Medication Guide

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 )].

Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.

Starting dose: 150 mg in divided doses daily. May be increased by 50 mg per day every three to four days. Maximum dose: 400 mg per day in divided doses ( 2.1 ). Trazodone hydrochloride tablets should be taken shortly after a meal or light snack ( 2.2 ). Tablets should be swallowed whole or broken in half along the score line, and should not be chewed or crushed ( 2.2 ). When discontinued, gradual dose reduction is recommended ( 2.6 ).

Trazodone hydrochloride tablets, USP 50 mg are available for oral administration as white, round, biconvex, tablets. Engraved “APO” bisect “T50” on one side, other side plain. NDC: 70518-1410-00 PACKAGING: 30 in 1 BLISTER PACK Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense with a child-resistant closure in a tight, light-resistant container. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

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 )].

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(2 H )-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows 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, sodium lauryl sulfate, and sodium starch glycolate. FDA approved dissolution test specifications differ from USP.

CNS Depressants: Trazodone may enhance effects of alcohol, barbiturates, or other CNS depressants ( 7 ). CYP3A4 Inhibitors: Consider Trazodone dose reduction based on tolerability ( 2.5 , 7 ). CYP3A4 Inducers: Increase in Trazodone dosage may be necessary ( 2.5 , 7 ). Digoxin or Phenytoin: Monitor for increased digoxin or phenytoin serum levels ( 7 ). Warfarin: Monitor for increased or decreased prothrombin time ( 7 ).

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down and instruct them to report such symptoms to the healthcare provider [see Box Warning and Warnings and Precautions ( 5.1 )] . Dosage and Administration Advise patients that trazodone hydrochloride tablets should be taken shortly after a meal or light snack. Advise patients regarding the importance of following dosage titration instructions [see Dosage and Administration ( 2 )]. Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of trazodone with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Patients should contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7 )] . Activation of Mania/Hypomania Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions ( 5.7 )]. Increased Risk of Bleeding Inform patients about the concomitant use of trazodone with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use of drugs that interfere with serotonin reuptake and these medications has been associated with an increased risk of bleeding. Advise them to inform their health care providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [see Warnings and Precautions ( 5.5 )] . Discontinuation Syndrome Advise patients not to abruptly discontinue trazodone hydrochloride tablets and to discuss any tapering regimen with their healthcare provider. Adverse reactions can occur when trazodone hydrochloride tablets is discontinued [see Warnings and Precautions ( 5.8 )] . Concomitant Medications Advise patients to inform their health care providers if they are taking, or plan to take any prescription or over-the-counter medications since there is a potential for interactions [see Drug Interactions ( 7.1 )]. Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy with trazodone hydrochloride tablets. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to trazodone hydrochloride tablets during pregnancy [see Use in Special Populations ( 8.1 )]. TRAZODONE HYDROCHLORIDE TABLETS, USP 50 mg Rev. 10 Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762

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 )]

Death from overdose has occurred in patients ingesting trazodone and other CNS depressant drugs concurrently (alcohol; alcohol and chloral hydrate and diazepam; amobarbital; chlordiazepoxide; or meprobamate). The most severe reactions reported to have occurred with overdose of trazodone alone have been priapism, respiratory arrest, seizures, and ECG changes, including QT prolongation and syndrome of inappropriate antidiuretic hormone secretion (SIADH). 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. There is no specific antidote for trazodone hydrochloride overdose. In managing overdosage, consider the possibility of multiple drug involvement. For current information on the management of poisoning or overdose, contact a poison control center (1-800-222-1222 or www.poison.org).

The efficacy and safety of trazodone hydrochloride were established from inpatient and outpatient trials of the trazodone immediate release formulation in the treatment of major depressive disorder.

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.

