Trazodone hydrochloride tablet

Warning: suicidal thoughts and behaviors

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 is not approved for use in pediatric patients [see Use in Specific Populations (8.4)].

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

See full prescribing information for complete boxed warning.

  • Antidepresants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients (5.1)
  • Closely monitor for clinical worsening and emergence ofsuicidal thoughts and behaviors (5.1)
  • Trazodone is not approved for use in pediatric patients (8.4)

1 indications and usage

Trazodone is a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) (1).

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

2 dosage and administration

  • 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 (2.2).
  • When discontinued, gradual dose reduction is recommended (2.6).

3 dosage forms and strengths

  • Scored tablets of 50mg, 100mg, 150 mg and 300 mg ( 3).

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Trazodone hydrochloride tablets, USP are available in the following strengths:

Trazodone hydrochloride tablets USP, 50 mg are white to off-white, round-shape, biconvex beveled tablets, bisect on one side and plain on other side. The bisected side oftablet is debossed with '8' on upper side of bisect and '05' on lower side of bisect.

Trazodone hydrochloride tablets USP, 100 mg are white to off-white, round-shape, biconvex beveled tablets, bisect on one side and plain on other side. The bisected side of tablet is debossed with '8' on upper side of bisect and '06' on lower side of bisect.

Trazodone hydrochloride tablets USP, 150 mg are white to off-white, oval-shape, flat faced beveled tablets having one full bisect and two trisect notches on one side and two trisects on other side. The full bisected side of tablet is debossed with '8' on one side of bisect and '07' on other bisect segments.

Trazodone hydrochloride tablets USP, 300 mg are white to off-white, oval-shape, flat faced beveled tablets having one full bisect and two trisect notches on one side and two trisects on other side. The full bisected side of tablet is debossed with '8' on one side of bisect and '08' on other bisect segment.

4 contraindications

None ( 4).

  • Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs (4).

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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)].

5 warnings and precautions

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 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, in patients with untreated anatomically narrow angles. (5.10).

6 adverse reactions

Most common adverse reactions (incidence 5% and twice that of placebo) are: edema, blurred vision, syncope, drowsiness, fatigue, diarrhea, nasal congestion, weight loss (6).

To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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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)]

7 drug interactions

  • 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).

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MAOIs

MAOIs should not be used within 14 days of trazodone [see Warnings and Precautions ( 5.8)].

Central Nervous System (CNS) Depressants

Trazodone may enhance the response to alcohol, barbiturates, and other CNS depressants.

Cytochrome P450 3A4 Inhibitors

In vitrodrug metabolism studies suggest that there is a potential for drug interactions when trazodone is given with cytochrome P450 3A4 (CYP3A4) inhibitors. 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 C maxof 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. It is likely that ketoconazole, indinavir, and other CYP3A4 inhibitors such as itraconazole may lead to substantial increases in trazodone plasma concentrations with the potential for adverse effects. If trazodone is used with a potent CYP3A4 inhibitor, the risk of cardiac arrhythmia may be increased [see Warnings and Precautions ( 5.4)]and a lower dose of trazodone should be considered.

Cytochrome P450 Inducers (e.g., Carbamazepine)

Carbamazepine induces CYP3A4. Following coadministration of carbamazepine 400 mg per day with trazodone 100 mg to 300 mg daily, carbamazepine reduced plasma concentrations of trazodone and m-chlorophenlypiperazine (an active metabolite) by 76% and 60% respectively, compared to pre-carbamazepine values. Patients should be closely monitored to see if there is a need for an increased dose of trazodone when taking both drugs.

Digoxin and Phenytoin

Increased serum digoxin or phenytoin levels have been reported in patients receiving trazodone concurrently with either of these drugs. Monitor serum levels and adjust dosages as needed.

Serotonergic Drugs

Based on the mechanism of action of trazodone and the potential for serotonin syndrome, caution is advised when trazodone is coadministered with other drugs that may affect the neurotransmitter systems [ see Warnings and Precautions ( 5.2)].

NSAIDs, Aspirin, or Other Drugs Affecting Coagulation or Bleeding

Due to a possible association between serotonin modulating drugs and gastrointestinal bleeding, patients should be monitored for and cautioned about the potential risk of bleeding associated with the concomitant use of trazodone and NSAIDs, aspirin, or other drugs that affect coagulation or bleeding [s ee Warnings and Precautions ( 5.7)].

