Phenelzine Sulfate (Page 4 of 4)

DOSAGE AND ADMINISTRATION

Initial dose

The usual starting dose of Phenelzine Sulfate Tablets is one tablet (15 mg) three times a day.

Early phase treatment

Dosage should be increased to at least 60 mg per day at a fairly rapid pace consistent with patient tolerance. It may be necessary to increase dosage up to 90 mg per day to obtain sufficient MAO inhibition. Many patients do not show a clinical response until treatment at 60 mg has been continued for at least 4 weeks.

Maintenance dose

After maximum benefit from Phenelzine Sulfate Tablets is achieved, dosage should be reduced slowly over several weeks. Maintenance dose may be as low as one tablet, 15 mg, a day or every other day, and should be continued for as long as is required.

OVERDOSAGE

Note— For management of hypertensive crises see WARNINGS section.

Accidental or intentional overdosage may be more common in patients who are depressed. It should be remembered that multiple drugs and/or alcohol may have been ingested.

Depending on the amount of overdosage with Phenelzine Sulfate Tablets, a varying and mixed clinical picture may develop, including signs and symptoms of central nervous system and cardiovascular stimulation and/or depression. Signs and symptoms may be absent or minimal during the initial 12-hour period following ingestion and may develop slowly thereafter, reaching a maximum in 24–48 hours. Death has been reported following overdosage. Therefore, immediate hospitalization, with continuous patient observation and monitoring throughout this period, is essential.

Signs and symptoms of overdosage may include, alone or in combination, any of the following: drowsiness, dizziness, faintness, irritability, hyperactivity, agitation, severe headache, hallucinations, trismus, opisthotonus, rigidity, convulsions, and coma; rapid and irregular pulse, hypertension, hypotension, and vascular collapse; precordial pain, respiratory depression and failure, hyperpyrexia, diaphoresis, and cool, clammy skin.

Treatment

Respiration should be supported by appropriate measures, including management of the airway, use of supplemental oxygen, and mechanical ventilatory assistance, as required.

Body temperature should be monitored closely. Intensive management of hyperpyrexia may be required. Maintenance of fluid and electrolyte balance is essential.

There are no data on the lethal dose in man. The pathophysiologic effects of massive overdosage may persist for several days, since the drug acts by inhibiting physiologic enzyme systems. With symptomatic and supportive measures, recovery from mild overdosage may be expected within 3 to 4 days.

Hemodialysis, peritoneal dialysis, and charcoal hemoperfusion may be of value in massive overdosage, but sufficient data are not available to recommend their routine use in these cases.

Toxic blood levels of phenelzine have not been established, and assay methods are not practical for clinical or toxicological use.

HOW SUPPLIED

Each Phenelzine Sulfate Tablets is orange, biconvex, film-coated tablets, debossed with “NL” on one side and “360” on the other side. Contains phenelzine sulfate equivalent to 15 mg of phenelzine base.

NDC 60429-348-60 Bottle of 60

Storage and Handling

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

Preserve in tight containers, protected from heat and light.

Rx only

Manufactured by:

Novel Laboratories Inc,

Somerset, NJ-08873

Distributed by:

GAVIS Pharmaceuticals, LLC

Somerset, NJ-08873

Marketed/Packaged by:

GSMS, Inc.

Camarillo, CA 93012

GIN-360-00

Rev: 12/2010

Medguide

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
  • an extreme increase in activity and talking (mania)
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • 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

Medication Guide revised on May 2007

This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

Manufactured by:

Novel Laboratories Inc,

Somerset, NJ-08873

Distributed by:

GAVIS Pharmaceuticals, LLC

Somerset, NJ-08873

Marketed/Packaged by:

GSMS, Inc.

Camarillo, CA 93012

GIN-360-00

Rev: 12/2010

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Graphic -- 15mg 60s
(click image for full-size original)
PHENELZINE SULFATE
phenelzine sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-348(NDC:43386-360)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENELZINE SULFATE (PHENELZINE) PHENELZINE 15 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
SILICON DIOXIDE
POVIDONES
EDETATE DISODIUM
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
POLYETHYLENE GLYCOL 3350
FD&C YELLOW NO. 6
TALC
TITANIUM DIOXIDE
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 261mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-348-60 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200181 12/14/2010
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 REPACK (60429-348), RELABEL (60429-348)

Revised: 07/2011 Golden State Medical Supply, Inc.

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