Trazodone hydrochloride tablets, USP , for oral use (traz' oh done hye'' droe klor' ide) What is the most important information I should know about trazodone hydrochloride tablets? Antidepressant medicines, depression or other serious mental illnesses, and suicidal thoughts or actions: Talk to your healthcare provider about: All risks and benefits of treatment with antidepressant medicines All treatment choices for depression or other serious mental illnesses 1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment . 2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions . Some people may have a higher risk of having suicidal thoughts or actions . These include people who have or have a family history of bipolar illness (also called manic- depressive illness) or suicidal thoughts or actions. 3. How can I watch for and try to prevent suicidal thoughts and actions? Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Call a healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: Thoughts about suicide or dying Attempts to commit suicide New or worse depression New or worse anxiety Feeling very agitated or restless Panic attacks Trouble sleeping (insomnia) New or worse irritability Acting aggressive, being angry or violent Acting on dangerous impulses An extreme increase in activity and talking (mania) Other unusual changes in behavior or mood What else do I need to know about antidepressant medicines? Never stop an antidepressant medicine without first talking to a healthcare provider . Stopping an antidepressant medicine suddenly can cause other symptoms. Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider, not just the use of antidepressants. Antidepressant medicines have other side effects . Talk to your healthcare provider about the side effects of your medicines. Antidepressant medicines can interact with other medicines. Know all of the medicines that you take. Keep a list of all medicines to show your healthcare provider. Do not start new medicines without first checking with your healthcare provider. It is not known if trazodone is safe and effective in children. What are trazodone hydrochloride tablets? Trazodone hydrochloride tablets are a prescription medicine used in adults to treat major depressive disorder (MDD). Trazodone belongs to a class of medicines known as SSRIs (or selective serotonin reuptake inhibitors). Do not take trazodone hydrochloride tablets: If you take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid, and intravenous methylene blue. Do not take an MAOI within 2 weeks of stopping trazodone hydrochloride tablets unless directed to do so by your healthcare provider. Do not start trazodone hydrochloride tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider. Before you take trazodone hydrochloride tablets tell your healthcare provider about all of your medical conditions, including if you: have heart problems, including QT prolongation or a family history of it have ever had a heart attack have bipolar disorder have liver or kidney problems have other serious medical conditions are pregnant or plan to become pregnant. It is not known if trazodone hydrochloride tablets harm your unborn baby. Talk to your healthcare provider about the risk to your unborn baby if you take trazodone hydrochloride tablets. If you become pregnant during treatment with trazodone hydrochloride tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-844-405-6185. are breastfeeding or plan to breastfeed. Trazodone hydrochloride passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take trazodone hydrochloride tablets. have taken a Monoamine Oxidase Inhibitor (MAOI) or if you have stopped taking an MAOI in the last 2 weeks. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using trazodone hydrochloride tablets with certain other medicines can affect each other causing serious side effects. Especially tell your healthcare provider if you take: triptans used to treat migraine headache medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, buspirone, or antipsychotics tramadol over-the-counter supplements such as tryptophan or St. John’s Wort nonsteroidal anti-inflammatory drugs (NSAIDS) aspirin warfarin (Coumadin, Jantoven) phenytoin (Mesantoin) diuretics Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. How should I take trazodone hydrochloride tablets? Take trazodone hydrochloride tablets exactly as your healthcare provider tells you. Trazodone hydrochloride tablets should be taken shortly after a meal or light snack. If you feel drowsy after taking trazodone hydrochloride tablets, talk to your healthcare provider. Your healthcare provider may change your dose or the time of day you take your trazodone hydrochloride tablets. Do not stop taking trazodone hydrochloride tablets without talking to your healthcare provider. Trazodone hydrochloride tablets should be swallowed whole or broken in half along the score line. Do not chew or crush trazodone hydrochloride tablets. Tell your healthcare provider if you cannot swallow trazodone either whole or as a half tablet. If you take too much trazodone hydrochloride, call your healthcare provider, your Poison Control Center at 1-800-222-1222, or go to the nearest emergency room right away. What should I avoid while taking trazodone hydrochloride tablets? Do not drive, operate heavy machinery, or do other dangerous activities until you know how trazodone hydrochloride tablets affect you. Trazodone hydrochloride tablets can slow your thinking and motor skills. Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking trazodone hydrochloride tablets until you talk with your healthcare provider. Trazodone hydrochloride tablets may make your sleepiness or dizziness worse if you take it with alcohol or other medicines that cause sleepiness or dizziness. What are the possible side effects of trazodone hydrochloride tablets? Trazodone hydrochloride tablets can cause serious side effects or death, including: See “What is the most important information I should know about trazodone hydrochloride tablets?” Serotonin syndrome. Symptoms of serotonin syndrome include: agitation, hallucinations, problems with coordination, fast heartbeat, tight muscles, trouble walking, sweating, fever, nausea, vomiting, and diarrhea. Irregular or fast heartbeat or faint (QT prolongation) Low blood pressure. You feel dizzy or faint when you change positions (go from sitting to standing) Unusual bruising or bleeding Erection lasting for more than 6 hours (priapism) Feeling high or in a very good mood, then becoming irritable, or having too much energy, feeling like you have to keep talking or do not sleep (mania). Withdrawal symptoms. Symptoms of withdrawal can include anxiety, agitation, and sleep problems. Do not stop taking trazodone hydrochloride tablets without talking to your healthcare provider. Visual problems. eye pain changes in vision swelling or redness in or around the eye Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Low sodium in your blood (hyponatremia). Symptoms of hyponatremia include: headache, feeling weak, feeling confused, trouble concentrating, memory problems and feeling unsteady when you walk. Get medical help right away, if you have any of the symptoms listed above. The most common side effects of trazodone hydrochloride tablets include: swelling blurred vision dizziness sleepiness tiredness diarrhea stuffy nose weight loss These are not all the possible side effects of trazodone hydrochloride tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store trazodone hydrochloride tablets? Store trazodone hydrochloride tablets between 20°C to 25°C (68°F to 77°F). Keep in tight container Keep out of the light Safely throw away medicine that is out of date or no longer needed. Keep trazodone hydrochloride tablets and all medicines out of the reach of children. General information about the safe and effective use of trazodone hydrochloride tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use trazodone hydrochloride tablets for a condition for which it was not prescribed. Do not give trazodone hydrochloride tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about trazodone hydrochloride tablets that is written for health professionals. For more information contact Apotex Corp., Drug Safety at 1-800-706-5575. What are the ingredients in trazodone hydrochloride tablets? Active ingredient: trazodone hydrochloride, USP Inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and sodium starch glycolate. This Medication Guide has been approved by the U.S. Food and Drug Administration. TRAZODONE HYDROCHLORIDE TABLETS, USP 50 mg Revised: August 2025 Rev. 10 Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762

