Product Description.:
M, 6 0
tablet , film-coated , white , scored , round round
Beveled edgeBiconvex
Ludiomil, maprotiline hydrochloride USP, is a tetracyclic antidepressant, available as 25-mg, 50-mg and 75-mg tablets for oral administration.
Maprotiline hydrochloride USP is a fine, white to off-white, practically odorless crystalline powder. It is freely soluble in methanol and in chloroform, slightly soluble in water, and practically insoluble in isooctane. Its molecular weight is 313.87.
Inactive Ingredients. Calcium phosphate, cellulose compounds, colloidal silicon dioxide, FD&C Yellow No. 6 Aluminum Lake (25-mg and 50-mg tablets), lactose, magnesium stearate, stearic acid, talc, titanium dioxide, polyethylene glycol, polysorbate, crospovidone, and iron oxide (75-mg tablets).
INDICATIONS AND USAGE
Ludiomil is indicated for the treatment of depressive illness in patients with depressive neurosis (dysthymic disorder) and manic-depressive illness, depressed type (major depressive disorder). Ludiomil is also effective for the relief of anxiety associated with depression.
CONTRAINDICATIONS
Ludiomil is contraindicated in patients hypersensitive to Ludiomil and in patients with known or suspected seizure disorders. It should not be given concomitantly with monoamine oxidase (MAO) inhibitors. A minimum of 14 days should be allowed to elapse after discontinuation of MAO inhibitors before treatment with Ludiomil is initiated. Effects should be monitored with gradual increase in dosage until optimum response is achieved. The drug is not recommended for use during the acute phase of myocardial infarction.
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.
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.
PRECAUTIONS
General
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.
