Trazodone Hydrochloride 150 mg Tablet, 30-count
Other active recalls for Trazodone Hydrochloride (different manufacturers) — 3 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Serotonin Reuptake Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Trazodone is used to treat depression. Trazodone is in a class of medications called serotonin modulators. It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.
Read the full MedlinePlus article ↗- Trazodone is FDA-approved to treat major depressive disorder — that's clinical depression — in adults. It comes as a tablet (Trazodone Hydrochloride or Trazodone Hcl) or as an oral...
- Always take it shortly after a meal or a light snack. Food helps your body absorb the drug more consistently, and it can also help reduce any stomach upset. Just try to keep that t...
- Should I take trazodone with food or on an empty stomach?
- Drowsiness is one of the most commonly reported side effects — your prescriber may actually suggest taking the larger dose at bedtime for that reason. Other common ones include diz...
Patient education
Supplement & herbal interactions
Trazodone may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.2383 | $7.15 / 30 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Trazodone Hydrochloride 150 mg 00904-7212-61 | Major | 100 tablets | $0.086 | AB | Availability likely | — |
| Trazodone Hydrochloride 150 mg 13107-0081-01 | Aurolife | 100 tablets | $0.086 | AB | Availability likely | — |
| Trazodone Hydrochloride 150 mg 13668-0332-01 | Torrent | 100 tablets | $0.086 | AB | Availability likely | — |
| Trazodone Hydrochloride 150 mg 50111-0450-01 | Teva | 100 tablets | $0.086 | — | Discontinued | — |
| Trazodone Hydrochloride 150 mg 50268-0776-15 | AvPAK | 50 tablets | $0.086 | AB | Availability likely | — |
| Trazodone Hydrochloride 150 mg 57664-0053-72 | Sun | 100 tablets | $0.086 | AB | Availability likely | — |
| Trazodone Hydrochloride 150 mg 60505-2655-01 | Apotex | 100 tablets | $0.086 | AB | Availability likely | — |
| Trazodone Hydrochloride 150 mg 60687-0432-01 | American | 100 tablets | $0.086 | AB | Availability likely | — |
| Trazodone Hydrochloride 150 mg 64980-0674-01 | Rising | 100 tablets | $0.086 | AB | Availability likely | — |
| Trazodone Hydrochloride 150 mg 68382-0807-01 | Zydus | 100 tablets | $0.086 | AB | Availability likely | — |
| Trazodone Hydrochloride 150 mg 70010-0233-01 | Granules | 100 tablets | $0.086 | AB | Availability likely | — |
| Trazodone Hydrochloride 150 mg 16729-0301-01 | Accord | 100 tablets | $0.091 | AB | Availability likely | — |
| Trazodone Hydrochloride 150 mg 00615-8339-39 | NCS | 30 tablets | — | AB | Discontinued | — |
| Trazodone Hydrochloride 150 mg 42291-0829-50 | AvKARE | 500 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 150 mg 50090-4825-02 | A-S | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 150 mg 50090-7439-02 | A-S | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 150 mg 68788-7166-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 150 mg 70518-2180-01 | REMEDYREPACK | 30 tablets | — | AB | Discontinued | — |
| Trazodone Hydrochloride 150 mg 70518-3479-00 | REMEDYREPACK | 30 tablets | — | AB | Discontinued | — |
| Trazodone Hydrochloride 150 mg 70771-1130-00 | Zydus | 1000 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 150 mg 71205-0815-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 150 mg 71335-0742-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 150 mg 71335-1483-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 150 mg 71335-2084-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 150 mg 71335-3024-01 | Bryant | 90 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 150 mg 71335-3112-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 150 mg 72162-2532-00 | Bryant | 1000 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 150 mg 72789-0079-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 150 mg 76420-0675-01 | Asclemed | 100 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 150 mgthis 80425-0302-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 150 mg 80425-0462-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 150 mg 70518-4690-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 80425-0302-01 You're viewing this | 30 TABLET in 1 BOTTLE (80425-0302-1) | 2023-04-10 | Active |
| 80425-0302-02 | 60 TABLET in 1 BOTTLE (80425-0302-2) | 2023-04-10 | Active |
| 80425-0302-03 | 90 TABLET in 1 BOTTLE (80425-0302-3) | 2023-04-10 | Active |
You're viewing the smallest of 3 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 80425-0302-01?
