ترازودون
Trazodone Hydrochloride (Desyrel)
ترازودون

نام ژنریک

Trazodone

شکل دارویی

اشكال دارويي:


Tablet: 50mg

موارد مصرف

موارد و مقدار مصرف


الف)‌ افسردگي.


بزرگسالان: مقدار اوليه mg/day 150 در مقادير منقسم است كه مي‌توان هر 4-3 روز مقدار mg/day 50 به آن افزود. متوسط مقدار مصرف mg/day 400-150، حداكثر مقدار مصرف در بيماران سرپايي mg/day 400 و در بيماران بستري mg/day 600 است.


ب)‌ رفتار تهاجمي.


بزرگسالان: مقدار 50 ميلي گرم دو بار در روز مصرف مي‌شود.


پ) اختلال پانيك.


بزرگسالان: مقدار mg/day 300 مصرف مي‌شود.


مكانيسم اثر


اثر ضدافسردگي: تصور مي‌شود ترازودون از طريق مهار باز جذب نوراپي نفرين و سروتونين در پايانه‌هاي عصبي CNS (نورونهاي پيش سيناپسي) اثر خود را اعمال كرده و باعث افزايش غلظت و تشديد فعاليت اين نوروترانسميترها در شكاف سيناپسي مي‌شود.

موارد منع مصرف

تداخل دارويي


داروهاي ضد فشار خون و دپرس كننده‌هاي سيستم اعصاب مركزي مي‌توانند اثرات پايين آوردن فشار خون و تضعيف كننده CNS دارو را تقويت كنند. ممكن است تنظيم دوز دارو نياز باشد.


مهار كننده‌هاي CYP3A4 مانند كتوكونازول و مهاركننده‌هاي پروتئاز مي‌تواند سطح كتوكونازول و عوارض جانبي آن را افزايش دهد. در صورت لزوم بيمار پايش شده دوز دارو تنظيم شود.


ترازودون مي‌تواند سطح ديگوكسين و فني توئين را افزايش دهد.


استفاده تو ام با SSRIs ممكن است خطر سندرم سروتونين را افزايش دهد.


استفاده تو ام با الكل مي‌تواند دپرسيون سيستم اعصاب مركزي را تقويت كند.


غذا مي‌تواند سبكسري و هيپوتانسيون اورتواستاتيك ناشي از دارو را كم كند.

موارد قابل توجه

-

تداخل دارویی

اثر بر آزمايشهاي تشخيصي ‌


اين دارو ممكن است نتايج آزمونهاي عملكرد كبد را افزايش، ‌تعداد گلبولهاي سفيد و سطح هموگلوبين و هماتوكريت را كاهش دهد.

مکانیزم اثر

اثر بر آزمايشهاي تشخيصي ‌


اين دارو ممكن است نتايج آزمونهاي عملكرد كبد را افزايش، ‌تعداد گلبولهاي سفيد و سطح هموگلوبين و هماتوكريت را كاهش دهد.

فارماكوكینتیك

موارد منع مصرف و احتياط


موارد منع مصرف: مرحله اوليه بهبود انفاركتوس قلبي، حساسيت مفرط به دارو.


موارد احتياط: بيماري قلبي، تمايل به خودكشي.

سایر اطلاعات

طبقه‌بندي فارماكولوژيك: مشتق تريازولوپيريدين.


طبقه‌بندي درماني: ضد افسردگي.


طبقه‌بندي مصرف در بارداري: رده C


ملاحظات اختصاصي


1ـ به احتمال تمايل به خودكشي با بهبود وضعيت افسردگي توجه شود. در شروع درمان بيماران در معرض خطر زياد خودكشي به دقت زير نظر قرار گيرند.


2ـ به نظر مي‌رسد شيوع عوارض جانبي با مصرف مقادير بيش از mg/day 300 بيشتر است.


3ـ تحمل به عوارض جانبي (بخصوص اثرات رخوت زا) معمولاً بعد از 2-1 هفته درمان ظاهر مي‌شود.


4ـ اين دارو نسبت به ضد افسردگي هاي سه حلقه‌اي عوارض قلبي و آنتي كولينرژيك كمتري دارد.


5ـ اين دارو مي‌تواند سبب نعوظ مداوم و دردناك شود. اركشن ناخواسته كه بيش از يك ساعت طول بكشد به عنوان يك اورژانس پزشكي در نظر گرفته مي‌شود.


6ـ مصرف اين دارو نبايد به طور ناگهاني قطع شود. با اين وجود، اين دارو بايد حداقل 48 ساعت قبل از اعمال جراحي قطع شود.


7ـ ممكن است كمي فشار خون عارض شود ؛ فشار خون بيمار پيگيري شود.


نكات قابل توصيه به بيمار


1ـ دارو را دقيقاً طبق دستور مصرف كنيد.


2ـ اين دارو ممكن است موجب خواب آلودگي يا سرگيجه شود؛ از انجام فعاليتهاي مستلزم هوشياري، نامشخص شدن اثرات كامل دارو، خودداري كنيد.


3ـ از مصرف فرآورده‌هاي حاوي الكل خودداري كنيد.


4ـ هر اثر غيرمعمول دارو و مواردي چون نعوظ مداوم و دردناك، اختلال عملكرد جنسي، سرگيجه، غش، يا ضربان سريع قلب را اطلاع دهيد. نعوظ غير ارادي براي بيش از يك ساعت مورد اورژانس محسوب مي‌شود.


5-اثر كامل دارو قبل از 2 هفته نشان داده نمي‌ شود.


مصرف در سالمندان: بيماران سالخورده معمولاً به مقادير اوليه كمتر نياز دارند، زيرا احتمال بروز عوارض جانبي در آنها بيشتر است. با اين وجود، مصرف اين دارو در سالخوردگان به دليل اثرات قلبي كمتر آن ترجيح داده مي‌شود.


مصرف در كودكان: مصرف اين دارو در كودكان توصيه نمي‌ شود.


مصرف در شيردهي: دارو در شير ترشح مي‌شود. با احتياط مصرف شود.


عوارض جانبي


اعصاب مركزي: ‌خواب آلودگي ، سرگيجه، عصبانيت، خستگي، اغتشاش شعور، لرزش، ضعف، حالت تهاجمي، عصباني شدن، كابوسهاي شبانه، روياي زنده، سردرد، بي‌خوابي، صرع ژنراليزه تونيك ـ‌كلونيك.


