Trazodone Hydrochloride Extended-Release Tablets

Your pharmacist can provide more information about trazodone.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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The following serious adverse reactions are described elsewhere in the labeling:

• Clinical Worsening and Suicide Risk [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
• Serotonin Syndrome or NMS-like Reactions [see WARNINGS AND PRECAUTIONS]
• QT Prolongation and Risk of Sudden Death [see WARNINGS AND PRECAUTIONS]
• Orthostatic Hypotension [see WARNINGS AND PRECAUTIONS]
• Abnormal bleeding events [see WARNINGS AND PRECAUTIONS]
• Priapism [see WARNINGS AND PRECAUTIONS]
• Hyponatremia [see WARNINGS AND PRECAUTIONS]
• Cognitive and Motor Impairment [see WARNINGS AND PRECAUTIONS]
• Discontinuation symptoms [see WARNINGS AND PRECAUTIONS]

The most common adverse reactions (reported in ≥ 5% and at twice the rate of placebo) are: somnolence/sedation, dizziness, constipation, vision blurred.

Table 2 presents the summary of adverse events (AEs) leading to discontinuation of Oleptro treatment with an incidence of at least 1% and at least twice that for placebo.

Table 2: AEs with discontinuation as action taken ( ≥ 1% incidence and incidence 2x placebo)

Clinical Studies Experience

The data described below reflects exposure in a clinical trial of 406 patients, including 204 exposed to placebo and 202 exposed to Oleptro. Patients were between 18-80 years of age and 69.3% and 67.5% of patients had at least one previous episode of depression in the last 24 months in the placebo and active-treated group, respectively. In individual patients, doses were flexible and ranged from 150 to 375 mg per day. The mean daily dose during the 6-week treatment period was 310 mg. The tablets were administered orally and were given once a day for a total duration of 8 weeks, including the titration period.

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 3 presents the summary of all treatment emergent AEs that occurred at an incidence of ≥ 5% in the Oleptro group, whether considered by the clinical investigator to be related to the study drug or not.

Table 3: Most Common Treatment Emergent Adverse Events ( ≥ 5% of Patients on Active Treatment)

Adverse events related to sexual dysfunction (regardless of causality) were reported by 4.9% and 1.5% of patients treated with Oleptro and placebo, respectively. In the Oleptro group, ejaculation disorders occurred in 1.5% of patients, decreased libido occurred in 1.5% of patients, and erectile dysfunction and abnormal orgasm < 1% of patients.

There were no notable changes in vital signs (blood pressure, respiratory rate, pulse) or weight in either treatment group.

Following is a list of treatment-emergent adverse reactions with an incidence of ≥ 1% to < 5% (i.e., less common) in patients treated with Oleptro. This listing is not intended to include reactions (i) already listed in previous tables or elsewhere in the labeling (ii) for which the association with treatment is remote, (iii) which were so general as to be uninformative, and (iv) which were not considered to have significant clinical implications. Reactions are classified by body-system using the following definitions: frequent adverse reactions are those occurring in at least 1/100 patients; Infrequent adverse reactions are those occurring in less than 1/100 patients.

Ear and Labyrinth Disorders- Infrequent: hypoacusis, tinnitus, vertigo

Eye Disorders- Frequent: visual disturbance; Infrequent: dry eye, eye pain, photophobia

Gastrointestinal Disorders- Frequent: abdominal pain, vomiting; Infrequent: reflux esophagitis

General Disorders and Administration Site Conditions- Frequent: edema; Infrequent: gait disturbance

Immune System Disorders- Infrequent: hypersensitivity

Musculoskeletal and Connective Tissue Disorders- Frequent: musculoskeletal complaints, myalgia; Infrequent: muscle twitching

Nervous System Disorders- Frequent: coordination abnormal, dysgeusia, memory impairment, migraine, paraesthesia, tremor; Infrequent: amnesia, aphasia, hypoesthesia, speech disorder

Psychiatric Disorders- Frequent: agitation, confusional state, disorientation

Renal and Urinary Disorders- Frequent: micturition urgency; Infrequent: bladder pain, urinary incontinence

Respiratory, Thoracic and Mediastinal Disorders- Frequent: dyspnea

Skin and Subcutaneous Tissue Disorders- Frequent: night sweats; Infrequent: acne, hyperhidrosis, photosensitivity reaction

Vascular Disorders- Infrequent: flushing

Postmarketing Experience

Spontaneous reports regarding trazodone hydrochloride received from postmarketing experience include the following: abnormal dreams, agitation, alopecia, anxiety, aphasia, apnea, ataxia, breast enlargement or engorgement, cardiospasm, cerebrovascular accident, chills, cholestasis, clitorism, congestive heart failure, diplopia, edema, extrapyramidal symptoms, grand mal seizures, hallucinations, hemolytic anemia, hirsutism, hyperbilirubinemia, increased amylase, increased salivation, insomnia, leukocytosis, leukonychia, jaundice, lactation, liver enzyme alterations, methemoglobinemia, nausea/vomiting (most frequently), paresthesia, paranoid reaction, priapism [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION], pruritus, psoriasis, psychosis, rash, stupor, inappropriate ADH syndrome, tardive dyskinesia, unexplained death, urinary incontinence, urinary retention, urticaria, vasodilation, vertigo, and weakness.

Cardiovascular system effects which have been reported include the following: conduction block, orthostatic hypotension and syncope, palpitations, bradycardia, atrial fibrillation, myocardial infarction, cardiac arrest, arrhythmia, ventricular ectopic activity, including ventricular tachycardia and QT prolongation. In postmarketing surveillance, prolonged QT interval, Torsades de Pointes, and ventricular tachycardia have been reported with the immediate-release form of trazodone at doses of 100 mg per day or less [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Oleptro (Trazodone Hydrochloride Extended-Release Tablets)