NOTICE TO PATIENTS AND HEALTH CARE PROFESSIONALS: Validus is no longer manufacturing or distributing this product. This website is maintained solely for reference purposes. Patients — Validus recommends that you talk to your Health Care Professional about alternative therapies.

HOW SHOULD THIS MEDICINE BE USED?

Take this medication by mouth with or without food, usually 1-3 times daily or as directed by your doctor. Dosage is based on your medical condition and response to therapy. Your doctor may start you at a low dose and gradually increase your dose.

Follow your doctor’s instructions carefully. Do not take more or less medication or take it more frequently than prescribed. Your condition will not improve any faster and your risk of side effects will increase. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day.

It is important to continue taking this medication even if you feel well. Do not suddenly stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased.

This medication does not work right away. It may take 2 to 3 weeks before you experience the full benefits when this medication is used for depression.

Inform your doctor if your condition persists or worsens.

YOU SHOULD NOT TAKE NORPRAMIN® (DESIPRAMINE HYDROCHLORIDE TABLETS USP ) IF YOU ARE TAKING ANY MAOI (MONOAMINE OXIDASE INHIBITOR) DRUGS OR IF YOU HAVE TAKEN ANY MAOI’S IN THE LAST 14 DAYS.  MAOI’s include Selpar, Eldepryl and Emsam (selegiline), Parnate (tranylcypromine), Marplan (isocarboxyzid), Eldepryl (selegiline), Nardil (phenlzine), linezolid, and intravenous methylene blue. Taking Norpramin tablets at the same time as, or within 14 days after stopping, another MAOI can cause serotonin syndrome, a life threatening condition caused by the build up of too much serotonin in the body. Similarly, Norpramin tablets must be discontinued at least 14 days prior to treatment with an MAOI.

You should also not take Norpramin® (desipramine hydrochloride tablets USP) if you have recently had a heart attack of if you are allergic to the active ingredient in the drug (desipramine hydrochloride) or any of the inactive ingredients in the tablet. Please see the full prescribing information for a complete list of all ingredients in Norpramin tablets.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

WHAT WARNINGS SHOULD I KNOW ABOUT NORPRAMIN® TABLETS?

Your doctor will monitor you closely while you are taking Norpramin tablets, particularly during the first few months after you start taking the drug and when your dose is increased or decreased.

If you have been diagnosed with major depressive disorder (MDD), you may experience a worsening of your depression symptoms. You are also at risk for increased thoughts and actions leading to suicide, and unusual changes in your mood or behavior. This risk may continue until your depression improves.

Anti-depressants have been shown to increase the risk of thoughts and actions leading to suicide in children, adolescents and young adults (ages 18-24) with major depressive disorder.

You may experience the following symptoms while taking Norpramin tablets:

  • Anxiety
  • Agitation
  • Panic attacks
  • Insomnia
  • Irritability
  • Hostility
  • Aggressiveness
  • Impulsivity
  • Restless limbs
  • Mild mania
  • General mania

All of these symptoms are considered precursors to suicide.

Your family and/or caregivers should be aware that they will need to monitor you for any of the symptoms listed above as well as for suicide behaviors.

Bipolar Disorder Screening:

Your doctor will likely screen you for bipolar disorder by asking you for your psychiatric history and your family history of suicide, bipolar disorder and depression. NORPRAMIN TABLETS ARE NOT APPROVED FOR TREATMENT OF BIPOLAR DISORDER.

Serotonin Syndrome:

Norpramin tablets may cause serotonin syndrome. Serotonin syndrome occurs when there is excess serotonin in the body. This can have serious, potentially life-threatening and sometime fatal consequences.  Norpramin tablets can cause excess serotonin levels in the body.

If you are taking Norpramin tablets, watch for the following symptoms:

  • change in your mental status
  • changes in basic body functions such as blood pressure, heart rate, sweating, and digestion
  • tremors
  • rigidity
  • seizures
  • lack of coordination, or overactive reflexes

If any of these symptoms occur stop taking Norpramin tablets and seek emergency treatment.

