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Ludiomil®
C96-65 (Rev. 11/96)
666536
Ludiomil ®
maprotiline hydrochloride tablets USP
Prescribing Information
DESCRIPTION
Ludiomil, maprotiline hydrochloride USP, is a tetracyclic antidepressant, available as 25-mg, 50-mg and 75-mg tablets for oral administration. Its chemical name is N-methyl-9,10-ethanoanthracene-9 (10H)-propylamine hydrochloride, and its structural formula is
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).
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CLINICAL PHARMACOLOGY
The mechanism of action of Ludiomil is not precisely known. It does not act primarily by stimulation of the central nervous system and is not a monoamine oxidase inhibitor. The postulated mechanism of Ludiomil is that it acts primarily by potentiation of central adrenergic synapses by blocking reuptake of norepinephrine at nerve endings. This pharmacologic action is thought to be responsible for the drug's antidepressant and anxiolytic effects.
The mean time to peak is 12 hours. The half-life of elimination averages 51 hours.
Steady-state levels measured prior to the morning dose on a one-dosage regimen are summarized as follows:
| Regimen | Average Minimum
Concentration
ng/ml | 95% Confidence
Limits
ng/mL |
| 50 mg x 3 daily | 238 | 181—295 |
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