Warfarin

There have been reports of altered (either increased or decreased) prothrombin times in taking both warfarin and trazodone.

8 use in specific populations

  • Pregnancy: Based on animal data, may cause fetal harm ( 8.1).
  • Nursing Mothers: Use with caution ( 8.3).

8.1 pregnancy

Teratogenic Effects

Pregnancy Category C

Trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in the rat when given at dose levels approximately 6 to 9 times the maximum recommended human dose (MRHD) of 400 mg/day on mg/m 2in adolescents. There is also an increase in congenital anomalies in the rabbit at approximately 6 to 17 times the MRHD on mg/m 2basis in adolescents. There are no adequate and well-controlled studies in pregnant women. Trazodone hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Animal Data

No teratogenic effects were observed when trazodone was given to pregnant rats and rabbits during the period of organogenesis at oral doses up to 450 mg/kg/day. This dose is 9 and 17 times, in rats and rabbits, respectively, the maximum recommended human dose (MRHD) of 400 mg/day on mg/m 2basis in adolescents. Increased fetal resorption and other adverse effects on the fetus in rats at 6 to 9 times the MRHD and increase in congenital anomalies in rabbits at 6 to 17 times the MRHD on mg/m 2basis in adolescents were observed.

8.3 nursing mothers

Trazodone 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 trazodone is administered to a nursing woman.

8.4 pediatric use

Safety and effectiveness in the pediatric population have not been established. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [ see Boxed Warning, Warnings and Precautions ( 5.1)].

8.5 geriatric use

Reported clinical literature and experience with trazodone has not identified differences in responses between elderly and younger patients. However, as experience in the elderly with trazodone hydrochloride is limited, it should be used with caution in geriatric patients.

Serotonergic antidepressants have been associated with cases of clinically significant hyponatremia in elderly patients who may be at greater risk for this adverse reaction [ see Warnings and Precautions (5.11)].

9 drug abuse and dependence

9.2 abuse

Although trazodone hydrochloride has not been systematically studied in preclinical or clinical studies for its potential for abuse, no indication of drug-seeking behavior was seen in the clinical studies with trazodone hydrochloride.

10 overdosage

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. 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).

11 description

Trazodone hydrochloride is a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride, USP 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 to off-white, crystalline powder which is sparingly soluble in chloroform and in water. The structural formula is represented as follows:

Trazodone Hydrochloride Tablets USP

Molecular Formula:C 19H 22C lN 5OHCl

Molecular Weight:408.33

Each trazodone hydrochloride tablet, USP 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.

The USP Dissolution Test is pending.

12 clinical pharmacology

12.1 mechanism of action

The mechanism of trazodone's antidepressant action is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS. Trazodone is both a selective serotonin reuptake inhibitor (SSRI) and a 5HT2 receptor antagonist and the net result of this action on serotonergic transmission and its role in trazodone's antidepressant effect is unknown.

12.2 pharmacodynamics

Preclinical studies have shown that trazodone selectively inhibits neuronal reuptake of serotonin (Ki = 367 nM) and acts as an antagonist at 5-HT-2A (Ki = 35.6 nM) serotonin receptors. Trazodone is also an antagonist at several other monoaminergic receptors including 5-HT2B (Ki = 78.4 nM), 5-HT2C (Ki = 224 nM), 1A (Ki = 153 nM), 2C (Ki = 155 nM) receptors and it is a partial agonist at 5HT1A (Ki = 118 nM) receptor.

Trazodone antagonizes alpha 1-adrenergic receptors, a property which may be associated with postural hypotension.

12.3 pharmacokinetics

Absorption

In humans, trazodone hydrochloride is absorbed after oral administration without selective localization in any tissue. When 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 trazodone hydrochloride is taken on an empty stomach or 2 hours after dosing when taken with food.

Metabolism

In vitrostudies in human liver microsomes show that trazodone is metabolized, via oxidative cleavage, to an active metabolite, m-chlorophenylpiperazine (mCPP) by CYP3A4. Other metabolic pathways that may be involved in the metabolism of trazodone have not been well characterized. Trazodone is extensively metabolized; less than 1% of an oral dose is excreted unchanged in the urine.

