Pronunciation:

ma-PROE-ti-leen

Brand Names:

• Ludiomil

Dosage Forms:

• Tablet

Warnings:

Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of maprotiline or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be 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. Maprotiline is not approved for use in pediatric patients.

Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials .

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients 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. Not approved for use in pediatric patients .

Classifications:

Therapeutic—

Antidepressant

Pharmacologic—

Antidepressant, Tetracyclic

Uses of This Medicine:

Maprotiline is used to relieve mental depression, including anxiety that sometimes occurs with depression.

Maprotiline is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, maprotiline is used in certain patients with the following medical condition:

• Chronic neurogenic pain (a certain type of pain that is continuing)

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Maprotiline must be used with caution in children with depression. Studies have shown occurrences of children thinking about suicide or attempting suicide in clinical trials for this medicine. More study is needed to be sure maprotiline is safe and effective in children

Older adults—

Drowsiness, dizziness or lightheadedness; confusion; vision problems; dryness of mouth; constipation; and difficulty in urinating may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of maprotiline.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Cisapride
• Clorgyline
• Iproniazid
• Isocarboxazid
• Moclobemide
• Nialamide
• Pargyline
• Phenelzine
• Procarbazine
• Selegiline
• Toloxatone
• Tranylcypromine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse or
• Seizure disorders (including epilepsy)—The risk of seizures may be increased

• Asthma or
• Difficult urination or
• Enlarged prostate or
• Glaucoma or
• Mental illness (severe) or
• Stomach or intestinal problems—Maprotiline may make the condition worse

• Heart or blood vessel disease or
• Overactive thyroid—Serious effects on your heart may occur

• Liver disease—Higher blood levels of maprotiline may occur, increasing the chance of side effects

Proper Use of This Medicine:

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Sometimes this medicine must be taken for up to two or three weeks before you begin to feel better. Your doctor should check your progress at regular visits.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For depression:
    • Adults—At first, 25 milligrams (mg) taken one to three times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 150 mg a day, unless you are in the hospital. Some hospitalized patients may need higher doses.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For once daily dosing at bedtime: Do not take the missed dose in the morning since it may cause disturbing side effects during waking hours. Instead, check with your doctor.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your dosage to be changed if necessary and will help to reduce side effects.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine .

Maprotiline may cause some people to be agitated, irritable or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these adverse effects, tell your doctor right away.

This medicine may cause blurred vision, especially during the first few weeks of treatment. It may also cause some people to become drowsy or less alert than they are normally. If these effects occur, do not drive, use machines, or do anything else that could be dangerous if you are not alert or able to see well.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

Maprotiline may cause dryness of the mouth. For temporary relief, use sugarless gum or candy, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Taking maprotiline together with medicines that are used during surgery or dental or emergency treatments may increase the CNS depressant effects.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely. This will allow your body to adjust properly and will reduce the possibility of unwanted effects.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Skin rash, redness, swelling, or itching

Less common

Constipation (severe)

nausea or vomiting

shakiness or trembling

seizures (convulsions)

unusual excitement

weight loss

Rare

Breast enlargement—in males and females

confusion (especially in the elderly)

difficulty in urinating

fainting

hallucinations (seeing, hearing, or feeling things that are not there)

inappropriate secretion of milk—in females

irregular heartbeat (pounding, racing, skipping)

sore throat and fever

swelling of testicles

yellow eyes or skin

Symptoms of overdose

Convulsions (seizures)

dizziness (severe)

drowsiness (severe)

fast or irregular heartbeat

fever

muscle stiffness or weakness (severe)

restlessness or agitation

trouble in breathing

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Blurred vision

decreased sexual ability

dizziness or lightheadedness (especially in the elderly)

drowsiness

dryness of mouth

headache

increased or decreased sexual drive

tiredness or weakness

Less common

Constipation (mild)

diarrhea

heartburn

increased appetite and weight gain

increased sensitivity of skin to sunlight

increased sweating

trouble in sleeping

weight loss

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.