Trazodone hydrochloride tablets, USP are available in the following strengths: 50 mg : white, round, biconvex, scored tablets. Engraved “APO” bisect “T50” on one side, other side plain.

Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue trazodone hydrochloride tablets and initiate supportive treatment ( 5.2 ). Cardiac Arrhythmias: Increases the QT interval. Avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval ( 5.3 ). Orthostatic Hypotension and Syncope: Warn patients of risk and symptoms of hypotension ( 5.4 ). Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk ( 5.5 ). Priapism: Cases of painful and prolonged penile erections and priapism have been reported. Immediate medical attention should be sought if signs and symptoms of prolonged penile erections or priapism are observed ( 5.6 ). Activation of Mania or Hypomania: Screen for bipolar disorder and monitor for mania or hypomania ( 5.7 ). Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills. Advise patients to use caution when operating machinery ( 5.9 ). Angle-Closure Glaucoma: Avoid use of antidepressants, including trazodone hydrochloride tablets, in patients with untreated anatomically narrow angles ( 5.10 ).

DRUG: Trazodone Hydrochloride GENERIC: Trazodone Hydrochloride DOSAGE: TABLET ADMINSTRATION: ORAL NDC: 70518-1410-0 COLOR: white SHAPE: ROUND SCORE: No score SIZE: 8 mm IMPRINT: APO;T50 PACKAGING: 30 in 1 BLISTER PACK ACTIVE INGREDIENT(S): TRAZODONE HYDROCHLORIDE 50mg in 1 INACTIVE INGREDIENT(S): SILICON DIOXIDE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE STARCH, CORN SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO

Risk Summary Data from published literature report the transfer of trazodone into human milk. There are no data on the effect of trazodone on milk production. Limited data from postmarketing reports have not identified and association of adverse effects on the breastfed child. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for trazodone and any potential adverse effects on the breastfed child from trazodone or from the underlying maternal condition.