If you are taking Norpramin tablets with any of the following drugs, you have an increased risk for developing serotonin syndrome:

  • Tripans
  • Tricyclic antidepressants
  • Fentanyl
  • Lithium
  • Tramadol
  • Buspirone
  • Tryptophan
  • St. John’s wort

Angle-Closure Glaucoma:

Norpramin tablets can cause an increase in pressure in the eye in certain individuals which can damage the eye and lead to blindness.

Norpramin tablets may impair your ability to drive or operate machinery safely.

Combining Norpramin tablets with excessive alcohol may increase the likelihood of suicide or overdosage.

Safe use in pregnancy has not been established

Lower doses of Norpramin tablets are recommended in older patients.

Safe use in children has not been established.

PLEASE REVIEW THE MEDICATION GUIDE TITLED “ANTIDEPRESSANT MEDICINES, DEPRESSION AND OTHER SERIOUS MENTAL ILLNESSES, AND SUICIDAL THOUGHTS OR ACTIONS” BEFORE TAKING NORPRAMIN TABLETS AND DISCUSS ANY CONCERNS YOU MAY HAVE WITH YOUR DOCTOR

Norpramin tablets may increase psychosis in schizophrenic patients.

Norpramin tablets may cause elevated or lowered blood sugar levels.

WHO SHOULD NOT TAKE NORPRAMIN® (desipramine hydrochloride tablets USP)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (such as imipramine, amitriptyline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

TELL YOUR DOCTOR IF YOU ARE TAKING AN MAOI OR IF YOU HAVE TAKEN AN MAOI WITHIN THE LAST 14 DAYS.

Tell your doctor if any of the following occur when you are taking Norpramin tablets:

  • Anxiety
  • Agitation
  • Panic attacks
  • Insomnia
  • Irritability
  • Hostility
  • Aggressiveness
  • Impulsivity
  • Restless limbs
  • Mind mania
  • General mania
  • Other unusual changes in behavior
  • Worsening of depression
  • Suicidal feelings

To make sure Norpramin tablets are safe for you, tell your doctors if:

  • You have been diagnosed with bipolar disorder
  • You are pregnant or planning to become pregnant or breastfeeding
  • If you have a history of excessive alcohol consumption
  • If you have previously been diagnosed with manic depressive illness

You should not take Norpramin tablets if you have recently had a heart attack, or if you are allergic to the active ingredient in Norpramin tablets or to similar tricyclic antidepressants such as amitriptyline, amoxapine, clomipramine, doxepin, imipramine, nortriptyline, protriptyline, or trimipramine.

Do not use Norpramin tablets if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction may occur. MAO inhibitors include furazolidone, isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, tranylcypromine, and intravenous methylene blue.  DO NOT TAKE NORPRAMIN TABLETS IF YOU ARE TAKING MAOI’S TO TREAT A PSYCHIATRIC DISORDER.

To make sure Norpramin tablets are safe for you, tell your doctor if you have:

  • Heart disease
  • A family history of sudden death, abnormal heart rhythms, or conduction disturbances of your heart
  • A history or urinary retention or glaucoma
  • Thyroid disease or are taking thyroid medication
  • A seizure disorder

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are taking Norpramin tablets. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Serious side effects may be more likely in older adults and those who are ill or debilitated.

Do not give this medicine to a child without medical advice.

TAKING OTHER MEDICINES:

Use of Monoamine Oxidase Inhibitors (MAOIs) with Norpramin tablets may cause a life threatening reaction.

Taking MAO inhibitors with Norpramin tablets may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication.

Norpramin tablets may exaggerate the effects of alcohol.

If Norpramin tablets are combined with tranquilizers, sedatives, or benzodiazepines, the effects of those drugs are additive to the effects of Norpramin tablets.

The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/”ecstasy,” St. John’s wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, and SNRIs such as duloxetine/venlafaxine). The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs. If you have taken or are taking fluoxetine, you must wait 5 weeks before taking Norpramin tablets.