قلبي ـ ‌عروقي: ‌كمي فشار خون در حالت ايستاده، تاكيكاردي، زيادي فشار خون، سنكوپ، طولاني شدن زمان هدايت در ECG.


چشم، گوش، حلق، بيني:‌ تاري ديد ، وزوز گوش، احتقان بيني.


دستگاه گوارش:‌ خشكي دهان ، اختلال چشايي، يبوست، تهوع، استفراغ، بي اشتهايي.


ادراري ـ تناسلي: احتباس ادرار، نعوظ مداوم و دردناك آلت تناسلي (priapism) كه ممكن است به ناتواني جنسي منجر شود، هماچوري.


خون: كم خوني.


پوست: بثورات پوستي، كهير، تعريق.


تنفسي:‌ كوتاهي دامنه تنفس.


ساير عوارض: كاهش ميل جنسي.


مسموميت و درمان


تظاهرات باليني: خواب آلودگي، استفراغ (شايع ترين عوارض) ؛ كمي فشار خون در حالت ايستاده، تاكيكاردي، سردرد، تشنج، ايست تنفس، تغييرات ECG، كوتاهي دامنه تنفس، خشكي دهان، و بي اختياري ادرار. ممكن است اغما عارض شود.


درمان: علامتي و حمايتي است و عبارت است از حفظ راه هوايي، تثبيت علائم حياتي، و حفظ تعادل آب و الكتروليتهاي بدن، در صورت سالم بودن رفلكس حلقي، بيمار را وادار به استفراغ كرده و به دنبال آن لاواژ معده انجام (در صورت عدم امكان استفراغ لاواژ معده اول انجام مي‌شود) و ذغال فعال براي جلوگيري از جذب بيشتر تجويز مي‌شود. واداشتن بيمار به ديورز ممكن است به دفع دارو كمك كند. دياليز معمولاً بي اثر است.

Trazodone Hydrochloride (Desyrel)

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

DESYREL®
(trazodone HCl)

SUICIDALITY IN CHILDREN AND ADOLESCENTS

Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of DESYREL (trazodone hydrochloride) or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. DESYREL (trazodone hydrochloride) is not approved for use in pediatric patients. (See WARNINGS AND PRECAUTIONS: Pediatric Use).

Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials.

DRUG DESCRIPTION

DESYREL (trazodone hydrochloride) is an antidepressant chemically unrelated to tricyclic, tetracyclic, or other known antidepressant agents. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4- triazolo[4,3-a]pyridin-3(2H)-one hydrochloride. It is a white, odorless, crystalline powder which is freely soluble in water. Its molecular weight is 408.3. The empirical formula is C19H22ClN5O•HCl and the structural formula is represented as follows:

DESYREL® (trazodone HCl) Structural Formula Illustration

DESYREL (trazodone hydrochloride) is supplied for oral administration in 50 mg, 100 mg, 150 mg, and 300 mg tablets.

DESYREL (trazodone hydrochloride) Tablets, 150 mg, contain the following inactive ingredients: microcrystalline cellulose, FD&C Yellow No. 6 (aluminum lake), magnesium stearate, pregelatinized starch, and stearic acid.

DESYREL (trazodone hydrochloride) Tablets, 300 mg, contain the following inactive ingredients: microcrystalline cellulose, yellow ferric oxide, magnesium stearate, sodium starch glycolate, pregelatinized starch, and stearic acid.

What are the possible side effects of trazodone (Desyrel, Oleptro)?

Stop taking trazodone and call your doctor at once if you have a penis erection that is painful or lasts 6 hours or longer. This is a medical emergency and could lead to a serious condition that must be corrected with surgery.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable,...

Read All Potential Side Effects and See Pictures of Desyrel »

What are the precautions when taking trazodone hydrochloride (Desyrel)?

Before taking trazodone, tell your doctor or pharmacist if you are allergic to it; or to nefazodone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of priapism from taking trazodone, recent heart attack.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of bipolar disorder, personal or family history of suicide attempts, heart disease (e.g., irregular heartbeat), liver disease, kidney disease, blood pressure...

Read All Potential Precautions of Desyrel »

Last reviewed on RxList: 4/13/2011
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

INDICATIONS

DESYREL (trazodone hydrochloride) is indicated for the treatment of depression. The efficacy of DESYREL (trazodone hydrochloride) has been demonstrated in both inpatient and outpatient settings and for depressed patients with and without prominent anxiety. The depressive illness of patients studied corresponds to the Major Depressive Episode criteria of the American Psychiatric Association's Diagnostic and Statistical Manual, III1.

Major Depressive Episode implies a prominent and relatively persistent (nearly every day for at least two weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.

DOSAGE AND ADMINISTRATION

The dosage should be initiated at a low level and increased gradually, noting the clinical response and any evidence of intolerance. Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage. DESYREL (trazodone hydrochloride) should be taken shortly after a meal or light snack. Symptomatic relief may be seen during the first week, with optimal antidepressant effects typically evident within two weeks. Twenty-five percent of those who respond to DESYREL (trazodone hydrochloride) require more than two weeks (up to four weeks) of drug administration.

Usual Adult Dosage

An initial dose of 150 mg/day in divided doses is suggested. The dose may be increased by 50 mg/day every three to four days. The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses. Inpatients (ie, more severely depressed patients) may be given up to but not in excess of 600 mg/day in divided doses.

Maintenance

Dosage during prolonged maintenance therapy should be kept at the lowest effective level. Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response.

Although there has been no systematic evaluation of the efficacy of DESYREL (trazodone hydrochloride) beyond six weeks, it is generally recommended that a course of antidepressant drug treatment should be continued for several months.

HOW SUPPLIED

DESYREL® (trazodone hydrochloride)

Tablets, 150 mg—orange, in the Dividose® tablet design (debossed with MJ and 778 on front; “50,” “50,” “50” on reverse)

NDC 0087-0778-43 Bottles of 100

Tablets, 300 mg—yellow, in the Dividose® tablet design (debossed with MJ and 796 on front; “100,”“100,”“100” on reverse)

NDC 0087-0796-41 Bottles of 100

Storage

Store at room temperature. Protect from temperatures above 104°F (40°C).

Dispense in tight, light-resistant container (USP).

REFERENCES

1. Williams JBW, Ed: Diagnostic and Statistical Manual of Mental Disorders-III, American Psychiatric Association May, 1980.