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 )].

Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.

Starting dose: 150 mg in divided doses daily. May be increased by 50 mg per day every three to four days. Maximum dose: 400 mg per day in divided doses ( 2.1 ). Trazodone hydrochloride tablets should be taken shortly after a meal or light snack ( 2.2 ). Tablets should be swallowed whole or broken in half along the score line, and should not be chewed or crushed ( 2.2 ). When discontinued, gradual dose reduction is recommended ( 2.6 ).

Trazodone hydrochloride tablets, USP 50 mg are available for oral administration as white, round, biconvex, tablets. Engraved “APO” bisect “T50” on one side, other side plain. NDC: 70518-1410-00 PACKAGING: 30 in 1 BLISTER PACK Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense with a child-resistant closure in a tight, light-resistant container. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

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 )].

CNS Depressants: Trazodone may enhance effects of alcohol, barbiturates, or other CNS depressants ( 7 ). CYP3A4 Inhibitors: Consider Trazodone dose reduction based on tolerability ( 2.5 , 7 ). CYP3A4 Inducers: Increase in Trazodone dosage may be necessary ( 2.5 , 7 ). Digoxin or Phenytoin: Monitor for increased digoxin or phenytoin serum levels ( 7 ). Warfarin: Monitor for increased or decreased prothrombin time ( 7 ).

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down and instruct them to report such symptoms to the healthcare provider [see Box Warning and Warnings and Precautions ( 5.1 )] . Dosage and Administration Advise patients that trazodone hydrochloride tablets should be taken shortly after a meal or light snack. Advise patients regarding the importance of following dosage titration instructions [see Dosage and Administration ( 2 )]. Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of trazodone with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Patients should contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7 )] . Activation of Mania/Hypomania Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions ( 5.7 )]. Increased Risk of Bleeding Inform patients about the concomitant use of trazodone with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use of drugs that interfere with serotonin reuptake and these medications has been associated with an increased risk of bleeding. Advise them to inform their health care providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [see Warnings and Precautions ( 5.5 )] . Discontinuation Syndrome Advise patients not to abruptly discontinue trazodone hydrochloride tablets and to discuss any tapering regimen with their healthcare provider. Adverse reactions can occur when trazodone hydrochloride tablets is discontinued [see Warnings and Precautions ( 5.8 )] . Concomitant Medications Advise patients to inform their health care providers if they are taking, or plan to take any prescription or over-the-counter medications since there is a potential for interactions [see Drug Interactions ( 7.1 )]. Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy with trazodone hydrochloride tablets. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to trazodone hydrochloride tablets during pregnancy [see Use in Special Populations ( 8.1 )]. TRAZODONE HYDROCHLORIDE TABLETS, USP 50 mg Rev. 10 Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762

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 )]

Death from overdose has occurred in patients ingesting trazodone and other CNS depressant drugs concurrently (alcohol; alcohol and chloral hydrate and diazepam; amobarbital; chlordiazepoxide; or meprobamate). The most severe reactions reported to have occurred with overdose of trazodone alone have been priapism, respiratory arrest, seizures, and ECG changes, including QT prolongation and syndrome of inappropriate antidiuretic hormone secretion (SIADH). 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. There is no specific antidote for trazodone hydrochloride overdose. In managing overdosage, consider the possibility of multiple drug involvement. For current information on the management of poisoning or overdose, contact a poison control center (1-800-222-1222 or www.poison.org).

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(2 H )-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows 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, sodium lauryl sulfate, and sodium starch glycolate. FDA approved dissolution test specifications differ from USP.

The efficacy and safety of trazodone hydrochloride were established from inpatient and outpatient trials of the trazodone immediate release formulation in the treatment of major depressive disorder.

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.

