Drug Facts
Composition & Profile
Identifiers & Packaging
16. How Supplied/Storage and Handling Trazodone Hydrochloride Tablets, USP 150 mg are white to off-white, oval, flat faced, beveled-edge, uncoated tablets with one side scored (functional) with full bisect debossed with ‘J’ and ‘45’ on either side and having two partial trisect on one side and plain on the other side. Bottles of 30 Tablets NDC: 80425-0302-01 Bottles of 60 Tablets NDC: 80425-0302-02 Bottles of 90 Tablets NDC: 80425-0302-03 Directions for using the correct score when breaking the tablet, please refer to the following: -For 50 mg, break the score on either the left or right side of the tablet (one-third of a tablet). -For 75 mg, break the score down the middle of the tablet (one-half of a tablet). -For 100 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet). -For 150 mg, use the entire tablet. Store at 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15ºC and 30ºC (59°F to 86ºF) [see USP Controlled Room Temperature]. Dispense with a child-resistant closure in a tight, light-resistant container. fig 1 fig 2 fig3 fig 4; label 1 label 2 label 3
- 16. How Supplied/Storage and Handling Trazodone Hydrochloride Tablets, USP 150 mg are white to off-white, oval, flat faced, beveled-edge, uncoated tablets with one side scored (functional) with full bisect debossed with ‘J’ and ‘45’ on either side and having two partial trisect on one side and plain on the other side. Bottles of 30 Tablets NDC: 80425-0302-01 Bottles of 60 Tablets NDC: 80425-0302-02 Bottles of 90 Tablets NDC: 80425-0302-03 Directions for using the correct score when breaking the tablet, please refer to the following: -For 50 mg, break the score on either the left or right side of the tablet (one-third of a tablet). -For 75 mg, break the score down the middle of the tablet (one-half of a tablet). -For 100 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet). -For 150 mg, use the entire tablet. Store at 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15ºC and 30ºC (59°F to 86ºF) [see USP Controlled Room Temperature]. Dispense with a child-resistant closure in a tight, light-resistant container. fig 1 fig 2 fig3 fig 4
- label 1 label 2 label 3
Overview
Trazodone hydrochloride tablets for oral administration contain trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1piperazinyl]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. The structural formula is represented as follows: Molecular Formula: C19H22CIN5O • HCl Molecular Weight: 408.33 Each tablet, for oral administration, contains 50 mg, 100 mg, 150 mg or 300 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (physically modified corn (maize) starch), sodium lauryl sulfate, and sodium starch glycolate. Meets USP Dissolution Test 2. Description
Indications & Usage
Trazodone Hydrochloride Tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
Dosage & Administration
2.1 Dose Selection An initial dose of 150 mg/day in divided doses is suggested. The dosage should be initiated at a low-dose 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. The dose may be increased by 50 mg/day every 3 to 4 days. The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses. Inpatients (i.e., more severely depressed patients) may be given up to but not in excess of 600 mg/day in divided doses. Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response. 2.2 Important Administration Instructions Trazodone Hydrochloride Tablets can be swallowed whole or administered as a half tablet by breaking the tablet along the score line. Trazodone Hydrochloride Tablets should be taken shortly after a meal or light snack. 2.3 Screen for Bipolar Disorder Prior to Starting Trazodone Hydrochloride Tablets Prior to initiating treatment with Trazodone Hydrochloride Tablets or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see WARNINGS AND PRECAUTIONS (5.7)]. 2.4 Switching to or from Monoamine Oxidase Inhibitor Antidepressant At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of Trazodone Hydrochloride Tablets. In addition, at least 14 days must elapse after stopping Trazodone Hydrochloride Tablets before starting an MAOI antidepressant [see CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.2)]. 2.5 Dosage Recommendations for Concomitant Use with Strong CYP3A4 Inhibitors or Inducers Coadministration with Strong CYP3A4 Inhibitors Consider reducing Trazodone Hydrochloride Tablets dose based on tolerability when Trazodone Hydrochloride Tablets are coadministered with a strong CYP3A4 inhibitor [see DRUG INTERACTIONS (7.1)]. Coadministration with Strong CYP3A4 Inducers Consider increasing Trazodone Hydrochloride Tablets dose based on therapeutic response when Trazodone Hydrochloride Tablets are coadministered with a strong CYP3A4 inducer [see DRUG INTERACTIONS (7.1)]. 2.6 Discontinuation of Treatment with Trazodone Hydrochloride Tablets Adverse reactions may occur upon discontinuation of Trazodone Hydrochloride Tablets [See WARNINGS AND PRECAUTIONS (5.8)]. Gradually reduce the dosage rather than stopping Trazodone Hydrochloride Tablets abruptly whenever possible.