Bristol-Myers Squibb Company Princeton, NJ 08543-4500, USA. Rev February 2009

Last reviewed on RxList: 4/13/2011
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

SIDE EFFECTS

Because the frequency of adverse drug effects is affected by diverse factors (eg, drug dose, method of detection, physician judgment, disease under treatment, etc.) a single meaningful estimate of adverse event incidence is difficult to obtain. This problem is illustrated by the variation in adverse event incidence observed and reported from the inpatients and outpatients treated with DESYREL (trazodone hydrochloride) . It is impossible to determine precisely what accounts for the differences observed.

Clinical Trial Reports

The table below is presented solely to indicate the relative frequency of adverse events reported in representative controlled clinical studies conducted to evaluate the safety and efficacy of DESYREL (trazodone hydrochloride).

The figures cited cannot be used to predict precisely the incidence of untoward events in the course of usual medical practice where patient characteristics and other factors often differ from those which prevailed in the clinical trials. These incidence figures, also, cannot be compared with those obtained from other clinical studies involving related drug products and placebo as each group of drug trials is conducted under a different set of conditions.

Treatment-Emergent Symptom Incidence

  Inpts. Outpts.
D P D P
Number of Patients 142 95 157 158
% of Patients Reporting        
Allergic
  Skin Condition/Edema 2.8 1.1 7.0 1.3
  Autonomic        
  Blurred Vision 6.3 4.2 14.7 3.8
  Constipation 7.0 4.2 7.6 5.7
  Dry Mouth 14.8 8.4 33.8 20.3
Cardiovascular
  Hypertension 2.1 1.1 1.3 *
  Hypotension 7.0 1.1 3.8 0.0
  Shortness of Breath * 1.1 1.3 0.0
  Syncope 2.8 2.1 4.5 1.3
  Tachycardia/Palpitations 0.0 0.0 7.0 7.0
CNS
  Anger/Hostility 3.5 6.3 1.3 2.5
  Confusion 4.9 0.0 5.7 7.6
  Decreased Concentration 2.8 2.1 1.3 0.0
  Disorientation 2.1 0.0 * 0.0
  Dizziness/Lightheadedness 19.7 5.3 28.0 15.2
  Drowsiness 23.9 6.3 40.8 19.6
  Excitement 1.4 1.1 5.1 5.7
  Fatigue 11.3 4.2 5.7 2.5
  Headache 9.9 5.3 19.8 15.8
  Insomnia 9.9 10.5 6.4 12.0
  Impaired Memory 1.4 0.0 * *
  Nervousness 14.8 10.5 6.4 8.2
Gastrointestinal
  Abdominal/Gastric Disorder 3.5 4.2 5.7 4.4
  Bad Taste in Mouth 1.4 0.0 0.0 0.0
  Diarrhea 0.0 1.1 4.5 1.9
  Nausea/Vomiting 9.9 1.1 12.7 9.5
  Musculoskeletal        
  Musculoskeletal Aches/Pains 5.6 3.2 5.1 2.5
Neurological
  Incoordination 4.9 0.0 1.9 0.0
  Paresthesia 1.4 0.0 0.0 *
  Tremors 2.8 1.1 5.1 3.8
Sexual Function
  Decreased Libido * 1.1 1.3 *
Other
  Decreased Appetite 3.5 5.3 0.0 *
  Eyes Red/Tired/Itching 2.8 0.0 0.0 0.0
  Head Full-Heavy 2.8 0.0 0.0 0.0
  Malaise 2.8 0.0 0.0 0.0
  Nasal/Sinus Congestion 2.8 0.0 5.7 3.2
  Nightmares/Vivid Dreams * 1.1 5.1 5.7
  Sweating/Clamminess 1.4 1.1 * *
  Tinnitus 1.4 0.0 0.0 *
  Weight Gain 1.4 0.0 4.5 1.9
  Weight Loss * 3.2 5.7 2.5
* Incidence less than 1%
D = DESYREL P = PLACEBO

Occasional sinus bradycardia has occurred in long-term studies.

In addition to the relatively common (ie, greater than 1%) untoward events enumerated above, the following adverse events have been reported to occur in association with the use of DESYREL® (trazodone hydrochloride) in the controlled clinical studies: akathisia, allergic reaction, anemia, chest pain, delayed urine flow, early menses, flatulence, hallucinations/delusions, hematuria, hypersalivation, hypomania, impaired speech, impotence, increased appetite, increased libido, increased urinary frequency, missed periods, muscle twitches, numbness, and retrograde ejaculation.

Post-Introduction Reports

Although the following adverse reactions have been reported in DESYREL (trazodone hydrochloride) users, the causal association has neither been confirmed nor refuted.

Voluntary reports received since market introduction include the following: abnormal dreams, agitation, alopecia, anxiety, aphasia, apnea, ataxia, breast enlargement or engorgement, cardiospasm, cerebrovascular accident, chills, cholestatis, clitorism, congestive heart failure, diplopia, edema, extrapyramidal symptoms, grand mal seizures, hallucinations, hemolytic anemia, hirsutism, hyperbilirubinemia, increased amylase, increased salivation, insomnia, leukocytosis, leukonychia, jaundice, lactation, liver enzyme alterations, methemoglobinemia, nausea/vomiting (most frequently), paresthesia, paranoid reaction, priapism (See WARNINGS and PRECAUTIONS: Information for Patients; some patients have required surgical intervention), pruritus, psoriasis, psychosis, rash, stupor, inappropriate ADH syndrome, tardive dyskinesia, unexplained death, urinary incontinence, urinary retention, urticaria, vasodilation, vertigo and weakness.

Cardiovascular system effects which have been reported include the following: conduction block, orthostatic hypotension and syncope, palpitations, bradycardia, atrial fibrillation, myocardial infarction, cardiac arrest, arrhythmia, and ventricular ectopic activity, including ventricular tachycardia (see WARNINGS).

Read the Desyrel (trazodone hydrochloride) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

In vitro drug metabolism studies suggest that there is a potential for drug interactions when trazodone is given with CYP3A4 inhibitors. Ritonavir, a potent CYP3A4 inhibitor, increased the Cmax, AUC, and elimination half-life, and decreased clearance of trazodone after administration of ritonavir twice daily for 2 days. Adverse effects including nausea, hypotension, and syncope were observed when ritonavir and trazodone were coadministered. It is likely that ketoconazole, indinavir, and other CYP3A4 inhibitors such as itraconazole or nefazodone may lead to substantial increases in trazodone plasma concentrations, with the potential for adverse effects. If trazodone is used with a potent CYP3A4 inhibitor, a lower dose of trazodone should be considered.

