Nefazodone Information
Nefazodone (Nefazodone hydrochloride)
Nefazodone (Nefazodone hydrochloride)
Nefazodone (Nefazodone hydrochloride)
Nefazodone (Nefazodone hydrochloride) Description
Nefazodone (Nefazodone hydrochloride) hydrochloride tablets USP are an antidepressant for oral administration with a chemical structure unrelated to selective serotonin reuptake inhibitors, tricyclics, tetracyclics, or monoamine oxidase inhibitors (MAOI).
Nefazodone (Nefazodone hydrochloride) hydrochloride is a synthetically derived phenylpiperazine antidepressant. The chemical name for Nefazodone (Nefazodone hydrochloride) hydrochloride is 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-5-ethyl-2,4-dihydro-4-(2-phenoxyethyl)-3H-1,2,4-triazol-3-one monohydrochloride. The structural formula is:
CHCINO•HCl M.W. 506.5
Nefazodone (Nefazodone hydrochloride) hydrochloride is a nonhygroscopic, white crystalline solid. It is freely soluble in chloroform, soluble in propylene glycol, and slightly soluble in polyethylene glycol and water.
Nefazodone (Nefazodone hydrochloride) hydrochloride tablets USP are supplied as capsule-shaped tablets containing 50 mg, 100 mg, 150 mg, 200 mg, or 250 mg of Nefazodone (Nefazodone hydrochloride) hydrochloride and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and povidone. Additionally, the 50 mg tablets include ferric oxide red as a colorant, the 150 mg tablets include ferric oxide red and yellow as colorants, and the 200 mg tablets include ferric oxide yellow as a colorant.
Nefazodone (Nefazodone hydrochloride) Clinical Pharmacology
The mechanism of action of Nefazodone (Nefazodone hydrochloride) , as with other antidepressants, is unknown.
Preclinical studies have shown that Nefazodone (Nefazodone hydrochloride) inhibits neuronal uptake of serotonin and norepinephrine.
Nefazodone (Nefazodone hydrochloride) occupies central 5-HTreceptors at nanomolar concentrations, and acts as an antagonist at this receptor. Nefazodone (Nefazodone hydrochloride) was shown to antagonize alpha-adrenergic receptors, a property which may be associated with postural hypotension. binding studies showed that Nefazodone (Nefazodone hydrochloride) had no significant affinity for the following receptors: alpha and beta adrenergic, 5-HT, cholinergic, dopaminergic, or benzodiazepine.
Nefazodone (Nefazodone hydrochloride) is rapidly and completely absorbed but is subject to extensive metabolism, so that its absolute bioavailability is low, about 20%, and variable. Peak plasma concentrations occur at about one hour and the half-life of Nefazodone (Nefazodone hydrochloride) is 2 to 4 hours.
Both Nefazodone (Nefazodone hydrochloride) and its pharmacologically similar metabolite, hydroxyNefazodone (Nefazodone hydrochloride) , exhibit nonlinear kinetics for both dose and time, with AUC and C increasing more than proportionally with dose increases and more than expected upon multiple dosing over time, compared to single dosing. For example, in a multiple-dose study involving BID dosing with 50, 100, and 200 mg, the AUC for Nefazodone (Nefazodone hydrochloride) and hydroxyNefazodone (Nefazodone hydrochloride) increased by about 4 fold with an increase in dose from 200 to 400 mg per day; C increased by about 3 fold with the same dose increase. In a multiple-dose study involving BID dosing with 25, 50, 100, and 150 mg, the accumulation ratios for Nefazodone (Nefazodone hydrochloride) and hydroxyNefazodone (Nefazodone hydrochloride) AUC, after 5 days of BID dosing relative to the first dose, ranged from approximately 3 to 4 at the lower doses (50 to 100 mg/day) and from 5 to 7 at the higher doses (200 to 300 mg/day); there were also approximately 2 to 4 fold increases in C after 5 days of BID dosing relative to the first dose, suggesting extensive and greater than predicted accumulation of Nefazodone (Nefazodone hydrochloride) and its hydroxy metabolite with multiple dosing. Steady-state plasma Nefazodone (Nefazodone hydrochloride) and metabolite concentrations are attained within 4 to 5 days of initiation of BID dosing or upon dose increase or decrease.
