Dosing and uses of Oleptro, Trazodone D (trazodone)
Adult dosage forms and strengths
tablet
- 50mg
- 100mg
- 150mg
- 300mg
tablet, extended-release
- 150mg
- 300mg
Depression
Initial 150 mg/day PO divided q8-12hr
Increase by 50 mg/day q3-7Days
Outpatient: No more than 400 mg/day
Inpatient: No more than 600 mg/day
Oleptro (extended-release)
- 150 mg PO HS initially; may increase by increments of 75 mg/day q3Days; not to exceed 375 mg/day
- Swallow whole or may break in half along scored line; do not chew or crush
Insomnia (Off-label)
50-100 mg PO qDay
Aggressive Behavior (Off-label)
Initial: 50 mg PO q12hr
Maintenance: 75-400 mg/day divided PO q6-12hr
Cocaine Withdrawal (Off-label)
150-200 mg PO qDay
Alcohol Withdrawal (Off-label)
100-600 mg/day divided PO
Insomnia (Off-label)
25-100 mg PO qHs
Prevention of Migraine (Off-label)
100 mg PO qDay
Dose considerations
MAO inhibitors: Do not administer trazodone within 14 days of administering a MAO inhibitor when treating a psychiatric disorder
Coadministration with MAO inhibitors linezolid or IV methylene blue: Trazodone not recommended in patients actively receiving linezolid or IV methylene blue; consider other interventions if treating psychiatric condition; if coadministration necessary, because benefits outweigh risks, monitor for serotonin syndrome for 2 weeks or until 24 hr after last dose of linezolid or IV methylene blue, whichever comes first; may resume trazodone 24 hr after last dose of linezolid or IV methylene blue
Administration
Take with food
Pediatric dosage forms and strengths
tablet
- 50mg
- 100mg
- 150mg
- 300mg
tablet, extended-release
- 150mg
- 300mg
Depression (Off-label)
< 6 years: Safety and efficacy not established
6-12 years: 1.5-2 mg/kg/day PO in divided doses initially; not to exceed 6 mg/kg/day divded q8hr
> 12 years: 25-50 mg/day PO; increase by 100-150 mg in divided doses
See Black Box Warning
Administration
Take with food
Geriatric dosage forms and strengths
Depression
Immediate release: 25-50 mgPO qHS; increase dose by 25-50 mg every three days if inpatient or every week if oupatient not to exceed 75-150 mg/day
Extended release: Experience limited; use 150 mg PO HS initially; may increase by increments of 75 mg/day q3Days; not to exceed 375 mg/day
Oleptro, Trazodone D (trazodone) adverse (side) effects
>10%
Blurred vision (5-15%)
Dizziness (20-28%)
Drowsiness (24-40%)
Dry mouth (15-34%)
Fatigue (6-15%)
Headache (10-33%)
Nausea/vomiting (10-21%)
1-10%
Constipation (7-8%)
Edema (3-7%)
Confusion (5-6%)
Disorientation (<2%)
Incoordination (2-5%)
Nasal congestion (3-6%)
Orthostatic hypotension (<7%)
Syncope (<5%)
Tremor (1-5%)
Weight change (5%)
Ejaculation disorder (2%)
Decreased libido (1-2%)
<1%
Priapism
Sedation
Alopecia
Anxiety
Acne
Anemia
Increased apetite
Diplopia
Insomnia
Urinary retention
Vertigo
Warnings
Black box warnings
In short-term studies, antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults (<24 yr of age) taking antidepressants for major depressive disorders and other psychiatric illnesses
This increase was not seen in patients aged >24 years; a slight decrease in suicidal thinking was seen in adults >65 years
In children and young adults, risks must be weighed against the benefits of taking antidepressants
Patients should be monitored closely for changes in behavior, clinical worsening, and suicidal tendencies; this should be done during initial 1-2 months of therapy and dosage adjustments
The patient’s family should communicate any abrupt changes in behavior to the healthcare provider
Worsening behavior and suicidal tendencies that are not part of the presenting symptoms may require discontinuation of therapy
This drug is not FDA approved for use in pediatric patients or for treatment of bipolar depression
Contraindications
Hypersensitivity
Coadministration with serotonergic drugs
- Risk of serotonin syndrome when coadministered within 14 days of MAOIs, or coadministered with other strong serotonergic drugs (eg, SNRIs, SSRIs)
- Starting trazodone in a patient who is being treated with linezolid or IV methylene blue is contraindicated because of an increased risk of serotonin syndrome
- If linezolid or IV methylene blue must be administered, discontinue trazodone immediately and monitor for CNS toxicity; may resume clomipramine 24 hr after last linezolid or methylene blue dose or after 2 weeks of monitoring, whichever comes first
Cautions
Administer shortly after meal; if drowsiness occurs, decrease dosage or give most of divided dosage Hs
Discontinue if prolonged or inappropriate erection occurs
Discontinue if neutropenia, leukopenia
Use caution in patients with risk of seizures
Clinical worsening and suicide ideation may occur despite medication in adolescents and young adults (18-24 years)
Perform leukocyte and differential with fever, sore throat, or other signs of infection
Discontinue if leukocytes/ANC decreases below normal range
Coadministration with MAO inhibitors: risk of serotonin syndrome
Drugs that interfere with serotonin reuptake have been associated with bleeding; trazodone may also impair platelet aggregation resulting in increased risk of bleeding events
Potentially life-threatening serotonin syndrome reported when coadministered with drugs that impair serotonin metabolism (in particular, MAOIs, including nonpsychiatric MAOIs, such as linezolid and IV methylene blue) (see Contraindications)
Coadministration with NSAIDs and aspirin, may increase risk of bleeding
Bone fractures associated with antidepressant treatments
Increases risk of hyponatremia
Use caution in patients with risk of seizures including head trauma, alcoholism, brain damage
May worsen psychosis in patients or precipitate mania or hypomania; screen, for bipolar disorder, patients presenting with depressive symptoms
May cause orthostatic hypotension and syncope; use wiht caution
QT prolongation with or without torsade de pointes and ventricular tachycardia reported
May increase risk associated with electroconvulsive therapy (ECT); discontinue ECT before initiating trazodone therapy
Risk of mydriasis; may trigger angle closure attack in patients with angle closure glaucoma with anatomically narrow angles without a patent iridectomy
Pregnancy and lactation
Pregnancy category: C
Lactation: excreted into milk; use caution (AAP states effect on nursing infants is unknown but may be of concern)
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Oleptro, Trazodone D (trazodone)
Mechanism of action
Antidepressant structurally unrelated to SSRIs, tricyclics, tetracyclics or MAOIs, but also inhibits neuronal uptake of serotonin (but not NE); it is a histamine and alpha1-adrenergic receptor antagonist; causes adrenoceptor subsensitivity
Absorption
Almost completely absorbed (increased by food)
Onset: 6 weeks (antidepressant); 1-3 hr sleep aid
Peak serum time: 30-100 min (up to 2.5 hr if taken with food); 9 hr (extended release)
Concentration: 480-1620 ng/mL (dose-dependent)
Distribution
Protein bound: 85-95%
Metabolism
Metabolism: hepatic P450 enzyme CYP2D6
Metabolites: l-m-chlorophenylpiperazine
Elimination
Half-life: 7-10 hr
Excretion: Urine (75%); feces (25%)
Dialyzable: No
