IMPORTANT SAFETY 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:
- Panic attacks
- 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.
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,
- 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:
- Tricyclic antidepressants
- St. John’s wort
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
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:
- Panic attacks
- Restless limbs
- Mind mania
- General mania
- Other unusual changes in behavior
- Worsening of depression
- Suicidal feelings
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:
- If you have heart disease
- If you have a family history of sudden death, abnormal heart rhythms, or conduction disturbances of your heart
- If you have a history or urinary retention or glaucoma
- If you have thyroid disease or are taking thyroid medication
- If you have a seizure disorder
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:
- feeling like you might pass out
- new or worsening chest pain, pounding heartbeats or fluttering in your chest
- sudden numbness or weakness, problems with vision, speech, or balance
- fever, sore throat
- easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin
- confusion, hallucinations, unusual thoughts or behavior
- stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors
- painful or difficult urination
- upper stomach pain, loss of appetite, yellowing of the skin or eyes
Other common side effects may include:
- tingly feeling, weakness, lack of coordination
- dry mouth, nausea, vomiting, constipation, diarrhea
- blurred vision, ringing in your ears
- breast swelling (in men or women)
- decreased sex drive, impotence, or difficulty having an orgasm
Report any of these side effects to your doctor.
In addition, report any new or worsening symptoms to your doctor, such as:
- mood or behavior changes
- panic attacks
- trouble sleeping
- if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed
- have thoughts about suicide or hurting yourself
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