Nefazodone (Nefazodone hydrochloride) is extensively metabolized after oral administration by n-dealkylation and aliphatic and aromatic hydroxylation, and less than 1% of administered Nefazodone (Nefazodone hydrochloride) is excreted unchanged in urine. Attempts to characterize three metabolites identified in plasma, hydroxyNefazodone (Nefazodone hydrochloride) (HO-NEF), meta-chlorophenylpiperazine (mCPP), and a triazole-dione metabolite, have been carried out. The AUC (expressed as a multiple of the AUC for Nefazodone (Nefazodone hydrochloride) dosed at 100 mg BID) and elimination half-lives for these three metabolites were as follows:
HO-NEF possesses a pharmacological profile qualitatively and quantitatively similar to that of Nefazodone (Nefazodone hydrochloride) . mCPP has some similarities to Nefazodone (Nefazodone hydrochloride) , but also has agonist activity at some serotonergic receptor subtypes. The pharmacological profile of the triazole-dione metabolite has not yet been well characterized. In addition to the above compounds, several other metabolites were present in plasma but have not been tested for pharmacological activity.
After oral administration of radiolabeled Nefazodone (Nefazodone hydrochloride) , the mean half-life of total label ranged between 11 and 24 hours. Approximately 55% of the administered radioactivity was detected in urine and about 20 to 30% in feces.
Nefazodone (Nefazodone hydrochloride) Indications And Usage
Nefazodone (Nefazodone hydrochloride) hydrochloride tablets are indicated for the treatment of depression. When deciding among the alternative treatments available for this condition, the prescriber should consider the risk of hepatic failure associated with Nefazodone (Nefazodone hydrochloride) hydrochloride treatment (see ). In many cases, this would lead to the conclusion that other drugs should be tried first.
The efficacy of Nefazodone (Nefazodone hydrochloride) in the treatment of depression was established in 6 to 8 week controlled trials of outpatients and in a 6 week controlled trial of depressed inpatients whose diagnoses corresponded most closely to the DSM-III or DSM-IIIR category of major depressive disorder (see ).
A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks). It must include either depressed mood or loss of interest or pleasure and at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
The efficacy of Nefazodone (Nefazodone hydrochloride) in reducing relapse in patients with major depression who were judged to have had a satisfactory clinical response to 16 weeks of open-label Nefazodone (Nefazodone hydrochloride) treatment for an acute depressive episode has been demonstrated in a randomized placebo-controlled trial (see ). Although remitted patients were followed for as long as 36 weeks in the study cited (i.e., 52 weeks total), the physician who elects to use Nefazodone (Nefazodone hydrochloride) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
Nefazodone (Nefazodone hydrochloride) Contraindications
Coadministration of terfenadine, astemizole, cisapride, pimozide, or carbamazepine with Nefazodone (Nefazodone hydrochloride) hydrochloride is contraindicated (see and ).
Nefazodone (Nefazodone hydrochloride) hydrochloride tablets are contraindicated in patients who were withdrawn from Nefazodone (Nefazodone hydrochloride) because of evidence of liver injury (see ). Nefazodone (Nefazodone hydrochloride) hydrochloride tablets are also contraindicated in patients who have demonstrated hypersensitivity to Nefazodone (Nefazodone hydrochloride) hydrochloride, its inactive ingredients, or other phenylpiperazine antidepressants.
The coadministration of triazolam and Nefazodone (Nefazodone hydrochloride) causes a significant increase in the plasma level of triazolam (see and ), and a 75% reduction in the initial triazolam dosage is recommended if the two drugs are to be given together. Because not all commercially available dosage forms of triazolam permit a sufficient dosage reduction, the coadministration of triazolam and Nefazodone (Nefazodone hydrochloride) should be avoided for most patients, including the elderly.
Nefazodone (Nefazodone hydrochloride) Warnings
Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older.
The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in
.
No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.
It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.
All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.
Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.
(See .)
Cases of life-threatening hepatic failure have been reported in patients treated with Nefazodone (Nefazodone hydrochloride) hydrochloride tablets.
