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Ludiomil (Maprotiline Hydrochloride) - Indications and Dosage

 
 



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.

DOSAGE AND ADMINISTRATION

A single daily dose is an alternative to divided daily doses. Therapeutic effects are sometimes seen within 3 to 7 days, although as long as 2 to 3 weeks are usually necessary.

Initial Adult Dosage

An initial dosage of 75 mg daily is suggested for outpatients with mild-to-moderate depression. However, in some patients, particularly the elderly, an initial dosage of 25 mg daily may be used. Because of the long half-life of Ludiomil, the initial dosage should be maintained for two weeks. The dosage may then be increased gradually in 25-mg increments as required and tolerated. In most outpatients a maximum dose of 150 mg daily will result in therapeutic efficacy. It is recommended that this dose not be exceeded except in the most severely depressed patients. In such patients, dosage may be gradually increased to a maximum of 225 mg.

      More severely depressed, hospitalized patients should be given an initial daily dose of 100 mg to 150 mg which may be gradually increased as required and tolerated. Most hospitalized patients with moderate-to-severe depression respond to a daily dose of 150 mg although dosages as high as 225 mg may be required in some cases. Daily dosage of 225 mg should not be exceeded.

Elderly Patients

In general, lower dosages are recommended for patients over 60 years of age. Dosages of 50 mg to 75 mg daily are usually satisfactory as maintenance therapy for elderly patients who do not tolerate higher amounts.

Maintenance

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.

HOW SUPPLIED

Tablets 25 mg   – oval, dark orange, scored, coated (imprinted CIBA 110)

      Bottles of 100……………………………………………………...NDC 0083-0110-30

Tablets 50 mg   – round, dark orange, scored, coated (imprinted CIBA 26)

      Bottles of 100……………………………………………………...NDC 0083-0026-30

Tablets 75 mg   – oval, white, scored, coated (imprinted CIBA 135)

      Bottles of 100……………………………………………………...NDC 0083-0135-30

Do not store above 86°F (30°C).

Dispense in tight container (USP).

C96-65 (Rev. 11/96)

C I B A

Ciba-Geigy Corporation

Pharmaceuticals Division

Summit, New Jersey 07901

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