Trazodone Hydrochloride 150 mg/1
Trazodone Hydrochloride · TABLET · Accord Healthcare, Inc.
Trazodone Hydrochloride is a tablet containing trazodone hydrochloride at 150 mg/1, taken oral. Manufactured by Accord Healthcare, Inc..
Key Facts
- Brand Name
- Trazodone Hydrochloride
- Generic Name
- Trazodone Hydrochloride
- NDC Code (Product)
16729-301- Manufacturer
- Accord Healthcare, Inc.
- Strength
- 150 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA206923
- Marketing Start
- 10/17/2018
Recall History
AVKARE Inc.
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Zydus Pharmaceuticals (USA) Inc
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Granules Pharmaceuticals Inc.
Presence of Foreign Tablets/Capsules
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Trazodone is a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) ( 1 ). Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
Dosage & Administration
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 ). Trazodone hydrochloride tablets should be taken shortly after a meal or light snack ( 2 ). Tablets should be swallowed whole or broken in half along the score line, and should not be chewed or crushed ( 2 ). When discontinued, gradual dose reduction is recommended ( 2 ). 2.1 Dose Selection An initial dose of 150 mg/day in divided doses is suggested. The dosage should be initiated at a low-dose and increased gradually, noting the clinical response and any evidence of intolerance. Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage. The dose may be increased by 50 mg/day every 3 to 4 days. The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses. Inpatients (i.e., more severely depressed patients) may be given up to but not in excess of 600 mg/day in divided doses. Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic re…
Contraindications
4 CONTRAINDICATIONS None ( 4 ). Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs ( 4 ). 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 )].
Drug Interactions
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 ). 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 vitro drug 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 max of trazodone increased by 34%, the AUC increased 2.4 fold, the half-life increased by 2.2 fold, and the clearance decreased by 52%. Adverse eff…
Adverse Reactions
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. 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…
Frequently Asked Questions
What is Trazodone Hydrochloride used for?
Trazodone Hydrochloride contains Trazodone Hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.
Is Trazodone Hydrochloride a controlled substance?
Trazodone Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Trazodone Hydrochloride?
The generic name for Trazodone Hydrochloride is Trazodone Hydrochloride. There are 1 other brand versions of Trazodone Hydrochloride.
What is the NDC code for Trazodone Hydrochloride 150 mg/1?
The NDC (National Drug Code) for Trazodone Hydrochloride 150 mg/1 is 16729-301, listed by Accord Healthcare, Inc..
Other Trazodone Hydrochloride Dosages
- Trazodone Hydrochloride50 mg/142291-868
- Trazodone Hydrochloride150 mg/150090-7439
- Trazodone Hydrochloride50 mg/150090-7943
- Trazodone Hydrochloride150 mg/150268-776
- Trazodone Hydrochloride50 mg/151655-366
- Trazodone Hydrochloride150 mg/168382-807
- Trazodone Hydrochloride150 mg/170518-2180
- Trazodone Hydrochloride100 mg/170518-3426
- Trazodone Hydrochloride150 mg/171205-815
- Trazodone Hydrochloride50 mg/171335-0705
Other Trazodone Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)