Carbamazepine reduced plasma concentrations of trazodone when co-administered. Patients should be closely monitored to see if there is a need for an increased dose of trazodone when taking both drugs.

Increased serum digoxin or phenytoin levels have been reported to occur in patients receiving DESYREL (trazodone hydrochloride) concurrently with either of those two drugs.

It is not known whether interactions will occur between monoamine oxidase (MAO) inhibitors and DESYREL (trazodone hydrochloride) . Due to the absence of clinical experience, if MAO inhibitors are discontinued shortly before or are to be given concomitantly with DESYREL (trazodone hydrochloride) , therapy should be initiated cautiously with gradual increase in dosage until optimum response is achieved.

Therapeutic Interactions

Concurrent administration with electroshock therapy should be avoided because of the absence of experience in this area.

There have been reports of increased and decreased prothrombin time occurring in warfarinized patients who take DESYREL (trazodone hydrochloride) .

Last reviewed on RxList: 4/13/2011
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

WARNINGS

Clinical Worsening and Suicide Risk

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. There has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients. Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders.

Pooled analyses of short-term placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with MDD, OCD, or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal behavior or thinking (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. There was considerable variation in risk among drugs, but a tendency toward an increase for almost all drugs studied. The risk of suicidality was most consistently observed in the MDD trials, but there were signals of risk arising from some trials in other psychiatric indications (obsessive compulsive disorder and social anxiety disorder) as well. No suicides occurred in any of these trials. It is unknown whether the suicidality risk in pediatric patients extends to longer-term use, ie, beyond several months. It is also unknown whether the suicidality risk extends to adults.

All pediatric patients being treated with antidepressants for any indication should be 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. Such observation would generally include at least weekly face-toface contact with patients or their family members or caregivers during the first 4 weeks of treatment, then every other week visits for the next 4 weeks, then at 12 weeks, and as clinically indicated beyond 12 weeks. Additional contact by telephone may be appropriate between face-to-face visits.

Adults with MDD or co-morbid depression in the setting of other psychiatric illness being treated with antidepressants should be observed similarly for clinical worsening and suicidality, 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.

Families and caregivers of pediatric patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for DESYREL (trazodone hydrochloride) should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose. Families and caregivers of adults being treated for depression should be similarly advised.

Screening Patients for Bipolar Disorder

A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that DESYREL (trazodone hydrochloride) is not approved for use in treating bipolar depression.

TRAZODONE HAS BEEN ASSOCIATED WITH THE OCCURRENCE OF PRIAPISM. IN MANY OF THE CASES REPORTED, SURGICAL INTERVENTION WAS REQUIRED AND, IN A SOME OF THESE CASES, PERMANENT IMPAIRMENT OF ERECTILE FUNCTION OR IMPOTENCE RESULTED. MALE PATIENTS WITH PROLONGED OR INAPPROPRIATE ERECTIONS SHOULD IMMEDIATELY DISCONTINUE THE DRUG AND CONSULT THEIR PHYSICIAN.

The detumescence of priapism and drug-induced penile erections has been accomplished by both pharmacologic, eg, the intracavernosal injection of alpha-adrenergic stimulants such as epinephrine and norepinephrine, as well as surgical procedures.2-7 Any pharmacologic or surgical procedure utilized in the treatment of priapism should be performed under the supervision of a urologist or a physician familiar with the procedure and should not be initiated without urologic consultation if the priapism has persisted for more than 24 hours.

DESYREL (trazodone hydrochloride) is not recommended for use during the initial recovery phase of myocardial infarction.

Caution should be used when administering DESYREL (trazodone hydrochloride) to patients with cardiac disease, and such patients should be closely monitored, since antidepressant drugs (including DESYREL (trazodone hydrochloride) ) have been associated with the occurrence of cardiac arrhythmias. Recent clinical studies in patients with pre-existing cardiac disease indicate that DESYREL (trazodone hydrochloride) may be arrhythmogenic in some patients in that population. Arrhythmias identified include isolated PVCs, ventricular couplets, and in two patients, short episodes (3–4 beats) of ventricular tachycardia.

PRECAUTIONS

General

The possibility of suicide in seriously depressed patients is inherent in the illness and may persist until significant remission occurs. Therefore, prescriptions should be written for the smallest number of tablets consistent with good patient management.

Hypotension, including orthostatic hypotension and syncope, has been reported to occur in patients receiving DESYREL (trazodone hydrochloride) . Concomitant administration of antihypertensive therapy with DESYREL (trazodone hydrochloride) may require a reduction in the dose of the antihypertensive drug.

Little is known about the interaction between DESYREL (trazodone hydrochloride) and general anesthetics; therefore, prior to elective surgery, DESYREL (trazodone hydrochloride) should be discontinued for as long as clinically feasible.

As with all antidepressants, the use of DESYREL (trazodone hydrochloride) should be based on the consideration of the physician that the expected benefits of therapy outweigh potential risk factors.

Information for Patients

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with DESYREL (trazodone hydrochloride) and should counsel them in its appropriate use. A patient Medication Guide About Using Antidepressants in Children and Teenagers is available for DESYREL (trazodone hydrochloride) . 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 DESYREL (trazodone hydrochloride) .

Clinical Worsening and Suicide Risk

Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to observe for the emergence of such symptoms on a day-today basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.

Because priapism has been reported to occur in patients receiving DESYREL (trazodone hydrochloride) , patients with prolonged or inappropriate penile erection should immediately discontinue the drug and consult with the physician (see WARNINGS).

Antidepressants may impair the mental and/or physical ability required for the performance of potentially hazardous tasks, such as operating an automobile or machinery; the patient should be cautioned accordingly.

DESYREL (trazodone hydrochloride) may enhance the response to alcohol, barbiturates, and other CNS depressants.

DESYREL (trazodone hydrochloride) should be given shortly after a meal or light snack. Within any individual patient, total drug absorption may be up to 20% higher when the drug is taken with food rather than on an empty stomach. The risk of dizziness/lightheadedness may increase under fasting conditions.

