious ventricular arrhythmias eg, Torsades de pointes-type arrhythmias and sudden death. This risk is expected to increase with Fludac-induced inhibition of thioridazine metabolism. Anticonvulsants: Patients on stable doses of phenytoin and carbamazepine have developed elevated plasma anticonvulsant concentrations and clinical anticonvulsant toxicity following initiation of concomitant Fludac treatment. Antipsychotics: Clinical studies indicate a potential interaction between SSRIs and antipsychotics. Elevation of blood levels of haloperidol and clozapine has been observed in patients receiving concomitant Fludac. Fludac side effectsSee also: The following adverse reactions are discussed in more detail in other sections of the labeling:
When using Fludac and olanzapine in combination, also refer to the Adverse Reactions section of the package insert for Symbyax. Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect or predict the rates observed in practice. Multiple doses of Fludac have been administered to 10,782 patients with various diagnoses in US clinical trials. In addition, there have been 425 patients administered Fludac in panic clinical trials. The stated frequencies represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. Incidence In Major Depressive Disorder, OCD, bulimia, And Panic Disorder placebo-controlled Clinical Trials (excluding data from extensions of trials)Table 3 enumerates the most common treatmentemergent adverse reactions associated with the use of Fludac (incidence of at least 5% for Fludac and at least twice that for placebo within at least 1 of the indications) for the treatment of Major Depressive Disorder, OCD, and bulimia in US controlled clinical trials and Panic Disorder in US plus non-US controlled trials. Table 5 enumerates treatment-emergent adverse reactions that occurred in 2% or more patients treated with Fludac and with incidence greater than placebo who participated in US Major Depressive Disorder, OCD, and bulimia controlled clinical trials and US plus non-US Panic Disorder controlled clinical trials. Table 4 provides combined data for the pool of studies that are provided separately by indication in Table 3. Table 3: Most Common Treatment-Emergent Adverse Reactions : Incidence in Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical TrialsThese terms represent serious adverse events, but do not meet the definition for adverse drug reactions. They are included here because of their seriousness. Fludac contraindicationsSee also: Fludac® is contraindicated in patients known to be hypersensitive to it.
Monoamine Oxidase InhibitorsThere have been reports of serious, sometimes fatal, reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma) in patients receiving Fludac in combination with a monoamine oxidase inhibitor (MAOI), and in patients who have recently discontinued Fludac and are then started on an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Therefore, Fludac should not be used in combination with an MAOI, or within a minimum of 14 days of discontinuing therapy with an MAOI. Since Fludac and its major metabolite have very long elimination half-lives, at least 5 weeks [perhaps longer, especially if Fludac has been prescribed chronically and/or at higher doses ] should be allowed after stopping Fludac before starting an MAOI.
PimozideConcomitant use in patients taking pimozide is contraindicated.
ThioridazineThioridazine should not be administered with Fludac® or within a minimum of 5 weeks after Fludac® has been discontinued.
Active ingredient matches for Fludac:Fluoxetine in Eritrea, Ethiopia, India, Kenya, Nigeria, Tanzania, Uganda, Zambia, Zimbabwe. Fluoxetine hydrochloride in India.
References
ReviewsThe results of a survey conducted on ndrugs.com for Fludac are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Fludac. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports2 consumers reported usefulWas the Fludac drug useful in terms of decreasing the symptom or the disease?According to the reports released by ndrugs.com website users, the below mentioned percentages of users say the drug is useful / not useful to them in decreasing their symptoms/disease. The usefulness of the drug depends on many factors, like severity of the disease, perception of symptom, or disease by the patient, brand name used [matters only to a certain extent], other associated conditions of the patient. If the drug is not effective or useful in your case, you need to meet the doctor to get re-evaluated about your symptoms/disease, and he will prescribe an alternative drug.
2 consumers reported price estimatesWas the price you paid to purchase the drug reasonable? Did you feel it was expensive?The below mentioned numbers have been reported by ndrugs.com website users about whether the Fludac drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
3 consumers reported time for resultsTo what extent do I have to use Fludac before I begin to see changes in my health conditions?As part of the reports released by ndrugs.com website users, it takes 2 weeks and a few days before you notice an improvement in your health conditions. Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Fludac. To get the time effectiveness of using Fludac drug by other patients, please click here.
6 consumers reported age
Consumer reviews
Information checked by Dr. Sachin Kumar, MD Pharmacology More about FludacClinician Information
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