Warnings & Precautions
5.1 Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,400 pediatric patients, the incidence of suicidal thoughts and behaviors in pediatric and young adult patients was greater in antidepressant-treated patients than in placebo-treated patients. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 1. No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide. Table 1: Risk Differences of the Number of Cases of Suicidal Thoughts or Behaviors in the Pooled Placebo-Controlled Age Range (years) Drug-Placebo Differencein Number of Patients of Suicidal Thoughts or Behaviors per 1000 Patients Treated Increases Compared to Placebo <18 14 additional patients 18-24 5 additional patients Decreases Compared to Placebo 25-64 1 fewer patient ≥65 6 fewer patients It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adult patients extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression. Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing Trazodone Hydrochloride Tablets, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors. 5.2 Serotonin Syndrome Serotonin-norepinephrine reuptake inhibitors (SNRIs) and SSRIs, including Trazodone Hydrochloride Tablets, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [see CONTRAINDICATIONS (4), DRUG INTERACTIONS (7.1)]. Serotonin syndrome can also occur when these drugs are used alone. Serotonin syndrome signs and symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The concomitant use of Trazodone Hydrochloride Tablets with MAOIs is contraindicated. In addition, do not initiate Trazodone Hydrochloride Tablets in a patient being treated with MAOIs such as linezolid or intravenous methylene blue. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection). If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking Trazodone Hydrochloride Tablets, discontinue Trazodone Hydrochloride Tablets before initiating treatment with the MAOI [see CONTRAINDICATIONS (4), DRUG INTERACTIONS (7.1)]. Monitor all patients taking Trazodone Hydrochloride Tablets for the emergence of serotonin syndrome. Discontinue treatment with Trazodone Hydrochloride Tablets and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of Trazodone Hydrochloride Tablets with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome and monitor for symptoms. 5.3 Cardiac Arrhythmias Clinical studies indicate that trazodone hydrochloride may be arrhythmogenic in patients with preexisting cardiac disease. Arrhythmias identified include isolated PVCs, ventricular couplets, tachycardia with syncope, and torsade de pointes. Post marketing events, including torsade de pointes have been reported at doses of 100 mg or less with the immediate-release form of Trazodone Hydrochloride Tablets. Trazodone Hydrochloride Tablets should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval. Trazodone Hydrochloride Tablets are not recommended for use during the initial recovery phase of myocardial infarction. Caution should be used when administering Trazodone Hydrochloride Tablets to patients with cardiac disease and such patients should be closely monitored, since antidepressant drugs (including Trazodone Hydrochloride Tablets) may cause cardiac arrhythmias [see ADVERSE REACTIONS (6.2)]. Trazodone Hydrochloride Tablets prolongs the QT/QTc interval. The use of Trazodone Hydrochloride Tablets should be avoided in patients with known QT prolongation or in combination with other drugs that are inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, voriconazole), or known to prolong QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), certain antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and certain antibiotics (e.g., gatifloxacin). Concomitant administration of drugs may increase the risk of cardiac arrhythmia [see DRUG INTERACTIONS (7.1)]. 5.4 Orthostatic Hypotension and Syncope Hypotension, including orthostatic hypotension and syncope has been reported in patients receiving trazodone hydrochloride. Concomitant use with an antihypertensive may require a reduction in the dose of the antihypertensive drug. 5.5 Increased Risk of Bleeding Drugs that interfere with serotonin reuptake inhibition, including Trazodone Hydrochloride Tablets, increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDS), other antiplatelet drugs, warfarin, and other anticoagulants may add to this risk. