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Medications: Desyrel ® – trazodone

MEDICATIONS

Desyrel® – trazodone (View the FDA label)

Discontinued

INDICATION AND USES:

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

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).
  • DESYREL 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).

SIDE EFFECTS:

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

CONTRAINDICATIONS:

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

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

DRUG INTERACTIONS:

  • CNS Depressants: DESYREL may enhance effects of alcohol, barbiturates, or other CNS depressants (7).
  • CYP3A4 Inhibitors: Consider DESYREL dose reduction based on tolerability (2.5, 7).
  • CYP3A4 Inducers: Increase in DESYREL 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).

OVERDOSE:

Death from overdose has occurred in patients ingesting DESYREL 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 DESYREL 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).

Uses

INDICATION AND USES:

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

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).
  • DESYREL 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).
Side Effects

SIDE EFFECTS:

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

Precautions

CONTRAINDICATIONS:

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

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

DRUG INTERACTIONS:

  • CNS Depressants: DESYREL may enhance effects of alcohol, barbiturates, or other CNS depressants (7).
  • CYP3A4 Inhibitors: Consider DESYREL dose reduction based on tolerability (2.5, 7).
  • CYP3A4 Inducers: Increase in DESYREL 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).
Overdose

OVERDOSE:

Death from overdose has occurred in patients ingesting DESYREL 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 DESYREL 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).

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