Trazodone Full Prescribing Information

Bookmark and Share

Brand Name: Desyrel, Trazon, Trialodine
Generic Name: Trazodone

Desyrel (Trazodone) is an antidepressant used to treat depression. Usage, dosage, side effects of Desyrel.

outside U.S., Brand Names also known as: Beneficat; Bimaran; Deprax; Desirel; Manegan; Molipaxin; Pragmarel; Sideril; Taxagon; Thombran; Trazalon; Trazolan; Trazonil; Trittico

Description
Pharmacology
Indications and Usage
Contraindications
Warnings
Precautions
Drug Interactions
Adverse Reactions
Overdose
Dosage
Supplied

Desyrel patient information (in plain English)

Description

This medicine, Trazodone (Desyrel), is a modified cyclic antidepressant. Trazodone belongs to the group of medicines known as antidepressants or "mood elevators." It is used to treat mental depression and depression that sometimes occurs with anxiety.

Pharmacology

Trazodone's mechanism of action in humans is not clear.

In animals, trazodone HCl selectively inhibits serotonin uptake by brain synaptosomes and potentiates the behavioral changes induced by the serotonin precursor, 5-hydroxytryptophan.

Peak plasma levels occur approximately one hour after dosing when trazodone HCl is taken on an empty stomach or two hours after dosing when taken with food.

For those patients who responded to trazodone HCl in clinical trials, one-third of the inpatients and one-third of the outpatients had a significant therapeutic response by the end of the first week of treatment. Three-fourths of all responders demonstrated a significant therapeutic effect by the end of the second week. One-fourth of responders required 2-4 weeks for a significant therapeutic response.

Indications and Usage

advertisement

For relief of depression.

Contraindications

Trazodone is contraindicated in patients hypersensitive to trazodone.

top

Warnings

Trazodone has been associated with the occurrence of priapism. In approximately 1/3 of the cases reported, surgical intervention was required and, in a portion of these cases, permanent impairment of erectile function or impotence resulted. Male patients with prolonged or inappropriate erections should immediately discontinue the drug and consult their physician. If the condition persists for more than 24 hours, it would be advisable for the treating physician to consult a urologist or appropriate specialist in order to decide on a management approach.

Trazodone is not recommended for use during the initial recovery phase of myocardial infarction.

Caution should be used when administering trazodone to patients with cardiac disease, and such patients should be closely monitored, since antidepressant drugs (including trazodone) have been associated with the occurrence of cardiac arrhythmias.

Precautions

The possibility of suicide in seriously depressed patients is inherent in the illness and may persist until significant remission occurs. Therefore, prescriptions should be written for the smallest number of tablets consistent with good patient management.

Hypotension, including orthostatic hypotension and syncope, has been reported to occur in patients receiving trazodone. Concomitant administration of antihypertensive therapy with trazodone may require a reduction in the dose of the antihypertensive drug.

Little is known about the interaction between trazodone and general anesthetics; therefore, prior to elective surgery, trazodone should be discontinued for as long as clinically feasible.

As with all antidepressants, the use of trazodone should be based on the consideration of the physician that the expected benefits of therapy outweigh potential risk factors.

Trazodone should be given shortly after a meal or light snack. Within any individual patient, total drug absorption may be up to 20% higher when the drug is taken with food rather than on an empty stomach. The risk of dizziness/lightheadedness may increase under fasting conditions.

Do not stop taking this medicine without checking with your doctor.

Pregnancy & Nursing: There are no adequate and well-controlled studies in pregnant women. Trazodone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Trazodone and/or its metabolites have been found in the milk of lactating rats, suggesting that the drug may be secreted in human milk. Caution should be exercised when trazodone is administered to a nursing woman.

Interference with Cognitive or Motor Performance: Trazodone may cause drowsiness, dizziness, or lightheadedness. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to this medicine.

top

Drug Interactions

Trazodone may enhance the response to alcohol, barbiturates, and other CNS depressants.

Increased serum digoxin and phenytoin levels have been reported to occur in patients receiving trazodone concurrently with either of those 2 drugs. Little is known about the interaction between trazodone and general anesthetics; therefore, prior to elective surgery, trazodone should be discontinued for as long as clinically feasible.

It is not known whether interactions will occur between monoamine oxidase (MAO) inhibitors and trazodone. Due to the absence of clinical experience, if MAO inhibitors are discontinued shortly before or are to be given concomitantly with trazodone, therapy should be initiated cautiously with gradual increase in dosage until optimum response is achieved.

Trazodone may cause hypotension including orthostatic hypotension and syncope; caution is required if it is given to patients receiving antihypertensive drugs and an adjustment in the dose of the antihypertensive medication may be required.