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events related to drugs that interfere with serotonin reuptake have ranged from ecchymosis, hematoma, epistaxis, and petechiae to life-threatening hemorrhages. Inform patients about the risk of bleeding associated with the concomitant use of Trazodone Hydrochloride Tablets and antiplatelet agents or anticoagulants. For patients taking warfarin, carefully monitor coagulation indices when initiating, titrating, or discontinuing Trazodone Hydrochloride Tablets. 5.6 Priapism Cases of priapism (painful erections greater than 6 hours in duration) have been reported in men receiving Trazodone Hydrochloride Tablets. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Men who have an erection lasting greater than 4 hours, whether painful or not, should immediately discontinue the drug and seek emergency medical attention [see ADVERSE REACTIONS (6.2), OVERDOSAGE (10)]. Trazodone Hydrochloride Tablets should be used with caution in men who have conditions that might predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia), or in men with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie’s disease). 5.7 Activation of Mania or Hypomania In patients with bipolar disorder, treating a depressive episode with Trazodone Hydrochloride Tablets or another antidepressant may precipitate a mixed/manic episode. Activation of mania/hypomania has been reported in a small proportion of patients with major affective disorder who were treated with antidepressants. Prior to initiating treatment with Trazodone Hydrochloride Tablets, screen patients for any personal or family history of bipolar disorder, mania, or hypomania [see DOSAGE AND ADMINISTRATION (2.3)]. 5.8 Discontinuation Syndrome Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesia, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible [See DOSAGE AND ADMINISTRATION (2.6)]. 5.9 Potential for Cognitive and Motor Impairment Trazodone Hydrochloride Tablets may cause somnolence or sedation and may impair the mental and/or physical ability required for the performance of potentially hazardous tasks. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that the drug treatment does not affect them adversely. 5.10 Angle-Closure Glaucoma The pupillary dilation that occurs following use of many antidepressant drugs including Trazodone Hydrochloride Tablets may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Avoid use of antidepressants, including Trazodone Hydrochloride Tablets, in patients with untreated anatomically narrow angles. 5.11 Hyponatremia Hyponatremia may occur as a result of treatment with SNRIs and SSRIs, including Trazodone Hydrochloride Tablets. Cases with serum sodium lower than 110 mmol/L have been reported. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which can lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). In patients with symptomatic hyponatremia, discontinue Trazodone Hydrochloride Tablets and institute appropriate medical intervention. Elderly patients, patients taking diuretics, and those who are volume-depleted may be at greater risk of developing hyponatremia with SSRIs and SNRIs [see USE IN SPECIFIC POPULATIONS (8.5)].
Boxed Warning
SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see WARNINGS AND PRECAUTIONS (5.1)]. Trazodone Hydrochloride Tablets are not approved for use in pediatric patients [see USE IN SPECIFIC POPULATIONS (8.4)].
Contraindications
Trazodone Hydrochloride Tablets are contraindicated in: Patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see WARNINGS AND PRECAUTIONS (5.2), DRUG INTERACTIONS (7.1)].
Adverse Reactions