Laboratory Tests

Occasional low white blood cell and neutrophil counts have been noted in patients receiving DESYREL (trazodone hydrochloride) . These were not considered clinically significant and did not necessitate discontinuation of the drug; however, the drug should be discontinued in any patient whose white blood cell count or absolute neutrophil count falls below normal levels. White blood cell and differential counts are recommended for patients who develop fever and sore throat (or other signs of infection) during therapy.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No drug- or dose-related occurrence of carcinogenesis was evident in rats receiving DESYREL (trazodone hydrochloride) in daily oral doses up to 300 mg/kg for 18 months.

Pregnancy Category C

DESYREL (trazodone hydrochloride) has been shown to cause increased fetal resorption and other adverse effects on the fetus in two studies using the rat when given at dose levels approximately 30 to 50 times the proposed maximum human dose. There was also an increase in congenital anomalies in one of three rabbit studies at approximately 15 to 50 times the maximum human dose. There are no adequate and well-controlled studies in pregnant women. DESYREL (trazodone hydrochloride) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

DESYREL (trazodone hydrochloride) and/or its metabolites have been found in the milk of lactating rats, suggesting that the drug may be secreted in human milk. Caution should be exercised when DESYREL (trazodone hydrochloride) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established (see BOXED WARNING and WARNINGS: Clinical Worsening and Suicide Risk).

Anyone considering the use of DESYREL (trazodone hydrochloride) in a child or adolescent must balance the potential risks with the clinical need.

REFERENCES

2. Lue TF, Physiology of erection and pathophysiology of impotence. In: Wash PC, Retik AB, Stamey TA, Vaughan ED, eds. Campbell's Urology. Sixth edition. Philadelphia: W.B. Saunders; 1992: 722-725.

3. Goldstein I, Krane RJ, Diagnosis and therapy of erectile dysfunction. In: Wash PC, Retik AB, Stamey TA, Vaughan ED, eds. Campbell's Urology. Sixth edition. Philadelphia: W.B. Saunders; 1992: 3071-3072.

4. Yealy DM, Hogya PT: Priapism. Emerg Med Clin North Am. 1988; 6:509-520.

5. Banos JE, Bosch F, Farre M, Drug-induced priapism. Its aetiology, incidence and treatment. Med Toxicol Adverse Drug Exp. 1989; 4:46-58.

6. O'Brien WM, O'Connor KP, Lynch JH. Priapism: current concepts. Ann Emerg Med. 1989: 980-983.

7. Bardin ED, Krieger JN. Pharmacological priapism: comparison of trazodone- and papaverine-associated cases. Int Urol Nephrol . 1990; 22:147-152.

Last reviewed on RxList: 4/13/2011
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

OVERDOSE

Animal Oral LD50

The oral LD50 of the drug is 610 mg/kg in mice, 486 mg/kg in rats, and 560 mg/kg in rabbits.

Signs and Symptoms

Death from overdose has occurred in patients ingesting DESYREL (trazodone hydrochloride) and other drugs concurrently (namely, alcohol; alcohol + chloral hydrate + diazepam; amobarbital; chlordiazepoxide; or meprobamate).

The most severe reactions reported to have occurred with overdose of DESYREL (trazodone hydrochloride) alone have been priapism, respiratory arrest, seizures, and EKG changes. The reactions reported most frequently have been drowsiness and vomiting. Overdosage may cause an increase in incidence or severity of any of the reported adverse reactions (see ADVERSE REACTIONS).

Treatment

There is no specific antidote for DESYREL (trazodone hydrochloride) . Treatment should be symptomatic and supportive in the case of hypotension or excessive sedation. Any patient suspected of having taken an overdose should have the stomach emptied by gastric lavage. Forced diuresis may be useful in facilitating elimination of the drug.

CONTRAINDICATIONS

DESYREL (trazodone hydrochloride) is contraindicated in patients hypersensitive to DESYREL (trazodone hydrochloride) .

Last reviewed on RxList: 4/13/2011
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

CLINICAL PHARMACOLOGY

The mechanism of DESYREL (trazodone hydrochloride) 's antidepressant action in man is not fully understood. In animals, DESYREL (trazodone hydrochloride) selectively inhibits serotonin uptake by brain synaptosomes and potentiates the behavioral changes induced by the serotonin precursor, 5-hydroxytryptophan. Cardiac conduction effects of DESYREL (trazodone hydrochloride) in the anesthetized dog are qualitatively dissimilar and quantitatively less pronounced than those seen with tricyclic antidepressants. DESYREL (trazodone hydrochloride) is not a monoamine oxidase inhibitor and, unlike amphetamine-type drugs, does not stimulate the central nervous system.

Pharmacokinetics

Absorption

In humans, DESYREL (trazodone hydrochloride) is well absorbed after oral administration without selective localization in any tissue. When DESYREL (trazodone hydrochloride) is taken shortly after ingestion of food, there may be an increase in the amount of drug absorbed, a decrease in maximum concentration and a lengthening in the time to maximum concentration. Peak plasma levels occur approximately one hour after dosing when DESYREL (trazodone hydrochloride) is taken on an empty stomach or two hours after dosing when taken with food.

Metabolism

In vitro studies in human liver microsomes show that trazodone is metabolized to an active metabolite, m-chlorophenylpiperazine (mCPP) by cytochrome P450 3A4 (CYP3A4). Other metabolic pathways that may be involved in metabolism of trazodone have not been well characterized.

Elimination

In some patients, DESYREL (trazodone hydrochloride) may accumulate in the plasma.

Drug-Drug Interactions

See also PRECAUTIONS: DRUG INTERACTIONS. In vitro drug metabolism studies reveal that trazodone is a substrate of the cytochrome P450 3A4 (CYP3A4) enzyme and trazodone metabolism can be inhibited by the CYP3A4 inhibitors ketoconazole, ritonavir, and indinavir. The effect of short-term administration of ritonavir (200 mg twice daily, 4 doses) on the pharmacokinetics of a single dose of trazodone (50 mg) has been studied in 10 healthy subjects. The Cmax of trazodone increased by 34%, the AUC increased 2.4-fold, the half-life increased by 2.2-fold, and the clearance decreased by 52%. Adverse effects including nausea, hypotension, and syncope were observed when ritonavir and trazodone were coadministered.

Carbamazepine induces CYP3A4. Following co-administration of carbamazepine 400 mg/day with trazodone 100 mg to 300 mg daily, carbamazepine reduced plasma concentrations of trazodone (as well as mCPP) by 76% and 60%, respectively, compared to pre-carbamazepine values.

