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:
- 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 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:
- Panic attacks
- 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.