Pamelor

DRUG DESCRIPTION

Pamelor® (nortriptyline HCl) is 1-Propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride.

The structural formula is as follows:

Pamelor® (nortriptyline HCl) structural formula illustration

10 mg, 25 mg, 50 mg, and 75 mg Capsules
Active Ingredient: nortriptyline hydrochloride USP.

10 mg, 25 mg, and 75 mg Capsules
Inactive Ingredients: D&C Yellow #10, FD&C Yellow #6, gelatin, silicone fluid, starch, and titanium dioxide.

50 mg Capsules
Inactive Ingredients: gelatin, silicone fluid, starch, and titanium dioxide.

Solution
Active Ingredient: nortriptyline hydrochloride USP.
Inactive Ingredients: alcohol, benzoic acid, flavoring, purified water, and sorbitol.

What are the possible side effects of nortriptyline (Pamelor)?

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

Call your doctor at once if you have any new or worsening symptoms 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 any of these...

Read All Potential Side Effects and See Pictures of Pamelor »

What are the precautions when taking nortriptyline hcl (Pamelor)?

See also Warning section.

Before taking nortriptyline, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (such as 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems, liver problems, recent heart attack, problems urinating (such as due to enlarged prostate), overactive thyroid (hyperthyroidism), a certain eye problem (glaucoma), personal or family history of mental/mood conditions (such as bipolar disorder, psychosis), family history of suicide, seizures, conditions that...

Read All Potential Precautions of Pamelor »


Pamelor Consumer (continued)

SIDE EFFECTS: See also Warning section.

Drowsiness, dizziness, dry mouth, blurred vision, constipation, weight gain, or trouble urinating may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but serious side effects occur: persistent heartburn, shaking, mask-like facial expressions, muscle spasms, severe stomach/abdominal pain, decreased sexual ability/desire, enlarged/painful breasts.

Seek immediate medical attention if any of these rare but very serious side effects occur: severe dizziness, fast/irregular heartbeat, fainting, seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.

Before taking nortriptyline, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (such as 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems, liver problems, recent heart attack, problems urinating (such as due to enlarged prostate), overactive thyroid (hyperthyroidism), a certain eye problem (glaucoma), personal or family history of mental/mood conditions (such as bipolar disorder, psychosis), family history of suicide, seizures, conditions that may increase your risk of seizures (such as other brain disease, alcohol withdrawal).

Nortriptyline may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using nortriptyline, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using nortriptyline safely.

This drug may make you drowsy or dizzy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

The liquid form of this medication may contain alcohol. Caution is advised if you have diabetes, alcohol dependence, liver disease, or any other condition that requires you to limit/avoid alcohol in your diet. Ask your doctor or pharmacist about using this product safely.

If you have diabetes, this drug may make it harder to control your blood sugar levels. Monitor your blood sugar levels regularly and tell your doctor of the results. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Caution is advised when using this drug in older adults because they may be more sensitive to its side effects, especially dry mouth, dizziness, confusion, and difficulty urinating.

During pregnancy, this medication should be used only when clearly needed. Since untreated depression can be a serious condition, do not stop using this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.

This medication passes into breast milk and and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.


Pamelor Patient Information Including Side Effects

Brand Names: Pamelor

Generic Name: nortriptyline (Pronunciation: nor TRIP ti leen)

  • What is nortriptyline (Pamelor)?
  • What are the possible side effects of nortriptyline (Pamelor)?
  • What is the most important information I should know about nortriptyline (Pamelor)?
  • What should I discuss with my healthcare provider before taking nortriptyline (Pamelor)?
  • How should I take nortriptyline (Pamelor)?
  • What happens if I miss a dose (Pamelor)?
  • What happens if I overdose (Pamelor)?
  • What should I avoid while taking nortriptyline (Pamelor)?
  • What other drugs will affect nortriptyline (Pamelor)?
  • Where can I get more information?

What is nortriptyline (Pamelor)?

Nortriptyline is in a group of drugs called tricyclic antidepressants. Nortriptyline affects chemicals in the brain that may become unbalanced.

Nortriptyline is used to treat symptoms of depression.

Nortriptyline may also be used for other purposes not listed in this medication guide.

What are the possible side effects of nortriptyline (Pamelor)?

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

Call your doctor at once if you have any new or worsening symptoms 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 any of these serious side effects:

  • fast, pounding, or uneven heart rate;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • confusion, hallucinations, or seizure (convulsions);
  • easy bruising or bleeding, unusual weakness;
  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • tremors;
  • extreme thirst with headache, nausea, vomiting, and weakness;
  • feeling light-headed or fainting; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • nausea, vomiting, stomach pain, loss of appetite;
  • constipation or diarrhea;
  • weight changes;
  • dry mouth, unpleasant taste;
  • weakness, lack of coordination;
  • numbness or tingly feeling;
  • blurred vision, headache, ringing in your ears;
  • mild skin rash;
  • breast swelling (in men or women); or
  • increased sweating.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about nortriptyline (Pamelor)?

Do not use nortriptyline if you have recently had a heart attack, or if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms 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.

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