Prescription Drug Information: Marplan (Page 4 of 4)

Other Events Observed During the Post - marketing Evaluation of Marplan

Isolated cases of akathisia, ataxia, black tongue, coma, dysuria, euphoria, hematologic changes, incontinence, neuritis, photosensitivity, sexual disturbances, spider telangiectases, and urinary retention have been reported. These side effects sometimes necessitate discontinuation of therapy. In rare instances, hallucinations have been reported with high dosages, but they have disappeared upon reduction of dosage or discontinuation of therapy. Toxic amblyopia was reported in one psychiatric patient who had received isocarboxazid for about a year; no causal relationship to isocarboxazid was established. Impaired water excretion compatible with the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) has been reported.

To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at

1-866-982-5438 (1-866-9VALIDUS) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG ABUSE AND DEPENDENCE

Controlled Substance Class

Marplan is not a controlled substance.

Physical and Psychological Dependence

Marplan has not been systematically studied in animals or humans for its potential for abuse, tolerance, or physical dependence. There have been reports of drug dependency in patients using doses of Marplan significantly in excess of the therapeutic range. Some of these patients had a history of previous substance abuse. The following withdrawal symptoms have been reported: restlessness, anxiety, depression, confusion, hallucinations, headache, weakness, and diarrhea. Consequently, physicians should carefully evaluate Marplan patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).

OVERDOSAGE

The lethal dose of Marplan in humans is not known. There has been one report of a fatality in a patient who ingested 400 mg of Marplan together with an unspecified amount of another drug. Symptoms: Major overdosage may be evidenced by tachycardia, hypotension, coma, convulsions, respiratory depression, sluggish reflexes, pyrexia, and diaphoresis; these signs may persist for 8 to 14 days. Treatment: General supportive measures should be used, along with immediate gastric lavage or emetics. If the latter are given, the danger of aspiration must be borne in mind. An adequate airway should be maintained, with supplemental oxygen if necessary. The mechanism by which amine-oxidase inhibitors produce hypotension is not fully understood, but there is evidence that these agents block the vascular bed response. Thus it is suggested that plasma may be of value in the management of this hypotension. Administration of pressor amines such as Levophed® (levarterenol bitartrate) may be of limited value (note that their effects may be potentiated by Marplan). Continue treatment for several days until homeostasis is restored. Liver function studies are recommended during the 4 to 6 weeks after recovery, as well as the time of overdosage.

In managing overdosage, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control center on the treatment of any overdose.

DOSAGE AND ADMINISTRATION

For maximum therapeutic effect, the dosage of Marplan must be individually adjusted on the basis of careful observation of the patient. Dosage should be started with one tablet (10 mg) of Marplan twice daily. If tolerated, dosage may be increased by increments of one tablet (10 mg) every 2 to 4 days to achieve a dosage of four tablets daily (40 mg) by the end of the first week of treatment. Dosage can then be increased by increments of up to 20 mg/week, if needed and tolerated, to a maximum recommended dosage of 60 mg/day. Daily dosage should be divided into two to four dosages. After maximum clinical response is achieved, an attempt should be made to reduce the dosage slowly over a period of several weeks without jeopardizing the therapeutic response. Beneficial effect may not be seen in some patients for 3 to 6 weeks. If no response is obtained by then, continued administration is unlikely to help.

Because of the limited experience with systematically monitored patients receiving Marplan at the higher end of the currently recommended dose range of up to 60 mg/day, caution is indicated in patients for whom a dose of 40 mg/day is exceeded (see ADVERSE REACTIONS).

HOW SUPPLIED

Marplan tablets 10 mg are peach colored, round and scored with “MARPLAN 10″ imprinted on one side and scored on the other. Supplied in bottles of 100 (NDC 30698-032-01).

Storage: Store at 77ºF (25ºC); excursions permitted to 59º to 86ºF (15º to 30ºC) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in USP.

R x O nly

Product of Canada

© 2018 Validus Pharmaceuticals LLC All rights reserved

60009-06 November 2018

Medication Guide

Marplan ® Tablets

(isocarboxazid)

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.
  • Tell your healthcare provider if you are pregnant or plan to become pregnant during treatment with Marplan.
    ○ If you become pregnant during treatment with Marplan, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-844-405-6185 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants

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

Manufactured for and Distributed by :
Validus Pharmaceuticals LLC
119 Cherry Hill Road, Suite 310

Parsippany, NJ 07054
info@validuspharma.com
www.validuspharma.com
1-866-982-5438 (1-866-9VALIDUS)

Product of Canada

© 2018 Validus Pharmaceuticals LLC All rights reserved

60143-01 November 2018

PRINCIPAL DISPLAY PANEL

NDC 30698-032-01
MARPLAN®
(isocarboxazid)
10 mg
100 TabletsRx Only

PRINCIPAL DISPLAY PANEL
NDC 30698-032-01
MARPLAN® 
(isocarboxazid) 
10 mg
100 Tablets
Rx Only
(click image for full-size original)
MARPLAN isocarboxazid tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:30698-032
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOCARBOXAZID (ISOCARBOXAZID) ISOCARBOXAZID 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE, UNSPECIFIED FORM
STARCH, CORN
POVIDONE
D&C RED NO. 27
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
Product Characteristics
Color ORANGE (peach) Score 2 pieces
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code MARPLAN;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:30698-032-01 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA011961 07/01/1959
Labeler — Validus Pharmaceuticals LLC (801194619)

Revised: 01/2020 Validus Pharmaceuticals LLC

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