For those patients who responded to DESYREL (trazodone hydrochloride) , one-third of the inpatients and one-half of the outpatients had a significant therapeutic response by the end of the first week of treatment. Three-fourths of all responders demonstrated a significant therapeutic effect by the end of the second week. One-fourth of responders required 2 to 4 weeks for a significant therapeutic response.

Last reviewed on RxList: 4/13/2011
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

PATIENT INFORMATION

DESYREL®
(Trazodone Hydrochloride) Tablets

Medication Guide

About Using Antidepressants in Children and Teenagers

What is the most important information I should know if my child is being prescribed an antidepressant?

Parents or guardians need to think about 4 important things when their child is prescribed an antidepressant:

  1. There is a risk of suicidal thoughts or actions
  2. How to try to prevent suicidal thoughts or actions in your child
  3. You should watch for certain signs if your child is taking an antidepressant
  4. There are benefits and risks when using antidepressants

1. There is a Risk of Suicidal Thoughts or Actions

Children and teenagers sometimes think about suicide, and many report trying to kill themselves.

Antidepressants increase suicidal thoughts and actions in some children and teenagers. But suicidal thoughts and actions can also be caused by depression, a serious medical condition that is commonly treated with antidepressants. Thinking about killing yourself or trying to kill yourself is called suicidality or being suicidal.

A large study combined the results of 24 different studies of children and teenagers with depression or other illnesses. In these studies, patients took either a placebo (sugar pill) or an antidepressant for 1 to 4 months. No one committed suicide in these studies, but some patients became suicidal. On sugar pills, 2 out of every 100 became suicidal. On the antidepressants, 4 out of every 100 patients became suicidal.

For some children and teenagers, the risk of suicidal actions may be especially high. These include patients with

  • Bipolar illness (sometimes called manic-depressive illness)
  • A family history of bipolar illness
  • A personal or family history of attempting suicide

If any of these are present, make sure you tell your healthcare provider before your child takes an antidepressant.

2. How to Try to Prevent Suicidal Thoughts and Actions

To try to prevent suicidal thought and actions in your child, pay close attention to changes in her or his moods or actions, especially if the changes occur suddenly. Other important people in your child's life can help by paying attention as well (eg, your child, brothers and sisters, teachers, and other important people). The changes to look out for are listed in Section 3, on what to watch for.

Whenever an antidepressant is started or its dose is changed, pay close attention to your child.

After starting an antidepressant, your child should generally see his or her healthcare provider:

  • Once a week for the first 4 weeks
  • Every 2 weeks for the next 4 weeks
  • After taking the antidepressant for 12 weeks
  • After 12 weeks, follow your healthcare provider's advice about how often to come back
  • More often if problems or questions arise (see Section 3)

You should call your child's healthcare provider between visits if needed.

3. You Should Watch For Certain Signs if Your Child is Taking an Antidepressant

Contact your child's healthcare provider right away if your child exhibits any of the following signs for the first time, or if they seem worse, or worry you, your child, or your child's teacher:

  • Thoughts about suicide or dying
  • Attempts to commit suicide
  • New or worse depression
  • New or worse anxiety
  • Feeling very agitated or restless
  • Panic attacks
  • Difficulty sleeping (insomnia)
  • New or worse irritability
  • Acting aggressive, being angry, or violent
  • Acting on dangerous impulses
  • An extreme increase in activity and talking
  • Other unusual changes in behavior or mood

Never let your child stop taking an antidepressant without first talking to his or healthcare provider. Stopping an antidepressant suddenly can cause other symptoms.

4. There are Benefits and Risks When Using Antidepressants

Antidepressants are used to treat depression and other illnesses. Depression and other illnesses can lead to suicide. In some children and teenagers, treatment with an antidepressant increases suicidal thinking or actions. It is important to discuss all the risks of treating depression and also the risks of not treating it. You and your child should discuss all treatment choices with your healthcare provider, not just the use of antidepressants.

Other side effects can occur with antidepressants (see section below).

Of all antidepressants, only fluoxetine (Prozac®) has been FDA approved to treat pediatric depression.

For obsessive compulsive disorder in children and teenagers, FDA has approved only fluoxetine (Prozac®), sertraline (Zoloft®), fluvoxamine, and clomipramine (Anafranil®).

Your healthcare provider may suggest other antidepressants based on the past experience of your child or other family members.

Is this all I need to know if my child is being prescribed an antidepressant?

No. This is a warning about the risk for suicidality. Other side effects can occur with antidepressants. Be sure to ask your healthcare provider to explain all the side effects of the particular drug he or she is prescribing. Also ask about drugs to avoid when taking an antidepressant. Ask your healthcare provider or pharmacist where to find more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Rev February 2009

Last reviewed on RxList: 4/13/2011
This monograph has been modified to include the generic and brand name in many instances.

>

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

PATIENT INFORMATION

DESYREL®
(Trazodone Hydrochloride) Tablets

Medication Guide

About Using Antidepressants in Children and Teenagers

What is the most important information I should know if my child is being prescribed an antidepressant?

Parents or guardians need to think about 4 important things when their child is prescribed an antidepressant:

  1. There is a risk of suicidal thoughts or actions
  2. How to try to prevent suicidal thoughts or actions in your child
  3. You should watch for certain signs if your child is taking an antidepressant
  4. There are benefits and risks when using antidepressants

1. There is a Risk of Suicidal Thoughts or Actions

Children and teenagers sometimes think about suicide, and many report trying to kill themselves.

Antidepressants increase suicidal thoughts and actions in some children and teenagers. But suicidal thoughts and actions can also be caused by depression, a serious medical condition that is commonly treated with antidepressants. Thinking about killing yourself or trying to kill yourself is called suicidality or being suicidal.

A large study combined the results of 24 different studies of children and teenagers with depression or other illnesses. In these studies, patients took either a placebo (sugar pill) or an antidepressant for 1 to 4 months. No one committed suicide in these studies, but some patients became suicidal. On sugar pills, 2 out of every 100 became suicidal. On the antidepressants, 4 out of every 100 patients became suicidal.

For some children and teenagers, the risk of suicidal actions may be especially high. These include patients with

  • Bipolar illness (sometimes called manic-depressive illness)
  • A family history of bipolar illness
  • A personal or family history of attempting suicide

If any of these are present, make sure you tell your healthcare provider before your child takes an antidepressant.

