Ludiomil (Oral)

Maprotiline is used to help with mental depression, including anxiety that can sometimes happen alongside depression.

Maprotiline is only available with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits. This will help change your dosage if needed and can reduce side effects.

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

Maprotiline may cause some people to feel agitated, irritable, or show other unusual behaviors. It may also lead some people to have suicidal thoughts and tendencies or to feel more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause blurred vision, especially in the first few weeks of treatment. It may also make some people feel drowsy or less alert than usual. If these effects happen, 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 happen, especially when you get up from lying down or sitting. Getting up slowly may help. If this problem continues or worsens, 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 stays dry for more than 2 weeks, check with your medical doctor or dentist. Ongoing dryness of the mouth may increase the risk of dental problems, including tooth decay, gum disease, and fungal infections.

Before having any type of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Taking maprotiline with medicines 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 gradually reduce the amount you are taking before stopping completely. This will help your body adjust properly and reduce the chance of unwanted effects.

In deciding to use a medicine, you need to consider the risks of taking it against the benefits it may provide. This choice will be made together with your doctor. For this medicine, please consider the following:

Allergies

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

Pediatric

Maprotiline must be used carefully in children with depression. Studies have shown that some children have thought about or attempted suicide during clinical trials for this medicine. More research is needed to confirm if maprotiline is safe and effective for children.

Geriatric

Elderly patients may be more likely to experience drowsiness, dizziness or lightheadedness, confusion, vision problems, dryness of mouth, constipation, and difficulty urinating. They are generally more sensitive than younger adults to the effects of maprotiline.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits against the risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together but could cause interactions. In these cases, your doctor may need to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions are highlighted based on their potential significance and may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or adjust some of your other medicines.

• Brofaromine
• Bromopride
• Clorgyline
• Furazolidone
• Iproniazid
• Isocarboxazid
• Lazabemide
• Linezolid
• Methylene Blue
• Moclobemide
• Nialamide
• Pargyline
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Toloxatone
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Bupropion

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Drinking alcohol or using tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using this medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Alcohol abuse or
• Seizure disorders (including epilepsy)—This may increase the risk of seizures

• Asthma or
• Difficulty urinating or
• Enlarged prostate or
• Glaucoma or
• Severe mental illness or
• Stomach or intestinal problems—Maprotiline may worsen these conditions

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

• Liver disease—This may lead to higher blood levels of maprotiline, increasing the chance of side effects.

Along with its necessary effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may require 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 cause some side effects that need attention. During this 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.

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

In the U.S.

• Ludiomil

Pharmacologic Class: Antidepressant, Tetracyclic

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.