The time to liver injury for the reported liver failure cases resulting in death or transplant generally ranged from 2 weeks to 6 months on Nefazodone (Nefazodone hydrochloride) therapy. Although some reports described dark urine and nonspecific prodromal symptoms (e.g., anorexia, malaise, and gastrointestinal symptoms), other reports did not describe the onset of clear prodromal symptoms prior to the onset of jaundice.
The physician may consider the value of liver function testing. Periodic serum transaminase testing has not been proven to prevent serious injury but it is generally believed that early detection of drug-induced hepatic injury along with immediate withdrawal of the suspect drug enhances the likelihood for recovery.
Patients should be advised to be alert for signs and symptoms of liver dysfunction (jaundice, anorexia, gastrointestinal complaints, malaise, etc.) and to report them to their doctor immediately if they occur. Ongoing clinical assessment of patients should govern physician interventions, including diagnostic evaluations and treatment.
In patients receiving antidepressants with pharmacological properties similar to Nefazodone (Nefazodone hydrochloride) in combination with a monoamine oxidase inhibitor (MAOI), there have been reports of serious, sometimes fatal, reactions. For a selective serotonin reuptake inhibitor (SSRI), these reactions have included 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. These reactions have also been reported in patients who have recently discontinued that drug and have been started on an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Severe hyperthermia and seizures, sometimes fatal, have been reported in association with the combined use of tricyclic antidepressants and MAOIs. These reactions have also been reported in patients who have recently discontinued these drugs and have been started on an MAOI.
Although the effects of combined use of Nefazodone (Nefazodone hydrochloride) and MAOI have not been evaluated in humans or animals, because Nefazodone (Nefazodone hydrochloride) is an inhibitor of both serotonin and norepinephrine reuptake, it is recommended that Nefazodone (Nefazodone hydrochloride) not be used in combination with an MAOI, or within 14 days of discontinuing treatment with an MAOI. At least 1 week should be allowed after stopping Nefazodone (Nefazodone hydrochloride) before starting an MAOI.
Terfenadine, astemizole, cisapride, and pimozide are all metabolized by the cytochrome P450 3A4 (CYP3A4) isozyme, and it has been demonstrated that ketoconazole, erythromycin, and other inhibitors of CYP3A4 can block the metabolism of these drugs, which can result in increased plasma concentrations of parent drug. Increased plasma concentrations of terfenadine, astemizole, cisapride, and pimozide are associated with QT prolongation and with rare cases of serious cardiovascular adverse events, including death, due principally to ventricular tachycardia of the torsade de pointes type. Nefazodone (Nefazodone hydrochloride) has been shown to be an inhibitor of CYP3A4. Consequently, it is recommended that Nefazodone (Nefazodone hydrochloride) not be used in combination with either terfenadine, astemizole, cisapride, or pimozide
CONTRAINDICATIONS
PRECAUTIONS
Nefazodone (Nefazodone hydrochloride) Precautions
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Nefazodone (Nefazodone hydrochloride) hydrochloride tablets and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions” is available for Nefazodone (Nefazodone hydrochloride) hydrochloride tablets. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Nefazodone (Nefazodone hydrochloride) hydrochloride tablets.
Of the approximately 7000 patients in clinical studies who received Nefazodone (Nefazodone hydrochloride) for the treatment of depression, 18% were 65 years and older, while 5% were 75 years and older. Based on monitoring of adverse events, vital signs, electrocardiograms, and results of laboratory tests, no overall differences in safety between elderly and younger patients were observed in clinical studies. Efficacy in the elderly has not been demonstrated in placebo-controlled trials. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Due to the increased systemic exposure to Nefazodone (Nefazodone hydrochloride) seen in single-dose studies in elderly patients (see , ), treatment should be initiated at half the usual dose, but titration upward should take place over the same range as in younger patients (see ). The usual precautions should be observed in elderly patients who have concomitant medical illnesses or who are receiving concomitant drugs.