Trazodone hydrochloride tablets, USP , for oral use (traz' oh done hye'' droe klor' ide) What is the most important information I should know about trazodone hydrochloride tablets? Antidepressant medicines, depression or other serious mental illnesses, and suicidal thoughts or actions: Talk to your healthcare provider about: All risks and benefits of treatment with antidepressant medicines All treatment choices for depression or other serious mental illnesses 1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment . 2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions . Some people may have a higher risk of having suicidal thoughts or actions . These include people who have or have a family history of bipolar illness (also called manic- depressive illness) or suicidal thoughts or actions. 3. How can I watch for and try to prevent suicidal thoughts and actions? Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Call a healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: Thoughts about suicide or dying Attempts to commit suicide New or worse depression New or worse anxiety Feeling very agitated or restless Panic attacks Trouble sleeping (insomnia) New or worse irritability Acting aggressive, being angry or violent Acting on dangerous impulses An extreme increase in activity and talking (mania) Other unusual changes in behavior or mood What else do I need to know about antidepressant medicines? Never stop an antidepressant medicine without first talking to a healthcare provider . Stopping an antidepressant medicine suddenly can cause other symptoms. Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider, not just the use of antidepressants. Antidepressant medicines have other side effects . Talk to your healthcare provider about the side effects of your medicines. Antidepressant medicines can interact with other medicines. Know all of the medicines that you take. Keep a list of all medicines to show your healthcare provider. Do not start new medicines without first checking with your healthcare provider. It is not known if trazodone is safe and effective in children. What are trazodone hydrochloride tablets? Trazodone hydrochloride tablets are a prescription medicine used in adults to treat major depressive disorder (MDD). Trazodone belongs to a class of medicines known as SSRIs (or selective serotonin reuptake inhibitors). Do not take trazodone hydrochloride tablets: If you take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid, and intravenous methylene blue. Do not take an MAOI within 2 weeks of stopping trazodone hydrochloride tablets unless directed to do so by your healthcare provider. Do not start trazodone hydrochloride tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider. Before you take trazodone hydrochloride tablets tell your healthcare provider about all of your medical conditions, including if you: have heart problems, including QT prolongation or a family history of it have ever had a heart attack have bipolar disorder have liver or kidney problems have other serious medical conditions are pregnant or plan to become pregnant. It is not known if trazodone hydrochloride tablets harm your unborn baby. Talk to your healthcare provider about the risk to your unborn baby if you take trazodone hydrochloride tablets. If you become pregnant during treatment with trazodone hydrochloride tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-844-405-6185. are breastfeeding or plan to breastfeed. Trazodone hydrochloride passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take trazodone hydrochloride tablets. have taken a Monoamine Oxidase Inhibitor (MAOI) or if you have stopped taking an MAOI in the last 2 weeks. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using trazodone hydrochloride tablets with certain other medicines can affect each other causing serious side effects. Especially tell your healthcare provider if you take: triptans used to treat migraine headache medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, buspirone, or antipsychotics tramadol over-the-counter supplements such as tryptophan or St. John’s Wort nonsteroidal anti-inflammatory drugs (NSAIDS) aspirin warfarin (Coumadin, Jantoven) phenytoin (Mesantoin) diuretics Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. How should I take trazodone hydrochloride tablets? Take trazodone hydrochloride tablets exactly as your healthcare provider tells you. Trazodone hydrochloride tablets should be taken shortly after a meal or light snack. If you feel drowsy after taking trazodone hydrochloride tablets, talk to your healthcare provider. Your healthcare provider may change your dose or the time of day you take your trazodone hydrochloride tablets. Do not stop taking trazodone hydrochloride tablets without talking to your healthcare provider. Trazodone hydrochloride tablets should be swallowed whole or broken in half along the score line. Do not chew or crush trazodone hydrochloride tablets. Tell your healthcare provider if you cannot swallow trazodone either whole or as a half tablet. If you take too much trazodone hydrochloride, call your healthcare provider, your Poison Control Center at 1-800-222-1222, or go to the nearest emergency room right away. What should I avoid while taking trazodone hydrochloride tablets? Do not drive, operate heavy machinery, or do other dangerous activities until you know how trazodone hydrochloride tablets affect you. Trazodone hydrochloride tablets can slow your thinking and motor skills. Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking trazodone hydrochloride tablets until you talk with your healthcare provider. Trazodone hydrochloride tablets may make your sleepiness or dizziness worse if you take it with alcohol or other medicines that cause sleepiness or dizziness. What are the possible side effects of trazodone hydrochloride tablets? Trazodone hydrochloride tablets can cause serious side effects or death, including: See “What is the most important information I should know about trazodone hydrochloride tablets?” Serotonin syndrome. Symptoms of serotonin syndrome include: agitation, hallucinations, problems with coordination, fast heartbeat, tight muscles, trouble walking, sweating, fever, nausea, vomiting, and diarrhea. Irregular or fast heartbeat or faint (QT prolongation) Low blood pressure. You feel dizzy or faint when you change positions (go from sitting to standing) Unusual bruising or bleeding Erection lasting for more than 6 hours (priapism) Feeling high or in a very good mood, then becoming irritable, or having too much energy, feeling like you have to keep talking or do not sleep (mania). Withdrawal symptoms. Symptoms of withdrawal can include anxiety, agitation, and sleep problems. Do not stop taking trazodone hydrochloride tablets without talking to your healthcare provider. Visual problems. eye pain changes in vision swelling or redness in or around the eye Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Low sodium in your blood (hyponatremia). Symptoms of hyponatremia include: headache, feeling weak, feeling confused, trouble concentrating, memory problems and feeling unsteady when you walk. Get medical help right away, if you have any of the symptoms listed above. The most common side effects of trazodone hydrochloride tablets include: swelling blurred vision dizziness sleepiness tiredness diarrhea stuffy nose weight loss These are not all the possible side effects of trazodone hydrochloride tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store trazodone hydrochloride tablets? Store trazodone hydrochloride tablets between 20°C to 25°C (68°F to 77°F). Keep in tight container Keep out of the light Safely throw away medicine that is out of date or no longer needed. Keep trazodone hydrochloride tablets and all medicines out of the reach of children. General information about the safe and effective use of trazodone hydrochloride tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use trazodone hydrochloride tablets for a condition for which it was not prescribed. Do not give trazodone hydrochloride tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about trazodone hydrochloride tablets that is written for health professionals. For more information contact Apotex Corp., Drug Safety at 1-800-706-5575. What are the ingredients in trazodone hydrochloride tablets? Active ingredient: trazodone hydrochloride, USP Inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and sodium starch glycolate. This Medication Guide has been approved by the U.S. Food and Drug Administration. TRAZODONE HYDROCHLORIDE TABLETS, USP 50 mg Revised: August 2025 Rev. 10 Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762