Elimination

In some patients trazodone may accumulate in the plasma.

Protein Binding

Trazodone is 89 to 95% protein bound in vitroat concentrations attained with therapeutic doses in humans.

13 nonclinical toxicology

Carcinogenesis

No drug- or dose-related occurrence of carcinogenesis was evident in rats receiving trazodone in daily oral doses up to7.3 times the maximum recommended human dose (MRSD) of 400 mg/day on mg/m 2basis.

Mutagenesis

No genotoxicity studies were conducted with trazodone.

Impairment of Fertility

Trazodone has no effect on fertility in rats at doses up to 6 times the MRHD on mg/m 2basis in adolescents.

14 clinical studies

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.

16 how supplied/storage and handling

Trazodone Hydrochloride Tablets USP, 50 mg are white to off-white, round-shape, biconvex beveled tablets, bisect on one side and plain on other side. The bisected side of tablet is debossed with 8 on upper side of bisect and 05 on lower side of bisect and are supplied as follows:

NDC 68071-4410-2 BOTTLES OF 20

NDC 68071-4410-8 BOTTLES OF 28

NDC 68071-4410-3 BOTTLES OF 30

NDC 68071-4410-4 BOTTLES OF 45

NDC 68071-4410-5 BOTTLES OF 56

NDC 68071-4410-6 BOTTLES OF 60

NDC 68071-4410-9 BOTTLES OF 90

-For 50 mg, break the score on either the left or right side of the tablet (one-third of a

tablet).

Trazodone Hydrochloride Tablets USP

Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature].

Dispense with a child-resistant closure in a tight, light-resistant container.

17 patient counseling information

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 hydrochloride tablets with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, 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 hydrochloride tablets 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 are 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)].

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Manufactured by:

Cadila Healthcare Limited

Ahmedabad, India.

Distributed by:

Zydus Pharmaceuticals (USA) Inc.

Pennington, NJ 08534

Rev.: 07/17

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MEDICATION GUIDE

Trazodone Hydrochloride (traz' oh done hye'' droe klor' ide) Tablets, USP

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 hydrochloride tablets are safe and effective in children.

What are trazodone hydrochloride tablets?

Trazodone hydrochloride tablets are prescription medicine used in adults to treat major depressive disorder (MDD). Trazodone hydrochloride tablets belong 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. Trazodone hydrochloride tablets may harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if trazodone hydrochloride passes into your breast milk. You and your healthcare provider should decide if you will take trazodone hydrochloride or breastfeed.
  • 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 tablets, 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?"
  • 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 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 to 25C (68 to 77F).
  • 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 .

Please address medical inquiries to, MedicalAffairs@zydususa.com Tel.: 1-877-993-8779.

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.

Spl unclassified section

Manufactured by:

Cadila Healthcare Limited

Ahmedabad, India.

Distributed by:

Zydus Pharmaceuticals (USA) Inc.

Pennington, NJ 08534

Rev.: 07/17

Ingredients and appearance - Product information

Trazodone hydrochloride tablet- Trazodone hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68071-4410
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Trazodone hydrochloride ( UNII: 6E8ZO8LRNM)( Trazodone - UNII: YBK48BXK30 ) 50 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Starch, pregelatinized corn ( UNII: O8232NY3SJ)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)

Product Characteristics

Color white (WHITE TO OFF-WHITE) Shape ROUND (ROUND)
Size 8 mm Score 2
Imprint Code 8;05

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 68071-4410-2 20 in 1 BOTTLE 2018/04/27
2 NDC: 68071-4410-3 30 in 1 BOTTLE 2018/04/27
3 NDC: 68071-4410-8 28 in 1 BOTTLE 2018/04/27
4 NDC: 68071-4410-4 45 in 1 BOTTLE 2018/04/27
5 NDC: 68071-4410-5 56 in 1 BOTTLE 2018/04/27
6 NDC: 68071-4410-6 60 in 1 BOTTLE 2018/04/27
7 NDC: 68071-4410-9 90 in 1 BOTTLE 2018/04/27

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA205253 USA 2018/04/27

Labeler - NuCare Pharmaceuticals,Inc.( 010632300)

Establishment

Name ID/FEI Business Operations
NuCare Pharmaceuticals,Inc. 010632300 repack( 68071-4410)

Package label.principal display panel