The following serious adverse reactions are described elsewhere in the labeling: Suicidal Thoughts and Behavior in Children, Adolescents and Young Adults [see BOXED WARNING and WARNINGS AND PRECAUTIONS (5.1)] Serotonin Syndrome [see WARNINGS AND PRECAUTIONS (5.2)] Cardiac Arrythmias [see WARNINGS AND PRECAUTIONS (5.3)] Orthostatic Hypotension and Syncope [see WARNINGS AND PRECAUTIONS (5.4)] Increased Risk of Bleeding [see WARNINGS AND PRECAUTIONS (5.5)] Priapism [see WARNINGS AND PRECAUTIONS (5.6)] Activation of Mania or Hypomania [see WARNINGS AND PRECAUTIONS (5.7)] Discontinuation Syndrome [see WARNINGS AND PRECAUTIONS (5.8)] Potential for Cognitive and Motor Impairment [see WARNINGS AND PRECAUTIONS (5.9)] Angle-Closure Glaucoma [see WARNINGS AND PRECAUTIONS (5.10)] Hyponatremia [see WARNINGS AND PRECAUTIONS (5.11)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Table 2: Common Adverse Reactions Occurring in ≥ 2% of Trazodone Hydrochloride Tablets-treated Patients and Greater than the Rate of Placebo-Treated Patients as Observed in Controlled Clinical Studies Inpatients Outpatients Trazodone Hydrochloride Tablets N=142 Placebo N=95 Trazodone Hydrochloride Tablets N=157 Placebo N=158 Allergic Skin Condition/Edema 3% 1% 7% 1% Autonomic Blurred Vision 6% 4% 15% 4% Constipation 7% 4% 8% 6% Dry Mouth 15% 8% 34% 20% Cardiovascular Hypertension 20% 1% 1% * Hypotension 7% 1% 4% 0 Syncope 3% 2% 5% 1% CNS Confusion 5% 0 6% 8% Decreased Concentration 3% 2% 1% 0 Disorientation 2% 0 * 0 Fatigue 11% 4% 6% 3% Headache 10% 5% 20% 16% Nervousness 15% 11% 6% 8% Gastrointestinal Abdominal/Gastric Disorder 4% 4% 6% 4% Diarrhea 0 1% 5% 1% Nausea/Vomiting 10% 1% 13% 10% Musculoskeletal Aches/Pains 6% 3% 5% 3% Neurological Incoordination 5% 0 2% * Tremors 3% 1% 5% 4% Other Eyes Red/Tired/Itching 3% 0 0 0 Head Full-Heavy 3% 0 0 0 Malaise 3% 0 0 0 Nasal/Sinus Congestion 3% 0 6% 3% Weight Gain 1% 0 5% 2% Weight Loss * 3% 6% 3% Other adverse reactions occurring at an incidence of <2% with the use of 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 memory, impaired speech, impotence, increased appetite, increased libido, increased urinary frequency, missed periods, muscle twitches, numbness, paresthesia, retrograde ejaculation, shortness of breath, and tachycardia/palpitations. Occasional sinus bradycardia has occurred in long-term studies. 6.2 Post marketing Experience The following adverse reactions have been identified during post-approval use of Trazodone Hydrochloride Tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure: Blood and lymphatic system disorders: hemolytic anemia, leukocytosis Cardiac disorders: cardio spasm, congestive heart failure, conduction block, orthostatic hypotension and syncope, palpitations, bradycardia, atrial fibrillation, myocardial infarction, cardiac arrest, arrhythmia, ventricular ectopic activity, including ventricular tachycardia and QT prolongation. Prolonged QT interval, torsade de pointes, and ventricular tachycardia have been reported at doses of 100 mg per day or less [see WARNINGS AND PRECAUTIONS (5.3)]. Endocrine disorders: inappropriate ADH syndrome Eye disorders: diplopia Gastrointestinal disorders: increased salivation, nausea/vomiting General disorders and administration site conditions: chills, edema, unexplained death, weakness Hepatobiliary disorders: cholestasis, jaundice, hyperbilirubinemia, liver enzyme alterations Investigations: increased amylase Metabolism and nutrition disorders: methemoglobinemia Nervous system disorders: aphasia, ataxia, cerebrovascular accident, extrapyramidal symptoms, grand mal seizures, paresthesia, tardive dyskinesia, vertigo Psychiatric disorders: abnormal dreams, agitation, anxiety, hallucinations, insomnia, paranoid reaction, psychosis, stupor Renal and urinary disorders: urinary incontinence, urinary retention Reproductive system and breast disorders: breast enlargement or engorgement, clitorism, lactation, priapism [see WARNINGS AND PRECAUTIONS (5.6)]Respiratory, thoracic and mediastinal disorders: apnea Skin and subcutaneous tissue disorders: alopecia, hirsutism, leukonychia, pruritus, psoriasis, rash, urticaria Vascular disorders: vasodilation
Drug Interactions