Other medications may affect the removal of Norpramin tablets  from your body, which may affect how Norpramin tablets work. Examples include alcohol, barbiturates (such as phenobarbital), cimetidine, cisapride, haloperidol, certain drugs for heart rhythm (such as flecainide, propafenone), halofantrine, HIV protease inhibitors (such as fosamprenavir), phenothiazines (such as thioridazine), pimozide, certain anti-seizure drugs (such as carbamazepine, phenytoin), antidepressants (such as trazodone), terbinafine, among others.

THIS LIST IS NOT COMPLETE AND OTHER DRUGS MAY INTERACT WITH NORPRAMIN TABLETS. TELL YOUR DOCTORS ABOUT ALL MEDICINES YOU USE. THIS INCLUDES PRESCRIPTION, OVER-THE-COUNTER, VITAMIN AND HERBAL PRODUCTS. DO NOT START A NEW MEDICATION WITHOUT TELLING YOUR DOCTOR.

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IMPORTANT SAFETY INFORMATION

Download Full Prescribing Information

Norpramin® (desipramine hydrochloride tablets USP)

Suicidality and Antidepressant Drugs

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 NORPRAMIN 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. NORPRAMIN is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)

Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.

Tell the doctor immediately if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

WHAT ARE NORPRAMIN® (desipramine hydrochloride tablets USP) USED FOR?

Norpramin® (despiramine hydrochloride tablets USP) are used for the treatment of depression.

WHEN SHOULD I NOT TAKE THE DRUG?

You should not take Norpramin tablets if you are taking any MAOI (monoamine oxidase inhibitor) drugs or if you have taken any MAOI’s in the last 14 days.  MAOI’s include Selpar, Eldepryl and Emsam (selegiline), Parnate (tranylcypromine), Marplan (isocarboxyzid), Eldepryl (selegiline), Nardil (phenlzine), linezolid, and intravenous methylene blue.  DO NOT TAKE NORPRAMIN TABLETS IF YOU ARE TAKING MAOI’S TO TREAT A PSYCHIATRIC DISORDER. Taking Norpramin tablets at the same time as, or within 14 days after stopping, another MAOI can cause serotonin syndrome, a life threatening condition caused by the build up of too much serotonin in the body.  Similarly, Norpramin tablets must be discontinued at least 14 days prior to treatment with an MAOI.

You should also not take Norpramin tablets if you have recently had a heart attack of if you are allergic to the active ingredient in the drug (desipramine hydrochloride) or any of the inactive ingredients in the tablet.  Please see the full prescribing information for a complete list of all ingredients in Norpramin tablets.

WHAT WARNINGS SHOULD I KNOW ABOUT NORPRAMIN TABLETS?

If you have been diagnosed with major depressive disorder (MDD), you may experience a worsening of your depression symptoms. You are also at risk for increased thoughts and actions leading to suicide, and unusual changes in your mood or behavior. This risk may continue until your depression improves.

Anti-depressants have been shown to increase the risk of thoughts and actions leading to suicide in children, adolescents and young adults (ages 18-24) with major depressive disorder.

Your doctor will monitor you closely while you are taking Norpramin tablets, particularly during the first few months after you start taking the drug and when your dose is increased or decreased.

You may experience the following symptoms while taking Norpramin tablets:

All of these symptoms are considered precursors to suicide.

Your family and/or caregivers should be aware that they will need to monitor you for any of the symptoms listed above as well as for suicide behaviors.

Bipolar Disorder Screening:

Your doctor will likely screen you for bipolar disorder by asking you for your psychiatric history and your family history of suicide, bipolar disorder and depression. NORPRAMIN TABLETS ARE NOT APPROVED FOR TREATMENT OF BIPOLAR DISORDER.

Serotonin Syndrome:

Norpramin tablets may cause serotonin syndrome. Serotonin syndrome occurs when there is excess serotonin in the body. This can have serious, potentially life-threatening and sometime fatal consequences.  Norpramin tablets can cause excess serotonin levels in the body.

If you are taking Norpramin tablets, watch for the following symptoms:

If any of these symptoms occur stop taking Norpramin tablets and seek emergency treatment.

If you are taking Norpramin tablets with any of the following drugs, you have an increased risk for developing serotonin syndrome:

Angle-Closure Glaucoma:

Norpramin tablets may cause an increase in pressure in the eye in certain individuals which can damage the eye and lead to blindness.