Nefazodone (Nefazodone hydrochloride) Adverse Reactions
During its premarketing assessment, multiple doses of Nefazodone (Nefazodone hydrochloride) were administered to 3496 patients in clinical studies, including more than 250 patients treated for at least one year. The conditions and duration of exposure to Nefazodone (Nefazodone hydrochloride) varied greatly, and included (in overlapping categories) open and double-blind studies, uncontrolled and controlled studies, inpatient and outpatient studies, fixed-dose and titration studies. Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of untoward events into a smaller number of standardized event categories.
In the tabulations that follow, reported adverse events were classified using standard COSTART-based Dictionary terminology. The frequencies presented, therefore, represent the proportion of the 3496 patients exposed to multiple doses of Nefazodone (Nefazodone hydrochloride) who experienced an event of the type cited on at least one occasion while receiving Nefazodone (Nefazodone hydrochloride) . All reported events are included except those already listed in the Treatment-Emergent Adverse Experience Incidence table, those events listed in other safety-related sections of this insert, those adverse experiences subsumed under COSTART terms that are either overly general or excessively specific so as to be uninformative, those events for which a drug cause was very remote, and those events which were not serious and occurred in fewer than two patients.
It is important to emphasize that, although the events reported occurred during treatment with Nefazodone (Nefazodone hydrochloride) , they were not necessarily caused by it.
Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring on one or more occasions in at least 1/100 patients (only those not already listed in the tabulated results from placebo-controlled trials appear in this listing); infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.
Dermatological system – Infrequent:
a
Postmarketing experience with Nefazodone (Nefazodone hydrochloride) has shown an adverse experience profile similar to that seen during the premarketing evaluation of Nefazodone (Nefazodone hydrochloride) . Voluntary reports of adverse events temporally associated with Nefazodone (Nefazodone hydrochloride) have been received since market introduction that are not listed above and for which a causal relationship has not been established. These include:
Anaphylactic reactions; angioedema; convulsions (including grand mal seizures); galactorrhea; gynecomastia (male); hyponatremia; liver necrosis and liver failure, in some cases leading to liver transplantation and/or death (see ); priapism (see ); prolactin increased; rhabdomyolysis involving patients receiving the combination of Nefazodone (Nefazodone hydrochloride) and lovastatin or simvastatin (see ); serotonin syndrome; and Stevens-Johnson syndrome; and thrombocytopenia.
Nefazodone (Nefazodone hydrochloride) Drug Abuse And Dependence
In animal studies, Nefazodone (Nefazodone hydrochloride) did not act as a reinforcer for intravenous self-administration in monkeys trained to self-administer cocaine, suggesting no abuse liability. In a controlled study of abuse liability in human subjects, Nefazodone (Nefazodone hydrochloride) showed no potential for abuse.
Nefazodone (Nefazodone hydrochloride) has not been systematically studied in humans for its potential for tolerance, physical dependence, or withdrawal. While the premarketing clinical experience with Nefazodone (Nefazodone hydrochloride) did not reveal any tendency for a withdrawal syndrome or any drug-seeking behavior, it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of Nefazodone (Nefazodone hydrochloride) (e.g., development of tolerance, dose escalation, drug-seeking behavior).
Nefazodone (Nefazodone hydrochloride) Overdosage
In premarketing clinical studies, there were seven reports of Nefazodone (Nefazodone hydrochloride) overdose alone or in combination with other pharmacological agents. The amount of Nefazodone (Nefazodone hydrochloride) ingested ranged from 1000 mg to 11,200 mg. Commonly reported symptoms from overdose of Nefazodone (Nefazodone hydrochloride) included nausea, vomiting, and somnolence. One nonstudy participant took 2000 to 3000 mg of Nefazodone (Nefazodone hydrochloride) with methocarbamol and alcohol; this person reportedly experienced a convulsion (type not documented). None of these patients died.
In postmarketing experience, overdose with Nefazodone (Nefazodone hydrochloride) alone and in combination with alcohol and/or other substances has been reported. Commonly reported symptoms were similar to those reported from overdose in premarketing experience. While there have been rare reports of fatalities in patients taking overdoses of Nefazodone (Nefazodone hydrochloride) , predominantly in combination with alcohol and/or other substances, no causal relationship to Nefazodone (Nefazodone hydrochloride) has been established.
