Suicidality and Antidepressant Drugs
id: d6bb08c1-ac95-49f2-9d22-be20f38bb6b9
displayName: Boxed Warning section
FDA Article Code: 34066-1
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of trazodone HCl or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Trazodone HCl is not approved for use in pediatric patients. (See WARNINGS, Clinical Worsening and Suicide Risk, PRECAUTIONS, Information for Patients, and PRECAUTIONS, Pediatric Use
DESCRIPTION
id: 614d4ccd-9e4c-4f20-990d-0d60c0ca2245
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Trazodone Hydrochloride Tablets USP is an antidepressant chemically unrelated to tricyclic, tetracyclic, or other known antidepressant agents. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1, 2, 4-triazolo[4, 3-a]-pyridin-3(2H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows:
Each tablet, for oral administration, contains 50 mg, 100 mg or 150 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
CLINICAL PHARMACOLOGY
id: f4f716f7-659e-4ffb-b831-c6968fc65fae
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
The mechanism of trazodone hydrochloride’s antidepressant action in man is not fully understood. In animals, trazodone selectively inhibits its serotonin uptake by brain synaptosomes and potentiates the behavioral changes induced by the serotonin precursor, 5-hydroxytryptophan. Cardiac conduction effects of trazodone in the anesthetized dog are qualitatively dissimilar and quantitatively less pronounced than those seen with tricyclic antidepressants. Trazodone is not a monoamine oxidase inhibitor and, unlike amphetamine-type drugs, does not stimulate the central nervous system.
INDICATIONS AND USAGE
id: 30665b51-d86e-4b91-9a8a-f9eaf3663aa3
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Trazodone Hydrochloride Tablets USP are indicated for the treatment of depression. The efficacy of Trazodone Hydrochloride Tablets USP has been demonstrated in both inpatient and outpatient settings and for depressed patients with and without prominent anxiety. The depressive illness of patients studied corresponds to the Major Depressive Episode criteria of the American Psychiatric Association’s Diagnostic and Statistical Manual, lll.a
Major Depressive Episode implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.
CONTRAINDICATIONS
id: a9c58836-5ed2-4129-9f0c-133853cc2e20
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Trazodone hydrochloride tablets are contraindicated in patients hypersensitive to trazodone hydrochloride.
ADVERSE REACTIONS
id: e4fecbde-eb35-4c10-a20d-532fa3d99638
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Because the frequency of adverse drug effects is affected by diverse factors (e.g., drug dose, method of detection, physician judgment, disease under treatment, etc.) a single meaningful estimate of adverse event incidence is difficult to obtain. This problem is illustrated by the variation in adverse event incidence observed and reported from the inpatients and outpatients treated with trazodone hydrochloride. It is impossible to determine precisely what accounts for the differences observed.
DOSAGE AND ADMINISTRATION
id: 07641b4e-2a31-495d-8b91-2fac0d5f8111
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
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 Hydrochloride Tablets USP should be taken shortly after a meal or light snack. 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 Hydrochloride Tablets USP require more than two weeks (up to four weeks) of drug administration.
HOW SUPPLIED
id: 81ad30e9-9242-4693-9196-62b77eb42f24
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Trazodone Hydrochloride Tablets USP:
50 mg – White, round, scored, compressed tablets. Imprinted PLIVA 433
Available in bottles of 100, 500 and 1000 Tablets.
100 mg – White, round, scored, compressed tablets. Imprinted PLIVA 434
Available in bottles of 100, 500 and 1000 Tablets.
150 mg – White, trapezoid, bisected on one side, trisected on the other side. Imprinted PLIVA 441 on one side and 50 in each triangular segment on the other side.
Available in bottles of 100 and 500 Tablets.
Directions for using the correct score when breaking the tablet please refer to the following:
-For 50 mg, break the score on either the left or right side of the tablet (one-third of a tablet).
-For 75 mg, break the score down the middle of the tablet (one-half of a tablet).
-For 100 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet).
-For 150 mg, use the entire tablet.
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
REFERENCES
id: c4ae8192-da54-4990-85ff-f110dc130b0f
displayName: REFERENCES SECTION
FDA Article Code: 34093-5
(a) Williams JBW, Ed: Diagnostic and Statistical Manual of Mental Disorders-III, American Psychiatric Association, May 1980. (b) Lue TF, Physiology of erection and pathophysiology of impotence. In: Wash PC, Retik AB, Stamey TA, Vaughan ED, eds. Campbell’s Urology. Sixth edition. Philadelphia: W.B. Saunders: 1992: 722-725. (c) Goldstein I, Krane RJ, Diagnosis and therapy of erectile dysfunction. In: Wash PC, Retik AB, Stamey TA, Vaughan ED, eds. Campbell’s Urology. Sixth edition. Philadelphia: W.B. Saunders: 1992: 3071-3072. (d) Yealy DM, Hogya PT: Priapism. Emerg Med Clin North Am, 1988: 6:509-520. (e) Banos JE, Bosch F, Farre M. Drug-induced priapism. Its aetiology, incidence and treatment. Med Toxicol Adverse Drug Exp. 1989: 4:46-58. (f) O’Brien WM, O’Connor KP, Lynch JH. Priapism: current concepts. Ann Emerg Med. 1989: 980-983. (g) Bardin ED, Krieger JN. Pharmacological priapism: comparison of trazodone- and papaverine-associated cases. Int Urol Nephrol. 1990: 22:147-152.
Manufactured In Croatia By:
PLIVA HRVATSKA d.o.o.
Zagreb, Croatia
Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Iss. 2/2010
FLEXIDOSE® is a registered trademark of PLIVA®, Inc. for its tablets. The trapezoidal shaped tablet is a trademark and original design of PLIVA® Inc.
Medication Guide
id: 5e7510f0-b423-4a72-80e7-603ba3c1761f
displayName: SPL MEDGUIDE SECTION
FDA Article Code: 42231-1
Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions
Read the Medication Guide that comes with your or your family member’s antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member’s, healthcare provider about:
• all risks and benefits of treatment with antidepressant medicines
• all treatment choices for depression or other serious mental illness
What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?
1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
• Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
• Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
• Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.
Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:
- thoughts about suicide or dying
- attempts to commit suicide
- new or worse depression
- new or worse anxiety
- feeling very agitated or restless
- panic attacks
- trouble sleeping (insomnia)
- new or worse irritability
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- other unusual changes in behavior or mood
What else do I need to know about antidepressant medicines?
• Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
• Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
• Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
• Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
• Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.
Manufactured In Croatia By:
PLIVA HRVATSKA d.o.o.
Zagreb, Croatia
Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. E 5/2008
11001630
