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Ludiomil (Maprotiline Hydrochloride) - Warnings and Precautions



Seizures have been associated with the use of Ludiomil.

      Most of the seizures have occurred in patients without a known history of seizures. However, in some of these cases, other confounding factors were present, including concomitant medications known to lower the seizure threshold, rapid escalation of the dosage of Ludiomil, and dosage that exceeded the recommended therapeutic range. The incidence of direct reports is less than 1/10 of 1%. The risk of seizures may be increased when Ludiomil is taken concomitantly with phenothiazines, when the dosage of benzodiazepines is rapidly tapered in patients receiving Ludiomil or when the recommended dosage of Ludiomil is exceeded. While a cause-and-effect relationship has not been established, the risk of seizures in patients treated with Ludiomil may be reduced by (1) initiating therapy at a low dosage, (2) maintaining the initial dosage for 2 weeks before raising it gradually in small increments as necessitated by the long half-life of Ludiomil (average 51 hours), and (3) keeping the dosage at the minimally effective level during maintenance therapy. (See DOSAGE AND ADMINISTRATION.)

Extreme caution should be used when this drug is given to:

  • patients with a history of myocardial infarction;
  • patients with a history or presence of cardiovascular disease because of the possibility of conduction defects, arrhythmias, myocardial infarction, strokes and tachycardia.



The possibility of suicide in seriously depressed patients is inherent in their illness and may persist until significant remission occurs. Therefore, patients must be carefully supervised during all phases of treatment with Ludiomil, and prescriptions should be written for the smallest number of tablets consistent with good patient management.

      Hypomanic or manic episodes have been known to occur in some patients taking tricyclic antidepressant drugs, particularly in patients with cyclic disorders. Such occurrences have also been noted, rarely, with Ludiomil.

      Prior to elective surgery, Ludiomil should be discontinued for as long as clinically feasible, since little is known about the interaction between Ludiomil and general anesthetics.

      Ludiomil should be administered with caution in patients with increased intraocular pressure, history of urinary retention, or history of narrow-angle glaucoma because of the drug's anticholinergic properties.

Information for Patients

Patients should be warned of the association between seizures and the use of Ludiomil. Moreover, they should be informed that this association is enhanced in patients with a known history of seizures and in those patients who are taking certain other drugs. (See WARNINGS.)

      Warn patients to exercise caution about potentially hazardous tasks, or operating automobiles or machinery since the drug may impair mental and/or physical abilities.

      Ludiomil may enhance the response to alcohol, barbiturates, and other CNS depressants, requiring appropriate caution of administration.

Laboratory Tests

Ludiomil should be discontinued if there is evidence of pathological neutrophil depression. Leukocyte and differential counts should be performed in patients who develop fever and sore throat during therapy.

Drug Interactions

Close supervision and careful adjustment of dosage are required when administering Ludiomil concomitantly with anticholinergic or sympathomimetic drugs because of the possibility of additive atropine-like effects.

      Concurrent administration of Ludiomil with electroshock therapy should be avoided because of the lack of experience in this area.

      Caution should be exercised when administering Ludiomil to hyperthyroid patients or those on thyroid medication because of the possibility of enhanced potential for cardiovascular toxicity of Ludiomil.

      Ludiomil 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 Ludiomil is taken concomitantly with phenothiazines or when the dosage of benzodiazepines is rapidly tapered in patients receiving Ludiomil.

      Because of the pharmacologic similarity of Ludiomil to the tricyclic antidepressants, the plasma concentration of Ludiomil 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 Ludiomil may therefore be necessary in such cases.

      (See PRECAUTIONS, Information for Patients.)

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity and chronic toxicity studies have been conducted in laboratory rats and dogs. No drug- or dose-related occurrence of carcinogenesis was evident in rats receiving daily oral doses up to 60 mg/kg of Ludiomil for eighteen months or in dogs receiving daily oral doses up to 30 mg/kg of Ludiomil for one year. In addition, no evidence of mutagenic activity was found in offspring of female mice mated with males treated with up to 60 times the maximum daily human dose.

Pregnancy Category B

Reproduction studies have been performed in female laboratory rabbits, mice, and rats at doses up to 1.3, 7, and 9 times the maximum daily human dose respectively and have revealed no evidence of impaired fertility or harm to the fetus due to Ludiomil. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery

Although the effect of Ludiomil on labor and delivery is unknown, caution should be exercised as with any drug with CNS depressant action.

Nursing Mothers

Ludiomil is excreted in breast milk. At steady state, the concentrations in milk correspond closely to the concentrations in whole blood. Caution should be exercised when Ludiomil is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 18 have not been established.

Page last updated: 2006-02-22

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