FDA label 746a1fb6-fa70-441c-868e-0563864d4b5e

WARNINGS 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.

ADVERSE REACTIONS The following adverse reactions have been noted with Ludiomil and are generally similar to those observed with tricyclic antidepressants. Cardiovascular Rare occurrences of hypotension, hypertension, tachycardia, palpitation, arrhythmia, heart block, and syncope have been reported with Ludiomil. Psychiatric Nervousness (6%), anxiety (3%), insomnia (2%), and agitation (2%); rarely, confusional states (especially in the elderly), hallucinations, disorientation, delusions, restlessness, nightmares, hypomania, mania, exacerbation of psychosis, decrease in memory, and feelings of unreality. Neurological Drowsiness (16%), dizziness (8%), tremor (3%), and, rarely, numbness, tingling, motor hyperactivity, akathisia, seizures, EEG alterations, tinnitus, extrapyramidal symptoms, ataxia, and dysarthria. Anticholinergic Dry mouth (22%), constipation (6%), and blurred vision (4%); rarely, accommodation disturbances, mydriasis, urinary retention, and delayed micturition. Allergic Rare instances of skin rash, petechiae, itching, photosensitization, edema, and drug fever. Gastrointestinal Nausea (2%) and, rarely, vomiting, epigastric distress, diarrhea, bitter taste, abdominal cramps and dysphagia. Endocrine Rare instances of increased or decreased libido, impotence, and elevation or depression of blood sugar levels. Other Weakness and fatigue (4%) and headache (4%); rarely, altered liver function, jaundice, weight loss or gain, excessive perspiration, flushing, urinary frequency, increased salivation, nasal congestion, and alopecia. Note Although there have been only isolated reports of the following adverse reactions with Ludiomil, its pharmacologic similarity to tricyclic antidepressants requires that each reaction be considered when administering Ludiomil. Bone marrow depression, including agranulocytosis, eosinophilia, purpura, and thrombocytopenia, myocardial infarction, stroke, peripheral neuropathy, sublingual adenitis, black tongue, stomatitis, paralytic ileus, gynecomastia in the male, breast enlargement and galactorrhea in the female, and testicular swelling. Post-Introduction Reports Several voluntary reports of interstitial pneumonitis, which were in some cases associated with eosinophilia and increased liver enzymes, have been received since market introduction. However, there is no clear causal relationship.