Treatment should consist of those general measures employed in the management of overdosage with any antidepressant.
Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion, or in symptomatic patients.
Activated charcoal should be administered. Due to the wide distribution of Nefazodone (Nefazodone hydrochloride) in body tissues, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be of benefit. No specific antidotes for Nefazodone (Nefazodone hydrochloride) are known.
In managing overdosage, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control center for additional information on the treatment of any overdose. Telephone numbers for certified poison control centers are listed in the (PDR).
Nefazodone (Nefazodone hydrochloride) Dosage And Administration
When deciding among the alternative treatments available for depression, the prescriber should consider the risk of hepatic failure associated with Nefazodone (Nefazodone hydrochloride) hydrochloride treatment (see ).
Nefazodone (Nefazodone hydrochloride) How Supplied
Nefazodone (Nefazodone hydrochloride) hydrochloride tablets USP, 50 mg, are light-pink to pink (mottled), capsule-shaped, beveled-edged tablets, debossed “7178” on one side and debossed “93” on the other side. They are available in bottles of 100.
Nefazodone (Nefazodone hydrochloride) hydrochloride tablets USP, 100 mg, are white to off-white, capsule-shaped tablets, debossed “1024” on one side and scored on the other side with a debossed “93” on one side of the score. They are available in bottles of 60.
Nefazodone (Nefazodone hydrochloride) hydrochloride tablets USP, 150 mg, are peach (mottled), capsule-shaped tablets, debossed “7113” on one side and scored on the other side with a debossed “93” on one side of the score. They are available in bottles of 60.
Nefazodone (Nefazodone hydrochloride) hydrochloride tablets USP, 200 mg, are light-yellow to yellow (mottled), capsule-shaped tablets, debossed “1025” on one side and debossed “93” on the other side. They are available in bottles of 60.
Nefazodone (Nefazodone hydrochloride) hydrochloride tablets USP, 250 mg, are white to off-white, capsule-shaped tablets, debossed “1026” on one side and debossed “93” on the other side. They are available in bottles of 60.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Nefazodone (Nefazodone hydrochloride) References
Manufactured In Israel By:
Jerusalem, 91010, Israel
Manufactured For:
Sellersville, PA 18960
Rev. J 8/2008
Nefazodone (Nefazodone hydrochloride) Patient Information
Rarely, people who take Nefazodone (Nefazodone hydrochloride) can develop serious liver problems. because you may be developing a liver problem:
People who currently have liver problems should not take Nefazodone (Nefazodone hydrochloride) .
Nefazodone (Nefazodone hydrochloride) is a medicine used to treat depression. Nefazodone (Nefazodone hydrochloride) is thought to treat depression by correcting an imbalance in the amounts of certain natural chemicals, such as serotonin and norepinephrine, which are in your brain.
Do take Nefazodone (Nefazodone hydrochloride) if you
Be sure to tell your doctor if you
The most common side effects of Nefazodone (Nefazodone hydrochloride) are sleepiness, dry mouth, nausea, dizziness, constipation, weakness, lightheadedness, problems with vision, and confusion.
Tell your doctor right away about any side effects that you have or discomfort that you experience. Do not change your dose or stop taking Nefazodone (Nefazodone hydrochloride) without talking with your doctor first.
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Your doctor has prescribed Nefazodone (Nefazodone hydrochloride) for you and you alone. Do not give Nefazodone (Nefazodone hydrochloride) to other people even if they have the same condition. It may harm them.
This leaflet provides a summary of the most important information about Nefazodone (Nefazodone hydrochloride) . If you would like more information, talk with your doctor or pharmacist. You can ask for information about Nefazodone (Nefazodone hydrochloride) that is written for healthcare professionals.
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Halcion is a registered trademark of Pharmacia & Upjohn.
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Manufactured In Israel By:
Jerusalem, 91010, Israel
Manufactured For:
Sellersville, PA 18960
Rev. A 8/2008
This Patient Information Leaflet has been approved by the U.S. Food and Drug Administration.
Nefazodone (Nefazodone hydrochloride)
Nefazodone (Nefazodone hydrochloride) Package Label - Nefazodone - Mg Tabs
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