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Basic Drug Info
Drug Name:Ludiomil
Manufacturer:Ciba-Geigy Corporation
Other Info:

Dosage during prolonged maintenance therapy should be kept at the lowest effective level.

Dosage may be reduced to levels of 75 mg to 150 mg daily during such periods, with subsequent adjustment depending on therapeutic response.



Clinical Trials:


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.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Epilepsy -- A disorder characterized by recurrent episodes of paroxysmal brain dysfunction due to a sudden, disorderly, and excessive neuronal discharge. Epilepsy classification systems are generally based upon: (1) clinical features of the seizure episodes (e.g., motor seizure), (2) etiology (e.g., post-traumatic), (3) anatomic site of seizure origin (e.g., frontal lobe seizure), (4) tendency to spread to other structures in the brain, and (5) temporal patterns (e.g., nocturnal epilepsy). (From Adams et al., Principles of Neurology, 6th ed, p313)

Myocardial Infarction -- NECROSIS of the MYOCARDIUM caused by an obstruction of the blood supply to the heart (CORONARY CIRCULATION).

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.

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