What is the difference between NDC 80425-0302-01 and NDC 80425-0302-02?
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🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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)].
🎯 Indications and Usage ▾
1. Indications and Usage Trazodone Hydrochloride Tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
⏱️ Dosage and Administration ▾
2. Dosage and Administration
2.1Dose 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.
2.2Important 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.
2.3Screen 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)].
2.4Switching 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)].
2.5Dosage 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)].
2.6Discontinuation 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.
💊 Dosage Forms and Strengths ▾
3. Dosage Forms and Strengths Trazodone hydrochloride tablets USP are available in the following strengths: 50 mg: White to off-white, round, biconvex, uncoated tablets, debossed with ‘J’ and ‘43’ on either side of scoreline (functional) on one side and plain on the other side. 100 mg: White to off-white, round, biconvex, uncoated tablets, debossed with ‘J’ and ‘44’ on either side of scoreline (functional) on one side and plain on the other side.
150 mg: 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. 300 mg: White to off-white, oval, flat faced, beveled-edge, uncoated tablets with one side scored (functional) with full bisect debossed with ‘J’ and ‘46’ on either side and having two partial trisect on one side and plain on the other side.
⛔ Contraindications ▾
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)].
⚠️ Warnings and Cautions ▾
5. Warnings and Precautions
5.1Suicidal 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.
5.2Serotonin 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 treatm…
🤒 Adverse Reactions ▾
6. 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)]
6.1Clinical 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.
6.2Post 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 alteration…
🔄 Drug Interactions ▾
7. Drug Interactions
7.1Drugs 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 combi…
👥 Use in Specific Populations ▾
8. Use in Specific Populations
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405- 6185 or visiting online at https://womensmentalhealth.org/clinical-and-research programs/pregnancy registry/antidepressants/ Risk Summary Published prospective cohort studies, case series, and case reports over several decades with Trazodone Hydrochloride Tablets use in pregnant women have not identified any drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data).
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 7.3 to 11 times the maximum recommended human dose (MRHD) of 400 mg/day in adults on a mg/m2 basis. There was also an increase in congenital anomalies in the rabbit at approximately 7.3 to 22 times the MRHD on a mg/m2 basis (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo fetal risk A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy.
The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression that women who continued antidepressants. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Data Human Data While available studies cannot definitively establish the absence of risk, published data from prospective cohort studies, case series, and case reports over several decades have not identified an association with trazodone use during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
All available studies have methodological limitations, including small sample size and inconsistent comparator groups. 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 11 and 22 times, in rats and rabbits, respectively, the maximum recommended human dose (MRHD) of 400 mg/day in adults on a mg/m2 basis.
Increased fetal resorption and other adverse effects on the fetus in rats at 7.3 to 11 times the MRHD and increase in congenital anomalies in rabbits at 7.3 to 22 times the MRHD on a mg/m2 basis were observed. No further details on these studies are available.
8.2Lactation 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 post marketing 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 Hydrochloride Tablets and any potential adverse effects on the breastfed child from Trazodone Hydrochloride Tablets or from the underlying maternal condition.
8.4Pediatric 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 clini…
🆘 Overdosage ▾
10. Overdosage Death from overdose has occurred in patients ingesting Trazodone Hydrochloride Tablets 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 Hydrochloride Tablets 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).
🧬 Clinical Pharmacology ▾
12. Clinical Pharamcology
12.1Mechanism 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.
12.2Pharmacodynamics 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), α1A (Ki = 153 nM), α2C (Ki = 155 nM) receptors and it is a partial agonist at 5- HT1A (Ki = 118 nM) receptor. Trazodone antagonizes alpha 1-adrenergic receptors, a property which may be associated with postural hypotension.
12.3Pharmacokinetics 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 vitro studies 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 vitro at concentrations attained with therapeutic doses in humans.
📦 How Supplied / Storage and Handling ▾
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
📋 Description ▾
11. Description 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
💬 Medication Guide ▾
Medication Guide MEDICATION GUIDE Trazodone Hydrochloride Tablets, USP (traz’ oh done hye’’ droeklor’ 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 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 is Trazodone Hydrochloride Tablets? Trazodone Hydrochloride Tablets are a prescription medicine used in adults to treat major depressive disorder (MDD). Trazodone Hydrochloride Tablets 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 hi…