Pamelor

Pamelor 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.

• Mallinckrodt, Inc.

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.

Pamelor falls into category D. The safe use of Pamelor during pregnancy has not been established.

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

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

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;

• restless muscle movements in your eyes, tongue, jaw, or neck;

• a light-headed feeling, like you might pass out;

• seizure (convulsions);

• 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;

• jaundice (yellowing of the skin or eyes);

• painful or difficult urination; or

• high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Older adults may be more likely to have side effects from this medication.

Common side effects may include:

• nausea, vomiting, loss of appetite;

• anxiety, sleep problems (insomnia);

• dry mouth, unusual taste;

• little or no urinating;

• constipation;

• vision changes;

• breast swelling (in men or women); or

• decreased sex drive, impotence, or difficulty having an orgasm.

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 FDA at 1-800-FDA-1088.

Tricyclic antidepressant (TCA);a active metabolite of amitriptyline.d

Absorption

Bioavailability

Peak plasma concentrations occur within 7–8.5 hours after oral administration.d

Onset

Antidepressant effects may not be evident for ≥2 weeks.b

Plasma Concentrations

Optimal antidepressant effect may be associated with plasma concentrations of 50–150 ng/mL.103

Distribution

Extent

Distributes into milk;100 101 102 nortriptyline concentrations in milk appear to be similar to or slightly greater than those present in maternal serum.101 102

Elimination

Metabolism

Extensively metabolized in the liver via demethylation by various CYP isoenzymes (e.g., CYP1A2, CYP2D6, CYP3A4, CYP2C).b

Elimination Route

Excreted principally in urine (33% within 24 hours) as inactive metabolites; small amounts are also excreted in feces via biliary elimination.d

Half-life

Plasma half-life ranges from 16 to >90 hours.d

• Mechanism of action in the management of depression unknown but may involve inhibition of reuptake of norepinephrine and/or serotonin.a b

• Associated with more frequent anticholinergic, sedative, or cardiovascular effects and weight gain than SSRIs.b

It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to check for any unwanted effects.

For some children, teenagers, and young adults, this medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed and have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

Do not take nortriptyline with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], linezolid (Zyvox®), methylene blue, phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking nortriptyline during the 2 weeks after you stop a MAO inhibitor and wait 2 weeks after stopping nortriptyline before you start taking a MAO inhibitor. If you take them together or do not wait 2 weeks, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions.

Nortriptyline may cause a serious condition called serotonin syndrome if taken together with some medicines. Do not use nortriptyline with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, or some pain or migraine medicines (eg, sumatriptan, tramadol, Frova®, Maxalt®, Relpax®, Zomig®). Check with your doctor first before taking any other medicines with nortriptyline.

Do not stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as headache, nausea, or a general feeling of discomfort or illness.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that cause drowsiness). Some examples of CNS depressants are antihistamines, medicines for hay fever, other allergies or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicine or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines with nortriptyline.

Before having any kind of surgery, tell the medical doctor in charge that you are using this medicine. Taking nortriptyline together with medicines used during surgery may increase the risk of side effects.

This medicine may cause some people to become drowsy. Make sure you know how you react to this medicine before you drive, use medicines, or do anything else that could be dangerous if you are drowsy or not alert.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.
• Take at bedtime if it causes sleepiness.
• Keep taking Pamelor (nortriptyline capsules) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you take 1 daily dose at bedtime, do not take the missed dose the next morning.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• If you are planning to harm yourself or the want to harm yourself gets worse.
• Very bad dizziness or passing out.
• Feeling confused.
• Not able to pass urine.
• Feeling very tired or weak.
• Change in sex ability.
• Chest pain.
• Seizures.
• Any unexplained bruising or bleeding.
• Yellow skin or eyes.
• A very bad and sometimes deadly health problem called serotonin syndrome may happen. The risk may be greater if you take this medicine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.