2. How to Try to Prevent Suicidal Thoughts and Actions

To try to prevent suicidal thought and actions in your child, pay close attention to changes in her or his moods or actions, especially if the changes occur suddenly. Other important people in your child's life can help by paying attention as well (eg, your child, brothers and sisters, teachers, and other important people). The changes to look out for are listed in Section 3, on what to watch for.

Whenever an antidepressant is started or its dose is changed, pay close attention to your child.

After starting an antidepressant, your child should generally see his or her healthcare provider:

  • Once a week for the first 4 weeks
  • Every 2 weeks for the next 4 weeks
  • After taking the antidepressant for 12 weeks
  • After 12 weeks, follow your healthcare provider's advice about how often to come back
  • More often if problems or questions arise (see Section 3)

You should call your child's healthcare provider between visits if needed.

3. You Should Watch For Certain Signs if Your Child is Taking an Antidepressant

Contact your child's healthcare provider right away if your child exhibits any of the following signs for the first time, or if they seem worse, or worry you, your child, or your child's teacher:

  • Thoughts about suicide or dying
  • Attempts to commit suicide
  • New or worse depression
  • New or worse anxiety
  • Feeling very agitated or restless
  • Panic attacks
  • Difficulty sleeping (insomnia)
  • New or worse irritability
  • Acting aggressive, being angry, or violent
  • Acting on dangerous impulses
  • An extreme increase in activity and talking
  • Other unusual changes in behavior or mood

Never let your child stop taking an antidepressant without first talking to his or healthcare provider. Stopping an antidepressant suddenly can cause other symptoms.

4. There are Benefits and Risks When Using Antidepressants

Antidepressants are used to treat depression and other illnesses. Depression and other illnesses can lead to suicide. In some children and teenagers, treatment with an antidepressant increases suicidal thinking or actions. It is important to discuss all the risks of treating depression and also the risks of not treating it. You and your child should discuss all treatment choices with your healthcare provider, not just the use of antidepressants.

Other side effects can occur with antidepressants (see section below).

Of all antidepressants, only fluoxetine (Prozac®) has been FDA approved to treat pediatric depression.

For obsessive compulsive disorder in children and teenagers, FDA has approved only fluoxetine (Prozac®), sertraline (Zoloft®), fluvoxamine, and clomipramine (Anafranil®).

Your healthcare provider may suggest other antidepressants based on the past experience of your child or other family members.

Is this all I need to know if my child is being prescribed an antidepressant?

No. This is a warning about the risk for suicidality. Other side effects can occur with antidepressants. Be sure to ask your healthcare provider to explain all the side effects of the particular drug he or she is prescribing. Also ask about drugs to avoid when taking an antidepressant. Ask your healthcare provider or pharmacist where to find more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Rev February 2009

Last reviewed on RxList: 4/13/2011
This monograph has been modified to include the generic and brand name in many instances.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Disclaimer

Desyrel Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

TRAZODONE - ORAL

(TRAZ-oh-done)

COMMON BRAND NAME(S): Desyrel

WARNING: Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.

Tell the doctor immediately if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

USES: This medication is used to treat depression. Trazodone works by helping to restore the balance of a certain natural chemical (serotonin) in the brain.

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 used to help people with trouble sleeping (insomnia) to fall asleep. It is also used to help people with anxiety to relax.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using trazodone and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth, usually once or twice daily after a meal or snack or as directed by your doctor. If drowsiness is a problem and you are taking 1 dose daily, take it at bedtime. If you are taking 2 doses each day, it may help to take 1 of the doses at bedtime. Follow your doctor's directions carefully.

Dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may start you at a low dose and gradually increase your dose.

Take this medication exactly as prescribed. Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased.

It is important to continue taking this medication as prescribed even if you feel well. To help you remember, take it at the same time(s) each day. Do not stop taking this medication without consulting your doctor. Nausea, headache, or tiredness can occur if the drug is suddenly stopped.

It may take 2 to 4 weeks before you notice the full effects of this medication. Tell your doctor if your condition persists or worsens.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Disclaimer

Desyrel Consumer (continued)

SIDE EFFECTS: See also the Warning section.

Nausea, vomiting, diarrhea, drowsiness, dizziness, tiredness, blurred vision, changes in weight, headache, muscle ache/pain, dry mouth, bad taste in the mouth, stuffy nose, constipation, or change in sexual interest/ability may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: shaking (tremors), nightmares, ringing in the ears, problems urinating, blood in urine.

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (e.g., fever, persistent sore throat), shortness of breath, stomach/abdominal pain.

Get medical help right away if any of these rare but serious side effects occur: chest/jaw/left arm pain, fainting, fast/irregular heartbeat, seizures, severe dizziness.

For males, in the very unlikely event you have a painful or prolonged erection (priapism) lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Desyrel (trazodone hydrochloride) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking trazodone, tell your doctor or pharmacist if you are allergic to it; or to nefazodone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of priapism from taking trazodone, recent heart attack.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of bipolar disorder, personal or family history of suicide attempts, heart disease (e.g., irregular heartbeat), liver disease, kidney disease, blood pressure problems.

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Trazodone may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm. Before using trazodone, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using trazodone safely.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially drowsiness and dizziness.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Disclaimer

Desyrel Consumer (continued)

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medications because very serious interactions may occur: sibutramine.

If you are currently using the medication listed above, tell your doctor or pharmacist before starting trazodone.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other antidepressants (e.g., amitriptyline, bupropion, fluoxetine, nefazodone, venlafaxine), digoxin, drugs affecting liver enzymes that remove trazodone from your body (such as azole antifungals including ketoconazole/itraconazole, HIV protease inhibitor drugs including atazanavir/indinavir/ritonavir, macrolide antibiotics including erythromycin, cimetidine, rifamycins including rifampin, St. John's wort, certain anti-seizure medications including carbamazepine), drugs for high blood pressure, ginkgo, MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine).

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., phenytoin), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone).

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that may cause drowsiness. Ask your pharmacist about using those products safely.

Before you have surgery with a general anesthetic, including dental surgery, tell the doctor or dentist you are taking trazodone.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: painful/prolonged erection, slow/rapid/irregular heartbeat, unusual drowsiness, unusual dizziness, vomiting, trouble breathing, seizures.

NOTES: Do not share this medication with others.

Psychiatric and/or medical checkups (and laboratory tests) should be done periodically to monitor your progress and check for side effects. Consult your doctor for more details.

Have your blood pressure and pulse checked regularly while taking this medication. Discuss with your doctor how to monitor your own blood pressure and pulse.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store above 104 degrees F (40 degrees C). Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised February 2012. Copyright(c) 2012 First Databank, Inc.