Trazodone hydrochloride tablets, USP are available in the following strengths: 50 mg : white, round, biconvex, scored tablets. Engraved “APO” bisect “T50” on one side, other side plain.

Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue trazodone hydrochloride tablets and initiate supportive treatment ( 5.2 ). Cardiac Arrhythmias: Increases the QT interval. Avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval ( 5.3 ). Orthostatic Hypotension and Syncope: Warn patients of risk and symptoms of hypotension ( 5.4 ). Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk ( 5.5 ). Priapism: Cases of painful and prolonged penile erections and priapism have been reported. Immediate medical attention should be sought if signs and symptoms of prolonged penile erections or priapism are observed ( 5.6 ). Activation of Mania or Hypomania: Screen for bipolar disorder and monitor for mania or hypomania ( 5.7 ). Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills. Advise patients to use caution when operating machinery ( 5.9 ). Angle-Closure Glaucoma: Avoid use of antidepressants, including trazodone hydrochloride tablets, in patients with untreated anatomically narrow angles ( 5.10 ).

DRUG: Trazodone Hydrochloride GENERIC: Trazodone Hydrochloride DOSAGE: TABLET ADMINSTRATION: ORAL NDC: 70518-1410-0 COLOR: white SHAPE: ROUND SCORE: No score SIZE: 8 mm IMPRINT: APO;T50 PACKAGING: 30 in 1 BLISTER PACK ACTIVE INGREDIENT(S): TRAZODONE HYDROCHLORIDE 50mg in 1 INACTIVE INGREDIENT(S): SILICON DIOXIDE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE STARCH, CORN SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO

Risk Summary Data from published literature report the transfer of trazodone into human milk. There are no data on the effect of trazodone on milk production. Limited data from postmarketing reports have not identified and association of adverse effects on the breastfed child. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for trazodone and any potential adverse effects on the breastfed child from trazodone or from the underlying maternal condition.