Norpramin

Norpramin is a prescription medication used to treat the symptoms of depression. Norpramin belongs to a group of medications called tricyclic antidepressants (TCAs). These work by increasing the level of certain natural chemicals in the brain that are needed for mental balance.

Norpramin comes in an oral (by mouth) tablet form and is usually taken 1 or more times a day.

Common side effects of Norpramin include dry mouth, nausea, and constipation. Norpramin may also cause drowsiness and blurred vision. Do not drive or operate heavy machinery until you know how Norpramin affects you.

Norpramin is a prescription medication used to treat the symptoms of depression. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Sanofi-Aventis U.S. LLC

Serious side effects have been reported with Norpramin. See the "Norpramin Precautions" section.

Common side effects of Norpramin include the following:

• nausea
• drowsiness
• blurred vision
• dry mouth
• constipation
• skin that is sensitive to sunlight
• changes in weight or appetite
• sweating
• enhanced effects of alcohol, such as feeling drowsy more quickly

This is not a complete list of Norpramin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• anticholinergics such as glycopyrrolate (Cuvposa, Robinul), trospium (Sanctura), oxybutynin (Anturol, Gelnique, Oxytrol, Ditropan), solifenacin (Vesicare), dicyclomine (Bentyl), propantheline (Pro-Banthine), and atropine (Atropen, Sal-Tropine)
• monoamine oxidase inhibitors such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)
• antipsychotics such as paliperidone (Invega), lurasidone (Latuda), olanzapine (Zyprexa), aripiprazole (Abilify), asenapine (Saphris), iloperidone (Fanapt), haloperidol (Haldol), prochlorperazine (Compazine), chlorpromazine (Thorazine), clozapine (Clozaril), risperidone (Risperdal), quetiapine (Seroquel), and ziprasidone (Geodon)
• linezolid (Zyvox)
• methylene blue
• sedatives such as alcohol
• Barbiturates such as phenobarbital
• cimetidine
• anti-seizure medications such as carbamazepine (Tegretol), procarbazine (Matulane), and valproic acid (Depakote)
• atomoxetine (Strattera)
• histamine 2 (H2) blockers such as cimetidine (Tagamet), ranitidine (Zantac), famotidine (Pepcid), and nizatidine (Axid)
• hypericum perforatum (St. John's Wort)
• selective serotonin reuptake inhibitors (SSRIs) such as escitalopram (Lexapro), sertraline (Zoloft), citalopram (Celexa), paroxetine (Paxil), fluoxetine (Prozac, Sarafem), and fluvoxamine (Luvox)
• medications that could lead to serotonin syndrome such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), desvenlafaxine (Pristiq), nefazodone (Serzone), paroxetine (Paxil, Pexeva), sertraline (Zoloft), venlafaxine (Effexor), trimipramine (Surmontil), isocarboxazid (Marplan), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil), linezolid (Zyvox), hypericum perforatum (St. John's Wort), tramadol (Ultram), fentanyl (Duragesic, Actiq, Abstral, Sublimaze, Subsys, Fentora, Onsolis, Lazanda, Ionsys), and lithium (Lithane, Lithobid)
• tricyclic antidepressants such as trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil)
• medications that block a protein in the body (CYP2D6) such as quinidine (Qualaquin), fluoxetine (Prozac, Sarafem), amitriptyline (Elavil, Amitril), and paroxetine (Paxil)
• medications that use the enzyme CYP2D6 such as dextromethorphan (Delsym) and atomoxetine (Strattera)
• phenothiazines such as chlorpromazine (Thorazine), thioridazine (Mellaril), fluphenazine (Prolixin), perphenazine (Triavil), prochlorperazine (Compazine), and trifluoperazine (Stelazine)
• drugs that can cause an arrhythmia called Torsades des Point such as:
  • certain anti-arrhythmia medications including procainamide, sotalol (Betapace), quinidine, dofetilide (Tikosyn), amiodarone (Nexterone, Pacerone, Cordarone), ibutilide (Corvert)
  • certain fluoroquinolone antibiotics including levofloxacin (Levaquin), ciprofloxacin (Cipro), gatifloxacin (Zymar), moxifloxacin (Avelox)
  • certain macrolide antibiotics including clarithromycin (Biaxin), erythromycin (EES, others)
  • certain azole antifungals including ketoconazole (Nizoral), itraconazole (Sporanox, Onmel)
  • certain antidepressants including amitriptyline, desipramine (Norpramin), imipramine (Tofranil), doxepin (Silenor), fluoxetine (Prozac, Sarafem), sertraline (Zoloft), venlafaxine (Effexor XR)
  • certain antipsychotics including haloperidol (Haldol), droperidol (Inapsine), quetiapine (Seroquel XR), thioridazine, ziprasidone (Geodon)
  • and other medications including cisapride, sumatriptan (Treximet, Imitrex, Alsuma, Zecuity), zolmitriptan (Zomig), arsenic trioxide (Trisenox), dolasetron (Anzemet), and methadone (Methadone, Dolophine)

This is not a complete list of Norpramin drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Norpramin including the following:

• serotonin syndrome. This is a condition that can happen when you take multiple medications that increase the levels of serotonin in your brain. Very high levels of serotonin can lead to the following symptoms. Tell your healthcare provider right away if you experience any of the following symptoms of serotonin syndrome:
  • hyperactivity
  • sweating
  • redness of the skin
  • fever
  • nausea
  • diarrhea
  • confusion
• increased risk for suicidality, or suicidal behavior. You should be monitored closely by family and caregivers for any changes in behavior, and report any changes in behavior to your doctor right away.
• confusion including disorientation (more common in the elderly)
• hallucinations
• seizures. Norpramin should be used cautiously if you have a history of seizures because it may increase your chance of having a seizure. Seizures have preceeded cardiac (heart) rhythm problems and death in some patients. Do not abruptly stop taking Norpramin. If your doctor lowers your dose, this should be down so slowly over time.
• Decreased blood counts leading to an increased risk of infection. This medication may cause the number of white blood cells in your blood to decrease. This makes you more susceptible to getting an infection. Tell your doctor right away if you notice any signs of infection such as a fever or sore throat.
• shuffling walk
• severe rash
• tremors, or uncontrollable shaking of any part of the body
• jaw, neck, and back muscle spasms
• nightmares
• cardiovascular collapse, which rarely has been fatal with use of this medication. Tell your doctor if you notice any of the following symptoms of cardiac (heart problems):
  • rapid heart beat
  • felling like your heart is "beating out of your chest"
  • shortness of breath
  • chest pain
• heart attack. Tell your doctor if you have ever had a heart attack. Also tell your doctor if you or anyone in your family has ever been told they have an irregular heartbeat or has died suddenly. Tell your doctor if you have a history of cardiovascular disease such as heart attack, stroke, atherosclerosis (hardening of the arteries), or chest pain.
• increased thoughts of suicide or suicidal actions. It should be noted there is also an increased risk of suicide in patients with depression.
• QT prolongation. This is a condition when changes in the electrical activity of your heart occur, causing irregular heartbeats that can be life threatening. Talk to your healthcare provider about other medicines you are taking before you start taking Norpramin. Tell your healthcare provider right away if you have any signs or symptoms of QT prolongation:
  • feeling faint
  • lightheadedness
  • dizziness
  • feeling like your heart is beating irregularly or quickly
• angle-closure glaucoma. This is a condition in which fluid from the eye does not drain properly and can buildup pressure in the eye, leading to loss of vision. Talk to your doctor about a complete eye exam before starting this medication. Call your doctor or seek emergency medical treatment right away if you experience any of the following symptoms:
  • nausea
  • eye pain
  • changes in vision, including seeing colored rings or halos around lights
  • swelling or redness in or around the eye
• smoking may decrease how well Norpramin works. Tell your doctor if you smoke, and talk to your doctor or pharmacist about quitting. If you do quit smoking while using Norpramin, tell your doctor right away.
• liver disease. Tell your doctor right away if you experience yellowing of the skin or white parts of your eyes.
• slow speech or difficulty speaking. Tell your doctor right away if you experience this.
• changes in sexual functioning, including increased or decreased libido and impotence
• gynecomastia. Gynecomastia is a condition in which males grow enlarged breasts.
• galactorrhea. Galactorrhea refers to the discharge of breast milk from the nipple that is unrelated to breastfeeding.

Norpramin can cause drowsiness. Do not drive or operate heavy machinery until you know how Norpramin affects you.

Do not take Norpramin if you:

• are allergic to Norpramin, or any of its ingredients
• have been treated with MAOIs such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) for within the last 14 days. These two medications should not be used within 14 days of each other
• have recently suffered a heart attack

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Norpramin, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Norpramin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Norpramin or to any of its ingredients
• are allergic to clomipramine (Anafranil), imipramine (Tofranil), trimipramine (Surmontil)
• are taking MAOIs (a class of medications) such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking an MAO inhibitor within the past 14 days
• have or have had a heart attack
• have or have had any history of heart disease
• have anyone in your family who has, or has had, an irregular heartbeat or who has died suddenly
• have liver problems
• have kidney problems
• have a history of suicidal thoughts or behaviors
• are pregnant, plan to become pregnant, or are breastfeeding
• are having surgery, including dental surgery
• use tobacco products
• use alcohol

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Norpramin falls into category C. Safe use of Norpramin during pregnancy and lactation has not been established; therefore, if it is to be given to pregnant patients, nursing mothers, or women of childbearing potential, the possible benefits must be weighed against the possible hazards to mother and child. Animal reproductive studies have been inconclusive.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Norpramin crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Norpramin.

Take Norpramin exactly as prescribed.

Norpramin comes in tablet form and is taken one or more times a day.

Norpramin may be taken with or without food. You should take it at the same time every day.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Norpramin at the same time.

Do not abruptly stop taking Norpramin. If your dosage needs to be lowered, your doctor will slowly decrease your dose over time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

The recommended dose range of Norpramin (desipramine) for the treatment of depression in adults is 100-300 mg per day. This may be given as a single dose or as divided doses spaced throughout the day.

If you take too much Norpramin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Norpramin at room temperature.
• Keep this and all medicines out of the reach of children.
• Keep all your appointments with your doctor.

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.