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Elavil (Amitriptyline) - Indications and Dosage

 
 



INDICATIONS

For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.

DOSAGE AND ADMINISTRATION

Oral Dosage

Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance.

Initial Dosage for Adults:

For outpatients 75 mg of amitriptyline HCl a day in divided doses is usually satisfactory. If necessary, this may be increased to a total of 150 mg per day. Increases are made preferably in the late afternoon and/or bedtime doses. A sedative effect may be apparent before the antidepressant effect is noted, but an adequate therapeutic effect may take as long as 30 days to develop.
An alternate method of initiating therapy in outpatients is to begin with 50 to 100 mg amitriptyline HCl at bedtime. This may be increased by 25 or 50 mg as necessary in the bedtime dose to a total of 150 mg per day.
Hospitalized patients may require 100 mg a day initially. This can be increased gradually to 200 mg a day if necessary. A small number of hospitalized patients may need as much as 300 mg a day.

Adolescent and Elderly Patients:

In general, lower dosages are recommended for these patients. Ten mg 3 times a day with 20 mg at bedtime may be satisfactory in adolescent and elderly patients who do not tolerate higher dosages.

Maintenance:

The usual maintenance dosage of amitriptyline HCl is 50 to 100 mg per day. In some patients 40 mg per day is sufficient. For maintenance therapy the total daily dosage may be given in a single dose preferably at bedtime. When satisfactory improvement has been reached, dosage should be reduced to the lowest amount that will maintain relief of symptoms. It is appropriate to continue maintenance therapy 3 months or longer to lessen the possibility of relapse.

Intramuscular Dosage

Initially, 20 to 30 mg (2 to 3 ml) four times a day.

When ELAVIL (amitriptyline HCl) injection is administered intramuscularly, the effects may appear more rapidly than with oral administration.

When ELAVIL (amitriptyline HCl) injection is used for initial therapy in patients unable or unwilling to take ELAVIL tablets, the tablets should replace the injection as soon as possible.

Usage in Pediatric Patients:

In view of the lack of experience with the use of this drug in children, it is not recommended at the present time for patients under 12 years of age.

Plasma Levels:

Because of the wide variation in the absorption and distribution of tricyclic antidepressants in body fluids, it is difficult to directly correlate plasma levels and therapeutic effect. However, determination of plasma levels may be useful in identifying patients who appear to have toxic effects and may have excessively high levels, or those in whom lack of absorption or noncompliance is suspected. Adjustments in dosage should be made according to the patient's clinical response and not on the basis of plasma levels.***

HOW SUPPLIED

Tablets:

Elavil, 10 mg, are blue, round, film coated tablets, identified with "40" debossed on one side and "Elavil" on the other side.
Elavil, 25 mg, are yellow, round, film coated tablets, identified with "45" debossed on one side and "Elavil" on the other side.
Elavil, 50 mg, are beige, round, film coated tablets, identified with "41" debossed on one side and "Elavil" on the other side.
Elavil, 75 mg, are orange, round, film coated tablets, identified with "42" debossed on one side and "Elavil" on the other side.
Elavil, 100 mg, are mauve, round, film coated tablets, identified with "43" debossed on one side and "Elavil" on the other side.
Elavil, 150 mg, are blue, capsule shaped, film coated tablets, identified with "47" debossed on one side and "Elavil" on the other side.

Injection:

Elavil, 10 mg/ml, is a clear, colorless solution, and is supplied in 10 ml vials:

Storage: Store amitriptyline HCl tablets in a well-closed container. Avoid storage at temperatures above 30°C (86°F). In addition, amitriptyline HCl tablets 10 mg must be protected from light and stored in a well-closed, light-resistant container.

Protect amitriptyline HCl injection from freezing and avoid storage above 30°C (86°F).

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