Minds On Meds

Mental Health Medications

Antidepressants

Trazodone Hydrochloride, Page 3

Trazodone hydrochloride tablets are indicated for the treatment of depression. The efficacy of trazodone has been demonstrated in both inpatient and outpatient settings and for depressed patients with and without prominent anxiety.

OVERDOSAGE

Animal Oral LD50

The oral LD50 of the drug is 610 mg/kg in mice, 486 mg/kg in rats, and 560 mg/kg in rabbits.

Signs and Symptoms

Death from overdose has occurred in patients ingesting trazodone hydrochloride 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 (see ADVERSE REACTIONS).

Treatment

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 AND ADMINISTRATION

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 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 require more than two weeks (up to four weeks) of drug administration.

Usual Adult Dosage

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 outpatients 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.

Maintenance

Dosage during prolonged maintenance therapy should be kept at the lowest effective level. Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response.

Although there has been no systematic evaluation of the efficacy of trazodone beyond six weeks, it is generally recommended that a course of antidepressant drug treatment should be continued for several months.

HOW SUPPLIED

Trazodone Hydrochloride Tablets USP, 50 mg are white, film-coated, round, convex, scored tablets, debossed “61” bisect “60” on one side and debossed “V” on the reverse side. They are available in bottles of 100, 500 and 1000.

Trazodone Hydrochloride Tablets USP, 100 mg are white, film-coated, round, convex, scored tablets, debossed “61” bisect “61” on one side and debossed “V” on the reverse side. They are available in bottles of 100, 500 and 1000.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP.

REFERENCES

  1. Williams JBW, Ed: Diagnostic and Statistical Manual of Mental Disorders III, American Psychiatric Association, May, 1980.
  2. Lue TF: Physiology of erection and pathophysiology of impotence. In: Wash PC, Retik AB, Stamev TA, Vaughan ED, eds, Campbell’s Urology, Sixth edition. Philadelphia: W.B. Saunders; 1992:722–725.
  3. Goldstein I, Krane RJ: Diagnosis and therapy of erectile dysfunction. In: Wash PC, Retik AB, Stamev TA, Vaughan ED, eds, Campbell’s Urology. Sixth edition. Philadelphia: W.B. Saunders; 1992:3071–3072.
  4. Yealy DM, Hogya PT: Priapism. Emerg Med Clin North Am. 1988;6:509–520.
  5. Banos JE, Bosch F, Farre M: Drug-Induced priapism: Its aetiology, incidence and treatment. Med Toxicol Adverse Drug Exp. 1989;4:46–58.
  6. O’Brien WM, O’Connor KP, Lynch JH: Priapism, current concepts. Ann Emerg Med. 1989:980–983.
  7. Bardin ED, Krieger JN: Pharmacological priapism: comparison of trazodone- and papaverine-associated cases. Int Urol Nephrol. 1990;22:147–152.

Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811

8183136
R12/09-R0

MEDICATION GUIDE

Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions

Read the Medication Guide that comes with you 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 for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811

8181699
R4/09-R5

PRINCIPAL DISPLAY PANEL

This is an image of the label for 50 mg Trazodone Hydrochloride Tablets.
(click image for full-size original)

PRINCIPAL DISLPAY PANEL

This is an image of the label for 100 mg Trazodone Hydrochloride Tablets.
(click image for full-size original)
TRAZODONE HYDROCHLORIDE
trazodone hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-6160
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRAZODONE HYDROCHLORIDE (TRAZODONE) TRAZODONE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYDEXTROSE
POLYETHYLENE GLYCOL
POVIDONE
STARCH, CORN
SILICON DIOXIDE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND (convex) Size 9mm
Flavor Imprint Code 61;60;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0603-6160-21 100 TABLET, FILM COATED (100 TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:0603-6160-32 1000 TABLET, FILM COATED (1000 TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:0603-6160-28 500 TABLET, FILM COATED (500 TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072192 05/30/2010
TRAZODONE HYDROCHLORIDE
trazodone hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-6161
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRAZODONE HYDROCHLORIDE (TRAZODONE) TRAZODONE HYDROCHLORIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYDEXTROSE
POLYETHYLENE GLYCOL
POVIDONE
STARCH, CORN
SILICON DIOXIDE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND (convex) Size 11mm
Flavor Imprint Code 61;61;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0603-6161-21 100 TABLET, FILM COATED (100 TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:0603-6161-32 1000 TABLET, FILM COATED (1000 TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:0603-6161-28 500 TABLET, FILM COATED (500 TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072193 05/30/2010
Labeler — Qualitest Pharmaceuticals (011103059)
Establishment
Name Address ID/FEI Operations
Vintage Pharmaceuticals-Huntsville 825839835 MANUFACTURE

Revised: 05/2011 Qualitest Pharmaceuticals