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Medications: Desyrel ® – trazodone

MEDICATIONS

Desyrel® – trazodone (View the FDA label)

Oleptro is indicated for the treatment of major depressive disorder (1).

Efficacy was established in one 8-week trial of Oleptro as well as in trials of trazodone immediate release formulation in patients with major depressive disorder (14).

DOSAGE AND ADMINISTRATION

Starting dose: 150 mg once daily. May be increased by 75 mg per day every three days. Maximum dose: 375 mg per day (2).

Dosing at the same time every day in the late evening, preferably at bedtime, on an empty stomach (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).

Most common adverse reactions (incidence ≥5% and twice that of placebo) are: somnolence/sedation, dizziness, constipation, vision blurred (6).

Clinical Worsening/Suicide Risk: Monitor for clinical worsening and suicidal thinking and behavior (5.1).

Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including Oleptro, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone and St. John’s Wort). If such symptoms occur, discontinue Oleptro and initiate supportive treatment. If concomitant use of Oleptro with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.

Activation of Mania/Hypomania: Screen for bipolar disorder and monitor for mania/hypomania (5.3).

QT Prolongation: Increases the QT interval. Avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval (5.4).

Use in Patients with Heart Disease: Use with caution in patients with cardiac disease (5.5).

Orthostatic Hypotension and Syncope: Have occurred. Warn patients of risk and symptoms of hypotension (5.6).

Abnormal Bleeding: May increase the risk of bleeding. Use with NSAIDs, aspirin, or other drugs that affect coagulation may compound this risk (5.7).

Interaction with MAOIs: Do not use concomitantly or within 14 days of monoamine oxidase inhibitors (5.8).

Priapism: Has occurred. Warn male patients of this risk and how/when to seek medical attention (5.9).

Hyponatremia: Can occur in association with SIADH (5.10).

Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills. Advise patients to use caution when operating machinery (5.11).

Discontinuation Symptoms: May occur with abrupt discontinuation and include anxiety and sleep disturbance. Upon discontinuation, taper Oleptro and monitor for symptoms (5.12).

  • Monoamine Oxidase Inhibitors: Should not be used concomitantly with Oleptro (5.8, 7).
  • CNS Depressants: Trazodone may enhance effects of alcohol, barbiturates, or other CNS depressants (7).
  • CYP3A4 Inhibitors: May necessitate lower dose of Oleptro (7).
  • CYP3A4 Inducers (e.g., carbamazepine): May necessitate higher dose of Oleptro (7).
  • Digoxin or Phenytoin: Monitor for increased serum levels (7).
  • Warfarin: Monitor for increased or decreased prothrombin time (7).
  • Serotonergic Medications: Serotonin syndrome has been reported (5.2, 7).
  • NSAIDs, Aspirin or other Anticoagulants: Potential for increased risk of bleeding (5.7, 7).

Human Experience
It is expected that the health risks associated with overdose of Oleptro are most likely similar to those for trazodone immediate-release formulations.

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.

Management of Overdose
There is no specific antidote for Oleptro overdose.

Treatment should consist of those general measures employed in the management of overdosage with any drug effective in the treatment of major depressive disorder.

Ensure an adequate airway, oxygenation and ventilation. Monitor cardiac rhythm and vital signs.

General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended. Gastric lavage with a large bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion, or in symptomatic patients. Activated charcoal should be administered. Forced diuresis may be useful in facilitating elimination of the drug.

In managing overdosage, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control center for additional information on the treatment of any overdose.

Uses

Oleptro is indicated for the treatment of major depressive disorder (1).

Efficacy was established in one 8-week trial of Oleptro as well as in trials of trazodone immediate release formulation in patients with major depressive disorder (14).

DOSAGE AND ADMINISTRATION

Starting dose: 150 mg once daily. May be increased by 75 mg per day every three days. Maximum dose: 375 mg per day (2).

Dosing at the same time every day in the late evening, preferably at bedtime, on an empty stomach (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).

Side Effects

Most common adverse reactions (incidence ≥5% and twice that of placebo) are: somnolence/sedation, dizziness, constipation, vision blurred (6).

Precautions

Clinical Worsening/Suicide Risk: Monitor for clinical worsening and suicidal thinking and behavior (5.1).

Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including Oleptro, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone and St. John’s Wort). If such symptoms occur, discontinue Oleptro and initiate supportive treatment. If concomitant use of Oleptro with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.

Activation of Mania/Hypomania: Screen for bipolar disorder and monitor for mania/hypomania (5.3).

QT Prolongation: Increases the QT interval. Avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval (5.4).

Use in Patients with Heart Disease: Use with caution in patients with cardiac disease (5.5).

Orthostatic Hypotension and Syncope: Have occurred. Warn patients of risk and symptoms of hypotension (5.6).

Abnormal Bleeding: May increase the risk of bleeding. Use with NSAIDs, aspirin, or other drugs that affect coagulation may compound this risk (5.7).

Interaction with MAOIs: Do not use concomitantly or within 14 days of monoamine oxidase inhibitors (5.8).

Priapism: Has occurred. Warn male patients of this risk and how/when to seek medical attention (5.9).

Hyponatremia: Can occur in association with SIADH (5.10).

Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills. Advise patients to use caution when operating machinery (5.11).

Discontinuation Symptoms: May occur with abrupt discontinuation and include anxiety and sleep disturbance. Upon discontinuation, taper Oleptro and monitor for symptoms (5.12).

Interactions
  • Monoamine Oxidase Inhibitors: Should not be used concomitantly with Oleptro (5.8, 7).
  • CNS Depressants: Trazodone may enhance effects of alcohol, barbiturates, or other CNS depressants (7).
  • CYP3A4 Inhibitors: May necessitate lower dose of Oleptro (7).
  • CYP3A4 Inducers (e.g., carbamazepine): May necessitate higher dose of Oleptro (7).
  • Digoxin or Phenytoin: Monitor for increased serum levels (7).
  • Warfarin: Monitor for increased or decreased prothrombin time (7).
  • Serotonergic Medications: Serotonin syndrome has been reported (5.2, 7).
  • NSAIDs, Aspirin or other Anticoagulants: Potential for increased risk of bleeding (5.7, 7).
Overdose

Human Experience
It is expected that the health risks associated with overdose of Oleptro are most likely similar to those for trazodone immediate-release formulations.

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.

Management of Overdose
There is no specific antidote for Oleptro overdose.

Treatment should consist of those general measures employed in the management of overdosage with any drug effective in the treatment of major depressive disorder.

Ensure an adequate airway, oxygenation and ventilation. Monitor cardiac rhythm and vital signs.

General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended. Gastric lavage with a large bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion, or in symptomatic patients. Activated charcoal should be administered. Forced diuresis may be useful in facilitating elimination of the drug.

In managing overdosage, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control center for additional information on the treatment of any overdose.

Interpreting the GeneSight® Test:
Gene-Drug Interaction Chart

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