Norpramin tablets may impair your ability to drive or operate machinery safely.

Combining Norpramin tablets with excessive alcohol can increase the likelihood of suicide or overdosage.

Safe use in pregnancy has not been established.

Lower doses of Norpramin tablets are recommended in older patients.

Safe use in children has not been established.

PLEASE REVIEW THE MEDICATION GUIDE TITLED “ANTIDEPRESSANT MEDICINES, DEPRESSION AND OTHRE SERIOUS MENTAL ILLNESSES, AND SUICIDAL THOUGHTS OR ACTIONS” BEFORE TAKING NORPRAMIN TABLETS AND DISCUSS ANY CONCERNS YOU MAY HAVE WITH YOUR DOCTOR

Download Medication Guide

Norpramin tablets may increase psychosis in schizophrenic patients.

Norpramin tablets may cause elevated or lowered blood sugar levels.

WHAT SHOULD I TELL MY HEALTHCARE PROVIDER?

TELL YOU DOCTOR IF YOU ARE TAKING AN MAOI OR IF YOU HAVE TAKEN AN MAOI WITHIN THE LAST 14 DAYS.

Tell your doctor if any of the following occur when you are taking Norpramin tablets:

These symptoms may occur early in your antidepressant treatment or when your dose is adjusted up or down. All of these symptoms make increase your risk of suicide and must be reported to your doctor immediately.

You should tell your doctor if you have been diagnosed with bipolar disorder.

Tell your doctor if you are pregnant or planning to become pregnant

Norpramin tablets can cause very serious reactions, including death, in patients with the following conditions and will only be prescribed with extreme caution:

Tell your doctor if you have a history of excessive alcohol consumption or if you have previously been diagnosed with manic depressive illness.

WHAT OTHER MEDICATIONS MIGHT INTERACT WITH NORPRAMIN TABLETS?

Use of Monoamine Oxidase Inhibitors (MAOIs) and Norpramin tablets may cause a life threatening reaction.

Norpramin tablets may exaggerate the effects of alcohol.

If Norpramin tablets are combined with tranquilizers, sedatives, or benzodiazepines, the effects of those drugs are additive to the effects of Norpramin tablets.

Drugs Metabolized by P450  2D6

Certain individuals (about 7-10% of caucasians) are unable to properly metabolize cytochrome P450 2D6 (debrisoquin hydroxylase). When these individuals use certain antidepressants known as tricyclic antidepressants, such as Norpramin tablets, they may have a higher than expected build up of drug in their blood. In addition, if these individuals are given Norpramin tablets at the same time as other drugs which inhibit the activity of cytochrome P450 2D6, they might have a toxic build-up of Norpramin in their blood.  Drugs that inhibit cytochrome P450 2D6 include quinidine; cimetidine, many other antidepressants, phenothiazines, and propafenone and flecainide.

While all the selective serotonin reuptake inhibitors  (SSRIs) (fluoxetine, sertraline, paroxetine) inhibit P450 2D6, they may vary in the extent of inhibition, so your doctor may monitor you closely if you are taking an SSRI, or any drug that inhibits P450 2D6, with Norpramin tablets.  In particular, if you have taken or are taking fluoxetine, you must wait 5 weeks before taking Norpramin tablets.

WHAT ARE THE SIDE EFFECTS OF NORPRAMIN TABLETS?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of the following symptoms:

Other common side effects may include:

Report any of these side effects to your doctor.

In addition, report any new or worsening symptoms to your doctor, such as:

If you stop taking Norpramin tablets, you may experience nausea, headache and a general feeling of not being well (malaise).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to Validus Pharmaceuticals LLC at 1-866-982-5438.

WHAT IF I OVERDOSE?

Overdose can result in death.

There is no specific treatment for suspected overdose. Aggressive supportive care is the main treatment option. If an overdose is suspected, seek emergency medical treatment or call the Poison Help Line at 1-800-222-1222.

To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals, LLC at — VALIDUS (1-866-982-5438) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch