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Ludiomil
Generic Name: Maprotiline Hydrochloride
Drug Category: Tetracyclic Antidepressant
Litigation Alert Level: Medium
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 6 months.
| Approved Uses |
|
Indicated for the treatment of depressive illness in patients with: Depressive Neurosis (dysthymic disorder) Manic-Depressive Illness, Depressed Type (major depressive disorder) Relief of Anxiety Associated with Depression Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Maprotiline or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. Maprotiline Hydrochloride is not approved for use in treating bipolar depression. The pupillary dilation that occurs following use of many antidepressant drugs including maprotiline may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Seizures have been associated with the use of Maprotiline Hydrochloride. Most of the seizures have occurred in patients without a known history of seizures. Prior to elective surgery, maprotiline should be discontinued for as long as clinically feasible, since little is known about the interaction between maprotiline and general anesthetics. Maprotiline Hydrochloride should be administered with caution in patients with history of urinary retention, or history of narrow angle glaucoma because of the drug’s anticholinergic properties. Maprotiline Hydrochloride is contraindicated as follows:
Extreme caution should be used when this drug is given to:
Maprotiline should be discontinued if there is evidence of pathological neutrophil depression. Close supervision and careful adjustment of dosage are required when administering maprotiline concomitantly with anticholinergic or sympathomimetic drugs because of the possibility of additive atropine like effects. Concurrent administration of maprotiline with electroshock therapy should be avoided because of the lack of experience in this area. Caution should be exercised when administering maprotiline to hyperthyroid patients or those on thyroid medication because of the possibility of enhanced potential for cardiovascular toxicity of maprotiline. Maprotiline should be used with caution in patients receiving guanethidine or similar agents since it may block the pharmacologic effects of these drugs. The risk of seizures may be increased when maprotiline is taken concomitantly with phenothiazines or when the dosage of benzodiazepines is rapidly tapered in patients receiving maprotiline. Because of the pharmacologic similarity of maprotiline hydrochloride to the tricyclic antidepressants, the plasma concentration of maprotiline may be increased when the drug is given concomitantly with hepatic enzyme inhibitors (e.g., cimetidine, fluoxetine) and decreased by concomitant administration with hepatic enzyme inducers (e.g., barbiturates, phenytoin), as has occurred with tricyclic antidepressants. Adjustment of the dosage of maprotiline hydrochloride may therefore be necessary in such cases. There are no adequate and well controlled studies in pregnant women. Maprotiline is excreted in breast milk. |
| Off-label Uses |
|
• Dosage greater than 225 mg per day. GoToSource • Use in patients under the age of 18. GoToSource • Alzheimer’s disease. GoToSource • Chronic pain. GoToSource • Chronic headaches. GoToSource • Fibromyalgia. GoToSource • Bulimia. GoToSource • Duodenal ulcers. GoToSource • Enuresis. GoToSource • Urinary symptoms of multiple sclerosis. GoToSource • Use with fluvoxamine for panic attacks. GoToSource • Lupus. GoToSource |
| Adverse Events |
|
Seizures. GoToSource Hepatitis (inflammation of the liver). GoToSource Suicidal thoughts and behavior. GoToSource Disturbances in glucose control. GoToSource Prolongation of QTc interval (heart rhythm disorder). GoToSource Increased risk of acute myocardial infarction. GoToSource Acute pancreatitis (inflammation of the pancreas). GoToSource Pulmonary infiltrates. GoToSource Torsades de pointes (abnormal heart rhythm). GoToSource Weight gain. GoToSource Hypotension (low blood pressure). GoToSource Angle closure glaucoma. GoToSource Visual perseveration including palinopsia (visual disturbance). GoToSource Drug dispensing errors between Ludiomil and Lamisil and Lomotil. GoToSource |
| Litigation |
|
Lawsuits filed for suicidal behavior. |
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