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Desyrel Patient Information Including Side Effects

Brand Names: Desyrel, Oleptro

Generic Name: trazodone (Pronunciation: TRAZ oh done)

What is trazodone (Desyrel)?

Trazodone is an antidepressant medication. It affects chemicals in the brain that may become unbalanced and cause depression

Trazodone is used to treat depression.

Trazodone may also be used for other purposes not listed in this medication guide.

Desyrel 150 mg

rectangular, peach, imprinted with MJ 778, 50 50 50

Trazodone 100 mg-BAR

round, white, imprinted with barr, 555 490

Trazodone 100 mg-MUT

round, white, imprinted with MP 114

Trazodone 100 mg-SID

round, white, imprinted with SL 434

Trazodone 100 mg-TEV

round, white, imprinted with 93 638

Trazodone 100 mg-WAT

round, white, imprinted with 5599, DAN DAN

Trazodone 150 mg-BAR

oval, white, imprinted with barr 732, 50 50 50

Trazodone 150 mg-MUT

round, white, imprinted with 25 25 50 50, MP 168

Trazodone 150 mg-SID

trapezoid, white, imprinted with SL 441, 50 50 50

Trazodone 150 mg-WAT

round, white, imprinted with 2525 5050, MP168

Trazodone 300 mg-BAR

oval, white, imprinted with barr 733, 100 100 100

Trazodone 50 mg-BAR

round, white, imprinted with barr, 555 489

Trazodone 50 mg-MUT

round, white, imprinted with MP 118

Trazodone 50 mg-SID

round, white, imprinted with SL 433

Trazodone 50 mg-TEV

round, white, imprinted with 93 637

Trazodone 50 mg-WAT

round, white, imprinted with 5600, DAN DAN

What are the possible side effects of trazodone (Desyrel)?

Stop taking trazodone and call your doctor at once if you have a penis erection that is painful or lasts 6 hours or longer. This is a medical emergency and could lead to a serious condition that must be corrected with surgery.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Stop taking trazodone and call your doctor at once if you have a serious side effect such as:

  • extreme mood swings, restlessness, or sleep problems;
  • dizziness, fainting, fast or pounding heartbeat;
  • easy bruising or bleeding;
  • agitation, hallucinations, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination;
  • very stiff (rigid) muscles, high fever, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
  • headache, trouble concentrating, memory problems, weakness, loss of appetite, feeling unsteady, seizure, shallow breathing or breathing that stops; or
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Less serious side effects may be more likely to occur, such as:

  • drowsiness;
  • mild headache;
  • constipation; or
  • blurred vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Desyrel (trazodone hydrochloride) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about trazodone (Desyrel)?

Before taking trazodone, tell your doctor if you have bipolar disorder (manic depression), heart disease or "Long QT syndrome," liver or kidney disease, a history of drug abuse or suicidal thoughts, or if you have recently had a heart attack.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Trazodone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Stop taking trazodone and call your doctor at once if you have a penis erection that is painful or lasts 6 hours or longer. This is a medical emergency and could lead to a serious condition that must be corrected with surgery.

Side Effects Centers

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Desyrel Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking trazodone (Desyrel)?

Do not use this medication if you are allergic to trazodone.

Do not take trazodone if you have taken an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days.

If you have any of these other conditions, you may need a trazodone dose adjustment or special tests:

  • bipolar disorder (manic depression);
  • heart disease;
  • liver or kidney disease;
  • a history of drug abuse or suicidal thoughts;
  • a history of "Long QT syndrome"; or
  • if you have recently had a heart attack.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

FDA pregnancy category C. It is not known whether trazodone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Trazodone may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give trazodone to anyone younger than 18 years old without the advice of a doctor.

How should I take trazodone (Desyrel)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

The Desyrel brand of trazodone should be taken after a meal or a snack.

Take the Oleptro brand of trazodone on an empty stomach at bedtime, unless your doctor tells you otherwise.

Do not crush or chew an extended-release tablet. Swallow it whole. Your doctor may want you to break an extended-release tablet and take only half of it. Follow your doctor's instructions.

It may take up to 2 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 2 weeks of treatment.

Do not stop using trazodone suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using trazodone.

Store at room temperature away from moisture, heat, and light.

Side Effects Centers

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Desyrel Patient Information including If I Miss a Dose

What happens if I miss a dose (Desyrel)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Desyrel)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of trazodone can be fatal when it is taken with alcohol, barbiturates such as phenobarbital, or sedatives such as diazepam (Valium).

Overdose symptoms may include drowsiness, vomiting, penis erection that is painful or prolonged, fast or pounding heartbeat, seizure (black-out or convulsions), or breathing that slows or stops.

What should I avoid while taking trazodone (Desyrel)?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Trazodone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What other drugs will affect trazodone (Desyrel)?

Ask your doctor before taking any medicine for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others. Taking any of these drugs with trazodone may cause you to bruise or bleed easily.

Before taking trazodone tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures or anxiety). They can add to sleepiness caused by trazodone.

Many drugs can interact with trazodone. Below is just a partial list. Tell your doctor if you are using:

  • a blood thinner such as warfarin (Coumadin);
  • digoxin (Lanoxin, Lanoxicaps);
  • any other antidepressant, or a medication to treat psychiatric disorders;
  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), levofloxacin (Levaquin), pentamidine (NebuPent, Pentam), and others;
  • an antifungal medication such as ketoconazole (Extina, Ketozole, Nizoral, Xolegal), itraconazole (Sporanox), or voriconazole (Vfend);
  • anti-malaria medications such as chloroquine (Arelan), or mefloquine (Lariam);
  • heart or blood pressure medication such as diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;
  • heart rhythm medicine such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), procainamide (Pronestyl), quinidine (Quin-G), and others;
  • HIV/AIDS medicine such as fosamprenavir (Lexiva), indinavir (Crixivan), ritonavir (Norvir), and others;
  • medicine to prevent or treat nausea and vomiting, such as dolasetron (Anzemet) or ondansetron (Zofran);
  • migraine headache medicine such as sumatriptan (Imitrex);
  • narcotic medication such as methadone (Dolophine, Methadose); or
  • seizure medicine such as carbamazepine (Carbatrol, Tegretol) or phenytoin (Dilantin).

Where can I get more information?

Your pharmacist can provide more information about trazodone.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 8.02. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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