Ludiomil

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|Ludiomil

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MAPROTILINE (Systemic)

Some commonly used brand names are:

In the U.S.—

  • Ludiomil

In Canada—

  • Ludiomil

Generic name product may be available in the U.S.

Category

  • Antidepressant
  • Antineuralgic

Description

Maprotiline (ma-PROE-ti-leen) is used to relieve mental depression, including anxiety that sometimes occurs with depression.

Maprotiline is available only with your doctor"s prescription, in the following dosage form:

  • Oral
  • Tablets (U.S. and Canada)

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 maprotiline, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to maprotiline or tricyclic antidepressants. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Maprotiline has not been studied in pregnant women. However, this medicine has not been shown to cause birth defects or other problems in animal studies.

Breast-feeding—Maprotiline passes into the breast milk. However, this medicine has not been reported to cause problems in nursing babies.

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.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking maprotiline, it is especially important that your health care professional know if you are taking any of the following:

  • Amphetamines or
  • Appetite suppressants (diet pills) or
  • Medicine for asthma or other breathing problems or
  • Medicine for colds, sinus problems, or hay fever or other allergies (including nose drops or sprays)—Using these medicines with maprotiline may cause serious unwanted effects on your heart and blood pressure
  • Central nervous system (CNS) depressants (medicines that cause drowsiness)—Taking these medicines with maprotiline may increase the CNS depressant effects
  • Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—Taking maprotiline while you are taking or within 2 weeks of taking monoamine oxidase (MAO) inhibitors may cause very serious side effects, such as sudden high body temperature, extremely high blood pressure, and severe convulsions; at least 14 days should be allowed between stopping treatment with one medicine and starting treatment with the other

Other medical problems—The presence of other medical problems may affect the use of maprotiline. 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 maprotiline 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 maprotiline. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets 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 taking maprotiline .

  • 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 and your dosing schedule is:

  • One dose a day 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.
  • More than one dose a day—Take the missed dose as soon as possible. Then go back to your regular dosing schedule. 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. If you have any questions about this, check with your doctor.

Storage—To store this medicine:

  • Keep out of the reach of children.
  • Store away from heat and direct light.
  • Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
  • Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

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 taking this medicine, your body will need time to adjust. This usually takes about 3 to 10 days. Continue to follow the precautions listed above during this period of time.

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

Additional Information

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)

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

Revised: 01/10/2005

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