7.1 Drugs Having Clinically Important Interactions with Trazodone Hydrochloride Tablets Table 3: Clinically Important Drug Interactions with Trazodone Hydrochloride Tablets Monoamine Oxidase Inhibitors (MAOIs) ClinicalImpact: The concomitant use of MAOIs and serotonergic drugs including Trazodone hydrochloride tablets increases the risk of serotonin syndrome. Intervention: Trazodone hydrochloride tablets are contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [seeCONTRAINDICATIONS(4),DOSAGEANDADMINISTRATION(2.3,2.4), and WARNINGS AND PRECAUTIONS(5.2)]. Examples: isocarboxazid, moclobemide,phenelzine,selegiline, tranylcypromine Other Serotonergic Drugs ClinicalImpact: The concomitant use of serotonergic drugs including Trazodone hydrochloride tablets and other serotonergic drugs increases the risk of serotonin syndrome. Intervention: Monitorpatientsfor signsandsymptoms of serotoninsyndrome,particularly duringTrazodone hydrochloride tabletsinitiation. Ifserotoninsyndromeoccurs,considerdiscontinuation of Trazodone hydrochloride tablets and/or concomitantserotonergicdrugs[seeWARNINGS AND PRECAUTIONS(5.2)]. Examples: triptans,antidepressants(tricyclicandserotoninuptakeinhibitors),fentanyl,lithium,tramadol,tryptophan,buspirone,andSt.John's Wort AntiplateletAgents and Anticoagulants ClinicalImpact: Serotoninreleaseby platelets playsanimportantrole in hemostasis. Theconcurrentuseof an antiplateletagent or anticoagulantwithTrazodone hydrochloride tablets may potentiatetherisk of bleeding. Intervention: Inform patients of the increased risk of bleeding with the concomitantuse of Trazodone hydrochloride tablets and antiplateletagents and anticoagulants. For patients taking warfarin,carefully monitor the internationalnormalizedratio(INR)wheninitiating or discontinuing Trazodone hydrochloride tablets[see WARNINGS AND PRECAUTIONS(5.5)]. Examples: warfarin, rivaroxaban,dabigatran,clopidogrel StrongCYP3A4Inhibitors ClinicalImpact: Theconcomitantuse of Trazodone hydrochloride tablets and strongCYP3A4inhibitors increased the exposureoftrazodonecomparedtotheuse of Trazodone hydrochloride tabletsalone. Intervention: If Trazodone hydrochloride tablets areusedwith a potentCYP3A4inhibitor,therisk of adversereactions,includingcardiac arrhythmias,may be increased and a lowerdose of Trazodone hydrochloride tablets should be considered[see DOSAGEANDADMINISTRATION (2.5), WARNINGSANDPRECAUTIONS(5.3)]. Examples: itraconazole,ketoconazole,clarithromycin,indinavir StrongCYP3A4Inducers ClinicalImpact: The concomitant use of Trazodone hydrochloride tablets and strongCYP3A4inducers decreased the exposure of trazodone compared to the use of Trazodone hydrochloride tablets alone. Intervention: Patients should be closely monitored to see if there is a need for an increased dose of Trazodone hydrochloride tabletswhentakingCYP3A4inducers[seeDosageandAdministration(2.5)]. Examples: rifampin,carbamazepine,phenytoin,St.John’swort DigoxinandPhenytoin ClinicalImpact: Digoxinand phenytoin are narrowtherapeutic index drugs. Concomitant use of Trazodone hydrochloride tabletscan increase digoxin or phenytoinconcentrations. Intervention: Measureserumdigoxinor phenytoinconcentrations beforeinitiatingconcomitantuse of Trazodone hydrochloride tablets.Continuemonitoring and reducedigoxin or phenytoindoseas necessary. Examples: digoxin, phenytoin CentralNervousSystem(CNS)Depressants ClinicalImpact: Trazodone hydrochloride tabletsmay enhancethe responseCNSdepressants. Intervention: Patients shouldbe counseledthatTrazodone hydrochloride tablets mayenhancetheresponsetoalcohol,barbiturates, and other CNSdepressants. Examples: alcohol,barbiturates QTIntervalProlongation ClinicalImpact: Concomitant use of drugs that prolong the QT interval may add to the QT effects of Trazodone hydrochloride tablets and increase the risk of cardiac arrhythmia. Intervention Avoid the use of Trazodone hydrochloride tablets in combination with other drugs known to prolongQTc[seeWARNINGS AND PRECAUTIONS(5.3)]. Examples: Class 1A antiarrhythmics:quinidine,procainamide,disopyramide; Class 3 antiarrhythmics:amiodarone,sotalol; Antipsychotics:ziprasidone,chlorpromazine,thioridazine;Antibiotics:gatifloxacin
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