Trazodone may enhance the response to alcohol, barbiturates, and other CNS depressants.

BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding.

top

Adverse Reactions

The most common adverse reactions encountered are drowsiness, nausea/vomiting, headache and dry mouth.

For temporary relief of dry mouth, use sugarless gum or candy, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your physician or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungal infections.

Adverse reactions reported include the following:

drowsiness, dizziness, headache, or nausea. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience lightheadedness, fainting, blood in urine, shortness of breath, vomiting, irregular heartbeat, or in males prolonged, inappropriate, or painful erection. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

In addition to the relatively common side effects, the following adverse events have been reported to occur in association with the use of trazodone in the controlled clinical studies: akathisia, allergic reaction, anemia, chest pain, delayed urine flow, early menses, flatulence, hallucinations/delusions, hematuria, hypersalivation, hypomania, impaired speech, impotence, increased appetite, increased libido, increased urinary frequency, missed periods, muscle twitches, numbness, and retrograde ejaculation.

Other side effects have been reported: agitation, alopecia, apnea, ataxia, breast enlargement, diplopia, edema, extrapyramidal symptoms, grand mal seizures, hallucinations, hemolytic anemia, hyperbilirubinemia, leukonychia, jaundice, lactation, liver enzyme alterations, methemoglobinemia, nausea/vomiting (most frequently), paresthesia, priapism, pruritus, 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, and ventricular ectopic activity, including ventricular tachycardia.

top

Overdose

Signs and Symptoms

Death from overdose has occurred in patients ingesting trazodone and other drugs concurrently (namely, alcohol; alcohol + chloral hydrate + 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 EKG changes. 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.

Symptoms of overdose may include slow, rapid or irregular pulse; unusual drowsiness or dizziness; vomiting; weakness; loss of consciousness; and seizures.

top

Treatment

If you or someone you know may have used more than the recommended dose of this medicine, contact your local poison control center or emergency room immediately.

There is no specific antidote for trazodone. Treatment should be symptomatic and supportive in the case of hypotension or excessive sedation. Any patient suspected of having taken an overdose should have the stomach emptied by gastric lavage. Forced diuresis may be useful in facilitating elimination of the drug.

Dosage

1-4 weeks may pass before you feel the full effect of this medicine. Do not stop taking this medicine without checking with your doctor.Do not exceed the recommended dosage or take this medicine for longer than prescribed.

Continue to take this medicine even if you feel better. Do not miss any doses.

Follow the directions for using this medicine provided by your doctor.

Store this medicine at room temperature, in a tightly-closed container, away from heat and light.

Take this medicine with food.

If you miss a dose of this medicine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Additional Information: Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.

IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out.

The dosage should be initiated at a low level 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.

Trazodone should be given shortly after a meal or light snack. Within any individual patient, total drug absorption may be up to 20% higher when the drug is taken with food rather than on an empty stomach. The risk of dizziness/lightheadedness may increase under fasting conditions.

Symptomatic relief may be seen during the first week, with optimal antidepressant effects typically evident within two weeks. Twenty-five percent of those who respond to trazodone require more than two weeks (up to four weeks) of drug administration.

Usual Adult Dosage: 25 to 100 mg. An initial dose of 150 mg/day in divided doses is suggested. The dose may be increased by 50 mg/day every three to four days. The maximum dose for out patients 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.

Usage in Elderly: Oral, to start, 25 milligrams per dose taken three times a day. Your doctor may increase your dose if needed, with adjustments made depending on tolerance and response.

Children: Safety and effectiveness in children below the age of 18 have not been established.

top

How Supplied

Desyrel: Scored tablets are available in: Trazodone hydrochloride 50 mg, 100 mg, and 150 mg

Desyrel Dividose: Each orange rectangular-shaped, trisected and bisected tablet contains: Trazodone hydrochloride 150 mg. Each tablet can be broken accurately to provide any of the following dosages: 50 mg (1/3 tablet), 75 mg (1/2 of a tablet), 100 mg (2/3 of a tablet), 150 mg (entire tablet). To break a Dividose tablet accurately and easily, hold the tablet between your thumbs and index fingers, close to the appropriate score (groove). Then with the tablet score facing you, apply pressure and snap the tablet segments apart. Bottles of 100.

back to top

Desyrel (Trazodone) Patient Information Sheet (in plain English)

Detailed Info on Signs, Symptoms, Causes, Treatments of Depression


The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.

Copyright© 2007 Healthyplace Inc. All rights reserved.

back to: Psychiatric Medications Pharmacology Homepage